BR112020022139B1 - FLUID COLLECTION DEVICE, SYSTEM AND METHOD - Google Patents

Abstract

FLUID COLLECTION DEVICES, SYSTEMS AND METHODS. Examples relate to systems, devices and methods for attaching a fluid collection device to a user or removing fluid collected from a user in the fluid collection device using a vacuum source operatively coupled thereto. Fluid collection devices include urine collection devices shaped to complement the female anatomy near the urethra, attach to the user with one or more flanges, and the vacuum source is operatively coupled to the fluid collection device via one or more conduit sections.

Description

CROSS-REFERENCE TO RELATED ORDERS

[001] This application claims priority to US Provisional Application No. 62/665,321 filed May 1, 2018, the disclosure of which is incorporated into the present invention in its entirety by this reference.

BACKGROUND

[002] An individual may have limited or impaired mobility such that typical urination processes become challenging or impossible. For example, the individual may have surgery or a disability that impairs mobility. In another example, the individual may have restricted mobility conditions, such as those experienced by pilots, drivers, and workers in hazardous areas. In addition, collection of fluid from the individual may be necessary for monitoring or clinical testing purposes.

[003] Urinals and urinary catheters, such as a Foley catheter, can be used to address some of these circumstances. However, there are several problems associated with urinals and urinary catheters. For example, urinals can be prone to discomfort, spillage, and other hygiene problems. Urinary catheters can be uncomfortable, painful, and can cause urinary tract infections.

[004] Thus, users and manufacturers of fluid collection devices continue to seek new and improved devices, systems, and methods for collecting urine.

SUMMARY

[005] Embodiments disclosed in the present invention relate to devices, systems, and methods of using fluid collection devices. In one embodiment, a fluid collection device is disclosed. The fluid collection device includes a fluid collection member. The fluid collection member includes a fluid impermeable barrier at least partially defining a chamber, the fluid impermeable barrier also defining an orifice extending therethrough, the orifice configured to be positioned adjacent a female urethra or have a male urethra positioned therethrough. The fluid collection member includes a capillary material disposed at least partially within the chamber. The fluid collection member includes a conduit disposed within the chamber, the conduit including an inlet positioned within the fluid collection device and an outlet configured to be in fluid communication with a portable vacuum source. The fluid collection device includes at least one flange extending outwardly from the fluid collection member, the at least one flange including an adhesive member thereon.

[006] In one embodiment, a fluid collection system is disclosed. The fluid collection system includes a fluid storage container configured to hold a fluid. The fluid collection system includes a fluid collection device in fluid communication with the fluid storage container. The fluid collection device includes a fluid collection member. The fluid collection member includes a fluid impermeable barrier at least partially defining a chamber, the fluid impermeable barrier also defining an orifice extending therethrough, the orifice configured to be positioned adjacent a female urethra or have a male urethra positioned therethrough. The fluid collection member includes a capillary material disposed at least partially within the chamber. The fluid collection member includes a conduit disposed within the chamber, the conduit including an inlet positioned within the fluid collection device and an outlet configured to be in fluid communication with a portable vacuum source. The fluid collection device includes at least one flange extending outwardly from the fluid collection member, the at least one flange including an adhesive member thereon. The fluid collection system includes a vacuum source in fluid communication with one or more of the fluid storage container or the fluid collection device, the vacuum source configured to draw fluid from the fluid collection device.

[007] In one embodiment, a method for collecting fluid is disclosed. The method includes positioning an orifice of a fluid collection device adjacent to a female urethra or around a male urethra of a user, the orifice defined by a fluid impermeable barrier of the fluid collection device. The method includes positioning, securing the fluid collection device to the user. The method includes positioning to receive fluid from the female urethra or male urethra within a chamber of the fluid collection device, the chamber of the fluid collection device at least partially defined by the fluid impermeable barrier.

[008] Features of any of the disclosed embodiments may be used in combination with each other, without limitation. In addition, other features and advantages of the present disclosure will become apparent to those skilled in the art through consideration of the following detailed description and the accompanying drawings.

BRIEF DESCRIPTION OF THE FIGURES

[009] The drawings illustrate various 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.

[010] FIG. 1 is a block diagram of a fluid collection system, according to one embodiment.

[011] FIG. 2A is an isometric view of a fluid collection device, according to one embodiment.

[012] FIG. 2B is a front view of a user with the fluid collection device of FIG. 2A positioned for use, according to one embodiment.

[013] FIGS. 3-5 are schematic cross-sectional views of fluid collection devices taken along plane A-A of FIG. 2A, according to embodiments.

[014] FIGS. 6-8 are schematic cross-sectional views of fluid collection devices taken along the B-B plane of FIG. 2A, according to embodiments.

[015] FIG. 9A is an isometric view of a fluid collection device, according to one embodiment.

[016] FIG. 9B is a schematic cross-sectional view of the fluid collection device taken along the C-C plane of FIG. 9A, according to one embodiment.

[017] FIG. 10 is a flowchart of a method for collecting fluid, according to one embodiment.

DETAILED DESCRIPTION

[018] Embodiments disclosed in the present invention relate to devices, systems, and methods of using fluid collection devices and systems. The devices, systems, and methods of using fluid collection devices and systems include at least one flange extending from the fluid collection device, wherein the at least one flange is positioned to attach to the skin of a user and align the fluid collection device with one or more anatomical structures of the user (e.g., urethra). The devices, systems, and methods of using fluid collection devices and systems include a portable vacuum source for removing urine from the fluid collection device. The portable vacuum source may enable portable use of the systems and methods in the present invention, such as in non-hospital settings.

[019] In one embodiment, a fluid collection device includes a fluid impermeable barrier that at least partially defines a chamber. The fluid impermeable barrier also defines an orifice extending therethrough that is configured to be positioned adjacent to a female urethra or have a male urethra positioned therethrough. The fluid collection device also includes a tube having a channel extending between an inlet and an outlet thereof. The inlet is configured to be coupled to an aspiration source and the outlet is configured to be fluidly coupled (e.g., in fluid communication with) a fluid storage (vessel or container). The outlet is positioned downstream of the inlet. The channel also defines at least one opening therein that fluidly couples an interior of the channel to the remainder of the chamber.

[020] The fluid collection devices disclosed herein are configured to collect fluid(s) from a subject. The fluid(s) collected by the fluid collection devices may include urine. The fluid(s) collected by the fluid collection devices may also include at least one of vaginal secretion, penile secretion, reproductive fluids, blood, sweat, or other bodily fluids.

[021] The fluid collection devices disclosed herein are configured for use in fluid collection systems. The fluid collection systems disclosed herein include a gas source. Systems that include a gas source can, in some embodiments, solve various problems associated with systems that include a vacuum source. For example, a system that includes a vacuum source draws fluid(s) toward the vacuum source and deposits the majority of the fluid(s) into a fluid storage vessel before the fluid(s) can reach the vacuum source. However, a small amount of fluid(s) (e.g., vapor from the fluids) may still reach the vacuum source, which may contaminate and/or damage (e.g., rust) the vacuum source. Additionally, a large amount of the fluid(s) may reach the vacuum source when the fluid storage vessel is substantially full. However, a system that includes a gas source moves the fluid(s) away from the gas source, thereby preventing contamination and/or damage. For example, a gas source can be used to create a vacuum by flowing a gas past a connected end of the conduit at a perpendicular or oblique angle to the conduit to create a vacuum in the conduit. Fluids are drawn up along the conduit and into the gas stream in the direction of the gas flow, which is away from the gas source. In another embodiment, systems that include a vacuum source cannot be used in environments that do not include an available vacuum source (e.g., the environment does not include a vacuum source or the vacuum source is being used). As such, systems that include a gas source can be used in environments that do not include an available vacuum source. A liquid source can be used to create and implement a vacuum in the same manner as the gas source. The vacuum source or gas source can be used with any of the devices or systems disclosed herein to remove a fluid therefrom.

[022] FIG. 1 is a block diagram of a system 10 for collecting fluid, according to one embodiment. System 10 includes a fluid collection device 12, a fluid storage container 14, and a vacuum source 16. Fluid collection device 12, fluid storage container 14, and vacuum source 16 may be in fluid communication (e.g., fluidly coupled) with each other via one or more conduits 17. For example, fluid collection device 12 may be in fluid communication with one or more of fluid storage container 14 or vacuum source via conduit 17. Fluid (e.g., urine or other bodily fluids) collected in fluid collection device 12 may be removed from fluid collection device 12 via conduit 17 that projects into an interior region of fluid collection device 12. For example, a first open end of conduit 17 may extend into fluid collection device 12 to a reservoir therein. The second open end of conduit 17 may extend into fluid storage container 14 or vacuum source 16. A suction force may be introduced into the interior region of fluid collection device 12 via the first open end of conduit 17 in response to a suction force (e.g., vacuum) applied to the second end of conduit 17. The suction force may be applied to the second open end of conduit 17 by vacuum source 16, directly or indirectly.

[023] The suction force may be applied indirectly through the fluid storage container 14. For example, the second open end of the conduit 17 may be disposed within the fluid storage container 14 and an additional conduit 17 may extend from the fluid storage container 14 to the vacuum source 16. Accordingly, the vacuum source 16 may apply suction to the fluid collection device 12 via the fluid storage container 14. The suction force may be applied directly via the fluid storage container 14. For example, the second open end of the conduit 17 may be disposed within the vacuum source 16. An additional conduit 17 may extend from the vacuum source 16 to a point outside the fluid collection device 12, such as to the fluid storage container 14. In such examples, the vacuum source 16 may be disposed between the fluid collection device 12 and the fluid storage container 14.

[024] The fluid collection device 12 may be shaped and sized to be positioned adjacent to a female urethra. For example and as described in more detail below, the fluid collection device 12 may include a fluid collection member and at least one flange positioned and equipped to attach to the skin of a user and align the fluid collection member in a selected portion of the user's anatomy (e.g., adjacent to or in the urethra or vagina). For example, the at least one flange may include an adhesive for reversible attachment to the user's skin and may be positioned on the fluid collection member to align an orifice of the fluid collection member with the vagina (e.g., in or over the urethra or between the labia) of a female user.

[025] The fluid collection member of the fluid collection device 12 may include a fluid impermeable barrier at least partially defining a chamber (e.g., interior region of the fluid collection device member) of the fluid collection device 12. The fluid impermeable barrier also defines an orifice extending therethrough from the external environment. The orifice may be positioned in the fluid collection member to be aligned adjacent to a female urethra. The fluid collection member of the fluid collection device 12 may include a fluid permeable membrane disposed within the fluid impermeable barrier. The fluid collection member of the fluid collection device 12 may include a fluid permeable support disposed within the fluid permeable membrane. Conduit 17 may extend into fluid collection device 12 at a first end region, through one or more of the fluid impermeable barrier, fluid permeable membrane, or fluid permeable support to a second end region of the fluid collection member of fluid collection device 12. Exemplary fluid collection devices for use with the systems and methods of the present invention are described in more detail below.

[026] In examples, the fluid storage container 14 may include a bag (e.g., drainage bag), a bottle or cup (e.g., collection jar), or any other closed container for storing bodily fluid(s), such as urine. In examples, the conduit 17 may extend from the fluid collection device 12 and attach to the fluid storage container 14 at a first point thereon. An additional conduit 17 may attach to the fluid storage container 14 at a second point thereon and may extend and attach to the vacuum source 16. For example, the fluid storage container 14 may include a container in fluid communication with a first conduit section that is also in fluid communication with the fluid collection member of the fluid collection device 12. The container may be in fluid communication with a second conduit section 17 that is also in fluid communication with a vacuum source. In such examples, the vacuum source 16 may provide a vacuum/suction through the container to the fluid collection member to provide suction in the chamber of the fluid collection member. Accordingly, a vacuum (e.g., suction) may be drawn across the fluid collection device 12 via the fluid storage container 14. As fluid is drained from the chamber, the fluid may travel through the first conduit section to the fluid storage container where it may be retained. Fluid, such as urine, may be drained from the fluid collection device 12 using the vacuum source 16.

[027] In some examples, the vacuum source 16 may include a portable vacuum source. In examples, the portable vacuum source may be disposed in or on top of the fluid collection device 12. In such examples, the conduit 17 may extend from the fluid collection device and attach to the (portable) vacuum source 16 at a first point thereon. An additional conduit 17 may attach to the vacuum source 16 at a second point thereon and may extend outward from the fluid collection device 12, and may attach to the fluid storage container 14. Accordingly, a vacuum (e.g., suction) may be drawn across the fluid collection device 12 via the fluid storage container 14.

[028] The vacuum source 16 may include one or more of a vacuum line plumbed to the patient care facility, a hand-operated vacuum pump, an 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 16 may provide a vacuum or suction to remove fluid from the fluid collection member of the fluid collection device 12. In examples, the vacuum source 16 may be powered by one or more of a power cord (e.g., plugged into an outlet), one or more batteries, or even manual power (e.g., a hand-operated vacuum pump). In examples, the vacuum source 16 (e.g., portable vacuum source) may be sized and shaped to fit outside of, on, or inside the fluid collection device 12. For example, the vacuum source 16 (e.g., portable vacuum source) may include one or more miniaturized pumps or one or more micropumps. The vacuum sources 16 disclosed herein may include one or more of a switch, a button, a plug, a remote control, or any other suitable device for activating the vacuum source 16. It should be understood that the vacuum sources 16 disclosed herein may provide a portable means of providing a suction or vacuum that allows the use of the devices and systems herein outside of hospital or care facility environments where vacuum lines are plumbed to patient rooms or large vacuum sources (e.g., larger or heavier than a patient can readily carry) are located. For example, a portable vacuum source may be small and light enough to be carried by a user (e.g., patient) or helper (e.g., nurse) while transporting the user.

[029] FIG. 2A is an isometric view of a fluid collection device 100, according to one embodiment. The fluid collection device 100 includes a fluid collection member 101 and at least one flange 140 extending from the fluid collection member 101. In some examples, the fluid collection member 101 may be substantially cylindrical, ellipsoidal, prismatic, or any other shape suitable to complement or contour the vaginal region of a female subject. The fluid collection member 101 may include a fluid impermeable barrier 102, capillary material 115, and a conduit 108. The capillary material 115 may be disposed at least partially within the fluid impermeable barrier 102. The conduit 108 may be at least partially disposed with capillary material 115.

[030] The fluid impermeable barrier 102 at least partially defines at least a portion of an outer surface of the fluid collection member 101. The fluid impermeable barrier 102 at least partially defines a chamber 104 therein (e.g., interior region of the fluid collection member 101) and an orifice 106. The orifice 106 is formed in and extends through the fluid impermeable barrier 102, thereby allowing fluid(s) to enter the chamber 104 from the outside of the fluid collection member 101 of the fluid collection device 100. The orifice 106 may be configured to be positioned adjacent to a female urethra, such as between the labia majora of a female user.

[031] The fluid impermeable barrier 102 may also temporarily retain or store fluid(s) in the chamber 104. For example, the fluid impermeable barrier 102 may be formed of any suitable fluid impermeable material, such as a fluid impermeable polymer (e.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, a polycarbonate, a polyvinyl chloride, latex, silicone, etc.), a metal film, another suitable material, or combinations thereof. As such, the fluid impermeable barrier 102 may prevent at least some of the fluid(s) from exiting portions of the chamber 104 that are spaced from the orifice 106.

[032] In one embodiment, the fluid impermeable barrier 102 may be air permeable and fluid impermeable. In such an embodiment, the fluid impermeable barrier 102 may be formed of a hydrophobic material that defines a plurality of pores. In one example, one or more portions of at least one outer surface of the fluid impermeable barrier 102 may be formed from a soft and/or smooth material thereby reducing friction from the wearer's skin. The fluid impermeable barrier 102 may include markings thereon, such as one or more markings to assist a user in aligning the device 100 on the wearer. For example, a line on the fluid impermeable barrier 102 (e.g., opposite the orifice 106) may allow a healthcare professional to align the orifice 106 over the wearer's urethra. In examples, the markings may include one or more alignment guides or an orientation indicator, such as a stripe or hatching. These markings may be positioned to align the device 100 with one or more anatomical features such as a pubic bone, etc.

[033] The capillary material 115 may be disposed at least partially within the fluid impermeable barrier 102. The capillary material 115 may include permeable material designed to capillarize or allow fluid to pass therethrough. Permeable properties referred to herein may be capillarity, capillary action, diffusion, or other similar properties or processes and are referred to herein as “permeable” and/or “capillary.” Such “capillarity” may not include absorption into the capillary material. The capillary material 115 may collect fluid traveling through the orifice 106. The capillary material 115 may include more than one material, such as a plurality of materials. The plurality of materials may include a plurality of layers arranged concentrically within one another. The concentrically arranged layers of capillary materials may exhibit a capillary gradient, such as where the innermost capillary material includes the greatest or least capillary capacity of the plurality of materials.

[034] In examples, capillary material 115 may include one or more of a fluid-permeable support (FIGS. 3-8) or a fluid-permeable membrane 118. For example, fluid collection member 101 of fluid collection device 100 may include a fluid-permeable membrane 118 disposed in chamber 104. Fluid-permeable membrane 118 may cover at least a portion (e.g., all) of orifice 106. Fluid-permeable membrane 118 may be configured to capillary any fluid out of orifice 106, thereby preventing fluid from escaping chamber 104. Fluid-permeable membrane 118 may also capillary fluid generally toward an interior of chamber 104, as discussed in more detail below. Fluid-permeable membrane 118 may include any material that can capillary fluid. For example, the fluid permeable membrane 118 may include fabric, such as a gauze (e.g., a silk, linen, or cotton gauze), another soft fabric (e.g., jersey knit fabric or the like), or another smooth fabric (e.g., rayon, satin, or the like). In some examples, the fluid permeable membrane 118 may include an open-cell foam. Formation of the fluid permeable membrane 118 from gauze, soft fabric, and/or smooth fabric may reduce friction caused by the fluid collection device 100.

[035] The fluid collection device 100 may include a fluid-permeable support 120 (FIGS. 3-8) disposed in the chamber 104. The fluid-permeable support 120 may support the fluid-permeable membrane 118, since the fluid-permeable membrane 118 may be formed from a bendable, brittle, or otherwise easily deformable material. For example, the fluid permeable support 120 may be positioned such that the fluid permeable membrane 118 is disposed between the fluid permeable support and the fluid impermeable barrier 102. As such, the fluid permeable support 120 may support and maintain the position of the fluid permeable membrane 118. The fluid permeable support 120 may be formed from any fluid permeable material that is less deformable than the fluid permeable membrane 118. For example, the fluid permeable support 120 may include a porous nylon structure or an open cell foam. In embodiments, the fluid permeable support may be omitted from the fluid collection device 100.

[036] In some embodiments, the capillary material 115 (e.g., one or more of the fluid-permeable membrane 118 or the fluid-permeable support) may at least substantially completely fill portions of the chamber 104 that are not occupied by the conduit 108. For example, the capillary material 115 may fill portions of the chamber 104 that are not occupied by the conduit 108. In some examples, the fluid-permeable membrane 118 and the fluid-permeable support may not substantially completely fill portions of the chamber 104 that are not occupied by the conduit 108. In such examples, the fluid collection device 100 may include a reservoir (e.g., void space) disposed in the chamber 104. The reservoir may include a void space between the capillary material in the chamber 104 and the interior surface of the fluid-impermeable barrier 102. At least some of the fluid absorbed by the capillary material 115 may drain out of the capillary material 115. capillary 115 and collected in the reservoir.

[037] The fluid collection member 101 of the fluid collection device 100 may also include the conduit 108 that is disposed at least partially in the chamber 104. The conduit 108 may include a flexible material, such as plastic tubing (e.g., medical tubing). Such plastic tubing may include thermoplastic elastomer tubing, polyvinyl chloride, ethylene vinyl acetate, polytetrafluoroethylene, etc. In examples, the conduit 108 may include silicon or latex. The conduit 108 (e.g., a tube) includes an inlet at a first end region and an outlet at a second end region positioned downstream of the inlet. The conduit 108 places an interior region of the chamber 104 in fluid communication with one or more of the fluid storage vessel (FIG. 1) or the vacuum source (FIG. 1). Fluid may be removed from chamber 104 via conduit 108. As suction force or vacuum is applied to or formed in conduit 108 by the vacuum source (FIG. 1), fluid in chamber 104 may be drawn into the inlet and out of fluid collection member 101 via conduit 108.

[038] In examples, conduit 108 may be disposed at a more interior or gravimetrically low point in chamber 104. For example, conduit 108 may extend far enough into chamber 104 to position the inlet at a gravimetrically low point of chamber 104 (e.g., fluid reservoir within the interior of fluid collection member 101).

[039] The fluid collection member 101 and components thereof may be deformable (e.g., bendable) in response to pressure applied thereto. For example, the fluid collection member 101 and components thereof may bend to conform to the surface of the wearer, such as when disposed between a garment and the wearer. In examples, the fluid collection member 101 may bend when disposed proximate to the urethra (e.g., between the labia) when undergarments are pulled over the fluid collection member 101.

[040] The at least one flange 140 may extend from the fluid collection member 101. The at least one flange may include a flange body 142 and an adhesive member 144 disposed on the flange body 142. In some examples, the at least one flange 140 may include 2 or more flanges (e.g., 4 flanges). The at least one flange 140 may include a first flange body extending in a first direction outward from the fluid collection member 101 and a second flange body extending outward from the fluid collection member 101 in a second direction, wherein the first and second directions are substantially opposite each other (e.g., at least 120° apart). The at least one flange 140 may extend along at least a portion of the longitudinal length of the fluid collection member 101. For example, the at least one flange 140 may have a width, as viewed parallel to the B-B plane, of at least 5% (e.g., at least 10%, at least 20%, at least 30%, at least 40%, at least 50%, or less than 60%) of the longitudinal length of the fluid collection member 101. In the examples, the width of the flange 140 may be at least 1 cm, such as 2 cm, 5 cm, 10 cm, 15 cm, 20 cm, 30 cm, or in a range between any combination of the foregoing. The flange 140 (e.g., flange body 142) may extend at least 1 cm outward from the fluid collection member 101, such as 1 cm, 3 cm, 5 cm, 10 cm, 15 cm, 20 cm, 25 cm, 30 cm, or a range between any combination of the foregoing, outward from the fluid collection member 101.

[041] In examples, the flange body 142 of the at least one flange 140 may be formed of the same material as the fluid impermeable barrier 102. In examples, the flange body 142 of the at least one flange 140 may be formed from one or more of fabric, paper, plastic, or any other material suitable for deforming in response to pressure applied thereto and capable of withstanding moisture without breaking. For example, the flange body 142 may be formed from thermoplastic elastomer, polyethylene, polyvinyl chloride, ethylene vinyl acetate, polytetrafluoroethylene, latex, silicon, fabric, woven fabric, etc. In examples, the conduit 108 may include silicon or latex. The flange body 142 of the at least one flange 140 may be flexible and may conform to manipulation or movement by a user. The flange body 142 may exhibit any of the dimensions disclosed above for the flange 140.

[042] The flange body 142 may have the adhesive member 144 disposed thereon, such as on a distal portion thereof (e.g., distal from the fluid collection member 101). The adhesive member 144 may be affixed to the flange body 142 by mechanical means, such as a clamp(s), a clip, hook-and-loop fasteners, etc.; may be affixed by an adhesive; or may be formed integrally with the flange body 142. The adhesive member 144 may be positioned on the flange body 142 in an effective position to allow the adhesive to be applied to a wearer's skin garment to maintain a position of the fluid collection member 101 relative to one or more anatomical features (e.g., proximate to the female urethra or between the labia) of the wearer. For example, the adhesive member 144 may be positioned on the flange body 142 to allow at least one flange 140 to adhere to a user's inner thigh and maintain a position of the associated fluid collection member 101 between the user's labia 190. In examples, the adhesive member 144 may be flexible or otherwise configured to conform to the anatomical features of the user and accommodate the user's movement.

[043] FIG. 2B is a front view of a user 190 with the fluid collection device 100 positioned for use, according to one embodiment. The user 190 may be a female and the fluid collection device 100 may be positioned for use (e.g., collecting urine or other bodily fluids from the vagina). For example, the flanges 140 may be disposed on the fluid collection member 101 in a position to locate the fluid collection member 101 between the labia 192 when the at least one flange 140 is adhered to the inner thigh 194 of the user 190. In the examples, the at least one flange 140 may be adhered to the pubic region (e.g., lower abdominal region) of the user 190 to align the fluid collection member over the urethra of the user 190. In some examples, the at least one flange 140 may be adhered to the fabric of a garment worn by the user 190 (e.g., an undergarment). The conduit 108 may be in fluid communication with the fluid storage container or vacuum pump (not shown) to remove any fluid(s) collected from the fluid collection device 100.

[044] Returning to FIG. 2A, the at least one flange body 142 may include adhesive member 144 disposed thereon. For example, adhesive member 144 may face upward on flange body 142 (e.g., in the general direction of fluid collection member 101). In some examples, flange 140 may additionally or alternatively include adhesive member 144 facing downward on flange body 142. In examples, adhesive member 144 may be located on a distal portion of flange body 142 (e.g., distal from fluid collection member 101). In examples, the adhesive member 144 may cover at least 5% of the surface area of the flange body 142, such as 5%, 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, or ranges between any combination of the foregoing, of the surface area of the flange body 142.

[045] In examples, the adhesive member 144 may include a glue, contact adhesive, epoxy, hydrogel adhesive, tape, or other adhesive suitable for attaching the flange to skin or tissue. For example, the adhesive may include an acrylate (e.g., methacrylate or epoxy diacrylate) or any other adhesive suitable for use in bandages.

[046] The cross-sectional profiles of the fluid collection devices disclosed herein may vary. For example, a longitudinal cross-section is taken along plane A-A and an axial cross-section can be seen along plane B-B in FIG. 2A.

[047] FIG. 3 is a schematic cross-sectional view of fluid collection device 100 taken along plane A-A of FIG. 2A, according to one embodiment. Fluid collection device 100 is an example of a female fluid collection device 100 sized, shaped, and otherwise configured to receive fluid(s) from a female user. The fluid collection device 100 includes the fluid collection member 101 and the at least one flange 140. The fluid collection member 101 includes the fluid impermeable barrier 102. The fluid impermeable barrier 102 at least partially defines a chamber 104 (e.g., interior region) and the orifice 106. The orifice 106 is formed and extends through the fluid impermeable barrier 102, thereby allowing fluid(s) to enter the chamber 104 from the outside of the fluid collection device 100. The orifice 106 is configured to be positioned adjacent to a female urethra. The orifice 106 may be positioned in an upwardly facing portion of the fluid collection member 101 (e.g., region substantially opposite the flanges 140). The fluid collection device 100 also includes the conduit 108 that is disposed at least partially in the chamber 104. The conduit 108 (e.g., a tube) includes an inlet 110 at a first end region and an outlet 112 at a second end region positioned downstream of the inlet 110. The conduit 108 places the chamber 104 in fluid communication with the fluid storage vessel (not shown) or the vacuum source (not shown).

[048] In the illustrated embodiment, conduit 108 is disposed at least partially in chamber 104. For example, conduit 108 may extend into fluid impermeable barrier 102 from the first end region (e.g., proximate to outlet 112) and may extend to the second end region (e.g., opposite first end region) to a point proximate to reservoir 122 such that inlet 110 is in fluid communication with reservoir 122. Fluid collected in fluid collection member 101 may be removed from the interior region of chamber 104 via conduit 108. Conduit 108 may include a flexible material, such as plastic tubing (e.g., medical tubing) as disclosed herein. In some examples, conduit 108 may include one or more portions that are resilient, such as having one or more than one diameter or wall thickness that allows the conduit to be flexible.

[049] The fluid collection member 101 may be positioned proximate to the female urethra (e.g., on or between the labia) and urine may enter the chamber 104 of the fluid collection member 101 via the orifice 106. The fluid collection member 101 receives the fluid(s) into the chamber 104 via the orifice 106. For example, the orifice 106 may exhibit an elongated shape that is sized and positioned to extend from a first location below the urethral orifice (e.g., at or near the anus or vaginal orifice) to a second location above the urethral orifice (e.g., at or near the clitoris or mons pubis). The orifice 106 may exhibit an elongated shape since the space between the legs of a female person is relatively small when the female person's legs are closed, thus only allowing the flow of fluid(s) along a path that corresponds to the elongated shape of the orifice 106. The longitudinal dimension or axis of the fluid collection device refers to the axis or dimension that is parallel to the largest dimension of the device, such as axially along a cylindrical device as shown in FIG. 2A. The orifice 106 in the fluid impermeable barrier 102 may exhibit a width that is measured transversely to the longitudinal direction and may be at least about 10% of the circumference of the fluid collection member 101, such as about 25%, 30%, 40%, 50%, 60%, 75%, 85%, 100%, or ranges from any combination of the foregoing, of the circumference of the fluid collection member 101. The orifice 106 may exhibit a width that is greater than 50% of the circumference of the fluid collection member 101, since the vacuum (e.g., suction) through the conduit 108 draws fluid into the conduit 108. In some embodiments, the orifice 106 may be oriented vertically (e.g., having a major axis parallel to the longitudinal axis of the device 100). In some embodiments (not shown), the orifice 106 may be oriented horizontally (e.g., having a major axis perpendicular to the longitudinal axis of the device 100). In one example, one or more portions of the fluid impermeable barrier 102 may be configured to be attached to the subject, such as adhesively attached (e.g., with a hydrogel adhesive) to the subject. According to one embodiment, a suitable adhesive for the impermeable barrier (or flanges) is a hydrogel layer, such as that disclosed in U.S. Patent Application Publication No. 2017/0189225, the disclosure of which is incorporated herein by reference in its entirety.

[050] The fluid collection member 101 includes the capillary material 115 disposed in the chamber 104. The capillary material 115 may include one or more of the fluid permeable membrane 118 and the fluid permeable support 120, each disposed in the chamber 104. The fluid permeable membrane 118 may cover at least a portion (e.g., the entirety) of the orifice 106. The fluid permeable membrane 118 may be configured to capillary any fluid out of the orifice 106, thereby preventing fluid from escaping from the chamber 104. The fluid permeable membrane 118 may also capillary fluid generally toward an interior of the chamber 104, as discussed in more detail below. The fluid permeable membrane 118 may include any material that can capillary fluid. For example, the fluid permeable membrane 118 may include fabric, such as a gauze (e.g., a silk, linen, polymer-based materials such as polyester or cotton gauze), another soft fabric, or another smooth fabric. Formation of the fluid permeable membrane 118 from gauze, soft fabric, and/or smooth fabric may reduce friction caused by the fluid collection member 101.

[051] The fluid permeable support 120 may be disposed in the chamber 104, such as concentrically within the fluid permeable membrane 118. The fluid permeable support 120 may be formed from material that is more rigid (e.g., less deformable) than the fluid permeable membrane 118, such as any of the materials provided herein for a fluid permeable membrane. For example, the fluid permeable support 120 may include a porous nylon structure. The fluid permeable support 120 is configured to support the fluid permeable membrane 118, since the fluid permeable membrane 118 may be formed from a bendable, brittle, or otherwise easily deformable material. For example, the fluid permeable support 120 may be positioned such that the fluid permeable membrane 118 is disposed between the fluid permeable support 120 and the fluid impermeable barrier 102. As such, the fluid permeable support 120 may support and maintain the position of the fluid permeable membrane 118. In one embodiment, the fluid permeable support 120 may be omitted from the fluid collection member 101.

[052] In one embodiment, the fluid-permeable membrane 118 and the fluid-permeable support 120 may at least substantially completely fill the portions of the chamber 104 that are not occupied by the conduit 108. In another example, the fluid-permeable membrane 118 and the fluid-permeable support 120 may not substantially completely fill the portions of the chamber 104 that are not occupied by the conduit 108. In one such example, the fluid collection device 100 includes the reservoir 122 disposed in the chamber 104. The reservoir 122 is a substantially unoccupied portion of the chamber 104. The fluid(s) that are in the chamber 104 may flow through the fluid-permeable membrane 118 and/or the fluid-permeable support 120 to the reservoir 122. The reservoir 122 may store at least some of the fluid(s) in the same.

[053] The fluid impermeable barrier 102 may store fluid(s) in the reservoir 122. The reservoir 122 may be disposed in any portion of the interior region of the chamber 104. For example, the fluid reservoir 122 may be positioned in the second end region of the chamber 104.

[054] In one example, reservoir 122 may be located in the portion of chamber 104 that is closest to inlet 110 (e.g., second end region). However, reservoir 122 may be located at different locations in chamber 104. For example, reservoir 122 may be located at the end of chamber 104 that is closest to outlet 112. In another example, fluid collection device 100 may include multiple reservoirs, such as a first reservoir that is located in the portion of chamber 104 that is closest to inlet 110 (e.g., second end region) and a second reservoir that is located in the portion of chamber 104 that is closest to outlet 112 (e.g., first end region). In another example, the fluid permeable support 120 is spaced from at least a portion of the conduit 108 and the reservoir 122 may be the space between the fluid permeable support 120 and the conduit 108.

[055] Other examples of fluid impermeable barriers, fluid permeable membranes, fluid permeable supports, chambers, and their shapes and configurations are disclosed in U.S. Patent Application No. 15/611,587 filed June 1, 2017, and U.S. Patent Application No. 15/260,103 filed September 8, 2016, (published as U.S. Patent Application No. 2016-0374848 on December 29, 2016), the disclosure of each of which is incorporated herein in its entirety by this reference.

[056] The fluid impermeable barrier 102, the fluid permeable membrane 118, and the fluid permeable support 120 may be configured to have the conduit 108 at least partially disposed in the chamber 104. For example, at least one of the fluid permeable membrane 118 and the fluid permeable support 120 may be configured to form a space that accommodates the conduit 108. In another example, the fluid impermeable barrier 102 may define an opening 124 sized to receive the conduit 108 (e.g., at least one pipe). The at least one conduit 108 may be disposed in the chamber 104 via the opening 124 in the first end region of the device 100. The opening 124 may be configured to form an at least substantially fluid-tight seal against the conduit 108 or the at least one tube, thereby substantially preventing fluid(s) from escaping from the chamber 104. In some embodiments, the opening 124 may be disposed in the second end region closest to the reservoir 122. In such embodiments, the conduit 108 may be disposed only in the second end region with the inlet 110 being disposed in the second end region (e.g., the reservoir 122).

[057] As discussed previously, conduit 108 is configured to be coupled to, and at least partially extend between, one or more of the fluid storage vessel (not shown) and the vacuum source (not shown). In one example, conduit 108 is configured to be directly connected to the vacuum source (not shown). In such an example, conduit 108 may extend from the fluid impermeable barrier 102 by at least one foot, at least two feet, at least three feet, or at least six feet. In another example, conduit 108 is configured to be indirectly connected to at least one of the fluid storage vessel (not shown) and the vacuum source (not shown). In some embodiments, the conduit is secured to the skin of a person wearing it with a catheter securing device, such as a STATLOCK® catheter securing device available from C. R. Bard, Inc., including but not limited to that disclosed in U.S. Patent Nos. 6,117,163; 6,123,398; and 8,211,063, all of which disclosures are incorporated herein by reference in their entirety.

[058] Inlet 110 and outlet 112 are sized, positioned, or otherwise configured to place (e.g., directly or indirectly) the vacuum source (not shown) in fluid communication with chamber 104 (e.g., reservoir 122). In one example, inlet 110 and/or outlet 112 may form a male connector. In another example, inlet 110 and/or outlet 112 may form a female connector. In one example, inlet 110 and/or outlet 112 may include ribs that are configured to facilitate gripping of couplings. In one example, inlet 110 and/or outlet 112 may form a conical shape. In one example, inlet 110 and/or outlet 112 may include a rigid or flexible material.

[059] Locating the inlet 110 at or near a gravimetrically low point of the chamber 104 allows the conduit to receive more of the fluid(s) than if the inlet 110 were located elsewhere and reduces the likelihood of pooling (e.g., pooling of the fluid(s) can cause microbial growth and unpleasant odors). For example, the fluid(s) in the fluid-permeable membrane 118 and the fluid-permeable support 120 may flow in either direction due to capillary forces. However, the fluid(s) may exhibit a preference for flowing in the direction of gravity, especially when at least a portion of the fluid-permeable membrane 118 and/or the fluid-permeable support 120 is saturated with the fluid(s).

[060] As the vacuum source (FIG. 1) applies a vacuum/suction to the conduit 108, the fluid(s) in the chamber 104 (e.g., in the second end region, such as in the reservoir 122) may be drawn into the inlet 110 and out of the fluid collection member 101 of the fluid collection device 100 via the conduit 108.

[061] In one example, the conduit 108 is configured to be at least insertable into the chamber 104. In such an example, the conduit 108 may include one or more markings (not shown) on an exterior thereof that are configured to facilitate insertion of the conduit 108 into the chamber 104. For example, the conduit 108 may include one or more markings thereon that are configured to prevent over- or under-insertion of the conduit 108, such as when the conduit 108 defines an inlet 110 configured to be disposed in or adjacent to the reservoir 122. In another example, the conduit 108 may include one or more markings thereon that are configured to facilitate proper rotation of the conduit 108 relative to the chamber 104. In one example, the one or more markings may include a line, a dot, an adhesive sticker, or any other suitable marking. In some examples, the conduit may be matte or opaque (e.g., black) to obscure the visibility of the fluid(s) therein.

[062] In one example, one or more components of the fluid collection device 100 may include an antimicrobial material, such as an antibacterial material where the fluid collection device may come into contact with the wearer or the wearer's bodily fluid. The antimicrobial material may include an antimicrobial coating, such as nitrofurazone or silver coating. The antimicrobial material may inhibit microbial growth, such as microbial growth due to accumulation or stagnation of bodily fluid(s). In one example, one or more components (e.g., impermeable barrier 102, conduit 108, etc.) of the fluid collection device 100 may include an odor-blocking or absorbent material, such as a cyclodextrin-containing material or a thermoplastic elastomer (TPE) polymer.

[063] The at least one flange 140 may be disposed on a lower portion of the fluid collection member 101 (e.g., substantially opposite the port 106). For example, the at least one flange 140 may extend from the fluid collection member 101 or may have the at least one flange 140 affixed to or formed integrally with the fluid impermeable barrier 102.

[064] FIG. 4 is a schematic cross-sectional view of fluid collection device 400 taken along plane A-A of FIG. 2A, according to one embodiment. Fluid collection device 400 may include portable vacuum source 330 disposed therein. Except as otherwise disclosed herein, fluid collection device 400 may be the same or substantially similar to fluid collection device 100 of FIG. 2A, in one or more aspects. The fluid collection device 400 may include a fluid collection member 401 and at least one flange 140. The fluid collection member 401 may be similar or identical to the fluid collection member 101 in one or more aspects, such as including one or more of the fluid impermeable barrier 102 defining the chamber 104 and the orifice 106, the capillary material 115, the fluid permeable membrane 118, the fluid permeable support 120, and the reservoir 122 or the conduit 108. The fluid collection device 400 includes the portable vacuum source 330 disposed therein. The portable vacuum source 330 may be similar or identical to the vacuum source 16 as disclosed herein, in one or more aspects. The portable vacuum source 330 may be sized to fit on or within the fluid collection device. The portable vacuum source may be sized and shaped for a person to carry. As shown, portable vacuum source 330 may be at least partially disposed within fluid-impermeable barrier 102. While a portable vacuum source 330 is depicted in FIG. 4, a fixed vacuum source (e.g., vacuum line) may alternatively or additionally be used with fluid collection device 400.

[065] The fluid collection device 400 includes the conduit 108 that is at least partially disposed in the chamber 104. For example, the capillary material 115 (e.g., the fluid permeable membrane 118, the fluid permeable support 120) may fill a portion of the chamber 104 and leave a vacant portion thereby forming the reservoir 122 between the capillary material 115 and the fluid impermeable barrier 102. The conduit 108 may include one or more walls defining an inlet 110 and the outlet 112. The inlet 110 allows at least some of the fluid(s) that are present in the chamber 104 to enter the conduit 108. In one example, the conduit 108 may be configured to have the inlet 110 located at, near, or spaced from a gravimetrically low point of the chamber 104. In one example, the conduit 108 may be configured to have the inlet 110 located at, near, or spaced from a gravimetrically low point of the chamber 104. For example, conduit 108 may be configured to have at least one inlet 110 disposed at or adjacent to reservoir 122. As shown, conduit 108 may extend through at least a portion of chamber 104, such as longitudinally through at least a portion of capillary material 115 in a concentrically central region of fluid collection member 115.

[066] Conduit 108 may be in fluid communication with the interior region (e.g., reservoir 122) of chamber 104 via fluid impermeable barrier 102. As such, fluid impermeable barrier 102 may define opening 124. In one example, as illustrated, opening 124 allows conduit 108 to extend outwardly from chamber 104 when conduit 108 is only partially disposed in chamber 104. In examples, conduit 108 may include a plurality of separate sections. For example and as shown, conduit 108 may include a first section A and section B. First section A may include inlet 110 extending from the distal end (e.g., first end region) to portable vacuum source 330 and section B may extend from portable vacuum source 330 outward to opening 124, such as to a fluid storage container (not shown).

[067] Portable vacuum source 330 may include any of the portable vacuum pumps disclosed herein. For example, portable vacuum source 330 may include a hand-held 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. Portable vacuum source 330 may be sized to fit in chamber 104 within fluid-tight barrier 102. In examples, portable vacuum source 330 may be sealed in a fluid-tight enclosure or container. The portable vacuum source 330 may apply a vacuum (e.g., suction) to section A of conduit 108 effective for sucking fluid from chamber 104. Fluid may travel through section A to section B (e.g., through portable vacuum source 330) and out of fluid collection device 300 via section B by vacuum-induced flow or suction applied by portable vacuum source 330. For example, portable vacuum source 330 may include a centrifugal pump and an impeller therein that may draw fluid from chamber 104 via inlet 110 and force fluid out of chamber 104 via section B of conduit 108. Each of section A and section B of conduit 108 may be in fluid communication with (e.g., sealed to) portable vacuum source 330. In some examples, portable vacuum source 330 and conduit 108 may be formed integrally together (e.g., exhibiting one-piece construction).

[068] FIG. 5 is a schematic cross-sectional view of fluid collection device 500 taken along plane A-A of FIG. 2A , according to one embodiment. Fluid collection device 500 may include portable vacuum source 330 disposed therein. Except as otherwise disclosed herein, fluid collection device 500 may be the same or substantially similar to fluid collection device 100 of FIG. 2A , in one or more aspects. The fluid collection device 500 may include a fluid collection member 501 and the at least one flange 140. The fluid collection member 501 may be similar or identical to the fluid collection member 101 in one or more aspects, such as including one or more of the fluid impermeable barrier 102 defining the chamber 104 and the orifice 106, the capillary material 115, the fluid permeable membrane 118, the fluid permeable support 120, and the reservoir 122 or the conduit 108. The fluid collection member 501 of the fluid collection device 500 includes the portable vacuum source 330 disposed therein. The portable vacuum source 330 may be attached to the fluid collection device 500 at or on the fluid impermeable barrier 102. While a portable vacuum source 330 is depicted in FIG. 5, a fixed vacuum source (e.g., vacuum line) may alternatively or additionally be used with the fluid collection device 500.

[069] The fluid collection device 500 includes the conduit 108 that is at least partially disposed within the fluid collection member 501. For example, the capillary material 115 (e.g., the fluid permeable membrane 118, the fluid permeable support 120) may fill a portion of the chamber 104 and leave a vacant portion thereby forming the reservoir 122 between the capillary material 115 and the fluid impermeable barrier 102. As shown, the conduit 108 may extend through at least a portion of the chamber 104, such as longitudinally through at least a portion of the capillary material 115 in a concentrically central region of the fluid collection member 115 101 to the reservoir 122. The conduit 108 may extend through the capillary material 115 to the reservoir 122. The conduit 108 may include one or more walls defining an inlet 110 and outfall 112. Inlet 110 allows at least some of the fluid(s) that are present in chamber 104 to enter conduit 108. In one example, conduit 108 may be configured to have inlet 110 located at, near, or spaced from a gravimetrically low point of chamber 104. In one example, conduit 108 may be configured to have at least one inlet 110 disposed at or adjacent to reservoir 122.

[070] Conduit 108 may be in fluid communication with the interior region of chamber 104 via fluid impermeable barrier 102. As such, fluid impermeable barrier 102 may define opening 124. In one example, as illustrated, opening 124 allows conduit 108 to extend externally from chamber 104 when conduit 108 is only partially disposed within chamber 104. In examples, conduit 108 may include a plurality of separate sections. For example and as shown, conduit 108 may include first section A and second section B. First section A may include inlet 110 extending from the distal end (e.g., first end region), outward from opening 124, to portable vacuum source 330 mounted thereon. The portable vacuum source 330 may be mounted to the outer surface of the fluid collection device 400. Section B may be attached to and extend from the portable vacuum source 330, such as to a fluid storage container (not shown).

[071] Portable vacuum source 330 may include any of the portable vacuum pumps disclosed herein such as a hand-held 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. Portable vacuum source 330 may be sized to fit in chamber 104 within fluid-tight barrier 102. In examples, portable vacuum source 330 may be sealed in a fluid-tight enclosure or container. The portable vacuum source 330 may apply a vacuum (e.g., suction) to section A of conduit 108 effective for sucking fluid from chamber 104. Fluid may travel through section A out of fluid collection device 400 to portable vacuum source 330. Fluid may be removed from portable vacuum source 330 via section B by vacuum-induced flow or suction applied by portable vacuum source 330. For example, portable vacuum source 330 may include a centrifugal pump and impeller therein that may draw fluid from chamber 104 via inlet 110 and suck fluid out of chamber 104 via portable vacuum source 330 to section B of conduit 108. Each of section A and section B of conduit 108 may be in fluid communication with (e.g., sealed to) portable vacuum source 330. In some examples ... that may draw fluid from chamber 104 via inlet 110 and suck fluid out of chamber 104 via portable vacuum source 330 to section B of conduit 108. Each of section A and section B of conduit 108 may be in fluid communication with (e.g., sealed to) portable vacuum source 330. In some examples, portable vacuum source 330 may include a centrifugal pump and impeller that may draw fluid from chamber 104 via inlet 110 and suck fluid out of chamber 104 via portable vacuum source 330 to section B of conduit 108. portable vacuum 330 and conduit 108 (e.g., either or both of section A or section B) may be integrally formed together to exhibit one-piece construction.

[072] The fluid collection devices shown in FIGS. 2-5 are examples of female fluid collection devices that are configured to collect fluid(s) from female subjects (e.g., collecting urine from a female urethra). However, the devices, systems, and methods disclosed herein may include male fluid collection devices shaped, sized, and otherwise configured to collect fluid(s) from male subjects (e.g., a cup-shaped fluid collection member for collecting urine from a male urethra). In such examples, male fluid collection device flanges may be located on the male fluid collection device to position and maintain the fluid collection device over the male urethra (e.g., penis). In any of the embodiments disclosed herein, the conduits 108 may include or be operatively coupled to a flow meter (not shown) for measuring the flow of fluid(s) therein, one or more safety devices (e.g., a STATLOCK® safety device, not shown) or fittings for securing the conduit 108 to one or more components of the systems or devices disclosed herein (e.g., a vacuum source or fluid storage vessel), or one or more valves for controlling the flow of fluid(s) in the systems and devices herein.

[073] In one example, at least a portion of the conduit 108 of the fluid collection devices or systems herein may be formed of an at least partially opaque material that may obscure the fluid(s) that are present therein. For example, section B of the conduits 108 disclosed herein may be formed of an opaque material or translucent material, while section A may be formed of a transparent material or translucent material. In examples, section B may include transparent material or translucent material. Unlike opaque or nearly opaque material, translucent material allows a user of the devices and systems herein to visually identify fluid(s) or problems that are inhibiting the flow of fluid(s) within the conduit 108.

[074] In any of the examples, systems or devices disclosed herein, the fluid collection device system may include humidity sensors (not shown) disposed within the fluid collection device chamber. In such examples, the humidity sensor may be operatively coupled to a controller or directly to the vacuum source and may provide electrical signals indicating that moisture is or is not detected in one or more portions of the chamber. The humidity sensor(s) may provide an indication that moisture is present, and in response thereto, the vacuum source controller (e.g., vacuum device with a programmable controller) may direct the initiation of suction to the chamber to remove fluid therefrom. Suitable humidity sensors may include capacitance sensors, volumetric sensors, potential sensors, resistance sensors, frequency domain reflectometry sensors, time domain reflectometry sensors, or any other suitable humidity sensor. In practice, humidity sensors can detect humidity in the chamber and can provide a signal to the vacuum source controller to activate the vacuum source.

[075] As noted above, the at least one flange 140 (e.g., pair of flanges) may be positioned on the fluid collection member in any of a number of positions and may extend therefrom at any angle. The cross-sectional shape of the fluid collection members disclosed herein may include any of a number of shapes or sizes. For example, the cross-sectional shape (along the B-B plane of FIG. 2A) may be substantially round (e.g., circular), elliptical, rectangular, triangular, irregular (e.g., no particular shape), etc. FIGS. 6-8 are schematic cross-sectional views of female fluid collection devices taken along the B-B plane of FIG. 2, according to different embodiments.

[076] FIG. 6 is a schematic cross-sectional view of the fluid collection device 100 taken along the B-B plane of FIG. 2A, according to one embodiment. The fluid collection device 100 includes a fluid collection member 101 and the at least one flange 140 extending therefrom. As shown, the fluid collection member 101 includes the fluid impermeable barrier 102, the capillary member 115 (e.g., the fluid permeable membrane 118 and the fluid permeable support 120), and the conduit 108, all arranged concentrically. As shown, the cross-sectional shape of the fluid collection member 101, and one or more components therein, may be generally round (e.g., circular or ellipsoidal).

[077] The at least one flange 140 may extend substantially tangentially from the fluid collection member 101 (e.g., the fluid impermeable barrier 102). For example, the at least one flange 140 may include at least 2 flanges 140, each extending from the fluid collection member 101 tangentially in substantially opposite directions from each other. "Substantially tangentially" may include flanges 140 that extend outwardly at an angle within 10% of 0° from an attachment point of the flange(s) to the outer surface of the fluid impermeable barrier. In examples, the at least one flange 140 may attach to the fluid collection member 101 at a point substantially opposite the orifice 106. The fluid collection member 101 may extend toward the user beyond the flanges 140. Such arrangements may allow the fluid collection member 101 to be positioned in the region of the female urethra, such as on or between the labia.

[078] In examples, flange bodies 142 may have adhesive member 144 attached thereto on a surface thereof that generally faces the same direction as orifice 106. In some examples, flanges 140 may alternatively or additionally include adhesive members 144 on the surface of flange body 142 that generally face away from orifice 106. The adhesive members 144 may allow flange body 142 to be attached (e.g., temporarily adhered) to one or more surfaces of the subject's skin that are adjacent to the user's urethra, such as the thighs or pubic region. The adhesive members 144 may secure and maintain fluid collection device 100 in a position to collect fluid from the user, such as between the labia to collect urine from a female subject.

[079] FIG. 7 is a schematic cross-sectional view of fluid collection device 700 taken along plane B-B of FIG. 2A, according to one embodiment. Fluid collection device 100 includes a fluid collection member 101 and at least one flange 140 extending therefrom. As shown, fluid collection member 101 includes fluid impermeable barrier 102, capillary member 115 (e.g., fluid permeable membrane 118 and fluid permeable support 120), and conduit 108, all arranged concentrically. As shown, the cross-sectional shape of fluid collection member 101, and one or more components therein, may be generally round (e.g., circular or ellipsoidal).

[080] The at least one flange 140 may extend substantially perpendicularly outwardly from the fluid collection member 101 (e.g., the fluid impermeable barrier 102). For example, the at least one flange 140 may include at least 2 flanges 140, each extending from the fluid collection member 101 perpendicularly (e.g., in a radial direction) from the fluid impermeable barrier 102 and in substantially opposite directions from each other. "Substantially perpendicularly" may include flanges 140 that extend outwardly at an angle within 10% of 90° relative to an outer surface of the fluid impermeable barrier at the point of attachment of the flange(s) 140 thereto. For examples and as shown, the at least one flange 140 may attach to the fluid collection member 101 and extend radially therefrom in radially opposite directions. The fluid collection member 101 may extend toward the user beyond the flanges 140. Such arrangements may allow the fluid collection member 101 to be positioned in the region of the female urethra, such as on or between the labia.

[081] In examples, flange bodies 142 may have adhesive member 144 attached thereto on a surface thereof that generally faces the same direction as orifice 106. In some examples, flanges 140 may alternatively or additionally include adhesive members 144 on the surface of flange body 142 that generally face away from orifice 106. The adhesive members 144 may allow flange body 142 to be attached (e.g., temporarily adhered) to one or more surfaces of the subject's skin that are adjacent to the user's urethra, such as the thighs or pubic region. The adhesive members 144 may secure and maintain fluid collection device 100 in a position to collect fluid from the user, such as between the labia to collect urine from a female subject.

[082] The cross-sectional shape of the fluid collection member and the position(s) of components therein may vary. FIG. 8 is a schematic cross-sectional view of fluid collection device 800 taken from a view along plane B-B of FIG. 2A, according to one embodiment. Fluid collection device 800 may be similar or identical to fluid collection device 100, in one or more aspects. Fluid collection device 800 includes fluid collection member 801 and at least one flange 140 extending therefrom. Fluid collection member 801 may be similar or identical to fluid collection member 101, in one or more aspects. For example, fluid collection member 801 includes fluid impermeable barrier 102, capillary member 115 (e.g., fluid permeable membrane 118 and fluid permeable support 120), and conduit 108. The cross-sectional shape of fluid collection member 801 may be generally rectangular (e.g., with rounded corners) as shown, or elliptical. In such examples, fluid collection member 801 may provide coverage (e.g., fluid absorption) of a larger surface area than fluid collection member 101 (FIG. 6). In examples, fluid impermeable barrier 102 may be shaped to provide a relatively wide cross-sectional shape. As shown, fluid impermeable barrier 102 may form chamber 104 having a gravimetrically low portion, such as in a V-notch or domed shape. Capillary material 115 may fill at least a portion of chamber 104. For example, fluid permeable support 120 may fill an interior portion of chamber 104 and fluid permeable member 118 may extend around at least a portion of fluid permeable support 120. In examples, fluid permeable support 120 may include a region therein to accommodate conduit 108. In examples, conduit 108 may be disposed in the gravimetrically low region of chamber 104. As shown, one or more of conduit 108, fluid permeable member 118, or fluid permeable support 120 may be disposed non-concentrically (e.g., not centered) on fluid collection member 801 or fluid impermeable barrier 102.

[083] Additional or alternative shapes for the fluid collection members are considered. For example, the fluid collection member may have a substantially triangular cross-sectional shape, wherein one corner or vertex of the triangle faces the user.

[084] The at least one flange 140 may extend substantially perpendicularly outward from the fluid collection member 801 (e.g., the fluid impermeable barrier 102). For example, the at least one flange 140 may include at least 2 flanges 140, each extending from the fluid collection member 801 perpendicularly from the fluid impermeable barrier 102 and in substantially opposite directions from each other. For examples and as shown, the at least one flange 140 may attach to the fluid collection member 801 and extend in radially opposite directions. The fluid collection member 801 may extend toward the user beyond the flanges 140. Such arrangements may allow the fluid collection member 801 to be positioned in the region of the female urethra, such as on or between the labia.

[085] In examples, flange bodies 142 may have adhesive member 144 attached thereto on a surface thereof that generally faces the same direction as orifice 106. In some examples, flanges 140 may alternatively or additionally include adhesive members 144 on the surface of flange body 142 that generally face away from orifice 106. The adhesive members 144 may allow flange body 142 to be attached (e.g., temporarily adhered) to one or more surfaces of the subject's skin that are adjacent to the user's urethra, such as the thighs or pubic region. The adhesive members 144 may secure and maintain fluid collection device 100 in a position to collect fluid from the user, such as between the labia to collect urine from a female subject.

[086] In some examples, the fluid collection devices in the present invention may include more than one conduit therein. The more than one conduit may be disposed in a plurality of regions therein. In examples, conduit 108 may include a plurality of inlets.

[087] Fluid collection devices having flanges thereon may be configured for use with male users. Devices and methods described herein may be configured to collect urine from a male user, such as having a fluid collection device shaped and sized to receive a male urethra (e.g., penis) therein. FIGS. 9A and 9B are schematic, cross-sectional isometric views of a male fluid collection device 900, according to one embodiment.

[088] Referring to FIGS. 9A and 9B, fluid collection device 900 includes a receptacle 950 and a cup portion 952. Receptacle 950 is sized, shaped, and made of a material to be attached to the skin surrounding the male urethra and have the male urethra positioned therethrough. For example, receptacle 950 may include an annular base 954 that defines an orifice 956 in receptacle 950. Annular base 954 is sized and shaped to be positioned around the male urethra (e.g., positioned around and/or on the penis), and orifice 956 may be configured to have the male urethra positioned therethrough. The annular base 954 may also be sized, shaped, made of a material, or otherwise configured to be coupled (e.g., adhesively attached, such as with a hydrogel adhesive) to the skin surrounding the male urethra (e.g., around the penis) with one or more flanges 940. In examples, the receptacle 950 may include one or more flanges that extend outwardly to contact the person wearing the fluid collection device 900. The annular base 954 may include, define, or be affixed to at least one flange 940 that extends substantially perpendicular to the labia 960.

[089] Flange(s) 940 may be similar or identical to flange 140 disclosed herein, in one or more aspects. For example, flange 940 may include flange body 942 and an adhesive 944 (or other attachment body for attaching flange body 942 to a subject or to the subject's clothing). Flange body 942 may be similar or identical to flange body 142 disclosed herein, in one or more aspects. For example, flange body 942 may be formed from a thermoplastic elastomer, polyethylene, polyvinyl chloride, ethylene vinyl acetate, polytetrafluoroethylene, latex, silicon, fabric, woven fabric, etc. Flange body 942 may extend substantially perpendicular to lip 960. Adhesive 944 may be similar or identical to adhesive 144 disclosed herein, in one or more aspects. In some examples, more than two flanges 940 may extend from annular base 954. In some examples (not shown), flange 940 may include a single flange body 942 that extends from and around substantially the entire annular base 954. In such examples, adhesive 944 may be located at discrete points or around substantially the entire surface of flange body 942 that is expected to come into contact with the wearer. One or more portions of receptacle 950 may be formed from the same material as fluid impermeable barrier 102 such as a fluid impermeable polymer (e.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, polyurethane, a polycarbonate, polyvinyl chloride, latex, silicone, etc.), a metal film, other suitable material, or combinations thereof.

[090] In one example, the annular base 954 may exhibit the general shape of the skin surface to which the annular base 954 is selected to be engaged and/or may be flexible, thereby allowing the annular base 954 to conform to any shape of the skin surface. The receptacle 950 also defines a hollow region that is configured to receive (e.g., seal) the cup portion 952. For example, the receptacle 950 may include the lip 960 that extends upwardly from the annular base 954. The lip 960 may be tall enough to prevent the cup portion 952 from being accidentally removed from the receptacle 950 (e.g., at least 0.5 cm in height, 1 cm in height, at least 2 cm in height, or at least 5 cm in height). In some examples, the annular base 954 is optional. For example, receptacle 950 may only include flange 954. In some examples (not shown), the fluid collection device may be a one-piece design, with cup portion 952 and receptacle 950 being a single piece. In some examples, receptacle 950 is optional.

[091] Cup portion 952 includes (e.g., may be formed from) a fluid impermeable barrier 902 that is sized and shaped to fit within the hollow region of receptacle 950. Cup portion 952 may be shaped to retain a fluid therein. For example, fluid impermeable barrier 902 may define cup portion 952, such as a substantially tubular (e.g., cylindrical) body having a closed end, as illustrated in FIGS. 9A and 9B. Accordingly, cup portion 552 may have a generally cup-like shape with a chamber 504 therein. Fluid impermeable barrier 902 may be similar or identical to fluid impermeable barrier 102, in one or more aspects. The fluid impermeable barrier 902 partially defines the chamber 904. The fluid impermeable barrier 902 may also define an orifice 956 extending through the fluid impermeable barrier 902 that is configured to have a male urethra positioned therethrough. The fluid impermeable barrier 902 may also define at least one passageway 962 (e.g., vacuum relief port) that allows the chamber 904 to remain at substantially atmospheric pressure. The at least one passageway 962 may be located at any point in the cup portion 952, such as near or nearer to the orifice 956. The cup portion 952 also includes at least a portion of the conduit 108 therein, such as at least partially disposed in the chamber 904. For example, the conduit 108 may extend from the cup portion 952 to a region at least proximate to the orifice 956. The region proximate to the orifice 956 may be disposed near or on the skin surrounding the male urethra (e.g., on the penis). Accordingly, when a patient lies on his or her back, fluid (e.g., urine) may pool near the orifice 956 against the subject's skin. Fluid may be removed from chamber 904 via conduit 108. In some examples, cup portion 952 of fluid impermeable barrier 902 may be constructed of a material and/or have a thickness that allows cup portion 952 to collapse when placed under vacuum, so as to remove air from around a penis in fluid collection device 900 during use. In such examples, conduit 108 may extend only into chamber 904 at opening 924 (e.g., not through the area adjacent to the orifice). In such examples, urine may be collected and removed from fluid collection device 900 at the end closest to opening 924. In such examples, the at least one passageway may be located closest to orifice 956.

[092] The fluid collection device 900 may include capillary material therein. The fluid collection device 900 may include the fluid permeable membrane 118. The fluid permeable membrane 118 may be disposed between the fluid impermeable barrier 902 of the cup portion 952 and a penis inserted into the chamber 904. The fluid collection device 900 may include a fluid permeable support 120. The fluid permeable support 120 may be positioned between the cup portion 952 and a penis inserted into the chamber 904, such as between the fluid permeable membrane 118 and the fluid impermeable barrier 902. The side walls or end of the chamber 904 may be covered with either or both of the fluid permeable membrane 118 or the fluid permeable support 120.

[093] In some examples, a vacuum source (e.g., vacuum source 16 of FIG. 1) may be located remotely from cup portion 952. In such examples, conduit 108 may extend outward and away from cup portion 952 to the vacuum source (e.g., portable vacuum source). Inlet 110 of conduit 108 is in fluid communication with the vacuum source, either directly or indirectly. The outlet (not shown) may be in fluid communication with a fluid storage vessel (not shown) via conduit 108 in the direction shown by the arrows. The fluid impermeable barrier 902 may include at least one opening 924 that is sized and shaped to receive and seal against the conduit 108, such as within the chamber 904. Accordingly, the interior region of the chamber 904 may be in fluid communication with the vacuum source 16 via the conduit 108. As the vacuum source applies a vacuum/suction in the direction of the arrows in FIG. 9B, fluid in the chamber 904 may be removed through the conduit 108. In some examples, fluid may be pumped via the vacuum source 16 through one or more conduit sections to the fluid storage vessel (not shown). In some examples, the vacuum source may be located on or in the cup portion 952 in a manner similar or identical to the vacuum source 330 located in or on the fluid impermeable barrier 102 in FIGS. 4 and 5, in one or more aspects.

[094] In one example, portions of chamber 904 may be substantially empty due to the varying size and rigidity of the male penis. However, in some examples, the outermost regions of the chamber 904 (e.g., periphery of the interior regions of the cup portion 952) may include a porous material (e.g., one or more of the fluid-permeable membrane 118 and fluid-permeable support 120) positioned (e.g., at the end of the cavity) and configured to contain a stream of urine from the male urethra, thereby limiting splashback, and/or to direct the fluid(s) to a selected region of the chamber 904. Since the chamber 904 is substantially empty (e.g., substantially all of the chamber 904 forms a reservoir), fluids are susceptible to accumulating at a gravimetrically low point of the chamber 904. The gravimetrically low point of the chamber 904 may be at an intersection of an individual's skin and the fluid collection device 900, a corner formed in the cup portion 952, or another suitable location depending on the specific application of the chamber 904. the orientation of the person wearing it. The inlet 110 of the conduit 108 may be positioned to be adjacent or proximate to the gravimetrically low point of the chamber 904, such as adjacent to the annular base 954. For example, the inlet 110 may be coextensive with or offset from the orifice 956. In examples, the inlet may be positioned adjacent to the terminal end of the cup portion 952 (e.g., substantially opposite the orifice).

[095] During operation, a male subject wearing fluid collection device 900 may secrete fluid(s) (e.g., urine) into chamber 904. The fluid(s) may pool or otherwise collect in chamber 904. At least some of the fluid(s) may enter the interior of conduit 108 via inlet 110. Fluid may be withdrawn from fluid collection device 900 via vacuum/suction provided by the vacuum source. In some examples, during operation, passageway 962 may substantially maintain the pressure in chamber 904 at atmospheric pressure, even as fluid is introduced into and subsequently removed from chamber 904.

[096] FIG. 10 is a flowchart of a method 1000 for using any of the fluid collection devices and/or fluid collection systems disclosed herein, according to one embodiment. Method 1000 may include act 1010 which recited “positioning an orifice of a fluid collection device adjacent to a female urethra or around a male urethra of a user, the orifice defined by a fluid impermeable barrier of the fluid collection device.” Act 1010 may be guided by act 1020 which recited “attaching the fluid collection device to the user.” Act 1020 may be followed by act 1030 which recited “receiving fluids from the female urethra or male urethra into a chamber of the fluid collection device, the chamber of the fluid collection device at least partially defined by the fluid impermeable barrier.”

[097] Acts 1010, 1020, and 1030 of method 1000 are for illustrative purposes. For example, act 1010, 1020, 1030 of method 1000 may be performed in different orders, divided into multiple acts, modified, supplemented, or combined. In one example, one or more of acts 1010, 1020, 1030 of method 1000 may be omitted from method 1000. Any of acts 1010, 1020, or 1030 may include the use of any of the fluid collection devices or systems disclosed herein.

[098] Act 1010 recites “positioning an orifice of a fluid collection device adjacent to a female urethra or surrounding a male urethra of a user, the orifice defined by a fluid impermeable barrier of the fluid collection device.” In some examples, act 1010 may include positioning the orifice of a female fluid collection device such that the fluid permeable membrane of the female fluid collection device abuts or is positioned proximate to the female urethra. For example, positioning an orifice of a fluid collection device adjacent to a female urethra of a user may include positioning the orifice of the fluid collection member of the fluid collection device in, adjacent to, between the labia. In the examples, the female fluid collection device may be similar or identical to fluid collection device 100, 400, 500, 700, or 800 (FIGS. 2A-8, in one or more aspects.

[099] In some examples, act 1010 may include positioning the orifice of a male fluid collection device around a urethra of a male user such that the user's urethra is positioned within the fluid collection device. For example, positioning an orifice of a fluid collection device around a male urethra of a user may include positioning a user's penis in the cup portion of the male fluid collection device. In the examples, the male fluid collection device may be similar or identical to fluid collection device 900 (FIG. 9), in one or more aspects. In such examples, method 1000 may include positioning a cup portion of the male fluid collection device in a hollow region of the receptacle such that the male urethra is positioned in the cup portion through the orifice in the receptacle of the male fluid collection device. Flanges on the receptacle may be used to secure the fluid collection device to a male user.

[0100] Act 1020 recited “attaching the fluid collection device to the user.” Attaching the fluid collection device to the user may include affixing one or more flanges of the fluid collection device to the user or to the user’s clothing. In examples, attaching the fluid collection device to the user may include adhering the adhesion member(s) of at least one flange (e.g., flanges) of the fluid collection device to one or more of the user’s lower abdomen, inner thigh(s), testicles, pubic region, hip region, or perineum (or to clothing over any of the aforementioned regions). For example, attaching the fluid collection device to the user may include adhering the adhesion member(s) of the at least one flange of the fluid collection device to the inner thigh(s) of a female user. Attaching the fluid collection device to the user may include adhering the adhesion member of the at least one flange of the fluid collection device to the clothing (e.g., undergarments) of the user. For example, adhering the adhesion member of the at least one flange of the fluid collection device to the clothing may include adhering one or more flanges to or around the crotch (e.g., gusset) of the user's undergarments. Attaching the fluid collection device to the user may include attaching the fluid collection device to the user to maintain the port adjacent to, in, or on the user's urethra, even as the user moves.

[0101] Act 1030 recites “receiving fluids from the female urethra or male urethra within a chamber of the fluid collection device, the chamber of the fluid collection device at least partially defined by the fluid impermeable barrier.” In examples, act 1030 may include retaining the fluid within the chamber, such as at a gravimetrically low point therein. In some examples, act 1030 may include capillarizing the fluid outward from the orifice using the capillary material (e.g., a fluid-permeable membrane and a fluid-permeable support). In some examples, act 1030 may include receiving the fluid within the chamber of the fluid collection device. In any of the examples, act 1030 may include flowing the fluid toward a portion of the chamber that is in fluid communication with an inlet of a conduit in fluid communication with a vacuum source. For example, the act 1030 may include draining fluid into a substantially unoccupied portion of the chamber (e.g., a reservoir), to a gravimetrically low point in the chamber, etc. The fluid may include one or more fluids, such as urine, liquid blood, sweat, etc. In some examples, receiving fluid from the female urethra into a chamber of the fluid collection device, the chamber of the fluid collection device, at least partially defined by the fluid impermeable barrier, may include capillarizing fluid into the chamber via the fluid permeable membrane and fluid permeable support of the fluid collection device. For example, capillarizing fluid into the chamber via the fluid permeable membrane and fluid permeable support may include capillarizing urine into the reservoir in the fluid collection device.

[0102] Method 1000 may include removing at least some of the fluid from the fluid collection device. For example, removing at least some of the fluid from the fluid collection device may include removing fluid from within the chamber of the fluid collection device. Such removal may include applying suction with a vacuum source effective to suck fluids from the chamber via a conduit disposed therein (which conduit is in fluid communication with the vacuum source). In examples, removing fluids from the fluid collection device by applying suction with a vacuum source effective to suck (e.g., vacuum) fluid from the chamber via a conduit disposed therein includes using any of the vacuum sources disclosed herein, such as a portable vacuum source. In one example, applying suction may include activating the vacuum source (e.g., portable suction device) in fluid communication with the conduit inlet to the fluid collection device. In examples, activating the vacuum source in fluid communication with the conduit inlet to the fluid collection device may include providing power to the vacuum source by one or more of actuating an on/off switch, pressing a button, opening a valve, connecting the fluid collection device to a vacuum line, plugging a portable vacuum source into a power outlet, placing batteries in the vacuum source, etc. In examples, the vacuum source may include a manually operated vacuum pump, and applying suction with a vacuum source may include manually operating the manually operated vacuum pump effective to draw fluids from the chamber via the conduit disposed therein that is in fluid communication with the (portable) vacuum source. In examples, the vacuum source may include a plumbed vacuum line, and applying suction with a vacuum source may include manually connecting the plumbed vacuum line to the fluid collection device (e.g., the conduit) or opening a valve therebetween effective to draw fluid from the chamber via the conduit disposed therein.

[0103] In examples, applying suction with a vacuum source effective to aspirate fluids from the chamber via a conduit disposed therein and in fluid communication with the vacuum source can be effective to remove at least some fluid (e.g., urine) from the chamber (e.g., interior region) of the fluid collection device. In examples, applying suction with a vacuum source effective to aspirate fluid from the chamber via a conduit disposed therein and in fluid communication with the vacuum source can be effective to transfer at least some of the fluid from the chamber of the fluid collection device to a fluid storage container (e.g., a bottle or bag). In some examples, applying suction with a vacuum source effective to aspirate fluid(s) from the chamber can include removing fluid from one or more of a reservoir, fluid-permeable support, or fluid-permeable membrane of the fluid collection device.

[0104] In examples, the vacuum source (e.g., suction device) may be disposed on or within the fluid collection device, and applying suction with the vacuum source may include activating the vacuum source. In examples, the vacuum source may be spaced from the fluid collection device, and applying suction with the vacuum source may include activating the vacuum source, such as a portable vacuum source.

[0105] In examples, applying suction with a vacuum source effective to draw fluid from the chamber via a conduit disposed therein and in fluid communication with the vacuum source may include sensing moisture in the chamber (e.g., via one or more moisture sensors) and in response thereto, activating the vacuum source to provide suction to the chamber. Control of the vacuum source in response to signals indicating that moisture or a level thereof is present in the chamber may be automatic, such as via a controller, or may merely provide an indication that a level of moisture is present that may necessitate removal of fluid from the chamber of the fluid collection device. In the latter case, a user may receive the indication and activate the vacuum source such as a pump.

[0106] In one example, method 1000 may include collecting fluid that is removed from the fluid collection device, such as into a fluid storage container that is spaced from the fluid collection device and in fluid communication with the conduit. The fluid storage container may include any of the fluid storage containers disclosed herein.

[0107] While various aspects and embodiments have been disclosed in the present invention, other aspects and embodiments are contemplated. The various aspects and embodiments disclosed in the present invention are for purposes of illustration and are not intended to be limiting.

Claims (15)

1. A fluid collection device (12, 100), comprising: a fluid collection member (101), including: a fluid impermeable barrier (102) at least partially defining a chamber (104), the fluid impermeable barrier (102) also being cylindrical and defining an orifice (106) extending therethrough, the orifice (106) configured to be positioned adjacent a female urethra or have a male urethra positioned therethrough; capillary material (115) disposed at least partially within the chamber (104); a conduit (108) disposed within the chamber (104), the conduit (108) including an inlet (110) positioned within the fluid collection device (12, 100) and an outlet (112) configured to be fluidly coupled to a portable vacuum source (330); and at least one flange (140) extending outwardly from the fluid collection member (101) along a longitudinal axis thereof, the at least one flange (140) including an adhesive member (144) thereon. 2. The fluid collection device (12, 100) of claim 1, wherein the at least one flange (140) extends tangentially from the fluid collection member (101). 3. The fluid collection device (12, 100) of claim 1, wherein the at least one flange (140) extends perpendicularly from the fluid collection member (101). 4. Fluid collection device (12, 100) according to any one of claims 1 to 3, characterized in that the capillary material (115) includes one or more of a fluid-permeable membrane (118) or a fluid-permeable support (120). 5. The fluid collection device (12, 100) of claim 4, wherein the fluid-permeable membrane (118) extends through the orifice (106) and the fluid-permeable support (120) is disposed below the fluid-permeable membrane (118). 6. The fluid collection device (12, 100) of claim 4 or 5, further comprising a reservoir (122) defined between the fluid-impermeable barrier (102) and one or more of the fluid-permeable membrane (118) or fluid-permeable support (120), and wherein the inlet (110) is positioned at or adjacent to the reservoir (122). 7. A fluid collection system (10) comprising: a fluid storage container (14) configured to hold a fluid; the fluid collection device (12, 100) defined in claim 1; and a vacuum source (16) in fluid communication with one or more of the fluid storage container (14) or the fluid collection device (12, 100), the vacuum source (16) configured to extract fluid from the fluid collection device (12, 100). 8. The fluid collection system (10) of claim 7, wherein the vacuum source (16) includes a portable vacuum source (330) disposed within the fluid collection device (12, 100). 9. The fluid collection system (10) of claim 7, wherein: the fluid collection device (12, 100) is spaced and positioned upstream of the fluid storage container (14); and the vacuum source (16) is positioned downstream and outside of the fluid collection device (12, 100). 10. A method of collecting fluid (1000), wherein the method (1000) comprises: positioning an orifice (106) of a fluid collection device (12, 100) adjacent to a female urethra or a male urethra of a user (190), the orifice (106) defined by a fluid impermeable barrier (102) of the fluid collection device (12, 100), wherein the fluid collection device (12, 100) is cylindrical; securing the fluid collection device (12, 100) to the user (190) via at least one flange (140) of the fluid collection device (12, 100), the at least one flange (140) extending outwardly from the fluid collection device (12, 100) along a longitudinal axis thereof and including an adhesive member (144) thereon; and receive fluid from the female urethra or male urethra within a chamber (104) of the fluid collection device (12, 100), the chamber (104) of the fluid collection device (12, 100) at least partially defined by the fluid impermeable barrier (102). 11. The method (1000) of claim 10, wherein attaching the fluid collection device (12, 100) to the user (190) includes affixing the at least one flange (140) to the user (190) or to the user's clothing (190). 12. The method (1000) of claim 10 or 11, wherein: the fluid collection device (12, 100) is configured as a female fluid collection device having: a fluid-impermeable barrier (102) defining a chamber (104) therein; the at least one flange (140) extending from the fluid-impermeable barrier (102); and a conduit (108) extending into the chamber (104). 13. Method (1000) according to any one of claims 10 to 12, characterized in that it further comprises removing at least part of the fluid from the fluid collection device (12, 100) with a vacuum source (16) effective to suck the fluid from the chamber (104) through a conduit (108) disposed therein and in fluid communication with the vacuum source (16). 14. The method (1000) of any one of claims 10 to 13, wherein the vacuum source (16) is disposed within the fluid collection device (12, 100) and applying suction with the vacuum source (16) includes activating the vacuum source (16). 15. The method (1000) of any one of claims 10 to 13, wherein the vacuum source (16) is spaced from the fluid collection device (12, 100) and applying suction with the vacuum source (16) includes activating the vacuum source (16).