WO2025193539A1

WO2025193539A1 - Fluid collection assemblies including one or more three- dimensional structures

Info

Publication number: WO2025193539A1
Application number: PCT/US2025/018907
Authority: WO
Inventors: Kamil Szymaniak; Robert M. Hine
Original assignee: PureWick Corp
Current assignee: PureWick Corp
Priority date: 2024-03-13
Filing date: 2025-03-07
Publication date: 2025-09-18
Anticipated expiration: 2026-09-13
Also published as: WO2025193541A1; WO2025193540A1

Abstract

An example fluid collection assembly includes a fluid impermeable barrier including a proximal end region and a distal end region. The fluid impermeable barrier defines a chamber, a fluid outlet at the distal end region, an opening at or near the proximal end region, and at least one vacuum relief opening. The fluid impermeable barrier includes one or more rims at least partially surrounding the at least one vacuum relief opening, the one or more rims extending away from portions of the fluid impermeable barrier defining the at least one vacuum relief opening. The fluid collection assembly also includes at least one porous material disposed in the chamber.

Description

FLUID COLLECTION ASSEMBLIES INCLUDING ONE OR MORE THREE- DIMENSIONAL STRUCTURES

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Application No. 63/564,696 filed on March 13, 2024; U.S. Provisional Application No. 63/711,445 filed on October 24, 2024; and U.S. Provisional Application No. 63/711,438 filed on October 24, 2024, the disclosure of each 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 manufacturing and using the same. In an embodiment, a fluid collection assembly is disclosed. The fluid collection assembly includes a fluid impermeable barrier including a proximal end region and a distal end region. The fluid impermeable barrier defines a chamber, a fluid outlet at the distal end region, an opening at or near the proximal end region, and at least one vacuum relief opening. The fluid collection assembly includes one or more rims attached to or integrally formed with the fluid impermeable barrier. The one or more rims at least partially surround the at least one vacuum relief opening. The one or more rims extend away for a height from portions of the fluid impermeable barrier defining the at least one vacuum relief opening. The fluid collection assembly also includes at least one porous material disposed in the chamber. [0005] In an embodiment, a fluid collection system is disclosed. The fluid collection system includes a fluid collection assembly. The fluid collection assembly includes a fluid impermeable barrier including a proximal end region and a distal end region. The fluid impermeable barrier defines a chamber, a fluid outlet at the distal end region, an opening at or near the proximal end region, and at least one vacuum relief opening. The fluid collection assembly includes one or more rims attached to or integrally formed with the fluid impermeable barrier. The one or more rims at least partially surround the at least one vacuum relief opening. The one or more rims extend aw ay for a height from portions of the fluid impermeable barrier defining the at least one vacuum relief opening. The fluid collection assembly also includes at least one porous material disposed in the chamber. The fluid collection system also includes a fluid storage container and a vacuum source. The chamber of the fluid collection assembly, the fluid storage container, and the vacuum source are in fluid communication with each other such that, when one or more bodily fluids are present in the chamber, a suction provided from the vacuum source to the chamber of the fluid collection assembly removes the one or more bodily fluids from the chamber and deposits the bodily fluids in the fluid storage container.

[0006] In an embodiment, a method of forming a fluid collection assembly is disclosed. The method includes positioning at least one porous material in a chamber defined by a fluid impermeable barrier. The fluid impermeable barrier includes a proximal end region and a distal end region. The fluid impermeable barrier defines a fluid outlet at the distal end region, an opening at or near the proximal end region, and at least one vacuum relief opening. The fluid collection assembly includes one or more rims attached to or integrally formed with the fluid impermeable barrier. The one or more rims at least partially surround the at least one vacuum relief opening. The one or more rims extend away for a height from portions of the fluid impermeable barrier defining the at least one vacuum relief opening.

[0007] In an embodiment, a method of using a fluid collection assembly is disclosed. The method includes positioning an opening defined by a fluid impermeable barrier of the fluid collection assembly adjacent to a urethral opening of an individual or receive a penis of an individual through the opening. The fluid impermeable barrier includes a proximal end region and a distal end region. The fluid impermeable barrier defines a chamber, a fluid outlet at the distal end region, and at least one vacuum relief opening. The opening is located at or near the proximal end region. The fluid collection assembly includes one or more rims at least attached to or integrally formed with the fluid impermeable barrier. The one or more rims at least partially surround the at least one vacuum relief opening. The one or more rims extend away for a height from portions of the fluid impermeable barrier defining the at least one vacuum relief opening. The fluid collection assembly includes at least one porous material disposed in the chamber. [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 follow ing detailed description and the accompanying draw ings.

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] FIGS. 1A-1C are an isometric, a top view, and a bottom view, respectively, of a fluid collection assembly, according to an embodiment. [0011] FIG. ID is a cross-sectional view of the fluid collection assembly taken along plane ID- ID shown in FIG. IB.

[0012] FIG. 2 is an isometric view of a fluid collection assembly, according to an embodiment.

[0013] FIG. 3 is an isometric view of a fluid collection assembly, according to an embodiment.

[0014] FIG. 4 is an isometric view' of a fluid collection assembly, according to an embodiment.

[0015] FIGS. 5A-5C illustrate a cap attached to a drainage port assembly exhibiting different states, according to an embodiment. [0016] FIG. 6 is a top view of a cap attached to a drainage port assembly, according to an embodiment.

[0017] FIG. 7 is a cross-sectional view⁷ of a drainage port assembly including a check valve, according to an embodiment.

[0018] FIG. 8 is an isometric view of a cap attached to a drainage port assembly that is substantially similar to the drainage port assembly of FIGS. 1A-1D, according to an embodiment.

[0019] FIG. 9 is a top view of a drainage port assembly, according to an embodiment.

[0020] FIG. 10 is an exploded isometric view of a drainage port assembly, according to an embodiment. [0021] FIG. 11A is an isometric view of a rim, according to an embodiment.

[0022] 11B and 11C are cross-sectional view of the rim taken along plane 11B-11B, according to different embodiments.

[0023] FIG. 12 is an isometric view of a fluid collection assembly, according to an embodiment.

[0024] FIG. 13A is an isometric view of a fluid collection assembly, according to an embodiment.

[0025] FIGS. 13B and 13C are a top and side view of the fluid collection assembly.

[0026] FIG. 14 is a block diagram of a fluid collection system for fluid collection, according to an embodiment.

DETAILED DESCRIPTION

[0027] Embodiments disclosed herein are related to fluid collection assemblies, fluid collection systems including the same, and methods of manufacturing and using the same. An example fluid collection assembly includes a fluid impermeable barrier including a proximal end region and a distal end region. The fluid impermeable barrier defines a chamber, a fluid outlet at the distal end region, an opening at or near the proximal end region, and at least one vacuum relief opening. The fluid impermeable barrier includes one or more rims at least partially surrounding the at least one vacuum relief opening, the one or more rims extending away from portions of the fluid impermeable barrier defining the at least one vacuum relief opening. The fluid collection assembly also includes at least one porous material disposed in the chamber.

[0028] During use, the opening of the fluid collection assembly may be positioned adjacent to a urethral opening (e.g, buried penis) of an individual or have a penis of the individual positioned through the opening. When the penis is positioned through the opening, at least a portion of the penis may be positioned in the penis receiving area.

After positioning the fluid collection assembly, the individual may discharge one or more bodily fluids (e.g., urine) into the chamber. At least some of the bodily fluids may be received into the porous material and flow towards the fluid outlet. The bodily fluids may be removed from the chamber via the fluid outlet. For example, a vacuum may be applied to the chamber via the fluid outlet. The vacuum may cause the bodily fluids to preferentially flow' towards the fluid outlet and remove the bodily fluids from the chamber.

[0029] The fluid collection assemblies disclosed herein are described as being examples of male fluid collection assemblies that are configured to be used with buried penises or non-buried penises. That said, the fluid collection assemblies disclosed herein may also be used with females. For example, the openings of the fluid collection assemblies disclosed herein may be positioned adjacent to the urethral opening of a female. [0030] FIGS. 1A-1C are an isometric, a top view, and a bottom view, respectively, of a fluid collection assembly 100. according to an embodiment. FIG. ID is a cross- sectional view of the fluid collection assembly 100 taken along plane ID-ID shown in FIG. IB. The fluid collection assembly 100 includes a sheath 102 and a base 104. The sheath 102 includes a fluid impermeable barrier 106. The fluid impermeable barrier 106 includes a proximal end region 108 and a distal end region 110. The fluid impermeable barrier 106 defines a chamber 112, an opening 114, and a fluid outlet (not shown, obscured by the drainage port assembly 144). The sheath 102 also include at least one porous material 118 disposed in the chamber 112. The base 104 includes an aperture 120 that generally corresponds to the opening 114. The base 104 is attached (e.g, permanently attached) to the sheath 102 and is configured to attach the sheath 102 to an individual.

[0031] The fluid impermeable barrier 106 includes a top panel 122 and a bottom panel 124. The top panel 122 and the bottom panel 124 are attached together. For example, the outer edges 126 of the top panel 122 and the outer edges 128 of the bottom panel 124 are attached together. As used herein, the outer edges 126. 128 may refer to the outermost edges of the panels 122, 124 and/or may refer to a region of the panels 122, 124 extending a short distance (e.g., about 2 cm or less or about 1 cm or less) from the outermost edges thereof. The top and bottom panels 122, 124 may be attached together using any suitable technique. For example, the top and bottom panels 122. 124 may be attached together using an adhesive, ultrasonic (‘"US”) welding, radio frequency (“RF”) welding, heat seals, any other suitable technique, or combinations thereof. In an embodiment, as shown, the top and bottom panels 122, 124 are distinct and separate panels that are attached together along all of the outer edges 126, 128 thereof. In an embodiment, the top and bottom panels 122, 124 are integrally formed together. In such an embodiment, the top and bottom panels 122, 124 may initially exhibit a tubular shape or a folded sheet and the outer edges thereof that are not initially attached together are then attached together.

[0032] The top panel 122 and the bottom panel 124 collectively define at least a portion of the chamber 112. For example, the interior surfaces of the top panel 122 and the bottom panel 124 may define the chamber 112. The fluid impermeable barrier 106 temporarily stores the bodily fluids in the chamber 112. As such, the top and bottom panels 122, 124 may be formed from any suitable fluid impermeable material(s), such as a fluid impermeable polymer (e.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, neoprene, polyurethane, a polycarbonate, etc.), a metal film, natural rubber, another suitable material, any other fluid impermeable barrier material disclosed herein, or combinations thereof. As such, the fluid impermeable barrier 106 substantially prevents the bodily fluids from passing through the fluid impermeable barrier 106. In an example, the fluid impermeable barrier 106 may be air permeable and fluid impermeable. In such an example, the fluid impermeable barrier 106 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 106 may be formed from a soft and/or smooth material, thereby reducing chaffing. In an embodiment, the top panel 122 and the bottom panel 124 may include the same material. Forming the top and bottom panels 122. 124, from the same material may facilitate or be necessary to attach the top and bottom panels 122, 124 together depending on the method used to attach the top and bottom panels 122, 124 together (e.g., heat seals).

[0033] In an embodiment, at least one of the top panel 122 or the bottom panel 124 is formed from an at least partially transparent fluid impermeable material, such as polyethylene, polypropylene, polycarbonate, polyvinyl chloride, or polyurethane. As used herein, at least partially transparent fluid impermeable material refers to a fluid impermeable material that is sufficiently transparent that one or more features of a penis (e.g., skin degradation or sores) may be accurately detected (e.g., a fluid impermeable barrier that allows at least 50% of light to be transmitted therethrough). Forming at least one of the top panel 122 or the bottom panel 124 from an at least partially transparent fluid impermeable material allows a person (e.g., medical practitioner) to examine the penis without having to detach the fluid collection assembly 100 from the individual. For example, as will be discussed in more detail below, the base 104 may adhesively attach the fluid collection assembly 100 to the individual which (without being able to examine the penis through the top panel 122 or the bottom panel 124) may make examining the penis a painful and difficult process that may discourage examination of the penis.

[0034] The chamber 112 may include a penis receiving area 130. The penis receiving area 130 is a portion of the chamber 112 that is configured to receive the penis when the penis extends into the chamber 112. The penis receiving area 130 is the portion of the chamber 112 between the porous material 118 and one of the top panel 122 or the bottom panel 124. In an embodiment, as shown, the penis receiving area 130 is the portion of the chamber 1 12 between the porous material 118 and the top panel 122. In such an embodiment, at least the top panel 122 is formed from an at least partially transparent material to allow the person to view a penis in the penis receiving area 130. It is noted that allowing the person to view the penis through the top panel 122 precludes the need to lift the sheath 102 to view the penis through the bottom panel 124 as would be the case when the penis receiving area 130 is between the porous material 118 and the bottom panel 124. Also, forming the top panel 122 from an at least partially transparent material also allows a buried penis that does not extend into the penis receiving area 130 to be viewed which may be difficult to do when the penis receiving area 130 is between the porous material 118 and the bottom panel 124 and the penis receiving area 130 is viewed through the bottom panel 124.

[0035] In an embodiment, not shown, the penis receiving area 130 is the portion of the chamber 112 between the porous material 118 and the bottom panel 124. In such an embodiment, at least the bottom panel 124 is at least partially transparent to allow the person to view the penis receiving area 130 between the porous material 118 and the bottom panel 124. Forming the penis receiving area 130 between the porous material 118 and the bottom panel 124 allows the porous material 118 to cover the penis during normal use (z.e., when the bottom panel 124 faces the legs or a space between the legs of the individual). The porous material 1 18 covering the penis may require the sheath 102 to be lifted to view the penis through the bottom panel 124. However, the porous material 118 covering the penis may maintain the individual’s dignity by prevent bystanders from viewing the penis when the fluid collection assembly 100 is uncovered. [0036] At least the top panel 122 may be relatively rigid. The top panel 122 is relatively rigid when the top panel 122 maintains a shape thereof when a vacuum applied to the chamber 112. The vacuum applied to the chamber 112 may be (in either absolute or gauge) about 40 kPa or less, about 30 kPa or less, about 20 kPa or less, or about 5 kPa to about 15 kPa. The relative rigidity of the top panel 122 prevents the collapse of the top panel 122 during use. For example, at least some conventional male fluid collection assemblies are formed from non-rigid panel(s) (e.g, flimsy and compliant panel(s)). When a vacuum is applied to the conventional male fluid collection assemblies, air in the conventional fluid collection assemblies is removed and the non-rigid panel(s) collapse. The collapsed panels may cover the urethral opening of the penis thereby preventing or at least inhibiting the individual from discharging urine into the conventional male fluid collection assemblies. However, unlike the conventional male fluid collection assemblies, the relatively rigid top panel 122 is unlikely to collapse when a vacuum is applied to the chamber 1 12. When the top panel 122 defines a portion of the penis receiving area 130, the relative rigidity of the top panel 122 prevents the top panel 122 from covering the urethral opening of the penis.

[0037] It is noted that the relatively rigid top panel 122 may still be flexible and soft thereby allowing the fluid collection assembly 100 to be comfortable to use. For example, the fluid collection assembly 100 is configured to rest on top of the thighs of the individual during use. However, the relatively rigid top panel 122 may still be able to allow the fluid collection assembly 100 to fall between the thighs of the individual when the individual opens the individual’s thighs thereby preventing uncomfortable pulling on the area about the penis if the fluid collection assembly 100 was not flexible. Further, the relatively rigid top panel 122 may easily collapse if the individual closed the individual’s thighs after the fluid collection assembly 100 fell between the thigs to prevent the top panel 122 from uncomfortably pressing into the thighs of the individual.

[0038] The top panel 122 may be relatively rigid because the top panel 122 exhibits a thickness that is greater than the thickness of the fluid impermeable barrier of conventional male fluid collection assemblies. The fluid impermeable barrier of at least some of the conventional male fluid collection assembly generally exhibits a thickness of about 0.08 mm or less since such fluid impermeable barriers are relatively flimsy and compliant. In an embodiment, the top panel 122 exhibits a thickness of about 0. 15 mm or more, about 0.02 mm or more, about 0.25 mm or more, such as about 0.3 mm or more, about 0.35 mm or more, about 0.4 mm or more, about 0.45 mm or more, about 0.5 mm or more, about 0.6 mm or more, or in ranges of about 0. 15 mm to about 0.25 mm, about 0.2 mm to about 0.3 mm, about 0.25 mm to about 0.35 mm, about 0.3 mm to about 0.4 mm, about 0.35 mm to about 0.45 mm, about 0.4 mm to about 0.5 mm, or about 0.45 mm to about 0.6 mm. It has been found that the top panel 122 exhibiting any of the above thicknesses, and in particular a thickness greater than 0.25 mm, is able to be relatively rigid while also being able to be flexible and comfortable.

[0039] The top panel 122 may be relatively rigid because the top panel 122 is formed from a material exhibiting a ri gi di ty that is greater the rigidity of the fluid impermeable barrier of at least some conventional male fluid collection assemblies. For example, the fluid impermeable barrier of at least some conventional male fluid collection assemblies include polyurethane due to the flexibility and soft feel of polyurethane. The top panel 122 may include a more rigid material then polyurethane. For example, the top panel 122 may include polyethylene which generally exhibits a rigidity that is greater than polyurethane. As will be discussed in more detail below, forming the top panel 122 from polyethylene also facilitates manufacturing the fluid collection assembly 100 (e.g., facilitate attaching an injection moldable polyethylene drainage port assembly 144 to the top panel 122).

[0040] The top panel 122 may be relatively rigid because the top panel 122 has one or more three-dimensional structures formed therein. The three-dimensional structures may be formed in the top panel 122, for example, using a thermoforming technique since thermosetting is able to form the three-dimensional structures quickly, cheaply, and efficiently. The three-dimensional structures may resist bending of which, in turn, increases the rigidity of the top panel 122. The three-dimensional structures may include, for example, the bulge 132, one or more reinforcement structures 136, one or more fold lines (e.g., fold lines 454 of FIG. 4), any other suitable three-dimensional structure, or combinations thereof. It is noted that the three-dimensional structures may be formed using other techniques, such as by selectively varying a thickness of the top panel 122, adding a material to the top panel 122, or via any other suitable technique.

[0041] In an embodiment, the bottom panel 124 may be relatively rigid. In such an embodiment, the bottom panel may exhibit any of the characteristics discussed above regarding the relatively rigid top panel 122. The bottom panel 124 may be relatively rigid, for example, when the penis receiving area 130 is between the porous material 118 and the bottom panel 124. It is noted that the top panel 122 may or may not be relatively rigid when the bottom panel 124 is relatively rigid. In an embodiment, the bottom panel 124 is not relatively rigid. The bottom panel 124 may not be relatively rigid, for example, when the penis receiving area 130 is between the porous material 1 18 and the top panel 122 and/or the relative rigidity of the top panel 122 maintains the bottom down 124 taut.

[0042] As previously discussed, the top panel 122 may include a bulge 132. The bulge 132 is a portion of the top panel 122 that extends upwardly and away from the bottom panel 124 when the top and bottom panels 122, 124 are attached together. The bulge 132 prevents the fluid impermeable barrier 106 and the fluid collection assembly 100, as a whole, from lying flat or substantially flat when the fluid collection assembly 100 is lying on a flat surface. The bulge 132 forms and maintains an open, unoccupied space in the chamber 1 12. The open, unoccupied space formed by the bulge 132 forms at least a portion of the penis receiving area 130 of the chamber 112. In an embodiment, the bulge 132 is positioned at least above the opening 114 and a corresponding passageway 134 formed in the porous material 118. In such an embodiment, the bulge 132 prevents the top panel 122 from extending across the opening 114. In an embodiment, the bulge 132 extends at least from the opening 114 at least partially towards the fluid outlet. In such an embodiment, the open, unoccupied space in the chamber 112 formed by the bulge 132 provides a spaced in the chamber 1 12 to have at least a portion of the penis positioned therein. In an embodiment, the bulge 132 substantially only extends above the passageway 134 which may limit unoccupied space in the chamber 112 in which bodily fluids may pool.

[0043] The bulge 132 prevents or at least inhibits the top panel 122 from covering and/or otherwise obstructing the urethral opening of the penis even when a vacuum is applied to the chamber 112 since covering or otherwise obstructing the urethral opening of the penis may inhibit urination. As previously discussed, the fluid impermeable barriers of at least some conventional male fluid collection assemblies are likely to collapse during use. It has been found that the collapse of the fluid impermeable barriers of such conventional male fluid collection assemblies may cause the fluid impermeable barriers to cover or otherwise obstruct the urethral openings which, in turn, makes urinating difficult or impossible. The collapse of the fluid impermeable barriers of such conventional male fluid collection assemblies may prevent or inhibit use of the conventional male fluid collection assemblies with buried penises. For example, conventional male fluid collection assemblies that did not include a porous material extending over the opening thereof (e.g., porous materials defining a passageway extending through a thickness thereof) allows the portion of the fluid impermeable barrier opposite the opening to be pulled towards the opening. The portions of the fluid impermeable barrier pulled towards the opening may cover and obstruct a buried penis thereby making urinating difficult. However, unlike such conventional male fluid collection assemblies, the bulge 132 keeps the top panel 122 spaced from the opening 114 because the top panel 122 is relatively rigid and thereby maintains a shape thereof. In other words, even though the porous material 118 defines a passageway 134 that prevents the porous material 118 from covering the opening 114, the presence of the bulge 132 prevents the top panel 122 from covering the buried penis. Further, the collapse of the fluid impermeable barriers of the conventional male fluid collection assemblies may prevent or inhibit use of the conventional male fluid collection assemblies with non- buried penises. For example, regardless if the porous material extended over the opening or not, the vacuum would cause the fluid impermeable barrier of conventional male fluid collection assemblies to collapse and decrease the volume of the chamber defined thereby. When the penis is disposed in the chamber, decreasing the volume of the chamber would cause the fluid impermeable barrier to contact, conform to, and cover at least a portion of the penis. The fluid impermeable barrier would impede urination if the fluid impermeable barrier contacts, conforms to. and/or covers the portion of the penis forming the urethral opening. However, the bulge 132 partially defines and maintains the penis receiving area 130 open even when a vacuum is applied to the chamber 112. As such, the bulge 132 minimizes contact with the penis, prevents the top panel 122 from conforming to the penis, and otherwise minimizes the likelihood that the top panel 122 covers the urethral opening of the penis.

[0044] In an embodiment, the three-dimensional structure of the fluid impermeable barrier 106 may include a recess 135. The recess 135 may extend at least partially around the bulge 132. The recess 135 may increase the bending resistance of the fluid impermeable barrier 106 about the bulge 132. As such, the recess 135 indirectly increases the strength of the fluid impermeable barrier 106.

[0045] The top panel 122 may include or have attached thereto one or more reinforcement structures 136. The reinforcement structures 136 are configured to strength the three-dimensional structure (e.g, the bulge 132) and prevent the collapse of the three- dimensional structure during use. For example, the reinforcement structure 136 allows the rigidity' of the top panel 122 to be decreased thereby making the fluid collection assembly 100, as a whole, more comfortable to use while still preventing or at least inhibiting collapse of the bulge 132. The reinforcement structure 136 may also prevent collapse of the bulge 132 when the fluid collection assembly 100 is used improperly. For instance, most hospitals recommend applying a vacuum pressure of about 5 kPa to about 8 kPa to external fluid collection assemblies. The top panel 122 and, in particular the bulge 132, may be configured to prevent collapse thereof when such vacuum pressures are applied thereof. However, in practice, it has been found that vacuum pressures significantly exceeding 8 kPa, such as vacuum pressures of about 40 kPa, have been applied to fluid collection assemblies due to mishaps (e.g., accidently hitting the valve that controls the vacuum pressure such that the vacuum pressure is increased). The reinforcement structures 136 may be configured to prevent or inhibit collapse of the top panel 122 even when such large vacuum pressures are applied to the chamber 112 of the fluid collection assembly 100.

[0046] The reinforcement structures 136 may include any structure that increases the rigidity of and prevents collapse of the bulge 132. In an example, as shown, the reinforcement structures 136 may include ridges formed in the top panel 122 (e.g., using a thermosetting process) that extend from a lateral side of the bulge 132 towards the outer edge 126 of the top panel 122. The ridges may extend into and at least partially across the recesses 135 when the fluid impermeable barrier 106 includes the recess 135. In an example, as shown in FIG. 2, the reinforcement structures 136 may include ridges extending across the bulge 132 (e g., using a thermosetting process). In an example, the reinforcing structures 136 may include selectively increasing the thickness of the top panel 122, attaching an additional structure to the top panel 122, or any other suitable structure. In an example, the reinforcement structures 136 may include a combination of any of the reinforcement structures 136 disclosed herein. [0047] The top panel 122 may completely define at least one vacuum relief opening

(not labeled, obscured) that allows atmospheric air to flow into the chamber 112. The vacuum relief opening is an opening formed in the fluid impermeable barrier 106 that allows air to flow through the fluid impermeable barrier 106. Such air flow' through the fluid impermeable barrier 106 causes the chamber 112 to exhibit substantially atmospheric pressure thereby preventing the vacuum applied to the chamber 112 from giving “hickeys” to the individual. The vacuum relief opening also causes air to flow in the chamber 112 from the vacuum relief opening towards the fluid outlet. Such air flow' causes any bodily fluids in the chamber 112 to preferentially flow towards the fluid outlet. The air flow in the chamber 112 also dries the chamber 112 after the individual urinates thereby making the fluid collection assembly 100 more comfortable to use and prevents or inhibits skin degradation caused by continuous contact with moisture. The vacuum relief opening may be covered by an air permeable, water impermeable membrane (“membrane”) 138. The membrane 138 allows the air to flow into the chamber 112 through the vacuum relief opening while preventing or at least inhibiting bodily fluids leaking from the chamber 112 through the vacuum relief opening.

[0048] In an embodiment, the vacuum relief opening is located in the proximal end region 108 of the top panel 122 (e.g., betw een the opening 114 and the proximal outer edge 126a, as shown). In such an embodiment, the vacuum relief opening causes the air flow to pass over the opening 114 and a penis adjacent to the opening 114 or at least partially received through the opening 114. Such air flow may minimize stagnation of the bodily fluids in the proximal end region 108 and facilitate drying of the penis. In an embodiment, the vacuum relief opening includes two vacuum relief openings on each side of the opening 114 with at least a portion of each vacuum relief opening extending into the proximal end region 108. In such an embodiment, the two vacuum relief openings may minimize stagnation of the bodily fluids in the proximal end region 108 and may cause some air flow around to penis which may dry the penis. In an embodiment, the vacuum relief opening may be located in any other location of the top panel 122. [0049] The top panel 122 may define any number of vacuum relief openings, such as

1, 2, 3, 4, or 5 or more vacuum relief openings. However, it is generally desired to minimize the number of vacuum relief openings due to complications of manufacturing the vacuum relief openings. For example, each membrane 138 covering the vacuum relief opening is generally attached to the top panel 122 in separate manufacturing steps. As such, minimizing the number of vacuum relief openings decreases the number of manufacturing steps necessary to form the fluid collection assembly 100. Further, the membranes 138 are generally attracted to the top panel 122 due to the static electrical charges thereof which may cause alignment issues during manufacture. Such alignment issues may result in the fluid collection assembly 100 failing to pass quality control and results in waste. Thus, decreasing the number of vacuum relief openings minimizes such waste. As such, in some embodiments, the top panel 122 may define a single vacuum relief opening or two vacuum relief openings to minimize these issues.

[0050] Generally, conventional male fluid collection assemblies that include vacuum relief openings include three or more vacuum relief openings. The conventional male fluid collection assemblies include three or more vacuum leak openings because obese or swollen individuals (e.g, pannus stomach) are likely to cover one or two vacuum relief openings during use. As such, at least some the conventional male fluid collection assemblies include three or more vacuum relief openings to ensure that one or more of the vacuum relief openings are uncovered at any given time. [0051] With regards to the fluid collection assembly 100, the top panel 122 may include a single vacuum relief opening or two vacuum relief openings because the top panel 122 may include a rim 140 at least partially surrounding the vacuum relief opening. The rim 140 includes one or more walls. The rim 140 define a passageway that is aligned with the vacuum relief opening defined by the fluid impermeable barrier 106. The passageway defined by the rim 140 allows air to flow through the rim 140 to the vacuum relief opening, and through the vacuum relief opening into the chamber 112. The rim 140 extend upwardly (e.g., away from the bottom panel 124) from the portions of the fluid impermeable barrier 106. The rim 140 decrease the likelihood that anatomy of the individual (e.g, anatomy of obese or swollen individuals, such as a pannus stomach) cover the vacuum relief open. For example, the rim 140 decrease the likelihood that the anatomy may completely prevent air from reaching the vacuum relief opening since the anatomy must extend over and cover the passageway defined by the rim 140 to prevent air from reaching the vacuum relief opening. It is noted that the rim 140 may be integrally formed (e.g., exhibit single piece construction) with the fluid impermeable barrier 106, as shown, or may be attached to the fluid impermeable barrier 106.

[0052] The rim 140 may extend upwardly from such portions of the fluid impermeable barrier 106 by about 1 mm or more, about 2 mm or more, about 3 mm or more, about 4 mm or more, about 5 mm or more, about 6 mm or more, about 8 mm or more, about 10 mm or more, about 12.5 mm or more, about 15 mm or more, about 20 mm or more, or in ranges of about 1 mm to about 3 mm, about 2 mm to about 4 mm, about 3 mm or about 5 mm, about 4 mm to about 6 mm, about 5 mm to about 8 mm, about 6 mm to about 10 mm, about 8 mm to about 12.5 mm, about 10 mm to about 15 mm, or about 12.5 mm to about 20 mm. Generally, increasing the height of the rim 140 (z.e., the maximum height that the rim 140 extends from the fluid impermeable barrier 106) may make it less likely that the anatomy of the individual completely covers the passageway defined by the rim 140 thereby preventing airfrom reaching the vacuum relief opening. However, increasing the height of the rim 140 may make using the fluid collection assembly 106 more uncomfortable and increase the likelihood of causing pressure sores should the anatomy contact and extend over the rim 140.

[0053] In an embodiment, the rim 140 may also define one or more cutouts 141. As used herein, the cutouts 141 may include, as shown) valleys that are partially defined by the rim 140 (e.g.. between peaks 143) or passageways that are completely laterally defined by the rim 140. The cutouts 141 extend at least partially through the walls forming the rim 140 and, more preferably, extend completely through the walls forming the rim. The cutouts 141 may allow air to flow through the rim 140 even when the anatomy individual covers at least a portion of the rim 140. For example, anatomy that completely covers the top of the rim 140 may not extend into the cutouts 141 and, instead, may extend between th peaks 143. In such an example, air may flow through the cutout 141, into the passageway, and to the vacuum relief opening. Even if the anatomy does not completely cover the top of the rim 140, the cutouts 141 may increase the volume of air that may reach the vacuum relief opening compared to a substantially similar rim 140 that does not define the cutout 141. In an example, as shown, the cutouts or valleys may be present around substantially all of the circumference of the rim 140. In an example, the cutouts or valleys may be present on portions of the rims 140 that are most likely, during use. to be at least partially covered by the anatomy of an individual. For instance, the cutouts or valleys may be present on the proximal side of the rims 140 since such portions of the rim 140 is most likely to be covered. In such an instance, the rim 140 may still include one or more cutouts or valleys on a distal side of the rim 140 (e.g., a side closest to the distal end region 110 that is opposite the proximal side of the rim 140) in case the anatomy of the individual completely covers the cutouts 141 on the proximal side of the rim 140.

[0054] In an example, the exposed edges of the rim 140 may be rounded, chamfered, or otherwise blunted to prevent or at least inhibit the edges of the rim 140 from pressing into an individual. The exposed edges of the rim 140 may include the protrusions separating the valleys from each other. For instance, during use, skin folds, stomachs of obese or swollen individuals, or other anatomy may partially cover the rim 140. The rounded, chamfered, or otherwise blunted edges of the rim 140 may prevent the rim 140 from causing discomfort, pain, or pressure sores when such anatomy at least a portion covers the rim 140. In an embodiment, at least a portion the rim 140 may include a tapered surface that extends from a portion of the fluid impermeable barrier 106 that is spaced from the vacuum relief opening 138 to a maximum height of the rim 140. In an embodiment, the rim 140 may be hollow or otherwise collapsible to prevent the rim 140 from pressing into an individual.

[0055] As previously discussed, the fluid impermeable barrier 106 defines fluid outlet. The fluid outlet is an opening in the fluid impermeable barrier 106 allows bodily fluids to be removed from the chamber 112. The fluid outlet may be located at or near the distal end region 110 of the sheath 102 because, during use, the distal end region 110 is likely to be the gravimetrical low point of the chamber 112. In an embodiment, a conduit 142 is directly attached to the fluid outlet. In other words, the conduit 142 may be attached to the fluid impermeable barrier 106. However, it has been found that it is difficult to directly attach the conduit 142 to the fluid impermeable barrier 106. As such, in an embodiment, the fluid collection assembly 100 may include a drainage port assembly 144. The drainage port assembly 144 is atached to the fluid impermeable barrier 106 such that the drainage port assembly 144 is in fluid communication with the chamber 112 via the fluid outlet. For example, the drainage port assembly 144 may include a barrier attachment portion 146 that is atached to the fluid impermeable barrier 106 and covers or extends through the fluid outlet. The drainage port assembly 144 is also configured to be atached to a conduit 142 and thereby allowing the conduit 142 to be in fluid communication with the chamber 1 12. For example, the drainage port assembly 144 may include a conduit atachment portion 148 extending from the barrier attachment portion 146 that is configured to be atached to the conduit 142. The drainage port assembly 144 also defines a passageway extending from the barrier atachment portion 146 to the conduit atachment portion 148. thereby allowing the conduit 142 to remove bodily fluids from the chamber 112. For example, the passageway may extend from a region of the barrier atachment portion 146 adjacent to the fluid outlet to a terminal end of the conduit atachment portion 148. [0056] The drainage port assembly 144 is configured to allow the conduit 142 to extend from the distal end region 110 generally towards the proximal end region 108. In some setings, the vacuum that is used to remove the bodily fluids from the chamber is located behind the individual or generally towards the head of the individual. For example, wall-mounted vacuum sources in hospitals are generally located behind the bed. When the vacuum is behind the individual, allowing the conduit 142 to extend from the distal end region 1 10 generally towards the proximal end region 108 decreases the need to form bends the conduit 142 since such bends may cause the conduit 142 to kink or cause the sheath 102 to bend or twist. It is noted that it is desirably to prevent or at least inhibit bending or twisting of the sheath 102 since such bending or twisting which may form gravimetric low spots that are spaced from the fluid outlet and it may be difficult to remove the bodily fluids from gravimetric low spots that are spaced from the fluid outlet. In an embodiment, the drainage port assembly 144 is attached to the top panel 122 which better facilitate directing the conduit 142 from the distal end region 110 generally towards the proximal end region 108 without twisting or bending of the sheath 102 that if the drainage port assembly 144 was atached to the botom panel 124 or attached to both (i.e., between) the top and botom panels 122, 124.

[0057] The drainage port assembly 144 may exhibit a rigidity that is greater than the rigidity of the fluid impermeable barrier 106. The increase rigidity of the drainage port assembly 144 may facilitate atachment of the conduit 142 to the drainage port assembly 144 (e.g.. via an interference fit) than if the conduit 142 was directly attached to the fluid impermeable barrier 106. The increased rigidity of the drainage port assembly 144 also allows the conduit attachment portion 148 to generally maintain an orientation thereof.

[0058] In an embodiment, the drainage port assembly 144 is integrally formed. That is, the drainage port assembly 144 exhibit a single piece construction. However, it has been found to be difficult to manufacture that drainage port assembly 144 using an injection molding process if the drainage port assembly 144 is integrally formed. As such, in an embodiment, the drainage port assembly 144 exhibits multi -piece construction that is assembled (e.g., attached) together. For example, as shown, the drainage port assembly 144 may include a first piece that includes at least the barrier attachment portion 146 and, optionally, a portion of the conduit attachment portion 148 extending from the barrier attachment portion 146. The drainage port assembly 144 may also include a second piece including at least partially of the conduit attachment portion 148 that is directly attached to the conduit 142. In such an example, the drainage port assembly 144 including the first piece and the second piece has been found to be easily injection molded.

[0059] In an embodiment, the drainage port assembly 144 includes the same material as the portion of the fluid impermeable barrier 106 to which the drainage port assembly 144 is attached. Forming the drainage port assembly 144 from the same material as the portion of the fluid impermeable barrier 106 to which the drainage port assembly 144 is attached facilitates attachment of the drainage port assembly 144 to the fluid impermeable barrier 106 using a technique that melts or otherwise softens at least one of the drainage port assembly 144 or the fluid impermeable barrier 106 (e.g., heat sealing, US welding, RF welding, etc.). In a particular embodiment, the drainage port assembly 144 and the portion of the fluid impermeable barrier 106 include (e.g, consist essentially only of) polyethylene. Forming the fluid impermeable barrier 106 from polyethylene allows the fluid impermeable barrier 106 to exhibit the characteristics discussed above, such as being comfortable, relatively rigid, and thermosetting processable. Forming the drainage port assembly 144 from polyethylene allows the drainage port assembly 144 to be easily injection molded unlike some other materials, such as polyurethane.

[0060] In an embodiment, as shown, the drainage port assembly 144 is partially disposed in the chamber 112. For example, the barrier attachment portion 146 may be disposed in the chamber 112 and the a portion of the drainage port assembly 144 extends through the fluid outlet such that at least a portion of the conduit attachment portion 148 is positioned outside of the chamber 112 to allow the conduit 142 to be attached thereto. In such an example, the barrier attachment portion 146 may be attached to the interior surface of the fluid impermeable barrier 106. Partially disposing the drainage port assembly 144 inside the chamber 112 allows the fluid impermeable barrier 106 to cover a portion of the drainage port assembly 144 thereby decreasing the pressure points formed by the drainage port assembly 144 that may cause pressure sores. In an embodiment, the drainage port assembly 144 is not partially disposed in the chamber 112. In such an embodiment, the drainage port assembly 144 may be attached to the exterior surface of the fluid impermeable barrier 106. Attaching the drainage port assembly 144 on an exterior surface of the fluid impermeable barrier 106 may allow for retrofitting of the fluid collection assembly 100 to include the drainage port assembly 144.

[0061] As previously discussed, the sheath 102 includes at least one porous material 118 disposed in the chamber 112. The porous material 118 may direct the bodily fluids to one or more selected regions of the chamber 112, such as away from the penis and towards the fluid outlet. As such, the porous material 118 may facilitate the removal of the bodily fluids from the chamber 112 and form a padding layer that prevents the penis from resting against a damp material which may cause degradation of the skin of the penis and/or make the fluid collection assembly 100 more uncomfortable to wear. The porous material 118 may also blunt a stream of urine from the penis. [0062] In an embodiment, the porous material 118 is a wicking material configured to wick any bodily fluids away from the opening 1 14 thereby preventing the bodily fluids from escaping the chamber 112. Such “wicking” may not include absorption of fluid into the wicking material. Put another way, substantially no absorption of fluid into the material may take place after the material is exposed to the fluid and removed from the fluid for a time. While no absorption is desired, the term “substantially no absorption” may allow for nominal amounts of absorption of fluid into the wicking material (e.g., absorbency), such as less than about 30 wt % of the dry weight of the wicking material, less than 20 wt %, less than 15 wt %, less than 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 wicking material. The wicking material may also wick the fluid generally towards an interior of the chamber 112, as discussed in more detail below. In an embodiment, the porous material 118 is configured to adsorb or absorb the bodily fluids. Similar, to the wicking material, such adsorbing or absorbing material may move bodily fluids away from the opening 114 thereby preventing the bodily fluids from escaping the chamber 112.

[0063] The porous material 118 may be formed from any suitable porous material. For example, the porous material 118 may be formed from nylon (e.g., spun nylon fibers), polyester, polyurethane, polyethylene, polypropylene, other porous polymers, hydrophobic foam, an open cell foam, wool, silk, linen, cotton (e.g., cotton gauze), felt, one or more nonwoven materials e.g, vertical nonwoven material, a carded web. airlaid nonwoven material, etc ), other fabrics, a coated porous material (e.g., a water repellent coated porous material), any other suitable porous materials, or combinations thereof. [0064] In an embodiment, not shown, the porous material 118 includes a first layer and a second layer. The first and second layers may be a woven material. The porous material 118 also includes a plurality of fibers forming a layer between the first layer and the second layer. Each of the first layer, the second layer, and the plurality⁷ of fibers define a plurality of pores, thereby allowing transport of the bodily fluids and air circulation through the porous material 118. The pores defined by the plurality of fibers may be at least one of larger or more numerous, thereby decreasing the likelihood that dried bodily fluids clog the porous material 118. The presence of the plurality⁷ of fibers also cause the porous material 118 feel soft against the penis and provides a cushioning effect to the penis. The plurality of fibers may also prevent the suction force from collapsing the porous material. The plurality of fibers may space the first layer and the second layer by a distance. The distance may be selected based on the number of fibers that form the plurality⁷ of fibers and the density⁷ at which the plurality⁷ of fibers are packed together. For example, the distance may be selected to be about 0.25 mm or more, about 0.5 mm or more, about 1 mm or more, about 2 mm or more, about 4 mm or more, about 6 mm or more, about 10 mm or more, about 15 mm or more, or in ranges of about 0.25 mm to about 1 mm, about 0.5 mm to about 2 mm, about 1 mm to about 4 mm, about 2 mm to about 6 mm, about 4 mm to about 10 mm, or about 6 mm to about 15 mm. The thickness of the distance may be selected to adjust the absorbency of the porous material 118. For example, increasing the thickness may increase the volume of the plurality of fibers and/or the porosity defined by the plurality⁷ of fibers which increases the volume of bodily fluids that may be received by and at least partially stored in the porous material 118. The first layer, the second layer, and the plurality of fibers may be formed from any suitable material, such as a hydrophobic material, a hydrophilic material, polyester, cotton, or any other porous material disclosed herein. In an embodiment, one or more of the first layer, the second layer, or the plurality of fibers are formed from a hydrophobic material that inhibits the porous material 118 from storing the bodily fluids therein which may facilitate removal of the bodily fluids from the chamber 112. In an embodiment, one or more of the first layer, and second layer, or the plurality of fibers are formed from a hydrophilic material which allows the porous material 118 to temporarily store the bodily fluids therein thereby limiting the quantity of bodily fluids that pool around the skin of the individual. In an embodiment, two or more of the first layer, the second layer, or the plurality of fibers are formed from different materials. In such an embodiment, the first layer may define the penis receiving area 130 or is otherwise closer to the penis receiving area 130 than the second layer. The first layer may be formed from a hydrophobic material while the plurality of fibers are formed from a hydrophilic material. Such a configuration may cause the bodily fluids to be pulled through the first layer and temporarily stored in the plurality⁷ of fibers. However, the first layer may remain substantially dry due to the hydrophobicity thereof which allows the porous material 118 to feel dry to the penis.

[0065] In an embodiment, not shown, the porous material 1 18 may be formed from two layers instead of the three layers discussed above. For example, the porous material 118 may be formed from a fluid permeable membrane defining a portion of the penis receiving area 130 and a fluid permeable support. The fluid permeable membrane may be composed and/or structured to wick bodily fluids away from the penis receiving area 130, thereby^ minimizing the quantity' of bodily fluids that are present in the penis receiving area 130 or otherwise present against the skin of the individual. It is also noted that the fluid permeable membrane may also be configured to adsorb or absorb the bodily fluids to minimize the quantity⁷ of bodily fluids that are present in the penis receiving area 130 or otherwise present against the skin of the individual. The fluid permeable membrane may be formed from any of the porous materials disclosed herein. For example, the fluid permeable membrane may be formed from fabric, such as a gauze (e.g., silk, linen, or cotton gauze), another soft fabric, or another smooth fabric. Forming the fluid permeable membrane from gauze, soft fabric, and/or smooth fabric (or any of the other porous materials disclosed herein that may contact the penis) may reduce chaffing caused by the fluid collection assembly 100.

[0066] The fluid permeable support is configured to support the fluid permeable membrane since the fluid permeable membrane may be formed from a relatively foldable, flimsy, or otherwise easily deformable material. For example, the fluid permeable support may be positioned such that the fluid permeable membrane is disposed between the fluid permeable support and the fluid impermeable barrier 106. As such, the fluid permeable support may support and maintain the position of the fluid permeable membrane. The fluid permeable support may include any of the fluid permeable membrane materials disclosed herein above. For example, the fluid permeable membrane material(s) may be utilized in a more dense or rigid form than in the fluid permeable membrane when used as the fluid permeable support. The fluid permeable support may be formed from any fluid permeable material that is less deformable than the fluid permeable membrane. For example, the fluid permeable support may include a porous polymer (e.g., nylon, polyester, polyurethane, polyethylene, polypropylene, etc.) structure or an open cell foam.

In some examples, the fluid permeable support may be formed from a natural material, such as cotton, wool, silk, or combinations thereof. In such examples, the material may have a coating to prevent or limit absorption of fluid into the material, such as a water repellent coating. In some examples, the fluid permeable support may be formed from fabric, felt, gauze, or combinations thereof.

[0067] In a particular example, the fluid permeable membrane may include first layer and a second layer. The first layer may be positioned to generally receive bodily fluid before the second layer. The first layer 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 may include bamboo. In such an example, the first layer and the second layer may have a synergistic effect that allows the first layer to quickly receive bodily fluids therein, move the bodily fluids from the first layer into the second layer, and maintain the first layer relatively dry. For instance, the hydrophilicity of the first layer allows the first layer 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 may exhibit a hydrophilicity that is greater than (i.e., exhibits a contact angle with water that is less than) the first layer. The greater hydrophilicity of the bamboo second layer pulls bodily fluids from the first layer and into the second layer, thereby facilitating quick transfer of bodily fluids from the first layer to the second layer. The greater hydrophilicity of the bamboo second layer also helps dry the first layer since the hydrophilic pull from the bamboo second layer removes most of the bodily fluids from the first layer. The dry first layer minimizes discomfort caused by using a fluid collection assembly including the porous material, minimizes skin degradation caused by the bodily fluids, and allows the fluid collection assembly including the porous material to be used for longer periods of time (e.g., greater than 24 hours). In this particular example, the first layer and the second layer may be positioned adjacent to a polyethylene terephthalate (‘ PET”) fluid permeable support since the bamboo second layer is able to transfer bodily fluids quickly and effectively into the PET fluid permeable support thereby preventing the first and second layers from becoming saturated with bodily fluids. Further, the PET fluid permeable support is able to quickly move substantially all of the bodily fluids towards a fluid outlet such that the PET fluid permeable support is substantially dry a short period of time after receiving the bodily fluids. The dry⁷ PET fluid permeable support facilitates drying of the particular first and second layers of this example. It is noted that the PET fluid permeable support may include a nonwoven material and, more particularly a vertical lapped nonwoven material, since such nonwoven materials facilitate drawing fluids into the PET fluid permeable support from the bamboo second layer and improve flow of the bodily fluids in the PET fluid permeable support towards the fluid outlet thereby facilitating drying of the porous material 118. That said, the first layer and/or the second layer may include porous materials other than hydrophilic polypropylene/poly ethylene and bamboo, respectively, as discussed in more detail herein. Further, the first layer and/or the second layer may be used with an inner fluid permeable support other than PET, as discussed in more detail herein. [0068] In an embodiment, the porous material 118 may include a single layer (e.g., one of the first layer, the second layer, the layer formed from the plurality of fibers, the fluid permeable membrane, the fluid permeable support, or another porous layer). In an embodiment, the porous material 118 may be formed from four or more layers.

[0069] In an embodiment, the porous material 118 may be a sheet (e.g., a multi-layer sheet). The porous material 118 is a sheet when the porous material 118 at least one of is generally planar when lying on a flat surface and is not tubular. The porous material 118 that is a sheet may prevent or at least inhibit pooling of the bodily fluids in the chamber 112. For example, the bottom panel 124 and, optionally, the portions of the top panel 122 that do not form a three-dimensional structure (e.g., the bulge 132) may be a sheet or exhibit a generally planar shape. In such an example, the porous material 118 that is a sheet may prevent or at least inhibit the formation of gaps between the porous material 118 and the bottom panel 124 and the optional generally planar portions of the top panel 122 in which bodily fluids may pool. It is noted that pooled bodily fluids may be difficult to remove from the chamber 112, may create undesirable odors, and may create unsanitary conditions in the chamber 112.

[0070] In an embodiment, the porous material 118 may define a passageway 134 extending therethrough. The passageway 134 may be located above the opening 114 and may exhibit a shape and size that generally corresponds to a shape and size of the opening 114. The passageway 134 allows a penis disposed in the chamber 112 to pass through the porous material 118 such that the penis may be positioned in the penis receiving area 130. In an example, the passageway 134 may be completely laterally surrounded by the porous material 118 (e.g, the porous material 118 does not define one or more slits extend from the passageway 134) thereby preventing the formation of gaps adjacent to the passageway 134 in which bodily fluids may pool or otherwise not be received by the porous material 1 18.

[0071] The porous material 118 may extend completely around the opening 114. The porous material 118 extending completely around the opening 114 causes substantially all of the bodily fluids in the chamber 112 to be received into the porous material 118 without pooling. The porous material 118 extends completely around the opening 114 when no slits are formed in the portions of the porous material 118 that extend around the opening 114 since such slits may open (e.g., due to erroneous attachment of the fluid collection assembly 100 to the individual or due to stresses and strains applied to the porous material 118) and form gaps in which bodily fluids pool and/or leak from the chamber 112.

[0072] The porous material 118 may be secured in the chamber using any suitable technique. In an embodiment, during the manufacturing of the fluid collection assembly 100, the top panel 122. the bottom panel 124, and the porous material 118 may be stacked and then attached to each other in the same manufacturing step. For instance, the porous material 118 may exhibit a shape that is the same size or slightly smaller than the size of the top panel 122 and the second panel 124. As such, attaching the top panel 122 and the bottom panel 124 together along the outer edges 126, 128 thereof may also attach the porous material 118 to the top panel 122 and the bottom panel 124. The porous material 1 18 may be slightly smaller than the top panel 122 and the bottom panel 124 such that the top panel 122 and the bottom panel 124 extend around the porous material 118 such that the porous material 118 does not form a passageway through the fluid impermeable barrier 106 through which the bodily fluids may leak. Also, attaching the porous material 1 18 to the top panel 122 and the bottom panel 124 may prevent the porous material 118 from significantly moving in the chamber 112, such as preventing the porous material 118 from bunching together near the outlet. In an example, the porous material 118 may define one or more holes extending therethrough and the portions of the top and bottom panels 122, 124 adjacent to the holes may be attached together (e.g, via US or RF welding) thereby securing the porous material 118 in the chamber 112. In an example, the porous material 118 may be attached to the top panel 122 and/or the bottom panel 124 (e.g.. via an adhesive) before or after attaching the top panel 122 and the bottom panel 124 together. In an example, the porous material 118 may merely be disposed in the chamber 112 without attaching the porous material 118 to at least one of the top panel 122 and/or the bottom panel 124.

[0073] Further examples of porous materials that may be included in the fluid collection assembly are disclosed in U.S. Patent Application No. 18/003,029 filed on June 30, 2021, PCT International Application No. PCT/US2022/011281 filed on January 5, 2022, PCT International Application No. PCT/US2022/042719 filed on September 7, 2022. PCT International Application No. PCT/US2022/042725 filed on September 7,

2022, U.S. Provisional Patent Application No. 63/241,564 filed on September 8, 2021, PCT International Application No. PCT/US 2022/015418 filed on February 7, 2022, and PCT International Application No. PCT/US2022/015420 filed on February' 7, 2022, the disclosure of each of which is incorporated herein, in its entirety, by this reference. [0074] As previously discussed, the fluid collection assembly 100 includes a base 104 that is configured to be permanently attached to the sheath 102. The base 104 is configured to be permanently attached to the sheath 102 when, for example, the fluid collection assembly 100 is provided with the base 104 permanently attached to the sheath 102 or the base 104 is provided without being permanently attached to the sheath 102 but is configured to be permanently attached to the sheath 102 at some point in the future.

The base 104 may' be permanently⁷ attached to the sheath 102 using any⁷ suitable technique. For example, the base 104 may be permanently attached to the sheath 102 using an adhesive, sewing, heat sealing, RF welding, or US welding.

[0075] As previously discussed, the base 104 is sized, shaped, and made of a material to be coupled to the skin that surrounds the penis (e.g., mons pubis, thighs, testicles, and/or perineum) and have the penis disposed therethrough. For example, the base 104 may define an aperture 120 configured to have the penis positioned therethrough. The aperture 120 may be positioned adjacent to the opening 114 and may exhibit a size and shape that generally corresponds to the size and shape of the opening 1 14. In an example, the base 104 may exhibit the general shape or contours of the skin surface that the base 104 is configured to be coupled with. The base 104 may be flexible, thereby allowing the base 104 to conform to any shape of the skin surface and mitigate the base 104 pulling the on-skin surface. The base 104 may extend laterally past the sheath 102 thereby increasing the surface area of the skin of the individual to which the fluid collection assembly 100 may be attached compared to a substantially similar fluid collection assembly 100 that did not include a base.

[0076] The base 104 may be configured to be adhesively attached to the individual using an adhesive. For example, the base 104 may also include an adhesive layer disposed on at least a portion of a surface thereof that is configured to abut the skin of the individual. The adhesive layer may be configured to attach the base 104 to the skin around the penis. The adhesive layer may be formed from any adhesive that may safely attach the base 102 to the skin surrounding the penis. In an example, the adhesive layer may be formed from a silicone -based adhesive, such as a silicone-gel adhesive. Silicone- based adhesives, such as Silicone Medical Silicone Tape 2475P available from 3M, has been found to secure the fluid collection assembly 100 to the skin surrounding the penis for at least 24 hours, even immediately after cleaning the skin surface with a wipe. In an example, the adhesive layer may be formed from an acrylic gel adhesive or a hydrogel. The base 104 may also include a release liner is configured to be easily removed from the adhesive layer and is configured to prevent the adhesive layer inadvertently becoming attached to an object. The base 104 may be configured to be attached to the individual using other technique other than or instead of adhesives, such as using Gecko tape.

[0077] In an embodiment, the base 104 is at least partially transparent. In such an embodiment, a person (e.g., medical practitioner) may be able to examiner the skin surrounding the penis, such as to determine the health of the skin. Further, the person may be able to detect any gaps between the base 104 and the skin of the individual through which bodily fluids may leak. A person may be able to eliminate the gaps or replace the fluid collection assembly 100 after detecting the gaps to prevent leaks and prevent degradation of the skin caused by the skin being in contact with the bodily fluids. [0078] The base 104 may exhibit a generally partially triangular shape or any other suitable shape. In a particular example, the base 104 may exhibit one or more apexes. The apexes may be rounded to prevent the base 104 from digging into and hurting the individual. The aperture 120 may be located off-center and closer to one of the apexes than the other apexes to maximize the surface area of the base that is attached to the relatively less sensitive skin and minimize the surface area of the base 104 that is attached to the relatively sensitive skin. For example, the apex closest the aperture 120 may be configured to be attached to the skin between the penis and the testicles and/or the testicles which has limited surface area to be attached to the base 104 and/or may be sensitive. Meanwhile, the portion of the base 104 opposite the apex that is closest to the aperture 120 is configured to be attached to the mons pubis which has a large surface area and is less sensitive. Other examples of shapes that the base 104 may form are disclosed in PCT Application No. PCT/US2021/015787 filed on January 29, 2021, the disclosure of which is incorporated herein, in its entirety, by this reference. [0079] At least some conventional male fluid collection assemblies exhibit a maximum length and a maximum width (excluding any conduits attached thereto and any release liners included therein) that are 26 cm or greater and 14 cm or greater, respectively. It is currently believed that such maximum lengths and widths of the conventional male fluid collection assemblies cause such conventional fluid collection assemblies unwieldy and non-ergonomic. However, it is currently believed that decreasing the maximum length and maximum width of fluid collection assembly 100 compared to such conventional male fluid collection assemblies, even by one or two centimeters, may have a significant beneficial effect on the handability of the fluid collection assembly 100. As such, the fluid collection assembly 100 (e.g., the sheath 102 and the base 104 excluding the conduit 142 and any release liner) may exhibit a maximum length L that is 25 cm or less (e.g., 24.75 cm or less, 24.5 cm or less, 24 cm or less, 23 cm or less, 22 cm or less, or 20 cm or less) and a maximum width W of 13 cm or less (e.g., 12.5 cm or less, 12 cm or less. 11.5 cm or less, 11 cm or less, or about 10 cm or less). [0080] The fluid collection assemblies disclosed herein may exhibit shapes and configurations other than the shape and configuration illustrated in FIGS. 1A-1D. For example, FIG. 2 is an isometric view of a fluid collection assembly 200, according to an embodiment. Except as otherwise disclosed herein, the fluid collection assembly 200 is the same as or substantially similar to any of the fluid collection assemblies disclosed herein. For example, the fluid collection assembly 200 includes a sheath 202 and a base. The sheath 202 includes a fluid impermeable barrier 206 and at least one porous material disposed in a chamber defined by the fluid impermeable barrier 206.

[0081] The fluid impermeable barrier 206 includes a bulge 232. The bulge 232 may include one or more substantially planar surfaces. For example, the bulge 232 may include a substantially planar and angled top surface 250. The top surface 250 may extend from or near an apex of the bulge 232 towards the fluid outlet (not shown, obscured by the drainage port assembly 244). The substantially planar top surface 250 may slightly decrease the volume in the penis receiving area compared to the bulge 132 shown in FIGS. 1A and IB. However, the substantially planar top surface 250 may allow the fluid collection assembly 200 to be used more discretely under clothing, blanket, or other covering.

[0082] The fluid collection assembly 200 includes one or more reinforcement structures 236. Unlike the reinforcement structures 136 illustrated in FIGS. 1A and IB, the reinforcement structures 236 are ridges that are predominately formed on the bulge 232 and do not extend a significant distance from the bulge 232 into the adjacent portions of the fluid impermeable barrier 206. In an embodiment, at least one of the ridges extend around a complete periphery of the bulge 232, wherein the periphery of the bulge 232 extends in a plane that is not parallel to (e.g, perpendicular to) a longitudinal axis of the sheath 202. The ridges extending around a completely periphery of the bulge 232 strengthens all of the bulge 232 rather than merely the lateral sides of the bulge 232. For example, the ridges that extend around a periphery of the bulge 232 may extend across the top surface 250. The ridges that extend across the top surface 250 may prevent the collapse of the top surface 250 since the planar shape of the top surface 250 makes the top surface 250 more susceptible to collapse than the curved bulge 132. In an embodiment, at least one of the ridges extends only along the lateral surface of the bulge 232.

[0083] FIG. 3 is an isometric view of a fluid collection assembly 300, according to an embodiment. Except as otherwise disclosed herein, the fluid collection assembly 300 is the same as or substantially similar to any of the fluid collection assemblies disclosed herein. For example, the fluid collection assembly 300 includes a sheath 302 and a base.

The sheath 302 includes a fluid impermeable barrier 306 and at least one porous material disposed in a chamber defined by the fluid impermeable barrier 306. The fluid impermeable barrier 306 may include one or more three-dimensional structures, such as a bulge 332 (e.g., a bulge 332 including a planar top surface 350), a recess 335. and/or one or more reinforcement structures 336.

[0084] The drainage port assembly 344 includes a barrier attachment portion 346 and a conduit attachment portion 348. The barrier attachment portion 346 is configured to be attached to the fluid impermeable barrier 306 and, optionally, to be at least partially disposed in the chamber. The conduit attachment portion 348 is configured to attach to a conduit (e.g., conduit 142 of FIG. 1A). The barrier attachment portion 346 defines an inlet and the conduit attachment portion 348 defines an outlet 352 of the drainage port assembly 344 that is downstream from the inlet. The drainage port assembly 344 also defines a channel (not shown) extending from the inlet to the outlet 352. It is noted that the inlet refers to the inlet of the channel and not necessarily the inlet of the drainage port assembly 344. In an example, the inlet may be the inlet of both the drainage port assembly 344 and the channel when the drainage port assembly 344 does not include a sink. In an example the inlet may not be the inlet of the drainage port assembly 344 when the drainage port assembly 344 includes sink (not shown, obscured) since the sink forms the inlet of the drainage port assembly 344.

[0085] The barrier attachment portion 346 of the drainage port assembly 344 may be attached to the fluid impermeable barrier 306 using any suitable technique. In an embodiment, the barrier attachment portion 346 is disposed betw een the top panel 322 and the bottom panel (not shown, obscured) before attaching the barrier attachment portion 346 to the fluid impermeable barrier 306. In such an embodiment, the barrier attachment portion 346 abuts and is attached to the inner surface of the fluid impermeable barrier 306. In an embodiment, the barrier attachment portion 346 is attached to the fluid impermeable barrier 306 using at least one of an adhesive, impulse heating, direct heating, US welding, RF welding, any other attachment technique disclosed herein, or another other suitable attachment technique.

[0086] At least the conduit attachment portion 348 exhibits a rigidity that is greater than the fluid impermeable barrier 306. The conduit attachment portion 348 may exhibit a rigidity that is greater than the fluid impermeable barrier 306 because at least one of conduit attachment portion 348 exhibits a thickness that is greater than the fluid impermeable barrier 306 or at least a portion of the conduit attachment portion 348 is formed from a material exhibiting a Young’s modulus (i.e., modulus of elasticity) that is greater than a Young’s modulus of a material forming at least a portion of the fluid impermeable barrier 306. The increased rigidity of the conduit attachment portion 348 relative to the fluid impermeable barrier 306 allows the conduit attachment portion 348 to be attached to the conduit using techniques that may be difficult or impossible to do when the conduit is directly attached to the fluid impermeable barrier 306. In an example, the conduit may be attached to the conduit attachment portion 348 using an interference fit which may be difficult or impossible to do when the conduit is directly attached to the fluid impermeable barrier 306. In such an example, a surface of the conduit attachment portion 348 that is configured to abut the conduit is tapered. The tapered surface of the conduit attachment portion 348 may make inserting the conduit attachment portion 348 into the conduit easier when the conduit attachment portion 348 forms a male connector and may make receiving the conduit into the conduit attachment portion 348 easier when the conduit attachment portion 348 forms a female connector. The tapered surface of the conduit attachment portion 348 also allows the strength of the interference fit between the conduit attachment portion 348 and the conduit to be controlled by controlling how much the conduit attachment portion 348 is inserted into the conduit or how much the conduit is inserted into the conduit attachment portion 348. In an example, not shown, a surface of the conduit attachment portion 348 is configured to be threadedly attached to the conduit which may be difficult or impossible to do when the conduit is directly attached to the fluid impermeable barrier 306. In such an example, the conduit attachment portion 348 may include one or more helically extending ridges extending from a surface of the conduit attachment portion 348 that contacts or is closest to the conduit. It is noted that the surface of the conduit attachment portion 348 that includes the threads and/or the threads may be tapered. In an example, not shown, a surface of the conduit attachment portion 348 that contacts or is closest to the conduit may include circumferentially extending ridges. It is noted that the surface of the conduit attachment portion 348 that includes the ridges and/or the ridges may be tapered.

[0087] In an embodiment, at least the conduit attachment portion 348 exhibits a rigidity that is greater than the conduit. The conduit attachment portion 348 may exhibit a rigidity that is greater than the conduit because at least one of the conduit attachment portion 348 exhibits a thickness that is greater than the conduit or at least a portion of the conduit attachment portion 348 is formed from a material exhibiting a Young’s modulus that is greater than a Young’s modulus of a material forming at least a portion of the conduit. The increased rigidity⁷ of the conduit attachment portion 348 prevents collapse of the channel. For example, it has been found that, in certain circumstances, directly attaching the conduit to the fluid impermeable barrier 306 may cause the drainage port assembly 344 of the conduit attached to the fluid impermeable barrier 306 to at least partially collapse when a strong vacuum is applied to the chamber. However, the increased rigidity of the drainage port assembly 344 prevents such collapse.

[0088] In an embodiment, the barrier attachment portion 346 exhibits a rigidity⁷ that is greater than the fluid impermeable barrier 306 and/or the conduit. For example, the barrier attachment portion 346 may exhibit a rigi di ty that is comparable to the conduit attachment portion 348. The increased rigidity of the barrier attachment portion 346 prevents collapse of the inlet, any drainage port assembly 344 of the channel defined thereby, and the sink. The increased rigidity of the barrier attachment portion 346 may also make attaching the drainage port assembly 344 to the barrier attachment portion 346 easier since pressure may be applied to the barrier attachment portion 346 during the attachment process substantially without deforming the barrier attachment portion 346.

[0089] The barrier attachment portion 346 may exhibit a shape that is different than the conduit attachment portion 348. For example, the barrier attachment portion 346 may exhibit a first elongated shape that extend in a direction that is generally perpendicular to the longitudinal axis and the conduit attachment portion 348 may exhibit a second elongated shape (e.g., generally cylindrical shape) that extends generally parallel to the longitudinal axis . The first elongated shape of the barrier attachment portion 346 may strengthen the attachment between the barrier attachment portion 346 and the fluid impermeable barrier 306 by increasing the surface area of the barrier attachment portion 346 that is attached to the fluid impermeable barrier 306. The first elongated shape of the barrier attachment portion 346 also prevents or at least inhibits twisting of the sheath 302. Examples of the first elongated shape include a generally rectangular cross-sectional shape, a generally oval cross-sectional shape, a generally elliptical cross- sectional shape, or a generally diamond cross-sectional shape. In a particular example, the first elongated shape is a generally diamond cross-sectional shape since the relatively sharp comers of the generally diamond cross-sectional shape that are furthest spaced from the conduit attachment portion 348 facilitate attaching the fluid impermeable barrier 306 to the barrier attachment portion 346 without forming a gap between the barrier attachment portion 346, the top panel 322, and the bottom panel (not shown) compared to a more rounded comer. In a particular example, the first elongated shape included rounded comers since the rounded comers are less likely to uncomfortably press into the individual than sharp comers. The second elongated shape of the conduit attachment portion 348 that extends parallel to the longitudinal axis may facilitate attachment to the conduit.

[0090] The drainage port assembly 344 may be located at or near the distal most portion of the distal end region 310 of the sheath 302 which is expected to be the gravimetrically low point of the chamber when worn by a user. Locating the fluid outlet and the drainage port assembly 344 at or near the distal most portion of the distal end region 310 of the sheath 302 enables the conduit to receive more of the bodily fluids than if the fluid outlet and the drainage port assembly 344 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 may exhibit a preference to flow in the direction of gravity, especially when at least a portion of the porous material 122 is saturated with the bodily fluids. Accordingly, the fluid outlet and the drainage port assembly 344 may be located in the fluid collection assembly 300 in a position expected to most likely be the gravimetrically low point in the fluid collection assembly 300 when worn by a user, namely the distal most portion of the distal end region 310. [0091] It is noted that the drainage port assembly 344 may be used in any of the fluid collection assemblies disclosed herein. Further examples of drainage port assemblies that may be used in any of the fluid collection assemblies disclosed herein are disclosed in U.S. Patent Application No. 18/164,800 filed on February 6, 2023 and U.S. Provisional Patent Application No. 63/561,893 filed on December 11, 2023, the disclosure of each of which is incorporated herein, in its entirety, by this reference.

[0092] The fluid collection assemblies disclosed herein may include three- dimensional structures other than the bulges and other three-dimensional structures disclosed above. For example, FIG. 4 is an isometric view of a fluid collection assembly 400, according to an embodiment. Except as otherwise disclosed herein, the fluid collection assembly 400 may be the same as or substantially similar to any of the fluid collection assemblies disclosed herein. For example, the fluid collection assembly 400 may include a sheath 402 and a base. The sheath 402 may include a fluid impermeable barrier 406 and at least one porous material disposed in a chamber defined by the fluid impermeable barrier 406. [0093] The top panel 422 includes at least one three-dimensional structure formed thereon, for example, using a thermosetting process. The three-dimensional structure may include one or more fold lines 454. The fold lines 454 may include upper apexes, lower apexes that are positioned between adjacent ones of the upper apexes and are positioned closer to the bottom surface than the upper apexes, and angles surfaces extending betw een adjacent ones of the upper and lower apexes. In other words, the fold lines 454 may cause at least a portion of the top panel 422 to exhibit a corrugated structure. The fold lines 454 may extend generally parallel to a longitudinal axis of the sheath 402 when the sheath 402 exhibits a maximum length. The fold lines 454 formed in the top panel 422 resist bending (e.g., resists bending along the longitudinal axis) and, thus, increase the bending strength of the top panel 422 and the fluid impermeable barrier 406 overall. It is noted that the bottom panel may include or may not include fold lines.

[0094] The fluid impermeable barrier 406 supports the rest of the sheath 402 and, thus, the increased bending strength of the fluid impermeable barrier 406 prevents or inhibits bending of the sheath 402. It has also been found that the fold lines 454 resist twisting of the fluid impermeable barrier 406 which causes the fluid impermeable barrier 406 to inhibit twisting of the sheath 402. As previously discussed, bending and twisting of the sheaths disclosed herein may form gravimetric low spots that are spaced from the fluid outlet (not shown, obscured by the drainage port assembly 444) or the inlet of the conduit (e.g., an inlet of a conduit disposed in the chamber). Bodily fluids received into a bent or twisted sheath of may pool in such gravimetric low spots and be difficult to remove using the fluid outlet and the conduit. The pooling of the bodily fluids in the gravimetric low spots may have a compounding effect since the weight of the pooling bodily fluids may cause additional bending and/or twisting of a sheath thereby allowing additional bodily fluids to pool in the gravimetric low spots. The pooling of the bodily fluids may cause several issues, including leaking of the bodily fluids from a sheath, cause moisture to remain in contact with the penis which may cause discomfort and skin degradation, make using a fluid collection assembly unsanitary , and cause undesirable odors to originate from a sheath. However, the fold lines 454 formed in the top panel 422 prevent or at least inhibit bending and twisting of the sheath 402 thereby alleviating at least some of these issues.

[0095] In an embodiment, the fluid collection assemblies disclosed herein may be configured to be detached from a vacuum source (e.g., the fluid collection assemblies are detached from a conduit that is in fluid communication with the vacuum source, such as the conduit 142). For example, the fluid collection assemblies may be detached from the vacuum source when moving the individual (e.g., moving the individual from one room to another room). However, the fluid collection assemblies may leak if the individual urinates while the fluid collection assemblies are detached from the vacuum source. Since the fluid outlets and the optional drainage port assemblies are located in the distal end regions (e.g., the expected gravimetric low point of the chamber), any' urine received into the chamber are likely to leak from the chamber via the fluid outlet and/or the drainage port assembly when the fluid collection assemblies are detached from vacuum source. As such, the fluid collection assemblies disclosed herein may include a device that is configured to close the fluid outlet and/or drainage port assembly while the fluid collection assemblies are detached from the vacuum source. FIGS. 5A-8 illustrated devices that are configured to close the fluid outlet and/or drainage port assembly while the fluid collection assemblies are detached from the vacuum source.

[0096] FIGS. 5A-5C illustrate a cap 556 attached to a drainage port assembly 544 exhibiting different states, according to an embodiment. The cap 556 includes a connector 558, a lid 560, and at least one tether 562 extending between and connecting together the connector 558 and the lid 560. The cap 556 may exhibit a first, close state, as shown in FIG. 5A. When the cap 556 is in the first, closed state, the lid 560 interfaces with the fluid outlet or a drainage port assembly 544 to prevent or at least inhibit bodily fluids flowing out of the fluid collection assembly via the fluid outlet or the drainage port assembly 544. The cap 556 may be in the first, closed state when the fluid collection assembly is detached from the vacuum source. The cap 556 may also exhibit a second, open state, as shown in FIG. 5B. When the cap 556 is in the second, open state, the lid 560 does not interface with the fluid outlet or the drainage port assembly 544 thereby allowing bodily fluids to flow out of the fluid collection assembly via the fluid outlet or the drainage port assembly 544. The cap 556 may also allow a conduit (e.g., conduit 142) to be attached to the fluid outlet when the cap 556 exhibits the second, open state.

[0097] The connector 558 is configured to secure the cap 556 to a fluid collection assembly (only the drainage port assembly 544 of the fluid collection assembly is illustrated). In an example, the connector 558 is attached to or configured to be attached to the drainage port assembly 544. In such an example, the connector 558 may be attached or configured to be attached to the drainage port assembly 544 using any suitable technique. For instance, the connector 558 may define a hollowed portion configured to receive at least a portion of the drainage port assembly 544 (e.g., the conduit attachment portion 548 and, optionally, the barrier attachment portion 546). Receiving the drainage port assembly 544 into the hollowed portion may attach the connector 558 to the drainage port assembly 544 using an interference fit, an adhesive, etc. In another instance, the connector 558 does not include a hollowed portion and, instead, is configured to be adhesively or otherwise attached to the drainage port assembly 544. In an example, the connector 558 is attached or configured to be attached to a fluid impermeable barrier of the fluid collection assembly, for instance, using an adhesive, US welding, RF welding, stitching, or any other suitable technique.

[0098] The lid 560 is configured to interact with the fluid outlet or the drainage port assembly 544 to obstruct a fluid flow passageway extending therethrough (e.g, obstruct an outlet 552 of the fluid flow passageway). In an example, the lid 560 may form a female attachment that is configured to be disposed in the fluid flow passageway (as shown) or a male attachment that is configured to receive a portion of the fluid outlet or the conduit attachment portion 548. The lid 560 may be configured to remain attached to the fluid outlet or the drainage port assembly 544 using any suitable technique, such as an interference fit, a threaded attachment, etc.

[0099] In an embodiment, as shown in FIG. 5B, the lid 560 may be free to move when in the second, open state. The lid 560 that is free to move may become entangled or otherwise attached to an object (e.g., clothing, blankets, etc.) such that moving the object pulls on the lid 560 and, by extension, the rest of the cap 556 and the fluid collection assembly. To minimize the likelihood that the lid 560 becomes entangled or attached to an object, the cap 556 may exhibit a third state in which movement of the lid 560 is restricted. For example, the cap 556 may include a receiving structure 564 configured to receive and retain the lid 560. The receiving structure 564 be formed on the connector 558 and may, for instance, include one or more side walls defining an interior region exhibiting a size and shape that corresponds to the size and shape of the lid 560. The cap 556 may be in the third state when the lid 560 is received by and temporarily attached to the receiving structure 564.

[00100] The cap 556 includes a single tether 562 extending from the connector 558 to the lid 560. However, the caps disclosed herein may include two or more tethers since it has been found that increasing the number of tethers decreases movement of the lid when the cap is in the second, open state. For example, FIG. 6 is a top view of a cap 656 attached to a drainage port assembly 644, according to an embodiment. Except as otherwise disclosed herein, the cap 656 is the same as or substantially similar to any of the caps disclosed herein. For example, the cap 656 include a connector 658 and a lid

660. The connector 658 and the lid 660 are attached together using two tethers 662. The two tethers 662 better restrict the movement of the lid 660 while the cap 656 is in the second, open state (e.g., by maintain the lid 660 against the conduit attachment portion 648) than the single tether 562 of FIGS. 5A-5C. [00101] The fluid collection assemblies disclosed herein may include a check valve instead of or in addition to a cap to close the fluid outlet and/or drainage port assembly while the fluid collection assemblies are detached from the vacuum source. For example, FIG. 7 is a cross-sectional view of a drainage port assembly 744 including a check valve 766, according to an embodiment. Except as otherwise disclosed herein, the drainage port assembly 744 may be the same as or substantially similar to any of the drainage port assemblies disclosed herein. Further, the drainage port assembly 744 may be used with any of the fluid collection assemblies disclosed herein.

[00102] The drainage port assembly 744 includes a barrier attachment portion 746 and a conduit attachment portion 748. The drainage port assembly 744 also defines a fluid passageway 768 extending through the barrier attachment portion 746 and the conduit attachment portion 748 (e.g, from an inlet 751 of the drainage port assembly 744 to an outlet 752 of the drainage port assembly 744) thereby allowing bodily fluids to flow through the drainage port assembly 744. The drainage port assembly 744 includes a check valve 766 disposed in the fluid passageway 768. The check valve 766 may include any suitable check valve, such as an umbrella valve or a duck bill valve. The check valve 766 is configured to control flow of the bodily fluids through fluid passageway 768. For example, the check valve 766 may switch between an open state that allows bodily fluids to flow through the fluid passageway 768 and a closed state that prevents or otherwise inhibits flow of the bodily fluids through the fluid passageway 768. The check valve 766 may be in the open state when a vacuum is applied to the drainage port assembly 744 and may automatically switch to the closed state when the vacuum is no longer applied to the drainage port assembly 744.

[00103] In a particular embodiment, the fluid passageway 768 includes a wider portion 770, a narrower portion 772 upstream from the wider portion 770 (relative to the flow of bodily fluids in the fluid passageway 768 when a vacuum is applied to the drainage port assembly 744), and a step forming the narrower portion 772. The check valve 766 may be at least partially positioned in the wider portion 770 and biased to press against the step 774. Pressing the check valve 766 against the step 774 causes the check valve 766 to close the fluid passageway 768. The check valve 766 may be configured to move away from the step 774 when a vacuum is applied to the drainage port assembly 744 thereby opening the fluid passageway 768 and allowing bodily fluids to flow through the fluid passageway 768.

[00104] FIGS. 5A-7 illustrate the caps and check valves being used with a drainage port assembly that is the same as or substantially similar to the drainage port assembly 344 of FIG. 3. It is noted that the caps and check valves disclosed herein may be used with any suitable drainage port assembly. For example, FIG. 8 is an isometric view of a cap 856 attached to a drainage port assembly 844 that is substantially similar to the drainage port assembly 144 of FIGS. 1A-1D, according to an embodiment. Except as otherwise disclosed herein, the cap 856 and the drainage port assembly 844 may be the same as or substantially similar to any of the caps or drainage port assemblies disclosed herein, respectively, and may be used with any of the fluid collection assemblies disclosed herein. The cap 856 may be attached to the drainage port assembly 844. For example, the drainage port assembly 844 may define a recess (e.g., at the base of the conduit attachment portion 848) configured to receive and maintain the connector 858 attached thereto.

[00105] It is noted that the caps and check valves disclosed herein may be used with fluid collection assemblies other than the fluid collection assemblies illustrated in FIGS. 1A-4. Examples of fluid collection assemblies that may include the caps and check valves disclosed herein are disclosed in U.S. Patent No. 10.973,678 filed on June 2, 2017, U.S. Patent No. 10,390,989 filed on September 8, 2016, U.S. Patent No. 10,226,376 filed on June 3, 2017, PCT Patent Application No. PCT/US2021/039866 filed on June 30, 2021, U.S. Patent Application No. 16/433,773 filed on June 6, 2019, PCT International Application No. PCT/US2022/011281 filed on January 5, 2022, PCT International Application No. PCT/US2022/042719 filed on September 7, 2022, PCT International Application No. PCT/US2022/042725 filed on September 7, 2022, U.S. Provisional Patent Application No. 63/241,564 filed on September 8, 2021, PCT International Application No. PCT/US2022/015418 filed on February 7, 2022, PCT International Application No. PCT/US2022/015420 filed on February 7, 2022. and PCT Patent Application No. PCT/US2020/042262 filed on July 16, 2020, the disclosure of each of which is incorporated herein, in its entirety, by this reference.

[00106] During use. the conduits attached to the fluid collection assemblies disclosed herein may move, for example, due to the individual moving. In an embodiment, the conduit attachment portion of the drainage port assemblies disclosed herein are non- moveably attached to the barrier attachment portion. In such an embodiment, movement of the conduit may cause pulling on the drainage port assembly which, in turn, may cause the fluid collection assembly to uncomfortably pull on the individual and the sheath to bend or twist. In an embodiment, the conduit attachment portion of the drainage port assemblies disclosed herein are moveably attached to the barrier attachment portion. In such an embodiment, the conduit attachment portion can move to accommodate at least a portion of the movement of the conduit thereby preventing or at least inhibiting the movement of the conduit from pulling on the fluid collection assembly. FIGS. 9 and 10 illustrate conduit attachment portions that are configured to move relative to the barrier atachment portion. It is noted that the drainage port assemblies illustrated in FIGS. 9 and 10 may be used with any of the fluid collection assemblies disclosed herein.

[00107] FIG. 9 is a top view of a drainage port assembly 944, according to an embodiment. Except as otherwise disclosed herein, the drainage port assembly 944 is the same as or substantially similar to any of the drainage port assemblies disclosed herein.

For example, the drainage port assembly 944 includes a barrier atachment portion 946 and a conduit atachment portion 948. The conduit atachment portion 948 is configured to rotate in a direction R. The direction R may extend substantially perpendicular to a longitudinal axis of the fluid impermeable barrier 906 of the fluid collection assembly 900. Allowing the conduit attachment portion 948 to rotate in the R direction may allow the conduit atachment portion 948 to accommodate side-to-side movement of the conduit.

[00108] FIG. 10 is an exploded isometric view of a drainage port assembly 1044, according to an embodiment. Except as otherwise disclosed herein, the drainage port assembly 1044 is the same as or substantially similar to any of the drainage port assemblies disclosed herein. For example, the drainage port assembly 1044 includes a barrier atachment portion 1046 and a conduit atachment portion 1048. The conduit atachment portion 1048 include a ball-shaped structure 1076 at a proximal end thereof opposite the outlet 1052. The conduit attachment portion 1048 defines a fluid passageway extending therethrough to the outlet 1052 (e.g, the fluid passageway extends through the ball-shaped structure 1076). The barrier atachment portion 1046 defines a socket 1078 configured to receive the ball-shaped structure 1076. The socket 1078 is configured to allow the ball-shaped structure 1076 to rotate therein. Allowing the ballshaped structure 1076 to rotate in the socket 1078 allows the conduit atachment portion 1048 to move to accommodate side-to-side and up-and-down movement of the conduit.

[00109] As previously discussed, the fluid collection assemblies disclosed herein may include a rim at least partially surrounding the vacuum relief opening defined by the fluid impermeable barrier. FIGS. 1A, IB, and ID-3 illustrate rims that may be used in any of the fluid collection assemblies disclosed herein or in any conventional fluid collection assembly that includes a vacuum relief opening. It is noted that the fluid collection assemblies disclosed herein or any conventional fluid collection assembly may include rims other than the rims illustrated in FIGS. 1A, IB, and ID-3. FIGS. 11A-13C illustrate different rims that may be included in any of the fluid collection assemblies disclosed herein or in any conventional fluid collection assembly that includes vacuum relief openings.

[00110] FIG. 11A is an isometric view of a rim 1140, according to an embodiment. Except as otherwise disclosed herein, the rim 1140 is the same as or substantially similar to any of the rims disclosed herein. For example, the rim 1140 may define a passageway 1145. The rim 1140 may also define one or more cutouts 1141 at least partially defined thereby, such as cutouts 1141 that are valleys positioned between peaks 1143. It is further noted that, except as otherwise disclosed herein, any of the rims disclosed herein may include the features of the rim 1140. [00111] As previously discussed, the rim 1140 defines a passageway 1145. Generally, the passageway 1145 may exhibit a shape that generally corresponds to the shape of the vacuum relief opening defined by the fluid impermeable barrier. For example, the passageway 1145 may exhibit a generally elongated shape when the vacuum relief opening exhibits a generally elongated shape. The passageway 1145 may also exhibit a size that generally corresponds to or is larger than the vacuum relief opening to prevent or at least inhibit the rim 1140 from covering the vacuum relief opening and limiting the air flow through the vacuum relief opening.

[00112] The rim 1140 includes a proximal side 1147 and a distal side 1149 opposite the proximal side 1147. Generally , when positioned on the fluid impermeable barrier, the proximal side 1147 of the rim 1140 is the side of the rim 1140 that is furthest from the distal end region while the distal side 1 150 is the side of the rim 1 140 that is closest to the distal end region. As such, the proximal side 1147 is the side of the rim 1140 most likely to be covered by the anatomy of the individual. Generally, the proximal and distal sides 1147. 1149 are separated from each other by the passageway 1145. [00113] The walls of the rim 1140 may exhibit a width, wherein the width of the walls is measured perpendicular to a height of the rim 1140 (the distance the rim 1140 extends above the fluid impermeable barrier). In an embodiment, as shown in FIGS. 1A, IB, and ID-3, the width of the walls of the rim 1140 forming the proximal and distal sides 1147, 1149 may be substantially equal. In an embodiment, as shown in FIG. 11A. the width of the walls of the rim 1140 forming the proximal side 1147 are different than the width of the walls of the rim 1140 forming the distal side 1149. In a particular example, as show n, the walls of the rim 1140 forming the proximal side 1147 are greater than the width of the walls of the rim 1140 forming the distal side 1149. The greater width of the proximal side 1147 decreases the likelihood that the anatomy of the individual covers any of the passageway 1145 by moving the initial portions of the rim 1140 that the anatomy must extend over further from the passageway 1145 and increasing the area of the rim 1140 that the anatomy must cover before reaching the passageway 1145. The greater width of the proximal side 1147 may increase the surface area of the anatomy that contacts the rim 1140 thereby decreasing the likelihood that the contact between the anatomy and the rim

1140 causes pressure sores. The smaller width of the distal side 1149 minimizes the likelihood that the distal side 1148 interferes with the formation of a bulge in the fluid impermeable barrier.

[00114] In an embodiment, the proximal side 1147 may include more cutouts 1141 than the distal side 1149. For example, as previously discussed, the proximal side 1147 is more likely to be covered by the anatomy of the individual than the distal side 1149. The greater number of cutouts 1141 on the proximal side 1147 increases the volume of air that can flow through the proximal side 1147 even when the proximal side 1147 is at least partially covered by the anatomy of the individual. In an embodiment, the rim 1140 may include one or two lateral sides 1150 extending between the proximal and distal sides 1147, 1149. The lateral sides 1150 may define one or more cutouts.

[00115] In an embodiment, the rim 1140 may include a lip 1151. The lip 1151 may include walls extending laterally inwardly from the portions of the rim 1140 that define the passageway 1145. The lip 1151 forms a location on which the air permeable, fluid impermeable membrane may be attached to the rim 1140. The air permeable, fluid impermeable membrane may be attached to a top side of the lip 1 151 (e.g., a side facing away from the chamber defined by the fluid impermeable barrier) or a bottom side of the lip 1151 (e.g., a side facing towards the chamber defined by the fluid impermeable barrier). [00116] FIGS. 11B and 11C are cross-sectional view of the rim 1 140 taken along plane 11B-11B, according to different embodiments. Referring to FIG. 11B, in an embodiment, the rim 1140b may be formed from a solid material. That is, the bottom side 1153b of the rim 1140b may be generally planar. The rim 1140b formed from a solid material may facilitate attaching the rim 1140b to the fluid impermeable barrier by increasing the surface area that may contact and be attached to the fluid impermeable barrier. The rim 1140b formed from a solid material may also increase the rigidity of the rim 1140b thereby decreasing the likelihood that the anatomy contacting the rim 1140b causes the cutouts 1141b to collapse. The rim 1140b may be formed by machining a solid block of material to form the cutouts 1141b and the passageway. Referring to FIG. lie, in an embodiment, the rim 1140c may not be formed from a solid material. Instead, the bottom side 1153c of the rim 1140c may generally correspond to the top side 1154c of the rim 1 140c or otherwise form a cavity 1155c. The rim 1 140c that is not formed from a solid material may increase the flexibility of the rim 1140c thereby decreasing the likelihood that the rim 1140c causes pressure sores or is otherw ise uncomfortably presses into the anatomy.

[00117] In an embodiment, as shown in FIGS. 11A-11C, the rim 1140 may be distinct and separate from the fluid impermeable barrier. In such an embodiment, the rim 1 140 may be attached to the fluid impermeable barrier using any suitable technique, such as with an adhesive, ultrasonic welding, or any other suitable technique. The rim 1140 that is distinct and separate from the fluid impermeable barrier allows the rim 1140 to be attached to any of the fluid collection assemblies disclosed herein that do not initially include a rim. Further, the rim 1140 that is distinct and separate from the fluid impermeable barrier allows the rim 1140 to be attached to any other suitable fluid collection assembly. Examples of fluid collection assemblies that the rim 1140 may be attached to are disclosed in International Application No. PCT/US2021/039866 filed on

June 30, 2021; International Application No. PCT/US2021/043893 filed on July 30,

2021; International Application No. PCT/US2022/021103 filed on March 21, 2022;

International Application No. PCT/US2022/041688 filed on August 26, 2022;

International Application No. PCT/US2022/041085 filed on August 22, 2022;

International Application No. PCT/US2023/030365 filed on August 16, 2023;

International Application No. PCT/US2023/030373 filed on August 16, 2023;

International Application No. PCT/US2023/075507 filed on August 29, 2023;

International Application No. PCT/US2024/058598 filed on December 5, 2024; U.S.

Patent No. 11,000,401 filed on February 14, 2019; the disclosure of each of which is incorporated herein, in its entirety, by this reference. In an embodiment, the rim 1140 may be integrally formed (e.g., exhibit single piece construction) with the fluid impermeable barrier. In such an embodiment, the rim 1140 may be formed in the fluid impermeable barrier using a thermosetting process.

[00118] FIG. 12 is an isometric view' of a fluid collection assembly 1200, according to an embodiment. Except as otherwise disclosed herein, the fluid collection assembly 1200 is the same as or substantially similar to any of the fluid collection assemblies disclosed herein. For example, the fluid collection assembly 1200 includes a fluid impermeable barrier 1206 defining a vacuum relief opening (not labeled, under the air permeable, water impermeable membrane 1238). The fluid impermeable barrier 1206 may also form a bulge 1232. The fluid collection assembly 1200 also includes a rim 1240 and a drainage port assembly 1244.

[00119] The rim 1240 includes a proximal side 1247 and a distal side 1249. The distal side 1249 may form a tapered surface that extends away from (e.g., towards the distal end region 1210) the passageway 1245. The tapered surface of the distal side 1249 decreases the likelihood that the distal side 1249 forms pressure sores or otherwise uncomfortably presses into the anatomy when the anatomy contacts the distal side 1249. The tapered surface of the distal side 1249 may also make wearing the fluid collection assembly under clothing more discrete.

[00120] It is noted that the fluid collection assembly 1200 includes at least one reinforcement structure 1236 that prevents the collapse of the bulge 1232 or otherwise helps maintain a desired shape of the fluid impermeable barrier 1206. The reinforcement structure 1236 may be integrally formed with or attached to the fluid impermeable barrier 1206. For example, the reinforcement structure 1236 exhibits a generally Y-like shape.

The generally Y-like shape of the reinforcement structure 1236 may facilitate strengthening a significant portion of the fluid collection assembly 1200 since, as illustrated, the fluid collection assembly 1200 exhibits a generally triangular shape. The reinforcement structure 1236 may abut the distal side 1249 of the rim 1240 which allows the reinforcement structure 1236 to strengthen or otherwise inhibit collapse of the distal side 1249 of the rim 1240.

[00121] FIG. 13A is an isometric view⁷ of a fluid collection assembly 1300, according to an embodiment. FIGS. 13B and 13C are a top and side view of the fluid collection assembly 1300. Except as otherwise disclosed herein, the fluid collection assembly 1300 is the same as or substantially similar to any of the fluid collection assemblies disclosed herein. For example, the fluid collection assembly 1300 includes a fluid impermeable barrier 1306 defining a vacuum relief opening (not labeled, under the air permeable, water impermeable membrane 1338). The fluid impermeable barrier 1306 may also form a bulge 1332. The fluid collection assembly 1300 also includes a rim 1340 and a drainage port assembly 1344.

[00122] As previously discussed, the fluid collection assembly 1300 includes a rim 1340. The rim 1340 may be similar to any of the rims disclosed herein. For example, the rim 1340 may include a proximal side 1347. a distal side 1349 (that may include a tapered surface), and define one or more cutouts 1341. In an example, unlike the rim 1340 illustrated in FIG. 12, the rim 1340 includes at least one cutout 1341 formed on the distal side 1349.

[00123] In an embodiment, the fluid collection assembly 1300 may define a recess 1357 between the rim 1340 and the bulge 1332. For example, the bulge 1332 and the rim 1340 may be spaced from each other by the by the recess 1357. The recess 1357 may increase the bending resistance of the portions of the fluid collection assembly 1300 adjacent to the recess 1357. In an example, the cutout 1341 extends from the passageway 1345 of the rim 1340 to the recess 1357. In such an example, the recess 1357 forms an extension of the cutout 1341 since the recess 1357 allows air to flow therethrough, to the cutout 1341, and to the passageway 1345.

[00124] The rim 1340 may exhibit a maximum height measured from the fluid impermeable barrier 1306. Generally, the maximum height of the rim 1340 may be selected to be equal to or less than the height of the bulge 1332 and/or the drainage port assembly 1344. As such, the rim 1340 is not likely to be more pronounced than the bulge 1332 and the drainage port assembly 1344 and make using the fluid collection assembly

1300 less noticeable under clothing or blankets.

[00125] The bulges disclosed above are relatively large and generally extend from or near the distal end region to at least the opening defined by the fluid impermeable barrier. Such large bulges may facilitate insertion of relatively large penises into the chamber and make it more comfortable for the individual to have their penises disposed in the chamber. However, such large bulges increase the likelihood that there are unoccupied gaps in the chamber in which bodily fluids may undesirably pool, since such pooled bodily fluids may be difficult to remove from the chamber, increase unsanitary conditions in the chamber, and increase the odor of the fluid collection assembly. To resolve these issues, the bulge 1332 illustrate in FIGS. 13A-13C is relatively small by comparison.

For example, the bulge 1332 may only be present above the opening (not shown, obscured) defined by the fluid impermeable barrier 1306 and, optionally, the areas around the opening (e.g., within 3 cm or less, 2 cm or less, or 1 cm or less from the opening). Such a bulge 1332 may still facilitate insertion of the penis into the chamber and may be comfortably used with average sized penises and non-erect penises while decreasing the volume of any unoccupied space within the chamber.

[00126] In an embodiment, the bulge 1332 may include one or more indents 1359 formed therein. The indents 1359 decrease the volume of the bulge 1332 thereby decreasing the volume of unoccupied spaced formed by the bulge 1332 during use. Further, the indents 1332 form a reinforcement structure that inhibits collapsed of the bulged 1332 during use compared to a substantially similar bulge that does not include the indents. It is noted that the indents 1359 may extend from or near the base of the bulge 1332 and may extend along at least half the height of the bulge 1332. [00127] The bulge 1332 may exhibit a maximum height measured from the portions of the fluid impermeable barrier about the bulge 1332. The height of the bulge 1332 may be selected to be equal to or less than the height of the drainage port assembly 1344. As such, the bulge 1332 is not likely to be more pronounced than the drainage port assembly 1344 and make using the fluid collection assembly 1300 less noticeable under clothing or blankets. Limiting the height of the bulge 1332 to be equal to or less than the height of the drainage port assembly 1344 minimized the volume of any unoccupied space within the chamber.

[00128] The fluid impermeable barrier 1306 define edges 1326 extending from or near the proximal end region 1308 to or near distal end region 1310. These edges 1326 of the fluid impermeable barrier 1306 may be angled such that a width of the fluid impermeable barrier 1306, measured between opposing edges 1326 in a direction that is perpendicular to a longitudinal axis of the fluid collection assembly 1300, decreases with increasing proximity to the distal end region 1310. Such a shape of the edges 1326 may make using the fluid collection assembly 1300 more comfortable and decreases the volume of the chamber that may form unoccupied space during use. In a particular example, as shown, the edges 1326 may be concave from the perspective of an individual positioned on the side of the fluid collection assembly 1300. The concave curvature of the edges 1326 may help the edges 1326 conform to the curved shape of the thighs of the individual thereby making the fluid collection assembly 1300 more comfortable to use. [00129] FIG. 14 is a block diagram of a fluid collection system 1479 for fluid collection, according to an embodiment. The fluid collection system 1479 includes a fluid collection assembly 1400, a fluid storage container 1480, and a vacuum source 1482. The fluid collection assembly 1400 may be the same or substantially similar to any of the fluid collection assemblies disclosed herein. The fluid collection assembly 1400. the fluid storage container 1480, and the vacuum source 1482 may be fluidly coupled to each other via one or more conduits 1442. For example, fluid collection assembly 1400 may be operably coupled to one or more of the fluid storage container 1480 or the vacuum source 1482 via the conduit 1442. The bodily fluids collected in the fluid collection assembly 1400 may be removed from the fluid collection assembly 1400 via the conduit 1442 which protrudes into the fluid collection assembly 1400. For example, an inlet of the conduit 1442 may extend into the fluid collection assembly 1400, such as to a reservoir therein. The outlet of the conduit 1442 may extend into the fluid collection assembly 1400 or the vacuum source 1482. Suction force may be introduced into the chamber of the fluid collection assembly 1400 via the inlet of the conduit 1442 responsive to suction (e.g.. vacuum) force applied at the outlet of the conduit 1442.

[00130] The suction force may be applied to the outlet of the conduit 1442 by the vacuum source 1482 either directly or indirectly. The suction force may be applied indirectly via the fluid storage container 1480. For example, the outlet of the conduit 1442 may be disposed within the fluid storage container 1480 and an additional conduit

1442 may extend from the fluid storage container 1480 to the vacuum source 1482. Accordingly, the vacuum source 1482 may apply suction to the fluid collection assembly 1400 via the fluid storage container 1480. The suction force may be applied directly via the vacuum source 1482. For example, the outlet of the conduit 1442 may be disposed within the vacuum source 1482. An additional conduit 1442 may extend from the vacuum source 1482 to a point outside of the fluid collection assembly 1400, such as to the fluid storage container 1480. In such examples, the vacuum source 1482 may be disposed between the fluid collection assembly 1400 and the fluid storage container 1480. [00131] The fluid storage container 1480 is sized and shaped to retain bodily fluids therein. The fluid storage container 1480 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 1442 may extend from the fluid collection assembly 1400 and attach to the fluid storage container 1480 at a first point therein. An additional conduit 1442 may attach to the fluid storage container 1480 at a second point thereon and may extend and attach to the vacuum source 1482. Accordingly, a vacuum

(e.g., suction) may be drawn through fluid collection assembly 1400 via the fluid storage container 1480. Bodily fluids, such as urine, may be drained from the fluid collection assembly 1400 using the vacuum source 1482.

[00132] The vacuum source 1482 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 1482 may provide a vacuum or suction to remove bodily fluids from the fluid collection assembly 1400. In some examples, the vacuum source 1482 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 1482 may be sized and shaped to fit outside of, on, or within the fluid collection assembly 1400. For example, the vacuum source 1482 may include one or more miniaturized pumps or one or more micro pumps. The vacuum sources 1482 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 1482.

[00133] 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. [00134] 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.

Claims

CLAIMS What is claimed is:

1. A fluid collection assembly, comprising: a fluid impermeable barrier including a proximal end region and a distal end region, the fluid impermeable barrier defining a chamber, a fluid outlet at the distal end region, an opening at or near the proximal end region, and at least one vacuum relief opening; one or more rims attached to or integrally formed with the fluid impermeable barrier, the one or more rims at least partially surrounding the at least one vacuum relief opening, the one or more rims extending for a height away from portions of the fluid impermeable barrier defining the at least one vacuum relief opening; and at least one porous material disposed in the chamber.

2. The fluid collection assembly of claim 1, wherein the fluid impermeable barrier includes a top panel and a bottom panel attached to the top panel along outer edges thereof, the chamber defined between the top panel and the bottom panel.

3. The fluid collection assembly of claim 2, wherein the top panel is at least partially transparent.

4. The fluid collection assembly of any one of claims 2 or 3, wherein the at least one porous material and the top panel define at least a portion of the penis receiving area therebetween.

5. The fluid collection assembly of any one of claims 1-4, wherein the fluid impermeable barrier forms a three-dimensional structure, the three-dimensional structure configured to maintain a shape thereof when a vacuum is applied to the chamber.

6. The fluid collection assembly of claim 5, wherein the three-dimensional structure of the top panel includes a bulge extending at least above the opening to the fluid outlet, the at least one porous matenal and the bulge defining at least a portion of the penis receiving area.

7. The fluid collection assembly of claim 6, wherein the three-dimensional structure of the top panel includes one or more reinforcement structures configured to strengthen the bulge.

8. The fluid collection assembly of any one of claims 1-7, wherein the at least one porous material defines a passageway therethrough that corresponds to the opening.

9. The fluid collection assembly of any one of claims 1-8, wherein the at least one vacuum relief opening includes one or two vacuum relief openings; and further comprising one or two air permeable, water impermeable membranes attached to the portions of the fluid impermeable barrier defining the one or two vacuum relief openings.

10. The fluid collection assembly of claim 9, wherein the at least one vacuum relief opening includes a single vacuum relief opening and the one or two air permeable, water impermeable membranes includes a single air permeable, water impermeable membrane.

11. The fluid collection assembly of any one of claims 1-10, wherein the one or more rims define one or more valleys or openings.

12. The fluid collection assembly of any one of claims 1-11, wherein the one or more rims exhibit a maximum height measured from the portions of the fluid impermeable barrier defining the at least one vacuum relief opening, wherein the maximum height is about 8 mm to about 15 mm.

13. The fluid collection assembly of any one of claims 1-12, wherein the at least one vacuum relief opening is at or near the proximal end region.

14. The fluid collection assembly of any one of claims 1-13, further comprising a drainage port assembly attached to the fluid impermeable barrier, the drainage port assembly covering or extending through the fluid outlet and in fluid communication with the chamber via the fluid outlet.

15. The fluid collection assembly of claim 14, wherein at least a portion of the fluid impermeable barrier defining the fluid outlet and the drainage port assembly include same material.

16. The fluid collection assembly of claim 15, wherein the drainage port assembly is heat sealed to the fluid impermeable barrier.

17. The fluid collection assembly of any one of claims 14-16, wherein at least the portion of the fluid impermeable barrier defining the fluid outlet and the drainage port assembly include polyethylene.

18. The fluid collection assembly of any one of claims 14-17, wherein the drainage port assembly includes a barrier attachment portion attached to the fluid impermeable barrier and a conduit attachment portion configured to be attached to a conduit.

19. The fluid collection assembly of claim 18, wherein the conduit attachment portion is configured to rotate relative to the barrier attachment portion.

20. The fluid collection assembly of claim 19, wherein the conduit attachment portion include a ball-shaped portion and the barrier attachment portion defines a socket configured to receive the ball-shaped portion of the conduit attachment portion.

21. The fluid collection assembly of any one of claims 18-20, wherein the conduit attachment portion extends from the barrier attachment portion in a direction generally extending from the distal end region towards the proximal end region.

22. The fluid collection assembly of any one of claims 14-21, wherein the drainage port assembly defines a fluid passageway, the drainage port assembly including a check valve in fluid communication with the fluid passageway, the check valve configured to allow fluid flow through the passageway when a vacuum is applied to the chamber and to prevent fluid flow through the passageway when no vacuum is applied to the chamber.

23. The fluid collection assembly of any one of claims 1-22, further comprising a cap attached to the fluid outlet or a drainage port assembly, the cap including a connector, a lid configured to interface with the fluid outlet or the drainage port assembly to prevent bodily fluids flowing out of the fluid outlet or the drainage port assembly, and at least one tether extending from the connector to the lid.

24. The fluid collection assembly of any one of claims 1-23, wherein the fluid collection assembly exhibits a maximum length of 25 cm or less.

25. The fluid collection assembly of any one of claims 1-24, wherein the fluid collection assembly exhibits a maximum width of 12 cm or less.

26. A fluid collection system, comprising: the fluid collection assembly of any one of claims 1-26; a fluid storage container; and a vacuum source; wherein the chamber of the fluid collection assembly, the fluid storage container, and the vacuum source are in fluid communication with each other such that, when one or more bodily fluids are present in the chamber, a suction provided from the vacuum source to the chamber of the fluid collection assembly removes the one or more bodily fluids from the chamber and deposits the bodily fluids in the fluid storage container.

27. A method of forming a fluid collection assembly, the method comprising: positioning at least one porous material in a chamber defined a fluid impermeable barrier; wherein the fluid impermeable barrier includes a proximal end region and a distal end region, the fluid impermeable barrier defining a fluid outlet at the distal end region, an opening at or near the proximal end region, and at least one vacuum relief opening; and wherein the fluid collection assembly includes one or more rims attached to or integrally formed with the fluid impermeable barrier, the one or more rims at least partially surrounding the at least one vacuum relief opening, the one or more rims extending for a height away from portions of the fluid impermeable barrier defining the at least one vacuum relief opening.

28. The method of claim 27, further comprising, before positioning the at least one porous material in the chamber, attaching a top panel of the fluid impermeable barrier to a bottom panel of the fluid impermeable barrier along outer edges of the top panel and the bottom panel, the chamber defined between the top panel and the bottom panel.

29. The method of claim 27, further comprising, after positioning the at least one porous material in the chamber, attaching a top panel of the fluid impermeable barrier to a bottom panel of the fluid impermeable barrier along outer edges of the top panel and the bottom panel, the chamber defined between the top panel and the bottom panel.

30. The method of any one of claims 28 or 29, further comprising forming the top panel using a thermosetting process.

31. The method of any one of claims 27-30, further comprising attaching a drainage port assembly to the fluid impermeable barrier.

32. The method of claim 31, further comprising forming the drainage port assembly via injection molding.

33. The method of any one of claims 31 or 32, wherein attaching the drainage port assembly to the fluid impermeable barrier includes heat sealing the drainage port assembly to the fluid impermeable barrier.

34. The method of claim 33. wherein the drainage port assembly and the portion of the fluid impermeable barrier heat sealed to the drainage port assembly include same material.

35. A method of using a fluid collection assembly, the method comprising: positioning an opening defined by a bottom panel of a fluid impermeable barrier of the fluid collection assembly adjacent to a urethral opening of an individual or receive a penis of an individual through the opening; wherein the fluid impermeable barrier includes a proximal end region and a distal end region, the fluid impermeable barrier defining a fluid outlet at the distal end region, an opening at or near the proximal end region, and at least one vacuum relief opening; wherein the fluid collection assembly includes one or more rims attached to or integrally formed with the fluid impermeable barrier, the one or more rims at least partially surrounding the at least one vacuum relief opening, the one or more rims extending for a height away from portions of the fluid impermeable barrier defining the at least one vacuum relief opening; and wherein the fluid collection assembly includes at least one porous material disposed in the chamber.

36. The method of claim 35, further comprising applying a vacuum to the chamber.

37. The method of any one of claims 35 or 36, further comprising: receiving one or more bodily fluids from the urethral opening adjacent to the opening or the penis received through the opening into the chamber; and removing the one or more bodily fluids from the chamber via the fluid outlet.