Handheld urine collection pump device and related systems and methods

Abstract

Exemplary fluid collection devices, systems, and methods of use are described. The fluid collection device includes a handheld body, a fluid-permeable member, a conduit, and a pump. The handheld body has a proximal end region at least partially defining an opening, a distal end region at least partially defining an opening, and an interior region. The fluid-permeable member is disposed to extend at least partially across the opening. The conduit is in fluid communication with the fluid-permeable member and extends at least partially through the opening. The pump is secured to the handheld body and / or disposed within the interior region of the handheld body. The pump is configured to pump fluid from the fluid-permeable member at least partially through the conduit.

Description

[Technical Field]

[0001] The present invention relates to a handheld urine collection pump device and related systems and methods. [Background technology]

[0002] An individual may have limited or impaired mobility such that common urination procedures are difficult or impossible. For example, an individual may have undergone surgery or an injury that impairs mobility. In another example, an individual may have restricted mobility conditions such as those experienced by pilots, drivers, and workers in hazardous areas. Additionally, fluid collection from an individual may be necessary for monitoring purposes or clinical testing.

[0003] Bedpans and indwelling urinary catheters, such as Foley catheters, can be used to address some of these situations. However, bedpans and urinary catheters have several problems associated with them. For example, bedpans can be prone to discomfort, bedsores, spills, and other hygiene issues. Indwelling urinary catheters can be uncomfortable, painful, and can lead to urinary tract infections.

[0004] As a result, users and manufacturers of fluid collection devices continue to seek new and improved devices, systems, and methods for collecting urine. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] International Publication No. 2021 / 211568 [Patent Document 2] European Patent Publication No. 2601916 Summary of the Invention [Means for solving the problem]

[0006] Disclosed herein are bodily fluid collection devices, systems, and methods of use. In one embodiment, the fluid collection device includes a handheld body, a fluid-permeable member, a conduit, and a pump. The handheld body has a proximal end region at least partially defining an opening, a distal end region at least partially defining an opening, and an interior region. The fluid-permeable member is positioned to extend at least partially across the opening. The conduit is in fluid communication with the fluid-permeable member and extends at least partially through the opening. The pump is secured to the handheld body and / or positioned within the interior region of the handheld body. The pump is configured to pump fluid from the fluid-permeable member at least partially through the conduit.

[0007] In one embodiment, a method for collecting fluid includes holding at least a portion of a proximal end region of a handheld body of a fluid collection device. The handheld body includes a distal end region at least partially defining an opening, an interior region, and an opening at least partially defined by the proximal end region. The method also includes, while holding at least a portion of the proximal end region of the handheld body of the fluid collection device, placing a fluid-permeable member of the fluid collection device at least proximate to a urethral opening of a user. The fluid-permeable member is positioned to extend at least partially across the opening. The method also includes activating a pump secured to the handheld body and / or disposed within the interior region of the handheld body, the pump effective to generate a negative pressure at an inlet of a conduit in fluid communication with the fluid-permeable member. The conduit extends at least partially through the opening. The method also includes pumping fluid expelled by the urethra through the fluid-permeable member through a conduit extending at least partially through the opening and into the inlet of the conduit to remove the fluid from the fluid collection device while the pump is activated to generate the negative pressure.

[0008] In one embodiment, the fluid collection system includes a fluid collection device, a fluid collection container, and a pump. The fluid collection device includes a handheld body, a fluid-permeable member, and a conduit. The handheld body has a proximal end region at least partially defining an opening, a distal end region at least partially defining an opening, and an interior region. The fluid-permeable member is positioned to extend at least partially across the opening. The conduit is in fluid communication with the fluid-permeable member and extends at least partially through the opening. The fluid collection container has an interior region in fluid communication with the conduit. The pump is in fluid communication with the interior region of the fluid collection container and is configured to generate a negative pressure within the interior region of the fluid collection device effective to pump fluid from the fluid-permeable member at least partially through the conduit.

[0009]

[0013] In addition, other features and advantages of the present disclosure will become apparent to those skilled in the art upon consideration of the following detailed description and accompanying drawings.

[0010] The drawings illustrate several embodiments of the present disclosure, with the same reference numbers referring to the same or similar elements or features in different views or embodiments shown in the drawings. [Brief explanation of the drawings]

[0011] [Figure 1] FIG. 1 is a block diagram of a system for fluid collection, according to one embodiment. [Figure 2A] FIG. 1 is a side view of a fluid collection device according to one embodiment. [Figure 2B] 2B is a side view of the fluid collection device of FIG. 2A in use, according to one embodiment. [Figure 3] FIG. 1 is an isometric side view of a fluid collection device, according to one embodiment. [Figure 4A] FIG. 1 is an isometric side view of a fluid collection device, according to one embodiment. [Figure 4B] 4B is a cross-sectional view of the fluid collection device of FIG. 4A taken along line 4B. [Figure 5] FIG. 1 is a flow diagram of a method for collecting fluid, according to one embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0012] Embodiments disclosed herein relate to handheld urine collection pump devices and related systems and methods. In some embodiments, a handheld fluid (e.g., urine) collection device including a pump is configured to transport urine away from the body so that a user can expel fluid. According to one embodiment, the fluid collection device may include an all-in-one device having a handheld body, a pump disposed within or secured to the handheld body, and an actuator configured to activate and deactivate the pump. The pump may be powered by a battery selectively and removably secured within or disposed within the handheld body. The pump may provide suction through a fluid-permeable member that is at least one (e.g., all) of ergonomically shaped to interface with the female anatomy, disposable, and / or flushable. In some embodiments, the device body and fluid-permeable member are configured so that the fluid-permeable member can be removed after use via a button on the device body or by a flexible cup shape on the body that holds the fluid-permeable member. Urine discharged onto and pumped from the fluid-permeable member may be directed into a rigid urine collection container or directly into the toilet.

[0013] At least one, some, or all of the fluid collection devices, systems, and methods described herein provide technical effects that improve current standards of care. For example, compared to traditional diapers and bodily fluid collection pads, many of the fluid collection devices described herein provide the technical effect of allowing users to avoid the mental and physical strain of sitting on wet diapers and / or change diapers throughout the day. Furthermore, at least one, some, or all of the fluid collection device embodiments described herein provide the technical effect of avoiding the risks associated with transporting a patient from a wheelchair to a toilet. Instead, at least one, some, or all of the embodiments described herein provide the technical effect of allowing a patient to urinate while remaining in a wheelchair, bed, or other stationary position. Furthermore, at least one, some, or all of the fluid collection device embodiments described herein provide a more portable and attractive design that can be used only when needed, rather than always being placed in close proximity to the urethral opening of traditional fluid collection devices. At least one, some, or all of the embodiments of the fluid collection devices described herein may include a simple operation for removal and / or disposal of the fluid-permeable member of the device while retaining the remainder of the device for additional use.

[0014] FIG. 1 is a block diagram of a fluid collection system 10 according to one embodiment. The fluid collection system 10 may be included in the embodiments of the fluid collection system described herein. The system 10 includes a fluid collection device 12 (e.g., any of the fluid collection devices disclosed herein), a urine collection container 14, and a pump 16 (or vacuum source). The fluid collection device 12, the urine collection container 14, and the pump 16 may be fluidly connected to one another via one or more conduits 17. In some embodiments, the pump 16 is disposed within an interior region of the body of the fluid collection device 12. In some embodiments, the pump 16 is secured to the body of the fluid collection device 12 outside of the interior region. In some embodiments, the pump 16 may be secured directly to the urine collection container 14. Fluid (e.g., urine or other bodily fluid) collected within the fluid collection device 12 may be removed from the fluid collection device 12 via a conduit 17 secured to the fluid collection device 12. Suction may be introduced into the chamber of the fluid collection device 12 through the inlet of a conduit (e.g., conduit 17) between the pump and the opening of the fluid collection device 12 in response to suction (e.g., vacuum) force applied to the outlet of the conduit 17. The suction may be applied directly or indirectly to the outlet of the conduit 17 by the pump 16. The suction may be applied directly via the pump 16. For example, the outlet of the conduit 17 may be located inside the pump 16. An additional conduit 17 may extend from the pump 16 to a point outside the fluid collection device 12, such as the urine collection container 14. In such an example, the pump 16 may be located between the fluid collection device 12 and the urine collection container 14.

[0015] At least a portion of the urine collection container 14 is sized and shaped to hold a fluid therein. The urine collection container 14 may include a bag (e.g., a drainage bag), a bottle, a canister, or a cup (e.g., a collection jar), or any other enclosed container for storing a bodily fluid(s), such as urine. In some examples, a conduit 17 may extend from the fluid collection device 12 or the pump 16 and be attached to the urine collection container 14 at a first point therein. Fluid, such as urine, may be drained from the fluid collection device 12 using the pump 16.

[0016] The pump 16 may include one or more of a manual vacuum pump, an electric vacuum pump, a diaphragm pump, a centrifugal pump, a positive displacement pump, a magnetic drive pump, a peristaltic pump, or any pump configured to generate a vacuum. The pump 16 may provide a vacuum, suction, or other negative pressure to remove fluid from the fluid collection device 12. In some examples, the pump 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 a manual power source (e.g., a manually operated vacuum pump). In some examples, the pump 16 may be sized and shaped to fit outside, on, or inside the fluid collection device 12. For example, the pump 16 may include one or more miniature pumps or one or more micropumps. The vacuum sources disclosed herein may include one or more switches, buttons, plugs, remote controls, or any other devices suitable for activating the pump 16.

[0017] In some embodiments, the fluid collection device may include a urine collection device having a handheld body (e.g., a handheld "wand" design) with a configuration that provides the technical effect of providing easy access to and placement of the urine collection area of ​​the urine collection device when the user is in a seated or supine position. Referring to FIG. 2A , a fluid collection device 200 is shown having a handheld body 202, according to one embodiment. The handheld body 202 is ergonomically designed to provide the technical effect of enabling intuitive, one-handed operation of the fluid collection device 200. The handheld body 202 may include a proximal end region 225, a distal end region 227 (e.g., a urine collection area), and an inner region 205. The proximal end region 225 may define an opening 212 or port, and the distal end region 227 may at least partially define the opening 206. The handheld body 202 is sized, weighted, and dimensioned to provide the technical effect of allowing a user or caregiver to hold a portion (e.g., the proximal end region 225) in one hand while the distal end region 227 is positioned at least proximate to the user's urethra. When the distal end region 227 is positioned at least proximate to the user's urethra, the fluid collection device 200 provides the technical effect of allowing a user or caregiver to hold the proximal end region 225 in a spaced-apart position above the user's legs (e.g., when the distal end region 227 is positioned at least proximate to the user's urethra, the hand holding the proximal end region 225 is not positioned between the user's legs). For example, the fluid collection device 200 may comprise a longitudinal length of about 15 cm to about 55 cm, about 15 cm to about 25 cm, about 25 cm to about 35 cm, about 35 cm to about 45 cm, about 45 cm to about 55 cm, about 15 cm to about 20 cm, about 20 cm to about 25 cm, about 25 cm to about 30 cm, about 30 cm to about 35 cm, about 35 cm to about 40 cm, about 40 cm to about 45 cm, about 45 cm to about 50 cm, or about 50 cm to about 55 cm. In some embodiments, the fluid collection device 200 comprises a weight of less than about 2 kg, less than about 1.5 kg, less than about 1 kg, or less than about 0.5 kg.

[0018] One or more portions of the handheld body 202 may define an interior region 205 of the handheld body 202. In some embodiments, the interior region 205 defined by the handheld body 202 includes one or more regions of void space that accommodate one or more components described below. The proximal end region 225 of the handheld body 202 may at least partially define at least a portion of the interior region 205 and includes a handle 215. The handle 215 is sized and dimensioned to provide the technical effect of allowing a user to grip or hold the handheld body 202 with one hand during use. For example, FIG. 2B shows a user 50 holding the handheld body 202 on the handle 215 with one hand during use. In some embodiments, the handle 215 includes a through-hole through which the user's hand grips the handheld body 202. The through-hole in the handle 215 may include a length of about 5 cm to about 10 cm. In some embodiments, the handle 215 includes other gripping or fingering portions configured and / or contoured to provide a technique that allows a user to grip the handheld body 202 with one hand. The handle 215 may include a longitudinal length of about 5 cm to about 15 cm, about 5 cm to about 10 cm, about 10 cm to about 15 cm, about 5 cm to about 7 cm, about 7 cm to about 9 cm, 9 cm to about 11 cm, about 11 cm to about 13 cm, or about 13 cm to about 15 cm. In some embodiments, at least a portion of the handle 215 may comprise a cross-sectional width or diameter of between 1 cm and about 5 cm, between about 1 cm and about 3 cm, between about 3 cm and about 5 cm, between about 1 cm and about 2 cm, between about 2 cm and about 3 cm, between about 3 cm and about 4 cm, between about 4 cm and about 5 cm, about 2 cm, about 2.5 cm, about 3 cm, about 3.5 cm, about 4 cm, about 4.5 cm, about 5 cm, less than about 5 cm, less than about 4 cm, less than about 3 cm, or less than about 2 cm.

[0019] In some embodiments, the distal end region 227 at least partially defines a chamber 204 that is in fluid communication with the opening 206 defined by the distal end region 227. Components and features of the fluid collection device 200 inside the handheld body 202 are shown in dashed lines in FIG. 2A . When the fluid-permeable member 220 is removed from the distal end region 227, the chamber 204 may be a region of space that is entirely free of another material. The chamber 204 may be at least partially surrounded by one or more portions of the distal end region 227. For example, the distal end region 227 may be cup- or bowl-shaped with the opening 206 leading into the chamber 204 (e.g., an interior region) of the distal end region 227. In these and other embodiments, the distal end region 227 may include a transverse diameter of about 1 cm to about 5 cm, about 1 cm to about 3 cm, about 3 cm to about 5 cm, about 1 cm to about 2 cm, about 2 cm to about 3 cm, about 3 cm to about 4 cm, or about 4 cm to about 5 cm.

[0020] In some embodiments, the distal end region 227 may be elongated and oriented to extend longitudinally in the same direction as the handheld body 202. For example, the distal end region 227 may be substantially cylindrical. In these and other embodiments, the distal end region 227 may have a length of about 5 cm to about 18 cm, about 5 cm to about 15 cm, about 5 cm to about 10 cm, about 10 cm to about 15 cm, about 5 cm to about 7.5 cm, about 7.5 cm to about 10 cm, about 10 cm to about 12.5 cm, about 12.5 cm to about 15 cm, or about 15 cm to about 18 cm. The distal end region 227 may include a cross-sectional diameter of about 1 cm to about 5 cm, about 1 cm to about 3 cm, about 3 cm to about 5 cm, about 1 cm to about 2 cm, about 2 cm to about 3 cm, about 3 cm to about 4 cm, or about 4 cm to about 5 cm. In these and other embodiments, the opening 206 may include an elongated opening extending longitudinally with an elongated distal end region 227. The distal end region 227 may include a back surface, a front surface spaced from the back surface and distal to at least a portion of the back surface, and two elongated edges spaced inward from the front surface such that the two elongated edges are disposed between the front surface and the back surface. The two elongated edges may at least partially define the longitudinally elongated opening 206 on the front surface. In other embodiments, the distal end region 227 may include other shapes, such as a more substantially flat surface, a triangle, or other suitable shape. For example, in some embodiments, the front surface of the distal end region 227 is generally arched or rounded, and the back surface of the distal end region 227 is generally flat.

[0021] Distal end region 227 is sized and dimensioned to be positioned at least proximate to the urethral opening of a woman or above the urethra of a man with a buried penis, and urine may enter chamber 204 of distal end region 227 via opening 206. For example, opening 206 may have an elongated shape configured to extend from a first location below the urethral opening (e.g., at or near the anus or vaginal opening) to a second location above the urethral opening (e.g., at or near the clitoris or pubic hair). Opening 206 may have an elongated shape because the space between a woman's legs when they are closed is relatively small, thereby permitting fluid flow only along a path corresponding to the elongated shape of opening 206. For example, the opening may extend longitudinally along distal end region 227. The opening 206 in the fluid-impermeable barrier 102 may have a width measured transverse to the longitudinal direction and may be at least about 10% of the circumference of the fluid collection device 100, for example, about 25% to about 50%, about 40% to about 60%, about 50% to about 75%, about 65% to about 85%, or about 75% to about 100% of the circumference of the distal end region 227. The opening 206 may have a width greater than 50% of the circumference of the distal end region 227 because a vacuum (e.g., suction) through the conduit 208 draws fluid into the conduit 208. In some embodiments, the opening 206 may be oriented vertically (e.g., with its major axis parallel to the longitudinal axis of the distal end region 227). In some embodiments (not shown), the opening 206 may be oriented horizontally (e.g., with its major axis perpendicular to the longitudinal axis of the distal end region 227). In some embodiments, an inward boundary or edge of the distal end region 227 defines the opening 206. The edge may include two opposing arcuate portions that follow the outer periphery or perimeter of the substantially cylindrical distal end region 227.

[0022] According to various embodiments, the distal end region 227 may include any of a number of different shapes and configurations, such as the fluid-impermeable barrier shapes and configurations disclosed in U.S. patent application Ser. No. 63 / 171,165, filed April 6, 2021, U.S. patent application Ser. No. 63 / 228,258, filed August 2, 2021, U.S. patent application Ser. No. 63 / 228,252, filed August 2, 2021, U.S. patent application Ser. No. 63 / 228,244, filed August 2, 2021, U.S. patent application Ser. No. 17 / 394,055, filed August 4, 2021, or PCT application No. PCT / US20 / 40860, the disclosures of each of which are incorporated herein by reference in their entirety.

[0023] At least a portion (e.g., all) of the distal end region 227 includes a fluid-impermeable barrier. For example, the front and back surfaces of the distal end region 227 may include a fluid-impermeable barrier. In some embodiments, the distal end region 227 includes an inner wall 209 that at least partially defines the chamber 204. The inner wall 209 may partially block or prevent fluid communication between the chamber 204 and the interior region 205 of the handheld body 202. In some embodiments, the inner wall 209 defines an opening 211 or port configured to provide fluid communication between the chamber 204 of the handheld body 202 and the conduit 208 disposed in the interior region 205. In some embodiments, the inner wall 209 forms a funnel that narrows toward the opening 211. In many embodiments, the opening 211 is located near the proximal end region 225 or the bottom of the chamber 204 distal to the handle 215, such that gravity assists in pulling fluid released into the fluid-permeable member 220 and chamber 204 toward the opening 211 and removing it from the chamber 204. Locating the opening 211 and inlet 210 at or near a gravitationally low point in the chamber 204 allows the conduit 208 to receive more fluid than if the inlet 210 were located elsewhere, reducing the likelihood of pooling (e.g., pooling of fluid, which can lead to microbial growth and foul odors). For example, fluid within the fluid-permeable member 220 may flow in any direction due to capillary forces. However, fluid may tend to flow in the direction of gravity, especially when at least a portion of the fluid-permeable member 220 is saturated with fluid.

[0024] The fluid-impermeable material of the distal end region 227 may allow the distal end region to temporarily store fluid within the chamber 204. For example, the fluid-impermeable barrier of the distal end region 227 may be formed from any suitable fluid-impermeable material, such as a fluid-impermeable polymer (e.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, polycarbonate, etc.), polyurethane film, thermoplastic elastomer (TPE), rubber, thermoplastic polyurethane, another suitable material, or a combination thereof. Thus, the fluid-impermeable barrier of the distal end region 227 substantially prevents fluid from exiting the portion of the chamber 204 spaced from the opening 206. The fluid-impermeable barrier of the distal end region 227 is flexible, thereby allowing the distal end region 227 to bend or curve when placed against the wearer's body. Examples of fluid impermeable barriers include, but are not limited to, liquid impermeable barriers comprising at least one of Versaflex CL 2000X TPE, Dynaflex G6713 TPE, or Silpuran 6000 / 05 A / B silicone.

[0025] In one embodiment, the fluid-impermeable barrier of the distal end region 227 may be air-permeable. In such an embodiment, the fluid-impermeable barrier of the distal end region 227 may be formed of a hydrophobic material defining a plurality of pores. In one embodiment, one or more portions of at least an outer surface of the fluid-impermeable barrier of the distal end region 227 may be formed of a soft and / or smooth material to reduce skin irritation due to chafing.

[0026] In some embodiments, the handheld body 202 includes a neck 223 extending between a distal end region 227 and a proximal end region 225. The neck 223 may be sealed around the conduit 208, or the neck 223 may define at least a portion of the conduit 208. As shown in FIG. 2B , the neck 223 may be elongated such that when the distal end region 227 is positioned at least proximate to the urethra of the user 50, the handle 215 is positioned above the user's legs (e.g., the handle is not positioned between the user's legs when the distal end region 227 is positioned at least proximate to the urethra of the user 50). At least one of the neck 223 and the proximal end region 225 may be substantially rigid and / or may include a substantially rigid frame or member. In some embodiments, the neck 223 is flexible but retains its shape after bending.

[0027] In some embodiments, the neck 223 is flexible and includes a shape memory material, which provides the technical effect of allowing the neck 223 to bend to a desired shape or configuration and retain that shape or configuration. The shape memory material may include a shape memory polymer or metal (e.g., a shape memory metal). Suitable shape memory materials are configured to assume an intermediate or permanent shape in response to a stimulus. The stimulus may include an external physical force (e.g., a bending force), heat, an electrical bias, or a magnetic field. While the term "shape memory" is used herein to describe some "shape memory materials," it should be understood that in some instances, materials modified by the term "shape memory" may not necessarily return to a preselected shape upon application of a stimulus, as understood as the classical definition of a "shape memory material." Rather, at least some of the shape memory materials herein, once bent, hardened, or cured into a particular shape and / or cooled to a particular shape, may simply retain the selected shape regardless of a stimulus subsequently applied thereto. The shape memory material may be reverted to its original shape or changed to a new shape upon application of a stimulus. For example, a metal wire bent into a first shape may be utilized as a shape memory material, and the metal wire may then be modified into a second shape via a physical force applied to it or via heating.

[0028] In one embodiment, the shape memory material may include a metal such as an elemental metal, alloy, or shape memory alloy. Suitable shape memory metals may include standard steel, stainless steel, carbon alloy steel, heat-treated steel, aluminum, silver, copper, iron, nickel, zinc, tin, beryllium, etc. Suitable shape memory alloys may include stainless steel, galvanized steel, aluminum alloys, nitinol, nickel-titanium alloys such as Ni-Ti-Cu and Ni-Ti-Co, copper-based alloys such as Cu-Zn-Al, Cu-Al-Ni, and Cu-Al-Sn, Co-Cr-Ni-Mo alloys (e.g., Elgiloy®), etc., or any other alloy with shape memory properties. As explained above, a shape memory metal or alloy may simply be a metal or alloy that may be formed into a selected configuration. In some examples, the shape memory metal or alloy may return to its initial shape upon application of an external stimulus. In some examples, the outer surface of the shape memory metal may be coated with a polymer, anodized, passivated, or otherwise treated to prevent corrosion.

[0029] Shape memory polymers (“SMPs”) may include polyurethane-based SMPs such as copolymers (e.g., copolyesters, polyurethanes, polyetheresters, etc.) comprising one or more blocks of poly(ε-caprolactone), polyethylene terephthalate (PET), polyethylene oxide (PEO), polyethylene glycol (PEG), polystyrene, polymethyl methacrylate (PMMA), polybutyl methacrylate (PBMA), poly(N,N-butadiene), poly(N-methyl-N-oxazoline), polytetrahydrofuran, or poly(butylene terephthalate), thermoplastic polymers such as polyetheretherketone (PEEK), nylon, acetal, polytetrafluoroethylene (PTFE), polysulfone, etc., polynorbornene, other deformable polymers, or any other shape memory polymer.

[0030] 2A , according to one embodiment, the fluid collection device 200 also includes a fluid-permeable member 220 positioned to extend at least partially across the opening 206. For example, the fluid-permeable member 220 may be positioned to fill substantially all of the chamber 204 and cover or extend across substantially all of the opening 206. Thus, at least a portion of the fluid-permeable member 220 may have a shape complementary to at least a portion of the chamber 204. In some embodiments, the distal end region 227, the chamber 204, and the fluid-permeable member 220 are all complementary elongated. For example, the distal end region 227 and the fluid-permeable member 220 may be substantially cylindrical. In these and other embodiments, the fluid-permeable body 220 may form an arched surface in the distal end region 227, which is positioned to be positioned at least proximate (e.g., adjacent) to the urethra of the user 50.

[0031] In use, the fluid-permeable member 220 of the fluid collection device is positioned adjacent to the user's urethra. The fluid-permeable member 220 is disposed within the chamber 204 (shown in FIG. 2A ) of the distal end region 227 of the fluid collection device 200 and is exposed to the user's urethra through an opening 206 in the distal end region 227. In some embodiments, the configuration of the fluid-permeable member 220 and / or the distal end region 227 provides the technical effect that the fluid-permeable member 220 is selectively removable from the chamber 204 and the distal end region 227 of the fluid collection device. Thus, according to one embodiment, the fluid-permeable member 220 is at least partially selectively removable and replaceable within the chamber 204 in the distal end region 227 of the handheld body 202. In some embodiments, the fluid-permeable member 220 may be manually withdrawn from the chamber 204 of the distal end region 227 by grasping the fluid-permeable member 220 with a hand or other instrument. In some embodiments, the fluid collection device 200 includes a configuration that provides the technical effect that a user does not need to touch a soiled or used fluid-permeable member 220 to remove it from the chamber of the distal end region 227. This configuration provides a more hygienic procedure for using and replacing the device. For example, the fluid-permeable member 220 may be removed from the chamber 204 and the distal end region 227 by pressing on the back surface of the distal end region 227. In some embodiments, the distal end region 227 may include a flexible material such as rubber (described above), which provides the technical effect that a force acting on the back surface of the distal end region 227 can push the fluid-permeable member 227 out of the chamber 204 and / or at least partially invert the distal end region 227 to remove the fluid-permeable body 220 from the distal end region 227. In some embodiments, the fluid collection device 200 includes an actuator 234 (e.g., a button) on the distal end region 227 of the handheld body 202. The actuator is configured to at least partially remove the fluid-permeable member 220 from the chamber 204 when the actuator 234 is depressed.For example, the actuator 234 may be biased away from the inner wall 209, but when depressed, exerts a force on the inner wall 209 and / or extends at least partially into the chamber 204, pushing the fluid-permeable member 220 out of the chamber 204. When the actuator 234 is released, the actuator may be biased back to its original position where it does not exert a force on the inner wall 209 and / or does not extend at least partially into the chamber 204.

[0032] When a soiled or used fluid-permeable member 220 is retrieved or removed from the chamber 204, a new replacement fluid-permeable member 220 may be inserted into the chamber 204 in the distal end region 227 for use with the original fluid collection device 200. The fluid-permeable member 220 may comprise a material that provides the technical effect that the fluid-permeable member 220 is safe to flush down a toilet for disposal. The fluid-permeable member 220 may be configured to wick fluid away from the opening 206, thereby preventing fluid from leaking from the chamber 204. The fluid-permeable member 220 as a whole may also wick fluid toward the interior of the chamber 204 and / or the opening 211. A portion of the fluid-permeable member 220 may define a portion of the exterior surface of the fluid collection device 200. Specifically, the portion of the fluid-permeable member 220 that defines a portion of the outer surface of the fluid collection device 200 may be the portion of the fluid-permeable member 220 that is exposed by the opening 206 defined by the distal end region 227.

[0033] The fluid-permeable member 220 may include one or more fluid-permeable materials. For example, the fluid-permeable member 220 may include one or more of a polypropylene-based material, a polyurethane-based foam, a bamboo-based material, and / or a nonwoven material. The fluid-permeable member 220 may include any material that may wick fluid. The permeability characteristics referred to herein may be wicking, capillary action, diffusion, or other similar properties or processes, and are referred to herein as "permeability" and / or "wicking." "Such wicking" may exclude absorption into the wicking material. The fluid-permeable member 220 may include a fabric with unidirectional fluid movement. Thus, the fluid-permeable member 220 may remove fluid from the area surrounding the female urethra, thereby leaving the urethra dry. The fluid-permeable member 220 may allow fluid to flow generally toward a void reservoir (not shown) formed within the chamber 204 and / or toward the inlet 210 of the conduit 208 located at the opening 211 in the inner wall 209. For example, the fluid-permeable member 220 may include a porous or fibrous material, such as a hydrophilic polyolefin. In some embodiments, the fluid-permeable member 220 consists of, or consists essentially of, a porous or fibrous material, such as a hydrophilic polyolefin. Examples of polyolefins that may be used for the fluid-permeable member 220 include, but are not limited to, polyethylene, polypropylene, polyisobutylene, ethylene propylene rubber, ethylene propylene diene monomer, or combinations thereof. The porous or fibrous material may be extruded into a substantially cylindrical shape or another shape to fit within the chamber 204 of the distal end region 227. The fluid-permeable member 220 may include various densities or dimensions. Additionally, the fluid-permeable member 220 may be manufactured by various manufacturing methods, such as molding, extrusion, or sintering.

[0034] In some embodiments, the fluid-permeable member 220 comprises a uniquely porous body. In some embodiments, a majority of the outer surface of the fluid-permeable member 220 is joined to the interior wall 209. In some embodiments, the fluid-permeable member 220 may include two or more layers of fluid-permeable material, and may include three or more layers of material (or none) between the opening 206 and the conduit 208 disposed within the fluid-permeable member 220. For example, the fluid-permeable member 220 may include a fluid-permeable membrane covering or encasing at least a portion of a fluid-permeable support, with both the fluid-permeable membrane and the fluid-permeable support being at least partially disposed within the chamber 204. The fluid-permeable membrane may cover or extend across at least a portion (e.g., all) of the opening 206. The fluid-permeable membrane may be configured to wick fluid away from the opening 206, thereby preventing fluid from leaking from the chamber 204. The permeability properties referred to herein may be wicking, capillary action, diffusion, or other similar properties or processes, and are referred to herein as "permeability" and / or "wicking." In some embodiments, at least one of the fluid-permeable membrane or fluid-permeable support comprises nylon configured to wick fluid away from the opening 206. The fluid-permeable membrane and fluid-permeable support materials may also comprise natural fibers. In such instances, the material may have a coating to prevent or limit absorption of fluid into the material, such as a water-repellent coating. Such "wicking" or other physical properties may not include absorption into the fluid-permeable member 220, such as not including absorption of bodily fluid into the fluid-permeable member 220. In other words, once the material has been exposed to and removed from bodily fluid, there may be substantially no absorption or dissolution of bodily fluid into the material.Although no absorption is desirable, the term "substantially no absorption" may refer to allowing a nominal amount of fluid absorption (e.g., absorbency) into the wicking material, such as less than about 30% by weight of the dry weight of the fluid-permeable member 220, less than about 20% by weight, less than about 10% by weight, less than about 7% by weight, less than about 5% by weight, less than about 3% by weight, less than about 2% by weight, less than about 1% by weight, or less than about 0.5% by weight of the fluid-permeable member 220. In one embodiment, the fluid-permeable member 220 may include at least one absorbent or adsorbent material.

[0035] The fluid-permeable membrane may generally wick fluid toward the interior of the chamber 204. The fluid-permeable membrane may include any material capable of wicking fluid. For example, the fluid-permeable membrane may include a fabric such as gauze (e.g., a polymeric material such as silk, linen, polyester, or cotton gauze), another soft fabric (e.g., a jersey knit fabric, etc.), or another smooth fabric (e.g., rayon, satin, etc.). Forming the fluid-permeable membrane from gauze, a soft fabric, and / or a smooth fabric may reduce skin irritation due to friction caused by the fluid collection device 200. Other embodiments of fluid-permeable membranes, fluid-permeable supports, chambers, and their shapes and configurations are disclosed in U.S. patent application Ser. No. 15 / 612,325, filed June 2, 2017, U.S. patent application Ser. No. 15 / 260,103, filed September 8, 2016, U.S. patent application Ser. No. 15 / 611,587, filed June 1, 2017, and International Application No. PCT / US19 / 29608, filed April 29, 2019, the disclosures of each of which are incorporated herein by reference in their entireties. In many embodiments, the fluid-permeable member 220 includes a fluid-permeable support including a porous nylon structure (e.g., spun nylon fibers) and a fluid-permeable membrane including gauze around or over the porous nylon structure of the fluid-permeable support.

[0036] Returning to FIG. 2A , the fluid collection device 200 also includes a conduit 208 in fluid communication with the fluid-permeable member 220 and extending at least partially through an opening 212 in the proximal end region 225. In some embodiments, one or more conduits 208 provide fluid communication between the opening 211 in the distal end region 227 and the opening 212 in the proximal end region 225. Fluid received from the urethra into the chamber 204 in the distal end region 227 may be removed through the conduit 208. The conduit 208 may extend through the proximal end region 225 and the neck 223. In some embodiments, the conduit 208 includes an inlet 210 disposed at least proximate to the opening 211 in the distal end region 227. For example, the inlet 210 of the conduit 208 may substantially join a portion of the fluid-permeable member 220 disposed within the chamber 204. In some embodiments, the conduit 208 may extend through the opening 211 into the fluid chamber 204 at the distal end region, thereby disposing the inlet 210 at least partially within the chamber 204. However, in other embodiments, the inlet 210 may be disposed flush with or behind the opening 211. Fluid collected within the fluid collection device 100 may be removed from the interior region of the chamber 204 via the conduit 208. At least a portion of the conduit 208 may comprise a flexible material, such as plastic tubing (e.g., medical tubing). Such plastic tubing may include tubing made of thermoplastic elastomer, polyvinyl chloride, ethylene vinyl acetate, polytetrafluoroethylene, or the like. In some embodiments, the conduit 108 may comprise silicone or latex. The opening 211 may be configured to abut the conduit 208 or at least one tube to form at least a substantially fluid-tight seal, thereby substantially preventing fluid from leaking from the chamber 204.

[0037] In some embodiments, the fluid-permeable member 220 and the chamber 204 may be sized and dimensioned such that a reservoir is defined within the chamber 204 for temporarily storing a fluid. The reservoir may be an unoccupied portion of the chamber 204, free of other materials. In some embodiments, the reservoir is at least partially defined by the fluid-permeable body 220 and the interior wall 209. For example, in certain embodiments, the reservoir may be located in a portion of the chamber 204 closest to the inlet 210. However, the reservoir may be located at a different location within the chamber 204. In these and other embodiments, the conduit 208 may extend into the reservoir through an opening 211 in the interior wall 209. In another example, the fluid-permeable body 220 is spaced from at least a portion of the conduit 208, and the reservoir may be the space between the fluid-permeable body 220 and the conduit 208. In some embodiments, the fluid-permeable body 220 fills or occupies substantially all of the chamber 204.

[0038] According to one embodiment, a pump 230 is disposed within the interior region 205 of the handheld body 202 and / or secured to the handheld body 202 of the fluid collection device 200. The pump 230 may pump discharged urine through the conduit 208 into the fluid-permeable member 220 and chamber 204, directing the urine to a storage container or a toilet. For example, the pump 230 may create a negative pressure at the inlet 210 effective to pump fluid within the chamber 204 and / or the fluid-permeable member 220 through the inlet 210 and into the conduit 208. The pump 230 may include at least one of a peristaltic pump, a wet pump, a positive displacement pump, a manual pump, an electric pump, a diaphragm pump, a centrifugal pump, a positive displacement pump, a magnetic drive pump, a micropump, or any pump configured to create a negative pressure at the inlet 210 of the conduit.

[0039] In some embodiments, the pump 230 may be located within the interior region 205 of the handheld body 202, between two portions of the conduit 208. In some embodiments, the pump 230 is secured to the handheld body 202 on the outside of the handheld body 202, for example, on the outside of the proximal end region 225.

[0040] The fluid collection device 200 may include an actuator 232 (e.g., one or more buttons) ergonomically located on the handheld body 202 operably coupled to the pump 230 by one or more wires 229, which provides the technical effect of enabling intuitive, one-handed operation of the fluid collection device 200. The actuator 232 is configured to selectively activate and deactivate the pump 230. In some embodiments, the actuator 232 is located in the proximal end region 225 of the handheld body 202, generally distal to the distal end region 227. In other embodiments, the actuator 232 may be located elsewhere on the handle 215 or neck 223.

[0041] In some embodiments, the handheld body 202 houses at least one (e.g., both) of the pump 230 and the power source 236 within the interior region 205 of the handheld body 202. The power source 236 may be fixed and / or disposed within the interior region 205 of the handheld body 202 and operably coupled to the actuator 232 and the pump 230. The power source 236 may include any power source configured to provide power to the pump 230. For example, the power source 236 may include one or more batteries, such as batteries that are rechargeable or replaceable by the user.

[0042] Referring to FIG. 2B , the fluid collection device 200 is shown in use by a user 50. While the user 50 is shown holding the fluid collection device 200 in one hand, the fluid collection device may equally be held in one hand by a caregiver and applied to the user 50. Thus, either the user 50 or the caregiver may hold the fluid collection device 200 to collect fluid from the user 50. The fluid-permeable member 220, which is at least partially disposed within the chamber 204 of the fluid collection device 200, may be positioned at least proximate (e.g., adjacent) to the urethra of the user 50. The user 50 or the caregiver then activates a pump 230 (not shown) using an actuator 232, which then expels urine into the fluid-permeable member 220. The pump 230 may draw the expelled urine in the fluid-permeable member 220 and chamber 204 into a conduit 208 (not shown). The pump 230 may further direct the urine in the conduit 208 from the handheld body 202 to at least one of the toilet 260 or the fluid collection container 250. In some embodiments, the conduit 208 is removably secured to the fluid collection container 250. After the user has finished urinating, the distal end region 227 may be moved away from the urethra of the user 50, and the soiled fluid-permeable member 220 may be retrieved or removed from the distal end region 227 of the handheld body 202 by the user 50 or a caregiver and discarded. A new fluid-permeable member 220 may be at least partially disposed in the chamber 204 of the distal end region 227 to replace the soiled fluid-permeable member 220 that was removed and discarded.

[0043] 3 , in some embodiments, a fluid collection device 300 may include a handheld body 302 and a fluid-permeable member 320 that is a compressible material that expands after compression, thereby providing the technical effect of allowing the fluid-permeable member 320 to be positioned at least proximate to a user's urethra. Unless otherwise specified, the fluid collection device 300 may include any aspect, material, feature, dimension, etc. of the fluid collection device 200. For example, the handheld body 302 may include a proximal end region 325 that at least partially defines an opening 312, a distal end region 327 that at least partially defines an opening 306, and an inner region 305. The fluid-permeable member 320 may be positioned to extend at least partially across the opening 306, and a conduit 308 in fluid communication with the fluid-permeable member 320 extends at least partially through the opening 312 in the proximal end region 327. A pump 330 may be secured to the handheld body 302 and / or disposed within the interior region 305 of the handheld body 302. The pump 330 may be configured to pump fluid from the fluid-permeable member 320 at least partially through the conduit 308. Although not shown in FIG. 3 , the fluid collection device 300 may include a power source similar to or identical to the power source 236 in the fluid collection device 200.

[0044] In some embodiments, the handheld body 302 may include substantially spoon-shaped front and rear profiles. For example, the proximal end region 325 of the handheld body 302 may include a generally elongated tubular proximal end region, and the distal end region 327 may include a generally oval profile. According to one embodiment, the opening 306 in the distal end region 327 may include a generally oval opening disposed within the generally oval profile of the distal end region 327. The distal end region 327 may at least partially define a chamber 306 recessed into the distal end region 327. The handheld body 302 may be effective in providing the technical effect of allowing the fluid collection device 300 to be more easily slid into place by the fluid-permeable member 320 at least proximate the urethra, by being substantially flat on the front and rear of the handheld body 302.

[0045] The fluid-permeable member 320 may include any aspect of the fluid-permeable member 220. In some embodiments, the fluid-permeable member 320 protrudes from the front surface of the distal end region 327 and comprises a resilient, compressible fluid-permeable foam sized and dimensioned to fit between the user's labia and over or at least proximate the user's urethral opening. In some embodiments, the fluid-permeable member 320 is substantially flat when the fluid collection device 300 is slid into place with the fluid-permeable member 320 at least proximate the user's urethra. For example, the fluid-permeable member 320 may be substantially flat until a cover (not shown) is removed from the fluid-permeable member 320 and the fluid-permeable member 320 expands and protrudes from the front surface of the distal end region 327. In some embodiments, the fluid-permeable member 320 compresses to lie substantially flat when the fluid collection device 300 is slid into place, and then the fluid-permeable member 320 expands to fit between the user's labia and over or at least proximate the user's urethral opening. In some embodiments, the fluid-permeable member 320 may expand to protrude from the distal end region 327 by expanding when the fluid-permeable member 320 is positioned at least proximate the user's urethra. For example, the pump 330 may include a selectively reversible pump that selectively applies positive pressure from the inlet 310 to cause the fluid-permeable member 320 to expand and protrude from the distal end region 327. In some embodiments, the fluid-permeable member 320 includes a peripheral lip disposed within the chamber 306 that engages with a front surface of the distal end region 327 to prevent the fluid-permeable member 320 from falling off and separating from the handheld body 302 without the use of additional force.

[0046] In some embodiments, the fluid-permeable member 320 is selectively removable or removably, as described above with respect to the fluid-permeable member 220 in the fluid collection device 200. Although not visible in FIG. 3 , the fluid collection device 300 may include an actuator in the distal end region 327 of the handheld body 302 that is configured to, when depressed, at least partially remove the fluid-permeable member 320 from the chamber 306.

[0047] According to one embodiment, the fluid collection apparatus 300 further includes a conduit 308 having an inlet 310 in fluid communication with the chamber 304 of the distal end region 327. The inlet 310 may be disposed at least proximate to and / or within the chamber 304. In some embodiments, the inlet 310 interfaces with a portion of the fluid-permeable member 320 disposed within the chamber 304 and / or is flush with a portion of the distal end region 327 that defines the chamber 304. The conduit 308 may include one or more members that extend through the interior region 305 of the fluid collection apparatus 300 before extending through the opening 312 in the proximal end region 325.

[0048] According to various embodiments, the fluid collection device 300 further includes a pump 330 disposed within the interior region 305 of the handheld body 302 and / or secured to the handheld body 302. The pump 330 may include any aspect of the pump 230 and may be configured to pump fluid from the fluid-permeable member 320 and the chamber 306 and direct or advance the fluid through the conduit 308 and out of the fluid collection device 300. The fluid collection device 332 may further include an actuator 332 disposed on the handheld body 302 and operably coupled to the pump 330. According to one embodiment, the actuator 332 is configured to selectively activate and deactivate the pump 330. The fluid collection device 300 may be used in a similar manner to the fluid collection device 200 described above. In some embodiments, the pump 330 is disposed outside the handheld body 302. For example, the pump 330 may be secured to the outside of the handheld body 302. In some embodiments, pump 330 comprises an external pump, such as a wall-mounted pump or a pump in a housing separate from fluid collection apparatus 300. For example, pump 330 may be in fluid communication with a fluid collection container that is in fluid communication with fluid collection apparatus 300. If pump 330 is capable of creating a negative pressure in the fluid collection container, it creates a negative pressure at inlet 310 effective to draw urine in chamber 304 and fluid-permeable member 320 into conduit 308 and the fluid collection container.

[0049] 4A , in some embodiments, a fluid collection device 400 may include a handheld body 402 and a fluid-permeable member 420 that tapers at two opposing ends toward the apex of the fluid-permeable member 420, thereby providing the technical effect of the fluid-permeable member 420 fitting comfortably between a user's labia. Unless otherwise noted, the fluid collection device 400 may include any aspect, material, feature, dimension, etc., of the fluid collection devices 200, 300. For example, the handheld body 402 may include a proximal end region 425 that at least partially defines an opening 412, a distal end region 427 that at least partially defines an opening 406, and an inner region 405. The fluid-permeable member 420 may be positioned to extend at least partially across the opening 406, with a conduit 408 in fluid communication with the fluid-permeable member 420 extending at least partially through the opening 412 in the proximal end region 427. The pump 430 may be fixed to the handheld body 402 and / or may be disposed within the interior region 405 of the handheld body 402. The pump 430 may be configured to pump fluid from the fluid-permeable member 420 and at least partially through the conduit 408. Although not shown in FIG. 4A , the fluid collection device 400 may include a power source similar to or identical to the power source 236 in the fluid collection device 200.

[0050] In some embodiments, the handheld body 402 may be substantially spoon-shaped, pear-shaped, teardrop-shaped, or pear-shaped. For example, the proximal end region 425 of the handheld body 402 may comprise a generally elongated tubular proximal end region, and the distal end region 427 may comprise a generally elongated oval profile. According to one embodiment, the opening 406 in the distal end region 427 may comprise a generally elongated opening disposed within the generally elongated oval profile of the distal end region 427. The distal end region 427 may at least partially define a chamber 406 recessed into the distal end region 427.

[0051] The fluid-permeable member 420 may include any aspect of the fluid-permeable member 220. Referring to the cross-sectional view of FIG. 4B , in some embodiments, the fluid-permeable member 420 may include a resilient, compressible fluid-permeable foam protruding from a front surface of the distal end region 427, sized and dimensioned to fit between the user's labia, and over or at least proximate to the user's urethral opening. The fluid-permeable member 420 may be partially disposed within the chamber and may include an elongated ridge 421 at the top of the fluid-permeable member 420, spaced from the distal end region 427. The fluid-permeable member 420 may be elongated and may taper toward two opposing end regions. In some embodiments, the fluid-permeable member 420 includes a substantially triangular cross-sectional profile with rounded corners, and the distal end region 427 may partially overlap the bottom end of the fluid-permeable member 420, thereby at least selectively retaining the fluid-permeable member partially within the chamber 406. In some embodiments, the fluid-permeable member 420 is selectively removable or removably, as described above with respect to the fluid-permeable member 220 in the fluid collection device 200. Although not visible in Figures 4A and 4B, the fluid collection device 400 may include an actuator in the distal end region 427 of the handheld body 402 that is configured to, when depressed, at least partially remove the fluid-permeable member 420 from the chamber 406.

[0052] According to one embodiment, the fluid collection apparatus 400 further includes a conduit 408 having an inlet 410 in fluid communication with the chamber 404 at the distal end region 427. The inlet 410 may be disposed at least proximate to and / or within the chamber 404. In some embodiments, the inlet 410 interfaces with a portion of a fluid-permeable member 420 disposed within the chamber 404 and / or is flush with a portion of the distal end region 427 that defines the chamber 404. The conduit 408 may include one or more members that extend through the interior region 405 of the fluid collection apparatus 400 before extending through the opening 412 at the proximal end region 425.

[0053] According to various embodiments, the fluid collection device 400 further includes a pump 430 disposed within the interior region 405 of the handheld body 402 and / or secured to the handheld body 402. The pump 430 may include any aspect of the pump 230 and may be configured to pump fluid from the fluid-permeable member 420 and the chamber 406 and direct or advance the fluid out of the fluid collection device 400 through the conduit 408. The fluid collection device 400 may further include an actuator 432 disposed on the handheld body 402 and operably coupled to the pump 430. According to one embodiment, the actuator 432 is configured to selectively activate and deactivate the pump 430. The fluid collection device 400 may be used similarly to the fluid collection device 200 described above.

[0054] In some embodiments, the pump 430 is disposed outside the handheld body 402. For example, the pump 430 may be fixed to the outside of the handheld body 402. In some embodiments, the pump 430 includes an external pump, such as a wall-mounted pump or a pump in a housing separate from the fluid collection device 400. For example, the pump 430 may be in fluid communication with a fluid collection container that is in fluid communication with the fluid collection device 400. If the pump 430 is capable of creating a negative pressure in the fluid collection container, it creates a negative pressure at the inlet 410 effective to draw urine in the chamber 404 and the fluid-permeable member 420 into the conduit 408 and the fluid collection container.

[0055] FIG. 5 is a flow diagram of a method 500 of collecting fluid, according to an embodiment. Method 500 may include the use of any of the fluid collection devices described herein. Method 500 may include operation 510 of holding at least a portion of a proximal end region of a handheld body of the fluid collection device. The handheld body includes a distal end region at least partially defining an opening, an interior region, and an opening at least partially defined by the proximal end region. Method 500 may include operation 520 of positioning a fluid-permeable member of the fluid collection device at least proximate to a user's urethral opening while holding at least a portion of the proximal end region of the body of the fluid collection device. The fluid-permeable member may be positioned to extend at least partially across the opening. Method 500 may include operation 530 of activating a pump secured to the body and / or disposed within the interior region of the body effective to generate a negative pressure at an inlet of a conduit in fluid communication with the fluid-permeable member. The conduit may extend at least partially through the opening. The method 500 may include an operation 540 of pumping fluid expelled by the urethra through the fluid-permeable member, through a conduit extending at least partially through the opening, and into an inlet of the conduit to remove fluid from the fluid collection device while the pump is activated to create a negative pressure.

[0056] In some embodiments, operation 530 includes actuating a pump secured to the body and / or disposed within an interior region of the body with an actuator disposed on the body and operably coupled to the pump. In these and other embodiments, operation 510 may include holding a handle at a proximal end region of a handheld body, the distal end region at least partially defining a chamber, the handheld body including a neck extending between the distal end region and the proximal end region, and the conduit extending through the proximal end region and the neck and including an inlet located proximate to and in fluid communication with the chamber. In these and other embodiments, method 500 may further include the operation of inserting a fluid-permeable member of a fluid collection device at least partially into the chamber before placing the fluid-permeable member at least proximate to the user's urethral opening. In some embodiments, method 500 may further include the operation of removing the fluid-permeable member from the chamber and disposing a replacement fluid-permeable member at least partially into the chamber after at least a portion of the fluid has been removed from the fluid collection device. In some embodiments, the act of removing the fluid-permeable member from the chamber includes depressing an actuator disposed in the distal end region and configured to at least partially remove the fluid-permeable member from the chamber. In some embodiments, act 520 includes positioning the fluid-permeable member between the user's labia and protruding from a front surface of the distal end region at least proximate the user's urethral meatus.

[0057] The operations of method 500 are for illustrative purposes. For example, the operations of method 500 may be performed in a different order, divided into multiple operations, modified, supplemented, or combined. In one example, one or more of the operations of method 500 may be omitted from method 500. Any of the operations of method 500 may include using any of the fluid collection devices and systems, or components thereof, disclosed herein.

[0058] As used herein, the terms "about" or "substantially" refer to an acceptable variation of the term modified by "about" by ±10% or ±5%. Furthermore, the terms "less than," "equal to or less than," "greater than," "more than," or "equal to or greater than" include, as endpoints, the value modified by the term "less than," "equal to or less than," "greater than," "more than," or "equal to or greater than."

[0059] While various aspects and embodiments have been disclosed herein, other aspects and embodiments are contemplated. The various aspects and embodiments disclosed herein are for purposes of illustration and not limitation.

Claims

1. a handheld body having a proximal end region at least partially defining an opening, a distal end region at least partially defining an opening and a chamber, and an interior region; a fluid-permeable member disposed to extend at least partially across the opening, the fluid-permeable member being selectively removable and replaceable at least partially within the chamber in the distal end region of the hand-held body; a first actuator at the distal end region of the handheld body, the first actuator configured to, when depressed, at least partially remove the fluid-permeable member from the chamber; a conduit in fluid communication with the fluid-permeable member and extending at least partially through the opening; a pump secured to the handheld body and / or disposed within the interior region of the handheld body, the pump configured to draw fluid from the fluid-permeable member at least partially through the conduit; A fluid collection device comprising:

2. 10. The fluid collection device of claim 1, further comprising a second actuator disposed on the handheld body and operably coupled to the pump, the second actuator configured to selectively activate and deactivate the pump.

3. 3. The fluid collection device of claim 2, wherein the proximal end region of the handheld body defines at least a portion of the interior region and includes a handle, the handheld body includes a neck extending between the distal end region and the proximal end region, and the conduit extends through the proximal end region and the neck and includes an inlet adjacent to and in fluid communication with the chamber.

4. The fluid collection device of claim 3 , wherein the pump is disposed within the interior region of the handle.

5. The fluid collection device of claim 3 , wherein the pump is secured to the proximal end region of the handheld body.

6. 10. The fluid collection device of claim 1, wherein the distal end region is generally cup-shaped and complementary to a portion of the fluid-permeable member disposed within the chamber.

7. The fluid collection device of claim 1 , wherein the fluid-permeable member is generally cylindrical and the distal end region is generally cylindrical.

8. 7. The fluid collection device of claim 6, wherein the inlet of the conduit substantially joins a portion of the fluid-permeable member disposed within the chamber.

9. The fluid collection device of claim 3 , wherein the proximal end region comprises a generally rigid material and the distal end region of the handheld body comprises a soft rubber or silicone material.

10. 2. The fluid collection device of claim 1, wherein the proximal end region comprises a generally elongated tubular proximal end region, the distal end region comprises a generally elliptical profile, and the opening comprises a generally elliptical opening disposed within the generally elliptical profile.

11. 11. The fluid collection device of claim 10, wherein the fluid-permeable member comprises a resilient, compressible, fluid-permeable foam protruding from a front surface of the distal end region and sized and dimensioned to fit between a user's labia and at least proximate to the user's urethral opening.

12. 2. The fluid collection device of claim 1, wherein the handheld body is elongated, the opening is elongated, the fluid-permeable member is elongated and protrudes from a distal end region of the handheld body, the fluid-permeable member including an elongated ridge spaced from the distal end region and two opposing tapered end regions.

13. The fluid collection device of claim 10 , wherein the conduit extends through the proximal end region and includes an inlet adjacent to and in fluid communication with the chamber.

14. The fluid collection device of claim 1 , further comprising a fluid collection vessel in fluid communication with the conduit and positioned to collect fluid from the fluid-permeable member through the conduit.

15. 1. A method of collecting a fluid, comprising: holding at least a portion of a proximal end region of a handheld body of a fluid collection device, the handheld body including a distal end region, an interior region, and an opening at least partially defined by the proximal end region, the distal end region at least partially defining an opening and a chamber; While holding at least a portion of the proximal end region of the handheld body of the fluid collection device, positioning a fluid-permeable member of the fluid collection device at least adjacent to the user's urethral opening, the fluid-permeable member being positioned to extend at least partially across the opening; activating a pump secured to the handheld body and / or disposed within the interior region of the handheld body effective to create a negative pressure at an inlet of a conduit in fluid communication with the fluid-permeable member, the conduit extending at least partially through the opening; pumping fluid expelled by the user's urethra through the fluid-permeable member and into the inlet of the conduit, the conduit extending at least partially through the opening, to remove the fluid from the fluid collection device while the pump is activated to create the negative pressure; removing the fluid-permeable member from the chamber after at least a portion of the fluid has been removed from the fluid collection device, the removing the fluid-permeable member from the chamber comprising depressing a first actuator disposed in the distal end region and configured to at least partially remove the fluid-permeable member from the chamber; placing an exchange fluid-permeable member at least partially within the chamber; A method comprising:

16. 16. The method of claim 15, wherein actuating a pump secured to the handheld body and / or disposed within the interior region of the handheld body comprises actuating the pump secured to the handheld body and / or disposed within the interior region of the handheld body using a second actuator disposed on the handheld body and operably coupled to the pump.

17. 17. The method of claim 16, wherein the step of holding at least a portion of a proximal end region of a handheld body of a fluid collection device includes holding a handle on the proximal end region of the handheld body, the handheld body including a neck extending between the distal end region and the proximal end region, the conduit extending through the proximal end region and the neck and including the inlet located adjacent to and in fluid communication with the chamber.

18. 20. The method of claim 17, further comprising inserting the fluid-permeable member of the fluid collection device at least partially into the chamber before positioning the fluid-permeable member at least proximate to the urethral opening of the user.

19. 16. The method of claim 15, wherein positioning the fluid-permeable member of the fluid collection device at least proximate to the user's urethral opening comprises positioning the fluid-permeable member protruding from a front surface of the distal end region between the user's labia and at least proximate to the user's urethral opening.

20. a handheld body having a proximal end region at least partially defining an opening, a distal end region at least partially defining an opening and a chamber, and an interior region; a fluid-permeable member disposed to extend at least partially across the opening, the fluid-permeable member being selectively removable and replaceable at least partially within the interior region of the hand-held body; a first actuator at the distal end region of the handheld body, the first actuator configured to, when depressed, at least partially remove the fluid-permeable member from the chamber; and a conduit in fluid communication with the fluid-permeable member and extending at least partially through the opening; a fluid collection device including: a fluid collection container having an interior region in fluid communication with the conduit; a pump in fluid communication with the interior region of the fluid collection container and configured to create a negative pressure within the interior region of the fluid collection device effective to pump fluid from the fluid-permeable member at least partially through the conduit; A fluid collection system comprising:

21. 21. The fluid collection system of claim 20, wherein the proximal end region of the handheld body defines at least a portion of the interior region and includes a handle, the handheld body includes a neck extending between the distal end region and the proximal end region, and the conduit extends through the proximal end region and the neck and includes an inlet adjacent to and in fluid communication with the chamber.

22. 21. The fluid collection system of claim 20, wherein the distal end region is generally cup-shaped and complementary to a portion of the fluid-permeable member disposed within the chamber.

23. 22. The fluid collection system of claim 21, wherein the fluid-permeable member is generally cylindrical and the distal end region is generally cylindrical.

24. 22. The fluid collection system of claim 21, wherein the proximal end region comprises a generally rigid material and the distal end region of the handheld body comprises a soft rubber or silicone material.

25. 21. The fluid collection system of claim 20, wherein the proximal end region comprises a generally elongated tubular proximal end region, the distal end region comprises a generally elliptical profile, and the opening comprises a generally elliptical opening disposed within the generally elliptical profile.

26. 26. The fluid collection system of claim 25, wherein the fluid-permeable member comprises a resilient, compressible, fluid-permeable foam protruding from a front surface of the distal end region and sized and dimensioned to fit between the labia of a user and at least proximate to the urethral opening of the user.

27. 21. The fluid collection system of claim 20, wherein the handheld body is elongated, the opening is elongated, the fluid-permeable member is elongated and protrudes from a distal end region of the handheld body, the fluid-permeable member including an elongated ridge spaced from the distal end region and two opposing tapered end regions.

28. 26. The fluid collection system of claim 25, wherein the conduit extends through the proximal end region and includes an inlet adjacent to and in fluid communication with the chamber.

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