WO2026039108A1 - Fluid collection assemblies including at least one of a plurality of melted regions or a plurality of entangled regions - Google Patents

Fluid collection assemblies including at least one of a plurality of melted regions or a plurality of entangled regions

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Publication number
WO2026039108A1
WO2026039108A1 PCT/US2025/035383 US2025035383W WO2026039108A1 WO 2026039108 A1 WO2026039108 A1 WO 2026039108A1 US 2025035383 W US2025035383 W US 2025035383W WO 2026039108 A1 WO2026039108 A1 WO 2026039108A1
Authority
WO
WIPO (PCT)
Prior art keywords
layer
porous material
fluid
fluid collection
collection assembly
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2025/035383
Other languages
French (fr)
Inventor
Zhihui Yin
Michael Anderson
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
PureWick Corp
Original Assignee
PureWick Corp
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Filing date
Publication date
Application filed by PureWick Corp filed Critical PureWick Corp
Publication of WO2026039108A1 publication Critical patent/WO2026039108A1/en
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
    • A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Colostomy devices
    • A61F5/451—Genital or anal receptacles
    • A61F5/453—Genital or anal receptacles for collecting urine or other discharge from male member
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
    • A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Colostomy devices
    • A61F5/451—Genital or anal receptacles
    • A61F5/455—Genital or anal receptacles for collecting urine or discharge from female member
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin

Definitions

  • a person or animal may have limited or impaired mobility so typical urination processes are challenging or impossible. For example, a person may experience or have a disability that impairs mobility. A person may have restricted travel conditions such as those experienced by pilots, drivers, and workers in hazardous areas. Additionally, sometimes bodily fluids collection is needed for monitoring purposes or clinical testing.
  • Urinary catheters such as a Foley catheter
  • urinary catheters can be uncomfortable, painful, and can lead to complications, such as infections.
  • bed pans which are receptacles used for the toileting of bedridden individuals are sometimes used.
  • bedpans can be prone to discomfort, spills, and other hygiene issues.
  • Embodiments disclosed herein are related to fluid collection assemblies, fluid collection systems including the same, and methods of making and using the same.
  • a fluid collection assembly includes a fluid impermeable barrier defining at least a chamber, at least one opening, and a fluid outlet.
  • the fluid collection assembly also includes a porous material disposed in the chamber.
  • the porous material includes a first layer, a second layer abutting the first layer, and a plurality of melted regions extending at least through the first layer into the second layer that attached the first layer to the second layer.
  • a method to form a fluid collection assembly includes positioning a first layer to abut a second layer.
  • the first layer and the second layer forms at least a portion of a porous material.
  • the method also includes melting a plurality of regions of the porous material to form a plurality of melted regions.
  • the plurality of melting regions extends at least through the first layer and into the second layer to attach the first layer to the second layer.
  • the method further includes, after melting a
  • the fluid impermeable barrier defines at least one opening and a fluid outlet.
  • a fluid collection assembly in an embodiment, includes a fluid impermeable barrier defining at least a chamber, at least one opening, and a fluid outlet.
  • the fluid collection assembly also includes a porous material disposed in the chamber.
  • the porous material includes an first layer and an second layer. The first layer and the second layer including a plurality of fibers.
  • the porous material also includes a plurality of entangled regions including some of the plurality of fibers of the first layer and the inner being entangled together. The plurality of entangled regions extend through the first layer into the second layer that attached the first layer to the second layer.
  • a method to form a fluid collection assembly includes positioning a first layer to abut a second layer.
  • the first layer and the second layer forming at least a portion of a porous material.
  • the first layer and the second layer include a plurality of fibers.
  • the method also includes entangling some of the plurality of fibers of the first layer and the second layer of the porous material to form a plurality of entangled regions.
  • the plurality of entangled regions extend at least through the first layer and into the second layer to attach the first layer to the second layer.
  • the method further includes, after entangling some of the plurality of fibers of the first layer and the second layer, disposing the porous material in a chamber defined by a fluid impermeable barrier.
  • the fluid impermeable barrier defines at least one opening and a fluid outlet.
  • FIG. 1A is a cross-sectional view of a portion of a porous material, according to an embodiment.
  • FIG. IB is a schematic view of a system configured to form the porous material, according to an embodiment.
  • FIG. 2A is a cross-sectional view of a porous material, according to an embodiment.
  • FIG. 2B is a schematic of a system configured to form the porous material, according to an embodiment.
  • FIG. 3A is an isometric view of a fluid collection assembly, according to an embodiment.
  • FIGS. 3B and 3C are cross-sectional views of the fluid collection assembly taken along planes 3B-1B and 3C-3C, respectively, shown in FIG. 3A.
  • FIG. 3D is a cross-sectional view of a portion of the fluid collection assembly taken from the box illustrated in FIG. 3C, according to an embodiment.
  • FIG. 3E is a cross-sectional view of the conduit, according to an embodiment.
  • FIG. 4A is an isometric view of a fluid collection assembly, according to an embodiment.
  • FIGS. 4B and 4C are cross-sectional views of the fluid collection assembly taken along planes 4B-4B and 4C-4C, respectively, shown in FIG. 4A.
  • FIG. 4D is a view illustration of a system 450 configured to form the porous material 410, according to an embodiment.
  • FIG. 5A is isometric view of a fluid collection assembly, according to an embodiment.
  • FIG. 5B is a cross-sectional view of the fluid collection assembly shown in
  • FIG. 5 A A first figure.
  • FIG. 6 is an isometric view of a fluid collection assembly, according to an embodiment.
  • FIGS. 7A and 7B are top isometric and bottom isometric views of a fluid collection assembly, respectively, according to an embodiment.
  • FIG. 8 is a cross-sectional view of a fluid collection assembly, according to an embodiment.
  • FIG. 9 is a front view of a male urine collection device, according to an embodiment.
  • FIG. 10A is an isometric view of a fluid collection assembly, according to an embodiment.
  • FIGS. 10B and 10C are cross-sectional views of the fluid collection assembly taken along planes 10B-10B and 10C-10C, respectively, shown in FIG. 10A.
  • FIG. 11 is a block diagram of a fluid collection system for fluid collection, according to an embodiment.
  • Embodiments disclosed herein are related to fluid collection assemblies, fluid collection systems including the same, and methods of making and using the same.
  • An example fluid collection assembly includes a fluid impermeable barrier defining at least a chamber, at least one opening, and a fluid outlet.
  • the fluid collection assembly also includes a porous material disposed in the chamber.
  • the porous material includes a first layer and a second layer.
  • the porous material also includes at least one of a plurality of melted regions or a plurality of entangled regions. The plurality of melted regions or the plurality of entangled regions extend through the first layer and into the second layer thereby attaching the first and second layers together.
  • the fluid collection assembly may be positioned on an individual such that the opening is positioned adjacent to a urethral opening (e.g., female urethral opening or a buried penis) or receives a male urethral opening (z.e., penis).
  • the individual may discharge one or more bodily fluids, such as urine, blood, or sweat.
  • the bodily fluids may flow through the opening and into the porous material.
  • the bodily fluids received by the porous material may flow from an outer layer to an inner layer.
  • the bodily fluids may be removed from the chamber via the fluid outlet (e.g., via an inlet of a conduit that is at least partially disposed in the fluid outlet).
  • a suction may be applied to the chamber from a vacuum source which removes the bodily fluids from the chamber.
  • the fluid collection assembly is configured to prevent or at least inhibit leaking of the bodily fluids therefrom during use.
  • factors that determine whether bodily fluids may leak from the fluid collection assembly during use such as the position of the fluid collection assembly on the individual, the anatomical fit of the fluid collection assembly, the rate at which the individual discharges the bodily fluids, etc.
  • One factor that determines whether the bodily fluids leak from the fluid collection assembly is the flow rate of the bodily fluids through the porous material.
  • the flow rate of the bodily fluids in the porous material is selected to be sufficient to prevent any portion of the porous material becoming saturated with the bodily fluids since bodily fluids are more likely to leak from saturated portions of the porous material.
  • the flow rate of the bodily fluids in the porous material may depend on a number of factors.
  • the flow rate of the bodily fluids in the porous material may depend on the contact angle between the porous material and water (water is typically
  • the flow rate of the bodily fluids in the porous material also depends on the flow rate of the bodily fluids between two immediately adj acent (z. e. , contacting) layers of the porous material. It has been found that any gaps between the two immediately adjacent layers of the porous material limits the flow rate of the bodily fluids between the two immediately adjacent layers.
  • the surface tension of the bodily fluids may cause the bodily fluids to at least initially remain in one of the layers of the porous material rather than flow through the gaps.
  • the gaps between the two immediately adjacent layers act as a fluid flow barrier between the two immediately adjacent layers.
  • Conventional fluid collection assemblies have used various techniques to prevent the formation of gaps between two immediately adjacent layers of the porous material.
  • some conventional fluid collection assemblies wrap one layer of the porous material tightly around another layer of the porous material to avoid the formation of gaps.
  • gaps may still form between the two layers due to stretching of the outer layer, localized compression of the inner layer, or bending of the porous material during use.
  • some conventional fluid collection assemblies apply an adhesive layer between the two adjacent layers of the porous material.
  • the adhesive layer at least partially occupies the pores of the porous material thereby limiting flow of the bodily fluids through the porous material and may also be a physical barrier between the two layers which limits flow of the bodily fluids therethrough.
  • the bodily fluids may cause the adhesive layer to degrade or soften during use limit may limit the ability of the adhesive to keep the two layers together.
  • the fluid collection assemblies disclosed herein include melted regions or entangled regions, as discussed in more detail below, to keep two adjacent layers of the porous material together.
  • the melted or entangled regions form physical attachments between the two layers of the porous material that are likely to keep the two layers together even if one layer stretches or becomes locally compressed or the porous material bends.
  • the melted or entangled regions also form physical attachments between the two layer of the porous material that are unlikely to degrade or soften during use.
  • the bodily fluids may be able to flow through the melted or entangled
  • FIG. 1A is a cross-sectional view of a portion of a porous material 100, according to an embodiment.
  • the porous material 100 is an example of a porous material formed using thermal needle punch lamination though, it is noted, that the porous material
  • the porous material 100 may be formed using another technique.
  • the porous material 100 includes a first layer 102 having a first outer surface 104 and a first inner surface 106 opposite the first outer surface 104.
  • the porous material 100 also includes a second layer 108 having a second inner surface 110 and a second outer surface 112 opposite the second inner surface 110.
  • the first and second layers 102, 108 are arranged such that the first inner surface 106 of the first layer 102 abuts the second inner surface 110 of the second layer 108.
  • the porous material 100 includes one or more melted regions 114.
  • the melted regions 114 extend through the first layer 102 and into the second layer 108.
  • the melted regions 114 attach the first layer 102 and the second layer 108 together.
  • the first layer 102 may positioned closer to a portion of the individual (e.g, the urethral opening of the individual) than the second layer 108 such that the first layer 102 may receive bodily fluids discharged from the individual before the second layer 108.
  • the first layer 102 may be the outermost layer of the porous material 100 (e.g, the outer layer 311 of FIG. 3A, the outer layer 412 of FIG. 4B. etc.) or the first layer 102 may be a non-outer layer of the porous material 100 (e.g, the intermediate layer 414 of FIG. 4B).
  • the second layer 108 may be an intermediate layer of the porous material 100 (e.g, the intermediate layer 414 of FIG.
  • the second layer 108 may be an innermost layer of the porous material 100 (e.g., the inner layer 313 of FIG. 3A or the inner layer 416 of FIG. 4B). Selecting the first layer 102 to be positioned closer to a portion of the individual may facilitate flow of the bodily fluids from the first layer 102 to the second layer 108, as will be discussed in more detail below.
  • the second layer 108 may be positioned closer to a portion of the individual than the first layer 102 such that the second layer 108 may receive bodily fluids discharged from the individual before the first layer 102.
  • the second layer 108 may be the outermost layer of the porous material 100 (e.g., the outer layer 311 of FIG. 3A, the outer layer 412 of FIG. 4B, etc.) or the second layer 108 may be a non-outer layer of the porous material 100 (e.g, the intermediate layer 414 of FIG. 4B).
  • the first layer 102 may be an intermediate layer of the porous material 100 (e.g, the intermediate layer 414 of FIG. 4B) or the first layer 102 may be an innermost layer of the
  • porous material 100 e.g., the inner layer 313 of FIG. 3A or the inner layer 416 of FIG.
  • the porous material 100 is configured to be disposed in a chamber defined by a fluid impermeable barrier of a fluid collection assembly.
  • One or more of the first layer 102 or the second layer 108 may include one or more of a foam, spun fibers, a vertical nonwoven material, a woven material, a quilted material, or the like.
  • One or more of the first layer 102 or the second layer 108 may be formed from any suitable natural material (e.g., fibers, fabric, foam) or synthetic material (e.g., fibers, fabric, foam).
  • one or more of the first layer 102 or the second layer 108 may include an open cell foam (e.g.
  • first layer 102 or the second layer 108 may include an open cell foam or a vertically nonwoven material.
  • first layer 102 or the second layer 108 may be formed from synthetic fibers or foam.
  • synthetic fibers or foam includes a polyester (e.g. , polyethylene terephthalate), polyethylene, polypropylene, polyurethane (e.g.
  • first layer 102 or the second layer 108 may be formed from natural fibers which may be more sustainable and biodegradable than the synthetic fibers. Examples of natural fibers includes cellulose, cotton, bamboo, wool, or the like. One or more of the first layer 102 or the second layer 108 may include any of the other porous materials disclosed herein.
  • the first layer 102 may include hydrophilic polypropylene or hydrophilic polyethylene (e.g., polypropylene or polyethylene including a polyethylene glycol fatty acid ester surfactant or otherwise treated to be hydrophilic) and the second layer 108 may include bamboo.
  • the first layer 102 and the second layer 108 may have a synergistic effect that allows the first layer 102 to quickly receive bodily fluids therein, move the bodily fluids from the first layer 102 into the second layer 108, and maintain the first layer 102 relatively dr ’.
  • the hydrophilicity of the first layer 102 allows the first layer 102 to quickly receive bodily fluids, such as to initially receive bodily fluids that are discharged from the urethral opening of the individual.
  • the bamboo second layer 108 may exhibit a hydrophilicity' that is greater than (i.e., exhibits a contact angle with water that is less than) the first layer 102. The greater hydrophilicity of the bamboo second layer 108 pulls bodily fluids from the first layer 102 and into the second layer 108, thereby facilitating quick transfer of bodily fluids
  • the greater hydrophilicity of the bamboo second layer 108 also helps dry the first layer 102 since the hydrophilic pull from the bamboo second layer 108 removes most of the bodily fluids from the first layer 102.
  • the dry first layer 102 minimizes discomfort caused by using a fluid collection assembly including the porous material 100, minimizes skin degradation caused by the bodily fluids, and allows the fluid collection assembly including the porous material 100 to be used for longer periods of time (e.g.. greater than 24 hours).
  • the first layer 102 and the second layer 108 may be positioned adjacent to a polyethylene terephthalate (“PET”) inner layer since the bamboo second layer 108 is able to transfer bodily fluids quickly and effectively into the PET inner layer thereby preventing the first and second layers 102. 108 from becoming saturated with bodily fluids.
  • PET polyethylene terephthalate
  • the PET inner layer is able to quickly move substantially all of the bodily fluids towards a fluid outlet such that the PET inner layer is substantially dry a short period of time after receiving the bodily fluids.
  • the dry PET inner layer facilitates drying of the particular first and second layers 102, 108 of this example.
  • the PET inner layer may include a nonwoven material and, more particularly a vertical lapped nonwoven material, since such nonwoven materials facilitate drawing fluids into the PET inner layer from the bamboo second layer 108 and improve flow of the bodily fluids in the PET inner layer towards the fluid outlet thereby facilitating drying of the porous material 100.
  • the first layer 102 and/or the second layer 108 may include porous materials other than hydrophilic polypropylene/poly ethylene and bamboo, respectively, as discussed in more detail herein.
  • the first layer 102 and/or the second layer 108 may be used with an inner layer other than PET, as discussed in more detail herein.
  • an open-cell foam may be used for one or more of the first layer 102 or the second layer 108.
  • the open-cell foam may have a density and porosity selected to provide a desired amount and rate of fluid transport therethrough.
  • the open-cell foam may have a density of at least 40 kg/m 3 , such as about 40 kg/m 3 to about 500 kg/m 3 , about 50 kg/m' to about 400 kg/m 3 , about 50 kg/m 3 to about 200 kg/m 3 , about 200 kg/m 3 to about 400 kg/m 3 , or less than 500 kg/m 3 .
  • the open-cell foam may exhibit a porosity of at least about 15 pores per inch (PPI), such as about 20 PPI to about 120 PPI, about 20 PPI to about 50 PPI, about 50 PPI to about 100 PPI, or less than about 120 PPI.
  • PPI pores per inch
  • the material of the open-cell foam may be selected to have desired surface properties (e.g., hydrophilicity or hydrophobicity) and structural properties (e.g.. bending stiffness or the
  • the open-cell foam may include any of a number of different materials, such as rubber, one or more polymers, or the like.
  • one or more of the first layer 102 or the second layer 108 may be selected to exhibit a basis weight of about 5 grams per square meter ("gsm") to about 10 gsm, about 7.5 gsm to about 15 gsm, about 10 gsm to about 20 gsm, about 15 gm/m 2 to about 25 gsm, about 20 gsm to about 30 gsm, about 25 gsm to about 35 gsm, about 30 gsm to about 40 gsm, about 35 gsm to about 45 gsm.
  • gsm grams per square meter
  • one or more of the first layer 102 or the second layer 108 exhibits a basis weight of about 10 gsm to about 35 gsm.
  • the basis weight of one or more of the first layer 102 or the second layer 108 is a function of the density and thickness of one or more of the first layer 102 or the second layer 108. It is noted that the surface area of one or more of the first layer 102 or the second layer 108 depends, in part, on the basis weight thereof.
  • increasing the basis w eight of one or more of the first layer 102 or the second layer 108 may increase the surface area of one or more of the first layer 102 or the second layer 108. How quickly one or more of the first layer 102 or the second layer 108 is able to pull bodily fluids into itself depends, in part, on the surface area thereof. In other words, increasing the basis weight of one or more of the first layer 102 or the second layer 108 may improve the rate at which one or more of the first layer 102 or the second layer 108 may receive the bodily fluids.
  • increasing the basis weight of one or more of the first layer 1 2 or the second layer 108 may decrease the volume of the void space of one or more of the first layer 102 or the second layer 108 that may temporarily hold the bodily fluids therein.
  • the basis weight of one or more of the first layer 102 or the second layer 108 may be selected by balancing these factors.
  • one or more of the first layer 102 or the second layer 108 is formed from a plurality of fibers.
  • the plurality of fibers may exhibit an average length and an average lateral dimension (e.g., diameter).
  • the plurality of fibers may be selected to exhibit an average length that is about 500 pm to about 2 mm, about 1 mm to about 3 mm, about 2 mm to about 4 mm, about 3 mm to about 5 mm, about 4 mm to about 6 mm, about 5 mm to about 7 mm, about 6 mm to about 8 mm, about 7 mm to about 9 mm, about 8 mm to about 1 cm, about 9 mm to about 1.2 cm, about 1 cm to about 1.4 cm, about 1.2 cm to about 1.6 cm, about 1.4 cm to about 1.8 cm, about 1.6 cm to about 2 cm, about 1.8 cm to about 2.25 cm, about 2 cm to about 2.5 cm, about 2.25 cm to about 2.75 cm,
  • the fibers may exhibit an average lateral dimension (e.g, diameter) that is about 1 pm to about 2 pm, about 1.5 pm to about 3 pm, about 2 pm to about 4 pm, about 3 pm to about 5 pm, about 4 pm to about 7 pm, about 6 pm to about 10 pm, about 8 pm to about 12.5 pm, about 10 pm to about 15 pm, about 12.5 pm to about 17.5 pm, about 15 pm to about 20 pm. about 17.5 pm to about 25 pm, about 20 pm to about 30 pm, about 25 pm to about 35 pm, about 30 pm to about 40 pm, about
  • the average length and average lateral dimension of the fibers may be selected such that the fibers exhibits an average aspect ratio.
  • the average length and average lateral dimension of the fibers may be selected such that the fibers exhibit an average aspect ratio (average length: average lateral dimension) of about 100: 1 to about 200: 1, about 150: 1 to about 250: 1 , about 200: 1 to about 300: 1 , about 250: 1 to about 350: 1, about 300: 1 to about 400: 1, about 350: 1 to about 450:1, about 400: 1 to about 500: 1, about 450:1 to about 550: 1, about 500: 1 to about 600: 1, about 550: 1 to about 650:1, about 600: 1 to about 700: 1, about 650: 1 to about 750: 1, about 700: 1 to about 800: 1, about 750: 1 to about 850: 1, about 800: 1 to about 900: 1, about 850: 1 to about 950: 1, or about 900: 1
  • the average length, average lateral dimension, and the average aspect ratio of the fibers may be selected based on a number of factors.
  • increasing the aspect ratio e.g., decreasing the average length and/or increasing the average lateral dimension
  • increasing the aspect ratio (e.g. , increasing average length) of the fibers may increase the mechanical binding of the fibers.
  • increasing the aspect ratio of the fibers facilitates entanglement of the fibers which increases the strength and durability of one or more of the first layer 102 or the second layer 108. The entanglement
  • the fibers may also preclude or minimize the amount of other binding techniques that are applied to one or more of the first layer 102 or the second layer 108, such as heat, chemical binding, or other mechanical binding (e.g., further entanglement caused by needle punching or high pressure water jets).
  • increasing the aspect ratio of the fibers may make dispersion of the fibers more difficult (e.g. , uniformity of one or more of the first layer 102 or the second layer 108 difficult). Further, increasing the aspect ratio may limit the type of nonwoven webs that may form one or more of the first layer 102 or the second layer 108.
  • fibers with large average lengths may not be used in carded webs and may have to be used in air laid webs.
  • decreasing the aspect ratio may decrease the entanglement of the fibers thereby necessitating further binding of the fibers.
  • the average length, average lateral dimension, and average aspect ratio of the fibers may be selected based on the desired strength, mechanical binding between the fibers, the amount of processing of one or more of the first layer 102 or the second layer 108 (e.g. , is further processing to increasing the binding via heat, etc. desired), the type of nonwoven web that includes the fibers, the uniformity of the fibers, etc.
  • the average person discharges urine at a rate of about 6 ml/s to about 50 ml/s, such as at a rate of about 10 ml/s to about 25 ml/s.
  • the rate at which the person urinate may vary', such as based on the size of the person and the age of the person.
  • One or more of the first layer 102 or the second layer 108 may be selected to capture and transport the bodily fluids at a rate that is comparable to the rate at which the individual discharged bodily fluids to prevent leaks.
  • one or more of the first layer 102 or the second layer 108 may be selected to capture and transport the bodily fluids at a rate that is greater than about 6 ml/s, greater than about 10 ml/s, greater than about 30 ml/s, about 6 ml/s to about 50 ml/s, about 6 ml/s to about 20 ml/s, about 20 ml/s to about 40 ml/s. about 6 ml/s to about 15 ml/s, about 15 ml/s to about 25 ml/s, less than about 50 ml/s, or less than about 30 ml/s.
  • one or more of the first layer 102 or the second layer 108 may be configured to wick and/or otherwise allow transport of any bodily fluids away from an opening defined by a fluid impermeable barrier or otherwise transport the bodily fluids away from the urethral opening and the individual, thereby preventing the bodily fluids from leaking or remaining in contact with the individual.
  • the permeable properties referred to herein may be wicking, capillary action, diffusion, or other similar properties or processes, and are referred to herein as ' ⁇ permeable” and/or ‘"wicking.” Such “wicking” and/or “permeable” properties may not include absorption of the bodily fluids into at least
  • substantially no absorption or solubility of the bodily fluids into one or more of the first layer 102 or the second layer 108 material may take place after one or more of the first layer 102 or the second layer 108 is exposed to the bodily fluids and removed from the bodily fluids for a time.
  • the term “substantially no absorption” may allow for nominal amounts of absorption and/or solubility of the bodily fluids into one or more of the first layer 102 or the second layer 108 (e.g, absorbency), such as less than about 30 wt% of the dry weight of one or more of the first layer 102 or the second layer 108, less than about 20 wt%, less than about 10 less than about 7 wt%, less than about 5 wt%, less than about 3 wt%, less than about 2 wt%, less than about 1 wt%, or less than about 0.5 wt% of the dry weight of one or more of the first layer 102 or the second layer 108.
  • one or more of the first layer 102 or the second layer 108 may include at least one absorbent or adsorbent material.
  • one or more of the first layer 102 or the second layer 108 may be hydrophobic.
  • One or more of the first layer 102 or the second layer 108 may be hydrophobic when one or more of the first layer 102 or the second layer 108 exhibits a contact angle with water that is about 90° to about 120°, about 105° to about 135°, about 120° to about 150°, about 135° to about 165°, or greater than 150°.
  • the hydrophobic one or more of the first layer 102 or the second layer 108 may more quickly transport the bodily fluids received thereby than if one or more of the first layer 102 or the second layer 108 is hydrophilic.
  • increasing the hydrophobicity of one or more of the first layer 102 or the second layer 108 may decrease the quantity of bodily fluids that are retained in one or more of the first layer 102 or the second layer 108 after one or more of the first layer 102 or the second layer 108 receives the bodily fluids.
  • increasing the hydrophobicity of one or more of the first layer 102 or the second layer 108 may decrease the quantity of bodily fluids that one or more of the first layer 102 or the second layer 108 may receive over a certain period of time.
  • the hydrophobicity of one or more of the first layer 102 or the second layer 108 may be selected based on balancing the need to receive bodily fluids quickly while also keeping one or more of the first layer 102 or the second layer 108 dry.
  • one or more of the first layer 102 or the second layer 108 may by hydrophilic.
  • the hydrophilicity of one or more of the first layer 102 or the second layer 108 may cause one or more of the first layer 102 or the
  • first layer 102 or the second layer 108 may be hydrophilic when one or more of the first layer 102 or the second layer 108 material exhibits a contact angle with water (a major constituent of bodily fluids) that is about 0° to about 90°, about 0° to about 15°, about 15° to about 30°, about 30° to about 45°, about 45° to about 60°, about 60° to about 90°, about 10° to about 40°. about 40° to about 80°.
  • increasing the hydrophilicity of one or more of the first layer 102 or the second layer 108 increases the quantity of bodily fluids that one or more of the first layer 102 or the second layer 108 may receive over a certain period of time.
  • increasing the hydrophilicity of one or more of the first layer 102 or the second layer 108 may increase the quantity' of bodily fluids that are retained in one or more of the first layer 102 or the second layer 108 after one or more of the first layer 102 or the second layer 108 receives the bodily fluids.
  • the hydrophilicity of one or more of the first layer 102 or the second layer 108 may be selected based on balancing the need to receive bodily fluids quickly while also keeping one or more of the first layer 102 or the second layer 108 dry.
  • a fluid collection assembly configured to be used with an individual with a large bladder for short periods of time may include a one or more of the first layer 102 or the second layer 108 exhibiting a hydrophilicity that is greater than an least one or more of the first layer 102 or the second layer 108 of a fluid collection assembly configured to be used with an individual with an average to small sized bladder for long period of time. It is noted that materials of at least some conventional fluid collection assemblies are selected to be hydrophobic to improve the fluid transport thereof.
  • the surfactant disposed on one or more of the first layer 102 or the second layer 108 may cause one or more of the first layer 102 or the second layer 108 to be hydrophilic (e.g, one or more of the first layer 102 or the second layer 108 is hydrophobic before disposing the surfactant on one or more of the first layer 102 or the second layer 108).
  • one or more of the first layer 102 or the second layer 108 is hydrophilic before disposing the surfactant on one or more of the first layer 102 or the second layer 108.
  • the surfactant may increase
  • the hydrophobicity or hydrophilicity of one or more of the first layer 102 or the second layer 108 may be an inherent property of the material(s) (e.g., fibers) used to form one or more of the first layer 102 or the second layer 108.
  • the hydrophobicity or hydrophilicity of one or more of the first layer 102 or the second layer 108 may be changed by at least one of impurities or functional groups added to one or more of the first layer 102 or the second layer 108, otherwise treating one or more of the first layer 102 or the second layer 108, or coating one or more of the first layer 102 or the second layer 108 with a material that exhibits a hydrophobicity or hydrophilicity that is different than one or more of the first layer 102 or the second layer 108.
  • a surfactant is disposed on (e.g., coated) at least a portion of one or more of the first layer 102 or the second layer 108.
  • the surfactant may be disposed on at least at least one surface of one or more of the first layer 102 or the second layer 108, such as one or more of the first outer surface 104, the first inner surface 106, the second inner surface 110, or the second outer surface 112.
  • the surfactant may be disposed on the surface of the first or second layers 102, 108 that first receives bodily fluids discharged from an individual.
  • Disposing the surfactant on at least the surface of one or more of the first layer 102 or the second layer 108 may modify the surface of one or more of the first layer 102 or the second layer 108. Modifying the surface of one or more of the first layer 102 or the second layer 108 with the surfactant allows one or more of the first layer 102 or the second layer 108 to quickly and effectively receive the bodily fluids into one or more of the first layer 102 or the second layer 108.
  • the surfactant may extend a distance from the surface into one or more of the first layer 102 or the second layer 108.
  • Extending the surfactant a distance from the surface into one or more of the first layer 102 or the second layer 108 may allow one or more of the first layer 102 or the second layer 108 to pull the bodily fluids received at the surface into one or more of the first layer 102 or the second layer 108 which, in turn, facilitates the flow of the bodily fluids through one or more of the first layer 102 or the second layer 108.
  • the distance that the surfactant extends from the surface into one or more of the first lay er 102 or the second layer 108 may depend on the thickness of one or more of the first layer 102 or the second layer 108.
  • the surfactant may only extend from the surface through a relatively small percentage of the thickness of one or more of the first layer 102 or the second layer 108 (e.g. , less than 50%) when the thickness of one or more of the first layer 102 or the second layer 108 is relatively thick (e.g., about 1.5 mm or greater, about 5 mm or greater, or about 1 cm or greater).
  • first layer 102 or the second layer 108 to receive the bodily fluids quickly and effectively into one or more of the first layer 102 or the second layer 108.
  • the portions of one or more of the first layer 102 or the second layer 108 that do not include the surfactant may push the bodily fluids out of one or more of the first layer 102 or the second layer 108 towards, for example, the innermost surface of the porous material 100.
  • the surfactant extending only partially through one or more of the first layer 102 or the second layer 108 may be beneficial when one or more of the first layer 102 or the second layer 108 forms substantially all of the porous material disposed in a chamber of a fluid collection assembly.
  • the surfactant may be disposed on one or more of the first layer 102 or the second layer 108 using any suitable technique.
  • the surfactant may be disposed on one or more of the first layer 102 or the second layer 108 using a spray coating technique, a kiss roll coating technique, a dip coating technique, or any other suitable technique.
  • the surfactant may only be disposed on one surface of one or more of the first layer 102 or the second layer 108.
  • the surfactant may be disposed on the surface of one or more of the first layer 102 or the second layer 108. It is noted that the surfactant may penetrate into one or more of the first layer 102 or the second layer 108 after being disposed on the surface.
  • one or more of the first layer 102 or the second layer 108 forms a long sheet that, at some later point, will be cut into a plurality of porous bodies that, for example, may each be disposed in different fluid collection assemblies.
  • the surfactant may be disposed on a surface (e.g., the surface) of one or more of the first layer 102 or the second layer 108. After disposing the surfactant on the surface, one or more of the first lay er 102 or the second layer 108 may be collected on a roll. Collecting one or more of the first layer 102 or the second layer 108 on the roll may cause the surface of one or more of the first layer 102 or
  • Disposing the surfactant on one or more of the first layer 102 or the second layer 108 may include disposing a solution that includes the surfactant on one or more of the first layer 102 or the second layer 108.
  • the solution includes a major component (e.g., water, alcohol, isopropanol, other polar solvents, or other non-polar solvents) and the surfactant.
  • the amount of the surfactant in one or more of the first layer 102 or the second layer 108 may be selected to be greater than 0.2 wt% since the surfactant may have a small but non-negligible effect on one or more of the first layer 102 or the second layer 108 when present at weight percentages between 0.1 wt% and 0.2 wt%.
  • one or more of the first layer 102 or the second layer 108 may still feel wet against the skin of certain sensitive individuals when the surfactant is present at weight percentages between 1.5 wt% and 2 wt% and, for certain extra-sensitive individuals, one or more of the first layer 102 or the second layer 108 may still feel wet against the skin of certain sensitive individuals when the surfactant is present at weight percentages between 0.9 wt% and 1.4 wt%.
  • one or more of the first layer 102 or the second layer 108 includes a hydrophobic material.
  • one or more of the first layer 102 or the second layer 108 may include hydrophobic polypropylene, hydrophobic polyethylene, a blend or other combination of hydrophobic polypropylene and hydrophobic polyethylene, or another hydrophobic material.
  • the surfactant present in one or more of the first layer 102 or the second layer 108 may cause one or more of the first layer 102 or the second layer 108 including the hydrophobic material to exhibit a water absorption rate and wicking ability that is comparable to a substantially similar porous body including a hydrophilic material.
  • the surfactant may include a polyethylene glycol fatty acid ester ("PEGFA").
  • PEGFA polyethylene glycol fatty acid ester
  • PEGFA increases the water absorption rate and wicking abilities of one or more of the first layer 102 or the second layer 108 even when one or more of the first layer 102 or the second layer 108 is formed from a hydrophobic material.
  • PEGFA remains attached to one or more of the first layer 102 or the second layer 108 for prolonged periods of times (e.g, 1 month to over a year).
  • non-PEGFA surfactants typically migrated from one or more of the first layer 102 or the second layer 108, such as from one or more of the first layer 102 or the second layer 108 to packaging or into another layer of the porous material that includes one or more of the first layer 102 or the second layer 108.
  • PEG a polyethylene glycol polymer chain of 200 to 4000 Daltons (Da).
  • the aliphatic chain R may include a saturated or unsaturated aliphatic carbon chain.
  • the aliphatic chain R may be a saturated aliphatic carbon chain since it is currently believed that a saturated aliphatic carbon chain may better attach the PEGFA to one or more of the first layer 102 or the second layer 108 including polypropylene or polyethylene since it is more similar to polypropylene or polyethylene that an unsaturated aliphatic carbon chain.
  • the aliphatic chain R may include 7 to 31 carbon atoms. In a particular example, the aliphatic chain R may include 8 to 24 carbon atoms since such aliphatic carbon chains are readily available.
  • the PEG chain of the PEGFA includes a plurality of repeating units [OCH2CH2]n.
  • n may be selected to be 5 to 600, such as in ranges of 5 to 50, 25 to 75, 50 to 100, 75 to 150, 100 to 200, 150 to 250, 200 to 300, 250 to 350, 300 to 400, 350 to 450, 400 to 500, 450 to 550, or 500 to 600.
  • the number of repeated units n and the molecular weight of the polyethylene glycol may affect the ability of the PEGFA to improve the water absorption rate and wicking ability of one or more of the first layer 102 or the second layer 108.
  • increasing the number of repeating units n and the molecular weight of the polyethylene glycol may cause the PEGFA to behave more like a hydrophobic material than a surfactant.
  • the surfactant may be disposed in and/or on one or more of the first layer 102 or the second layer 108 before a fluid collection assembly including one or more of the first layer 102 or the second layer 108 is formed.
  • the surfactant may be disposed in and/or on one or more of the first layer 102 or the second layer 108 after the fluid collection assembly including one or more of the first layer 102 orthe second layer 108 is formed.
  • the preformed fluid collection assembly may be retrofitted by spraying or otherwise disposing at least one surfactant on the porous material of the preformed fluid collection assembly.
  • the surfactant may be disposed on the porous material immediately (e.g. , within an hour) before the preformed fluid collection assembly is used (e.g., the surfactant may include at least one PEGFA surfactant or at least one non-PEGFA surfactant) or a period of time before the preformed fluid collection assembly is used (e.g, the surfactant may include at least one PEGFA surfactant).
  • the preformed fluid collection assembly may include the PurewickTM female external catheter available from Becton, Dickinson and Company, the PrimaFit® external urine management device available from Sage Products
  • polypropylene e.g., the first layer 102 and the portions of the second layer 108 into which polyethylene and/or polypropylene are displaced during the forming of the melted regions 114) may include melted material while the portions of the melted region 114 that does not include polyethylene and/or polypropylene (e.g., the portions of the second layer 108 that do not receive polyethylene and/or polypropylene while forming the melted regions 114) include enhanced fiber entanglement. It is noted that the portions of the melted regions 1 14 include polyethylene and/or polypropylene may also include enhanced fiber entanglement, as discussed in more detail below.
  • the melted regions 114 extend from the first outer surface 104 of the first layer 102, through the first layer 102, and into the second layer 108. Within the melted regions
  • the portions of the first layer 102 at or near the first inner surface 106 become bonded to the portions of the second layer 108 at or near the second inner surface 110 thereby attaching the first and second layers 102, 108 together.
  • the fibers within the melted region 114 at or near the first and second inner surfaces 106, 112 melt and bond with adjacent fibers. As such, the melting regions 114 attach the first and second layers 102, 108 together.
  • the melting regions 114 also bond some of the fibers in one or more of the first layer 102 or the second layers 108 together.
  • the bonding of the fibers of one or more of the first layer 102 or the second layers 108 together strengthens or otherwise increases the wear resistance of the first and second layers 102, 108.
  • the bonding between the fibers of the melted regions 114 provides another mechanism to maintain the structure of the first layer 102 and/or second layer 108. This additional mechanism to maintain the structure of the first layer 102 and/or the second layer 108 may be especially beneficial when the first layer 102 and/or the second layer 108 includes a nonwoven material.
  • Nonwoven materials ty pically maintain the structure thereof, at least in part, due to friction and entanglement between the fibers.
  • the bodily fluids received in the porous material 100 may lubricate the fibers thereby making it easier for the fibers to move relative to each other which, in turn, may cause accelerate breakdown of the porous material 100.
  • the bonding of the fibers in the melted region 114 may resist breakdown of the porous material 100 even if the bodily fluids lubricate the fibers.
  • the melted regions 114 may be formed by inserting one or more probes (e.g., needles or pins) into the porous material 100. Inserting the probes into the porous material 100 displaces some of the fibers of the porous material 100. The displacement of the fibers may cause fiber entanglement in the porous
  • inserting the probed into the porous material 100 may cause the fibers of the first layer 102 to be displaced into and become entangled with the fibers of the second layer 108.
  • Displacing the fibers of the first layer 102 into the second layer 108 and removing the probes from the porous material 100 may also cause some of the fibers of the second layer 108 to be displaced into and become entangled with the fibers of the first layer 102.
  • the quantity’ of fibers of the second layer 108 displaced into the fibers of the first layer 102 may be less than the quantity of fibers of the first layer 102 displaced into the fibers of the second layer 108.
  • the entanglement of the fibers of the first and second layers 102, 108 also attaches the first and second layers 102, 108 together.
  • the displacement of the fibers caused by inserting and removing the probes into and out of the porous material 100 also promotes entanglement of the fibers in each of the first and second layers 102, 108.
  • the amount of entanglement between the fibers in each of the first and second layers 102, 108 at least within the melted region 114 may be greater than regions of the porous material 100 outside of the melted regions 114.
  • the increased fiber entanglement in each of the first and second layers 102, 108 may further increase the strength and wear resistance of the first and second layers 102, 108.
  • the melted regions 114 may exhibit a porosity 7 allowing the bodily' fluids to flow through the melted regions 114. That said, the melted regions 114 may exhibit a porosity that is less than the porosity of the rest of the porous material 100 because the insertion of the probes into the porous material 100 compacts the portions of the porous material 100 forming the melted regions 1 14 and the melting of the fibers in the melted region 114 may at least partially block some of the passageways through the melted region 114.
  • the porosity of the melted regions 114 may be about 5% (z.e., significantly less than) to about 99% (z.e., slightly less than) the porosity of the rest of the porous material 100, such as in ranges of about 5% to about 20%, about 10% to about 30%, about 20% to about 40%, about 30% to about 50%, about 40% to about 60%, about 50% to about 70%, about 60% to about 80%, or about 70% to about 99% of the rest of the porous material 100.
  • the flow rate of the bodily fluids through the melted region 114 may be less than the flow rate of the bodily fluids through the rest of the porous material 100 due to the decreased porosity of the melted region 114.
  • the decreased flow rate through the porous material 100 as a whole caused by the melted regions 114 may be less than the decreased flow rate through a substantially similar porous material that does not include the melted regions 114 and instead includes an adhesive between adjacent layers or allows gaps to form between the first and second layer. Further, the porous material 100 may
  • the melted regions 114 may exhibit a maximum dimension that may be selected to be about 50 pm to about 2 mm, such as in ranges of about 50 pm to about 100 pm, about 75 pm to about 150 pm, about 100 pm to about 200 pm, about 150 pm to about 300 pm, about 200 pm to about 400 pm, about 300 pm to about 500 pm, about 400 pm to about 600 pm, about 500 pm to about 700 pm, about 600 pm to about 800 pm. about 700 pm to about 900 pm, about 800 pm to about 1 mm, about 900 pm to about 1.25 mm, about 1 mm to about 1.5 mm, about 1 mm to about 1.5 mm, or about 1.25 mm to about 2 mm.
  • increasing the maximum dimension of the melted regions 114 improves attachment between the first and second layer 102, 108 but may decrease fluid flow through the first and second layer 102, 108 due to the decreased porosity of the melted regions 114..
  • the porous material 100 may define one or more holes 116 extending at least partially therethrough.
  • each of the holes 116 may be partially defined by and partially enclosed on two or more sides by the melted regions 114.
  • the holes 116 may be formed at the same time that the melted regions 1 14 are formed.
  • probes may be inserted into the porous material 100 to form the melted regions 114. The insertion of the probes into the porous material 100 displaces the fibers. After removing the needles, the fibers of the porous material 100 may not reoccupy all of the space that was previously occupied by the probes since the melting of at least some of the fibers in the melted regions 1 14 essentially locks the fibers in place.
  • the holes 1 16 correspond to the location of the probes.
  • the holes 116 are substantially unoccupied portions of the porous material 100.
  • some fibers may enter the hole 116 after removal of the probe from the porous material 100.
  • the porosity of the hole 116 is significantly greater than the melted region 114 and greater the remainder of the porous material 100.
  • the holes 116 may facilitate flow of the bodily fluids through the porous material 100.
  • the holes 116 may provide less resistance to flow of the bodily fluids than the melted regions 114 and the remainder of the porous material 100.
  • the enhanced fluid flow through the holes 116 may at least partially negate the decreased fluid flow through the melted regions 114 caused by the decrease porosity of the melted regions 114.
  • the holes 116 may exhibit a maximum dimension D.
  • the maximum dimension D may be selected to be about 50 pm to about 2 mm, such as in ranges of about 50 pm to
  • the melted regions 114 may exhibit any suitable shape. Generally, the shape of the melted regions 114 corresponds to the shape of the probe that was used to form the melted regions 114.
  • the melted regions 114 may exhibit a generally conical shape (as shown), a generally cylindrical shape, a generally pyramidal shape, a generally half-spherical shape, a funnel like shape, a stepped shape, any other suitable shape, or a combination thereof (e.g., a cylindrical shape having a conical shape on a side of the cylindrical shape opposite the first outer surface 104).
  • the shape of the melted regions 114 may be selected such that the cross-sectional area of the melted region 114 decreases with further distance from the first outer surface 104 along at least a portion of a length of the melted region 114.
  • the decreased cross-sectional area of the melted region 114 with increasing distance from the first outer surface 104 may cause the cross- sectional area of the rest of the porous material 100 to increase with increasing distance from the first outer surface 104.
  • the fluid flow 7 rate through the remainder of the porous material 100 may be greater than the fluid flow rate through the melted regions 114.
  • the increasing cross-sectional area of the remainder of the porous material 100 with increasing distance from the outer surface 104 along with the improve fluid flow rate of the remainder of the porous material 100 promotes flow of the bodily fluids from the first outer surface 104 to the second outer surface 112 and inhibits backflow of the bodily fluids.
  • the center-to-center spaced S between immediately adj acent ones of the melted regions 114 may be selected to be about 2.5 mm to about 5 cm, such an in ranges of about 2.5 mm to about 4 mm, about 3 mm to about 5 mm, about 4 mm to about 6 mm, about 5 mm to about 7 mm, about 6 mm to about 8 mm, about 7 mm to about 9 mm, about 8 mm to about 1 cm, about 9 mm to about 1.25 cm, about 1 cm to about 1.5 cm, about 1.25 cm to about 1.75 cm, about 1.5 cm to about 2 cm, about 1.75 cm to about 2.5 cm, about 2 cm to
  • the spacing S between the melted regions 114 may be selected based on a number of factors. In an example, the spacing S may be increased as the maximum dimension D of the holes 116 is increased and the vice versa. In an example, the spacing S may be increased if the likelihood of gaps forming between the first and second layers 102, 108 without the melted regions 114 is low and spacing S may be decreased if the likelihood of gaps forming between the first and second layers 102, 108 without the melted regions 114 is high.
  • the melted regions 114 may have any arrangement on the porous material 100.
  • the melted regions 114 may be arranged on the porous material 100 such that, when viewed from above the first outer surface 104, the melted regions 114 exhibit one or more circular patterns, one or more hexagonal patterns, one or more square patterns, one or more triangular patterns, or any other suitable patterns.
  • the arrangement of the melted regions 114 may affect the concentration of melted regions 114 and the spacing S between the melted regions 114. For example, certain arrangement of the melted regions 114 may allow for a more close-packed arrangement of the melted regions 1 14 than another arrangement.
  • the melted regions 114 may only be present on about 10% or less of the surface area of one or more of the first outer surface 104, the first inner surface 106, or the second inner surface 110, such as about 9% or less, about 8% or less, about 7% or less, about 6% or less, about 5% or less, about 4% or less, about 3% or less, about 2% or less, about 1 % or less, or in ranges of greater than 0% to about 2%, about 1% to about 3%, about 2% to about 4%, about 3% to about 5%, about 4% to about 6%, about 5% to about 7%, about 6% to about 8%, about 7% to about 9%, or about 8% to about 10%.
  • the melted regions 114 may occupy less of the surface area of the first inner surface 106 and/or or the second inner surface 110 while substantially preventing the formation of gaps between the first and second layers 102, 108 than an adhesive layer. Further, the small surface area of melted regions 114 on one or more of the first outer surface 104, the first inner surface 106, or the second inner surface 1 10 minimizes the affect that the restricted fluid flow through the melted regions 114 has on the fluid flow through the entire porous material 100.
  • the porous material 100 may include at least one additional layer.
  • the additional layer may abut the second outer surface 112 of the second layer 108.
  • the melted regions 114 may or may not extend into the additional layer.
  • the melted regions 114 extend into the additional layer, the melted regions 114 may extend from the first outer surface 104. through the first layer 102, into and through the second layer 108, and into at least a portion of the additional layer.
  • the additional layer may include a PET inner layer.
  • the melted regions 114 may extend through the first layer 102 (e.g., a hydrophobic polyethylene or hydrophobic polypropylene with or without a surfactant), through the second layer 108 (e.g., bamboo), and into the PET inner layer.
  • FIG. IB is a schematic view of a system 120 configured to form the porous material 100, according to an embodiment.
  • the system 120 is an example of a thermal needle punch lamination system. That said, it is noted that the porous material 100 may be formed using other systems, without limitation.
  • the system 120 may include a support 122.
  • the support 122 is attached to an actuator 124 that is configured to move the support 122.
  • the actuator 124 may be configured as a hydraulic actuator, pneumatic actuator, or an electric-motor driven actuator.
  • the support 122 is also attached to a needle board 126.
  • the needle board 126 includes a plurality of needles 128 extending therefrom in one or more selected patterns.
  • the needles 128 are configured to be inserted into the porous material 100 to form the melted regions 114, as will be discussed in more detail below.
  • the needles 128 may include a barbed tip which will enhance entanglement between the fibers of the porous material 100.
  • the system 120 is configured to heat the needles 128 to a temperature sufficient to melt at least some of the fibers of the porous material 100.
  • the system 120 may heat the needles 128 to a temperature of about 150 °C to about 300 °C, such as in ranges of about 150 °C to about 180 °C.
  • the system 120 may be configured to heat the needles 128 to a temperature that is less than 150 °C or greater than 300 °C.
  • the temperature of the needles 128 may be selected based on a number of factors.
  • the temperature of the needles 128 may be selected to be greater than a melting temperature and lower than a combustion temperature of one or more materials of the porous material 100.
  • the temperature of the needles 128 is dependent on the composition of the porous material 100. For instance, when the porous material 100 includes a hydrophobic polyethylene and/or polypropylene first layer 102 and
  • the needles 128 may be heated to a temperature greater than the melting point of the hydrophobic polyethylene and/or polypropylene first layer 102 and lower than the combustion temperature of bamboo since bamboo may be difficult to melt.
  • the temperature of the needles 128 may be heated to a temperature that is 5 °C or greater (e.g., about 10 °C or greater, about 15 °C or greater, about 20 °C or greater, or in ranges of about 5 °C to about 15 °C greater or about 10 °C to about 20 °C greater) than the melting temperature of one or more materials of the porous material 100.
  • the needles 128 may be heated to a temperature that is greater than the melting temperature of one or more materials of the porous material 100 to improve the kinetics of melting the materials of the porous material 100 since, generally, it may take an unsatisfactory long period of time to melt the materials of the porous material 100 if the needles 128 are only heated to a temperature that is equal to or only slightly greater than (e.g, 1 or 2 °C greater than) the melting temperature of the materials of the porous material 100.
  • the needles 128 may not be heated to a temperature that is significantly greater (e.g, 50 °C or greater) than the melting temperature of the materials of the porous material 100 since such temperatures may cause extensive melting of the materials of the porous material 100 which may cause the melted materials to completely or substantially completely block the pores of the melted region 114.
  • the temperatures of the needles 128 may be selected based on the desired manufacturing speed. For instance, the manufacturing speed of the system 120 is dependent, in part, on the time that the needles 128 remain in the porous material 100. Increasing the temperature of the needles 128 decreases the time that the needles 128 need to remain in the porous material 100 to form the melted regions 114.
  • the system 120 may include a first set of rollers 134 and a second set of rollers 136.
  • the support 122 and the needle board 126 may be positioned between the first and second set of rollers 134, 136.
  • the first and second set of rollers 136 may hold the first and second layers 102, 108
  • the actuator 124 may move the needle board 126 away from the porous material 100 and the porous material 100 may then be collected by a collector 138.
  • the system 120 is not configured to heat the needles 128.
  • the system 120 is an example of a (non-thermal) needle punch system.
  • the needle punch system may operate by inserting non-heated needles 128 into the first and second layers 102, 108.
  • the non-heated needles 128 do not melt the material of the first and second layers 102, 108, but instead forms entangled regions in the first and second layers 102, 108.
  • the entangled regions may be substantially similar to the melted regions 114 discussed above except that the entangled regions do not include melted material.
  • the holes of the entangled regions (if present) may also be less pronounced than the holes 116 of the melted regions 114 since removal of the non-heated needles 128 may pull more material into the holes of the entangled region than the heated needles 128.
  • the entangled regions rely on entanglement between the fibers of the first and second layers 102. 108 to attach the first and second layers 102, 108 together and entanglement of the fibers in each of the first and second layers 102, 108 to increase the strength and wear resistance of each layer. Forming the entangled regions in each of the first and second layers 102, 108 more weakly attaches the first and second layers 102, 108 together and strengthens and increases the wear resistance of the first and second layers 102, 108 less than the melted regions 114.
  • FIG. 2A is a cross-sectional view of a porous material 200, according to an embodiment. Except as otherwise disclosed herein, the porous material 200 may be the same as or substantially similar to any of the porous materials disclosed herein.
  • the porous material 200 may include a first layer 202, a second layer 208, and a plurality of melted regions 214 attaching the first layer 202 to the second layer 208.
  • the melted regions 214 may be substantially similar to the melted regions 114 shown in FIG. 1A (e.g., similar any of the same shapes, center-to-center spacing, arrangements, etc.) except that the melted regions 214 may not define a hole that is at least partially surrounded on two sides by the melted region 214. That said, the melted regions 214 may be positioned adjacent to a divot (not shown) formed in the porous material 200 caused by the densification of the melted region 214.
  • the lack of a hole defined by the melted regions 114 causes the melted regions 214 to exhibit an average porosity that generally equal or at least more equal to the rest of the porous material 200 than the melted regions 114.
  • the average porosity of the melted regions 214 compared to the rest of the porous material 200 causes bodily fluids to flow through the melted regions 214 faster than through the melted regions 114 of FIG. 1A.
  • the quicker flow of the bodily fluids through the melted regions 214 compared to the melted regions 1 14 allows the flow rate of the bodily fluids through the porous material 200 to be comparable to the flow rate of the bodily fluids through the porous material 100 even though the porous material 200 does not include the holes.
  • the passageways through the melted regions 214 are at least partially obstructed by melting the materials of the porous material 200.
  • the flow rate of the bodily fluids through the melted regions 214 may be lower than the flow rate of the bodily fluids through the rest of the porous material 200.
  • the shape of the melted regions 214 may be configured to cause preferentially flow of the bodily fluids from the first layer 202 towards the second layer 208.
  • the cross-sectional area of the melted regions 214 may decrease along at least a portion of a length thereof with increasing distance from the first outer surface 204.
  • FIG. 2B is a schematic of a system 220 configured to form the porous material 200, according to an embodiment.
  • the system 220 is an example of an ultrasonic lamination manufacturing system. That said, the porous material 200 may be formed using systems other than an ultrasonic lamination manufacturing system.
  • the system 220 includes an ultrasound plate 222.
  • the ultrasonic plate 222 is configured to generate ultrasonic energy that is concentrated as defined bond points. The ultrasonic energy causes localized heating of the first and second layers 202, 208 to bond the first and second layers 202, 208 together.
  • the ultrasound plate 222 includes a plurality of pins 228 arranged in one or more selected patterns. The pins 228 are configured to generate and discharge the ultrasonic energy into the first and second layers 202, 208 to form the porous material 200.
  • the portions of the pins 228 configured to contact the first and second layers 202, 208 may exhibit a maximum dimension of about 50 pm to about 2 mm, such as in ranges of about 50 pm to about 100 pm, about 75 pm to about 150 pm, about 100 pm to about 200 pm, about 150 pm to about 300 pm, about 200 pm to about 400 pm, about 300 pm to about 500 pm, about 400 pm to about 600 pm, about 500 pm to about 700 pm, about 600 pm to about 800 pm, about 700 pm to about 900 pm, about 800 pm to about 1 mm, about 900 pm to about 1.25 mm, about 1 mm to about 1.5 mm, about 1 mm to about 1.5 mm, or about 1.25 mm to about 2 mm.
  • the maximum dimension of the pins 228 may correspond to the maximum dimension of the melted regions 214.
  • the pins 228 may form divots in the porous material 200 adjacent to the melted regions 214.
  • FIG. 2A illustrates the porous material 200 defining no holes, it is noted that, in some embodiments, the pins 228 may form holes in the porous material 200 that are at least partially defined by the melted regions 214 depending on the size of the pins 228, the configuration of the pins 228 (e.g., whether the pins 228 have or do not have a barbed tip), and the depth that the pins 228 penetrate into the first and second layers 202, 208.
  • the system 220 includes a source of the outer layer 230 and a source of the inner layer 232.
  • the source of the outer layer 230 may be a roll including the first layer 202 and the source of the inner layer 232 may be a roll including the second layer 208.
  • the sources of the outer and inner layers 230, 232 may be distinct and separate from each other.
  • the system 220 includes a source of the porous material 200, wherein the source of the porous material 200 includes the first layer 202 and the second layer 208 already positioned adjacent to each other.
  • the system 220 may include one or more rollers that facilitate movement of the first layer 202 and the inner layer 208 through the system 220.
  • the system 220 may include a first set of rollers 234 and a second set of rollers 236.
  • the ultrasound plate 222 may be positioned between the first and second set of rollers 234, 236.
  • the first and second set of rollers 236 may hold the first and second layers 202, 208 together and hold the first and second layers 202, 208 parallel to the ultrasound plate 222 which may allow controlled and predictable contact between the pins 228 and the first and second layers 202, 208.
  • the first set of rollers 234 may also pull the first and second layers 202, 208 off their respective source and pull the first and second layers 202, 208 towards the ultrasound plate 222.
  • a method of using the system 220 may include providing the source(s) of the first and second layers 202, 208.
  • the system 220 may then pull the first and second layers 202, 208 from their sources towards the ultrasound plate 222.
  • the system 220 may bring the first and second layers 202, 208 together (if not already together) while pulling the first and second layers 202, 208 towards the ultrasound plate 222 when the first and second layers 202, 208 are provided using distinct and separate sources.
  • the ultrasound plate 222 delivers ultrasonic energy into the first and second layers 202, 208 which may cause at least some of the materials of the first and second layers 202, 208 to melt and form the melted regions 214.
  • the actuator 224 may move the needle board 226 away from the porous material 200 and the porous material 200 may then be collected by a collector 238.
  • FIGS. 3A-10C are examples of fluid collection assemblies that may include one or more of the porous material 100 or the porous material 200.
  • FIG. 3A is an isometric view of a fluid collection assembly 300, according to an embodiment.
  • FIGS. 3B and 3C are cross-sectional views of the fluid collection assembly 300 taken along planes 3B-1B and 3C-3C, respectively, shown in FIG. 3A.
  • the fluid collection assembly is an example of a fluid collection assembly configured to receive bodily fluids from a urethral opening of a female or a male with a buried penis.
  • the fluid collection assembly 300 includes a fluid impermeable barrier 302.
  • the fluid impermeable barrier 302 at least partially defines a chamber 304 (e.g. , interior region) and an opening 306.
  • the fluid impermeable barrier 302 temporarily stores the bodily fluids in the chamber 304.
  • the fluid impermeable barrier 302 may be formed of any suitable fluid impermeable material(s), such as a fluid impermeable polymer (e.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, neoprene, a polycarbonate, etc.), a metal film, natural rubber, another suitable material, any other fluid impermeable material disclosed herein, or combinations thereof.
  • a fluid impermeable polymer e.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, neoprene, a polycarbonate, etc.
  • a metal film e.g., natural rubber, another suitable material, any other fluid impermeable material disclosed herein, or combinations thereof.
  • the opening 306 provides an ingress route for bodily fluids to enter the chamber
  • the fluid collection assembly 300 includes porous material 310 disposed in the chamber 304.
  • the porous material 310 may cover at least a portion (e.g., all) of the opening 306.
  • the porous material 310 may include one or more of a foam, spun fibers, a vertical nonwoven material, a woven material, a quilted material, or the like.
  • the porous material 310 may be the same as or substantially similar to the porous material 100 or the porous material 200.
  • the porous material 310 may include a first layer and a second layer that are bonded together using a plurality 7 of melted regions or entangled regions.
  • the first layer may form one of the outer layer 311 or the inner layer 313 and the second layer may form the other of the outer layer 311 or the inner layer 313.
  • the outer layer 311 may include any suitable porous material, such as a porous sheet.
  • the outer layer 311 may include gauze (e.g, a silk, linen, or cotton gauze), another soft fabric, another smooth fabric, a horizontal lapped nonwoven material, a cross lapped nonwoven material, a porous polymer (e.g., nylon, polyester, polyurethane, hydrophilic or hydrophobic polyethylene, hydrophilic or hydrophobic polypropylene, spun nylon fiber etc.) structure or an open cell foam (e.g., polyethylene or polyurethane foam), or any other suitable porous material.
  • gauze e.g, a silk, linen, or cotton gauze
  • another soft fabric e.g., another soft fabric, another smooth fabric, a horizontal lapped nonwoven material, a cross lapped nonwoven material
  • a porous polymer e.g., nylon, polyester, polyurethane, hydrophilic or hydrophobic polyethylene, hydrophilic or hydrophobic polypropylene, spun nylon
  • the porous material 336 may be formed from natural fibers which may be more sustainable and biodegradable than the synthetic fibers.
  • natural fibers includes cellulose, cotton, bamboo, wool, or the like.
  • the fibers of the outer layer 311 e.g., gauze
  • the outer layer 311 may include a blend of natural fibers and synthetic fibers.
  • the outer layer 311 may include bamboo fibers and polypropylene fibers.
  • the outer layer 311 may include a hydrophobic material or a hydrophilic material.
  • the outer layer 311 is disposed on an outer surface of the at least one inner layer 313 (e.g., between the fluid impermeable barrier 302 and the inner layer 313) such that the outer layer 311 extends across the opening 306 and contacts the individual during use.
  • the outer layer 311 may be disposed on the inner layer 313 to make the fluid collection assembly 300 more comfortable to use and/or improve capture of the bodily fluids.
  • an individual may find direct contact between the inner layer 313 and the sensitive vaginal region of the individual uncomfortable, for instance, due to the surface roughness of a foam or fibers protruding of the inner layer 313.
  • the outer layer 311 may include a material (e.g.
  • the hydrophilicity of the inner layer 313 may be limited to facilitate removing bodily fluids therefrom. However, limiting the hydrophilicity of the inner layer 313 may limit the ability’ of the inner layer 313 to capture bodily fluids. As such, the outer layer 311 may be selected to exhibit a hydrophilicity that is greater than (i.e., a contact angle with water that is less than) the inner layer 313 which allows the outer layer 311 to capture bodily fluids more quickly than the inner layer 313.
  • the outer layer 311 When the outer layer 311 exhibits a hydrophilicity that is greater than the inner layer 313, the outer layer 311 may exhibit a thickness that is significantly less than the thickness of the inner layer 313. The smaller thickness of the outer layer 311 decreases the volume of bodily fluids that are retained in the outer layer 311 that have to be evaporated by air flow through the chamber 304.
  • FIG. 3D is a cross-sectional view of a portion of the fluid collection assembly 300 taken from the box illustrated in FIG. 3C. according to an embodiment.
  • the outer layer 311 of the porous material 310 may include a vertical nonwoven material.
  • the vertical nonwoven material is formed from a nonwoven web 318 that is folded.
  • the folded nonwoven web 318 may include a plurality of folded portions 320 and a plurality of intermediate portions 322 extending between the folded portions 320.
  • the folded non woven web 318 may include an outer surface adjacent to the fluid impermeable barrier 302 and an opposing inner surface (e.g, defining a bore that received the conduit 314).
  • the folded portion 320 may extend generally parallel to the outer and inner surfaces of folded non woven web 318.
  • the intermediate portions 322 may extend between the outer and inner surfaces of the folded nonwoven web 318.
  • the folded nonwoven web 318 may be positioned in the chamber 304 such that the folded portions 320 extend generally parallel to a longitudinal (e.g., central) axis 316 of the fluid collection assembly 300 (e.g. , generally parallel to a longitudinal axis of the porous material 310) and/or extend circumferentially when the porous material 310 exhibits a generally cylindrical shape.
  • the folded nonwoven web 318 may be positioned in the chamber 304 such that the intermediate portions 322 extend generally parallel to the longitudinal axis 316 of the fluid collection assembly 300 (e.g., generally parallel to a longitudinal axis of the porous material 310) and/or extend radially when the porous material 310 exhibits a generally cylindrical shape.
  • the vertical nonwoven material includes a plurality of fibers 324.
  • the nonwoven web 318 that forms the vertical nonwoven material may include a plurality of generally oriented fibers 324.
  • the generally oriented fibers 324 may improve the ability of the vertical nonwoven material to capture bodily fluids and transport bodily fluids.
  • the generally oriented fibers 324 may also improve the mechanical properties of the vertical nonwoven material.
  • the fibers 324 are ‘’generally aligned” when a certain percentage of the fibers 324 are substantially parallel to each other.
  • the certain percentage of the fibers 324 refers to at least about 70% of the fibers 324, more preferably at least about 80% of the fibers 324, more preferable 90% of the fibers 324, and even more preferably at least about 95% of the fibers 324.
  • the fibers 324 are generally parallel to each other when the certain percentage of fibers 324 are parallel to each other ⁇ 30° more preferable ⁇ 20°, more preferably ⁇ 10°, or even more preferably ⁇ 5°.
  • the nonwoven web 318 may be disposed in the chamber 304 such that the fibers 324 of the folded portions 320 are generally oriented circumferentially and the fibers 324 of the intermediate portions 322 are generally oriented radially. Not wishing to be bound
  • the circumferentially orientation of the fibers 324 of the folded portions 320 may cause the bodily fluids received by the vertical nonwoven material to initially preferentially disperse circumferentially and the radial orientation of the fibers 324 of the intermediate portions may cause the bodily fluids to initially preferentially disperse radially into the porous material 310. Causing the bodily fluids to initially disperse circumferentially and radially quickly disperses the bodily fluids throughout a large volume of the vertical nonwoven material thereby allowing the vertical nonwoven material to quickly capture and transport the bodily fluids.
  • the fibers 324 do not inhibit flow of the bodily fluids in a direction that is generally parallel to the longitudinal axis 316, especially after the fibers 324 are wetted. Further, dispersing the bodily fluids throughout the vertical nonwoven material increases the surface area of any bodily fluids that may remain in the vertical nonwoven material after removing the bodily fluids from the porous material 310. The large surface area facilitates evaporation of the remaining bodily fluids with the air flow through the porous material 310. In an embodiment, the fibers 324 are randomly oriented or may be oriented differently than what is shown in FIG. 3D.
  • folding the nonwoven web 318 may cause the formation of gaps 325 that extending generally parallel to the longitudinal axis 316.
  • the gaps 325 may facilitate fluid flow in a direction that is generally parallel to the longitudinal axis 316.
  • the nonwoven web 318 may be folded or compressed by the fluid impermeable barrier 302 to minimize the size of the gaps 325 to prevent pooling of the bodily fluids in the chamber 304.
  • the nonwoven web 318 may be folded or compressed by the fluid impermeable barrier 302 to cause the gaps 325 to exhibit a dimension measured perpendicular to the longitudinal axis 316 that is less than about 1 mm, less than about 0.75 mm, less than about 0.5 mm, or less than about 0.25 mm.
  • the vertical nonwoven material may be formed from at least one nonwoven web 318 that is folded.
  • the vertical nonwoven material may be formed from any suitable nonwoven web.
  • the nonwoven web includes at least one carded web.
  • the carded web includes a plurality of fibers 324 that may be generally oriented in the same direction.
  • the generally same orientation of the fibers 324 of the carded web cause the carded web to be anisotropic.
  • the strength of the carded web is greatest when a force applied thereto is generally parallel to the fibers 324 but the strength of the carded web decreases as the force applied thereto becomes more oblique or perpendicular to the orientation of the fibers 324.
  • the carded web may need to be positioned in the chamber 304 to mitigate forces being applied to the carded web
  • the nonwoven web 318 may include at least one needle punched web.
  • the needle punched web may be formed from a sheet including a plurality of fibers 324.
  • the sheet may include a plurality of randomly oriented fibers 324 (e.g., the fibers 324 are generally parallel to and randomly oriented in the plane), or generally oriented fibers 324 (e.g., a carded web) since the orientation of the fibers 324 may better facilitate flow of the bodily fluids therethrough.
  • a plurality 7 of needles e.g., a plurality of barbed needles
  • the nonwoven web 318 may include at least one air laid web.
  • the air laid web may exhibit a plurality of randomly oriented fibers 324.
  • the plurality of random fibers 324 may exhibit a length that is sufficiently large that the fibers 324 become entangled and do not need be bounded together or the fibers 324 may be bonded. Due to the random orientation of the fibers 324, the air laid web tends to be isotropic and exhibit a high porosity. Similar, due to the random orientation of the fibers 324, the air laid web may exhibit a high loft.
  • the air laid web may be formed from fibers 324 that cannot be carded (e.g, short fibers).
  • the nonwoven web 318 may include at least one spunlaced web.
  • the spunlaced web is formed by providing a sheet that includes randomly oriented fibers 324 or a carded web. High pressure water jets that are generally parallel to the thickness of the sheet are directed towards the sheet. Similar to the needle punched web, the high pressure jets of water cause some of the fibers 324 to migrate from an exterior of the sheet to an interior thereof to form columns.
  • the spunlaced web may function similar to the needle punched web, namely that the spunlaced web may be more isotropic than the carded web and includes divots.
  • the vertical nonwoven material may include one or more nonwoven webs other than the carded web, needle punched web, the air laid web, and the spunlaced web.
  • the vertical nonwoven material may include a wet laid web, a spunbond nonwoven web, or a meltblown nonwoven web.
  • the folded nonwoven web 318 may be formed from a sheet. When resting the sheet on a horizontal planar surface, the folded portions 320 may extend parallel to the horizontal planar surface and the intermediate portions 322 may extend vertically from the horizontal planar surface. The folded nonwoven web 318 may then be rolled to form the cylindrical folded non woven web 318.
  • the vertical nonwoven material may include a material there does not have fibers.
  • a foam body may be utilized instead of a nonwoven web 318.
  • the foam body may be sized, shaped, and folded similarly or identically to the folded nonwoven w eb 318 to form the porous body of the porous material 310.
  • the foam body may include an open cell foam body folded to have the plurality of folded portions 320 and the plurality of intermediate portions 322 extending between the folded portions 320 to form the vertical nonwoven material.
  • the foam body may include a foam of any of the polymers disclosed herein, such as polyurethane, polyethylene, polyethylene terephthalate, other polyesters, polyether, or the like. Bodily fluids may move through the open cell structure of the foam toward the reservoir or vacuum force (e.g., inlet of conduit 314).
  • Suitable vertical nonwoven materials and their properties for use in the porous material 100 are disclosed in International Patent Application No. PCT/US2022/042719 filed on 7 September 2022, and U.S. Provisional Patent Application No. 63/241.575 filed on 8 September 2021, the disclosure of each of which is incorporated herein, in its entirety, by this reference for any purpose.
  • the porous material 310 may exhibit a thickness that is greater than about 1 mm, such as in ranges of 1 mm to about 30 mm, about 1 mm to about 10 mm, about 10 mm to about 20 mm, about 20 mm to about 30 mm, about 5 mm to about 15 mm, about 15 mm to about 25 mm, less than about 30 mm, or less than about 20 mm.
  • Increasing the thickness of the porous material 310 generally increases the volume of bodily fluids that may be temporarily stored in the porous material 310, and allows greater flexibility in selecting the density and basis weight of the porous material 310.
  • the thickness of the porous material 310 may be limited by the size and functionality of the fluid collection assembly 300.
  • the thickness of the porous material 310 may be selected such that the porous material 310 may be disposed in the chamber 304, along with any other components that may also be disposed in the chamber 304. such as outer layer 336 (FIG. 3B), or a conduit 314.
  • the rate at which the porous material 310 captures and transports the bodily fluids may depend on a number of factors.
  • the rate at which a vertical nonwoven material captures and transports the bodily fluids may depend inversely on the density and weight basis of the vertical nonwoven material, wherein increasing the density and/or weight basis of the vertical nonwoven material may decrease the rate at which the vertical nonwoven material captures and transports the bodily fluids and vice versa.
  • the rate at which the porous material 310 captures and transports the bodily fluids may depend on the material (e.g., hydrophilicity of the material) that forms the porous material 310.
  • the rate at which the porous material 310 captures and transports the bodily fluids may increase with increasing thickness t since increasing the thickness t increases the cross-sectional area through which the bodily fluids may flow.
  • the porous material 310 may only or substantially only include a single porous layer.
  • the single porous layer may define a bore that is configured to receive the conduit 314 and the single porous layer extends from the bore to the fluid impermeable barrier 302.
  • the porous material 310 includes only or substantially only the single porous layer, all of the porous material 310 is able to quickly capture and transport the bodily fluids.
  • the porous material 310 may include at least one additional material, such as outer layer, even though such additional material may decrease at least one of the ability of the porous material 310 to capture and/or transport the bodily fluids.
  • the fluid collection assembly 300 may include a sump or reservoir therein to collect bodily fluids.
  • the sump may be an occupied or unoccupied portion of the chamber 304.
  • the sump may be a portion within the chamber 304 at or near where the inlet of the conduit 314 is located.
  • the porous material 310 may at least substantially completely fill the portions of the chamber 304 that are not occupied by the conduit 314. In some examples, the porous material 310 may not substantially completely fill the portions of the chamber 304 that are not occupied by the conduit 314.
  • the fluid collection assembly 300 includes a reservoir 326 (e.g.. sump) disposed in the chamber 304.
  • the reservoir 326 (sump) may be a substantially unoccupied portion of the chamber 304.
  • the reservoir 326 may be defined between the fluid impermeable barrier 302 and porous material 310.
  • the bodily fluids that are in the chamber 304 may flow through the porous material 310 to the reservoir 326.
  • the reservoir 326 may retain of the bodily fluids therein.
  • the fluid impermeable barrier 302 may retain the bodily fluids in
  • the reservoir 326 While depicted in the distal end region 332. the reservoir 326 may be located in any portion of the chamber 304 such as the proximal end region 334. The reservoir 326 may be located in a portion of the chamber 304 that is designed to be located in a gravimetrically low point of the fluid collection assembly when the fluid collection assembly 300 is worn.
  • the reservoir 326 or sump may be occupied by the porous material 310 and still function as a reservoir or sump.
  • the porous material 310 may fill substantially of the chamber 304 not occupied by the conduit 314 and the reservoir 326 may be a distal end region of the chamber or any other region of the chamber 304 configured to retain the bodily fluid therein while or prior to being removed via the conduit 314.
  • the fluid collection assembly 300 may include multiple reservoirs, such as a first reservoir that is located at the portion of the chamber 304 closest to the inlet of the conduit 314 (e.g., distal end region 332) and a second reservoir that is located at the portion of the of the chamber 304 that is at or near proximal end region 334).
  • the porous material 310 is spaced from at least a portion of the conduit 314, and the reservoir 326 may be the space between the porous material 310 and the conduit 314.
  • FIG. 3E is a cross-sectional view of the conduit 314, according to an embodiment. Referring to FIGS.
  • the conduit 314 includes a fluid lumen 347 and a shape memory' lumen 349 therein.
  • the conduit 314 includes an outer wall 346 and an inner wall 348 at least partially defining the fluid lumen 347 and shape memory lumen 349. respectively.
  • the outer wall 346 and the inner wall 348 of the conduit 314 may be constructed of a polymer, such as silicone, polyvinyl chloride (PVC), polyethylene, thermoplastic polyurethane, a thermoplastic elastomer (e.g., a synthetic rubber), or the like.
  • the conduit 314 may have a Shore A hardness of at least 30, such as about 30 to about 95, about 50 to about 95.
  • the conduit 314 may have a length of at least a meter, such as about 1 m to about 5 m, about 1 m to about 3 m, about 2 m to about 3 m, or less than 5 m.
  • the conduit 314 may be at least partially disposed in the chamber 304.
  • the conduit 314 may be used to remove the bodily fluids from the chamber 304.
  • the conduit 314 includes at least one wall (e.g.. outer wall 346) defining an inlet 312, an outlet (not shown) downstream from the inlet 312, and a passageway therebetween.
  • the outlet of the conduit 314 may be operably coupled to a vacuum source, such as a vacuum pump for withdrawing fluid from the chamber 304 through the conduit 314.
  • a vacuum source such as a vacuum pump for withdrawing fluid from the chamber 304 through the conduit 314.
  • the conduit 314 may extend into the fluid impermeable barrier 302 from the proximal end region 334 and may extend to the distal end region 332 to a point proximate to the reservoir 326 therein such that the inlet 312 is in fluid communication with the reservoir 326.
  • the conduit 314 fluidly couples the chamber 304 with the fluid storage container (not shown) or the vacuum source (not shown).
  • the inlet 312 may be disposed at or near the fluid impermeable barrier 302 in the distal end region 332.
  • the conduit 314 may extend through a bore in the porous material 310.
  • the conduit 314 extends from the fluid outlet 308, through the bore, to a location that is proximate to the reservoir 326.
  • the inlet 312 may not extend into the reservoir 326 and, instead, the inlet 312 may be disposed within the porous material 310 or at a terminal end thereof.
  • an end of the conduit 314 may be coextensive with or recessed within the porous material 310.
  • the conduit 314 is at least partially disposed in the reservoir 326 and the inlet 312 may be extended into or be positioned in the reservoir 326. In an embodiment, the inlet 312 may be positioned aft of the reservoir 326.
  • the bodily fluids collected in the fluid collection assembly 300 may be removed from the chamber 304 via the conduit 314. [00127] Locating the inlet 312 at or near a location expected to be the gravimetrically low point of the chamber 304 when worn by an individual enables the conduit 314 to receive more of the bodily fluids than if inlet 312 was located elsewhere and reduce the likelihood of pooling (e.g., pooling of the bodily fluids may cause microbe growth and foul odors).
  • the bodily fluids in the porous material 310 may flow in any direction due to capillar ⁇ ’ forces.
  • the bodily fluids may exhibit a preference to flow in the direction of gravity, especially when at least a portion of the porous material 310 is saturated with the bodily fluids.
  • one or more of the inlet 312 or the reservoir 326 may be located in the fluid collection assembly 300 in a position expected to be the gravimetrically low point in the fluid collection assembly 300 when worn by an individual. such as the distal end region 332.
  • the inlet 312 and the outlet of the conduit 314 are configured to fluidly couple (e.g., directly or indirectly) the vacuum source (not shown) to the chamber 304 (e.g., the reservoir 326).
  • the vacuum source FIG. 11
  • the bodily fluids in the chamber 304 e.g., at the distal end region 332 such as in the
  • conduit 314 may be frosted or opaque (e.g., black) to obscure visibility of the bodily fluids therein.
  • the conduit 314 may be configured to be at least insertable into the chamber 304.
  • the conduit 314 may be positioned in the chamber 304 such that a terminal end of the conduit 314 is spaced from the fluid impermeable barrier 302 or other components of the fluid collection assembly 300 that may at least partially obstruct or block the inlet 312.
  • the inlet 312 of the conduit 314 may be offset relative to a terminal end of the porous material 310 such that the inlet 312 is closer to the proximal end region 334 of the fluid collection assembly 300 than the terminal end of the porous material 310.
  • the multiple lumen configuration may include the fluid lumen 347 for transporting fluids and at least one shape memory lumen 349 for containing a shape memory material 350 therein.
  • the fluid lumen 347 is sized and shaped to allow bodily fluids to flow 7 therethrough. As shown in FIG. 3E, the fluid lumen 347 may be a larger than the shape memory lumen 349.
  • the fluid lumen 347 may have an inside diameter (or major dimension) of at least about 0.1 inches (2.5 mm), such as about 0. 1 inches to about 0.5 inches (12.7 mm), about 0.15 inches (3.8 mm) to about 0.35 inches (8.9 mm), about 0.25 inches (6.3 mm) to about 0.4 inches (10.2 mm), or less than about 0.5 inches.
  • the shape memory lumen 349 is sized and shaped to accommodate a shape memory material 350 therein.
  • the shape memory lumen 349 may have an inside diameter (or major dimension) of at least about 0.03 inches (0.76 mm), such as about 0.03 inches to about 0.1 inches (2.5 mm), about 0.03 inches to about 0.05 inches (1.3 mm), about 0.05 inches to about 0.07 inches (1.8 mm), or less than about 0.1 inches.
  • shape memory lumen 349 is depicted as being positioned in the gravimetrically low point of the conduit 314 (e.g., in the bottom of the fluid lumen 347), the shape memory lumen may be disposed at any point in the fluid lumen 347, such as at the lateral sides (e.g., 3 o’clock or 9 o’clock) or the top (e.g., 12 o’clock position).
  • the shape memory lumen 349 may contain the shape memory material 350 in a discrete portion of the longitudinal length of the conduit
  • the shape memory material 350 may include an element configured to allow the shape of the fluid collection assemblies to be controllably changed and/or maintain a selected shape.
  • the at least one shape memory material 350 may prevent or at least inhibit bodily fluids leaking from the fluid collection assembly 300.
  • bodily fluids may leak from the fluid collection assembly because, initially, the fluid collection assembly 300 may exhibit a poor fit with the anatomy of a wearer (e.g., user) about the urethral opening.
  • the fluid collection assembly 300 includes the shape memory material 350 disposed in the shape memory 7 lumen 349.
  • the shape memory material 350 is configured to be manipulated (e.g., bent or otherwise shaped) which, in turn, causes the fluid collection assembly 300 to exhibit a shape that matches the anatomical shape of the patient and to conform to the shape of the anatomy of the wearer about the urethral opening (e.g., vaginal region).
  • the shape memory 7 material 350 enables a more anatomically precise fit for the fluid collection assembly 300 with the region about the urethral opening than conventional fluid collection assemblies.
  • the shape memory material 350 is sized, shaped, and positioned in the fluid collection assembly 300 to cause at least a portion of the fluid collection assembly 300 to retain a selected shape (e.g., geometric configuration).
  • the shape memory material 350 is configured to be bent, shaped, or otherwise deformed (hereafter collectively referred to as '‘shape,” '‘shaped,” or “shaping”).
  • the shape memory 7 material 350 may be configured to be shaped along an entire length thereof. Allowing the shape memory ⁇ material 350 to be shaped along the entire length thereof may allow the fluid collection assembly 300 to exhibit a shape that substantially corresponds to the anatomical features of the patient.
  • the shape memory material 350 may exhibit a first (e.g., initial) shape and the fluid collection assembly 300 may exhibit the first configuration (i.e., a generally linear shape) when the shape memory 7 material 350 exhibits the first shape.
  • the shape memory 7 material 350 may be manipulated to exhibit a second shape that is different than the first shape and the fluid collection assembly 300 may exhibit the second configuration (e.g., a generally curved cylindrical shape) when the shape memory material 350 exhibits the first (e.g., initial) shape and the fluid collection assembly 300 may exhibit the first configuration (i.e., a generally linear shape) when the shape memory 7 material 350 exhibits the first shape.
  • the shape memory 7 material 350 may be manipulated to exhibit a second shape that is different than the first shape and the fluid collection assembly 300 may exhibit the second configuration (e.g., a generally curved cylindrical shape) when the shape memory material 350 exhibits the second configuration
  • the shape memory material 350 may include a shape memory polymer or a metal (e.g., shape memory metal). Generally, the shape memory material 350 is composed to adopt an intermediate or permanent shape in response to a stimuli. For example, the shape memory material 350 may exhibit a first (e.g., initial) shape and may be switched from the first shape to a second shape by an external stimuli to adopt a second shape that is different from the first shape. The shape memory material 350 may also be switched from the second shape back to the first shape or a third shape that is different than the first and second shapes in response to the stimuli.
  • a first e.g., initial
  • the shape memory material 350 may also be switched from the second shape back to the first shape or a third shape that is different than the first and second shapes in response to the stimuli.
  • the stimuli may include an external physical force (e.g., bending force), heat, electrical bias, or a magnetic field.
  • an external physical force e.g., bending force
  • heat e.g., heat
  • electrical bias e.g., heat
  • magnetic field e.g., a magnetic field
  • shape memory is used to describe some of the “shape memory materials” herein, it should be understood that, in some examples, the material modified by the term “shape memory” may not necessarily need to return to a preselected shape upon application of a stimuli, as understood as the classical definition of the “shape memory material.” Rather, at least some of the shape memory materials disclosed herein may simply hold a selected shape when bent, set, or cured into a specific shape and/or when cooled in a specific shape, regardless of the stimuli applied thereto after.
  • the shape memory materials may be returned to the original shape or changed to a new shape by application of the stimuli.
  • a metal wire bent to a first shape may be utilized as the shape memory material 350, whereinafter the metal wire may be modified to a second shape via physical force applied thereto or via heating.
  • the shape memory material 350 may exhibit a selected shape, as discussed above and application of the stimuli may cause the shape memory material to deform (e.g., elastically deform or bend) into an intermediate shape.
  • the shape memory material 350 may return to the first initial shape upon removal of the stimuli such that the shape memory material 350 does not maintain the intermediate shape.
  • the shape memory material 350 is distinct (e.g., may move independently) from the conduit 314.
  • the shape memory material 350 may include a rod, a wire, a cable, or other structure disposed in the shape memory lumen 349.
  • the shape memory material 350 may have a cylindrical shape, an extruded ovoid shape, or a polygonal extruded shape.
  • the shape memory material 350 may be sized to fit within the shape memory' lumen 349.
  • the shape memory material 350 may have a diameter (or major dimension) that is at least about 0.03 inches, such as about 0.03 inches to about 0. 1 inches, about 0.03 inches
  • the shape memory material 350 may include a 12 gauge (2.05 mm) to 20 gauge (0.81 mm) wire, such as a 14 gauge (1.63 mm) wire.
  • the shape memory material 350 may be smaller than the shape memory lumen 349, such as at least 0.001 inches (25.4 pm) smaller, 0.001 inches to 0.1 inches, 0.001 inches to 0.01 inches (254 pm), 0.01 inches to 0.04 inches, 0.04 inches to 0. 1 inches smaller than the shape memory lumen 349.
  • Such examples provide a selected fit between the shape memory material 350 and the shape memory lumen 349, such as a slip fit, a sliding fit, a running fit, a loose fit, or the like that allow the shape memory material 150 to move (e.g., longitudinally) with respect to the shape memory lumen 349.
  • the shape memory material 350 may be slightly larger than the shape memory lumen 349, such as 0.001 inches larger to 0.01 inches larger. Such examples may provide a tight fit between the shape memory material 350 and the shape memory' lumen 349 such that the shape memory material 350 does not move with respect to the shape memory lumen 349.
  • the shape memory material 350 may include metal, such as an elemental metal, an alloy, or shape memory alloy.
  • Suitable shape memory metals may include aluminum, silver, copper, iron, nickel, zinc, tin, beryllium, or the like.
  • Suitable shape memory alloys may include standard steels, stainless steel, carbon alloy steel, head treated steel, galvanized steel, aluminum alloys, nickel-titanium alloys (e.g., Nitinol.
  • the shape memory metals or alloys may merely be metals or alloys that may be shaped to a selected configuration. In some examples, the shape memory metals or alloys may return to a primary shape when an external stimuli is applied thereto.
  • the outer surface of the shape memory metal may be coated with a polymer, anodized, passivated, or otherwise treated to prevent corrosion.
  • the shape memory metal may be annealed, tempered, or otherwise heat treated. Such heat treating may reduce brittle breakage and increase ductility of the shape memory material 350.
  • Shape memory' polymers may include polyurethane-based SMPs such as a copolymer (e.g., copolyester, polyurethane, polyetherester, etc.) including blocks of one or more of poly(s-caprolactone).
  • PET polyethyleneoxide
  • PEG polyethylene glycol
  • Pstyrene polymethylmethacrylate (612MA)
  • Poly butylmethacrylate polyurethane-based SMPs such as a copolymer (e.g., copolyester, polyurethane, polyetherester, etc.) including blocks of one or more of poly(s-caprolactone).
  • PET polyethyleneoxide
  • PEG polyethylene glycol
  • polystyrene polymethylmethacrylate
  • 612MA polymethylmethacrylate
  • PBMA Poly(N,N-butadiene), poly(N-methyl-N-oxazoline), polytetrahydrofuran, or poly(butylene terephthalate); thermoplastic polymers such as polyether ether ketone (PEEK), nylon, acetal, polytetrafluoroethylene (PTFE), polypropylene, polyethylene, acrylonitrile butadiene styrene (ABS), polysulphone, or the like; Polynorbonene; other deformable polymers; or any other shape memory polymer.
  • PEEK polyether ether ketone
  • PTFE polytetrafluoroethylene
  • ABS acrylonitrile butadiene styrene
  • ABS acrylonitrile butadiene styrene
  • Polysulphone or the like
  • Polynorbonene other deformable polymers
  • any other shape memory polymer any other shape memory polymer.
  • the shape memory material 350 may be retained within the shape memory lumen 349 by one or more plugs disposed at or near the (opposite) longitudinal ends thereof.
  • the plugs may include a stop plug 354 and an end plug 352.
  • the plugs may be sized, shaped, and located to fit within the shape memory lumen 349 and to prevent the shape memory material 350 from moving (longitudinally) within the shape memory' lumen 349 beyond the plugs.
  • the stop plug 354 and end plug 352 may be disposed at opposite ends of the shape memory material 350 in the shape memory' lumen 349 to prevent longitudinal movement of the shape memory material 350 within the shape memory' lumen 349.
  • the stop plug 354 and end plug 352 may be constructed of a resilient material, such as a polymer, an epoxy, rubber, a metal, wood, or the like. Suitable polymers may include a PVC, a polycarbonate, a polyethylene, a polypropylene, a poly acetal, polytetrafluoroethylene, an acrylic, or any of the polymers disclosed herein.
  • the stop plug 354 and end plug 352 may be constructed of a heat seal PVC.
  • the stop plug 354 and end plug 352 may be constructed of any of the metal materials disclosed herein. In such examples, the stop plug 354 and end plug 352 may be annealed, tempered, or otherwise heat treated.
  • the stop plug 354 and end plug 352 may be constructed of an adhesive, such as adhesive dams formed in the shape memory lumen 349.
  • the adhesive may be a UV cured adhesive, a catalyst cured adhesive, a heat cured adhesive, or the like.
  • the stop plug 354 and end plug 352 may have a major dimension that is sized to provide a press fit, an interference fit, a fixed fit, a similar fit, a force fit, or any' other tight fit within the shape memory' lumen 349.
  • the stop plug 354 and end plug 352 may have a largest outer dimension that is about 0.001 inches to 0.03 inches, about 0.001 inches to about 0.01 inches, about 0.01 inches to about 0.02 inches, or less than about 0.03 inches smaller than the inner dimension of the shape memory lumen 349.
  • the stop plug 354 and end plug 352 may match the shape of the shape memory' lumen 349, such as cylindrical, an extruded ovoid, an extruded polygonal shape, or the like.
  • one or more portions of the stop plug 354 and end plug 352 may have a tapered shape, such as cylindrical, rounded, or the like.
  • the stop plug 354 and end plug 352 may have a length or
  • the end plug 352 may (longitudinally) positioned within the shape memory lumen 349 at a point therein selected to be a distal-most point that the shape memory material 350 may extend.
  • the end plug 352 may be positioned within the shape memory lumen 349 at or adjacent to the inlet 312.
  • the end plug 352 may be spaced from the inlet 312 by at least about 0.01 inches, about 0.01 inches to about 0.25 inches, or less than about 0.5 inches.
  • the end plug 352 is sized, shaped, and positioned to retain the shape memory material 350 within the shape memory lumen 349 by preventing the shape memory material 350 from falling out of the distal end of the shape memory lumen 349. Accordingly, the end plug 352 is retained in place within the shape memory lumen 349 such as by fit with the shape memory lumen 349, an adhesive, or welding.
  • the stop plug 354 may be (longitudinally) positioned within the shape memory lumen 349 at a point therein selected to be a proximal-most point that the shape memory material 350 may extend.
  • the stop plug 354 may be disposed at a point in the shape memory lumen 349 that is within the chamber 304, within the fluid outlet 308, or even outside of the fluid outlet 308 (e.g., more proximal to the wearer or user than the fluid impermeable barrier).
  • the stop plug 354 may be disposed at a point in the shape memory lumen 349 that is outside of the fluid outlet 308 (e g., more proximal to the wearer or user than the fluid impermeable barrier 302).
  • the stop plug 354 is sized, shaped, and positioned to retain the shape memory material 350 within the distal end region of the shape memory lumen 349 by preventing the shape memory material 350 from sliding into a more proximal region of the shape memory lumen 349 than the region within or near the fluid impermeable barrier 302. Accordingly, the stop plug 354 is retained in place within the shape memory lumen 349 such as by fit with the shape memory lumen 349, an adhesive, or welding.
  • the space in the shape memory lumen 349 between the end plug 352 and the stop plug 354 may be longer than the shape memory material 350 to allow a selected amount of movement of the shape memory material 350 therein.
  • the space in the shape memory lumen 349 between the end plug 352 and the stop plug 354 may be at least about 0.1 inches longer than the shape memory material 350. such as about 0. 1 inches to about 1 inch (2.5 cm), about 0.1 inches to about 0.3 inches (0.76 cm), 0.15 (0.38 cm)
  • the ability of the shape memory material 350 to move within the shape memory lumen 349, provided by the space and a shape memory material 350 that is slidable within the shape memory lumen 349, allows for better bending (radial bending, kinking, or the like) of the shape memory material 350, conduit 314, and fluid collection assembly 300, than a shape memory material 350 that is fixed with respect to the shape memory lumen 349.
  • Such improved bending is due to a reduction in tensile forces introduced during bending of the shape memory material 350 when the shape memory material 350 is not adhered to the inside surface of the shape memory lumen 349.
  • the end plug 352 and stop plug 354 may be retained within the shape memory lumen 349 by an adhesive, fit (between the plugs and the lumen), or welding (e.g., melting).
  • the stop plug 354 may have an adhesive applied thereto prior to positioning with the shape memory’ lumen 349.
  • the shape memory material 350 may be disposed in the shape memory' lumen 349 so that the shape memory material can slide or move longitudinally therein.
  • the end plug 352 may have an adhesive applied thereto prior to positioning with the shape memory’ lumen 349. such that a selected amount of space is provided between the plugs and the shape memory material 350.
  • FIG. 4A is an isometric view’ of a fluid collection assembly 400, according to an embodiment.
  • FIGS. 4B and 4C are cross- sectional views of the fluid collection assembly 400 taken along planes 4B-4B and 4C-4C, respectively, shown in FIG. 4A. Except as otherwise disclosed herein, the fluid collection assembly’ 400 is the same as or substantially similar to any of the fluid collection assemblies disclosed herein.
  • the fluid collection assembly 400 includes a fluid impermeable barrier 402.
  • the fluid impermeable barrier 402 at least defines a chamber 404, at least one opening 406, and a fluid outlet 408.
  • the fluid collection assembly 400 also includes a porous material 410 disposed in the chamber 404 that extends across the opening 406.
  • the porous material 410 may be the same as or substantially similar to any of the porous materials disclosed herein.
  • the porous material 410 includes an outer layer 412. an intermediate layer 414, and an inner layer 416.
  • the porous material 410 includes a first layer and a second layer bonded to the first layer using one or more melted regions or
  • the first layer forms one of the outer layer 412. the intermediate layer 414, or the inner layer 416 and the second layer forms an adjacent layer of the porous material 410.
  • the fluid collection assembly 400 includes a porous material 410 disposed in the chamber 404.
  • the porous material 410 may cover at least a portion (e.g., all) of the opening 406.
  • the porous material 410 is exposed to the environment outside of the chamber 404 through the opening 406.
  • the porous material 410 may include an outer layer 412, an intermediate layer 414, and at least one inner layer 416 that are each distinct from each other (e.g., formed from different materials, exhibit different contact angles with water, etc.).
  • the outer layer 412 of the porous material 410 is positioned within the chamber 404 to extend across the opening 406.
  • the outer layer 412 is positioned in the porous material 410 to be closer to the urethral opening of the individual than the intermediate layer 414.
  • the outer layer 412 may include the portions of the porous material 410 that initially receive the bodily fluids from the individual.
  • the outer layer 412 may include at least one hydrophilic material.
  • the outer layer 412 is configured to quickly receive the bodily fluids discharged from the individual since the outer layer 412 may initially receive (or at least receive before the intermediate layer 414) the bodily fluids to prevent the bodily fluids leaking from the porous material 410.
  • the outer layer 412 is able to quickly receive the bodily fluids and, thus, forming the outer layer 412 from at least one hydrophilic material allows the outer layer 412 to quickly receive the bodily fluids.
  • the outer layer 412 may be hydrophilic.
  • the hydrophilicity of the outer layer 412 may cause the outer layer 412 to quickly receive bodily fluids therein, thereby preventing or at least inhibiting leakage of bodily fluids caused by a large discharge of bodily fluids over a short period of time.
  • the outer layer 412 is selected to exhibit a hydrophilicity that is less than (e.g. , exhibit a contact angle that is greater than) the intermediate hydrophilic material of the intermediate layer 414. Since the outer layer 412 is hydrophilic, the outer layer 412 is able to quickly receive bodily fluids.
  • the decreased hydrophilicity of the outer layer 412 relative to the inner hydrophilic material allows the portions of the porous material 410 that contact the patient to be drier than if the outer layer 412 or the intermediate layer 414 was omitted from the porous material 410.
  • the outer layer 412 may include at least one of polypropylene or polyethylene, such as a blend of polypropylene and polyethylene. It is noted that, generally, polypropylene and polyethylene are hydrophobic. As such, the outer layer 412 may include at least one surfactant (e.g., any of the surfactants disclosed herein) disposed in at least a portion thereof which effectively causes the outer layer 412 to behave similar to a hydrophilic material. In other words, the outer layer 412 may be the same as or substantially similar to the porous body 101 of FIG. 1.
  • the outer layer 412 may include one or more hydrophilic materials other than or in addition to polypropylene and polyethylene.
  • the outer layer 412 may include at least one of natural or treated acry lics, polyvinylchloride, polyester, polyurethane, cellulose-based fibers, or any other suitable hydrophilic material.
  • the outer layer 412 of the porous material 410 may be selected to exhibit a density of about 50 kg/m 3 to about 100 kg/m 3 , about 75 kg/m 3 to about 125 kg/m 3 , about 100 kg/m 3 to about 150 kg/m 3 , about 125 kg/m 3 to about 175 kg/m 3 , about 150 kg/m 3 to about 200 kg/m 3 , about 175 kg/m 3 to about 225 kg/m 3 , about 200 kg/m 3 to about 250 kg/m 3 , about 225 kg/m 3 to about 275 kg/m 3 , about 250 kg/m 3 to about 300 kg/m 3 , about 275 kg/m 3 to about 325 kg/m 3 , about 300 kg/m 3 to about 350 kg/m 3 , about 325 kg/m 3 to about 375 kg/m 3 , or about 350 kg/m 3 to about 400 kg/m 3 .
  • the outer layer 412 may be hydrophilic due to the presence of the surfactant therein which may cause the outer layer 412 to retain the bodily fluids therein. It is noted that the hydrophobicity of the polypropylene or the polyethylene may reduce the quantity of bodily fluids that are retained in the outer layer 412. However, to further decrease the quantity of bodily fluids retained by the outer layer 412, the outer layer 412 may be configured to be relatively thin.
  • the outer layer 412 may be configured to exhibit a thickness measured perpendicularly to the longitudinal axis 430 (e.g., measured radially) that is about 2 mm or less, about 1.5 mm or less, about 1.25 mm or less, about 1 mm or less, about 800 pm or less, about 700 pm or less, about 600 pm or less, about 500 pm or less, about 400 pm or less, about 300 pm or less, about 250 pm or less, about 200 pm or less, about 150 pm or less, about 130 pm or less, about 100 pm or less, about 75 pm or less, about 60 pm or less, about 50 pm or less, about 40 pm or less, about 30 pm or less, about 25 pm or less, about 20 pm or less, or in ranges of about 20 pm to about 30 pm, about 25 pm to about 40 pm, about 30 pm to about 50 pm, about 40 pm to about 60 pm. about 50 pm to about 75 pm, about 60 pm to about 100 pm, about 75 pm to about 130 pm, about 100 pm to about 150 pm, about 130 pm to about 200
  • the decreasing volume of bodily fluids held within the outer layer 412 allows the air flow through the chamber 404 to quickly evaporate the bodily fluids that are retained in the outer layer 412 (z.e., the bodily fluids that failed to transfer from the outer layer 412 to the intermediate layer 414) thereby maintaining the porous material 410 dry. Further, decreasing the thickness of the outer layer 412 may allow the intermediate layer 414 to pull more bodily fluids from the outer layer 412.
  • the outer layer 412 may be formed from at least one nonwoven web.
  • the outer layer 412 may be formed from any suitable nonwoven web.
  • the nonwoven web of the outer layer 412 includes one or more of at least one carded web, at least one needle punched web, at least one air laid web, at least one spunbonded web, at least one spunlaced web, at least one vertical lapped nonwoven fabric, at least one horizontal lapped nonwoven fabric, at least one crossed lapped nonwoven fabric, or any of the other nonwoven webs disclosed herein.
  • the outer layer 412 may include a woven fabric instead of or in addition to a nonwoven web.
  • Forming the outer layer 412 from a woven material may increase the durability of the porous material 410 than if the outer layer 412 is formed from a nonwoven material. However, forming the outer layer 412 from a woven material may decrease the compressibility of the porous material 410 thereby making the porous material 410 less comfortable and may make conforming the porous material 410 to the vaginal region, which limits leaks, more difficult. Also, it is more difficult to form a woven outer layer 412 than a nonwoven outer layer 412. As such, using the woven outer layer 412 may cause logistic issues, increase manufacturing difficulties, and increase cost. Further, it may be difficult to obtain a woven outer layer 412 exhibiting a sufficiently low basis weight to be effective wherein a nonwoven outer layer 412 exhibiting a sufficiently low basis weight may be easy to obtain.
  • the outer layer 412 is disposed on an outer surface of the intermediate layer 414.
  • the bodily fluids received (e.g., directly) by the outer layer 412 flow from the outer layer 412 to the intermediate layer 414.
  • the bodily fluids may flow from the outer layer 412 to the intermediate layer 414 for a variety of reasons. For example, the relatively small
  • the outer layer 412 only allows the outer layer 412 to hold a relatively small volume of bodily fluids. As such, the outer layer 412 may become quickly saturated with the bodily fluids thereby forcing the bodily fluids to flow from the outer layer 412 to the intermediate layer 414. Further, as will be discussed in more detail below, a suction may be applied to the chamber 404. The suction may cause the bodily fluids to flow from the outer layer 412 into the intermediate layer 414. Additionally, the intermediate layer 414 includes an intermediate hydrophilic material. The hydrophilicity of the intermediate hydrophilic material pulls the bodily fluids from the outer layer 412 into the intermediate layer 414.
  • the intermediate layer 414 may be hydrophilic.
  • the intermediate layer 414 may include an intermediate hydrophilic material that is hydrophilic.
  • the overall hydrophilicity of the intermediate layer 414 is greater than the overall hydrophilicity of the outer layer 412.
  • the intermediate layer 414 may exhibit a contact angle with water than is less than the outer layer 412. respectively, by about 5° of more, about 10° or more, about 15° or more, about 20° or more, about 25° or more, about 30° or more, about 35° or more, about 40° or more, about 45° or more, about 50° or more, about 60° or more, about 70° or more, about 80° or more, or in ranges of about 5° to about 15°, about 10° to about 20°, about 15° to about 25°, about 20° to about 30°, about 25° to about 35°, about 30° to about 40°, about 35° to about 45°, about 40° to about 50°, about 45° to about 60°, about 50° to about 70°, or about 60° to about 80°.
  • the increased hydrophilicity of the intermediate layer 414 relative to the outer layer 412 causes the intermediate hydrophilic material to pull bodily fluids from the outer layer 412.
  • the increased hydrophilicity of the intermediate layer 414 relative to the outer layer 412 causes the intermediate layer 414 to exhibit a greater affinity for the bodily fluids thereby causing the bodily fluids in the outer layer 412 to preferentially flow' to the intermediate layer 414.
  • Due to hydrogen bonding the bodily fluids that flow' into the intermediate layer 414 also pull additional bodily fluids into the intermediate layer 414.
  • the ability of the intermediate layer 414 to pull bodily fluids from the outer layer 412 into the intermediate layer 414 decreases the volume of bodily fluids in the outer layer 412 (i.e.,
  • the intermediate layer 414 may pull sufficient quantities of bodily fluids from the outer layer 412 that the quantities of bodily fluids in the outer layer 412 is negligible and may be relatively quickly evaporated due to air flow through the outer layer 412 caused by the suction provided to the chamber 404. Further, the increased hydrophilicity of the intermediate layer 414 prevent or at least minimizes backflow of the bodily fluids from the intermediate layer 414 to the outer layer 412.
  • the intermediate layer 414 includes bamboo.
  • bamboo is a hydrophilic material that exhibits a relatively low contact angle of water.
  • bamboo naturally exhibits a hydrophilicity' that is greater than polypropylene and polyethylene. It has also been found that bamboo has a greater synergistic effect with polypropylene and polyethylene than expected.
  • an intermediate layer 414 including bamboo is able to pull a greater percentage of bodily fluids from a polypropylene and/or polyethylene and minimize back flow of bodily fluids from the intermediate layer 414 to the outer layer 412 better than expected.
  • the bamboo of the intermediate layer 414 may be formed from any bamboo material.
  • the intermediate layer 414 is formed from natural bamboo.
  • the natural bamboo may be more ecologically friendly than other bamboo materials and may require less manufacturing than non-natural bamboo.
  • the intermediate layer 414 may include black bamboo (z.e., bamboo from phyllostachys nigra). Black bamboo exhibits greater antimicrobial properties than other types of bamboo; though, it is noted, the other types of bamboo also exhibit antimicrobial properties.
  • the bamboo of the intermediate layer 414 may include bamboo kun.
  • bamboo kun is a material naturally found in bamboo.
  • the bamboo kun causes the intermediate layer 414 to exhibit antifungal properties and antibacterial properties against both Gram-positive and Gram-negative bacteria.
  • CAUTI catheter-assisted urinary tract infections
  • the bamboo kun of the intermediate layer 414 is not vulnerable to attack by infectious microbials that may cause CAUTI.
  • the bamboo kun also causes the intermediate layer 414 to be odor resistant, unlike porous materials used in conventional fluid collection assemblies.
  • the odor resistant abilities of the intermediate layer 414 makes using the fluid collection assemblies including the intermediate layer 414 less embarrassing to use since, unlike conventional fluid collection assemblies, the fluid collection assemblies including
  • the intermediate layer 414 are unlikely to have a noticeable odor of urine or blood.
  • the bamboo kun also causes the intermediate layer 414 to repel dust mites, other bugs, other infectious microorganisms, and viruses.
  • the bamboo kun also repeals these organisms while the bamboo that forms the intermediate layer 414 is grown.
  • the bamboo that forms the intermediate layer 414 may be grown without pesticides, fungicides, and insecticides.
  • the intermediate layer 414 to be less likely to be contaminated with pesticides, fungicides, and insecticides compared to other natural porous materials without having to process the intermediate layer 414 to remove such materials. Also, the bamboo kun causes the intermediate layer 414 to be more hypoallergenic than other porous materials used in conventional fluid collection assemblies.
  • the intermediate layer 414 may include one or more hydrophilic intermediate materials instead of or in addition to bamboo.
  • the intermediate layer 414 includes at least one of cotton, rayon, or viscose.
  • the intermediate layer 414 may be formed from any cellulose-based material.
  • the intermediate layer 414 is formed from naturally derived cellulose which may be more ecologically friendly than other cellulose materials.
  • the intermediate layer 414 may include any of the nonwoven or woven fabrics disclosed herein.
  • the intermediate layer 414 may include any of the porous materials disclosed herein, such as a porous material including at least one surfactant disposed therein.
  • cotton, rayon, viscose, and other cellulose-base materials have a more synergistic relationship with the outer layer 412 (e.g., polypropylene and polyethylene) than other hydrophilic materials.
  • the synergistic relationship includes quickly and effectively moving the bodily fluids from the outer layer 412 to the intermediate layer 414. That said, it is currently believed that bamboo is better able to receive bodily fluids from the outer layer 412 and minimize back flow of the bodily fluids than cotton, rayon, viscose, and other cellulose-base materials.
  • the hydrophilicity of the intermediate layer 414 may be an inherent property of the bamboo and some of the other materials disclosed herein that are used to form the intermediate layer 414.
  • the hydrophilicity of the intermediate layer 414 may be changed (e.g., increased or decreased) by at least one of impurities or functional groups added to the intermediate layer 414, otherwise treating the intermediate layer 414, or coating the intermediate layer 414 with a material that exhibits a
  • hydrophilicity of the intermediate layer 414 may depend on the temperature, humidity’, and other factors and that the hydrophilicity of the materials disclosed herein are measured at room temperature, at sea level, and at a humidity of 30-50%.
  • the intermediate layer 414 of the porous material 410 may be selected to exhibit a density of about 50 kg/m 3 to about 100 kg/m 3 , about 75 kg/m' to about 125 kg/m 3 , about 100 kg/m 3 to about 150 kg/m 3 , about 125 kg/m 3 to about 175 kg/m 3 , about 150 kg/m 3 to about 200 kg/m 3 , about 175 kg/m 3 to about 225 kg/m 3 , about 200 kg/m 3 to about 250 kg/m 3 , about 225 kg/m 3 to about 275 kg/m 3 , about 250 kg/m 3 to about 300 kg/m 3 , about 275 kg/m 3 to about 325 kg/m 3 , about 300 kg/m 3 to about 350 kg/m 3 , about 325 kg/m 3 to about 375 kg/m 3 , about 350 kg/m 3 to about 400 kg/m 3 , about 375 kg/m 3 to about 425 kg/m 3 , about
  • the intermediate layer 414 may be formed from a hydrophilic material which may cause the intermediate layer 414 to retain the bodily fluids therein. To decrease the quantity of bodily fluids retained by the intermediate layer 414, the intermediate layer 414 may be configured to be relatively thin.
  • the intermediate layer 414 may be configured to exhibit a thickness measured perpendicularly to the longitudinal axis 130 (e.g, measured radially) that is about 2 mm or less, about 1.5 mm or less, about 1.25 mm or less, about 1 mm or less, about 800 pm or less, about 700 pm or less, about 600 pm or less, about 500 pm or less, about 400 pm or less, about 300 pm or less, about 250 pm or less, about 200 pm or less, about 150 pm or less, about 130 pm or less, about 100 pm or less, about 75 pm or less, about 60 pm or less, about 50 pm or less, about 40 pm or less, about 30 pm or less, about 25 pm or less, about 20 pm or less, or in ranges of about 20 pm to about 30 pm, about 25 pm to about 40 pm, about 30 pm to about 50 pm, about 40 pm to about 60 pm, about 50 pm to about 75 pm, about 60 pm to about 100 pm, about 75 pm to about 130 pm, about 100 pm to about 150 pm, about 130 pm to about 200 pm.
  • the relatively small thickness of the intermediate layer 414 decreases the overall volume of the intermediate layer 414 thereby decreasing the volume of bodily fluids that may be retained in the
  • the intermediate layer 414 may be disposed on an outer surface of the inner layer 416.
  • the inner layer 416 is configured to support the outer layer 412 and the intermediate layer 414 since the outer layer 412 and the intermediate layer 414 may be formed from a relatively foldable, flimsy, or otherwise easily deformable material.
  • the inner layer 416 may be positioned such that the outer layer 412 and the intermediate layer 414 are disposed between the inner layer 416 and the fluid impermeable barrier 402.
  • the inner layer 416 may support and maintain the position of the outer layer 412 and the intermediate layer 414.
  • the inner layer 416 may include any hydrophobic
  • the inner layer 416 may include any other suitable hydrophobic material (e.g, spun nylon fiber, a gauze, a polyurethane foam, a polyethylene foam, hydrophobic polypropylene, hydrophobic polyethylene, PET, or a polyvinyl chloride foam).
  • the inner layer 416 may include a plurality of fibers formed into a nonwoven material (e.g., any of the nonwoven materials disclosed herein), a woven material, or an open cell foam.
  • the inner layer 416 is substantially similar to the porous material 200.
  • the inner layer 416 may include any of the porous material disclosed herein.
  • the intermediate layer 414 is able to effectively cause bodily fluids to flow effectively through the porous material 410 even though the intermediate layer 414 using two different interactions. Further, it is currently believed that the cellulose materials disclosed herein, and in particular bamboo, have a more effective hydrophilic-hydrophobic interaction with the inner layer 416 (z.e.. are able to more effectively move bodily fluids from the intermediate layer 414 to the inner layer 416) than other hydrophilic materials.
  • the inner layer 416 may exhibit a thickness (e.g., radius and/or diameter) that is about 100 jam to about 150 pm, about 130 pm to about 200 pm, about 150 pm to about 300 pm, about 200 pm to about 400 pm, about 300 pm to about 500 pm, about 400 pm to
  • increasing the thickness of the inner layer 416 increases the quantity of bodily fluids that may be temporarily stored therein and may flow therethrough thereby decreasing the likelihood that the fluid collection assembly 400 leaks.
  • increasing the thickness of the inner layer 416 may dilute any suction force applied to the chamber 404 and may make it difficult to position the fluid collection assembly 400 between the legs of the patient.
  • the thickness of the inner layer 416 may be greater than the thickness of the outer layer 412. Generally, decreasing the thickness of the outer layer 412 decreases the volume of bodily fluids that may be stored in the outer layer 412 and decreases the volume of bodily fluids that the inner layer 416 may pull from the outer layer 412. Also, increasing the thickness of the inner layer 416 may increase the ability of inner layer 416 to promote flow of the bodily fluids towards to the fluid outlet 408 (e.g, towards an inlet of the conduit 426).
  • the inner layer 416 includes at least one inner porous material.
  • the inner porous material 416 includes at least one of a vertical lapped nonwoven material, another nonwoven material, a woven material, spun nylon fibers, a polyurethane foam, a polyvinyl chloride foam, a polyethylene foam, a hydrophobic polypropylene, or hydrophobic polyethylene.
  • the inner layer 416 includes one of the porous materials (e.g., a porous material including a first layer, a second layer, and a plurality of fibers extending between the first and second layers, wherein the first and second layers may include a woven material) disclosed in U.S. Patent Application No.
  • the inner porous material is able to quickly receive bodily fluids from the individual, even when the individual discharges a large quantity of bodily fluids over a short period of time.
  • the inner porous material may facilitate moving the bodily fluids through the chamber 404 of the fluid collection assembly 400 and towards an outlet (e.g. , the fluid outlet 408 or an inlet of a conduit 426 disposed through the fluid outlet 408) which allows the porous material 410 to remain dry.
  • an outlet e.g. , the fluid outlet 408 or an inlet of a conduit 426 disposed through the fluid outlet 408
  • the inner porous material may exhibit a density of about 100 g/m 2 /cm to about 250 g/m 2 /cm, such as about 130 g/m 2 /cm to about 240 g/m 2 /cm, about 100 g/m 2 /cm to about
  • 140 g/m 2 /cm about 120 g/m 2 /cm to about 160 g/m 2 /cm, about 140 g/m 2 /cm to about 180 g/m 2 /cm. about 160 g/m 2 /cm to about 200 g/m 2 /cm, about 180 g/m 2 /cm to about 220 g/m 2 /cm, or about 200 g/m 2 /cm to about 250 g/m 2 /cm.
  • increasing the density of the inner porous material increases the strength of the inner porous material.
  • increasing the density of the inner porous material may decrease the porosity of the inner porous material which decreases the quantity of bodily fluids that may be temporarily stored in the porous material 410 and decrease the flow rate of the bodily fluids through the inner porous material.
  • the density of the inner porous material may be selected based on balancing the desired strength, porosity, and flow rate of the bodily fluids through the inner porous material.
  • the inner porous material may exhibit a density of about 50 kgsm cm or greater, about 75 kgsm cm or greater, about 100 kgsm cm or greater, about 125 kgsm cm or greater, about 150 kgsm cm or greater, about 175 kgsm cm or greater, about 200 kgsm cm or greater, about 250 kgsm cm or greater, about 300 kgsm cm or greater, or in ranges of about 50 kgsm cm to about 100 kgsm cm, about 75 kgsm cm to about 125 kgsm cm, about 100 kgsm cm to about 150 kgsm cm, about 125 kgsm cm to about 175 kgsm cm, about 150 kgsm cm to about 200 kgsm cm, about 175 kgsm cm to about 250 kgsm cm, or about 200 kgsm cm to about 300 kgsm cm.
  • increasing the density of the inner porous material increases the strength of the inner porous material.
  • increasing the density of the inner porous material may decrease the porosity’ of the inner porous material which decreases the quantity of bodily fluids that may be temporarily stored in the porous material 410 and decrease the flow rate of the bodily fluids through the inner porous material.
  • the density of the inner porous material may be selected based on balancing the desired strength, porosity, and flow rate of the bodily fluids through the inner porous material.
  • the inner layer 416 may exhibit a basis weight of about 2 gsm to about 5 gsm, about 4 gsm to about 7.5 gsm. about 5 gsm to about 10 gsm, about 7.5 gsm to about 12.5 gsm, about 10 gsm to about 15 gsm, about 12.5 gsm to about 20 gsm, about 15 gsm to about
  • the basis weight of the inner layer 416 is a function of the density and thickness of the inner layer 416. As such, the basis weight of the inner layer 416 may be selected for any of the same reasons as the density and thickness of the inner layer 416.
  • the basis weight of the inner layer 416 is selected to be less than the basis weight of the outer layer 412.
  • the lower basis weight of the inner layer 416 increases the void space in the inner layer 416 which facilitate flowing the bodily fluids therethrough (e.g., towards the fluid outlet 408) whereas the greater basis weight of the outer layer 412 may increase the surface area thereof.
  • the porous material 410 includes an outer layer 412 including hydrophilic polypropylene or hydrophilic polyethylene with at least one surfactant, an intermediate layer 414 including bamboo, and an inner support layer 416 including polyurethane, polyether, nylon, PET, or hydrophobic polypropylene.
  • the porous material 410 includes an outer layer 412 including at least one of hydrophilic polypropylene or hydrophilic polyethylene with at least one surfactant, an intermediate layer 414 including bamboo, and an inner support layer 41 including a nonwoven material (e g, a vertical lapped nonwoven material and/or a polyethylene terephthalate nonwoven material).
  • the porous material 410 includes an outer layer 412 including hydrophilic polypropylene or hydrophilic polyethylene with at least one surfactant, an intermediate layer 414 including bamboo, and an inner support layer 416 including a first layer, a second layer, and a plurality of fibers extending between the first and second layers, wherein the first and second layers may include a woven material.
  • the porous material 410 includes an outer layer 412 including hydrophilic polypropylene or hydrophilic polyethylene with at least one surfactant, an intermediate layer 414 including bamboo, and an inner support layer 416 including PET. It is currently believed that these particular porous materials 410 may exhibit a relatively good synergistic relationship compared to other porous materials.
  • the embodiment that includes the hydrophilic polyethylene and/or polypropylene outer layer 412, the bamboo intermediate layer 414, and the PET inner support layer 416 is able to quickly and effectively transfer bodily fluids from the outer layer 412 to the intermediate layer 414, and from the inner support layer 416 to the inner support layer 416.
  • the layers are able to quickly and effectively transfer bodily fluids from the outer layer 412 to the intermediate layer 414, and from the inner support layer 416 to the inner support layer 416.
  • each of the layers of the porous materials should directly contact adjacent layers of the porous material for the quick and effective transfer of bodily fluids from the outer layer to the intermediate layer and from the intermediate layer to the inner layer to occur.
  • two or more layers of the porous material 410 may be bonded together using one or more melting and entangled regions to avoid these issues associated with adhesively attached two different porous layers together.
  • two of the outer layer 412, the intermediate layer 414, and the inner layer 416 may be attached to an adjacent one of the layers using the melted or entangled regions discussed above while the remaining layer may be attached to the other layers using an adhesive layer.
  • the outer layer 412 and the intermediate layer 414 may be attached together using the melted regions or entangled regions discussed above since these layers of the porous material 410 initially receive the bodily fluids and the melted regions or entangle regions facilitate quickly receiving the bodily fluids and moving the bodily fluids into an interior of the porous material 410.
  • the inner layer 416 may be attached to the intermediate layer using an adhesive layer 418 (shown schematically in FIGS.
  • the bodily fluids are already received, flowed, and dispersed into the porous material 410 before reaching the inner layer 416 and, thus, the decreased fluid flow through the adhesive layer 418 is less important. Further, it may be easier to attach the intermediate and inner layers 414, 416 together using the adhesive layer 418 since the relatively large thickness of the inner layer 416 may make attaching the intermediate and inner layers 414, 416 using melting or entangled regions difficult.
  • the adhesive layer 418 bonds the intermediate layer 414 and the inner layer 416 together such that substantially no air gaps form therebetween.
  • the adhesive layer 418 may prevent or at least inhibit air gaps from forming between the intermediate and inner layers 414, 416 of the porous material 410 even during prolonged use of the fluid collection assembly 400, when the fluid collection assembly 400 is bent, or even when the porous material 410 accidently rips.
  • the adhesive layer 418 may include any suitable material that bonds the layers of the porous material 410 together.
  • the adhesive layer 418 includes a hot melt adhesive or any other suitable adhesive.
  • the adhesive layer 418 is only positioned between a portion of the adjacent layers of the porous material 410.
  • the adhesive layer 418 may be positioned between about 40% to about 80% of the surface area of the adjacent layers of the porous material 410. such as about 40% to about 30%, about 20% to about 40%, about 30% to about 50%, about 40% to about 60%, about 50% to about 70%, or about 60% to about 80%.
  • Positioning the adhesive layer 418 between a portion of the adjacent layers allows holes to be present in the adhesive layer 418.
  • the bodily fluids may flow between the layers of the porous material 410 through the holes in the adhesive layer 418. It is noted that the adhesive layer 418 may form a plurality of patches.
  • the patches formed by the adhesive layer 418 may be interconnected or not interconnected (z.e., spaced from each other).
  • one or more layers of the porous material 410 may be omitted.
  • one or more of the outer layer 412, the intermediate layer 414, or the inner layer 416 may be omitted.
  • the thicknesses of the layers of the porous material 410 may be adjusted when one or more layers are omitted.
  • the thickness of the intermediate layer 414 may be increased to extend from the conduit 426 to the outer layer 412 when the inner layer 416 is omitted.
  • the porous material 410 may include one or more additional layers (not shown), such as a thin layer on the outer layer 412 that is more comfortable than the outer layer 412.
  • FIG. 4D is a view illustration of a system 450 configured to form the porous material 410, according to an embodiment. It is noted that the system 450 may be configured to form any of the porous materials disclosed herein, for example, by adding or removing rollers.
  • the system 450 includes a first roll 452, a second roll 454, and a third roll 456.
  • the first roll 452 includes and is a source of an initial porous material 413.
  • the initial porous material 413 may be the same as the porous material 100 illustrated in FIG. 1A or the porous material 200 illustrated in FIG. 2A.
  • the initial porous material 413 may include a first layer and a second layer bonded together using a plurality of melted or entangled regions.
  • the first roll 452 may be omitted and replaced with one of the systems 120 or 220 illustrated in FIGS. IB or 2B, respectively.
  • the initial porous material 413 includes the outer layer 414 and the intermediate layer 416 though, it is noted, that the initial porous material 413 may include
  • the second roll 454 includes and is a source of the remaining layer of the porous material 410.
  • the second roll 454 includes and is the source of the inner layer 416 though, it is noted, the second roll 454 may include the outer layer 412.
  • the third roll 456 includes an adhesive material (e.g., hot melt adhesive, poly urethane, polyether, or acry lic) configured to form the adhesive layer 418.
  • the system 450 is configured to position the initial porous material 413 adjacent to the inner layer 416.
  • the system 450 may also be configured to position the adhesive layer 418 between the two layers, such as between the initial porous material 413 an the inner layer 416.
  • the third roll 456 may be positioned between the first and second rolls 452. 454.
  • the system 450 may pull the materials from the rolls to form the porous material 410 using any suitable technique.
  • the system 450 may include one or more rollers 462.
  • the roller 462 may rotate and, responsive to the rotation thereof, pull the materials from the rolls to form the porous material 410.
  • the rollers 462 may allow each of the layers to be simultaneously or substantially simultaneously positioned adjacent to each other.
  • the system 450 including the rollers 462 may pull the layers into the rollers 462 and form the porous material 410 at a rate of about 45 cm/minute to 300 cm/minute, such as in ranges of about 45 cm/minutes to about 50 cm/minutes, about 25 cm/minute to about 75 cm/minute.
  • the system 450 may include a conveyor belt and one or more of the layers may be positioned sequentially on the conveyor belt to form the porous material 410.
  • the layers of the porous material 410 may be attached to each other using any suitable technique.
  • the rollers 462 may be configured to attach the initial porous material 413 to the inner layer 416 together.
  • the adhesive layer 418 may include a heat-activated adhesive (e.g., a hot melt adhesive).
  • one or more of the rollers 462 may be heated such that passing the layers of the porous material 410 adjacent to the heated roller 462 activates the heat-activated adhesive.
  • the temperature of the heated rollers 462 may depend on the composition of the heat-activated adhesive. In a particular example, the heated rollers 462 may exhibit a temperature of about 90 °C to about 120 °C (e.g., when the adhesive is a polyethylene
  • the first and second bonding layers 418, 420 may include a pressure-activated adhesive and passing the layers of the porous material 410 adj acent to the roller 462 provides the pressure that activates the adhesive.
  • the first and second bonding layers 418, 420 are formed using an ultrasonic weld, a radio frequency weld, or any other suitable weld.
  • the system 450 forms a porous material 410 that is a long, continuous sheet.
  • the system 450 may include cutting the long, continuous porous material 410 to form a plurality of porous materials 410 that are sized to fit in the chamber 404.
  • the system 450 may cut the continuous porous materials 410 into a plurality of porous materials 410 exhibiting a length of about 10 cm to about 30 cm (e.g, about 10 cm to 20 cm, about 15 cm to about 25 cm, or about 20 cm to about 30 cm) and a width of about 4 cm to about 12 cm (e g., about 4 cm to about 8 cm, about 6 cm to about 10 cm, or about 8 cm to about 12 cm).
  • the fluid collection assemblies disclosed herein may include four or more porous materials.
  • FIG. 5A is an isometric of a fluid collection assembly 500, according to an embodiment.
  • FIG. 5B is a cross-sectional view of the fluid collection assembly 500.
  • the fluid collection assembly 500 is the same as or substantially similar to any of the fluid collection assemblies disclosed herein.
  • the fluid collection assembly 500 includes a fluid impermeable barrier 502.
  • the fluid impermeable barrier 502 at least defines a chamber 504, at least one opening 506, and a fluid outlet 508.
  • the fluid collection assembly 500 also includes a porous material 510 disposed in the chamber 504 that extends across the opening 506.
  • the porous material 510 includes an outer layer 536 and an inner layer 538. Except as otherwise disclosed herein, the outer layer 536 and the inner layer 548 may be the same as or substantially similar to any of the outer and inner layers disclosed herein.
  • the outer layer 536 may be disposed on the inner layer 538, extend across the opening 506.
  • the outer layer 536 may not not extend around the circumference of the inner layer 538 but only extends around a portion of the inner layer 538, such as around the portion of the inner layer 538 adjacent to the opening 506.
  • the fluid collection assembly 500 include flexible gooseneck tubing 555.
  • the gooseneck tubing 555 may be disposed over the conduit 514 (as shown)
  • gooseneck tubing that may be used in the fluid collection assembly 555 or any of the fluid collection assemblies disclosed herein are disclosed in U.S. Patent No. 11,865,030 issued on January 9, 2024, U.S. Patent Application No. 17/013,822 filed on September 7, 2020, and U.S. Patent 11,839,567 issued on December 12, 2023, the disclosure of each of which are incorporated herein, in its entirety, by this reference.
  • the two arms 557 are positioned on the fluid collection assembly 100 on a rear or back surface of the fluid impermeable barrier 502, generally distal to the opening 506. In other embodiments, the two arms 557 may be positioned at various positions on the rear or back surface of the fluid impermeable barrier 502. In some embodiments (not shown), the two arms 557 may be positioned on the fluid collection assembly on a front surface of the fluid impermeable barrier 502.
  • the urine collection device 900 also includes a porous material 910 positioned within the chamber and extending at least partially between the distal end region 905 and the proximal end region 903.
  • the porous material 910 may be shaped generally complementary to the shape of the chamber of the fluid impermeable barrier 902.
  • the porous material 910 is spaced from the edges of the fluid impermeable barrier 902 that extend at least partially between the distal end region 905 and the proximal end region 903.
  • the porous material 910 is positioned to abut the edges of the fluid impermeable barrier 902 such that fluid impermeable barrier 902 retains fluid in the porous material 910 from the opening 906 to the sump 909.
  • the porous material 910 can be configured to wick and/or allow transport of fluid away from the opening 906, thereby preventing the fluid from escaping the chamber.
  • the porous material 910 also can wick and/or allow transport of the fluid generally towards the sump 909.
  • the porous material 910 may include any of the porous materials disclosed herein.
  • the porous material 910 may include a first layer and a second layer bonded together using one or more melted or entangled regions.
  • the porous material 910 can include a one-way fluid movement fabric. As such, the porous material 910 can remove fluid from the area around the penis, thereby leaving the area and urethra dry.
  • the porous material 910 can enable the fluid to flow generally towards the sump 909 and the tube 908 within the chamber.
  • the porous material 910 can include a porous or fibrous material, such as hydrophilic polyolefin.
  • the porous material 910 consists of or consists essentially of a porous or fibrous material, such as hydrophilic polyolefin.
  • polyolefin that can be used in the porous material 910 include, but are not limited to, polyethylene, polypropylene, polyisobutylene, ethylene propylene rubber, ethylene propylene diene monomer, or combinations thereof.
  • the porous material 910 can be manufactured according to various manufacturing methods, such as molding, extrusion, or sintering.
  • the porous material 910 can include varying densities or dimensions.
  • the porous material 910 can include two or more layers of fluid permeable materials.
  • the porous material 910 can include a outer layer (e.g, that includes at least one surfactant disposed therein) covering or wrapped around a inner layer, with both the outer layer and the inner layer being disposed in the chamber.
  • the outer layer can cover or extend across at least a portion (e.g., all) of at least
  • the outer layer and the inner layer can be configured to wick any fluid away from the opening 906, thereby preventing the fluid from escaping the chamber and promoting removal of the fluid through the tube 908.
  • the permeable properties referred to herein can be wicking, capillary action, diffusion, or other similar properties or processes, and are referred to herein as “permeable’' and/or “wicking.”
  • the outer layer and the inner layer also can wick the fluid generally towards an interior of the chamber, such as the sump 909.
  • the outer layer can include any material that can wick the fluid.
  • the outer layer can include fabric, such as a gauze (e.g. , a silk, linen, polymer based materials such as polyester, or cotton gauze), nylon (such as a spun nylon fibers), another soft fabric (e.g., jersey knit fabric or the like), or another smooth fabric (e.g, rayon, satin, or the like).
  • a gauze e.g., a silk, linen, polymer based materials such as polyester, or cotton gauze
  • nylon such as a spun nylon fibers
  • another soft fabric e.g., jersey knit fabric or the like
  • another smooth fabric e.g, rayon, satin, or the like.
  • Forming the outer layer from gauze, soft fabric, and/or smooth fabric can reduce chaffing caused by the urine collection device 900.
  • Other embodiments of outer layers and inner layers are disclosed
  • the porous material 910 includes a inner layer including a porous spun nylon fiber structure and a fluid permeable wicking membrane including gauze at least partially enclosing the spun nylon fiber structure.
  • the urine collection device 900 also includes a tube 908 extending into the chamber and having an end 918 positioned proximate to the distal end region 905 of the fluid impermeable barrier 902.
  • the tube 908 includes a tube opening proximate to the end of the tube 908.
  • the sump 909 may be defined as the region or area between the tube opening 906 and the distal end region 905 of the fluid impermeable barrier 902. At least some of the porous material 910 may extend into the sump 909. Fluid discharged on the porous material 910 may flow to and pool in the sump 909 for removal when a vacuum is applied on the tube 908.
  • the tube 908 may extend through a fluid outlet 912 in the distal end region 905 of the fluid impermeable barrier 902 and into the chamber.
  • the urine may flow to the lowest point to form a pool of urine at the distal end region 905 of the fluid impermeable barrier 902.
  • the end of the tube 908 and the tube opening are spaced
  • the distal portion of the porous material 910 is shaped substantially complementary to the distal end region 905.
  • the distal portion 925 of the porous material 910 may be spaced from the distal end region 905 of the fluid impermeable barrier 902, such that a portion of the sump 909 is devoid of the porous material 910.
  • the distal portion of the porous material 910 interfaces at least a portion (e.g., all) of the fluid impermeable barrier 902 at the distal end region 905.
  • FIG. 10A is an isometric view of a fluid collection assembly 1000, according to an embodiment.
  • FIGS. 10B and 10C are cross-sectional views of the fluid collection assembly 1000 taken along planes 10B-10B and 10C- 10C, respectively, shown in FIG. 10A.
  • the fluid collection assembly 1000 is the same as or substantially similar to any of the fluid collection assemblies disclosed herein.
  • the fluid collection assembly 1000 includes sheath 1001 including a fluid impermeable barrier 1002.
  • the fluid impermeable barrier 1002 at least defines a chamber 1004, at least one opening 1006, and a fluid outlet 1008.
  • the fluid collection assembly 1000 also includes a porous material 1010 disposed in the chamber 1004 that extends at least adjacent to the opening 1006.
  • the porous material 1010 may include any of the porous materials disclosed herein, such as a porous material including a first layer and a second layer bonded together using one or more melted or entangled regions.
  • the fluid collection assembly 1000 also includes a base 1003.
  • the fluid outlet 1008 may be located at or near the proximal end region 1012 of the sheath 1001.
  • a conduit 1014 may extend through the fluid outlet 1008 into the chamber 1004.
  • the conduit 1014 may include a plurality of branches in the chamber 1004 extending from the primary portion of the conduit 1014 that extends through the fluid outlet 1008.
  • the conduit 1014 may include branches that extend along an outer periphery of the chamber 1004.
  • the branches may extend to or near the distal end region 1013.
  • the fluid impermeable barrier 1002 may include one or more folds 1016 formed therein.
  • the folds 1016 may allow the volume of the fluid impermeable barrier 1002 to expand as a penis is inserted into the chamber 1004 and/or the penis disposed in the chamber 1004 changes sizes (e.g., becomes erect or flaccid).
  • fluid collection assemblies that may include any of the features disclosed herein, such as a porous body that includes at least one surfactant disposed in at least a portion thereof, are disclosed in U.S. Patent No. 11,504,265 issued on
  • FIG. 11 is a block diagram of a fluid collection system 1170 for fluid collection, according to an embodiment.
  • the fluid collection system 1170 includes a fluid collection assembly 1100, a fluid storage container 1172, and a vacuum source 1174.
  • the fluid collection assembly 1 100 may be the same or substantially similar to any of the fluid collection assemblies disclosed herein.
  • the fluid collection assembly 1100, the fluid storage container 1172, and the vacuum source 1174 may be fluidly coupled to each other via one or more conduits 1176.
  • fluid collection assembly 1100 may be operably coupled to one or more of the fluid storage container 1172 or the vacuum source 1174 via the conduit 1176.
  • the bodily fluids collected in the fluid collection assembly 1100 may be removed from the fluid collection assembly 1100 via the conduit 1176 which protrudes into the fluid collection assembly 1100.
  • an inlet of the conduit 1176 may extend into the fluid collection assembly 1100, such as to a reservoir therein.
  • the outlet of the conduit 1176 may extend into the fluid collection assembly 1100 or the vacuum source 1174.
  • Suction force may be introduced into the chamber of the fluid collection assembly 1100 via the inlet of the conduit 1176 responsive to suction (e.g., vacuum) force applied at the outlet of the conduit 1176.
  • the suction force may be applied to the outlet of the conduit 1176 by the vacuum source 1174 either directly or indirectly.
  • the suction force may be applied indirectly via the fluid storage container 1172.
  • the outlet of the conduit 1 176 may be disposed within the fluid storage container 1172 and an additional conduit 1176 may extend from the fluid storage container 1172 to the vacuum source 1174.
  • the vacuum source 1174 may apply suction to the fluid collection assembly 1100 via the fluid storage container 1172.
  • the suction force may be applied directly via the vacuum source 1174.
  • the outlet of the conduit 1176 may be disposed within the vacuum source 1174.
  • An additional conduit 1176 may extend from the vacuum source 1174 to a point outside of the fluid collection assembly 1100, such as to the fluid storage container 1172.
  • the vacuum source 1174 may be disposed between the fluid collection assembly 1100 and the fluid storage container 1 172.
  • the fluid storage container 1172 is sized and shaped to retain bodily fluids therein.
  • the fluid storage container 1172 may include a bag (e.g, drainage bag), a bottle or cup (e.g., collection jar), or any other enclosed container for storing bodily fluids such as urine.
  • the conduit 1176 may extend from the fluid collection assembly 1100 and attach to the fluid storage container 1172 at a first point therein.
  • An additional conduit 1176 may attach to the fluid storage container 1172 at a second point thereon and may extend and attach to the vacuum source 1174.
  • a vacuum e.g., suction
  • Bodily fluids, such as urine may be drained from the fluid collection assembly 1100 using the vacuum source 1174.
  • the vacuum source 1174 may include one or more of a manual vacuum pump, and electric vacuum pump, a diaphragm pump, a centrifugal pump, a displacement pump, a magnetically driven pump, a peristaltic pump, or any pump configured to produce a vacuum.
  • the vacuum source 1174 may provide a vacuum or suction to remove bodily fluids from the fluid collection assembly 1100.
  • the vacuum source 1174 may be powered by one or more of a power cord (e.g, connected to a power socket), one or more batteries, or even manual power (e.g., a hand operated vacuum pump).
  • the vacuum source 1174 may be sized and shaped to fit outside of, on, or within the fluid collection assembly 1100.
  • the vacuum source 1174 may include one or more miniaturized pumps or one or more micro pumps.
  • the vacuum sources 1174 disclosed herein may include one or more of a switch, a button, a plug, a remote, or any other device suitable to activate the vacuum source 1174.
  • Terms of degree indicate structurally or functionally insignificant variations.
  • the term of degree when the term of degree is included with a term indicating quantity, the term of degree is interpreted to mean ⁇ 10%, ⁇ 5%. or ⁇ 2% of the term indicating quantity.
  • the term of degree when the term of degree is used to modify a shape, the term of degree indicates that the shape being modified by the term of degree has the appearance of the disclosed shape.
  • the term of degree may be used to indicate that the shape may have rounded comers instead of sharp comers, curved edges instead of straight edges, one or more protrusions extending therefrom, is oblong, is the same as the disclosed shape, etc.

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Abstract

An example fluid collection assembly includes a fluid impermeable barrier defining at least a chamber, at least one opening, and a fluid outlet. The fluid collection assembly also includes a porous material disposed in the chamber. The porous material includes a first layer and a second layer. The porous material also includes at least one of a plurality of melted regions or a plurality of entangled regions. The plurality of melted regions or the plurality of entangled regions extend through the first layer and into the second layer thereby attaching the first and second layers together.

Description

FLUID COLLECTION ASSEMBLIES INCLUDING AT LEAST ONE OF A PLURALITY OF MELTED REGIONS OR A PLURALITY OF ENTANGLED REGIONS
CROSS-REFERENCE TO RELATED APPLICATION(S)
[0001] This application claims priority to U.S. Provisional Application No. 63/683,428 filed on August 15, 2024, the disclosure of which is incorporated herein, in its entirety, by this reference.
BACKGROUND
[0002] A person or animal may have limited or impaired mobility so typical urination processes are challenging or impossible. For example, a person may experience or have a disability that impairs mobility. A person may have restricted travel conditions such as those experienced by pilots, drivers, and workers in hazardous areas. Additionally, sometimes bodily fluids collection is needed for monitoring purposes or clinical testing.
[0003] Urinary catheters, such as a Foley catheter, can address some of these circumstances, such as incontinence. Unfortunately, urinary catheters can be uncomfortable, painful, and can lead to complications, such as infections. Additionally, bed pans, which are receptacles used for the toileting of bedridden individuals are sometimes used. However, bedpans can be prone to discomfort, spills, and other hygiene issues.
SUMMARY
[0004] Embodiments disclosed herein are related to fluid collection assemblies, fluid collection systems including the same, and methods of making and using the same. In an embodiment, a fluid collection assembly is disclosed. The fluid collection assembly includes a fluid impermeable barrier defining at least a chamber, at least one opening, and a fluid outlet. The fluid collection assembly also includes a porous material disposed in the chamber. The porous material includes a first layer, a second layer abutting the first layer, and a plurality of melted regions extending at least through the first layer into the second layer that attached the first layer to the second layer.
[0005] In an embodiment, a method to form a fluid collection assembly is disclosed. The method includes positioning a first layer to abut a second layer. The first layer and the second layer forms at least a portion of a porous material. The method also includes melting a plurality of regions of the porous material to form a plurality of melted regions. The plurality of melting regions extends at least through the first layer and into the second layer to attach the first layer to the second layer. The method further includes, after melting a
- Page 1 - Docket No. 318812WO01 504795-1114 plurality of regions of the first layer, disposing the porous material in a chamber defined by a fluid impermeable barrier. The fluid impermeable barrier defines at least one opening and a fluid outlet.
[0006] In an embodiment, a fluid collection assembly is disclosed. The fluid collection assembly includes a fluid impermeable barrier defining at least a chamber, at least one opening, and a fluid outlet. The fluid collection assembly also includes a porous material disposed in the chamber. The porous material includes an first layer and an second layer. The first layer and the second layer including a plurality of fibers. The porous material also includes a plurality of entangled regions including some of the plurality of fibers of the first layer and the inner being entangled together. The plurality of entangled regions extend through the first layer into the second layer that attached the first layer to the second layer.
[0007] In an embodiment, a method to form a fluid collection assembly is disclosed. The method includes positioning a first layer to abut a second layer. The first layer and the second layer forming at least a portion of a porous material. The first layer and the second layer include a plurality of fibers. The method also includes entangling some of the plurality of fibers of the first layer and the second layer of the porous material to form a plurality of entangled regions. The plurality of entangled regions extend at least through the first layer and into the second layer to attach the first layer to the second layer. The method further includes, after entangling some of the plurality of fibers of the first layer and the second layer, disposing the porous material in a chamber defined by a fluid impermeable barrier. The fluid impermeable barrier defines at least one opening and a fluid outlet.
[0008] Features from any of the disclosed embodiments may be used in combination with one another, without limitation. In addition, other features and advantages of the present disclosure will become apparent to those of ordinary skill in the art through consideration of the following detailed description and the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] The drawings illustrate several embodiments of the present disclosure, wherein identical reference numerals refer to identical or similar elements or features in different views or embodiments shown in the drawings.
[0010] FIG. 1A is a cross-sectional view of a portion of a porous material, according to an embodiment.
[0011] FIG. IB is a schematic view of a system configured to form the porous material, according to an embodiment.
- Page 2 - Docket No. 318812WO01 504795-1114 [0012] FIG. 2A is a cross-sectional view of a porous material, according to an embodiment.
[0013] FIG. 2B is a schematic of a system configured to form the porous material, according to an embodiment. [0014] FIG. 3A is an isometric view of a fluid collection assembly, according to an embodiment.
[0015] FIGS. 3B and 3C are cross-sectional views of the fluid collection assembly taken along planes 3B-1B and 3C-3C, respectively, shown in FIG. 3A.
[0016] FIG. 3D is a cross-sectional view of a portion of the fluid collection assembly taken from the box illustrated in FIG. 3C, according to an embodiment.
[0017] FIG. 3E is a cross-sectional view of the conduit, according to an embodiment.
[0018] FIG. 4A is an isometric view of a fluid collection assembly, according to an embodiment.
[0019] FIGS. 4B and 4C are cross-sectional views of the fluid collection assembly taken along planes 4B-4B and 4C-4C, respectively, shown in FIG. 4A.
[0020] FIG. 4D is a view illustration of a system 450 configured to form the porous material 410, according to an embodiment.
[0021] FIG. 5A is isometric view of a fluid collection assembly, according to an embodiment. [0022] FIG. 5B is a cross-sectional view of the fluid collection assembly shown in
FIG. 5 A
[0023] FIG. 6 is an isometric view of a fluid collection assembly, according to an embodiment.
[0024] FIGS. 7A and 7B are top isometric and bottom isometric views of a fluid collection assembly, respectively, according to an embodiment.
[0025] FIG. 8 is a cross-sectional view of a fluid collection assembly, according to an embodiment.
[0026] FIG. 9 is a front view of a male urine collection device, according to an embodiment. [0027] FIG. 10A is an isometric view of a fluid collection assembly, according to an embodiment.
[0028] FIGS. 10B and 10C are cross-sectional views of the fluid collection assembly taken along planes 10B-10B and 10C-10C, respectively, shown in FIG. 10A.
- Page 3 - Docket No. 318812WO01 504795-1114 [0029] FIG. 11 is a block diagram of a fluid collection system for fluid collection, according to an embodiment.
DETAILED DESCRIPTION
[0030] Embodiments disclosed herein are related to fluid collection assemblies, fluid collection systems including the same, and methods of making and using the same. An example fluid collection assembly includes a fluid impermeable barrier defining at least a chamber, at least one opening, and a fluid outlet. The fluid collection assembly also includes a porous material disposed in the chamber. The porous material includes a first layer and a second layer. The porous material also includes at least one of a plurality of melted regions or a plurality of entangled regions. The plurality of melted regions or the plurality of entangled regions extend through the first layer and into the second layer thereby attaching the first and second layers together.
[0031] During use, the fluid collection assembly may be positioned on an individual such that the opening is positioned adjacent to a urethral opening (e.g., female urethral opening or a buried penis) or receives a male urethral opening (z.e., penis). The individual may discharge one or more bodily fluids, such as urine, blood, or sweat. The bodily fluids may flow through the opening and into the porous material. The bodily fluids received by the porous material may flow from an outer layer to an inner layer. The bodily fluids may be removed from the chamber via the fluid outlet (e.g., via an inlet of a conduit that is at least partially disposed in the fluid outlet). In an embodiment, a suction may be applied to the chamber from a vacuum source which removes the bodily fluids from the chamber.
[0032] The fluid collection assembly is configured to prevent or at least inhibit leaking of the bodily fluids therefrom during use. There are many factors that determine whether bodily fluids may leak from the fluid collection assembly during use, such as the position of the fluid collection assembly on the individual, the anatomical fit of the fluid collection assembly, the rate at which the individual discharges the bodily fluids, etc. One factor that determines whether the bodily fluids leak from the fluid collection assembly is the flow rate of the bodily fluids through the porous material. Generally, the flow rate of the bodily fluids in the porous material is selected to be sufficient to prevent any portion of the porous material becoming saturated with the bodily fluids since bodily fluids are more likely to leak from saturated portions of the porous material.
[0033] The flow rate of the bodily fluids in the porous material may depend on a number of factors. For example, the flow rate of the bodily fluids in the porous material may depend on the contact angle between the porous material and water (water is typically
- Page 4 - Docket No. 318812WO01 504795-1114 a major constituent of bodily fluids), the porosity of the porous material, the suction applied to the chamber from the vacuum source, and the anatomical fit between the fluid collection assembly and the individual (e.g., to prevent the vacuum from being lost through gaps between the fluid impermeable barrier and the individual). The flow rate of the bodily fluids in the porous material also depends on the flow rate of the bodily fluids between two immediately adj acent (z. e. , contacting) layers of the porous material. It has been found that any gaps between the two immediately adjacent layers of the porous material limits the flow rate of the bodily fluids between the two immediately adjacent layers. For example, the surface tension of the bodily fluids may cause the bodily fluids to at least initially remain in one of the layers of the porous material rather than flow through the gaps. As such, the gaps between the two immediately adjacent layers act as a fluid flow barrier between the two immediately adjacent layers.
[0034] Conventional fluid collection assemblies have used various techniques to prevent the formation of gaps between two immediately adjacent layers of the porous material. In an example, some conventional fluid collection assemblies wrap one layer of the porous material tightly around another layer of the porous material to avoid the formation of gaps. However, in such conventional fluid collection assemblies, gaps may still form between the two layers due to stretching of the outer layer, localized compression of the inner layer, or bending of the porous material during use. In an example, some conventional fluid collection assemblies apply an adhesive layer between the two adjacent layers of the porous material. However, the adhesive layer at least partially occupies the pores of the porous material thereby limiting flow of the bodily fluids through the porous material and may also be a physical barrier between the two layers which limits flow of the bodily fluids therethrough. Further, the bodily fluids may cause the adhesive layer to degrade or soften during use limit may limit the ability of the adhesive to keep the two layers together.
[0035] The fluid collection assemblies disclosed herein include melted regions or entangled regions, as discussed in more detail below, to keep two adjacent layers of the porous material together. The melted or entangled regions form physical attachments between the two layers of the porous material that are likely to keep the two layers together even if one layer stretches or becomes locally compressed or the porous material bends. The melted or entangled regions also form physical attachments between the two layer of the porous material that are unlikely to degrade or soften during use. Also, unlike at least some adhesives, the bodily fluids may be able to flow through the melted or entangled
- Page 5 - Docket No. 318812WO01 504795-1114 regions such that the melted or entangled regions do not form a barrier or at least form less of a barrier to the flow of the bodily fluids than the adhesives.
[0036] FIG. 1A is a cross-sectional view of a portion of a porous material 100, according to an embodiment. The porous material 100 is an example of a porous material formed using thermal needle punch lamination though, it is noted, that the porous material
100 may be formed using another technique. The porous material 100 includes a first layer 102 having a first outer surface 104 and a first inner surface 106 opposite the first outer surface 104. The porous material 100 also includes a second layer 108 having a second inner surface 110 and a second outer surface 112 opposite the second inner surface 110. The first and second layers 102, 108 are arranged such that the first inner surface 106 of the first layer 102 abuts the second inner surface 110 of the second layer 108. The porous material 100 includes one or more melted regions 114. The melted regions 114 extend through the first layer 102 and into the second layer 108. The melted regions 114 attach the first layer 102 and the second layer 108 together. [0037] In an embodiment, the first layer 102 may positioned closer to a portion of the individual (e.g, the urethral opening of the individual) than the second layer 108 such that the first layer 102 may receive bodily fluids discharged from the individual before the second layer 108. In such an embodiment, the first layer 102 may be the outermost layer of the porous material 100 (e.g, the outer layer 311 of FIG. 3A, the outer layer 412 of FIG. 4B. etc.) or the first layer 102 may be a non-outer layer of the porous material 100 (e.g, the intermediate layer 414 of FIG. 4B). The second layer 108 may be an intermediate layer of the porous material 100 (e.g, the intermediate layer 414 of FIG. 4B) or the second layer 108 may be an innermost layer of the porous material 100 (e.g., the inner layer 313 of FIG. 3A or the inner layer 416 of FIG. 4B). Selecting the first layer 102 to be positioned closer to a portion of the individual may facilitate flow of the bodily fluids from the first layer 102 to the second layer 108, as will be discussed in more detail below.
[0038] In an embodiment, the second layer 108 may be positioned closer to a portion of the individual than the first layer 102 such that the second layer 108 may receive bodily fluids discharged from the individual before the first layer 102. In such an embodiment. the second layer 108 may be the outermost layer of the porous material 100 (e.g., the outer layer 311 of FIG. 3A, the outer layer 412 of FIG. 4B, etc.) or the second layer 108 may be a non-outer layer of the porous material 100 (e.g, the intermediate layer 414 of FIG. 4B). The first layer 102 may be an intermediate layer of the porous material 100 (e.g, the intermediate layer 414 of FIG. 4B) or the first layer 102 may be an innermost layer of the
- Page 6 - Docket No. 318812WO01 504795-1114 porous material 100 (e.g., the inner layer 313 of FIG. 3A or the inner layer 416 of FIG.
4B)
[0039] The porous material 100 is configured to be disposed in a chamber defined by a fluid impermeable barrier of a fluid collection assembly. One or more of the first layer 102 or the second layer 108 may include one or more of a foam, spun fibers, a vertical nonwoven material, a woven material, a quilted material, or the like. One or more of the first layer 102 or the second layer 108 may be formed from any suitable natural material (e.g., fibers, fabric, foam) or synthetic material (e.g., fibers, fabric, foam). In some embodiments, one or more of the first layer 102 or the second layer 108 may include an open cell foam (e.g. , polyethylene terephthalate foam), a carded web, spun fibers (e.g.. spun nylon fibers), nonwoven fibers (e.g., polyethylene terephthalate nonwoven material), woven fibers, or the like. For example, one or more of the first layer 102 or the second layer 108 may include an open cell foam or a vertically nonwoven material. In an embodiment, one or more of the first layer 102 or the second layer 108 may be formed from synthetic fibers or foam. Examples of synthetic fibers or foam includes a polyester (e.g. , polyethylene terephthalate), polyethylene, polypropylene, polyurethane (e.g. viscoelastic polyurethane), latex, silicone, nylon, nitrile, or the like. Some embodiments, one or more of the first layer 102 or the second layer 108 may be formed from natural fibers which may be more sustainable and biodegradable than the synthetic fibers. Examples of natural fibers includes cellulose, cotton, bamboo, wool, or the like. One or more of the first layer 102 or the second layer 108 may include any of the other porous materials disclosed herein.
[0040] In a particular example, the first layer 102 may include hydrophilic polypropylene or hydrophilic polyethylene (e.g., polypropylene or polyethylene including a polyethylene glycol fatty acid ester surfactant or otherwise treated to be hydrophilic) and the second layer 108 may include bamboo. In such an example, the first layer 102 and the second layer 108 may have a synergistic effect that allows the first layer 102 to quickly receive bodily fluids therein, move the bodily fluids from the first layer 102 into the second layer 108, and maintain the first layer 102 relatively dr ’. For instance, the hydrophilicity of the first layer 102 allows the first layer 102 to quickly receive bodily fluids, such as to initially receive bodily fluids that are discharged from the urethral opening of the individual. However, the bamboo second layer 108 may exhibit a hydrophilicity' that is greater than (i.e., exhibits a contact angle with water that is less than) the first layer 102. The greater hydrophilicity of the bamboo second layer 108 pulls bodily fluids from the first layer 102 and into the second layer 108, thereby facilitating quick transfer of bodily fluids
- Page 7 - Docket No. 318812WO01 504795-1114 from the first layer 102 to the second layer 108. The greater hydrophilicity of the bamboo second layer 108 also helps dry the first layer 102 since the hydrophilic pull from the bamboo second layer 108 removes most of the bodily fluids from the first layer 102. The dry first layer 102 minimizes discomfort caused by using a fluid collection assembly including the porous material 100, minimizes skin degradation caused by the bodily fluids, and allows the fluid collection assembly including the porous material 100 to be used for longer periods of time (e.g.. greater than 24 hours). In this particular example, the first layer 102 and the second layer 108 may be positioned adjacent to a polyethylene terephthalate (“PET”) inner layer since the bamboo second layer 108 is able to transfer bodily fluids quickly and effectively into the PET inner layer thereby preventing the first and second layers 102. 108 from becoming saturated with bodily fluids. Further, the PET inner layer is able to quickly move substantially all of the bodily fluids towards a fluid outlet such that the PET inner layer is substantially dry a short period of time after receiving the bodily fluids. The dry PET inner layer facilitates drying of the particular first and second layers 102, 108 of this example. It is noted that the PET inner layer may include a nonwoven material and, more particularly a vertical lapped nonwoven material, since such nonwoven materials facilitate drawing fluids into the PET inner layer from the bamboo second layer 108 and improve flow of the bodily fluids in the PET inner layer towards the fluid outlet thereby facilitating drying of the porous material 100. That said, the first layer 102 and/or the second layer 108 may include porous materials other than hydrophilic polypropylene/poly ethylene and bamboo, respectively, as discussed in more detail herein. Further, the first layer 102 and/or the second layer 108 may be used with an inner layer other than PET, as discussed in more detail herein.
[0041] In some embodiments, an open-cell foam may be used for one or more of the first layer 102 or the second layer 108. The open-cell foam may have a density and porosity selected to provide a desired amount and rate of fluid transport therethrough. For example, the open-cell foam may have a density of at least 40 kg/m3, such as about 40 kg/m3 to about 500 kg/m3, about 50 kg/m' to about 400 kg/m3, about 50 kg/m3 to about 200 kg/m3, about 200 kg/m3 to about 400 kg/m3, or less than 500 kg/m3. The open-cell foam may exhibit a porosity of at least about 15 pores per inch (PPI), such as about 20 PPI to about 120 PPI, about 20 PPI to about 50 PPI, about 50 PPI to about 100 PPI, or less than about 120 PPI. The material of the open-cell foam may be selected to have desired surface properties (e.g., hydrophilicity or hydrophobicity) and structural properties (e.g.. bending stiffness or the
- Page 8 - Docket No. 318812WO01 504795-1114 like). As explained in more detail below, the open-cell foam may include any of a number of different materials, such as rubber, one or more polymers, or the like.
[0042] In some embodiments, one or more of the first layer 102 or the second layer 108 may be selected to exhibit a basis weight of about 5 grams per square meter ("gsm") to about 10 gsm, about 7.5 gsm to about 15 gsm, about 10 gsm to about 20 gsm, about 15 gm/m2 to about 25 gsm, about 20 gsm to about 30 gsm, about 25 gsm to about 35 gsm, about 30 gsm to about 40 gsm, about 35 gsm to about 45 gsm. about 40 gsm to about 50 gsm, about 45 gsm to about 55 gsm, about 50 gsm to about 60 gsm, or about 55 gsm to about 70 gsm. In a particular embodiment, one or more of the first layer 102 or the second layer 108 exhibits a basis weight of about 10 gsm to about 35 gsm. The basis weight of one or more of the first layer 102 or the second layer 108 is a function of the density and thickness of one or more of the first layer 102 or the second layer 108. It is noted that the surface area of one or more of the first layer 102 or the second layer 108 depends, in part, on the basis weight thereof. As such, increasing the basis w eight of one or more of the first layer 102 or the second layer 108 (to an extent) may increase the surface area of one or more of the first layer 102 or the second layer 108. How quickly one or more of the first layer 102 or the second layer 108 is able to pull bodily fluids into itself depends, in part, on the surface area thereof. In other words, increasing the basis weight of one or more of the first layer 102 or the second layer 108 may improve the rate at which one or more of the first layer 102 or the second layer 108 may receive the bodily fluids. However, increasing the basis weight of one or more of the first layer 1 2 or the second layer 108 may decrease the volume of the void space of one or more of the first layer 102 or the second layer 108 that may temporarily hold the bodily fluids therein. As such, the basis weight of one or more of the first layer 102 or the second layer 108 may be selected by balancing these factors.
[0043] In an embodiment, one or more of the first layer 102 or the second layer 108 is formed from a plurality of fibers. The plurality of fibers may exhibit an average length and an average lateral dimension (e.g., diameter). In an example, the plurality of fibers may be selected to exhibit an average length that is about 500 pm to about 2 mm, about 1 mm to about 3 mm, about 2 mm to about 4 mm, about 3 mm to about 5 mm, about 4 mm to about 6 mm, about 5 mm to about 7 mm, about 6 mm to about 8 mm, about 7 mm to about 9 mm, about 8 mm to about 1 cm, about 9 mm to about 1.2 cm, about 1 cm to about 1.4 cm, about 1.2 cm to about 1.6 cm, about 1.4 cm to about 1.8 cm, about 1.6 cm to about 2 cm, about 1.8 cm to about 2.25 cm, about 2 cm to about 2.5 cm, about 2.25 cm to about 2.75 cm,
- Page 9 - Docket No. 318812WO01 504795-1114 about 2.5 cm to about 3 cm, about 2.75 cm to about 3.25 cm, about 3 cm to about 3.5 cm, about 3.25 cm to about 3.75 cm. about 3.5 cm to about 4 cm, about 3.75 cm to about 4.25 cm, about 4 cm to about 4.5 cm, about 4.25 cm to about 4.75 cm, about 4.5 cm to about 5 cm, about 4.75 cm to about 5.5 cm, about 5 cm to about 6 cm, about 5.5 cm to about 6.5 cm, about 6 cm to about 7 cm, about 6.5 cm to about 7.5 cm, about 7 cm to about 8 cm, about 7.5 cm to about 8.5 cm, about 8 cm to about 9 cm, about 8.5 cm to about 9.5 cm, or about 9 cm to about 10 cm. In an example, the fibers may exhibit an average lateral dimension (e.g, diameter) that is about 1 pm to about 2 pm, about 1.5 pm to about 3 pm, about 2 pm to about 4 pm, about 3 pm to about 5 pm, about 4 pm to about 7 pm, about 6 pm to about 10 pm, about 8 pm to about 12.5 pm, about 10 pm to about 15 pm, about 12.5 pm to about 17.5 pm, about 15 pm to about 20 pm. about 17.5 pm to about 25 pm, about 20 pm to about 30 pm, about 25 pm to about 35 pm, about 30 pm to about 40 pm, about
35 pm to about 45 pm, about 40 pm to about 50 pm, about 45 pm to about 55 pm, about
50 pm to about 60 pm, about 55 pm to about 65 pm, about 60 pm to about 70 pm, about 65 pm to about 75 pm, about 70 pm to about 80 pm, about 75 pm to about 85 pm, about
80 pm to about 90 pm, about 85 pm to about 95 pm, or about 90 pm to about 100 pm. The average length and average lateral dimension of the fibers may be selected such that the fibers exhibits an average aspect ratio. For example, the average length and average lateral dimension of the fibers may be selected such that the fibers exhibit an average aspect ratio (average length: average lateral dimension) of about 100: 1 to about 200: 1, about 150: 1 to about 250: 1 , about 200: 1 to about 300: 1 , about 250: 1 to about 350: 1, about 300: 1 to about 400: 1, about 350: 1 to about 450:1, about 400: 1 to about 500: 1, about 450:1 to about 550: 1, about 500: 1 to about 600: 1, about 550: 1 to about 650:1, about 600: 1 to about 700: 1, about 650: 1 to about 750: 1, about 700: 1 to about 800: 1, about 750: 1 to about 850: 1, about 800: 1 to about 900: 1, about 850: 1 to about 950: 1, or about 900: 1 to about 1,000: 1.
[0044] The average length, average lateral dimension, and the average aspect ratio of the fibers may be selected based on a number of factors. In an example, increasing the aspect ratio (e.g., decreasing the average length and/or increasing the average lateral dimension) increases the durability of one or more of the first layer 102 or the second layer 108 but may decrease the strength of one or more of the first layer 102 or the second layer
108. In an example, increasing the aspect ratio (e.g. , increasing average length) of the fibers may increase the mechanical binding of the fibers. For instance, increasing the aspect ratio of the fibers facilitates entanglement of the fibers which increases the strength and durability of one or more of the first layer 102 or the second layer 108. The entanglement
- Page 10 - Docket No. 318812WO01 504795-1114 of the fibers may also preclude or minimize the amount of other binding techniques that are applied to one or more of the first layer 102 or the second layer 108, such as heat, chemical binding, or other mechanical binding (e.g., further entanglement caused by needle punching or high pressure water jets). However, increasing the aspect ratio of the fibers may make dispersion of the fibers more difficult (e.g. , uniformity of one or more of the first layer 102 or the second layer 108 difficult). Further, increasing the aspect ratio may limit the type of nonwoven webs that may form one or more of the first layer 102 or the second layer 108. For instance, fibers with large average lengths (e.g., large aspect ratios) may not be used in carded webs and may have to be used in air laid webs. In an example, decreasing the aspect ratio may decrease the entanglement of the fibers thereby necessitating further binding of the fibers. As such, the average length, average lateral dimension, and average aspect ratio of the fibers may be selected based on the desired strength, mechanical binding between the fibers, the amount of processing of one or more of the first layer 102 or the second layer 108 (e.g. , is further processing to increasing the binding via heat, etc. desired), the type of nonwoven web that includes the fibers, the uniformity of the fibers, etc.
[0045] Generally, the average person discharges urine at a rate of about 6 ml/s to about 50 ml/s, such as at a rate of about 10 ml/s to about 25 ml/s. The rate at which the person urinate may vary', such as based on the size of the person and the age of the person. One or more of the first layer 102 or the second layer 108 may be selected to capture and transport the bodily fluids at a rate that is comparable to the rate at which the individual discharged bodily fluids to prevent leaks. For example, one or more of the first layer 102 or the second layer 108 may be selected to capture and transport the bodily fluids at a rate that is greater than about 6 ml/s, greater than about 10 ml/s, greater than about 30 ml/s, about 6 ml/s to about 50 ml/s, about 6 ml/s to about 20 ml/s, about 20 ml/s to about 40 ml/s. about 6 ml/s to about 15 ml/s, about 15 ml/s to about 25 ml/s, less than about 50 ml/s, or less than about 30 ml/s.
[0046] In some embodiments, one or more of the first layer 102 or the second layer 108 may be configured to wick and/or otherwise allow transport of any bodily fluids away from an opening defined by a fluid impermeable barrier or otherwise transport the bodily fluids away from the urethral opening and the individual, thereby preventing the bodily fluids from leaking or remaining in contact with the individual. The permeable properties referred to herein may be wicking, capillary action, diffusion, or other similar properties or processes, and are referred to herein as '■permeable" and/or ‘"wicking.” Such “wicking” and/or “permeable” properties may not include absorption of the bodily fluids into at least
- Page 11 - Docket No. 318812WO01 504795-1114 a portion of one or more of the first layer 102 or the second layer 108. Put another way, substantially no absorption or solubility of the bodily fluids into one or more of the first layer 102 or the second layer 108 material may take place after one or more of the first layer 102 or the second layer 108 is exposed to the bodily fluids and removed from the bodily fluids for a time. While no absorption or solubility is desired, the term “substantially no absorption” may allow for nominal amounts of absorption and/or solubility of the bodily fluids into one or more of the first layer 102 or the second layer 108 (e.g, absorbency), such as less than about 30 wt% of the dry weight of one or more of the first layer 102 or the second layer 108, less than about 20 wt%, less than about 10 less than about 7 wt%, less than about 5 wt%, less than about 3 wt%, less than about 2 wt%, less than about 1 wt%, or less than about 0.5 wt% of the dry weight of one or more of the first layer 102 or the second layer 108. In an embodiment, one or more of the first layer 102 or the second layer 108 may include at least one absorbent or adsorbent material.
[0047] In an embodiment, one or more of the first layer 102 or the second layer 108 may be hydrophobic. One or more of the first layer 102 or the second layer 108 may be hydrophobic when one or more of the first layer 102 or the second layer 108 exhibits a contact angle with water that is about 90° to about 120°, about 105° to about 135°, about 120° to about 150°, about 135° to about 165°, or greater than 150°. The hydrophobic one or more of the first layer 102 or the second layer 108 may more quickly transport the bodily fluids received thereby than if one or more of the first layer 102 or the second layer 108 is hydrophilic. Generally, increasing the hydrophobicity of one or more of the first layer 102 or the second layer 108 (z.e., increasing the contact angle between one or more of the first layer 102 or the second layer 108 and water) may decrease the quantity of bodily fluids that are retained in one or more of the first layer 102 or the second layer 108 after one or more of the first layer 102 or the second layer 108 receives the bodily fluids. However, increasing the hydrophobicity of one or more of the first layer 102 or the second layer 108 may decrease the quantity of bodily fluids that one or more of the first layer 102 or the second layer 108 may receive over a certain period of time. As such, the hydrophobicity of one or more of the first layer 102 or the second layer 108 may be selected based on balancing the need to receive bodily fluids quickly while also keeping one or more of the first layer 102 or the second layer 108 dry.
[0048] Notwithstanding the foregoing, in an embodiment, one or more of the first layer 102 or the second layer 108 may by hydrophilic. The hydrophilicity of one or more of the first layer 102 or the second layer 108 may cause one or more of the first layer 102 or the
- Page 12 - Docket No. 318812WO01 504795-1114 second layer 108 to quickly capture bodily fluids therein thereby preventing or at least inhibiting leakage of bodily fluids caused by a large discharge of bodily fluids over a short period of time. One or more of the first layer 102 or the second layer 108 may be hydrophilic when one or more of the first layer 102 or the second layer 108 material exhibits a contact angle with water (a major constituent of bodily fluids) that is about 0° to about 90°, about 0° to about 15°, about 15° to about 30°, about 30° to about 45°, about 45° to about 60°, about 60° to about 90°, about 10° to about 40°. about 40° to about 80°. less than about 90°, less than about 60°, or less than about 30°. Generally, increasing the hydrophilicity of one or more of the first layer 102 or the second layer 108 (/.<?., decreasing the contact angle between one or more of the first layer 102 or the second layer 108 and water) increases the quantity of bodily fluids that one or more of the first layer 102 or the second layer 108 may receive over a certain period of time. However, increasing the hydrophilicity of one or more of the first layer 102 or the second layer 108 may increase the quantity' of bodily fluids that are retained in one or more of the first layer 102 or the second layer 108 after one or more of the first layer 102 or the second layer 108 receives the bodily fluids. As such, the hydrophilicity of one or more of the first layer 102 or the second layer 108 may be selected based on balancing the need to receive bodily fluids quickly while also keeping one or more of the first layer 102 or the second layer 108 dry. For example, a fluid collection assembly configured to be used with an individual with a large bladder for short periods of time may include a one or more of the first layer 102 or the second layer 108 exhibiting a hydrophilicity that is greater than an least one or more of the first layer 102 or the second layer 108 of a fluid collection assembly configured to be used with an individual with an average to small sized bladder for long period of time. It is noted that materials of at least some conventional fluid collection assemblies are selected to be hydrophobic to improve the fluid transport thereof. However, it has been unexpectedly found that vertical nonwoven materials exhibit quick fluid transport even when the vertical nonwoven materials are hydrophilic. In an embodiment, the surfactant disposed on one or more of the first layer 102 or the second layer 108 may cause one or more of the first layer 102 or the second layer 108 to be hydrophilic (e.g, one or more of the first layer 102 or the second layer 108 is hydrophobic before disposing the surfactant on one or more of the first layer 102 or the second layer 108). In an embodiment, one or more of the first layer 102 or the second layer 108 is hydrophilic before disposing the surfactant on one or more of the first layer 102 or the second layer 108. In such an embodiment, the surfactant may increase
- Page 13 - Docket No. 318812WO01 504795-1114 or otherwise modify the hydrophilicity of one or more of the first layer 102 or the second layer 108.
[0049] In an embodiment, the hydrophobicity or hydrophilicity of one or more of the first layer 102 or the second layer 108 may be an inherent property of the material(s) (e.g., fibers) used to form one or more of the first layer 102 or the second layer 108. In an embodiment, the hydrophobicity or hydrophilicity of one or more of the first layer 102 or the second layer 108 may be changed by at least one of impurities or functional groups added to one or more of the first layer 102 or the second layer 108, otherwise treating one or more of the first layer 102 or the second layer 108, or coating one or more of the first layer 102 or the second layer 108 with a material that exhibits a hydrophobicity or hydrophilicity that is different than one or more of the first layer 102 or the second layer 108.
[0050] In an embodiment, a surfactant is disposed on (e.g., coated) at least a portion of one or more of the first layer 102 or the second layer 108. In an embodiment, the surfactant may be disposed on at least at least one surface of one or more of the first layer 102 or the second layer 108, such as one or more of the first outer surface 104, the first inner surface 106, the second inner surface 110, or the second outer surface 112. In particular, the surfactant may be disposed on the surface of the first or second layers 102, 108 that first receives bodily fluids discharged from an individual. Disposing the surfactant on at least the surface of one or more of the first layer 102 or the second layer 108 may modify the surface of one or more of the first layer 102 or the second layer 108. Modifying the surface of one or more of the first layer 102 or the second layer 108 with the surfactant allows one or more of the first layer 102 or the second layer 108 to quickly and effectively receive the bodily fluids into one or more of the first layer 102 or the second layer 108. [0051] In an embodiment, the surfactant may extend a distance from the surface into one or more of the first layer 102 or the second layer 108. For example, the surfactant may extend from the surface about 1% or more of a thickness of one or more of the first layer 102 or the second layer 108, such as at least about 5% or more, about 10% or more, about 15% or more, about 20% or more, about 20% or more, about 30% or more, about 40% or more, about 50% or more, about 60% or more, about 70% or more, about 80% or more, about 90% or more, or about 100% (i.e., extends through all of one or more of the first layer 102 or the second layer 108) of the thickness, such as in ranges of about 1% to about 10%, about 5% to about 15%, about 10% to about 20%. about 15% to about 30%, about 20% to about 40%, about 30% to about 50%, about 40% to about 60%, about 50% to about 70%,
- Page 14 - Docket No. 318812WO01 504795-1114 about 60% to about 80%, about 70% to about 90%, or about 80% to about 100% of the thickness. Extending the surfactant a distance from the surface into one or more of the first layer 102 or the second layer 108 may allow one or more of the first layer 102 or the second layer 108 to pull the bodily fluids received at the surface into one or more of the first layer 102 or the second layer 108 which, in turn, facilitates the flow of the bodily fluids through one or more of the first layer 102 or the second layer 108. The distance that the surfactant extends from the surface into one or more of the first lay er 102 or the second layer 108 may depend on the thickness of one or more of the first layer 102 or the second layer 108. For example, the surfactant may only extend from the surface through a relatively small percentage of the thickness of one or more of the first layer 102 or the second layer 108 (e.g. , less than 50%) when the thickness of one or more of the first layer 102 or the second layer 108 is relatively thick (e.g., about 1.5 mm or greater, about 5 mm or greater, or about 1 cm or greater). Meanwhile, the surfactant may extend from the surface through a relatively large percentage (e.g., greater than 50%) or all of the thickness of one or more of the first layer 102 or the second layer 108 when the thickness of one or more of the first layer 102 or the second layer 108 is relatively small (e.g., about 2 mm or less, about 1 mm or less, or about 0.75 mm or less). The distance that the surfactant extends from the surface into one or more of the first layer 102 or the second layer 108 may also depend on the process used to apply the surfactant to one or more of the first layer 102 or the second layer 108, the viscosity of the surfactant or the solution that includes the surfactant applied to one or more of the first layer 102 or the second layer 108, the water contact angle between the surfactant or the solution that includes the surfactant and one or more of the first layer 102 or the second layer 108, the quantity' of the surfactant or the solution that includes the surfactant that is applied to one or more of the first layer 102 or the second layer 108, or any other suitable factor.
[0052] In an embodiment, the surfactant is only disposed through a portion of the thickness of one or more of the first layer 102 or the second layer 108 which allows the water absorption rates and wicking ability of one or more of the first layer 102 or the second layer 108 to vary in one or more of the first layer 102 or the second layer 108. For example. the portions of one or more of the first layer 102 or the second layer 108 that include the surfactant may exhibit a water absorption rate and wicking ability that is better than the portions of one or more of the first layer 102 or the second layer 108 that does not include the surfactant. The better water absorption and wicking ability of the portions of one or more of the first layer 102 or the second layer 108 that include the surfactant allows one or
- Page 15 - Docket No. 318812WO01 504795-1114 more of the first layer 102 or the second layer 108 to receive the bodily fluids quickly and effectively into one or more of the first layer 102 or the second layer 108. The portions of one or more of the first layer 102 or the second layer 108 that do not include the surfactant may push the bodily fluids out of one or more of the first layer 102 or the second layer 108 towards, for example, the innermost surface of the porous material 100. The surfactant extending only partially through one or more of the first layer 102 or the second layer 108 may be beneficial when one or more of the first layer 102 or the second layer 108 forms substantially all of the porous material disposed in a chamber of a fluid collection assembly. In an embodiment, the surfactant is disposed through all or substantially all of the thickness of one or more of the first layer 102 or the second layer 108 which allows the water absorption rates and wi eking ability of all of one or more of the first layer 102 or the second layer 108 to be improved. As such, all of one or more of the first layer 102 or the second layer 108 is able to quickly receive the bodily fluids. The surfactant disposed in all or substantially all of one or more of the first layer 102 or the second layer 108 may be beneficial when one or more of the first layer 102 or the second layer 108 only forms a portion of a porous material disposed in a chamber of a fluid collection assembly since the porous material may have another porous body that is able to push the bodily fluids towards the fluid outlet.
[0053] The surfactant may be disposed on one or more of the first layer 102 or the second layer 108 using any suitable technique. In an embodiment, the surfactant may be disposed on one or more of the first layer 102 or the second layer 108 using a spray coating technique, a kiss roll coating technique, a dip coating technique, or any other suitable technique. In an embodiment, the surfactant may only be disposed on one surface of one or more of the first layer 102 or the second layer 108. For example, the surfactant may be disposed on the surface of one or more of the first layer 102 or the second layer 108. It is noted that the surfactant may penetrate into one or more of the first layer 102 or the second layer 108 after being disposed on the surface. In a particular embodiment, one or more of the first layer 102 or the second layer 108 forms a long sheet that, at some later point, will be cut into a plurality of porous bodies that, for example, may each be disposed in different fluid collection assemblies. In such an embodiment, the surfactant may be disposed on a surface (e.g., the surface) of one or more of the first layer 102 or the second layer 108. After disposing the surfactant on the surface, one or more of the first lay er 102 or the second layer 108 may be collected on a roll. Collecting one or more of the first layer 102 or the second layer 108 on the roll may cause the surface of one or more of the first layer 102 or
- Page 16 - Docket No. 318812WO01 504795-1114 the second layer 108 that received the surfactant to contact the surface of one or more of the first layer 102 or the second layer 108 that did not receive the surfactant. Contacting the two surfaces together may cause the surfactant to migrate from the surface that received the surfactant to the surface that did not receive the surfactant such that both surfaces of one or more of the first layer 102 or the second layer 108 are able to receive the surfactant while the surfactant was only disposed on one surface of one or more of the first layer 102 or the second layer 108. In an embodiment, the surfactant may be disposed on two or more surfaces of one or more of the first layer 102 or the second layer 108. It is noted that the surfactant may penetrate into one or more of the first layer 102 or the second layer 108 after disposing the surfactant on the surfaces of one or more of the first layer 102 or the second layer 108.
[0054] Disposing the surfactant on one or more of the first layer 102 or the second layer 108 may include disposing a solution that includes the surfactant on one or more of the first layer 102 or the second layer 108. The solution includes a major component (e.g., water, alcohol, isopropanol, other polar solvents, or other non-polar solvents) and the surfactant.
The surfactant may or may not be at least partially soluble in the major component. The surfactant may form about 1 wt% or more of the solution, such as in ranges of about 1 wt% to about 3 wt%, about 2 wt% to about 4 wt%, about 3 wt% to about 5 wt%, about 4 wt% to about 6 wt%. about 5 wt% to about 7 wt%, about 6 wt% to about 8 wt%, about 7 wt% to about 9 wt%. about 8 wt% to about 10 wt%, about 9 wt% to about 12 wt%, about 10 wt% to about 15 wt%, or greater than 15 \\t% of the solution. In a particular example, the surfactant may form about 2 wt% to about 10 wt% of the solution since, for some surfactants (e.g., polyethylene glycol fatty acid ester), decreasing the concentration of the surfactant below 2 wt% may cause too little of the surfactant to be disposed on one or more of the first layer 102 or the second layer 108 and increasing the concentration of the surfactant above 10 wt% may cause too much of the surfactant to be on one or more of the first layer 102 or the second layer 108.
[0055] The surfactant may form about 0. 1 wt% to about 2 wt% of one or more of the first layer 102 or the second layer 108. such as in ranges of about 0. 1 wt% to about 1.4 wt% or about 0.2 wt% to about 0.8 wt%. It is noted that these weight percentages refer to the average weight percent of the surfactant in the portions of one or more of the first layer 102 or the second layer 108 that includes the surfactant. Generally, the amount of the surfactant in one or more of the first layer 102 or the second layer 108 is selected to be 0.1 wt% or greater since lesser concentrations of the surfactant may have negligible effect on one or
- Page 17 - Docket No. 318812WO01 504795-1114 more of the first layer 102 or the second layer 108. It is noted that the amount of the surfactant in one or more of the first layer 102 or the second layer 108 may be selected to be greater than 0.2 wt% since the surfactant may have a small but non-negligible effect on one or more of the first layer 102 or the second layer 108 when present at weight percentages between 0.1 wt% and 0.2 wt%. Generally, the amount of the surfactant in one or more of the first layer 102 or the second layer 108 may be selected to be about 2 wt% or less since increasing the quantity of the surfactant in one or more of the first layer 102 or the second layer 108 above 2 wt% may cause one or more of the first layer 102 or the second layer 108 to feel wet against the skin of the individual. It is noted that one or more of the first layer 102 or the second layer 108 may still feel wet against the skin of certain sensitive individuals when the surfactant is present at weight percentages between 1.5 wt% and 2 wt% and, for certain extra-sensitive individuals, one or more of the first layer 102 or the second layer 108 may still feel wet against the skin of certain sensitive individuals when the surfactant is present at weight percentages between 0.9 wt% and 1.4 wt%. [0056] In a particular embodiment, one or more of the first layer 102 or the second layer 108 includes a hydrophobic material. For example, one or more of the first layer 102 or the second layer 108 may include hydrophobic polypropylene, hydrophobic polyethylene, a blend or other combination of hydrophobic polypropylene and hydrophobic polyethylene, or another hydrophobic material. The surfactant present in one or more of the first layer 102 or the second layer 108 may cause one or more of the first layer 102 or the second layer 108 including the hydrophobic material to exhibit a water absorption rate and wicking ability that is comparable to a substantially similar porous body including a hydrophilic material. However, one or more of the first layer 102 or the second layer 108 is still formed from a hydrophobic material and, thus, may push the bodily fluids out of one or more of the first layer 102 or the second layer 108 (e.g. , due to the hydrophobic material repelling the water such that one or more of the first layer 102 or the second layer 108 does not retain the bodily fluids) instead of retaining the bodily fluids therein. As such, the hydrophobic material of one or more of the first layer 102 or the second layer 108 may be relatively dry shortly after the individual stops discharging bodily fluids. [0057] The surfactant may include any suitable type of surfactant. For example, the surfactants may include at least one anionic surfactant, at least one nonionic surfactant, at least one cationic surfactant, at least one amphoteric surfactant, or combinations thereof. In an example, the surfactant may include at least one nonionic surfactant. In some examples, the surfactant may include polyethylene glycol oleic acid ester, polysorbate 20,
- Page 18 - Docket No. 318812WO01 504795-1114 polysorbate 40. polysorbate 60 and polysorbate 80, silicone polyether, fluorinated silicone poly ether surfactants, or the like.
[0058] In an embodiment, the surfactant may include a polyethylene glycol fatty acid ester ("PEGFA"). Like the surfactants disclosed herein, PEGFA increases the water absorption rate and wicking abilities of one or more of the first layer 102 or the second layer 108 even when one or more of the first layer 102 or the second layer 108 is formed from a hydrophobic material. However, unlike at least some surfactants. PEGFA remains attached to one or more of the first layer 102 or the second layer 108 for prolonged periods of times (e.g, 1 month to over a year). For example, it has been found that non-PEGFA surfactants typically migrated from one or more of the first layer 102 or the second layer 108, such as from one or more of the first layer 102 or the second layer 108 to packaging or into another layer of the porous material that includes one or more of the first layer 102 or the second layer 108. This means that the ability of one or more of the first layer 102 or the second layer 108 including non-PEGFA surfactants disposed thereon to quick and effectively receive bodily fluids decreases over time which may result in unneeded waste if the fluid collection assembly including the non-PEGFA surfactants are not promptly used. Unlike these other surfactants, it has been found that PEGFA surfactants remain attached to one or more of the first layer 102 or the second layer 108 and did not significantly migrate from one or more of the first layer 102 or the second layer 108 over time. As such, one or more of the first layer 102 or the second layer 108 including PEGFA may be able to quickly and effectively receive bodily fluids even if a prolonged period of time lapses between manufacturing and use of fluid collection assembly including PEGFA. [0059] The PEGFA surfactant includes a fatty acid chain, an ester, and a polyethylene glycol chain. For example, the PEGFA may exhibit the chemical formula R COO PEG, where R is an aliphatic chain, COO is the ester group, and PEG is polyethylene glycol chain. The aliphatic chain R forms at least a portion of the hydrophobic portion of the PEGFA surfactant and attaches the PEGFA to one or more of the first layer 102 or the second layer 108. The PEG chain forms the hydrophilic head of the PEGFA surfactant. The ester group bonds the aliphatic chain R and the PEG chain together. It is noted that the ester group and the PEG chain may also help attach the PEGFA to one or more of the first layer 102 or the second layer 108. Particular example of PEGFA include STANTEX® S 6887 and STANTEX® S 6327.
[0060] Suitable PEGFA surfactants may include surfactants of formula 1 below:
Formula 1: Ri-COO-PEG, where:
- Page 19 - Docket No. 318812WO01 504795-1114 Ri = C7-C31 aliphatic chain; and
PEG = a polyethylene glycol polymer chain of 200 to 4000 Daltons (Da).
[0061] The aliphatic chain R may include a saturated or unsaturated aliphatic carbon chain. In a particular example, the aliphatic chain R may be a saturated aliphatic carbon chain since it is currently believed that a saturated aliphatic carbon chain may better attach the PEGFA to one or more of the first layer 102 or the second layer 108 including polypropylene or polyethylene since it is more similar to polypropylene or polyethylene that an unsaturated aliphatic carbon chain. The aliphatic chain R may include 7 to 31 carbon atoms. In a particular example, the aliphatic chain R may include 8 to 24 carbon atoms since such aliphatic carbon chains are readily available.
[0062] The PEG chain of the PEGFA includes a plurality of repeating units [OCH2CH2]n. In an example, n may be selected to be 5 to 600, such as in ranges of 5 to 50, 25 to 75, 50 to 100, 75 to 150, 100 to 200, 150 to 250, 200 to 300, 250 to 350, 300 to 400, 350 to 450, 400 to 500, 450 to 550, or 500 to 600. In an example, the polyethylene glycol may exhibit a molecular weight of about 200 daltons to about 10,000 daltons, such as in ranges of about 200 daltons to about 500 daltons, about 400 daltons to about 1,000 daltons, about 750 daltons to about 1,500 daltons, about 1,000 daltons to about 2,000 daltons, about 1,500 daltons to about 2,500 daltons, about 2,000 daltons to about 3,000 daltons, about 2,500 daltons to about 3,500 daltons, about 3,000 daltons to about 4,000 daltons, about 3.500 daltons to about 5,000 daltons, about 4,000 daltons to about 6.000 daltons, about 5,000 daltons to about 7,000 daltons, about 6,000 daltons to about 8,000 daltons, about 7,000 daltons to about 9,000 daltons, or about 8,000 daltons to about 10,000 daltons. It is noted that the number of repeated units n and the molecular weight of the polyethylene glycol may affect the ability of the PEGFA to improve the water absorption rate and wicking ability of one or more of the first layer 102 or the second layer 108. For example, increasing the number of repeating units n and the molecular weight of the polyethylene glycol may cause the PEGFA to behave more like a hydrophobic material than a surfactant.
[0063] In an embodiment, as previously discussed, the surfactant may be disposed in and/or on one or more of the first layer 102 or the second layer 108 before a fluid collection assembly including one or more of the first layer 102 or the second layer 108 is formed. In an embodiment, the surfactant may be disposed in and/or on one or more of the first layer 102 or the second layer 108 after the fluid collection assembly including one or more of the first layer 102 orthe second layer 108 is formed. In such an embodiment, a preformed fluid
- Page 20 - Docket No. 318812WO01 504795-1114 collection assembly may be retrofitted to include the surfactant. The preformed fluid collection assembly may be retrofitted by spraying or otherwise disposing at least one surfactant on the porous material of the preformed fluid collection assembly. The surfactant may be disposed on the porous material immediately (e.g. , within an hour) before the preformed fluid collection assembly is used (e.g., the surfactant may include at least one PEGFA surfactant or at least one non-PEGFA surfactant) or a period of time before the preformed fluid collection assembly is used (e.g, the surfactant may include at least one PEGFA surfactant). In an example, the preformed fluid collection assembly may include the Purewick™ female external catheter available from Becton, Dickinson and Company, the PrimaFit® external urine management device available from Sage Products
LLC. or the Versette® external catheter available from Medline. In such an example, disposing the surfactant on the preformed fluid collection assembly may include disposing the surfactant on the porous material extending across the opening defined by the fluid impermeable barrier. In an example, the preformed fluid collection assembly may include the Purewick™ male external catheter available from Becton, Dickinson and Company, the PrimoFit® external urine management device available from Sage Products LLC, or the Qivi external urine management device from Consure Medical. In such an example, disposing the surfactant on the preformed fluid collection assembly may include disposing the surfactant through an opening defined by the fluid impermeable barrier, into a chamber defined by the fluid impermeable barrier, and into the porous material.
[0064] Further examples of surfactants that may be included in the porous material 100 are disclosed in U.S. Provisional Patent Application No. 63/568,615 filed on March 22, 2024, the disclosure of which is incorporated herein, in its entirety, by this reference.
[0065] As previously discussed, the porous material 100 includes a plurality of melted regions 1 14. It is noted that, as used herein, the ‘'melted region” refers to portions of the porous material 100 are at least partially melted (e.g., fibers that are at least partially melted). The melting portions of the porous material 100 may cause adjacent portions of the porous material 100 to become bonded to each other. As used herein, the '‘melted region” may also refer to portions of the porous material 100 having enhanced fiber entanglement caused by forming the melted regions 114. For example, as previously discussed, the first layer 102 may include polyethylene and/or polypropylene while the second layer 108 includes bamboo. The polyethylene and/or polypropylene of the first layer 102 are easily melted but the bamboo of the second layer 108 is difficult to melt. As such, in such an example, the portions of the melted regions 114 including polyethylene
- Page 21 - Docket No. 318812WO01 504795-1114 and/or polypropylene (e.g., the first layer 102 and the portions of the second layer 108 into which polyethylene and/or polypropylene are displaced during the forming of the melted regions 114) may include melted material while the portions of the melted region 114 that does not include polyethylene and/or polypropylene (e.g., the portions of the second layer 108 that do not receive polyethylene and/or polypropylene while forming the melted regions 114) include enhanced fiber entanglement. It is noted that the portions of the melted regions 1 14 include polyethylene and/or polypropylene may also include enhanced fiber entanglement, as discussed in more detail below.
[0066] The melted regions 114 extend from the first outer surface 104 of the first layer 102, through the first layer 102, and into the second layer 108. Within the melted regions
114, the portions of the first layer 102 at or near the first inner surface 106 become bonded to the portions of the second layer 108 at or near the second inner surface 110 thereby attaching the first and second layers 102, 108 together. For example, at least some of the fibers within the melted region 114 at or near the first and second inner surfaces 106, 112 melt and bond with adjacent fibers. As such, the melting regions 114 attach the first and second layers 102, 108 together.
[0067] The melting regions 114 also bond some of the fibers in one or more of the first layer 102 or the second layers 108 together. The bonding of the fibers of one or more of the first layer 102 or the second layers 108 together strengthens or otherwise increases the wear resistance of the first and second layers 102, 108. For example, the bonding between the fibers of the melted regions 114 provides another mechanism to maintain the structure of the first layer 102 and/or second layer 108. This additional mechanism to maintain the structure of the first layer 102 and/or the second layer 108 may be especially beneficial when the first layer 102 and/or the second layer 108 includes a nonwoven material. Nonwoven materials ty pically maintain the structure thereof, at least in part, due to friction and entanglement between the fibers. However, the bodily fluids received in the porous material 100 may lubricate the fibers thereby making it easier for the fibers to move relative to each other which, in turn, may cause accelerate breakdown of the porous material 100. However, the bonding of the fibers in the melted region 114 may resist breakdown of the porous material 100 even if the bodily fluids lubricate the fibers.
[0068] As will be discussed in more detail below, the melted regions 114 may be formed by inserting one or more probes (e.g., needles or pins) into the porous material 100. Inserting the probes into the porous material 100 displaces some of the fibers of the porous material 100. The displacement of the fibers may cause fiber entanglement in the porous
- Page 22 - Docket No. 318812WO01 504795-1114 material 100. For example, inserting the probed into the porous material 100 may cause the fibers of the first layer 102 to be displaced into and become entangled with the fibers of the second layer 108. Displacing the fibers of the first layer 102 into the second layer 108 and removing the probes from the porous material 100 may also cause some of the fibers of the second layer 108 to be displaced into and become entangled with the fibers of the first layer 102. It is noted that the quantity’ of fibers of the second layer 108 displaced into the fibers of the first layer 102 may be less than the quantity of fibers of the first layer 102 displaced into the fibers of the second layer 108. The entanglement of the fibers of the first and second layers 102, 108 also attaches the first and second layers 102, 108 together. [0069] The displacement of the fibers caused by inserting and removing the probes into and out of the porous material 100 also promotes entanglement of the fibers in each of the first and second layers 102, 108. In other words, the amount of entanglement between the fibers in each of the first and second layers 102, 108 at least within the melted region 114 may be greater than regions of the porous material 100 outside of the melted regions 114. The increased fiber entanglement in each of the first and second layers 102, 108 may further increase the strength and wear resistance of the first and second layers 102, 108.
[0070] The melted regions 114 may exhibit a porosity7 allowing the bodily' fluids to flow through the melted regions 114. That said, the melted regions 114 may exhibit a porosity that is less than the porosity of the rest of the porous material 100 because the insertion of the probes into the porous material 100 compacts the portions of the porous material 100 forming the melted regions 1 14 and the melting of the fibers in the melted region 114 may at least partially block some of the passageways through the melted region 114. For example, the porosity of the melted regions 114 may be about 5% (z.e., significantly less than) to about 99% (z.e., slightly less than) the porosity of the rest of the porous material 100, such as in ranges of about 5% to about 20%, about 10% to about 30%, about 20% to about 40%, about 30% to about 50%, about 40% to about 60%, about 50% to about 70%, about 60% to about 80%, or about 70% to about 99% of the rest of the porous material 100. The flow rate of the bodily fluids through the melted region 114 may be less than the flow rate of the bodily fluids through the rest of the porous material 100 due to the decreased porosity of the melted region 114. However, the decreased flow rate through the porous material 100 as a whole caused by the melted regions 114 may be less than the decreased flow rate through a substantially similar porous material that does not include the melted regions 114 and instead includes an adhesive between adjacent layers or allows gaps to form between the first and second layer. Further, the porous material 100 may
- Page 23 - Docket No. 318812WO01 504795-1114 include one or more features (e.g., the holes 116) that improves flow of the bodily fluids through the melted regions 114, such as the holes 116.
[0071] The melted regions 114 may exhibit a maximum dimension that may be selected to be about 50 pm to about 2 mm, such as in ranges of about 50 pm to about 100 pm, about 75 pm to about 150 pm, about 100 pm to about 200 pm, about 150 pm to about 300 pm, about 200 pm to about 400 pm, about 300 pm to about 500 pm, about 400 pm to about 600 pm, about 500 pm to about 700 pm, about 600 pm to about 800 pm. about 700 pm to about 900 pm, about 800 pm to about 1 mm, about 900 pm to about 1.25 mm, about 1 mm to about 1.5 mm, about 1 mm to about 1.5 mm, or about 1.25 mm to about 2 mm. Generally increasing the maximum dimension of the melted regions 114 improves attachment between the first and second layer 102, 108 but may decrease fluid flow through the first and second layer 102, 108 due to the decreased porosity of the melted regions 114..
[0072] The porous material 100 may define one or more holes 116 extending at least partially therethrough. In particular, each of the holes 116 may be partially defined by and partially enclosed on two or more sides by the melted regions 114. The holes 116 may be formed at the same time that the melted regions 1 14 are formed. For example, as previously discussed, probes may be inserted into the porous material 100 to form the melted regions 114. The insertion of the probes into the porous material 100 displaces the fibers. After removing the needles, the fibers of the porous material 100 may not reoccupy all of the space that was previously occupied by the probes since the melting of at least some of the fibers in the melted regions 1 14 essentially locks the fibers in place. As such, the holes 1 16 correspond to the location of the probes. In an example, the holes 116 are substantially unoccupied portions of the porous material 100. In an example, some fibers may enter the hole 116 after removal of the probe from the porous material 100. However, in such an example, the porosity of the hole 116 is significantly greater than the melted region 114 and greater the remainder of the porous material 100.
[0073] The holes 116 may facilitate flow of the bodily fluids through the porous material 100. For example, the holes 116 may provide less resistance to flow of the bodily fluids than the melted regions 114 and the remainder of the porous material 100. The enhanced fluid flow through the holes 116 may at least partially negate the decreased fluid flow through the melted regions 114 caused by the decrease porosity of the melted regions 114.
[0074] The holes 116 may exhibit a maximum dimension D. The maximum dimension D may be selected to be about 50 pm to about 2 mm, such as in ranges of about 50 pm to
- Page 24 - Docket No. 318812WO01 504795-1114 about 100 pm, about 75 un to about 150 un, about 100 pun to about 200 pun, about 150 pun to about 300 pun, about 200 pun to about 400 pun, about 300 pun to about 500 pun, about 400 pun to about 600 pun, about 500 pun to about 700 pun, about 600 pun to about 800 pun, about 700 pun to about 900 pun, about 800 pun to about 1 nun, about 900 pun to about 1.25 mm, about 1 mm to about 1.5 mm, about 1 mm to about 1.5 mm, or about 1.25 mm to about
2 mm. Generally increasing the maximum dimension D of the holes 116 improves air flow and fluid flow through the porous material 100. However, increasing the maximum dimension D of the holes 116 may increase the percentage of the porous material 100 occupied by the melted regions 114. [0075] The melted regions 114 may exhibit any suitable shape. Generally, the shape of the melted regions 114 corresponds to the shape of the probe that was used to form the melted regions 114. In an example, the melted regions 114 may exhibit a generally conical shape (as shown), a generally cylindrical shape, a generally pyramidal shape, a generally half-spherical shape, a funnel like shape, a stepped shape, any other suitable shape, or a combination thereof (e.g., a cylindrical shape having a conical shape on a side of the cylindrical shape opposite the first outer surface 104). In an example, the shape of the melted regions 114 may be selected such that the cross-sectional area of the melted region 114 decreases with further distance from the first outer surface 104 along at least a portion of a length of the melted region 114. The decreased cross-sectional area of the melted region 114 with increasing distance from the first outer surface 104 may cause the cross- sectional area of the rest of the porous material 100 to increase with increasing distance from the first outer surface 104. As previously discussed, the fluid flow7 rate through the remainder of the porous material 100 may be greater than the fluid flow rate through the melted regions 114. The increasing cross-sectional area of the remainder of the porous material 100 with increasing distance from the outer surface 104 along with the improve fluid flow rate of the remainder of the porous material 100 promotes flow of the bodily fluids from the first outer surface 104 to the second outer surface 112 and inhibits backflow of the bodily fluids.
[0076] The center-to-center spaced S between immediately adj acent ones of the melted regions 114 may be selected to be about 2.5 mm to about 5 cm, such an in ranges of about 2.5 mm to about 4 mm, about 3 mm to about 5 mm, about 4 mm to about 6 mm, about 5 mm to about 7 mm, about 6 mm to about 8 mm, about 7 mm to about 9 mm, about 8 mm to about 1 cm, about 9 mm to about 1.25 cm, about 1 cm to about 1.5 cm, about 1.25 cm to about 1.75 cm, about 1.5 cm to about 2 cm, about 1.75 cm to about 2.5 cm, about 2 cm to
- Page 25 - Docket No. 318812WO01 504795-1114 about 3 cm, about 2.5 cm to about 3.5 cm, about 3 cm to about 4 cm, about 3.5 cm to about 4.5 cm. or about 4 cm to about 5 cm. The spacing S between the melted regions 114 may be selected based on a number of factors. In an example, the spacing S may be increased as the maximum dimension D of the holes 116 is increased and the vice versa. In an example, the spacing S may be increased if the likelihood of gaps forming between the first and second layers 102, 108 without the melted regions 114 is low and spacing S may be decreased if the likelihood of gaps forming between the first and second layers 102, 108 without the melted regions 114 is high.
[0077] The melted regions 114 may have any arrangement on the porous material 100. For example, the melted regions 114 may be arranged on the porous material 100 such that, when viewed from above the first outer surface 104, the melted regions 114 exhibit one or more circular patterns, one or more hexagonal patterns, one or more square patterns, one or more triangular patterns, or any other suitable patterns. The arrangement of the melted regions 114 may affect the concentration of melted regions 114 and the spacing S between the melted regions 114. For example, certain arrangement of the melted regions 114 may allow for a more close-packed arrangement of the melted regions 1 14 than another arrangement.
[0078] The melted regions 114 may only be present on about 10% or less of the surface area of one or more of the first outer surface 104, the first inner surface 106, or the second inner surface 110, such as about 9% or less, about 8% or less, about 7% or less, about 6% or less, about 5% or less, about 4% or less, about 3% or less, about 2% or less, about 1 % or less, or in ranges of greater than 0% to about 2%, about 1% to about 3%, about 2% to about 4%, about 3% to about 5%, about 4% to about 6%, about 5% to about 7%, about 6% to about 8%, about 7% to about 9%, or about 8% to about 10%. It has been found that the melted regions 114 may occupy less of the surface area of the first inner surface 106 and/or or the second inner surface 110 while substantially preventing the formation of gaps between the first and second layers 102, 108 than an adhesive layer. Further, the small surface area of melted regions 114 on one or more of the first outer surface 104, the first inner surface 106, or the second inner surface 1 10 minimizes the affect that the restricted fluid flow through the melted regions 114 has on the fluid flow through the entire porous material 100.
[0079] In an embodiment, not shown, the porous material 100 may include at least one additional layer. The additional layer may abut the second outer surface 112 of the second layer 108. The melted regions 114 may or may not extend into the additional layer. When
- Page 26 - Docket No. 318812WO01 504795-1114 the melted regions 114 extend into the additional layer, the melted regions 114 may extend from the first outer surface 104. through the first layer 102, into and through the second layer 108, and into at least a portion of the additional layer. In an example, as previously discussed, the additional layer may include a PET inner layer. The melted regions 114 may extend through the first layer 102 (e.g., a hydrophobic polyethylene or hydrophobic polypropylene with or without a surfactant), through the second layer 108 (e.g., bamboo), and into the PET inner layer.
[0080] FIG. IB is a schematic view of a system 120 configured to form the porous material 100, according to an embodiment. In particular, the system 120 is an example of a thermal needle punch lamination system. That said, it is noted that the porous material 100 may be formed using other systems, without limitation.
[0081] The system 120 may include a support 122. The support 122 is attached to an actuator 124 that is configured to move the support 122. For example, the actuator 124 may be configured as a hydraulic actuator, pneumatic actuator, or an electric-motor driven actuator. The support 122 is also attached to a needle board 126. The needle board 126 includes a plurality of needles 128 extending therefrom in one or more selected patterns. The needles 128 are configured to be inserted into the porous material 100 to form the melted regions 114, as will be discussed in more detail below. In an example, the needles 128 may include a barbed tip which will enhance entanglement between the fibers of the porous material 100.
[0082] In an embodiment, during use, the system 120 is configured to heat the needles 128 to a temperature sufficient to melt at least some of the fibers of the porous material 100. For example, the system 120 may heat the needles 128 to a temperature of about 150 °C to about 300 °C, such as in ranges of about 150 °C to about 180 °C. about 165 °C to about 195 °C, about 180 °C to about 210°C, about 195 °C to about 225 °C, about 210 °C to about 240 °C, about 225 °C to about 255 °C, about 240 °C to about 270 °C, 255 °C to about 285 °C, or about 270 °C to about 300 °C. In some examples, the system 120 may be configured to heat the needles 128 to a temperature that is less than 150 °C or greater than 300 °C. The temperature of the needles 128 may be selected based on a number of factors. In an example, the temperature of the needles 128 may be selected to be greater than a melting temperature and lower than a combustion temperature of one or more materials of the porous material 100. In such an example, the temperature of the needles 128 is dependent on the composition of the porous material 100. For instance, when the porous material 100 includes a hydrophobic polyethylene and/or polypropylene first layer 102 and
- Page 27 - Docket No. 318812WO01 504795-1114 a bamboo second layer 108, the needles 128 may be heated to a temperature greater than the melting point of the hydrophobic polyethylene and/or polypropylene first layer 102 and lower than the combustion temperature of bamboo since bamboo may be difficult to melt. In an example, the temperature of the needles 128 may be heated to a temperature that is 5 °C or greater (e.g., about 10 °C or greater, about 15 °C or greater, about 20 °C or greater, or in ranges of about 5 °C to about 15 °C greater or about 10 °C to about 20 °C greater) than the melting temperature of one or more materials of the porous material 100. The needles 128 may be heated to a temperature that is greater than the melting temperature of one or more materials of the porous material 100 to improve the kinetics of melting the materials of the porous material 100 since, generally, it may take an unsatisfactory long period of time to melt the materials of the porous material 100 if the needles 128 are only heated to a temperature that is equal to or only slightly greater than (e.g, 1 or 2 °C greater than) the melting temperature of the materials of the porous material 100. That said, the needles 128 may not be heated to a temperature that is significantly greater (e.g, 50 °C or greater) than the melting temperature of the materials of the porous material 100 since such temperatures may cause extensive melting of the materials of the porous material 100 which may cause the melted materials to completely or substantially completely block the pores of the melted region 114. In an example, the temperatures of the needles 128 may be selected based on the desired manufacturing speed. For instance, the manufacturing speed of the system 120 is dependent, in part, on the time that the needles 128 remain in the porous material 100. Increasing the temperature of the needles 128 decreases the time that the needles 128 need to remain in the porous material 100 to form the melted regions 114. [0083] In an embodiment, the system 120 includes a source of the outer layer 130 and a source of the second layer 132. The source of the outer layer 130 may be a roll including the first layer 102 and the source of the second layer 132 may be a roll including the second layer 108. The sources of the outer and inner layers 130, 132 may be distinct and separate from each other. In an embodiment, not shown, the system 120 includes a source of the porous material 100, wherein the source of the porous material 100 includes the first layer 102 and the second layer 108 already positioned adjacent to each other. [0084] The system 120 may include one or more rollers that facilitate movement of the first layer 102 and the second layer 108 through the system 120. For example, the system 120 may include a first set of rollers 134 and a second set of rollers 136. The support 122 and the needle board 126 may be positioned between the first and second set of rollers 134, 136. The first and second set of rollers 136 may hold the first and second layers 102, 108
- Page 28 - Docket No. 318812WO01 504795-1114 together and hold the first and second layers 102, 108 parallel to the needle board 126 (e.g., perpendicular to the axis of the needles 128) which may allow controlled and predictable insertion of the needles 128 into first and second layers 102, 108. The first set of rollers 134 may also pull the first and second layers 102, 108 off their respective source and pull the first and second layers 102, 108 towards the needle board 126.
[0085] A method of using the system 120 may include providing the source(s) of the first and second layers 102, 108. The system 120 may then pull the first and second layers 102, 108 from their sources towards the needle board 126. The system 120 may bring the first and second layers 102, 108 together (if not already together) while pulling the first and second layers 102, 108 towards the needle board 126 when the first and second layers 102, 108 are provided using distinct and separate sources. When the first and second layers 102, 108 are below the needle board 126, the actuator 124 may move the needle board 126 towards the first and second layers 102, 108 such that heated needles 128 are inserted into the first and second layers 102, 108. Inserting the heated needles 128 into the first and second layers 102, 108 forms the melted regions 114 and forms the porous material 100.
After forming the melted regions 114, the actuator 124 may move the needle board 126 away from the porous material 100 and the porous material 100 may then be collected by a collector 138.
[0086] In an embodiment, the system 120 is not configured to heat the needles 128. In such an embodiment, the system 120 is an example of a (non-thermal) needle punch system.
The needle punch system may operate by inserting non-heated needles 128 into the first and second layers 102, 108. The non-heated needles 128 do not melt the material of the first and second layers 102, 108, but instead forms entangled regions in the first and second layers 102, 108. The entangled regions may be substantially similar to the melted regions 114 discussed above except that the entangled regions do not include melted material. The holes of the entangled regions (if present) may also be less pronounced than the holes 116 of the melted regions 114 since removal of the non-heated needles 128 may pull more material into the holes of the entangled region than the heated needles 128. The entangled regions rely on entanglement between the fibers of the first and second layers 102. 108 to attach the first and second layers 102, 108 together and entanglement of the fibers in each of the first and second layers 102, 108 to increase the strength and wear resistance of each layer. Forming the entangled regions in each of the first and second layers 102, 108 more weakly attaches the first and second layers 102, 108 together and strengthens and increases the wear resistance of the first and second layers 102, 108 less than the melted regions 114.
- Page 29 - Docket No. 318812WO01 504795-1114 However, forming the entangled regions using non-heated needles 128 may more quickly form the porous material 100 than the heated needles 128 since, unlike the heated needles 128, the non-heated needles 128 to not need to remain in the first and second layers 102, 108 for a time sufficient to melt a desired amount of the material. [0087] FIG. 2A is a cross-sectional view of a porous material 200, according to an embodiment. Except as otherwise disclosed herein, the porous material 200 may be the same as or substantially similar to any of the porous materials disclosed herein. For example, the porous material 200 may include a first layer 202, a second layer 208, and a plurality of melted regions 214 attaching the first layer 202 to the second layer 208. [0088] The melted regions 214 may be substantially similar to the melted regions 114 shown in FIG. 1A (e.g., similar any of the same shapes, center-to-center spacing, arrangements, etc.) except that the melted regions 214 may not define a hole that is at least partially surrounded on two sides by the melted region 214. That said, the melted regions 214 may be positioned adjacent to a divot (not shown) formed in the porous material 200 caused by the densification of the melted region 214. The lack of a hole defined by the melted regions 114 causes the melted regions 214 to exhibit an average porosity that generally equal or at least more equal to the rest of the porous material 200 than the melted regions 114. The average porosity of the melted regions 214 compared to the rest of the porous material 200 causes bodily fluids to flow through the melted regions 214 faster than through the melted regions 114 of FIG. 1A. The quicker flow of the bodily fluids through the melted regions 214 compared to the melted regions 1 14 allows the flow rate of the bodily fluids through the porous material 200 to be comparable to the flow rate of the bodily fluids through the porous material 100 even though the porous material 200 does not include the holes. [0089] That said, at least some of the passageways through the melted regions 214 are at least partially obstructed by melting the materials of the porous material 200. As such, the flow rate of the bodily fluids through the melted regions 214 may be lower than the flow rate of the bodily fluids through the rest of the porous material 200. As such, similar to the melted regions 1 14 of FIG. 1A, the shape of the melted regions 214 may be configured to cause preferentially flow of the bodily fluids from the first layer 202 towards the second layer 208. In particular, the cross-sectional area of the melted regions 214 may decrease along at least a portion of a length thereof with increasing distance from the first outer surface 204.
- Page 30 - Docket No. 318812WO01 504795-1114 [0090] The porous material 200 does not define any holes because of the method used to form the porous material 200. FIG. 2B is a schematic of a system 220 configured to form the porous material 200, according to an embodiment. The system 220 is an example of an ultrasonic lamination manufacturing system. That said, the porous material 200 may be formed using systems other than an ultrasonic lamination manufacturing system.
[0091] The system 220 includes an ultrasound plate 222. The ultrasonic plate 222 is configured to generate ultrasonic energy that is concentrated as defined bond points. The ultrasonic energy causes localized heating of the first and second layers 202, 208 to bond the first and second layers 202, 208 together. [0092] In an embodiment, the ultrasound plate 222 includes a plurality of pins 228 arranged in one or more selected patterns. The pins 228 are configured to generate and discharge the ultrasonic energy into the first and second layers 202, 208 to form the porous material 200. The portions of the pins 228 configured to contact the first and second layers 202, 208 may exhibit a maximum dimension of about 50 pm to about 2 mm, such as in ranges of about 50 pm to about 100 pm, about 75 pm to about 150 pm, about 100 pm to about 200 pm, about 150 pm to about 300 pm, about 200 pm to about 400 pm, about 300 pm to about 500 pm, about 400 pm to about 600 pm, about 500 pm to about 700 pm, about 600 pm to about 800 pm, about 700 pm to about 900 pm, about 800 pm to about 1 mm, about 900 pm to about 1.25 mm, about 1 mm to about 1.5 mm, about 1 mm to about 1.5 mm, or about 1.25 mm to about 2 mm. It is noted that the maximum dimension of the pins 228 may correspond to the maximum dimension of the melted regions 214. The pins 228 may form divots in the porous material 200 adjacent to the melted regions 214. Although FIG. 2A illustrates the porous material 200 defining no holes, it is noted that, in some embodiments, the pins 228 may form holes in the porous material 200 that are at least partially defined by the melted regions 214 depending on the size of the pins 228, the configuration of the pins 228 (e.g., whether the pins 228 have or do not have a barbed tip), and the depth that the pins 228 penetrate into the first and second layers 202, 208.
[0093] In an embodiment, the system 220 includes a source of the outer layer 230 and a source of the inner layer 232. The source of the outer layer 230 may be a roll including the first layer 202 and the source of the inner layer 232 may be a roll including the second layer 208. The sources of the outer and inner layers 230, 232 may be distinct and separate from each other. In an embodiment, not shown, the system 220 includes a source of the porous material 200, wherein the source of the porous material 200 includes the first layer 202 and the second layer 208 already positioned adjacent to each other.
- Page 31 - Docket No. 318812WO01 504795-1114 [0094] The system 220 may include one or more rollers that facilitate movement of the first layer 202 and the inner layer 208 through the system 220. For example, the system 220 may include a first set of rollers 234 and a second set of rollers 236. The ultrasound plate 222 may be positioned between the first and second set of rollers 234, 236. The first and second set of rollers 236 may hold the first and second layers 202, 208 together and hold the first and second layers 202, 208 parallel to the ultrasound plate 222 which may allow controlled and predictable contact between the pins 228 and the first and second layers 202, 208. The first set of rollers 234 may also pull the first and second layers 202, 208 off their respective source and pull the first and second layers 202, 208 towards the ultrasound plate 222.
[0095] A method of using the system 220 may include providing the source(s) of the first and second layers 202, 208. The system 220 may then pull the first and second layers 202, 208 from their sources towards the ultrasound plate 222. The system 220 may bring the first and second layers 202, 208 together (if not already together) while pulling the first and second layers 202, 208 towards the ultrasound plate 222 when the first and second layers 202, 208 are provided using distinct and separate sources. The ultrasound plate 222 delivers ultrasonic energy into the first and second layers 202, 208 which may cause at least some of the materials of the first and second layers 202, 208 to melt and form the melted regions 214. After forming the melted regions 214, the actuator 224 may move the needle board 226 away from the porous material 200 and the porous material 200 may then be collected by a collector 238.
[0096] The porous materials 100 and 200 may be used in any suitable fluid collection assembly. FIGS. 3A-10C are examples of fluid collection assemblies that may include one or more of the porous material 100 or the porous material 200. [0097] FIG. 3A is an isometric view of a fluid collection assembly 300, according to an embodiment. FIGS. 3B and 3C are cross-sectional views of the fluid collection assembly 300 taken along planes 3B-1B and 3C-3C, respectively, shown in FIG. 3A. The fluid collection assembly is an example of a fluid collection assembly configured to receive bodily fluids from a urethral opening of a female or a male with a buried penis. The fluid collection assembly 300 includes a fluid impermeable barrier 302. The fluid impermeable barrier 302 at least defines a chamber 304, at least one opening 306, and a fluid outlet 308. The fluid collection assembly 300 also includes a porous material 310 disposed in the chamber 304 that extends across the opening 306. The fluid collection assembly 300 also includes a conduit 314 having a multi-lumen configuration.
- Page 32 - Docket No. 318812WO01 504795-1114 [0098] The fluid impermeable barrier 302 at least partially defines a chamber 304 (e.g. , interior region) and an opening 306. The fluid impermeable barrier 302 temporarily stores the bodily fluids in the chamber 304. The fluid impermeable barrier 302 may be formed of any suitable fluid impermeable material(s), such as a fluid impermeable polymer (e.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, neoprene, a polycarbonate, etc.), a metal film, natural rubber, another suitable material, any other fluid impermeable material disclosed herein, or combinations thereof. As such, the fluid impermeable barrier 302 substantially prevents the bodily fluids from passing through the fluid impermeable barrier 302. In an example, the fluid impermeable barrier 302 may be air permeable and fluid impermeable. In such an example, the fluid impermeable barrier
302 may be formed of a hydrophobic material that defines a plurality of pores. At least one or more portions of at least an outer surface of the fluid impermeable barrier 302 may be formed from a soft and/or smooth material, thereby reducing chaffing on a wearer or user of the assembly. [0099] The opening 306 provides an ingress route for bodily fluids to enter the chamber
304. The opening 306 may be defined by the fluid impermeable barrier 302 such as by an inner edge of the fluid impermeable barrier 302. For example, the opening 306 is formed in and extends through the fluid impermeable barrier 302 thereby enabling bodily fluids to enter the chamber 304 from outside of the fluid collection assembly 300. [00100] In some examples, the fluid impermeable barrier 302 may define a fluid outlet
308 sized to receive the conduit 314. The at least one conduit 314 may be disposed in the chamber 304 via the fluid outlet 308. The fluid outlet 308 may be sized and shaped to form an at least substantially fluid tight seal against the conduit 314 (e.g., drainage tube) thereby substantially preventing the bodily fluids from escaping the chamber 304. [00101] As previously discussed, the fluid collection assembly 300 includes porous material 310 disposed in the chamber 304. The porous material 310 may cover at least a portion (e.g., all) of the opening 306. The porous material 310 may include one or more of a foam, spun fibers, a vertical nonwoven material, a woven material, a quilted material, or the like. The porous material 310 may be the same as or substantially similar to the porous material 100 or the porous material 200. For example, the porous material 310 may include a first layer and a second layer that are bonded together using a plurality7 of melted regions or entangled regions. The first layer may form one of the outer layer 311 or the inner layer 313 and the second layer may form the other of the outer layer 311 or the inner layer 313.
- Page 33 - Docket No. 318812WO01 504795-1114 [00102] The outer layer 311 may include any suitable porous material, such as a porous sheet. In an example, the outer layer 311 may include gauze (e.g, a silk, linen, or cotton gauze), another soft fabric, another smooth fabric, a horizontal lapped nonwoven material, a cross lapped nonwoven material, a porous polymer (e.g., nylon, polyester, polyurethane, hydrophilic or hydrophobic polyethylene, hydrophilic or hydrophobic polypropylene, spun nylon fiber etc.) structure or an open cell foam (e.g., polyethylene or polyurethane foam), or any other suitable porous material. The porous material 336 may be formed from natural fibers which may be more sustainable and biodegradable than the synthetic fibers. Examples of natural fibers includes cellulose, cotton, bamboo, wool, or the like. In some examples, the fibers of the outer layer 311 (e.g., gauze) may include a blend of natural fibers and synthetic fibers. For example, the outer layer 311 may include bamboo fibers and polypropylene fibers. In an example, the outer layer 311 may include a hydrophobic material or a hydrophilic material.
[00103] In an embodiment, as illustrated, the outer layer 311 is disposed on an outer surface of the at least one inner layer 313 (e.g., between the fluid impermeable barrier 302 and the inner layer 313) such that the outer layer 311 extends across the opening 306 and contacts the individual during use. The outer layer 311 may be disposed on the inner layer 313 to make the fluid collection assembly 300 more comfortable to use and/or improve capture of the bodily fluids. In an example, an individual may find direct contact between the inner layer 313 and the sensitive vaginal region of the individual uncomfortable, for instance, due to the surface roughness of a foam or fibers protruding of the inner layer 313. In such an example, the outer layer 311 may include a material (e.g. gauze) that is smoother or otherwise more comfortable than the inner layer 313. In an example, as previously discussed, the hydrophilicity of the inner layer 313 may be limited to facilitate removing bodily fluids therefrom. However, limiting the hydrophilicity of the inner layer 313 may limit the ability’ of the inner layer 313 to capture bodily fluids. As such, the outer layer 311 may be selected to exhibit a hydrophilicity that is greater than (i.e., a contact angle with water that is less than) the inner layer 313 which allows the outer layer 311 to capture bodily fluids more quickly than the inner layer 313. When the outer layer 311 exhibits a hydrophilicity that is greater than the inner layer 313, the outer layer 311 may exhibit a thickness that is significantly less than the thickness of the inner layer 313. The smaller thickness of the outer layer 311 decreases the volume of bodily fluids that are retained in the outer layer 311 that have to be evaporated by air flow through the chamber 304.
- Page 34 - Docket No. 318812WO01 504795-1114 [00104] FIG. 3D is a cross-sectional view of a portion of the fluid collection assembly 300 taken from the box illustrated in FIG. 3C. according to an embodiment. As shown, the outer layer 311 of the porous material 310 may include a vertical nonwoven material. The vertical nonwoven material is formed from a nonwoven web 318 that is folded. The folded nonwoven web 318 may include a plurality of folded portions 320 and a plurality of intermediate portions 322 extending between the folded portions 320. The folded non woven web 318 may include an outer surface adjacent to the fluid impermeable barrier 302 and an opposing inner surface (e.g, defining a bore that received the conduit 314). The folded portion 320 may extend generally parallel to the outer and inner surfaces of folded non woven web 318. The intermediate portions 322 may extend between the outer and inner surfaces of the folded nonwoven web 318. In an embodiment, the folded nonwoven web 318 may be positioned in the chamber 304 such that the folded portions 320 extend generally parallel to a longitudinal (e.g., central) axis 316 of the fluid collection assembly 300 (e.g. , generally parallel to a longitudinal axis of the porous material 310) and/or extend circumferentially when the porous material 310 exhibits a generally cylindrical shape. The folded nonwoven web 318 may be positioned in the chamber 304 such that the intermediate portions 322 extend generally parallel to the longitudinal axis 316 of the fluid collection assembly 300 (e.g., generally parallel to a longitudinal axis of the porous material 310) and/or extend radially when the porous material 310 exhibits a generally cylindrical shape. [00105] The vertical nonwoven material includes a plurality of fibers 324. In an embodiment, the nonwoven web 318 that forms the vertical nonwoven material may include a plurality of generally oriented fibers 324. The generally oriented fibers 324 may improve the ability of the vertical nonwoven material to capture bodily fluids and transport bodily fluids. The generally oriented fibers 324 may also improve the mechanical properties of the vertical nonwoven material. As used herein, the fibers 324 are ‘’generally aligned” when a certain percentage of the fibers 324 are substantially parallel to each other. The certain percentage of the fibers 324 refers to at least about 70% of the fibers 324, more preferably at least about 80% of the fibers 324, more preferable 90% of the fibers 324, and even more preferably at least about 95% of the fibers 324. The fibers 324 are generally parallel to each other when the certain percentage of fibers 324 are parallel to each other ±30° more preferable ±20°, more preferably ±10°, or even more preferably ±5°.
[00106] The nonwoven web 318 may be disposed in the chamber 304 such that the fibers 324 of the folded portions 320 are generally oriented circumferentially and the fibers 324 of the intermediate portions 322 are generally oriented radially. Not wishing to be bound
- Page 35 - Docket No. 318812WO01 504795-1114 to theory, the circumferentially orientation of the fibers 324 of the folded portions 320 may cause the bodily fluids received by the vertical nonwoven material to initially preferentially disperse circumferentially and the radial orientation of the fibers 324 of the intermediate portions may cause the bodily fluids to initially preferentially disperse radially into the porous material 310. Causing the bodily fluids to initially disperse circumferentially and radially quickly disperses the bodily fluids throughout a large volume of the vertical nonwoven material thereby allowing the vertical nonwoven material to quickly capture and transport the bodily fluids. It is noted that the fibers 324 do not inhibit flow of the bodily fluids in a direction that is generally parallel to the longitudinal axis 316, especially after the fibers 324 are wetted. Further, dispersing the bodily fluids throughout the vertical nonwoven material increases the surface area of any bodily fluids that may remain in the vertical nonwoven material after removing the bodily fluids from the porous material 310. The large surface area facilitates evaporation of the remaining bodily fluids with the air flow through the porous material 310. In an embodiment, the fibers 324 are randomly oriented or may be oriented differently than what is shown in FIG. 3D.
[00107] In an embodiment, as illustrated, folding the nonwoven web 318 may cause the formation of gaps 325 that extending generally parallel to the longitudinal axis 316. The gaps 325 may facilitate fluid flow in a direction that is generally parallel to the longitudinal axis 316. However, the nonwoven web 318 may be folded or compressed by the fluid impermeable barrier 302 to minimize the size of the gaps 325 to prevent pooling of the bodily fluids in the chamber 304. For example, the nonwoven web 318 may be folded or compressed by the fluid impermeable barrier 302 to cause the gaps 325 to exhibit a dimension measured perpendicular to the longitudinal axis 316 that is less than about 1 mm, less than about 0.75 mm, less than about 0.5 mm, or less than about 0.25 mm. [00108] As previously discussed, the vertical nonwoven material may be formed from at least one nonwoven web 318 that is folded. The vertical nonwoven material may be formed from any suitable nonwoven web. In an embodiment, the nonwoven web includes at least one carded web. The carded web includes a plurality of fibers 324 that may be generally oriented in the same direction. The generally same orientation of the fibers 324 of the carded web cause the carded web to be anisotropic. For example, the strength of the carded web is greatest when a force applied thereto is generally parallel to the fibers 324 but the strength of the carded web decreases as the force applied thereto becomes more oblique or perpendicular to the orientation of the fibers 324. As such, the carded web may need to be positioned in the chamber 304 to mitigate forces being applied to the carded web
- Page 36 - Docket No. 318812WO01 504795-1114 that are not generally parallel to the orientation of the fibers 324 or requires addition binding between the fibers 324 (e.g., heat or chemical) to prevent unsatisfactory wear of the carded web.
[00109] In an embodiment, the nonwoven web 318 may include at least one needle punched web. The needle punched web may be formed from a sheet including a plurality of fibers 324. The sheet may include a plurality of randomly oriented fibers 324 (e.g., the fibers 324 are generally parallel to and randomly oriented in the plane), or generally oriented fibers 324 (e.g., a carded web) since the orientation of the fibers 324 may better facilitate flow of the bodily fluids therethrough. A plurality7 of needles (e.g., a plurality of barbed needles) are inserted into the sheet in a direction that is generally parallel to a thickness of the sheet which causes some of the fibers 324 to become entangled and interlocked.
[00110] In an embodiment, the nonwoven web 318 may include at least one air laid web.
The air laid web may exhibit a plurality of randomly oriented fibers 324. The plurality of random fibers 324 may exhibit a length that is sufficiently large that the fibers 324 become entangled and do not need be bounded together or the fibers 324 may be bonded. Due to the random orientation of the fibers 324, the air laid web tends to be isotropic and exhibit a high porosity. Similar, due to the random orientation of the fibers 324, the air laid web may exhibit a high loft. The air laid web may be formed from fibers 324 that cannot be carded (e.g, short fibers).
[00111] In an embodiment, the nonwoven web 318 may include at least one spunlaced web. The spunlaced web is formed by providing a sheet that includes randomly oriented fibers 324 or a carded web. High pressure water jets that are generally parallel to the thickness of the sheet are directed towards the sheet. Similar to the needle punched web, the high pressure jets of water cause some of the fibers 324 to migrate from an exterior of the sheet to an interior thereof to form columns. Thus, the spunlaced web may function similar to the needle punched web, namely that the spunlaced web may be more isotropic than the carded web and includes divots.
[00112] While carded web, needle punched web, the air laid web. and the spunlaced web are the preferred nonwoven webs to be included in the vertical nonwoven material, the vertical nonwoven material may include one or more nonwoven webs other than the carded web, needle punched web, the air laid web, and the spunlaced web. For example, the vertical nonwoven material may include a wet laid web, a spunbond nonwoven web, or a meltblown nonwoven web.
- Page 37 - Docket No. 318812WO01 504795-1114 [00113] The folded nonwoven web 318 may be formed from a sheet. When resting the sheet on a horizontal planar surface, the folded portions 320 may extend parallel to the horizontal planar surface and the intermediate portions 322 may extend vertically from the horizontal planar surface. The folded nonwoven web 318 may then be rolled to form the cylindrical folded non woven web 318.
[00114] In some embodiments, the vertical nonwoven material may include a material there does not have fibers. For example, a foam body may be utilized instead of a nonwoven web 318. The foam body may be sized, shaped, and folded similarly or identically to the folded nonwoven w eb 318 to form the porous body of the porous material 310. For example, the foam body may include an open cell foam body folded to have the plurality of folded portions 320 and the plurality of intermediate portions 322 extending between the folded portions 320 to form the vertical nonwoven material. In such examples, the foam body may include a foam of any of the polymers disclosed herein, such as polyurethane, polyethylene, polyethylene terephthalate, other polyesters, polyether, or the like. Bodily fluids may move through the open cell structure of the foam toward the reservoir or vacuum force (e.g., inlet of conduit 314).
[00115] Suitable vertical nonwoven materials and their properties for use in the porous material 100 are disclosed in International Patent Application No. PCT/US2022/042719 filed on 7 September 2022, and U.S. Provisional Patent Application No. 63/241.575 filed on 8 September 2021, the disclosure of each of which is incorporated herein, in its entirety, by this reference for any purpose.
[00116] The porous material 310 may exhibit a thickness that is greater than about 1 mm, such as in ranges of 1 mm to about 30 mm, about 1 mm to about 10 mm, about 10 mm to about 20 mm, about 20 mm to about 30 mm, about 5 mm to about 15 mm, about 15 mm to about 25 mm, less than about 30 mm, or less than about 20 mm. Increasing the thickness of the porous material 310 generally increases the volume of bodily fluids that may be temporarily stored in the porous material 310, and allows greater flexibility in selecting the density and basis weight of the porous material 310. However, the thickness of the porous material 310 may be limited by the size and functionality of the fluid collection assembly 300. For example, the thickness of the porous material 310 may be selected such that the porous material 310 may be disposed in the chamber 304, along with any other components that may also be disposed in the chamber 304. such as outer layer 336 (FIG. 3B), or a conduit 314.
- Page 38 - Docket No. 318812WO01 504795-1114 [00117] The rate at which the porous material 310 captures and transports the bodily fluids may depend on a number of factors. For example, the rate at which a vertical nonwoven material captures and transports the bodily fluids may depend inversely on the density and weight basis of the vertical nonwoven material, wherein increasing the density and/or weight basis of the vertical nonwoven material may decrease the rate at which the vertical nonwoven material captures and transports the bodily fluids and vice versa. In an example, the rate at which the porous material 310 captures and transports the bodily fluids may depend on the material (e.g., hydrophilicity of the material) that forms the porous material 310. The rate at which the porous material 310 captures and transports the bodily fluids may increase with increasing thickness t since increasing the thickness t increases the cross-sectional area through which the bodily fluids may flow.
[00118] Referring back to FIGS. 3A-3C, in an embodiment, as illustrated, the porous material 310 may only or substantially only include a single porous layer. In such an embodiment, the single porous layer may define a bore that is configured to receive the conduit 314 and the single porous layer extends from the bore to the fluid impermeable barrier 302. When the porous material 310 includes only or substantially only the single porous layer, all of the porous material 310 is able to quickly capture and transport the bodily fluids. As explained in more detail below, the porous material 310 may include at least one additional material, such as outer layer, even though such additional material may decrease at least one of the ability of the porous material 310 to capture and/or transport the bodily fluids.
[00119] The fluid collection assembly 300 may include a sump or reservoir therein to collect bodily fluids. The sump may be an occupied or unoccupied portion of the chamber 304. The sump may be a portion within the chamber 304 at or near where the inlet of the conduit 314 is located. The porous material 310 may at least substantially completely fill the portions of the chamber 304 that are not occupied by the conduit 314. In some examples, the porous material 310 may not substantially completely fill the portions of the chamber 304 that are not occupied by the conduit 314. In such an example, the fluid collection assembly 300 includes a reservoir 326 (e.g.. sump) disposed in the chamber 304. [00120] As depicted, the reservoir 326 (sump) may be a substantially unoccupied portion of the chamber 304. The reservoir 326 may be defined between the fluid impermeable barrier 302 and porous material 310. The bodily fluids that are in the chamber 304 may flow through the porous material 310 to the reservoir 326. The reservoir 326 may retain of the bodily fluids therein. The fluid impermeable barrier 302 may retain the bodily fluids in
- Page 39 - Docket No. 318812WO01 504795-1114 the reservoir 326. While depicted in the distal end region 332. the reservoir 326 may be located in any portion of the chamber 304 such as the proximal end region 334. The reservoir 326 may be located in a portion of the chamber 304 that is designed to be located in a gravimetrically low point of the fluid collection assembly when the fluid collection assembly 300 is worn.
[00121] While depicted as portions of the chamber 304 not occupied by the porous material 310. the reservoir 326 or sump may be occupied by the porous material 310 and still function as a reservoir or sump. For example, the porous material 310 may fill substantially of the chamber 304 not occupied by the conduit 314 and the reservoir 326 may be a distal end region of the chamber or any other region of the chamber 304 configured to retain the bodily fluid therein while or prior to being removed via the conduit 314.
[00122] In some examples (not shown), the fluid collection assembly 300 may include multiple reservoirs, such as a first reservoir that is located at the portion of the chamber 304 closest to the inlet of the conduit 314 (e.g., distal end region 332) and a second reservoir that is located at the portion of the of the chamber 304 that is at or near proximal end region 334). In another example, the porous material 310 is spaced from at least a portion of the conduit 314, and the reservoir 326 may be the space between the porous material 310 and the conduit 314. [00123] FIG. 3E is a cross-sectional view of the conduit 314, according to an embodiment. Referring to FIGS. 3B, 3C and 3E, the conduit 314 includes a fluid lumen 347 and a shape memory' lumen 349 therein. The conduit 314 includes an outer wall 346 and an inner wall 348 at least partially defining the fluid lumen 347 and shape memory lumen 349. respectively. The outer wall 346 and the inner wall 348 of the conduit 314 may be constructed of a polymer, such as silicone, polyvinyl chloride (PVC), polyethylene, thermoplastic polyurethane, a thermoplastic elastomer (e.g., a synthetic rubber), or the like. The conduit 314 may have a Shore A hardness of at least 30, such as about 30 to about 95, about 50 to about 95. about 30 to about 60, about 60 to about 80, about 75 to about 95, less than 95, or less than 75. The conduit 314 may have a length of at least a meter, such as about 1 m to about 5 m, about 1 m to about 3 m, about 2 m to about 3 m, or less than 5 m.
[00124] The conduit 314 may be at least partially disposed in the chamber 304. The conduit 314 may be used to remove the bodily fluids from the chamber 304. The conduit 314 includes at least one wall (e.g.. outer wall 346) defining an inlet 312, an outlet (not shown) downstream from the inlet 312, and a passageway therebetween.
- Page 40 - Docket No. 318812WO01 504795-1114 [00125] The outlet of the conduit 314 may be operably coupled to a vacuum source, such as a vacuum pump for withdrawing fluid from the chamber 304 through the conduit 314. For example, the conduit 314 may extend into the fluid impermeable barrier 302 from the proximal end region 334 and may extend to the distal end region 332 to a point proximate to the reservoir 326 therein such that the inlet 312 is in fluid communication with the reservoir 326. The conduit 314 fluidly couples the chamber 304 with the fluid storage container (not shown) or the vacuum source (not shown). In some embodiments, the inlet 312 may be disposed at or near the fluid impermeable barrier 302 in the distal end region 332. [00126] The conduit 314 may extend through a bore in the porous material 310. In an embodiment, the conduit 314 extends from the fluid outlet 308, through the bore, to a location that is proximate to the reservoir 326. In such an embodiment, the inlet 312 may not extend into the reservoir 326 and, instead, the inlet 312 may be disposed within the porous material 310 or at a terminal end thereof. For example, an end of the conduit 314 may be coextensive with or recessed within the porous material 310. In an embodiment, the conduit 314 is at least partially disposed in the reservoir 326 and the inlet 312 may be extended into or be positioned in the reservoir 326. In an embodiment, the inlet 312 may be positioned aft of the reservoir 326. The bodily fluids collected in the fluid collection assembly 300 may be removed from the chamber 304 via the conduit 314. [00127] Locating the inlet 312 at or near a location expected to be the gravimetrically low point of the chamber 304 when worn by an individual enables the conduit 314 to receive more of the bodily fluids than if inlet 312 was located elsewhere and reduce the likelihood of pooling (e.g., pooling of the bodily fluids may cause microbe growth and foul odors). For instance, the bodily fluids in the porous material 310 may flow in any direction due to capillar}’ forces. However, the bodily fluids may exhibit a preference to flow in the direction of gravity, especially when at least a portion of the porous material 310 is saturated with the bodily fluids. Accordingly, one or more of the inlet 312 or the reservoir 326 may be located in the fluid collection assembly 300 in a position expected to be the gravimetrically low point in the fluid collection assembly 300 when worn by an individual. such as the distal end region 332.
[00128] The inlet 312 and the outlet of the conduit 314 are configured to fluidly couple (e.g., directly or indirectly) the vacuum source (not shown) to the chamber 304 (e.g., the reservoir 326). As the vacuum source (FIG. 11) applies a vacuum/suction in the conduit 314, the bodily fluids in the chamber 304 (e.g., at the distal end region 332 such as in the
- Page 41 - Docket No. 318812WO01 504795-1114 reservoir 326) may be drawn into the inlet 312 and out of the fluid collection assembly 300 via the conduit 314. In some examples, the conduit 314 may be frosted or opaque (e.g., black) to obscure visibility of the bodily fluids therein.
[00129] As previously discussed, the conduit 314 may be configured to be at least insertable into the chamber 304. In an example, the conduit 314 may be positioned in the chamber 304 such that a terminal end of the conduit 314 is spaced from the fluid impermeable barrier 302 or other components of the fluid collection assembly 300 that may at least partially obstruct or block the inlet 312. Further, the inlet 312 of the conduit 314 may be offset relative to a terminal end of the porous material 310 such that the inlet 312 is closer to the proximal end region 334 of the fluid collection assembly 300 than the terminal end of the porous material 310. Offsetting the inlet 312 in such a manner relative to the terminal end of the porous material 310 allows the inlet 312 to receive bodily fluids directly from the porous material 310 and, due to hydrogen bonding, pulls more bodily fluids from the porous material 310 into the conduit 314. [00130] The multiple lumen configuration may include the fluid lumen 347 for transporting fluids and at least one shape memory lumen 349 for containing a shape memory material 350 therein.
[00131] The fluid lumen 347 is sized and shaped to allow bodily fluids to flow7 therethrough. As shown in FIG. 3E, the fluid lumen 347 may be a larger than the shape memory lumen 349. For example, the fluid lumen 347 may have an inside diameter (or major dimension) of at least about 0.1 inches (2.5 mm), such as about 0. 1 inches to about 0.5 inches (12.7 mm), about 0.15 inches (3.8 mm) to about 0.35 inches (8.9 mm), about 0.25 inches (6.3 mm) to about 0.4 inches (10.2 mm), or less than about 0.5 inches.
[00132] The shape memory lumen 349 is sized and shaped to accommodate a shape memory material 350 therein. For example, the shape memory lumen 349 may have an inside diameter (or major dimension) of at least about 0.03 inches (0.76 mm), such as about 0.03 inches to about 0.1 inches (2.5 mm), about 0.03 inches to about 0.05 inches (1.3 mm), about 0.05 inches to about 0.07 inches (1.8 mm), or less than about 0.1 inches. While the shape memory lumen 349 is depicted as being positioned in the gravimetrically low point of the conduit 314 (e.g., in the bottom of the fluid lumen 347), the shape memory lumen may be disposed at any point in the fluid lumen 347, such as at the lateral sides (e.g., 3 o’clock or 9 o’clock) or the top (e.g., 12 o’clock position).
[00133] Referring back to FIGS. 3B and 3C, the shape memory lumen 349 may contain the shape memory material 350 in a discrete portion of the longitudinal length of the conduit
- Page 42 - Docket No. 318812WO01 504795-1114 314, such as a portion of the shape memory lumen 349 that is within the longitudinal length of the fluid impermeable barrier 302. The shape memory material 350 may include an element configured to allow the shape of the fluid collection assemblies to be controllably changed and/or maintain a selected shape. [00134] The at least one shape memory material 350 may prevent or at least inhibit bodily fluids leaking from the fluid collection assembly 300. For example, bodily fluids may leak from the fluid collection assembly because, initially, the fluid collection assembly 300 may exhibit a poor fit with the anatomy of a wearer (e.g., user) about the urethral opening. The poor fit may cause gaps to be present between the porous material 310 and the region about the urethral opening. These gaps may provide locations through which the bodily fluids may flow without being received by the porous material 310 and/or locations at which bodily fluids may leave the porous material 310. To minimize or eliminate the gaps, the fluid collection assembly 300 includes the shape memory material 350 disposed in the shape memory7 lumen 349. The shape memory material 350 is configured to be manipulated (e.g., bent or otherwise shaped) which, in turn, causes the fluid collection assembly 300 to exhibit a shape that matches the anatomical shape of the patient and to conform to the shape of the anatomy of the wearer about the urethral opening (e.g., vaginal region). In other words, the shape memory7 material 350 enables a more anatomically precise fit for the fluid collection assembly 300 with the region about the urethral opening than conventional fluid collection assemblies.
[00135] The shape memory material 350 is sized, shaped, and positioned in the fluid collection assembly 300 to cause at least a portion of the fluid collection assembly 300 to retain a selected shape (e.g., geometric configuration). The shape memory material 350 is configured to be bent, shaped, or otherwise deformed (hereafter collectively referred to as '‘shape,” '‘shaped,” or “shaping”). The shape memory7 material 350 may be configured to be shaped along an entire length thereof. Allowing the shape memory^ material 350 to be shaped along the entire length thereof may allow the fluid collection assembly 300 to exhibit a shape that substantially corresponds to the anatomical features of the patient. For example, the shape memory material 350 may exhibit a first (e.g., initial) shape and the fluid collection assembly 300 may exhibit the first configuration (i.e., a generally linear shape) when the shape memory7 material 350 exhibits the first shape. The shape memory7 material 350 may be manipulated to exhibit a second shape that is different than the first shape and the fluid collection assembly 300 may exhibit the second configuration (e.g., a generally curved cylindrical shape) when the shape memory material 350 exhibits the
- Page 43 - Docket No. 318812WO01 504795-1114 second shape. The second configuration of the fluid collection assembly 300 may better correspond to the shape of the region about the urethral opening than the first configuration. [00136] The shape memory material 350 may include a shape memory polymer or a metal (e.g., shape memory metal). Generally, the shape memory material 350 is composed to adopt an intermediate or permanent shape in response to a stimuli. For example, the shape memory material 350 may exhibit a first (e.g., initial) shape and may be switched from the first shape to a second shape by an external stimuli to adopt a second shape that is different from the first shape. The shape memory material 350 may also be switched from the second shape back to the first shape or a third shape that is different than the first and second shapes in response to the stimuli.
[00137] The stimuli may include an external physical force (e.g., bending force), heat, electrical bias, or a magnetic field. While the term “shape memory” is used to describe some of the “shape memory materials” herein, it should be understood that, in some examples, the material modified by the term “shape memory" may not necessarily need to return to a preselected shape upon application of a stimuli, as understood as the classical definition of the “shape memory material.” Rather, at least some of the shape memory materials disclosed herein may simply hold a selected shape when bent, set, or cured into a specific shape and/or when cooled in a specific shape, regardless of the stimuli applied thereto after. The shape memory materials may be returned to the original shape or changed to a new shape by application of the stimuli. For example, a metal wire bent to a first shape may be utilized as the shape memory material 350, whereinafter the metal wire may be modified to a second shape via physical force applied thereto or via heating. However, in some embodiments, the shape memory material 350 may exhibit a selected shape, as discussed above and application of the stimuli may cause the shape memory material to deform (e.g., elastically deform or bend) into an intermediate shape. In such embodiments, the shape memory material 350 may return to the first initial shape upon removal of the stimuli such that the shape memory material 350 does not maintain the intermediate shape. [00138] The shape memory material 350 is distinct (e.g., may move independently) from the conduit 314. The shape memory material 350 may include a rod, a wire, a cable, or other structure disposed in the shape memory lumen 349. The shape memory material 350 may have a cylindrical shape, an extruded ovoid shape, or a polygonal extruded shape. The shape memory material 350 may be sized to fit within the shape memory' lumen 349. For example, the shape memory material 350 may have a diameter (or major dimension) that is at least about 0.03 inches, such as about 0.03 inches to about 0. 1 inches, about 0.03 inches
- Page 44 - Docket No. 318812WO01 504795-1114 to about 0.05 inches, about 0.05 inches to about 0.07 inches, less than about 0. 15 inches, or less than about 0.1 inches. In some embodiments, the shape memory material 350 may include a 12 gauge (2.05 mm) to 20 gauge (0.81 mm) wire, such as a 14 gauge (1.63 mm) wire. The shape memory material 350 may be smaller than the shape memory lumen 349, such as at least 0.001 inches (25.4 pm) smaller, 0.001 inches to 0.1 inches, 0.001 inches to 0.01 inches (254 pm), 0.01 inches to 0.04 inches, 0.04 inches to 0. 1 inches smaller than the shape memory lumen 349. Such examples provide a selected fit between the shape memory material 350 and the shape memory lumen 349, such as a slip fit, a sliding fit, a running fit, a loose fit, or the like that allow the shape memory material 150 to move (e.g., longitudinally) with respect to the shape memory lumen 349.
[00139] In some examples, the shape memory material 350 may be slightly larger than the shape memory lumen 349, such as 0.001 inches larger to 0.01 inches larger. Such examples may provide a tight fit between the shape memory material 350 and the shape memory' lumen 349 such that the shape memory material 350 does not move with respect to the shape memory lumen 349.
[00140] In an embodiment, the shape memory material 350 may include metal, such as an elemental metal, an alloy, or shape memory alloy. Suitable shape memory metals may include aluminum, silver, copper, iron, nickel, zinc, tin, beryllium, or the like. Suitable shape memory alloys may include standard steels, stainless steel, carbon alloy steel, head treated steel, galvanized steel, aluminum alloys, nickel-titanium alloys (e.g., Nitinol. Ni — Ti — Cu, Ni — Ti, Co, or the like), copper, copper-based alloys (e.g., brass, Cu — Zn — Al, Cu — Al — Ni, Cu — Al — Sn, or the like), Co — Cr — Ni — Mo alloys (e.g., Elgiloy® or the like), or any other alloy having shape memory characteristics. As explained above, the shape memory metals or alloys may merely be metals or alloys that may be shaped to a selected configuration. In some examples, the shape memory metals or alloys may return to a primary shape when an external stimuli is applied thereto. In some examples, the outer surface of the shape memory metal may be coated with a polymer, anodized, passivated, or otherwise treated to prevent corrosion. In some examples, the shape memory metal may be annealed, tempered, or otherwise heat treated. Such heat treating may reduce brittle breakage and increase ductility of the shape memory material 350.
[00141] Shape memory' polymers (“SMPs”) may include polyurethane-based SMPs such as a copolymer (e.g., copolyester, polyurethane, polyetherester, etc.) including blocks of one or more of poly(s-caprolactone). PET, polyethyleneoxide (PEO), polyethylene glycol (PEG), polystyrene, polymethylmethacrylate (612MA), Poly butylmethacrylate
- Page 45 - Docket No. 318812WO01 504795-1114 (PBMA), poly(N,N-butadiene), poly(N-methyl-N-oxazoline), polytetrahydrofuran, or poly(butylene terephthalate); thermoplastic polymers such as polyether ether ketone (PEEK), nylon, acetal, polytetrafluoroethylene (PTFE), polypropylene, polyethylene, acrylonitrile butadiene styrene (ABS), polysulphone, or the like; Polynorbonene; other deformable polymers; or any other shape memory polymer.
[00142] The shape memory material 350 may be retained within the shape memory lumen 349 by one or more plugs disposed at or near the (opposite) longitudinal ends thereof. The plugs may include a stop plug 354 and an end plug 352. The plugs may be sized, shaped, and located to fit within the shape memory lumen 349 and to prevent the shape memory material 350 from moving (longitudinally) within the shape memory' lumen 349 beyond the plugs. For example, the stop plug 354 and end plug 352 may be disposed at opposite ends of the shape memory material 350 in the shape memory' lumen 349 to prevent longitudinal movement of the shape memory material 350 within the shape memory' lumen 349. [00143] The stop plug 354 and end plug 352 may be constructed of a resilient material, such as a polymer, an epoxy, rubber, a metal, wood, or the like. Suitable polymers may include a PVC, a polycarbonate, a polyethylene, a polypropylene, a poly acetal, polytetrafluoroethylene, an acrylic, or any of the polymers disclosed herein. For example, the stop plug 354 and end plug 352 may be constructed of a heat seal PVC. The stop plug 354 and end plug 352 may be constructed of any of the metal materials disclosed herein. In such examples, the stop plug 354 and end plug 352 may be annealed, tempered, or otherwise heat treated. The stop plug 354 and end plug 352 may be constructed of an adhesive, such as adhesive dams formed in the shape memory lumen 349. The adhesive may be a UV cured adhesive, a catalyst cured adhesive, a heat cured adhesive, or the like. The stop plug 354 and end plug 352 may have a major dimension that is sized to provide a press fit, an interference fit, a fixed fit, a similar fit, a force fit, or any' other tight fit within the shape memory' lumen 349. For example, the stop plug 354 and end plug 352 may have a largest outer dimension that is about 0.001 inches to 0.03 inches, about 0.001 inches to about 0.01 inches, about 0.01 inches to about 0.02 inches, or less than about 0.03 inches smaller than the inner dimension of the shape memory lumen 349. The stop plug 354 and end plug 352 may match the shape of the shape memory' lumen 349, such as cylindrical, an extruded ovoid, an extruded polygonal shape, or the like. In some examples, one or more portions of the stop plug 354 and end plug 352 may have a tapered shape, such as cylindrical, rounded, or the like. The stop plug 354 and end plug 352 may have a length or
- Page 46 - Docket No. 318812WO01 504795-1114 lengths that is at least about 0.05 inches (0.13 cm), such as about 0.05 inches to about 0.2 inches (0.51 cm), about 0.1 inches (0.25 cm) to about 0.25 inches (0.64 cm), or less than about 0.25 inches.
[00144] The end plug 352 may (longitudinally) positioned within the shape memory lumen 349 at a point therein selected to be a distal-most point that the shape memory material 350 may extend. For example, the end plug 352 may be positioned within the shape memory lumen 349 at or adjacent to the inlet 312. The end plug 352 may be spaced from the inlet 312 by at least about 0.01 inches, about 0.01 inches to about 0.25 inches, or less than about 0.5 inches. The end plug 352 is sized, shaped, and positioned to retain the shape memory material 350 within the shape memory lumen 349 by preventing the shape memory material 350 from falling out of the distal end of the shape memory lumen 349. Accordingly, the end plug 352 is retained in place within the shape memory lumen 349 such as by fit with the shape memory lumen 349, an adhesive, or welding.
[00145] The stop plug 354 may be (longitudinally) positioned within the shape memory lumen 349 at a point therein selected to be a proximal-most point that the shape memory material 350 may extend. For example, the stop plug 354 may be disposed at a point in the shape memory lumen 349 that is within the chamber 304, within the fluid outlet 308, or even outside of the fluid outlet 308 (e.g., more proximal to the wearer or user than the fluid impermeable barrier). [00146] In some embodiments, the stop plug 354 may be disposed at a point in the shape memory lumen 349 that is outside of the fluid outlet 308 (e g., more proximal to the wearer or user than the fluid impermeable barrier 302). The stop plug 354 is sized, shaped, and positioned to retain the shape memory material 350 within the distal end region of the shape memory lumen 349 by preventing the shape memory material 350 from sliding into a more proximal region of the shape memory lumen 349 than the region within or near the fluid impermeable barrier 302. Accordingly, the stop plug 354 is retained in place within the shape memory lumen 349 such as by fit with the shape memory lumen 349, an adhesive, or welding.
[00147] The space in the shape memory lumen 349 between the end plug 352 and the stop plug 354 may be longer than the shape memory material 350 to allow a selected amount of movement of the shape memory material 350 therein. For example, the space in the shape memory lumen 349 between the end plug 352 and the stop plug 354 may be at least about 0.1 inches longer than the shape memory material 350. such as about 0. 1 inches to about 1 inch (2.5 cm), about 0.1 inches to about 0.3 inches (0.76 cm), 0.15 (0.38 cm)
- Page 47 - Docket No. 318812WO01 504795-1114 inches to 0.35 inches (0.89 cm), 0.3 inches to 0.6 inches (1.52 cm), about 0.5 inches (1.27 cm) to 1 inch, less than 1 inch, or less than 0.5 inches. Such a space allows a selected amount of longitudinal movement of the shape memory material 350 within the shape memory lumen 349. The ability of the shape memory material 350 to move within the shape memory lumen 349, provided by the space and a shape memory material 350 that is slidable within the shape memory lumen 349, allows for better bending (radial bending, kinking, or the like) of the shape memory material 350, conduit 314, and fluid collection assembly 300, than a shape memory material 350 that is fixed with respect to the shape memory lumen 349. Such improved bending is due to a reduction in tensile forces introduced during bending of the shape memory material 350 when the shape memory material 350 is not adhered to the inside surface of the shape memory lumen 349.
[00148] As noted above, the end plug 352 and stop plug 354 may be retained within the shape memory lumen 349 by an adhesive, fit (between the plugs and the lumen), or welding (e.g., melting). The stop plug 354 may have an adhesive applied thereto prior to positioning with the shape memory’ lumen 349. After the stop plug 354 is positioned and the adhesive cures or dries, the shape memory material 350 may be disposed in the shape memory' lumen 349 so that the shape memory material can slide or move longitudinally therein. The end plug 352 may have an adhesive applied thereto prior to positioning with the shape memory’ lumen 349. such that a selected amount of space is provided between the plugs and the shape memory material 350.
[00149] The porous materials of fluid collection assemblies disclosed herein may include three or more layers. For example, FIG. 4A is an isometric view’ of a fluid collection assembly 400, according to an embodiment. FIGS. 4B and 4C are cross- sectional views of the fluid collection assembly 400 taken along planes 4B-4B and 4C-4C, respectively, shown in FIG. 4A. Except as otherwise disclosed herein, the fluid collection assembly’ 400 is the same as or substantially similar to any of the fluid collection assemblies disclosed herein. The fluid collection assembly 400 includes a fluid impermeable barrier 402. The fluid impermeable barrier 402 at least defines a chamber 404, at least one opening 406, and a fluid outlet 408. The fluid collection assembly 400 also includes a porous material 410 disposed in the chamber 404 that extends across the opening 406. The porous material 410 may be the same as or substantially similar to any of the porous materials disclosed herein. For example, the porous material 410 includes an outer layer 412. an intermediate layer 414, and an inner layer 416. The porous material 410 includes a first layer and a second layer bonded to the first layer using one or more melted regions or
- Page 48 - Docket No. 318812WO01 504795-1114 entangled regions. The first layer forms one of the outer layer 412. the intermediate layer 414, or the inner layer 416 and the second layer forms an adjacent layer of the porous material 410.
[00150] The fluid collection assembly 400 includes a porous material 410 disposed in the chamber 404. The porous material 410 may cover at least a portion (e.g., all) of the opening 406. The porous material 410 is exposed to the environment outside of the chamber 404 through the opening 406. The porous material 410 may include an outer layer 412, an intermediate layer 414, and at least one inner layer 416 that are each distinct from each other (e.g., formed from different materials, exhibit different contact angles with water, etc.).
[00151] The outer layer 412 of the porous material 410 is positioned within the chamber 404 to extend across the opening 406. The outer layer 412 is positioned in the porous material 410 to be closer to the urethral opening of the individual than the intermediate layer 414. In other words, the outer layer 412 may include the portions of the porous material 410 that initially receive the bodily fluids from the individual. As such, in an embodiment, the outer layer 412 may include at least one hydrophilic material. For example, the outer layer 412 is configured to quickly receive the bodily fluids discharged from the individual since the outer layer 412 may initially receive (or at least receive before the intermediate layer 414) the bodily fluids to prevent the bodily fluids leaking from the porous material 410. As previously discussed, the outer layer 412 is able to quickly receive the bodily fluids and, thus, forming the outer layer 412 from at least one hydrophilic material allows the outer layer 412 to quickly receive the bodily fluids.
[00152] The outer layer 412 may be hydrophilic. The hydrophilicity of the outer layer 412 may cause the outer layer 412 to quickly receive bodily fluids therein, thereby preventing or at least inhibiting leakage of bodily fluids caused by a large discharge of bodily fluids over a short period of time. As will be discussed in more detail below, the outer layer 412 is selected to exhibit a hydrophilicity that is less than (e.g. , exhibit a contact angle that is greater than) the intermediate hydrophilic material of the intermediate layer 414. Since the outer layer 412 is hydrophilic, the outer layer 412 is able to quickly receive bodily fluids. However, the decreased hydrophilicity of the outer layer 412 relative to the inner hydrophilic material allows the portions of the porous material 410 that contact the patient to be drier than if the outer layer 412 or the intermediate layer 414 was omitted from the porous material 410.
- Page 49 - Docket No. 318812WO01 504795-1114 [00153] In an embodiment, the outer layer 412 may include at least one of polypropylene or polyethylene, such as a blend of polypropylene and polyethylene. It is noted that, generally, polypropylene and polyethylene are hydrophobic. As such, the outer layer 412 may include at least one surfactant (e.g., any of the surfactants disclosed herein) disposed in at least a portion thereof which effectively causes the outer layer 412 to behave similar to a hydrophilic material. In other words, the outer layer 412 may be the same as or substantially similar to the porous body 101 of FIG. 1.
[00154] That said, the outer layer 412 may include one or more hydrophilic materials other than or in addition to polypropylene and polyethylene. For example, the outer layer 412 may include at least one of natural or treated acry lics, polyvinylchloride, polyester, polyurethane, cellulose-based fibers, or any other suitable hydrophilic material.
[00155] The outer layer 412 of the porous material 410 may be selected to exhibit a density of about 50 kg/m3 to about 100 kg/m3, about 75 kg/m3 to about 125 kg/m3, about 100 kg/m3 to about 150 kg/m3, about 125 kg/m3 to about 175 kg/m3, about 150 kg/m3 to about 200 kg/m3, about 175 kg/m3 to about 225 kg/m3, about 200 kg/m3 to about 250 kg/m3, about 225 kg/m3 to about 275 kg/m3, about 250 kg/m3 to about 300 kg/m3, about 275 kg/m3 to about 325 kg/m3, about 300 kg/m3 to about 350 kg/m3, about 325 kg/m3 to about 375 kg/m3, or about 350 kg/m3 to about 400 kg/m3.
[00156] As previously discussed, the outer layer 412 may be hydrophilic due to the presence of the surfactant therein which may cause the outer layer 412 to retain the bodily fluids therein. It is noted that the hydrophobicity of the polypropylene or the polyethylene may reduce the quantity of bodily fluids that are retained in the outer layer 412. However, to further decrease the quantity of bodily fluids retained by the outer layer 412, the outer layer 412 may be configured to be relatively thin. For example, the outer layer 412 may be configured to exhibit a thickness measured perpendicularly to the longitudinal axis 430 (e.g., measured radially) that is about 2 mm or less, about 1.5 mm or less, about 1.25 mm or less, about 1 mm or less, about 800 pm or less, about 700 pm or less, about 600 pm or less, about 500 pm or less, about 400 pm or less, about 300 pm or less, about 250 pm or less, about 200 pm or less, about 150 pm or less, about 130 pm or less, about 100 pm or less, about 75 pm or less, about 60 pm or less, about 50 pm or less, about 40 pm or less, about 30 pm or less, about 25 pm or less, about 20 pm or less, or in ranges of about 20 pm to about 30 pm, about 25 pm to about 40 pm, about 30 pm to about 50 pm, about 40 pm to about 60 pm. about 50 pm to about 75 pm, about 60 pm to about 100 pm, about 75 pm to about 130 pm, about 100 pm to about 150 pm, about 130 pm to about 200 pm, about 150
- Page 50 - Docket No. 318812WO01 504795-1114 pm to about 300 gm, about 200 gm to about 400 un, about 300 pun to about 500 pun, about 400 pun to about 600 pun, about 500 pun to about 700 pun. about 600 pun to about 800 pun, about 700 pun to about 1 mm, about 800 pun to about 1.25 mm, about 1 mm to about 1.5 mm, or about 1.25 mm to about 2 mm. The relatively small thickness of the outer layer 412 decreases the overall volume of the outer layer 412 thereby decreasing the volume of bodily fluids that may be retained in the outer layer 412. The decreasing volume of bodily fluids held within the outer layer 412 allows the air flow through the chamber 404 to quickly evaporate the bodily fluids that are retained in the outer layer 412 (z.e., the bodily fluids that failed to transfer from the outer layer 412 to the intermediate layer 414) thereby maintaining the porous material 410 dry. Further, decreasing the thickness of the outer layer 412 may allow the intermediate layer 414 to pull more bodily fluids from the outer layer 412.
[00157] In an embodiment, the outer layer 412 may be formed from at least one nonwoven web. The outer layer 412 may be formed from any suitable nonwoven web. In an embodiment, the nonwoven web of the outer layer 412 includes one or more of at least one carded web, at least one needle punched web, at least one air laid web, at least one spunbonded web, at least one spunlaced web, at least one vertical lapped nonwoven fabric, at least one horizontal lapped nonwoven fabric, at least one crossed lapped nonwoven fabric, or any of the other nonwoven webs disclosed herein. In an embodiment, the outer layer 412 may include a woven fabric instead of or in addition to a nonwoven web. Forming the outer layer 412 from a woven material may increase the durability of the porous material 410 than if the outer layer 412 is formed from a nonwoven material. However, forming the outer layer 412 from a woven material may decrease the compressibility of the porous material 410 thereby making the porous material 410 less comfortable and may make conforming the porous material 410 to the vaginal region, which limits leaks, more difficult. Also, it is more difficult to form a woven outer layer 412 than a nonwoven outer layer 412. As such, using the woven outer layer 412 may cause logistic issues, increase manufacturing difficulties, and increase cost. Further, it may be difficult to obtain a woven outer layer 412 exhibiting a sufficiently low basis weight to be effective wherein a nonwoven outer layer 412 exhibiting a sufficiently low basis weight may be easy to obtain.
[00158] The outer layer 412 is disposed on an outer surface of the intermediate layer 414. The bodily fluids received (e.g., directly) by the outer layer 412 flow from the outer layer 412 to the intermediate layer 414. The bodily fluids may flow from the outer layer 412 to the intermediate layer 414 for a variety of reasons. For example, the relatively small
- Page 51 - Docket No. 318812WO01 504795-1114 thickness of the outer layer 412 only allows the outer layer 412 to hold a relatively small volume of bodily fluids. As such, the outer layer 412 may become quickly saturated with the bodily fluids thereby forcing the bodily fluids to flow from the outer layer 412 to the intermediate layer 414. Further, as will be discussed in more detail below, a suction may be applied to the chamber 404. The suction may cause the bodily fluids to flow from the outer layer 412 into the intermediate layer 414. Additionally, the intermediate layer 414 includes an intermediate hydrophilic material. The hydrophilicity of the intermediate hydrophilic material pulls the bodily fluids from the outer layer 412 into the intermediate layer 414. It is noted that the flow of the bodily fluids from the outer layer 412 to the intermediate layer 414 prevents or at least inhibits the bodily fluids that are received into the outer layer 412 from leaking from the outer layer 412. The flow of the bodily fluids from the outer layer 412 to the intermediate layer 414 decreases the volume of bodily fluids that are retained in the outer layer 412 after the patient urinates (i.e., makes the outer layer 412 feel more dry). [00159] The intermediate layer 414 may be hydrophilic. For example, the intermediate layer 414 may include an intermediate hydrophilic material that is hydrophilic. In an embodiment, the overall hydrophilicity of the intermediate layer 414 is greater than the overall hydrophilicity of the outer layer 412. For example, the intermediate layer 414 may exhibit a contact angle with water than is less than the outer layer 412. respectively, by about 5° of more, about 10° or more, about 15° or more, about 20° or more, about 25° or more, about 30° or more, about 35° or more, about 40° or more, about 45° or more, about 50° or more, about 60° or more, about 70° or more, about 80° or more, or in ranges of about 5° to about 15°, about 10° to about 20°, about 15° to about 25°, about 20° to about 30°, about 25° to about 35°, about 30° to about 40°, about 35° to about 45°, about 40° to about 50°, about 45° to about 60°, about 50° to about 70°, or about 60° to about 80°. The increased hydrophilicity of the intermediate layer 414 relative to the outer layer 412 causes the intermediate hydrophilic material to pull bodily fluids from the outer layer 412. For example, the increased hydrophilicity of the intermediate layer 414 relative to the outer layer 412 causes the intermediate layer 414 to exhibit a greater affinity for the bodily fluids thereby causing the bodily fluids in the outer layer 412 to preferentially flow' to the intermediate layer 414. Due to hydrogen bonding, the bodily fluids that flow' into the intermediate layer 414 also pull additional bodily fluids into the intermediate layer 414. The ability of the intermediate layer 414 to pull bodily fluids from the outer layer 412 into the intermediate layer 414 decreases the volume of bodily fluids in the outer layer 412 (i.e.,
- Page 52 - Docket No. 318812WO01 504795-1114 dries the outer layer 412). For example, the intermediate layer 414 may pull sufficient quantities of bodily fluids from the outer layer 412 that the quantities of bodily fluids in the outer layer 412 is negligible and may be relatively quickly evaporated due to air flow through the outer layer 412 caused by the suction provided to the chamber 404. Further, the increased hydrophilicity of the intermediate layer 414 prevent or at least minimizes backflow of the bodily fluids from the intermediate layer 414 to the outer layer 412.
[00160] In an embodiment, the intermediate layer 414 includes bamboo. Bamboo is a hydrophilic material that exhibits a relatively low contact angle of water. For example, bamboo naturally exhibits a hydrophilicity' that is greater than polypropylene and polyethylene. It has also been found that bamboo has a greater synergistic effect with polypropylene and polyethylene than expected. For example, an intermediate layer 414 including bamboo is able to pull a greater percentage of bodily fluids from a polypropylene and/or polyethylene and minimize back flow of bodily fluids from the intermediate layer 414 to the outer layer 412 better than expected. [00161] The bamboo of the intermediate layer 414 may be formed from any bamboo material. In an example, the intermediate layer 414 is formed from natural bamboo. The natural bamboo may be more ecologically friendly than other bamboo materials and may require less manufacturing than non-natural bamboo. In an example, the intermediate layer 414 may include black bamboo (z.e., bamboo from phyllostachys nigra). Black bamboo exhibits greater antimicrobial properties than other types of bamboo; though, it is noted, the other types of bamboo also exhibit antimicrobial properties.
[00162] The bamboo of the intermediate layer 414 may include bamboo kun. Bamboo kun is a material naturally found in bamboo. The bamboo kun causes the intermediate layer 414 to exhibit antifungal properties and antibacterial properties against both Gram-positive and Gram-negative bacteria. As such, the presence of the bamboo kun in the intermediate layer 414 causes the fluid collection assemblies to be substantially as likely to cause catheter-assisted urinary tract infections (“CAUTI”) as sterilized conventional external fluid collection assemblies without actually sterilizing the fluid collection assemblies. Also, the bamboo kun of the intermediate layer 414 is not vulnerable to attack by infectious microbials that may cause CAUTI. The bamboo kun also causes the intermediate layer 414 to be odor resistant, unlike porous materials used in conventional fluid collection assemblies. The odor resistant abilities of the intermediate layer 414 makes using the fluid collection assemblies including the intermediate layer 414 less embarrassing to use since, unlike conventional fluid collection assemblies, the fluid collection assemblies including
- Page 53 - Docket No. 318812WO01 504795-1114 the intermediate layer 414 are unlikely to have a noticeable odor of urine or blood. Unlike the porous materials of conventional fluid collection assemblies, the bamboo kun also causes the intermediate layer 414 to repel dust mites, other bugs, other infectious microorganisms, and viruses. The bamboo kun also repeals these organisms while the bamboo that forms the intermediate layer 414 is grown. As such, unlike the materials used to form other natural porous materials (e.g.. cotton and cellulose), the bamboo that forms the intermediate layer 414 may be grown without pesticides, fungicides, and insecticides. This results in the intermediate layer 414 to be less likely to be contaminated with pesticides, fungicides, and insecticides compared to other natural porous materials without having to process the intermediate layer 414 to remove such materials. Also, the bamboo kun causes the intermediate layer 414 to be more hypoallergenic than other porous materials used in conventional fluid collection assemblies.
[00163] The intermediate layer 414 may include one or more hydrophilic intermediate materials instead of or in addition to bamboo. In an example, the intermediate layer 414 includes at least one of cotton, rayon, or viscose. In an embodiment, the intermediate layer 414 may be formed from any cellulose-based material. In an example, the intermediate layer 414 is formed from naturally derived cellulose which may be more ecologically friendly than other cellulose materials. In an example, the intermediate layer 414 may include any of the nonwoven or woven fabrics disclosed herein. In an example, the intermediate layer 414 may include any of the porous materials disclosed herein, such as a porous material including at least one surfactant disposed therein. It has been surprisingly found that cotton, rayon, viscose, and other cellulose-base materials have a more synergistic relationship with the outer layer 412 (e.g., polypropylene and polyethylene) than other hydrophilic materials. The synergistic relationship includes quickly and effectively moving the bodily fluids from the outer layer 412 to the intermediate layer 414. That said, it is currently believed that bamboo is better able to receive bodily fluids from the outer layer 412 and minimize back flow of the bodily fluids than cotton, rayon, viscose, and other cellulose-base materials.
[00164] In an embodiment, the hydrophilicity of the intermediate layer 414 may be an inherent property of the bamboo and some of the other materials disclosed herein that are used to form the intermediate layer 414. In an embodiment, the hydrophilicity of the intermediate layer 414 may be changed (e.g., increased or decreased) by at least one of impurities or functional groups added to the intermediate layer 414, otherwise treating the intermediate layer 414, or coating the intermediate layer 414 with a material that exhibits a
- Page 54 - Docket No. 318812WO01 504795-1114 hydrophilicity that is different than the intermediate layer 414. It is noted that the hydrophilicity of the intermediate layer 414 may depend on the temperature, humidity’, and other factors and that the hydrophilicity of the materials disclosed herein are measured at room temperature, at sea level, and at a humidity of 30-50%. [00165] The intermediate layer 414 of the porous material 410 may be selected to exhibit a density of about 50 kg/m3 to about 100 kg/m3, about 75 kg/m' to about 125 kg/m3, about 100 kg/m3 to about 150 kg/m3, about 125 kg/m3 to about 175 kg/m3, about 150 kg/m3 to about 200 kg/m3, about 175 kg/m3 to about 225 kg/m3, about 200 kg/m3 to about 250 kg/m3, about 225 kg/m3 to about 275 kg/m3, about 250 kg/m3 to about 300 kg/m3, about 275 kg/m3 to about 325 kg/m3, about 300 kg/m3 to about 350 kg/m3, about 325 kg/m3 to about 375 kg/m3, about 350 kg/m3 to about 400 kg/m3, about 375 kg/m3 to about 425 kg/m3, about
400 kg/m3 to about 450 kg/m3, about 425 kg/m3 to about 475 kg/m3, about 450 kg/m3 to about 500 kg/m3, about 475 kg/m3 to about 525 kg/m3, about 500 kg/m3 to about 550 kg/m3, about 525 kg/m3 to about 575 kg/m3, or about 550 kg/m3 to about 600 kg/m3. [00166] As previously discussed, the intermediate layer 414 may be formed from a hydrophilic material which may cause the intermediate layer 414 to retain the bodily fluids therein. To decrease the quantity of bodily fluids retained by the intermediate layer 414, the intermediate layer 414 may be configured to be relatively thin. For example, the intermediate layer 414 may be configured to exhibit a thickness measured perpendicularly to the longitudinal axis 130 (e.g, measured radially) that is about 2 mm or less, about 1.5 mm or less, about 1.25 mm or less, about 1 mm or less, about 800 pm or less, about 700 pm or less, about 600 pm or less, about 500 pm or less, about 400 pm or less, about 300 pm or less, about 250 pm or less, about 200 pm or less, about 150 pm or less, about 130 pm or less, about 100 pm or less, about 75 pm or less, about 60 pm or less, about 50 pm or less, about 40 pm or less, about 30 pm or less, about 25 pm or less, about 20 pm or less, or in ranges of about 20 pm to about 30 pm, about 25 pm to about 40 pm, about 30 pm to about 50 pm, about 40 pm to about 60 pm, about 50 pm to about 75 pm, about 60 pm to about 100 pm, about 75 pm to about 130 pm, about 100 pm to about 150 pm, about 130 pm to about 200 pm. about 150 pm to about 300 pm, about 200 pm to about 400 pm, about 300 pm to about 500 pm, about 400 pm to about 600 pm, about 500 pm to about 700 pm, about 600 pm to about 800 pm, about 700 pm to about 1 mm, about 800 pm to about 1.25 mm, about 1 mm to about 1.5 mm, or about 1.25 mm to about 2 mm. The relatively small thickness of the intermediate layer 414 decreases the overall volume of the intermediate layer 414 thereby decreasing the volume of bodily fluids that may be retained in the
- Page 55 - Docket No. 318812WO01 504795-1114 intermediate layer 414. The decreasing volume of bodily fluids held within the intermediate layer 414 allows air flow through the chamber 404 to quickly evaporate the bodily fluids that are retained in the intermediate layer 414 (i.e., the bodily fluids that failed to transfer from the intermediate layer 414 to the intermediate layer 414) thereby maintaining the porous material 410 dry. Further, decreasing the thickness of the intermediate layer 414 may allow the intermediate layer 414 to pull more bodily fluids from the intermediate layer 414.
[00167] The intermediate layer 414 of the porous material 410 may be selected to exhibit a basis weight of about 15 gsm to about 25 gsm, about 10 gsm to about 20 gsm, about 15 gm/m2 to about 25 gsm, about 20 gsm to about 30 gsm, about 25 gsm to about 35 gsm, about 30 gsm to about 40 gsm, about 35 gsm to about 45 gsm. about 40 gsm to about 50 gsm, about 45 gsm to about 55 gsm, about 50 gsm to about 60 gsm, about 55 gsm to about 70 gsm, about 60 gsm to about 80 gsm, about 70 gsm to about 90 gsm, about 80 gsm to about 100 gsm. about 90 gsm to about 120 gsm, or about 105 gsm to about 130 gsm. In a particular embodiment, the intermediate layer 414 exhibits a basis weight of about 25 gsm to about 65 gsm. The basis weight of the intermediate layer 414 is a function of the density and thickness of the intermediate layer 414. As such, the basis weight of the intermediate layer 414 may be selected for any of the same reasons as the density' and thickness of the intermediate layer 414. It is noted that the surface area of the intermediate layer 414 depends, in part, on the basis weight thereof. As such, increasing the basis weight of the intermediate layer 414 (to an extent) may increase the surface area of the intermediate layer 414. How quickly the intermediate layer 414 is able to pull bodily fluids into itself from the outer layer 412 depends, in part, on the surface area thereof. However, increasing the basis weight of the intermediate layer 414 may decrease the volume of the void space of the intermediate layer 414 that may temporarily hold the bodily fluids therein. As such, the basis weight of the intermediate layer 414 may be selected by7 balancing these factors.
[00168] The intermediate layer 414 may be disposed on an outer surface of the inner layer 416. The inner layer 416 is configured to support the outer layer 412 and the intermediate layer 414 since the outer layer 412 and the intermediate layer 414 may be formed from a relatively foldable, flimsy, or otherwise easily deformable material. For example, the inner layer 416 may be positioned such that the outer layer 412 and the intermediate layer 414 are disposed between the inner layer 416 and the fluid impermeable barrier 402. As such, the inner layer 416 may support and maintain the position of the outer layer 412 and the intermediate layer 414. The inner layer 416 may include any hydrophobic
- Page 56 - Docket No. 318812WO01 504795-1114 material. In an example, the inner layer 416 may include any other suitable hydrophobic material (e.g, spun nylon fiber, a gauze, a polyurethane foam, a polyethylene foam, hydrophobic polypropylene, hydrophobic polyethylene, PET, or a polyvinyl chloride foam). The inner layer 416 may include a plurality of fibers formed into a nonwoven material (e.g., any of the nonwoven materials disclosed herein), a woven material, or an open cell foam. In an example, the inner layer 416 is substantially similar to the porous material 200. In an example, the inner layer 416 may include any of the porous material disclosed herein.
[00169] In an embodiment, the inner layer 416 may be configured to move any bodily fluids away from the intermediate layer 414, thereby preventing the bodily fluids from escaping the chamber 404. Put another way. substantially no absorption or solubility of the bodily fluids into the material may take place after the inner layer 416 is exposed to the bodily fluids and removed from the bodily fluids for a time. While no absorption or solubility is desired, the term “substantially no absorption” may allow for nominal amounts of absorption and/or solubility of the bodily fluids into the inner layer 416 (e.g, absorbency), such as less than about 30 wt% of the dry weight of the inner layer 416, less than about 20 wt%, less than about 15 wt%, less than about 10 wt%, less than about 7 wt%, less than about 5 wt%, less than about 3 wt%, less than about 2 wt%, less than about 1 wt%, or less than about 0.5 wt% of the dry weight of the intermediate layer 414. The inner layer 416 may also wick the bodily fluids generally towards an interior of the chamber 404, as discussed in more detail below.
[00170] In an embodiment, at least a portion of the inner layer 416 may be hydrophobic or at least more hydrophobic than the intermediate layer 414. The inner layer 416 may be hydrophobic when the inner layer 416 exhibits a contact angle with water (a major constituent of bodily fluids) that is greater than about 90°, such as in ranges of about 90° to about 120°, about 105° to about 135°, about 120° to about 150°, about 135° to about 175°, or about 150° to about 180°. The hydrophobicity of the inner layer 416 may limit absorption, adsorption, and solubility of the bodily fluids in the inner layer 416 thereby decreasing the amount of bodily fluids held in the inner layer 416. The lower hydrophilicity of the outer layer 412 and the intermediate layer 414 may help the porous material 410 receive the bodily fluids from the urethral opening while the hydrophobicity of the inner layer 416 limits the bodily fluids that are retained in the porous material 410.
[00171] The hydrophobicity of the inner layer 416 facilitates flow of the bodily fluids from the outer layer 412 and the intermediate layer 414 towards the fluid outlet 408 (e.g,
- Page 57 - Docket No. 318812WO01 504795-1114 towards an inlet of the conduit 426 positioned through the fluid outlet 408). For example, some of the bodily fluids that are received by the intermediate layer 414 flow into the inner layer 416. The bodily fluids may flow from the intermediate layer 414 to the inner layer 416 because, for example, the bodily fluids are already flowing from the outer layer 412 into the intermediate layer 414 and the suction provided to the chamber 404 causes the bodily fluids to preferentially flow from the intermediate layer 414 towards the inner layer 416. The hydrophobicity of the inner layer 416 discourages the bodily fluids from remaining in the inner layer 416 which, in turn, pushes the bodily fluids towards the fluid outlet 408. However, the bodily fluids received into the inner layer 416 are still hydrogen bonded to the bodily fluids in the intermediate layer 414. As such, the inner layer 416 pulls bodily fluids from the intermediate layer 414 into the inner layer 416 as the inner layer 416 pushes the bodily fluids towards the fluid outlet 408. The ability of the inner layer 416 to pull bodily fluids into itself decreases the quantity of bodily fluids that are retained in the intermediate layer 414 (even when the intermediate layer 414 includes bamboo) can cause the intermediate layer 414 to more effectively pull bodily fluids into itself from the outer layer 412. Thus, the inner layer 416 effectively decreases the quantity of bodily fluids that are retained in the porous material 410 after urination.
[00172] It is noted that the intermediate layer’s 414 ability to pull bodily fluids from the outer layer 412 and move the bodily fluids into the inner layer 416 are different. For example, the intermediate layer 414 uses a hydrophilic-hydrophilic interaction between the outer layer 412 (e.g., the outer layer 412 may be hydrophilic due to the presence of the surfactant therein) and the intermediate layer 414 to move bodily fluids from the outer layer 412 to the intermediate layer 414 and a hydrophilic-hydrophobic interaction between the intermediate layer 414 and the inner layer 416 to move the bodily fluids from the intermediate layer 414 to the inner layer 416. It is surprising that the intermediate layer 414 is able to effectively cause bodily fluids to flow effectively through the porous material 410 even though the intermediate layer 414 using two different interactions. Further, it is currently believed that the cellulose materials disclosed herein, and in particular bamboo, have a more effective hydrophilic-hydrophobic interaction with the inner layer 416 (z.e.. are able to more effectively move bodily fluids from the intermediate layer 414 to the inner layer 416) than other hydrophilic materials.
[00173] The inner layer 416 may exhibit a thickness (e.g., radius and/or diameter) that is about 100 jam to about 150 pm, about 130 pm to about 200 pm, about 150 pm to about 300 pm, about 200 pm to about 400 pm, about 300 pm to about 500 pm, about 400 pm to
- Page 58 - Docket No. 318812WO01 504795-1114 about 600 pm, about 500 gm to about 700 gm, about 600 un to about 800 pun, about 700 pun to about 1 mm, about 800 pun to about 1.25 mm, about 1 mm to about 4 mm, about 2 mm to about 6 mm about 4 mm to about 8 mm, about 6 mm to about 10 mm, about 8 mm to about 12 mm, about 10 mm to about 14 mm, about 12 mm to about 16 mm, about 14 mm to about 18 mm, about 16 mm to about 20 mm, about 18 mm to about 22 mm, or about 20 mm to about 25 mm. Generally, increasing the thickness of the inner layer 416 increases the quantity of bodily fluids that may be temporarily stored therein and may flow therethrough thereby decreasing the likelihood that the fluid collection assembly 400 leaks. However, increasing the thickness of the inner layer 416 may dilute any suction force applied to the chamber 404 and may make it difficult to position the fluid collection assembly 400 between the legs of the patient.
[00174] In an embodiment, the thickness of the inner layer 416 may be greater than the thickness of the outer layer 412. Generally, decreasing the thickness of the outer layer 412 decreases the volume of bodily fluids that may be stored in the outer layer 412 and decreases the volume of bodily fluids that the inner layer 416 may pull from the outer layer 412. Also, increasing the thickness of the inner layer 416 may increase the ability of inner layer 416 to promote flow of the bodily fluids towards to the fluid outlet 408 (e.g, towards an inlet of the conduit 426).
[00175] In an embodiment, the inner layer 416 includes at least one inner porous material. In an example, the inner porous material 416 includes at least one of a vertical lapped nonwoven material, another nonwoven material, a woven material, spun nylon fibers, a polyurethane foam, a polyvinyl chloride foam, a polyethylene foam, a hydrophobic polypropylene, or hydrophobic polyethylene. In an example, the inner layer 416 includes one of the porous materials (e.g., a porous material including a first layer, a second layer, and a plurality of fibers extending between the first and second layers, wherein the first and second layers may include a woven material) disclosed in U.S. Patent Application No. 18/164,800 filed on February' 6, 2023, the disclosure of which is incorporated herein, in its entirety, by this reference The inner porous material is able to quickly receive bodily fluids from the individual, even when the individual discharges a large quantity of bodily fluids over a short period of time. In an example, the inner porous material may facilitate moving the bodily fluids through the chamber 404 of the fluid collection assembly 400 and towards an outlet (e.g. , the fluid outlet 408 or an inlet of a conduit 426 disposed through the fluid outlet 408) which allows the porous material 410 to remain dry. Further, it has been surprisingly found that the bodily fluids received into the outer layer 412 may flow easily
- Page 59 - Docket No. 318812WO01 504795-1114 from the outer layer 412 into the inner porous material and the inner porous material pulls bodily fluids from the outer layer 412 that would otherwise remain in the polyurethane foam.
[00176] The inner porous material may exhibit a density of about 100 g/m2/cm to about 250 g/m2/cm, such as about 130 g/m2/cm to about 240 g/m2/cm, about 100 g/m2/cm to about
140 g/m2/cm, about 120 g/m2/cm to about 160 g/m2/cm, about 140 g/m2/cm to about 180 g/m2/cm. about 160 g/m2/cm to about 200 g/m2/cm, about 180 g/m2/cm to about 220 g/m2/cm, or about 200 g/m2/cm to about 250 g/m2/cm. Generally, increasing the density of the inner porous material increases the strength of the inner porous material. However, increasing the density of the inner porous material may decrease the porosity of the inner porous material which decreases the quantity of bodily fluids that may be temporarily stored in the porous material 410 and decrease the flow rate of the bodily fluids through the inner porous material. As such, the density of the inner porous material may be selected based on balancing the desired strength, porosity, and flow rate of the bodily fluids through the inner porous material.
[00177] When the inner porous material includes a vertical lapped nonwoven material, the inner porous material may exhibit a density of about 50 kgsm cm or greater, about 75 kgsm cm or greater, about 100 kgsm cm or greater, about 125 kgsm cm or greater, about 150 kgsm cm or greater, about 175 kgsm cm or greater, about 200 kgsm cm or greater, about 250 kgsm cm or greater, about 300 kgsm cm or greater, or in ranges of about 50 kgsm cm to about 100 kgsm cm, about 75 kgsm cm to about 125 kgsm cm, about 100 kgsm cm to about 150 kgsm cm, about 125 kgsm cm to about 175 kgsm cm, about 150 kgsm cm to about 200 kgsm cm, about 175 kgsm cm to about 250 kgsm cm, or about 200 kgsm cm to about 300 kgsm cm. Generally, increasing the density of the inner porous material increases the strength of the inner porous material. However, increasing the density of the inner porous material may decrease the porosity’ of the inner porous material which decreases the quantity of bodily fluids that may be temporarily stored in the porous material 410 and decrease the flow rate of the bodily fluids through the inner porous material. As such, the density of the inner porous material may be selected based on balancing the desired strength, porosity, and flow rate of the bodily fluids through the inner porous material.
[00178] The inner layer 416 may exhibit a basis weight of about 2 gsm to about 5 gsm, about 4 gsm to about 7.5 gsm. about 5 gsm to about 10 gsm, about 7.5 gsm to about 12.5 gsm, about 10 gsm to about 15 gsm, about 12.5 gsm to about 20 gsm, about 15 gsm to about
- Page 60 - Docket No. 318812WO01 504795-1114 25 gsm, about 20 gsm to about 30 gsm. about 25 gsm to about 35 gsm, about 30 gsm to about 40 gsm, about 35 gsm to about 45 gsm, about 40 gsm to about 50 gsm, about 45 gsm to about 55 gsm, or about 50 gsm to about 60 gsm. The basis weight of the inner layer 416 is a function of the density and thickness of the inner layer 416. As such, the basis weight of the inner layer 416 may be selected for any of the same reasons as the density and thickness of the inner layer 416. Generally, the basis weight of the inner layer 416 is selected to be less than the basis weight of the outer layer 412. The lower basis weight of the inner layer 416 increases the void space in the inner layer 416 which facilitate flowing the bodily fluids therethrough (e.g., towards the fluid outlet 408) whereas the greater basis weight of the outer layer 412 may increase the surface area thereof.
[00179] In a particular example, the porous material 410 includes an outer layer 412 including hydrophilic polypropylene or hydrophilic polyethylene with at least one surfactant, an intermediate layer 414 including bamboo, and an inner support layer 416 including polyurethane, polyether, nylon, PET, or hydrophobic polypropylene. In a particular example, the porous material 410 includes an outer layer 412 including at least one of hydrophilic polypropylene or hydrophilic polyethylene with at least one surfactant, an intermediate layer 414 including bamboo, and an inner support layer 41 including a nonwoven material (e g, a vertical lapped nonwoven material and/or a polyethylene terephthalate nonwoven material). In a particular example, the porous material 410 includes an outer layer 412 including hydrophilic polypropylene or hydrophilic polyethylene with at least one surfactant, an intermediate layer 414 including bamboo, and an inner support layer 416 including a first layer, a second layer, and a plurality of fibers extending between the first and second layers, wherein the first and second layers may include a woven material. In a particular embodiment, as previously discussed, the porous material 410 includes an outer layer 412 including hydrophilic polypropylene or hydrophilic polyethylene with at least one surfactant, an intermediate layer 414 including bamboo, and an inner support layer 416 including PET. It is currently believed that these particular porous materials 410 may exhibit a relatively good synergistic relationship compared to other porous materials. For example, the embodiment that includes the hydrophilic polyethylene and/or polypropylene outer layer 412, the bamboo intermediate layer 414, and the PET inner support layer 416 is able to quickly and effectively transfer bodily fluids from the outer layer 412 to the intermediate layer 414, and from the inner support layer 416 to the inner support layer 416. Further, in such an example, the layers
- Page 61 - Docket No. 318812WO01 504795-1114 are able to be substantially dry a relatively short period of time after receiving the bodily fluids.
[00180] Generally, adhesively attaching two different porous layers together has been avoided since the adhesive or other attachment occupies the pores of the porous materials thereby preventing or inhibiting bodily fluids flowing through the porous material.
However, it has been found that each of the layers of the porous materials should directly contact adjacent layers of the porous material for the quick and effective transfer of bodily fluids from the outer layer to the intermediate layer and from the intermediate layer to the inner layer to occur. As previously discussed, two or more layers of the porous material 410 may be bonded together using one or more melting and entangled regions to avoid these issues associated with adhesively attached two different porous layers together.
[00181] In an embodiment, two of the outer layer 412, the intermediate layer 414, and the inner layer 416 may be attached to an adjacent one of the layers using the melted or entangled regions discussed above while the remaining layer may be attached to the other layers using an adhesive layer. For example, as illustrated, the outer layer 412 and the intermediate layer 414 may be attached together using the melted regions or entangled regions discussed above since these layers of the porous material 410 initially receive the bodily fluids and the melted regions or entangle regions facilitate quickly receiving the bodily fluids and moving the bodily fluids into an interior of the porous material 410. The inner layer 416 may be attached to the intermediate layer using an adhesive layer 418 (shown schematically in FIGS. 4B and 4C as a bolded line) since the bodily fluids are already received, flowed, and dispersed into the porous material 410 before reaching the inner layer 416 and, thus, the decreased fluid flow through the adhesive layer 418 is less important. Further, it may be easier to attach the intermediate and inner layers 414, 416 together using the adhesive layer 418 since the relatively large thickness of the inner layer 416 may make attaching the intermediate and inner layers 414, 416 using melting or entangled regions difficult.
[00182] The adhesive layer 418 bonds the intermediate layer 414 and the inner layer 416 together such that substantially no air gaps form therebetween. For example, the adhesive layer 418 may prevent or at least inhibit air gaps from forming between the intermediate and inner layers 414, 416 of the porous material 410 even during prolonged use of the fluid collection assembly 400, when the fluid collection assembly 400 is bent, or even when the porous material 410 accidently rips.
- Page 62 - Docket No. 318812WO01 504795-1114 [00183] The adhesive layer 418 may include any suitable material that bonds the layers of the porous material 410 together. In an example, the adhesive layer 418 includes a hot melt adhesive or any other suitable adhesive.
[00184] The adhesive layer 418 is only positioned between a portion of the adjacent layers of the porous material 410. For example, the adhesive layer 418 may be positioned between about 40% to about 80% of the surface area of the adjacent layers of the porous material 410. such as about 40% to about 30%, about 20% to about 40%, about 30% to about 50%, about 40% to about 60%, about 50% to about 70%, or about 60% to about 80%. Positioning the adhesive layer 418 between a portion of the adjacent layers allows holes to be present in the adhesive layer 418. The bodily fluids may flow between the layers of the porous material 410 through the holes in the adhesive layer 418. It is noted that the adhesive layer 418 may form a plurality of patches. At least some of the patches formed by the adhesive layer 418 may be interconnected or not interconnected (z.e., spaced from each other). [00185] In an embodiment, one or more layers of the porous material 410 may be omitted. For example, one or more of the outer layer 412, the intermediate layer 414, or the inner layer 416 may be omitted. The thicknesses of the layers of the porous material 410 may be adjusted when one or more layers are omitted. For example, the thickness of the intermediate layer 414 may be increased to extend from the conduit 426 to the outer layer 412 when the inner layer 416 is omitted. In an embodiment, the porous material 410 may include one or more additional layers (not shown), such as a thin layer on the outer layer 412 that is more comfortable than the outer layer 412.
[00186] FIG. 4D is a view illustration of a system 450 configured to form the porous material 410, according to an embodiment. It is noted that the system 450 may be configured to form any of the porous materials disclosed herein, for example, by adding or removing rollers. The system 450 includes a first roll 452, a second roll 454, and a third roll 456. The first roll 452 includes and is a source of an initial porous material 413. The initial porous material 413 may be the same as the porous material 100 illustrated in FIG. 1A or the porous material 200 illustrated in FIG. 2A. For example, the initial porous material 413 may include a first layer and a second layer bonded together using a plurality of melted or entangled regions. Alternatively, the first roll 452 may be omitted and replaced with one of the systems 120 or 220 illustrated in FIGS. IB or 2B, respectively. In the illustrated system 450. the initial porous material 413 includes the outer layer 414 and the intermediate layer 416 though, it is noted, that the initial porous material 413 may include
- Page 63 - Docket No. 318812WO01 504795-1114 the intermediate layer 414 and the inner layer 416. The second roll 454 includes and is a source of the remaining layer of the porous material 410. In the illustrated embodiment, the second roll 454 includes and is the source of the inner layer 416 though, it is noted, the second roll 454 may include the outer layer 412. The third roll 456 includes an adhesive material (e.g., hot melt adhesive, poly urethane, polyether, or acry lic) configured to form the adhesive layer 418.
[00187] The system 450 is configured to position the initial porous material 413 adjacent to the inner layer 416. The system 450 may also be configured to position the adhesive layer 418 between the two layers, such as between the initial porous material 413 an the inner layer 416. For example, the third roll 456 may be positioned between the first and second rolls 452. 454.
[00188] The system 450 may pull the materials from the rolls to form the porous material 410 using any suitable technique. In an example, as illustrated, the system 450 may include one or more rollers 462. The roller 462 may rotate and, responsive to the rotation thereof, pull the materials from the rolls to form the porous material 410. The rollers 462 may allow each of the layers to be simultaneously or substantially simultaneously positioned adjacent to each other. The system 450 including the rollers 462 may pull the layers into the rollers 462 and form the porous material 410 at a rate of about 45 cm/minute to 300 cm/minute, such as in ranges of about 45 cm/minutes to about 50 cm/minutes, about 25 cm/minute to about 75 cm/minute. about 50 cm/minute to about 400 cm/minute, about 75 cm/minute to about 425 cm/minute, about 400 cm/minute to about 450 cm/minutes, about 425 cm/minute to about 200 cm/minute, about 450 cm/minute to about 250 cm/minute, or about 200 cm/minute to about 300 cm/minute. In an example, the system 450 may include a conveyor belt and one or more of the layers may be positioned sequentially on the conveyor belt to form the porous material 410.
[00189] The layers of the porous material 410 may be attached to each other using any suitable technique. In an embodiment, as shown, the rollers 462 may be configured to attach the initial porous material 413 to the inner layer 416 together. In an example, the adhesive layer 418 may include a heat-activated adhesive (e.g., a hot melt adhesive). In such an example, one or more of the rollers 462 may be heated such that passing the layers of the porous material 410 adjacent to the heated roller 462 activates the heat-activated adhesive. The temperature of the heated rollers 462 may depend on the composition of the heat-activated adhesive. In a particular example, the heated rollers 462 may exhibit a temperature of about 90 °C to about 120 °C (e.g., when the adhesive is a polyethylene
- Page 64 - Docket No. 318812WO01 504795-1114 terephthalate web adhesive) or about 120 °C to about 180 °C since such temperature are able to activate some hot melt adhesives without significantly damaging the polypropylene and/or polyethylene outer layer 412 or the bamboo intermediate layer 414. In an example, the first and second bonding layers 418, 420 may include a pressure-activated adhesive and passing the layers of the porous material 410 adj acent to the roller 462 provides the pressure that activates the adhesive. In an embodiment, the first and second bonding layers 418, 420 are formed using an ultrasonic weld, a radio frequency weld, or any other suitable weld.
[00190] In an embodiment, the system 450 forms a porous material 410 that is a long, continuous sheet. In such an embodiment, the system 450 may include cutting the long, continuous porous material 410 to form a plurality of porous materials 410 that are sized to fit in the chamber 404. For example, the system 450 may cut the continuous porous materials 410 into a plurality of porous materials 410 exhibiting a length of about 10 cm to about 30 cm (e.g, about 10 cm to 20 cm, about 15 cm to about 25 cm, or about 20 cm to about 30 cm) and a width of about 4 cm to about 12 cm (e g., about 4 cm to about 8 cm, about 6 cm to about 10 cm, or about 8 cm to about 12 cm).
[00191] In some embodiments, the fluid collection assemblies disclosed herein may include four or more porous materials.
[00192] FIG. 5A is an isometric of a fluid collection assembly 500, according to an embodiment. FIG. 5B is a cross-sectional view of the fluid collection assembly 500. Except as otherwise disclosed herein, the fluid collection assembly 500 is the same as or substantially similar to any of the fluid collection assemblies disclosed herein. For example, the fluid collection assembly 500 includes a fluid impermeable barrier 502. The fluid impermeable barrier 502 at least defines a chamber 504, at least one opening 506, and a fluid outlet 508. The fluid collection assembly 500 also includes a porous material 510 disposed in the chamber 504 that extends across the opening 506.
[00193] The porous material 510 includes an outer layer 536 and an inner layer 538. Except as otherwise disclosed herein, the outer layer 536 and the inner layer 548 may be the same as or substantially similar to any of the outer and inner layers disclosed herein. For example, the outer layer 536 may be disposed on the inner layer 538, extend across the opening 506. However, the outer layer 536 may not not extend around the circumference of the inner layer 538 but only extends around a portion of the inner layer 538, such as around the portion of the inner layer 538 adjacent to the opening 506.
[00194] In an embodiment, the fluid collection assembly 500 include flexible gooseneck tubing 555. The gooseneck tubing 555 may be disposed over the conduit 514 (as shown)
- Page 65 - Docket No. 318812WO01 504795-1114 or in the conduit 514. The gooseneck tubing 555 may be a modular hose that is capable of manipulation responsive to external forces and rigid retention of a selected configuration after manipulation. For example, the gooseneck tubing 555 may include a ball and socket construction such as a Loc-Line® type modular hose or the like. The size of the balls and sockets of the gooseneck tubing 555 provide a selected fit therebetween (e.g., slip fit, interference fit, etc.) to provide a selected amount of resistance to deformation. Accordingly, the gooseneck tubing 555 may be selectively shaped (e.g., deformed) and retain the selected shape or conformation. In some examples, the gooseneck tubing 555 may be constructed of polymer balls and sockets. It is noted that the gooseneck tubing 555 may be used in any of the fluid collection assemblies disclosed herein.
[00195] Further examples of gooseneck tubing that may be used in the fluid collection assembly 555 or any of the fluid collection assemblies disclosed herein are disclosed in U.S. Patent No. 11,865,030 issued on January 9, 2024, U.S. Patent Application No. 17/013,822 filed on September 7, 2020, and U.S. Patent 11,839,567 issued on December 12, 2023, the disclosure of each of which are incorporated herein, in its entirety, by this reference.
[00196] In an embodiment, fluid collection assembly 500 includes an adhesive securement feature secured or securable to the fluid impermeable barrier 502 and configured to attach the fluid collection assembly 502 to an individual. The one or more adhesive securement features may be positioned on at least one of the fluid impermeable barrier 502 or the conduit 514 of the fluid collection assembly 500 resulting in the technical effect of attaching the one or more adhesive securement features to the abdominal, pubic, or pelvic area of the user. Once attached to the user, the one or more adhesive securement features also may provide the technical effect of preventing dislodgement of the fluid collection assembly 500 from the desired position against the user. For example, the fluid collection assembly 100 includes one or more (e.g., two) arms 557 or wings configured to attach or secure the fluid collection assembly 100 to an individual. The arms 557 may each include an adhesive surface oriented towards the opening 506 or generally in the same direction as the opening 506 is oriented. The adhesive surface may include an adhesive material, such as a glue, contact adhesive, epoxy, hydrogel adhesive, tape, an acrylic adhesive, a silicone adhesive, a hydrogel adhesive, other adhesives suitable for placement on the body of a user or fabric worn by the user, or any combination thereof. For example, the adhesive may include an acrylate (e.g., methacrylate or epoxy diacrylate) or any other adhesive suitable for use on bandages. The arms 557 also may include a removable cover
- Page 66 - Docket No. 318812WO01 504795-1114 secured to the adhesive layer that may be removed prior to securing the adhesive layer to the user.
[00197] The adhesive surface of each of the arms 557 may attach the fluid collection assembly 500 to the individual, and the arms 557 also may include a non-adhesive surface opposite or distal to the adhesive surface. The adhesive surface may attach directly to the skin of the individual or may attach to the fabric worn by the individual, such as undergarments. The arms 557 may be positioned at vanous areas on the fluid collection assembly 500 to secure the fluid collection assembly 500 directly to a predetermined area of the body of the individual, such as the abdominal region, the pubic region, the pelvic region, the hypogastrium (or hypogastric) region, the legs (including thighs) of the individual, or any combination thereof. For example, the arms 557 are positioned on the fluid collection assembly 500 to provide the technical effect of attaching the adhesive surface of each of the arms 555 to the pelvic region of the individual. The pelvic region may include the area of the individual between the abdomen and the pubic bone or labia of the individual.
[00198] In some embodiments, the two arms 557 are positioned on the fluid collection assembly 100 on a rear or back surface of the fluid impermeable barrier 502, generally distal to the opening 506. In other embodiments, the two arms 557 may be positioned at various positions on the rear or back surface of the fluid impermeable barrier 502. In some embodiments (not shown), the two arms 557 may be positioned on the fluid collection assembly on a front surface of the fluid impermeable barrier 502.
[00199] Further examples of arms or adhesive securement features that may be used in any of the fluid collection assemblies disclosed herein are disclosed in U.S. Patent Application No. 18/006,807 filed on January 25, 2023, the disclosure of which is incorporated herein, in its entirety, by this reference.
[00200] FIG. 6 is an isometric view of a fluid collection assembly 600, according to an embodiment. Except as otherwise disclosed herein, the fluid collection assembly 600 may be the same as or substantially similar to any of the fluid collection assemblies disclosed herein. For example, the fluid collection assembly 600 may include a fluid impermeable barrier 602 defining a chamber (not labeled, occupied), an opening 604, and a fluid outlet 606. The fluid collection assembly 600 also includes a porous material 608 disposed in the chamber and a conduit 610 extending through the fluid outlet 606 that is in fluid communication with the chamber.
- Page 67 - Docket No. 318812WO01 504795-1114 [00201] Unlike the fluid collection assemblies illustrated in FIGS. 3A-5B, the porous material 608 may exhibit a generally sheet-like shape. The porous material 608 may include any of the porous materials disclosed herein. In an example, the porous material 608 may include a first layer and a second layer bonded together using one or more melted or entangled regions.
[00202] The fluid collection assembly 600 may be configured to switch at least between a first state and a second state. The fluid collection assembly 600 may exhibit the first state (as shown) when the fluid collection assembly 600 exhibits a generally sheet-like shape. The fluid collection assembly 600 may exhibit the second state (not shown) when the fluid collection assembly 600 is folded and exhibits a generally U-like shape. The generally U- like shape of the fluid collection assembly 600 may help the fluid collection assembly 600 fit between the thighs of an individual. It is noted that the porous material 608 may exhibit a generally U-like shape when the fluid collection assembly 600 is in the second state. The fluid collection assembly 600 may switch between the first and second states by folding and unfolding the fluid collection assembly 600.
[00203] FIGS. 7A and 7B are top isometric and bottom isometric views of a fluid collection assembly 700, respectively, according to an embodiment. Except as otherwise disclosed herein, the fluid collection assembly 700 may be the same as or substantially similar to any of the fluid collection assemblies disclosed herein. For example, the fluid collection assembly 700 may include a fluid impermeable barrier 702 defining a chamber (not labeled, occupied), an opening 704, and a fluid outlet 706. The fluid collection assembly 700 also includes a porous material 708 disposed in the chamber and a conduit 710 extending through the fluid outlet 706 that is in fluid communication with the chamber. [00204] The porous material 708 includes a sheet portion 712 exhibiting a generally sheet-like shape. In an embodiment, the porous material 708 may include an overhanging portion 714 that overhands a portion of the sheet portion 712. The porous material 708 may include any of the porous materials disclosed herein. In an example, the porous material 708 may include a first layer and a second layer bonded together using one or more melted or entangled regions. In an embodiment, the fluid impermeable barrier 702 only extends along a portion of a back side of the porous material 708.
[00205] The fluid collection assembly 700 may include a base 716 that is configured to attach the fluid collection assembly 700 to an individual. The base 716 may be substantially similar to any of the bases disclosed herein and/or the other adhesive securement features disclosed herein.
- Page 68 - Docket No. 318812WO01 504795-1114 [00206] The conduit 710 may extend through the fluid outlet 706 to allow the conduit 710 to be in fluid communication with the chamber. In an embodiment, the conduit 710 may separate into two or more branches. The branches may allow the conduit 710 to receive bodily fluids from a plurality of locations in the porous material 708. [00207] The fluid collection assemblies illustrated in FIGS. 2A-7B are examples of female fluid collection assemblies. The porous materials including a surfactant disposed in at least a portion thereof may also be used in male fluid collection assemblies. FIGS. 8- 10C illustrate different male fluid collection assemblies that may include a porous material including a surfactant disposed therein or any of the other features disclosed herein. [00208] FIG. 8 is a cross-sectional view of a fluid collection assembly 800, according to an embodiment. The fluid collection assembly 800 includes a base 802 (e.g, annular base) and a sheath 804. The base 802 is sized, shaped, and made of a material to be coupled to skin that surrounds the male urethral opening (e.g, penis) and have the male urethral opening positioned therethrough. For example, the base 802 may define an aperture 806. The base 802 is sized and shaped to be positioned around the male urethral opening (e.g, positioned around and/or over the penis) and the aperture 806 may be configured to have the male urethral opening positioned therethrough. The base 802 may also be sized, shaped, made of a material, or otherwise configured to be coupled (e.g, adhesively attached, such as with a hydrogel adhesive) to the skin around the male urethral opening (e.g, around the penis). In an example, the base 802 may exhibit the general shape or contours of the skin surface that the base 802 is selected to be coupled with. The base 802 may be flexible thereby allowing the base 802 to conform to any shape of the skin surface. The base 802 may include a laterally (e.g, radially) extending flange. The base 802 also defines a hollowed region that is configured to receive (e.g, seal against) the sheath 804. For example, the base 802 may include a longitudinally extending flange that extends upwardly from the base 802. The longitudinally extending flange may be tall enough to prevent the sheath 804 from being accidentally removed from the base 802 (e.g, at least 0.25 cm tall, 1 cm tall, at least 3 cm talk or at least 5 cm tall). The base 802 is located at a proximal end region 824 (with respect to a wearer) of the fluid collection assembly 800. [00209] The sheath 804 includes (e g , may be formed from) a fluid impermeable barrier
808 that is sized and shaped to fit into the hollowed region of the base 802. For example, the sheath 804 may be generally tubular or cup-shaped, as shown. The generally tubular or cup-shaped fluid impermeable barrier 808 may at least partially define the outer surface of the sheath 804. The fluid impermeable barrier 808 may be similar or identical to and of
- Page 69 - Docket No. 318812WO01 504795-1114 the fluid impermeable barriers disclosed herein, in one or more aspects. For example, the fluid impermeable barrier 808 may be constructed of any of the materials disclosed herein for the fluid impermeable barrier. The fluid impermeable barrier 808 at least partially defines the chamber 810. For example, the inner surface of the fluid impermeable barrier 808 at least partially defines the perimeter of the chamber 810. The chamber 810 may at least temporarily retain bodily fluids therein. As shown, the fluid collection assembly 800 may include the porous material 812 therein. The porous material 812 may be similar or identical any of the porous materials disclosed herein, in one or more aspects. For example, as shown, the porous material 812 may include at least an outer layer 814 and an inner layer 816. The outer layer 814 and the inner layer 816 may be bonded together using one or more melted or entangled regions. In other words, the outer layer 814 may be the same as or substantially similar to the porous body 101 of FIG. 1. The fluid impermeable barrier 808 may also define an opening 818 extending through the fluid impermeable barrier 808 that is configured to have a male urethral opening positioned therethrough. [00210] The sheath 804 also includes at least a portion of the conduit 820 therein, such as at least partially disposed in the chamber 810. For example, the conduit 820 may extend from the sheath 804 at the distal end region 822 to a proximal end region 824 at least proximate to the opening 818. The proximal end region 824 may be disposed near or on the skin around the male urethral opening (e.g., on the penis or pubic area therearound). Accordingly, when an individual lays on their back, bodily fluids (e.g.. urine) may aggregate near the opening 818 against the skin of the subject. The bodily fluids may be removed from the chamber 810 via the conduit 820.
[00211] In some examples, the fluid impermeable barrier 808 may be constructed of a material and/or have a thickness that allows the sheath 804 to collapse when placed under vacuum, such as to remove air around a penis in the fluid collection assembly 800 during use. In such examples, the conduit 820 may extend only to or into the distal end region 822 in the chamber 810 (e.g, not through to the area adjacent the opening 818). In such examples, urine may be collected and removed from the fluid collection assembly 800 [00212] In an example, portions of the chamber 810 may be substantially empty due to the varying sizes and rigidity of the male penis. However, in some examples, the outermost regions of the chamber 810 (e.g., periphery of the interior regions of the sheath 804) may include the porous material 812 (e.g., one or more of the outer layer 814 and inner layer 816). For example, the porous material 812 may be bonded to the inner surface of the fluid impermeable barrier 808. The porous material 812 may be positioned (e.g., at the distal
- Page 70 - Docket No. 318812WO01 504795-1114 end of the chamber 810) to blunt a stream of urine from the male urethral opening thereby limiting splashing and/or to direct the bodily fluids to a selected region of the chamber 810. Since the chamber 810 is substantially empty (e.g., substantially all of the chamber 810 forms a reservoir), the bodily fluids are likely to pool at a gravimetrically low point of the chamber 810. The gravimetrically low point of the chamber 810 may be at an intersection of the skin of an individual and the fluid collection assembly 800, a comer formed in the sheath 804. or another suitable location depending on the orientation of the wearer.
[00213] The porous material 812 may include one or more of the outer layer 814 or the fluid permeable body 816. The outer layer 814 and the inner layer 816 may be similar or identical to any of the outer layer s and the inner layer s, respectively disclosed herein, in one or more aspects. One or more of the outer layer 814 or the inner layer 816 may be disposed between the fluid impermeable barrier 808 and a penis inserted into the chamber 810. The outer layer 814 may be positioned between the fluid impermeable barrier 808 and a penis inserted into the chamber 810, such as between the inner layer 816 and penis of a wearer as shown. The inner layer 816 may be positioned between the outer layer 814 and the fluid impermeable barrier 808. The inner surface, optionally including the end of the chamber 810 substantially opposite the opening 818, may be covered with one or both the outer layer 814 or the inner layer 816. The inner layer 816 or the outer layer 814 may be affixed (e.g., adhered) to the fluid impermeable barrier 808. The inner layer 816 or the outer layer 814 may be affixed to each other. In some examples, the porous material 812 only includes the outer layer 814 or the inner layer 816.
[00214] The fluid collection assembly 800 includes a cap 826 at a distal end region 822. The cap 826 defines an interior channel through which the bodily fluids may be removed from the fluid collection assembly 800. The interior channel is in fluid communication with the chamber 810. The cap 826 may be disposed over at least a portion of the distal end region 822 of one or more of the fluid impermeable barrier 808 or the porous material 812. The cap 826 may be made of a polymer, rubber, or any other fluid impermeable material. The cap 826 may be attached to one or more of the fluid impermeable barrier 808, the porous material 812, or the conduit 820. The cap 826 may cover at least a portion of the distal end region 822 of the fluid collection assembly 800. The cap 826 may define a fluid outlet 828 that is sized and configured to receive and fluidly seal against the conduit 820. The conduit 820 may extend a distance within or through the cap 826, such as to the porous material 812, through the porous material 812. or to a point set-off from the porous material 812.
- Page 71 - Docket No. 318812WO01 504795-1114 [00215] The reservoir 830 is an unoccupied portion of device such as in the cap 826 and is void of other material. In some examples, the reservoir 830 is defined at least partially by the porous material 812 and the cap 826. During use, the bodily fluids that are in the chamber 810 may flow through the porous material 812 to the reservoir 830. The reservoir 830 may store at least some of the bodily fluids therein and/or position the bodily fluids for removal by the conduit 820. In some examples, at least a portion of the porous material 812 may extend continuously between at least a portion of the opening of the intenor channel and chamber 810 to wick any bodily fluids from the opening directly to the reservoir 830. [00216] In some examples (not shown), the fluid impermeable barrier 808 may be disposed on or over the cap 826. such as enclosing the cap 826 within the chamber 810. [00217] The proximal end region 824 may be disposed near or on the skin around the male urethral opening (e.g., around the penis) and the inlet of the conduit 820 may be positioned in the proximal end region 824. The outlet of the conduit 820 may be directly or indirectly coupled to a vacuum source. Accordingly, bodily fluids may be removed from the proximal end region 824 of the chamber 810 via the conduit 820.
[00218] The base 802, the sheath 804, the cap 826, and the conduit 820 may be attached together using any suitable method. For example, at least two of the base 802, the sheath 804, the cap 826, or the conduit 820 may be attached together using at least one of an interference fit, an adhesive, stitching, welding (e.g, ultrasonic welding), tape, any other suitable method, or combinations thereof.
[00219] In some examples (not shown), the fluid collection assembly 800 may have a one piece design, with one or more of the sheath 804, the base 802, and the cap 826 being a single, integrally formed piece. [00220] Also as shown, the conduit 820 may be at least partially disposed with the chamber of a fluid collection assembly. The conduit 820 may extend from the distal end region 822 to the proximal end region 824. For example, the conduit 820 may extend through the cap 826 to a point adjacent to the base 802. The conduit 820 is sized and positioned to be coupled to a fluid storage container or the vacuum source (FIG. 11). An outlet of the conduit 820 may be operably coupled to the vacuum source, directly or indirectly. The inlet of the conduit 820 may be positioned within the chamber 810 such as at a location expected to be at the gravimetrically low point of the fluid collection assembly during use. By positioning the inlet in a location expected to be at the gravimetrically low point of the fluid collection assembly when worn by the user, bodily fluids introduced into
- Page 72 - Docket No. 318812WO01 504795-1114 the chamber 810 may be removed via the conduit 820 to prevent pooling or stagnation of the bodily fluids within the chamber 810.
[00221] In some examples, the vacuum source may be remotely located from the fluid collection assembly 800. In such examples, the conduit 820 may be fluidly connected to the fluid storage container, which may be disposed between the vacuum source and the fluid collection assembly 800.
[00222] During operation, a male using the fluid collection assembly 800 may discharge bodily fluids (e.g., urine) into the chamber 810. The bodily fluids may pool or otherwise be collected in the chamber 810. At least some of the bodily fluids may be pulled through the interior of the conduit 820 via the inlet. The bodily fluids may be drawn out of the fluid collection assembly 800 via the vacuum/suction provided by the vacuum source. During operation, the vacuum relief valve may substantially maintain the pressure in the chamber 810 at atmospheric pressure even though bodily fluids is introduced into and subsequently removed from the chamber 810. [00223] FIG. 9 is a front view of a male urine collection device 900, according to an embodiment. The urine collection device 900 includes a fluid impermeable barrier 902 at least partially defining an opening 906 and a chamber within the fluid collection assembly in fluid communication with the opening 906. In some embodiments, a bottom portion of the fluid impermeable barrier 902 may define the opening 906 and an opposite or a top portion of the fluid impermeable barrier 902 may define a fluid outlet 912. The fluid impermeable barrier 902 includes a proximal end region 903 and a distal end region 905. The opening 906 may be positioned proximate or closer to the proximal end region 903 than the distal end region 905 of the fluid impermeable barrier 902, and the fluid outlet 912 may be positioned proximate or closer to the distal end region 905 than the proximal end region 903. In some embodiments, the fluid impermeable barrier 902 narrows between the proximal end region 903 and the distal end region 905. For example, the fluid impermeable barrier 902 (and the chamber) may include a substantially triangular front profile, with the distal end region 905 being at the narrow end or tip of the triangular profile. The fluid impermeable barrier 902 may include a shape substantially complementary to the chamber. such as a substantially triangular front profile. The fluid impermeable barrier 902 may include a substantially flexible fluid impermeable material, such as a fluid impermeable polymer (e.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, a polycarbonate, etc.), polyurethane films, thermoplastic elastomer, oil, another suitable material, or combinations thereof. In some embodiments, the fluid impermeable barrier
- Page 73 - Docket No. 318812WO01 504795-1114 includes a paper-like or bag-like fluid impermeable material and/or a fluid impermeable fabric.
[00224] The urine collection device 900 also includes a porous material 910 positioned within the chamber and extending at least partially between the distal end region 905 and the proximal end region 903. The porous material 910 may be shaped generally complementary to the shape of the chamber of the fluid impermeable barrier 902. In some embodiments, the porous material 910 is spaced from the edges of the fluid impermeable barrier 902 that extend at least partially between the distal end region 905 and the proximal end region 903. In some embodiments, the porous material 910 is positioned to abut the edges of the fluid impermeable barrier 902 such that fluid impermeable barrier 902 retains fluid in the porous material 910 from the opening 906 to the sump 909.
[00225] The porous material 910 can be configured to wick and/or allow transport of fluid away from the opening 906, thereby preventing the fluid from escaping the chamber. The porous material 910 also can wick and/or allow transport of the fluid generally towards the sump 909. The porous material 910 may include any of the porous materials disclosed herein. In an embodiment, the porous material 910 may include a first layer and a second layer bonded together using one or more melted or entangled regions. In an embodiment, the porous material 910 can include a one-way fluid movement fabric. As such, the porous material 910 can remove fluid from the area around the penis, thereby leaving the area and urethra dry. The porous material 910 can enable the fluid to flow generally towards the sump 909 and the tube 908 within the chamber. The porous material 910 can include a porous or fibrous material, such as hydrophilic polyolefin. In some embodiments, the porous material 910 consists of or consists essentially of a porous or fibrous material, such as hydrophilic polyolefin. Examples of polyolefin that can be used in the porous material 910 include, but are not limited to, polyethylene, polypropylene, polyisobutylene, ethylene propylene rubber, ethylene propylene diene monomer, or combinations thereof. Moreover, the porous material 910 can be manufactured according to various manufacturing methods, such as molding, extrusion, or sintering. The porous material 910 can include varying densities or dimensions. [00226] In some embodiments, the porous material 910 can include two or more layers of fluid permeable materials. For example, the porous material 910 can include a outer layer (e.g, that includes at least one surfactant disposed therein) covering or wrapped around a inner layer, with both the outer layer and the inner layer being disposed in the chamber. The outer layer can cover or extend across at least a portion (e.g., all) of at least
- Page 74 - Docket No. 318812WO01 504795-1114 the side of the inner layer facing the penis of the user. The outer layer and the inner layer can be configured to wick any fluid away from the opening 906, thereby preventing the fluid from escaping the chamber and promoting removal of the fluid through the tube 908. The permeable properties referred to herein can be wicking, capillary action, diffusion, or other similar properties or processes, and are referred to herein as “permeable’' and/or “wicking.”
[00227] The outer layer and the inner layer also can wick the fluid generally towards an interior of the chamber, such as the sump 909. The outer layer can include any material that can wick the fluid. For example, the outer layer can include fabric, such as a gauze (e.g. , a silk, linen, polymer based materials such as polyester, or cotton gauze), nylon (such as a spun nylon fibers), another soft fabric (e.g., jersey knit fabric or the like), or another smooth fabric (e.g, rayon, satin, or the like). Forming the outer layer from gauze, soft fabric, and/or smooth fabric can reduce chaffing caused by the urine collection device 900. Other embodiments of outer layers and inner layers are disclosed in U.S. Patent Application No. 15/612,325 filed on June 7, 7017; U.S. Patent Application No. 15/260,103 filed on
September 8, 7016; U.S. Patent Application No. 15/611,587 filed on June 1, 2017; PCT Patent Application No. PCT/US 19/29608, filed on April 79, 7019, the disclosure of each of which is incorporated herein, in its entirety, by this reference. In many embodiments, the porous material 910 includes a inner layer including a porous spun nylon fiber structure and a fluid permeable wicking membrane including gauze at least partially enclosing the spun nylon fiber structure.
[00228] The urine collection device 900 also includes a tube 908 extending into the chamber and having an end 918 positioned proximate to the distal end region 905 of the fluid impermeable barrier 902. In an embodiment, the tube 908 includes a tube opening proximate to the end of the tube 908. The sump 909 may be defined as the region or area between the tube opening 906 and the distal end region 905 of the fluid impermeable barrier 902. At least some of the porous material 910 may extend into the sump 909. Fluid discharged on the porous material 910 may flow to and pool in the sump 909 for removal when a vacuum is applied on the tube 908. The tube 908 may extend through a fluid outlet 912 in the distal end region 905 of the fluid impermeable barrier 902 and into the chamber.
[00229] As urine is discharged onto the porous material 910, the urine may flow to the lowest point to form a pool of urine at the distal end region 905 of the fluid impermeable barrier 902. In an embodiment, the end of the tube 908 and the tube opening are spaced
- Page 75 - Docket No. 318812WO01 504795-1114 from the distal end region 905 of the fluid impermeable barrier 902 such that a sump 909 for the pool of urine is defined between the tube opening and/or the end of the tube 908.
[00230] In some embodiments, the distal portion of the porous material 910 is shaped substantially complementary to the distal end region 905. The distal portion 925 of the porous material 910 may be spaced from the distal end region 905 of the fluid impermeable barrier 902, such that a portion of the sump 909 is devoid of the porous material 910. In some embodiments, the distal portion of the porous material 910 interfaces at least a portion (e.g., all) of the fluid impermeable barrier 902 at the distal end region 905.
[00231] FIG. 10A is an isometric view of a fluid collection assembly 1000, according to an embodiment. FIGS. 10B and 10C are cross-sectional views of the fluid collection assembly 1000 taken along planes 10B-10B and 10C- 10C, respectively, shown in FIG. 10A. Except as otherwise disclosed herein, the fluid collection assembly 1000 is the same as or substantially similar to any of the fluid collection assemblies disclosed herein. For example, the fluid collection assembly 1000 includes sheath 1001 including a fluid impermeable barrier 1002. The fluid impermeable barrier 1002 at least defines a chamber 1004, at least one opening 1006, and a fluid outlet 1008. The fluid collection assembly 1000 also includes a porous material 1010 disposed in the chamber 1004 that extends at least adjacent to the opening 1006. The porous material 1010 may include any of the porous materials disclosed herein, such as a porous material including a first layer and a second layer bonded together using one or more melted or entangled regions. The fluid collection assembly 1000 also includes a base 1003.
[00232] The fluid outlet 1008 may be located at or near the proximal end region 1012 of the sheath 1001. A conduit 1014 may extend through the fluid outlet 1008 into the chamber 1004. The conduit 1014 may include a plurality of branches in the chamber 1004 extending from the primary portion of the conduit 1014 that extends through the fluid outlet 1008.
For example, the conduit 1014 may include branches that extend along an outer periphery of the chamber 1004. The branches may extend to or near the distal end region 1013.
[00233] The fluid impermeable barrier 1002 may include one or more folds 1016 formed therein. The folds 1016 may allow the volume of the fluid impermeable barrier 1002 to expand as a penis is inserted into the chamber 1004 and/or the penis disposed in the chamber 1004 changes sizes (e.g., becomes erect or flaccid).
[00234] Additional examples of fluid collection assemblies that may include any of the features disclosed herein, such as a porous body that includes at least one surfactant disposed in at least a portion thereof, are disclosed in U.S. Patent No. 11,504,265 issued on
- Page 76 - Docket No. 318812WO01 504795-1114 November 22, 2022, U.S. Patent No. 10,390,989 issued on August 27, 2019, U.S. Patent Application No. 17/996,155 filed on April 15, 2021, U.S. Patent Application No. 18/249,577 filed on October 19, 2021, U.S. Patent Application No. 18/563,672 filed on June 7, 2022, International Application No. PCT/US2022/022111 filed on March 28, 2022, U.S. Patent Application No. 17/996,253 filed on April 14, 2021, International Application No. PCT/US2023/031432 filed on August 29, 2023, International Application No. PCT/US2023/36875 filed on November 6, 2023, U.S. Provisional Patent Application No. 63/596,012 filed on November 3, 2023, U.S. Patent Application No. 17/444,792 filed on August 10, 2021, International Application No. PCT/US2022/018170 filed on February 28, 2022. International Application No. PCT/US2022/019254 filed on March 8, 2022, U.S.
Patent Application No. 16/478,180 filed on January 30. 2018, U.S. Patent No. 10,973,678 filed on June 2, 2017, U.S. Patent Application No. 17/614,173 filed on May 15, 2020, U.S. Patent Application No. 18/003,029 filed on June 30, 2021, U.S. Patent No. 11,925,575 issued on March 12, 2024, U.S. Patent Application No. 18/164,800 filed on February' 6, 2023. International Application No. PCT/US2023/025192 filed on June 13, 2023, and
International Application No. PCT/US2023/030365 filed on August 16, 2023, the disclosure of each of which is incorporated herein, in its entirety, by this reference.
[00235] FIG. 11 is a block diagram of a fluid collection system 1170 for fluid collection, according to an embodiment. The fluid collection system 1170 includes a fluid collection assembly 1100, a fluid storage container 1172, and a vacuum source 1174. The fluid collection assembly 1 100 may be the same or substantially similar to any of the fluid collection assemblies disclosed herein. The fluid collection assembly 1100, the fluid storage container 1172, and the vacuum source 1174 may be fluidly coupled to each other via one or more conduits 1176. For example, fluid collection assembly 1100 may be operably coupled to one or more of the fluid storage container 1172 or the vacuum source 1174 via the conduit 1176. The bodily fluids collected in the fluid collection assembly 1100 may be removed from the fluid collection assembly 1100 via the conduit 1176 which protrudes into the fluid collection assembly 1100. For example, an inlet of the conduit 1176 may extend into the fluid collection assembly 1100, such as to a reservoir therein. The outlet of the conduit 1176 may extend into the fluid collection assembly 1100 or the vacuum source 1174. Suction force may be introduced into the chamber of the fluid collection assembly 1100 via the inlet of the conduit 1176 responsive to suction (e.g., vacuum) force applied at the outlet of the conduit 1176.
- Page 77 - Docket No. 318812WO01 504795-1114 [00236] The suction force may be applied to the outlet of the conduit 1176 by the vacuum source 1174 either directly or indirectly. The suction force may be applied indirectly via the fluid storage container 1172. For example, the outlet of the conduit 1 176 may be disposed within the fluid storage container 1172 and an additional conduit 1176 may extend from the fluid storage container 1172 to the vacuum source 1174. Accordingly, the vacuum source 1174 may apply suction to the fluid collection assembly 1100 via the fluid storage container 1172. The suction force may be applied directly via the vacuum source 1174. For example, the outlet of the conduit 1176 may be disposed within the vacuum source 1174. An additional conduit 1176 may extend from the vacuum source 1174 to a point outside of the fluid collection assembly 1100, such as to the fluid storage container 1172. In such examples, the vacuum source 1174 may be disposed between the fluid collection assembly 1100 and the fluid storage container 1 172.
[00237] The fluid storage container 1172 is sized and shaped to retain bodily fluids therein. The fluid storage container 1172 may include a bag (e.g, drainage bag), a bottle or cup (e.g., collection jar), or any other enclosed container for storing bodily fluids such as urine. In some examples, the conduit 1176 may extend from the fluid collection assembly 1100 and attach to the fluid storage container 1172 at a first point therein. An additional conduit 1176 may attach to the fluid storage container 1172 at a second point thereon and may extend and attach to the vacuum source 1174. Accordingly, a vacuum (e.g., suction) may be drawn through fluid collection assembly 1 100 via the fluid storage container 1172. Bodily fluids, such as urine, may be drained from the fluid collection assembly 1100 using the vacuum source 1174.
[00238] The vacuum source 1174 may include one or more of a manual vacuum pump, and electric vacuum pump, a diaphragm pump, a centrifugal pump, a displacement pump, a magnetically driven pump, a peristaltic pump, or any pump configured to produce a vacuum. The vacuum source 1174 may provide a vacuum or suction to remove bodily fluids from the fluid collection assembly 1100. In some examples, the vacuum source 1174 may be powered by one or more of a power cord (e.g, connected to a power socket), one or more batteries, or even manual power (e.g., a hand operated vacuum pump). In some examples, the vacuum source 1174 may be sized and shaped to fit outside of, on, or within the fluid collection assembly 1100. For example, the vacuum source 1174 may include one or more miniaturized pumps or one or more micro pumps. The vacuum sources 1174 disclosed herein may include one or more of a switch, a button, a plug, a remote, or any other device suitable to activate the vacuum source 1174.
- Page 78 - Docket No. 318812WO01 504795-1114 [00239] While various aspects and embodiments have been disclosed herein, other aspects and embodiments are contemplated. The various aspects and embodiments disclosed herein are for purposes of illustration and are not intended to be limiting.
[00240] Terms of degree (e.g, “about,” “substantially,” “generally,” etc.) indicate structurally or functionally insignificant variations. In an example, when the term of degree is included with a term indicating quantity, the term of degree is interpreted to mean ± 10%, ±5%. or ±2% of the term indicating quantity. In an example, when the term of degree is used to modify a shape, the term of degree indicates that the shape being modified by the term of degree has the appearance of the disclosed shape. For instance, the term of degree may be used to indicate that the shape may have rounded comers instead of sharp comers, curved edges instead of straight edges, one or more protrusions extending therefrom, is oblong, is the same as the disclosed shape, etc.
- Page 79 - Docket No. 318812WO01 504795-1114

Claims

CLAIMS What is claimed is:
1. A fluid collection assembly, comprising: a fluid impermeable barrier defining at least a chamber, at least one opening, and a fluid outlet; a porous material disposed in the chamber, the porous material including: a first layer; a second layer abutting the first layer; and a plurality of melted regions extending at least through the first layer into the second layer that attached the first layer to the second layer.
2. The fluid collection assembly of claim 1, wherein the first layer includes a plurality of fibers, and wherein at least some of the plurality of fibers of the first layer at or near the plurality of melted regions extend into the second layer.
3. The fluid collection assembly of any one of claims 1 or 2, wherein the plurality of melted regions exhibits a diameter of about 0. 1 mm to about 1.5 mm.
4. The fluid collection assembly of any one of claims 1-3, wherein at least one of the plurality of melted regions defines a hole extending through at least a portion of the first layer, the hole exhibiting a maximum dimension of about 0.1 mm to about 1 mm.
5. The fluid collection assembly of any one of claims 1-4, wherein a center-to- center spacing between immediately adjacent ones of the plurality of melted regions is about 5 mm to about 25 mm.
6. The fluid collection assembly of any one of claims 1-5, wherein the plurality of melted regions are arranged in a one or more of at least one generally circular pattern, at least one generally triangular pattern, at least one generally hexagonal pattern, or at least one generally square pattern.
7. The fluid collection assembly of any one of claims 1-6, wherein the plurality of melted regions extends inwardly from about 5% or less of a surface area of an outer surface of the first layer, wherein the outer surface of the first layer is opposite a surface of the first layer that abuts the second layer.
8. The fluid collection assembly of any one of claims 1-7, wherein the first layer includes hydrophilic polypropylene, hydrophilic polyethylene, or a combinations thereof.
9. The fluid collection assembly of any one of claims 1-8, wherein the second layer includes bamboo.
- Page 80 - Docket No. 318812WO01 504795-1114
10. The fluid collection assembly of any one of claims 1-9, wherein the porous material further includes an inner layer, the second layer positioned between the first layer and the inner layer.
11. The fluid collection assembly of claim 10, wherein the porous material further includes an adhesive layer between a portion of the second layer and a corresponding portion of the inner layer.
12. The fluid collection assembly of any one of claims 10 or 11, wherein the plurality of melted regions extend through the second layer into the inner layer.
13. The fluid collection assembly of any one of claims 10-12, wherein: the first layer includes hydrophilic polypropylene, hydrophilic polyethylene, or blends thereof; the second layer includes bamboo; and the inner includes a polyethylene terephthalate.
14. A method to form a fluid collection assembly, the method comprising: positioning a first layer to abut a second layer, the first layer and the second layer forming at least a portion of a porous material; melting a plurality of regions of the porous material to form a plurality of melted regions, the plurality' of melting regions extending at least through the first layer and into the second layer to attach the first layer to the second layer; and after melting a plurality of regions of the porous material, disposing the porous material in a chamber defined by a fluid impermeable barrier, the fluid impermeable barrier defining at least one opening and a fluid outlet.
15. The method of claim 14, wherein melting a plurality' of regions of the porous material includes inserting a plurality of needles into the first layer and at least a portion of the second layer.
16. The method of claim 15, wherein inserting a plurality of needles into the first layer and at least a portion of the second layer includes inserting a plurality' of heated needles exhibiting a surface temperature that is greater than a melting temperature of at least one material of the porous material.
17. The method of claim 16, wherein the at least one material of the first layer includes polypropylene and the surface temperature of the plurality of needles is about 195 °C to about 245 °C.
- Page 81 - Docket No. 318812WO01 504795-1114
18. The method of any one of claims 16 or 17, wherein inserting a plurality of needles into the first layer and at least a portion of the second layer forms a plurality of holes extending through at least a portion of the porous material.
19. The method of any one of claims 14-18, wherein melting a plurality of regions of the porous material includes introducing ultrasonic energy into the porous material, the ultrasonic energy selected to melt at least portions of the first layer and the second layer.
20. The method of any one of claims 14-19, wherein a center-to-center spacing between immediately adjacent ones of the plurality of melted regions is about 5 mm to about 25 mm.
21. The method of any one of claims 14-20, wherein the plurality of melted regions extends inwardly from about 5% or less of a surface area of an outer surface of the first layer, wherein the outer surface of the first layer is opposite a surface of the first layer that abuts the second layer.
22. A fluid collection assembly, comprising: a fluid impermeable barrier defining at least a chamber, at least one opening, and a fluid outlet; a porous material disposed in the chamber, the porous material including: an first layer; an second layer, wherein the first layer and the second layer include a plurality of fibers; and a plurality of entangled regions including some of the plurality of fibers of the first layer and the second layer being entangled together, the plurality of entangled regions extending through the first layer into the second layer that attached the first layer to the second layer.
23. A method to form a fluid collection assembly, the method comprising: positioning a first layer to abut a second layer, the first layer and the second layer forming at least a portion of a porous material, wherein the first layer and the second layer include a plurality of fibers; entangling some of the plurality of fibers of the first layer and the second layer of the porous material to form a plurality of entangled regions, the plurality of entangled regions extending at least through the first layer and into the second layer to attach the first layer to the second layer; and
- Page 82 - Docket No. 318812WO01 504795-1114 after entangling some of the plurality of fibers of the first layer and the second layer, disposing the porous material in a chamber defined by a fluid impermeable barrier, the fluid impermeable barrier defining at least one opening and a fluid outlet.
- Page 83 - Docket No. 318812WO01 504795-1114
PCT/US2025/035383 2024-08-15 2025-06-26 Fluid collection assemblies including at least one of a plurality of melted regions or a plurality of entangled regions Pending WO2026039108A1 (en)

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