CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims priority to U.S. Provisional Patent Application No. 63/011,445 filed on April 17, 2020, the disclosure of which is incorporated herein, in its entirety, by this reference.

BACKGROUND

[0002] An individual may have limited or impaired mobility such that typical urination processes are challenging or impossible. For example, the individual may have surgery or a disability that impairs mobility. In another example, the individual may have restricted travel conditions such as those experienced by pilots, drivers, and workers in hazardous areas. Additionally, fluid collection from the individual may be needed for monitoring purposes or clinical testing.

[0003] Bed pans and urinary catheters, such as a Foley catheter, may be used to address some of these circumstances. However, bed pans and urinary catheters have several problems associated therewith. For example, bed pans may be prone to discomfort, spills, and other hygiene issues. Urinary catheters be may be uncomfortable, painful, and may cause urinary tract infections.

[0004] Thus, users and manufacturers of fluid collection devices continue to seek new and improved devices, systems, and methods to collect urine.

SUMMARY

[0005] Embodiments disclosed herein are related to female urinary capture devices (e.g. , urine or fluid collection devices) configured to secure to a vulva of a user, and related systems and methods. In an embodiment, a fluid collection device includes a fluid impermeable vessel, an opening and a securement element. The fluid impermeable vessel is sized and dimensioned to be positioned over a vulva of a user. The fluid impermeable vessel includes a chamber, a distal end region, and a proximal end region. The opening is positioned on the proximal end region to cover at least a urethral opening of the user when the fluid impermeable vessel is positioned over the vulva. The securement element is secured to the fluid impermeable vessel and configured to retain the fluid impermeable vessel over the vulva.

[0006] In an embodiment, a method of collecting urine includes positioning a fluid impermeable vessel of a fluid collection device over a vulva of the female user with an opening on the fluid collection device positioned over a urethral opening of the user. The method also includes securing the fluid impermeable vessel over the vulva with a securement element. The method also includes collecting urine in a chamber defined by the fluid impermeable vessel. The method also includes drawing urine from the fluid impermeable vessel with a tube in fluid communication with the chamber.

[0007] Features from any of the disclosed embodiments may be used in combination with one another, without limitation. In addition, other features and advantages of the present disclosure will become apparent to those of ordinary skill in the art through consideration of the following detailed description and the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS [0008] The drawings illustrate several embodiments of the present disclosure, wherein identical reference numerals refer to identical or similar elements or features in different views or embodiments shown in the drawings.

[0009] FIG. 1 is a block diagram of a fluid collection system, according to an embodiment.

[0010] FIG. 2A is an isometric front view of a fluid collection device, according to an embodiment.

[0011] FIG. 2B is an isometric rear view of the fluid collection device of FIG. 2A positioned on a user.

[0012] FIG. 2C is a side view of the fluid collection device of FIG. 2A positioned on a user in a supine position.

[0013] FIG. 2D is a side view of the fluid collection device of FIG. 2A positioned on a user in a sitting position.

[0014] FIG. 3A is an isometric front view of a fluid collection device, according to an embodiment.

[0015] FIG. 3B is an isometric rear view of the fluid collection device of FIG. 3A positioned on a user.

[0016] FIG. 3C is a side view of the fluid collection device of FIG. 3A positioned on a user in a supine position.

[0017] FIG. 3D is a side view of the fluid collection device of FIG. 3A positioned on a user in a sitting position.

[0018] FIG. 4A is a rear view of a fluid collection device, according to an embodiment. [0019] FIG. 4B is an isometric rear view of the fluid collection device of FIG. 4A positioned on a user. [0020] FIG. 4C is a side view of the fluid collection device of FIG. 4A positioned on a user in a supine position.

[0021] FIG. 4D is a side view of the fluid collection device of FIG. 4A positioned on a user in a sitting position.

[0022] FIG. 5A is a front isometric view of a fluid collection device in a first configuration, according to an embodiment.

[0023] FIG. 5B is a front isometric view of the fluid collection device of FIG. 5B is a second configuration.

[0024] FIG. 6A is a front isometric view of a fluid collection device, according to an embodiment.

[0025] FIG. 6B is a front isometric view of a valve for use with a fluid collection device, according to an embodiment.

[0026] FIG. 6C is a front isometric view of a fluid collection device, according to an embodiment.

[0027] FIG. 7A is a rear isometric view of a fluid collection device, according to an embodiment.

[0028] FIG. 7B is a front isometric view of the fluid collection device of FIG. 7A.

[0029] FIG. 8 is a rear isometric view of a fluid collection device, according to an embodiment.

[0030] FIG. 9A is a rear isometric view of a fluid collection device and a portion of a securement element.

[0031] FIG. 9B is a front isometric view of a fluid collection device, according to an embodiment.

[0032] FIG. 9C is a front isometric view of a fluid collection device, according to an embodiment.

[0033] FIG. 9D is a front isometric view of a fluid collection device, according to an embodiment.

[0034] FIG. 9E is a rear isometric view of a fluid collection device and a portion of a securement element, according to an embodiment.

[0035] FIG. 10A is a rear isometric view of a fluid collection device secured to a user, according to an embodiment.

[0036] FIG. 10B is a front isometric view of a fluid collection device, according to an embodiment. [0037] FIG. 11 is a flow diagram of a method for collecting fluid, according to an embodiment.

DETAILED DESCRIPTION

[0038] Embodiments disclosed herein are fluid collection devices configured to attach to or over the vulva of a woman for improved securement and urine capture. Urinary incontinent female patients are commonly managed by nurses/caregivers using diapers and pads which result in increased risk for urinary tract infections (UTIs), skin breakdown, risk of patient falls, and significant time spent on managing incontinence. Likewise, incontinent females in the non-acute care setting rely on similar means to manage their condition. [0039] Many embodiments of fluid collection devices described herein include an external female urinary “catheter” device. In general, the fluid collection device is securable or secured to the vulva of a woman to improve securement of the fluid collection device and fluid capture. Some embodiments also may be used on male patients, such as a when the male patient has a buried penis. The fluid collection device may be configured to simultaneously capture and transport voided urine or other fluids to an external reservoir or fluid collection container, thus leaving the woman dry and free of urine directly contacting the skin. Many fluid collection devices described herein may be utilized in either a gravity configuration or a vacuum-assisted configuration. In the gravity configuration, a collection reservoir may be located below the fluid collection device. In the vacuum-assisted configuration, the fluid collection device may be connected to a reservoir/pump system to actively pull urine away from the fluid collection device. The fluid collection device may be vented with a hydrophobic vent to prevent leakage.

[0040] In general, the fluid collection device includes an external collection vessel, such as a cup, pouch, and the like. The external collection vessel may be pushed against the anatomy of the female and/or secured to the anatomy of the female via one or more of straps, adhesives, securement element, or some combination thereof. The external collection vessel may be attached to a tube, and the fluid may be pulled away from the external collection vessel via gravity or vacuum to a collection device away from the patient anatomy. The fluids collected by the fluid collection devices may include urine. The fluids collected by the fluid collection devices may also include at least one of vaginal discharge, reproductive fluids, blood, sweat, or other bodily fluids.

[0041] FIG. 1 is a block diagram of a system 10 for fluid collection, according to an embodiment. The system 10 includes a fluid collection device 12, a fluid storage container 14 (or reservoir), and a vacuum source 16. In some embodiments, fluid may be withdrawn from the fluid collection device 12 with gravity, and the vacuum source 16 is absent. The fluid collection device 12 may include any of the fluid collection devices described herein. The fluid collection device 12, the fluid storage container 14, and the vacuum source 16 may be fluidly coupled to each other via one or more conduits 17 or tubes. The conduit 17 may include any of the conduits described herein, such as the conduit 108. The fluid collection device 12 may be operably coupled to one or more of the fluid storage container 14 or the portable vacuum source via the conduit 17. Fluid (e.g., urine or other bodily fluids) collected in the fluid collection device 12 may be removed from the fluid collection device 12 via the conduit 17, which protrudes into an interior region of the fluid collection device 12. For example, a first open end of the conduit 17 may extend into the fluid collection device 12 to a reservoir therein. The second open end of the conduit 17 may extend into the fluid storage container 14 or the vacuum source 16. The suction force may be introduced into the interior region of the fluid collection device 12 via the first open end of the conduit 17 responsive to a suction (e.g., vacuum) force applied at the second end of the conduit 17. The suction force may be applied to the second open end of the conduit 17 by the vacuum source 16 either directly or indirectly.

[0042] The suction force may be applied indirectly via 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 portable 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 portable vacuum source 16 to a point outside of the fluid collection device 12, such as to the fluid storage container 14. In such examples, the portable vacuum source 16 may be disposed between the fluid collection device 12 and the fluid storage container 14.

[0043] The fluid collection device 12 may be shaped and sized to be positioned at least proximate to a female urethra. 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 conduit 17 may extend into the fluid collection device 12 at a first end region, through one or more of the fluid impermeable barrier, fluid permeable membrane, or the fluid permeable support to a second end region of the fluid collection member of the fluid collection device 12. Example fluid collection devices for use with the systems and methods herein are described in more detail below.

[0044] In some embodiments, the fluid storage container 14 may include a bag (e.g., drainage bag), a bottle or cup (e.g., collection jar), or any other enclosed container for storing bodily fluids such as urine. In examples, the conduit 17 may extend from the fluid collection device 12 and attach to the fluid storage container 14 at a first point therein. 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 fluidly coupled to a first conduit section that is also fluidly coupled to the fluid collection member of the fluid collection device 12. The container may be fluidly coupled to a second section of the conduit 17 that is also fluidly coupled to a portable vacuum source. In such examples, the portable 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 through fluid collection device 12 via the fluid storage container 14. As the fluid is drained from the chamber, the fluid may travel through the first section of conduit 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 portable vacuum source 16.

[0045] In some embodiments, the vacuum source 16 may be disposed in or on the fluid collection device 12. In such examples, the conduit 17 may extend from the fluid collection device and attach to the vacuum source 16 at a first point therein. An additional conduit 17 may attach to the portable vacuum source 16 at a second point thereon and may extend out of the fluid collection device 12, and may attach to the fluid storage container 14. Accordingly, a vacuum (e.g., suction) may be drawn through fluid collection device 12 via the fluid storage container 14.

[0046] The vacuum source 16 may include one or more of a manual vacuum pump, and electric vacuum pump, a diaphragm pump, a centrifugal pump, a displacement pump, a magnetically driven pump, a peristaltic pump, or any pump configured to produce a vacuum. The vacuum source 16 may provide a vacuum or suction to remove fluid from the fluid collection member of the fluid collection device 12. In some embodiments, the vacuum source 16 may be powered by one or more of a power cord (e.g., connected to a power socket), one or more batteries, or even manual power (e.g., a hand operated vacuum pump). In examples, the vacuum source 16 may be sized and shaped to fit outside of, on, or within the fluid collection device 12. For example, the portable vacuum source 16 may include one or more miniaturized pumps or one or more micro pumps. The vacuum sources 16 disclosed herein may include one or more of a switch, a button, a plug, a remote, or any other device suitable to activate the vacuum source 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 use of the devices and systems herein outside of hospital or care facility environments where vacuum lines are plumbed into patient rooms or large (e.g., larger or heavier than a patient can readily carry) vacuum sources are located. For example, a portable vacuum source may be small and light enough to be carried by a user (e.g., patient) or aid (e.g., nurse) during transportation of the user.

[0047] FIGS. 2A-2D show a fluid collection device 200, according to an embodiment. The fluid collection device 200 may be sized to fit substantially all users, as the fluid collection device 200 is sized and dimensioned to cover a large range of anatomy. The fluid collection device 200 includes a fluid permeable pouch 202 sized and dimensioned to be positioned over a vulva of a user 50. In some embodiments, the fluid impermeable pouch 202 may include a film pouch, a hard or soft plastic/elastomer cup or other collection device. The fluid impermeable pouch 202 at least partially defines a chamber 204 and includes a distal end region and a proximal end region. The fluid collection device 206 includes an opening 206 positioned on the proximal end region to cover at least a urethral opening of the user 50 when the fluid impermeable pouch 202 is positioned over the vulva. [0048] The fluid collection device 200 also includes a securement element 220 secured to the fluid impermeable pouch 202 and configured to retain the fluid impermeable pouch 202 over the vulva of the user 50. In some embodiments, the pouch 202 may define an aperture 212 on the distal end region, and the fluid collection device 200 may include a tube 208 connected to the fluid impermeable pouch 202 and in fluid communication with the chamber 204 of the fluid impermeable pouch 202 through the aperture 212. In some embodiments, the fluid collection device 200 may include a one-way material 218 positioned at the proximal end region of the fluid impermeable pouch 202 and defining the opening 206. The one-way material 218 may be configured to allow fluid into the chamber 204 of the fluid impermeable pouch 202 and may prevent fluid from exiting the chamber 204 through the one-way material 218. In some embodiments, the one-way material 218 forms a ring around the opening 206. In some embodiments, a ring of non-permeable material defines the opening 206 and the one-way material is absent.

[0049] The fluid collection device 200 is configured to secure to a user by sliding a portion of the securement element 220 under the buttocks of the user 50, and the weight of the user may keep the fluid collection device 200 in place. In some embodiments, the securement element includes a handle 226 secured to the fluid impermeable pouch 202 and a base 222 (or plate) connected to the handle 226. The base 222 is positioned on the securement element 220 to slide under buttocks of the user when the user is in a supine position (shown in FIG. 2C) or a sitting position (shown in FIG. 2D) and retain the fluid impermeable pouch 202 over the vulva of the user 50. In some embodiments, the base 222 includes an absorbent material 224 positioned thereon to be underneath the fluid impermeable pouch 202 and the vulva of the user 50.

[0050] In some uses, the fluid collection device 200 may not be joined to the anatomy, but may be spaced to from the anatomy to the preference of the user. The base 222 may allow the fluid collection device 200 to slide in and out of position. For example, the base 222 may be slid under the buttocks of the user to position the fluid collection device against the anatomy of the user 50. The base 222 may include one or more features to secure the base to the surface of the user (bed, seat, etc.), such as but not limited to adhesive, suction cups, rubber feet. The base 222 may also be held in place by the weight of the user. In some embodiments, the base 222 is configured to allow an individual to modify an angle of a wicking material 210 or other portions of the fluid collection device 200 to an appropriate position for the user 50. For example, individual users may have different anatomical sizes requiring differing angles or positioning of the wicking material 210 or other portions of the fluid collection device 200. The user also may move between a seated and a supine position, requiring the fluid collection device 200 to be adjusted to be positioned against the anatomy of the wearer. Accordingly, the fluid collection device 200 may include an elbow or bendable portion between the base 222 and the handle 226 that angles the fluid collection device 200 to the desired position. In these and the other embodiments, at least a portion of the securement element 220 may include shape memory material configured to allow the user or caregiver to bend at least a portion of the securement element to a desired angle that is retained by the securement element 220.

[0051] In some embodiment, the handle 226 may be attached or secured to the fluid pouch 202 and configured to allow an individual to push the device against the anatomy for proper placement. The handle 226 may include a back section 226a positioned proximate the distal end region of the fluid impermeable pouch and one or more (e.g. , two) arm 226b extending from the back section 226a towards the proximal end region of the fluid impermeable pouch 202. At least a portion of the fluid impermeable pouch may be positioned between the two arms 226b. The securement element 220 also may include a flange 228 at least partially surrounding the opening 206 and/or the one-way material 218. The one or more arms 226b of the handle 226 may extend from the back section 226a to the flange 228. In some embodiments, the back section 226a may define an aperture through which the tube 208 extends before contacting or extending through the fluid impermeable pouch 202. The tube 208 may feed urine collected with the fluid collection device 200 to an external collection bag via gravity and/or a vacuum source.

[0052] In some embodiments, the fluid collection device includes the wicking material 210. The wicking material 210 may extend across at least a portion (e.g. , all) of the opening 206. In some embodiments, the wicking material 210 is configured at least partially as a strip or wick of wicking material 210 that extends from the opening 206 to an inlet of the tube 208. The strip or wick of wicking material 210 may extend at least partially into the tube 208. In some embodiments, wicking material 210 is secured to and/or at least partially surrounds a fluid permeable support or material. For example, the wicking material 210 may include gauze secured to spun nylon fibers material. Both the gauze and the spun nylon fibers material may extend at least partially (e.g., entirely) between the opening 206 and the tube 208. The strip of wick of wicking material 210 may be contoured to improve retention of a one-way material base to wick fluid away from the user and keep the user feeling dry. In some embodiments, the wicking material 210 is contoured to protrude from the one-way material 218 and/or the flange 228 through the opening 206 (shown in the side views of FIGS. 2C-2D). The wicking material 210 may be pushed against the anatomy of the user to cover one or more of the urethral opening 55 and/or the vagina 60 to capture urine and other fluids. The contoured portion of the wicking material 210 protruding through the opening may be held between the labia of the user 50 to assist in retaining the opening 206 over the urethral opening 55 and/or the vagina 60. The fluid impermeable pouch 202 may be positioned beyond the wicking material 210 protruding from the opening 206 to capture excess urine in the chamber 204 defined by an inner surface of the fluid impermeable pouch 202. That is, the wicking material 210 may be positioned between the user 50 and the fluid impermeable pouch 202. With the wicking material 210 extending through the chamber 204 and connected to the tube 208 extending at least partially into the chamber, the wicking material 210 may direct urine collected to the tube 208 for removal from the fluid collection device 200. Excess urine in the chamber 204 also may exit the fluid collection device 200 through the tube 208 when the wicking material 210 is connected to the tube 208. In some embodiments, the wick is not connected to the tube 208, and urine may collect in the chamber 204 before exiting the chamber 204 through the tube 208.

[0053] FIGS. 3A-3D shows another fluid collection device 300, according to an embodiment. The fluid collection device 300 may be configured to secure to a user 50 with an adhesive 320 on the fluid collection device 300, with the adhesive 320 being positioned on the fluid collection device 300 to generally be outside of the hairline of the user 50. Positioning of the fluid collection device 300 on the user is intuitive, and the shape of portions of the fluid collection device 300 contacting anatomy of the user may generally align with the anatomy. A tube 308 may feed urine collected with the fluid collection device 300 to an external collection bag via gravity and/or a vacuum. The fluid collection device 300 may be sized to fit substantially all users, as the fluid collection device 300 may include a large adhesive span. The fluid collection device 300 also may include a top layer having an extrusion that slightly tucks in-between at least a portion of the labia to prevent leaks from the fluid collection device 300. The fluid collection device 300 also may include a larger absorbent perimeter to reduce the chance of leaks from the fluid collection device 300.

[0054] Unless otherwise noted or shown, the fluid collection device 300 may include any of the features described or shown in relation to the fluid collection device 200. For example, in some embodiments, the fluid collection device 300 includes a fluid impermeable pouch 302 sized and dimensioned to be positioned over a vulva of the user 50. The fluid impermeable pouch at least partially defines a chamber 304 and includes a distal end region and a proximal end region. The fluid collection device 300 also includes an opening 306 positioned on the proximal end region to cover at least a urethral opening of the user when the fluid impermeable pouch 302 is positioned over the vulva of the user 50. In some embodiments, the fluid collection device 300 includes a tube 308 connected to the fluid impermeable pouch 302 and in fluid communication with the chamber 304 of the fluid impermeable pouch 302 through an aperture 312. The fluid collection device 300 also may include a one-way material 318 defining the opening 306 and configured to allow fluid into the chamber 304 of the fluid impermeable pouch 302 and prevent fluid from exiting the chamber 304 through the one-way material 318. In some embodiments, the one-way material 318 may be formed as a ring around the opening 306. In some embodiments, a fluid impermeable material may define the opening 306, and the one-way material 318 may be absent.

[0055] The fluid collection device 300 may include a wicking material 310 (and/or other fluid permeable material) positioned at least partially inside the fluid impermeable pouch 302. The wicking material 310 may include any aspect of the wicking material 210 describe above in relation to the fluid collection device 200, such as positioning relative to the opening 306, the chamber 304, and the tube 308. Moreover, the wicking material 310 may be contoured to protrude from the one-way material 318 and/or the sheet 322 through the opening 306 (shown in the side views of FIGS. 3C-3D). The wicking material 310 may be pushed against the anatomy of the user to cover one or more of the urethral opening 55 and/or the vagina 60 to capture urine and other fluids. The contoured portion of the wicking material 310 protruding through the opening 306 may be held between the labia of the user 50 to assist in retaining the opening 306 over the urethral opening 55 and/or the vagina 60. At least one of the wicking material 310 and/or the fluid impermeable pouch 302 may drain through the tube 308 to an external device. For example, the wicking material 210 and/or the fluid impermeable pouch 302 may drain into the tube 208 to an external device as described above in relation to FIG. 1 and/or FIGS. 2A-2D. The fluid impermeable pouch 302 may include a hard or soft plastic/elastomer cup or other collection device. The fluid impermeable pouch 302 or cup also may conform to anatomy of the user. In some embodiments, absorbent beads may be positioned inside of the chamber 304 defined by the fluid impermeable pouch 302. The absorbent beads may be configured to absorb extra fluid that is not moved to the tube 208, effective to prevent extra fluids from spilling from the fluid collection device 300 when the fluid collection device 300 is removed from the user 50.

[0056] The fluid collection device 300 may be secured to the user with an adhesive. For example, the fluid collection device may include a sheet 322, such as absorbent fabric layer or other material, which includes an adhesive 320 on one or more portions of the layer. The sheet 322 may be positioned near the proximal end region of the fluid impermeable pouch 302 and may contain any extra leakage during use or remove of the fluid collection device 300. In some embodiments, the sheet includes one or more (e.g., two, three, or four) fingers 314 and an adhesive 322 may be positioned on each finger 314. In some embodiments, the sheet 322 includes two top fingers 314 positioned to adhere to the user 50 beyond a pubic hairline of the user 50 and two bottom fingers 322 positioned to adhere to an inner thigh or buttock of the user 50. The fluid impermeable pouch 302 may be positioned between the two top fingers 314 and the two bottom fingers 314. Adhesives described herein may include any suitable adhesives, such as a hydrogel layer and those disclosed in U.S. Patent Application Publication No. 2017/0189225, the disclosure of which is incorporated herein by reference in its entirety.

[0057] FIGS. 4A-4D show fluid collection device 400, according to an embodiment. The fluid collection device 400 may be configured to secure to a user with one or more straps 420 and/or hook and loop fastener material (such as VELCRO®). A tube 408 may feed urine collected with the fluid collection device 400 to an external collection bag via gravity and/or a vacuum. The fluid collection device 400 may be sized to fit substantially all users, as the fluid collection device 400 may include adjustable straps 420 to fit a large range of sizes of users. The straps 420 of the fluid collection device 400 hold the fluid collection device 400 against the body of the user 50 to prevent leaks from the fluid collection device. The fluid collection device 400 also may prevent or reduce the chance of leaks by covering a significant amount of anatomy with absorptive material.

[0058] Unless otherwise noted or shown, the fluid collection device 400 may include any of the features described or shown in relation to the fluid collection devices 200, 300. For example, in some embodiments, the fluid collection device 400 may include a fluid impermeable pouch 402 sized and dimensioned to be positioned over a vulva of the user 50. The fluid impermeable pouch 402 may at least partially define a chamber 402 and may include a distal end region, and a proximal end region. The fluid collection device 400 may include an opening 406 positioned on the proximal end region to cover at least a urethral opening of the user 50 when the fluid impermeable pouch 402 is positioned over the vulva of the user 50. In some embodiments, the fluid collection device 400 includes the tube 408 connected to the fluid impermeable pouch 402 and in fluid communication with the chamber 404 through an aperture 412 defined by the fluid impermeable pouch 402. The fluid collection device 400 may include a one-way material defining the opening 406 and configured to allow fluid into the chamber 404 of the fluid impermeable pouch 402 and prevent fluid from exiting the chamber 402 through the one-way material. In some embodiments, the one-way material is absent, and a fluid impermeable material defines the opening 406.

[0059] The fluid collection device may include a wicking material 410 (and/or other fluid permeable material) positioned at least partially inside the fluid impermeable pouch 402. The wicking material 410 may include any aspect of the wicking materials 210, 310 describe above in relation to the fluid collection devices 200, 300, such as positioning relative to the opening 406, the chamber 404, and the tube 408. Moreover, the wicking material 410 may be contoured to protrude from the one-way through the opening 406 (shown in the side views of FIGS. 4C-4D). The wicking material 410 may be pushed against the anatomy of the user to cover one or more of the urethral opening 55 and/or the vagina 60 to capture urine and other fluids. The contoured portion of the wicking material 410 protruding through the opening 406 may be held between the labia of the user 50 to assist in retaining the opening 306 over the urethral opening 55 and/or the vagina 60. At least one of the wicking material 410 and/or the fluid impermeable pouch 402 may drain into the tube 408 to an external device. For example, the wicking material 410 and/or fluid impermeable pouch 402 may drain through the tube 408 to an external device as described above in relation to FIGS. 1 and 2A-2D. In some embodiments, the fluid collection device 400 does not include the wicking material 410, e.g. , the wicking material 410 is absent from the fluid collection device 400. For example, the fluid collection device 400 may include the fluid impermeable pouch 402 having the opening 406 without the wicking material 410 extending thereacross, with the opening 406 being positioned over the urethral opening of the user 50 when fluid collection device 400 is being worn. An absorbent material may surround the opening 406 and/or the wicking material 410. The fluid impermeable pouch 402 may include a hard or soft plastic/elastomer cup or other collection device. The fluid impermeable pouch 402 also may conform to anatomy of the user. In some embodiments, absorbent beads may be positioned inside of the chamber 404 defined by the fluid impermeable pouch 402. The absorbent beads are configured to absorb extra fluid that is not moved to the tube 408, effective to prevent extra fluids from spilling from the fluid collection device 400 when the fluid collection device 400 is removed from the user 50. [0060] The fluid collection device 400 may be secured to the user with one or more straps 422. The straps 422 may be secured to a border 424 surrounding and/or secured to a periphery of the fluid impermeable pouch 402. The straps 422 may be sized and dimensioned to extend around a portion of an abdomen and a buttock of the user to retain the fluid impermeable pouch 402 over the vulva of the user 50. For example, the straps 422 may include a strap passing between the buttocks of the user and a strap around the waist and/or buttocks of the user. The straps 422 may be adjustable with one or more of hook and loop fastener material, buttons, adhesives, and so on, to fit the particular size of the user 50. [0061] FIGS. 5A-6C illustrate additional fluid collection devices and components, according to various embodiments. Unless otherwise noted or shown, the fluid collection devices of FIGS. 5A-6C may include any of the features described or shown in relation to FIGS. 1-4. The fluid collection devices shown in FIGS. 5A-6C may be configured to secure to a user with at least one of adhesives, underwear, held in place with the legs, and/or one or more straps. A tube may feed urine collected with the fluid collection devices to an external collection bag via gravity and/or a vacuum. The fluid collection devices may include a fluid impermeable film pouch or cup having a hard or soft plastic/elastomer cup or other collection device. The fluid impermeable film pouch or cup also may conform to anatomy of the user.

[0062] Turning specifically to FIG. 5A, which illustrates a front isometric view of a fluid collection device 500, according to an embodiment. Unless otherwise noted, the fluid collection device 500 may include any aspect of the fluid collection devices 200, 300, 400. For example, the fluid collection device 500 may include a fluid impermeable pouch 502 sized and dimensioned to be positioned over a vulva of a user. The fluid impermeable pouch 502 may at least partially define a chamber 504 and includes a distal end region and a proximal end region. The fluid collection device 500 also may include an opening 506 positioned on the proximal end region to cover at least a urethral opening of the user when the fluid impermeable pouch 502 is positioned over the vulva. In some embodiments, the fluid collection device 500 includes a tube 508 connected to the fluid impermeable pouch 502 and in fluid communication with the chamber 504 of the fluid impermeable pouch 502 through an aperture 512 at the distal end region of the fluid impermeable pouch 502. [0063] In some embodiments, the fluid collection device 500 includes a securement element including one or more wings 520 or flaps configured to fold against the legs of the user. For example, the fluid collection device 500 may include a lip 522 or border at the proximal end region of the fluid impermeable pouch 502 and two opposing wings 520 may extend from the lip 522. Folding of the wings 520 or flaps against the legs of the user may assist in securing the fluid collection device between the legs and against the anatomy of the user. In some embodiments, the wings 520 may include an adhesive and/or microtexturing configured to inhibit slipping of the wings 520 on the skin of the user. [0064] The fluid collection device 500 may include a positioning feature 524 or protrusion that protrudes from the lip 522 to assist the user or caregiver in centering and securing the device. The positioning feature 524 may include a raised portion on the lip 522 of the fluid collection device 500 surrounding the opening 506 of the fluid impermeable pouch 502. The raised and/or curved positioning feature 524 may be used for locating the cup properly to the anatomy of the user. The fluid impermeable pouch 502, the lip 522, the wings 520, and/or the positioning feature 524 may include any of the fluid impermeable materials described herein. In some embodiments, an inner surface of the fluid impermeable pouch 502 may be at least partially (e.g. , entirely) lined with a fluid permeable (e.g., wicking) material. [0065] Turning to FIG. 5B, some embodiments of the fluid collection device 500 may include a container 530 secured or securable to the fluid impermeable pouch 502 and covering at least a portion of the fluid impermeable pouch 502 including the aperture 502. In some embodiments, the container 530 is detachably or fixedly secured to the lip 522 and/or the fluid impermeable pouch 502, and the tube 508 is absent from the fluid collection device 500. The container 530 may include any of the fluid impermeable materials described herein. Urine discharged into the fluid impermeable pouch 502 may flow through the aperture 512 via gravity for collection in the container 530, allowing the fluid collection device 500 to be used without a vacuum source.

[0066] Turning to FIG. 6A, which illustrates a front isometric view of a fluid collection device 600, according to an embodiment. In some embodiments, a fluid collection device 600 may include a pouch or cup having an edge or periphery that includes a curvature that closely follows or complements the curvature of a vulva of a user. Unless otherwise noted, the fluid collection device 600 may include any aspect of the fluid collection devices 200, 300, 400, 500. For example, in some embodiments the fluid collection device 600 may include the fluid impermeable pouch 602 or cup sized and dimensioned to be positioned over a vulva of a user. The fluid impermeable pouch 602 may at least partially define a chamber 604 and may include a distal end region and a proximal end region. The fluid collection device 600 also may include an opening 606 positioned on the proximal end region to cover at least a urethral opening of the user when the fluid impermeable pouch 602 is positioned over the vulva. A securement element such as an adhesive, one or more straps, or an undergarment may be secured or securable to the fluid impermeable pouch 602 and configured to retain the fluid impermeable pouch 602 over the vulva.

[0067] In some embodiments, the fluid collection device 600 may include a tube 608 connected to the fluid impermeable pouch 602 and in fluid communication with the chamber 604 of the fluid impermeable pouch 602. In some embodiments, a channel 615 may extend from the chamber 604 to the aperture 612. The channel 615 may be positioned at a bottom region of the fluid collection device 600 or chamber 604, and may angle from the chamber 604 to extend towards and/or beyond a periphery of the fluid impermeable pouch 602.

[0068] In some embodiments, the fluid collection device 600 may include a fluid permeable material 610 (e.g. , wicking material) lining at least a portion of the inner surface of the fluid impermeable pouch 602. The fluid permeable material 610 may include any fluid permeable material or wicking material described herein. In some embodiments, the fluid permeable material 610 is positioned in the fluid impermeable pouch 602 to cover at least the urethral opening of the user such that urine voided by the user is discharged onto the fluid permeable material 610. The fluid permeable material 610 may direct fluid to the channel 615 for either gravity-assisted or vacuum-assisted removal from the fluid collection device 600 through the aperture 612.

[0069] In some embodiments, the fluid collection device 600 may include a border on at least a portion (e.g. , all) of a periphery at the mouth of the fluid impermeable pouch 602. The border may include an open cell foam 620 that allows air flow into the fluid impermeable pouch 602 and also prevents leaks from the fluid impermeable pouch 602. [0070] Turning to FIG. 6B, which illustrates a duckbill or check valve 640 configured to prevent fluid collected in the fluid collection device 600 from coming back in contact with the body. The duckbill or check valve 640 may be secured or securable to a fluid collection device, such as the fluid collection device 600, where urine enters the fluid impermeable pouch 602 or cup and/or where urine exits the fluid impermeable pouch 602 or cup. For example, the check valve 640 may be secured to the fluid collection device 600 at the aperture 612. The check valve 642 may include an inlet 642 that allows fluid into the check valve 640 and an outlet 644 that allows fluid out of the check valve 640 but prevents fluid from returning through the check valve 642. The outlet 644, for example, may include a small, flat outlet 644.

[0071] The check valve 640 also may be used with the fluid collection device 650, illustrated in FIG. 6C. Unless otherwise noted, the fluid collection device 650 may include any aspect of the fluid collection device 600. The fluid collection device 600 also may include a rounded curve shape that is part of the fluid impermeable pouch 602 material. The rounded curve shape also may include the permeable material 610 that is used against the anatomy to keep the anatomy dry. In some embodiments, the fluid permeable material 610 includes a contoured strip 660 protruding from the surface of the fluid permeable material 610. The contoured strip 660 may extend from a top region in the chamber 604 to the channel 615 and/or aperture 612. The contoured strip 660 is raised to fit between labia of the user and may be positioned at least proximate (e.g., interfacing) the urethral opening of the user. The contoured strip 660 may assist in directing voided urine to the channel 615 and/or the aperture 612 for removal from the urine collection device 650. Removal of fluid from the fluid collection device 600 may be assisted by either gravity or a vacuum.

[0072] FIGS. 7A-7B illustrate rear isometric and front isometric views, respectively, of a fluid collection device 700, according to an embodiment. Unless otherwise noted or shown, the fluid collection device 700 may include any aspect or features described or shown in relation to FIGS. 1-6. The fluid collection device 700 may be shaped and dimensioned for use with either a male or female user. For example, the fluid collection device 700 may be sized to position over the vulva of a female user or over at least the penis (e.g., the penis and the scrotum) of a male.

[0073] The fluid collection device 700 may be configured to secure to a user with at least one of adhesives, underwear, held in place with the legs, and/or one or more straps. A tube 708 may feed urine collected with the fluid collection device 700 to an external collection bag via gravity and/or a vacuum. The tube 708 may include an adapter 716 or connector configured to connect to an additional tube (not shown). The fluid collection device 700 may include a fluid impermeable pouch 702 or cup having a hard or soft plastic/elastomer cup or other collection device. The fluid impermeable pouch 702 may be sized and shaped to secure to the vulva of a user. The fluid impermeable pouch 702 may at least partially define a chamber 704 and include a distal end region and a proximal end region. The fluid collection device 700 also includes an opening 706 positioned on the proximal end region to cover at least a urethral opening of the user when the fluid impermeable pouch 702 is positioned over the vulva. In some embodiments, the tube 708 is connected to the fluid impermeable pouch 702 and in fluid communication with the chamber 704 of the fluid impermeable pouch through an aperture 712 on the fluid impermeable pouch 702.

[0074] The fluid collection device 700 may further include a fluid permeable portion 710 positioned at least partially inside the chamber 704. The fluid permeable portion 710 may be configured to wick or transport urine to the aperture 712 and/or the tube 708 that provides fluid communication between the chamber 704 and a collection container or bag (not shown). The fluid permeable portion 710 may include any of the fluid permeable materials described herein. In some embodiments, the fluid impermeable pouch 702 defines an opening on a back side of the fluid collection device 700, shown in FIG. 7A. An additional material 714 may extend across the opening on the back side of the fluid collection device 700. For example, the additional material may include an additional fluid impermeable barrier and/or a one-way material that allows air into the chamber 704 but prevents fluid from leaving the chamber 704.

[0075] FIG. 8 shows a fluid collection device 800, according to an embodiment. Unless otherwise noted or shown, the fluid collection device 800 may include any of the features described or shown in relation to the fluid collection device 200, 300, 400, 500, 600, 650, 700. The fluid collection device 800 may be configured to secure to a user with at least one of adhesives, underwear, held in place with the legs, and/or one or more straps. A tube 808 may feed urine collected with the fluid collection device of FIG. 8 to an external collection bag via gravity and/or a vacuum. The fluid collection device may include a fluid impermeable pouch 802 or cup having a hard or soft plastic/elastomer cup or other collection device. The cup may be sized and shaped to secure to the vulva of a user. The fluid collection device may further include a fluid permeable portion (not visible) positioned inside a chamber defined by the fluid impermeable pouch 802. The fluid permeable portion configured to wick or transport urine to a tube 808 secured fluid impermeable pouch 802. For example, the fluid impermeable pouch 802 may define an aperture 812 that allows fluid communication between the chamber and the tube 808. The tube 808, then, may provide fluid communication between the chamber and the collection container or bag. The fluid collection device 800 also may include a vent hole 814 and cap distal to the aperture 812. The cap may be secured or securable to the vent 814. The fluid collection device 800 may include a flange 820 extending outward from the fluid impermeable pouch 802. The flange 820 may be securable to the user with and adhesive and/or securable to an undergarment.

[0076] FIGS. 9A-9E are views of various embodiments of fluid collection devices including a fluid impermeable pouch or cup configured to be integrated with an undergarment, according to some embodiments. The fluid collection devices of FIGS. 9A- 9E also may be used in some circumstances without an undergarment. Fluid may be withdrawn from the fluid collection devices of FIGS. 9A-9E via gravity or a vacuum. Unless otherwise noted or shown, the fluid collection devices of FIGS. 9A-9E may include any of the features described or shown in relation to FIGS. 1-8. In some embodiments, the fluid collection devices of FIGS. 9A-9E may include a fluid impermeable pouch or cup having a flange or wing secured to the undergarment. The flange or wing may be fixedly secured or detachably secured to the undergarment. Some embodiments of fluid collection devices of FIGS. 9A-9E may include vent holes that may be opened and closed. Some embodiments of fluid collection devices may include a urine sump and/or wicking material. [0077] Turning specifically to FIGS. 9A-9C, a urine collection device 920 is shown fixedly or detachably secured to a portion of an undergarment 900. The urine collection device 920 may include a fluid impermeable pouch 922 or cup sized and dimensioned to be positioned over a vulva of a user. The fluid impermeable pouch 922 may at least partially define a chamber 924. The fluid collection device 920 includes an opening 926 positioned at a proximal end region to cover at least a urethral opening of the user when the fluid impermeable pouch 922 is positioned over the vulva. The fluid collection device 920 also may include a vent 928 positioned at a top region of the fluid collection device 920 and an aperture 925 positioned at a bottom region of the fluid collection device 920. A tube 908 may be connected or connectable to the fluid impermeable pouch 922 and in fluid communication with the chamber of the fluid impermeable pouch through the aperture 925. [0078] With specific reference to FIG.9A, the fluid collection device 920 also includes a securement element secured to the fluid impermeable pouch 922 and configured to retain the fluid impermeable pouch over the vulva. The securement element may include a flange 932 or lip extending outwardly from the fluid impermeable pouch 922 proximate to the opening. The undergarment 900 may include an opening or space shaped and sized complementary to at least a portion of the fluid impermeable pouch 622, and the flange 632 may be secured to the undergarment 900 with a fastener 910 including at least one of hook and loop fastener material, a button, an adhesive region, magnets, or any other fastener adapted to secured the flange 932 to the undergarment 900. The fluid collection device 920 may include open cell foam positioned at or proximate to the flange 932. In some embodiments, the open cell foam forms the flange 932.

[0079] With specific reference to FIG. 9B, with the vent 928 at the top region and the aperture 924 at the bottom region of the fluid impermeable pouch 922, the fluid collection device 920 is oriented to have fluid 70 collect at the bottom region of the chamber for withdraw from the fluid collection device 920 with gravity pulling fluid 70 in the chamber 924 down to the tube 908. In some embodiments, fluid permeable material is absent from the chamber 924 when fluid is being drawn from the chamber 924 with gravity. In some embodiments, fluid permeable material may line or cover at least a portion of the fluid impermeable pouch 922 in the chamber 924, but the chamber 924 may also include open space void of other material.

[0080] With specific reference to FIG. 9C, a fluid permeable insert 930 may be positioned or positionable within the chamber 924. The fluid permeable insert 930 may be inserted into the chamber 924 when a vacuum source is applied to the tube 908. The fluid permeable insert may include any of the fluid permeable materials described herein and may fill at least a portion (e.g., substantially all) of the chamber 924. Urine or other fluid 70 may be voided into the fluid permeable insert 930 positioned in the chamber 924, and the vacuum applied to the tube 908 may draw the urine in the fluid permeable insert to the tube 908 for removal from the fluid collection device 920. [0081] FIG. 9D illustrates a front view of a fluid collection device 950 configured to use with a vacuum source. Unless otherwise noted, the fluid collection device 950 may include any aspect of the fluid collection device 920, such as the fluid impermeable pouch 922, the opening 926, the flange 934, and the chamber 924. The fluid collection device 950 may include a fluid permeable body 960 fixedly or removably secured in the chamber 924. The fluid permeable body 960 may include any fluid permeable materials described herein. In contrast to the fluid collection device 920, the fluid collection device 950 may include an aperture 962 at a top region of the fluid impermeable pouch 922 and the vent 928 may be absent from the fluid impermeable pouch 922 or also positioned at the top region of the fluid impermeable pouch 922. In some embodiments, the fluid collection device 920 may be rotated such that the aperture 925 is positioned at the top of the fluid collection device 920 and the vent 928 is positioned at the bottom of the fluid collection device 920. The vent 928 may then be closed (e.g., with a cap) to prevent fluids from leaking out of the chamber 924 through the vent 928.

[0082] With the aperture 962 (or the aperture 928) at the top of the fluid collection device 950, fluid 70 may be withdrawn from the fluid collection device 950 via application of a vacuum to the tube 908, which draws fluid in the chamber 924 into the tube 208. Though not visible in FIG. 9D behind the fluid permeable body 960, the tube 208 may extend through the chamber 924 proximate to the bottom region of the fluid collection device 950 to draw the fluid 70 into the tube 908. FIG. 9E shows the fluid collection device 950 secured to the undergarment 900 in a configuration and orientation for removal of fluid 70 from the fluid collection device 950 via a vacuum source applied to the tube 908. [0083] FIGS. 10A-10B are illustrations of fluid collection devices including securement elements configured to secure a fluid collection device to the user 50. The securement elements shown in FIG. 10A-10B may be included within any of the fluid collection devices described herein. Unless otherwise noted, the fluid collection devices shown in FIGS. 10A-10B may include any aspect of the fluid collection devices described herein. With specific reference to FIG. 10A, a fluid collection device 1000 may include an opening 1006 and a fluid impermeable pouch 1002 at least partially defining a chamber 1004, according to an embodiment. The fluid impermeable pouch 1002 may be sized and dimensioned to be positioned over a vulva of the user 50 and the opening 1006 is positioned to cover at least a urethral opening of the user 50 when the fluid impermeable pouch 1002 is positioned over the vulva. The fluid collection device 1000 also may include a tube 1008 connected to the fluid impermeable pouch 1002 and in fluid communication with the chamber 1004 of the fluid impermeable pouch 1002.

[0084] The fluid collection device 1000 also may include an adhesive region 1020. The adhesive region 1020 may include a top positioned above and wider than the fluid impermeable pouch 1002 when the fluid collection device 1000 is in use. The adhesive region may taper to be narrower around the fluid impermeable pouch 1002. In some embodiments, the adhesive region 1020 surrounds at least a portion (e.g., all) of the fluid impermeable pouch 1002. Prior to use, the fluid collection device 1000 may include a liner secured the adhesive region(s) 1020 that is removed before securement to the user 50. The fluid collection device 1000 may then be secured to the user 50 over the labial area, and pressed against the anatomy of the user 50 to secure the fluid collection device 1000 to the user 50. Once the fluid collection device 1000 is secured to the user 50, the user 50 can return to a seated or laying down position. To remove the fluid collection device 1000, the fluid collection device 1000 may be peeled off the labial area of the user 50.

[0085] FIG. 10B illustrates a fluid collection device 1050 separated from the user 50, according to an embodiment. The fluid collection device 1050 may include an opening 1056 and a fluid impermeable pouch 1052 at least partially defining a chamber. The fluid impermeable pouch 1052 may be sized and dimensioned to be positioned over a vulva of the user 50 and the opening 1056 is positioned to cover at least a urethral opening of the user 50 when the fluid impermeable pouch 1052 is positioned over the vulva. A fluid permeable body 1060 may extend across at least some (e.g., all) of the opening 1056. The fluid collection device 1050 also may include a tube (not shown) connected to the fluid impermeable pouch 1052 and in fluid communication with the chamber of the fluid impermeable pouch 1052.

[0086] The fluid collection device 1050 also may include an adhesive region 1070. Unless otherwise noted, the adhesive region may include any aspect of the adhesive region 1020 of the fluid collection device 1000. The fluid collection device 1050 may include an adhesive tail 1072 or strip configured to adhere to the user 50 at least partially between the buttocks of the user 50. Similar to the fluid collection device 1000, the fluid collection device 1050 may be placed over the labial area of the user.

[0087] Pouches, cups, securement elements, and/or fluid impermeable barriers described herein may include any suitable fluid impermeable materials, such as a fluid impermeable polymer (e.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, a polycarbonate, etc.), polyurethane films, thermoplastic elastomer (TPE), rubber, thermoplastic polyurethane, another suitable material, or combinations thereof. As such, the fluid impermeable barrier substantially prevents the fluids from exiting the portions of the chamber that are spaced from the opening. The fluid impermeable barrier is flexible, thereby enabling the fluid collection device to bend or curve when positioned against the body of a wearer. Example fluid impermeable barriers may include, but are not limited to, a fluid impermeable barrier including at least one of Versaflex CL 2000X TPE, Dynaflex G6713 TPE, or Silpuran 6000/05 A/B silicone. In some embodiments, the Pouches, cups and/or fluid impermeable barriers described herein may be air permeable. In these and other embodiments, the fluid impermeable barrier may be formed of a hydrophobic material that defines a plurality of pores.

[0088] Wicks, strips of wicking material, wicking material, and/or fluid permeable portions described herein may be configured to wick any fluid away from the anatomy, thereby preventing the fluid from escaping the pouch or cup. The fluid permeable body also may wick the fluid generally towards an interior of the chamber. Wicks, wicking material, and/or fluid permeable portions described herein may include any material that may wick the fluid. The permeable properties referred to herein may be wicking, capillary action, diffusion, or other similar properties or processes, and are referred to herein as “permeable” and/or “wicking.” Such “wicking” or other physical properties may exclude absorption into the wick, strip of wicking material, wicking material, and/or fluid permeable portion, such as not include adsorption of the bodily fluids into the wick, strip of wicking material, wicking material, and/or fluid permeable portion. Put another way, substantially no absorption or solubility of the bodily fluids into the material may take place after the material is exposed to the bodily fluids and removed from the bodily fluids for a time. While no absorption or solubility is desired, the term “substantially no absorption” may allow for nominal amounts of absorption and/or solubility of the bodily fluids into the wick, strip of wicking material, wicking material, and/or fluid permeable portion (e.g., absorbency), such as less than about 30 wt% of the dry weight of the wick, strip of wicking material, wicking material, and/or fluid permeable portion, less than about 20 wt%, less than about 10 wt%, less than about 7 wt%, less than about 5 wt%, less than about 3 wt%, less than about 2 wt%, less than about 1 wt%, or less than about 0.5 wt% of the dry weight of the wick, strip of wicking material, wicking material, and/or fluid permeable portion. In an embodiment, the wick, strip of wicking material, wicking material, and/or fluid permeable portion may include at least one absorbent or adsorbent material.

[0089] The wick, strip of wicking material, wicking material, and/or fluid permeable portion can include a one-way fluid movement fabric. As such, the wick, ship of wicking material, wicking material, and/or fluid permeable portion can remove fluid from the area around the penis, thereby leaving the area and urethra dry. The wick, strip of wicking material, wicking material, and/or fluid permeable portion can enable the fluid to flow generally towards the tube within the chamber. The wick, strip of wicking material, wicking material, and/or fluid permeable portion can include a porous or fibrous material, such as hydrophilic polyolefin. In some embodiments, the wick, strip of wicking material, wicking material, and/or fluid permeable portion consists of or consists essentially of a porous or fibrous material, such as hydrophilic polyolefin. Examples of polyolefin that can be used in the wick, strip of wicking material, wicking material, and/or fluid permeable portion include, but are not limited to, polyethylene, polypropylene, polyisobutylene, ethylene propylene rubber, ethylene propylene diene monomer, or combinations thereof. Moreover, the wick, strip of wicking material, wicking material, and/or fluid permeable portion can be manufactured according to various manufacturing methods, such as molding, extrusion, or sintering. The fluid permeable body 210 can include varying densities or dimensions.

[0090] In some embodiments, the wick, strip of wicking material, wicking material, and/or fluid permeable portion can include two or more layers of fluid permeable materials. For example, the wick, strip of wicking material, wicking material, and/or fluid permeable portion can include a fluid permeable membrane covering or wrapped around a fluid permeable support, with both the fluid permeable membrane and the fluid permeable support being disposed in the chamber. The fluid permeable membrane can cover or extend across at least a portion (e.g., all) of at least the side of the fluid permeable support facing the penis of the user. The fluid permeable membrane and the fluid permeable support can be configured to wick any fluid away from the opening, thereby preventing the fluid from escaping the chamber and promoting removal of the fluid through the tube. The permeable properties referred to herein can be wicking, capillary action, diffusion, or other similar properties or processes, and are referred to herein as “permeable” and/or “wicking.”

[0091] The fluid permeable membrane and the fluid permeable support also can wick and/or allow transport of the fluid generally towards an interior of the chamber and/or the tube. The fluid permeable membrane can include any material that can wick the fluid. For example, the fluid permeable membrane can include fabric, such as a gauze (e.g., a silk, linen, polymer based materials such as polyester, or cotton gauze), nylon (such as a spun nylon fibers), another soft fabric (e.g., jersey knit fabric or the like), or another smooth fabric (e.g., rayon, satin, or the like). Forming the fluid permeable membrane from gauze, soft fabric, and/or smooth fabric can reduce chaffing caused by the urine collection device 200. Other embodiments of fluid permeable membranes and fluid permeable supports are disclosed in U.S. Patent Application No. 15/612,325 filed on June 2, 2017; U.S. Patent Application No. 15/260,103 filed on September 8, 2016; U.S. Patent Application No. 15/611,587 filed on June 1, 2017; PCT Patent Application No. PCT/US 19/29608, filed on April 29, 2019, the disclosure of each of which is incorporated herein, in its entirety, by this reference. In many embodiments, the fluid collection devices may include a fluid permeable support including a porous spun nylon fiber structure and a fluid permeable wicking membrane including gauze at least partially enclosing the spun nylon fiber structure. For example, the fluid collection devices may include a gauze or other wicking fabric positioned to contact the skin of the user. In some embodiments, the gauze or other wicking fabric is wrapped around a body of spun nylon fibers material and/or covering both sides of a substantially planar spun nylon fibers material. In some embodiments, the gauze or other wicking fabric covers the side of substantially planar spun nylon fibers material that is oriented towards the skin of the user.

[0092] In an embodiment, one or more components of the fluid collection device may include an antimicrobial material, such as an antibacterial material where the fluid collection device may contact the wearer or the bodily fluid of the wearer. The antimicrobial material may include an antimicrobial coating, such as a nitrofurazone or silver coating. The antimicrobial material may inhibit microbial growth, such as microbial growth due to pooling or stagnation of the fluids. In an embodiment, one or more components of the fluid collection device (e.g., impermeable barrier, conduit, etc.) may include an odor blocking or absorbing material such as a cyclodextrine containing material or a thermoplastic elastomer (TPE) polymer.

[0093] In any of the embodiments disclosed herein, the conduits (or tubes) may include or be operably coupled to a flow meter (not shown) to measure the flow of fluids therein, one or more securement devices (e.g., a StatLock securement device, not shown) or fittings to secure the conduit to one or more components of the systems or devices disclosed herein (e.g., portable vacuum source or fluid storage container), or one or more valves to control the flow of fluids in the systems and devices herein. In an embodiment, at least one of portion of the conduit of the fluid collection devices or systems herein may be formed of an at least partially opaque material which may obscure the fluids that are present therein. For example, a first section of the conduit disclosed herein may be formed of an opaque material or translucent material while a second section of the conduit may be formed of a transparent material or translucent material. In some embodiments, the first section may include transparent or translucent material. Unlike the opaque or nearly opaque material, the translucent material allows a user of the devices and systems herein to visually identify fluids or issues that are inhibiting the flow of fluids within the conduit.

[0094] In any of the examples, systems or devices disclosed herein, the system of fluid collection device may include moisture sensors (not shown) disposed inside of the chamber of the fluid collection device. In such examples, the moisture sensor may be operably coupled to a controller or directly to the portable vacuum source, and may provide electrical signals indicating that moisture is or is not detected in one or more portions of the chamber. The moisture sensor(s) may provide an indication that moisture is present, and responsive thereto, the controller or portable vacuum device may direct the initiation of suction to the chamber to remove the fluid therefrom. Suitable moisture sensors may include capacitance sensors, volumetric sensors, potential sensors, resistance sensors, frequency domain reflectometry sensors, time domain reflectometry sensors, or any other suitable moisture sensor. In practice, the moisture sensors may detect moisture in the chamber and may provide a signal to the controller or portable vacuum source to activate the portable suction device.

[0095] FIG. 11 is a flow diagram of a method 1100 for collecting fluid from a user, according to an embodiment. The method includes an act 1110 of positioning a fluid impermeable pouch of a fluid collection device over a vulva of the female user with an opening on the fluid collection device positioned over a urethral opening of the user. The method also includes an act 1120 of securing the fluid impermeable pouch over the vulva with a securement element. The method also includes an act 1130 of collecting urine in a chamber defined by the fluid impermeable pouch. The method also includes an act 1140 of drawing urine from the fluid impermeable pouch with a tube in fluid communication with the chamber.

[0096] In some embodiments, the act 1130 of collecting urine in a chamber defined by the fluid impermeable pouch may include collecting urine in the chamber by drawing urine through the opening and a one-way material defining the opening at a proximal end of the fluid impermeable pouch. In these and other embodiments, the act 1120 of securing the fluid impermeable pouch over the vulva with a securement element may include sliding a base of a securement element under buttocks of the user when the user is in a sitting or supine position and pushing the fluid impermeable pouch to cover the vulva with a handle connected to the base. Collecting urine in a chamber defined by the fluid impermeable pouch also may include collecting urine on a strip of wicking material extending across at least a portion of the opening and extending to an inlet of the tube.

[0097] In some embodiments, the act 1120 of securing the fluid impermeable pouch over the vulva with a securement element may include adhering two fingers of a sheet to the user beyond a pubic hairline of the user and two bottom fingers of the sheet to an inner thigh or buttock of the user. The sheet may be positioned proximate to the proximal end of the fluid impermeable pouch and extending outward therefrom. In these and other embodiments, the method 1100 also may include positioning a contoured wicking material protruding through the opening between labia of the user.

[0098] In some embodiments, the act 1120 of securing the fluid impermeable pouch over the vulva with a securement element may include securing two adjustable straps around a portion of an abdomen and a different buttock of the user. In some embodiments, the act 1120 of securing the fluid impermeable pouch over the vulva with a securement element may include positioning opposing wings extending from the proximal end region of the fluid impermeable pouch between legs of the user. In these and other embodiments, the method 1100 also may include positioning a strip of wicking material protruding from an inner surface of the fluid impermeable pouch between labia of the user.

[0099] In some embodiments, the act 1110 of positioning a fluid impermeable pouch of a fluid collection device over a vulva of the female user may include positioning a periphery at the proximal end region of the fluid impermeable pouch that is curved and/or contoured complementary to the vulva over the vulva of the user. In some embodiments, the act 1120 of securing the fluid impermeable pouch over the vulva with a securement element may include securing the fluid impermeable pouch over the vulva with an undergarment secured or securable to a flange on the fluid impermeable pouch. In some embodiments, the act 1140 of drawing urine from the fluid impermeable pouch with a tube in fluid communication with the chamber may include drawing the urine from the fluid impermeable pouch into and through the tube in fluid communication with the chamber with gravity. In some embodiments, the act 1140 of drawing urine from the fluid impermeable pouch with a tube in fluid communication with the chamber may include drawing the urine from the fluid impermeable pouch into and through the tube in fluid communication with the chamber with a vacuum source in fluid communication with the tube.

[00100] In some embodiments, the act 1140 of drawing urine from the fluid impermeable pouch with a tube in fluid communication with the chamber may include drawing the urine from the fluid impermeable pouch with into and through the tube at a bottom region of the fluid impermeable pouch with gravity. In some embodiments, the act 1140 of drawing urine from the fluid impermeable pouch with a tube in fluid communication with the chamber may include drawing the urine from the fluid impermeable pouch with into and through the tube extending through a top region of the fluid impermeable pouch with a vacuum source in fluid communication with the tube. In these and other embodiments, the method 1100 may include an act of selectively venting the chamber with a vent positioned at a top region of the fluid impermeable pouch.

[00101] In some embodiments, the act 1110 of securing the fluid impermeable pouch over the vulva with a securement element may include securing an adhesive patch to the user with the fluid impermeable pouch over the vulva. Securing an adhesive patch to the user with the fluid impermeable pouch over the vulva may include securing adhesive tail patch extending from a bottom region of the fluid impermeable pouch to the user at least partially between buttocks of the user.

[00102] The acts of the method 1100 described above are for illustrative purposes. For example, the acts of the method 1100 can be performed in different orders, split into multiple acts, modified, supplemented, or combined. In an embodiment, one or more of the act of the method 1100 can be omitted from the method 1100. Any of the acts of the method 1100 can include using any of the portable urine collection systems disclosed herein.

[00103] As used herein, the term “about” or “substantially” refers to an allowable variance of the term modified by “about” by ±10% or ±5%. Further, the terms “less than,” “or less,” “greater than”, “more than,” or “or more” include as an endpoint, the value that is modified by the terms “less than,” “or less,” “greater than,” “more than,” or “or more.” [00104] While various aspects and embodiments have been disclosed herein, other aspects and embodiments are contemplated. The various aspects and embodiment disclosed herein are for purposes of illustration and are not intended to be limiting. Features from any of the disclosed embodiments may be used in combination with one another, without limitation. In addition, other features and advantages of the present disclosure will become apparent to those of ordinary skill in the art through consideration of the detailed description and the accompanying drawings.