External catheter with urinalysis capability and related systems and methods

Abstract

The embodiments relate to devices, systems, and methods for urine collection. The urine collection assembly may include a fluid impermeable barrier defining at least a chamber, at least one opening, and a fluid outlet. The urine collection assembly may also include a conduit having a first end disposed within the chamber, at least one porous material disposed within the chamber, and a urinalysis device disposed within the fluid collection assembly.

Description

[Technical field]

[0001] The present invention relates to external catheters with urinalysis capability and related systems and methods. [Background technology]

[0002] An individual may have limited or impaired mobility, making the normal process of urination difficult or impossible. For example, an individual may have undergone surgery or have a disability 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 trials.

[0003] Bedpans and urinary catheters, such as Foley catheters, may be used to address some of these situations. However, bedpans and urinary catheters have several problems associated with them. For example, bedpans can be uncomfortable, prone to spillage, and other hygiene issues. Urinary catheters can be uncomfortable, painful, and can lead to urinary tract infections. Conventional fluid collection devices may also be limited to use when the patient is lying on their back in bed.

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

[0005] [Patent Document 1] US Patent Application Publication No. 2016 / 374848 [Patent Document 2] International Publication No. 2019 / 150385 [Patent Document 3] U.S. Pat. No. 5,605,161 [Patent Document 4] International Publication No. 2021 / 102296 Summary of the Invention [Means for solving the problem]

[0006]

[0003] Embodiments disclosed herein relate to urine collection systems, urine testing, and methods of using urine collection systems. In one embodiment, the urine collection assembly may include a fluid impermeable barrier defining at least a chamber, at least one opening, and a fluid outlet. The urine collection assembly may further include a conduit having a first end disposed within the chamber, at least one porous material disposed within the chamber, and a urinalysis device disposed within the fluid collection assembly.

[0007] In one embodiment, the urine collection system may include a urine collection assembly, a conduit in fluid communication with the urine collection assembly, a urinalysis device, a urine collection container including an interior region in fluid communication with the conduit, and a pump in fluid communication with the urine collection container and the urine collection assembly. The pump may be configured to draw urine from the urine collection assembly and collect urine in the urine collection container via the conduit.

[0008] In one embodiment, a method of collecting a urine test sample is disclosed. The method may include positioning a urine collection assembly adjacent to a urethral opening of a user. The urine collection assembly may include a fluid impermeable barrier defining at least a chamber, at least one opening, and a fluid outlet. The urine collection assembly may further include at least one porous material disposed within the chamber, and a urine test device disposed within the chamber. The method may also include receiving urine from the urethral opening into the chamber of the urine collection assembly, saturating the urine test device with urine, and withdrawing the urine test device from within the urine collection assembly.

[0009] Features from any of the disclosed embodiments may be used in combination with each other without limitation.Furthermore, 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 description of the drawings]

[0011] [Figure 1A] FIG. 1 is a block diagram of a portable fluid collection system, according to one embodiment. [Figure 1B] 1 illustrates an isometric view of a fluid collection system, according to one embodiment. [Figure 2A] FIG. 1 is a cross-sectional view of a female urine collection assembly according to one embodiment. [Figure 2B] FIG. 1 is a cross-sectional view of a female urine collection assembly according to one embodiment. [Diagram 3] FIG. 1 illustrates an exploded view of a female urine collection assembly, according to one embodiment. [Figure 4A] FIG. 1 is a cross-sectional view of a male urine collection assembly according to one embodiment. [Figure 4B] FIG. 1 illustrates an isometric view of a male urine collection assembly, according to one embodiment. [Figure 4C] FIG. 4C is a cross-sectional view of the male urine collection assembly of FIG. 4B. [Diagram 5] FIG. 1 is a flow diagram of a method for collecting a urine test sample, according to one embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0012]

[0002] Embodiments disclosed herein relate to a urine collection system and associated methods. Many users of fluid collection devices are over 65 years of age, have limited mobility, and often rely on wheelchairs as their primary means of transportation. Many users also have medical conditions that may require a urine test sample for testing, treatment, or diagnosis of the condition. As such, users and caregivers may benefit from a urine collection system that may enable provision of a urine test sample without significant disassembly of the system, allowing the user and / or caregiver to collect fluids using the urine collection system as well as conveniently gather a urine test sample.

[0013] In many embodiments described herein, the urine collection system may be configured to facilitate urine sampling and analysis. Urine testing does not require sampling from a reservoir or disassembly of the system, which may lead to leaks or overflow. Urine collection system embodiments described herein allow for both collection of urine drawn from a urine collection assembly adjacent the user's urethral opening and convenient withdrawal of a urine test sample from the urine collection assembly.

[0014] In some embodiments, the urine collection assembly includes a fluid impermeable barrier and an opening in the fluid impermeable barrier. A urinalysis device may be placed in the fluid collection assembly and withdrawn through the opening for sampling. In some embodiments, the urinalysis device may be configured to analyze at least one of calcium, blood, glucose, bilirubin, urobilinogen, ketones, white blood cells, creatinine, microalbumin, pH, ascorbic acid, and protein when requested by a user or when directed by a caregiver.

[0015] FIG. 1A is a block diagram of a urine collection system 10, according to one embodiment. The urine collection system 10 may be included in the embodiments of the fluid collection system described herein. The system 10 includes a fluid (e.g., urine) collection device 12 (e.g., any of the urine collection assemblies disclosed herein), a urine collection container 14 (or reservoir), and a pump 16 (or vacuum device). The urine collection assembly 12, the urine collection container 14, and the pump 16 may be fluidly coupled to one another via one or more tubes 18. For example, the urine collection assembly 12 may be operably coupled to one or more of the urine collection container 14 or the pump 16 via the tube 18. In some embodiments, the pump 16 may be directly coupled to the urine collection container 14. Fluid (e.g., urine or other bodily fluids) collected in the urine collection assembly 12 may be removed from the urine collection assembly 12 via the tube 18 coupled to the urine collection assembly 12. A suction force may be introduced into a chamber of the urine collection assembly 12 via an inlet of the tube 18 in response to a suction (e.g., vacuum) force applied at an outlet of the tube 18.

[0016] Suction may be applied to the outlet of the tube 18 directly or indirectly by the pump 16. Suction may be applied indirectly via the urine collection container 14. For example, the outlet of the tube 18 may be disposed within or fluidly coupled to an interior region of the urine collection container 14, and an additional tube 18 may extend from the urine collection container 14 to the pump 16. Thus, the pump 16 may apply suction to the urine collection assembly 12 via the urine collection container 14. Suction may be applied directly via the pump 16. For example, the outlet of the tube 18 may be disposed within the pump 16. An additional tube 18 may extend from the pump 16 to a point outside the urine collection assembly 12, such as the urine collection container 14. In such an example, the pump 16 may be disposed between the urine collection device 12 and the urine collection container 14.

[0017] The urine collection container 14 may be sized and shaped to hold fluid therein. The urine collection container 14 may include a bag (e.g., a drainage bag), a bottle or cup (e.g., a collection jar), or any other enclosed container for storing bodily fluid(s), such as urine. In some examples, a tube 18 may extend from the urine collection assembly 12 and be attached to the urine collection container 14 at a first point thereon. An additional tube 18 may be attached to the urine collection container 14 at a second point thereon and may extend and be attached to the pump 16. Thus, a vacuum (e.g., suction) may be drawn into the urine collection assembly 12 through the urine collection container 14. Fluids, such as urine, may be evacuated from the urine collection assembly 12 using the pump 16.

[0018] The pump 16 or vacuum source 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 magnetically driven pump, a peristaltic pump, or any pump configured to generate a vacuum. The pump 16 may provide a vacuum or suction to remove fluid from the urine collection assembly 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), an alternator, one or more batteries, or even a manual power source (e.g., a manual vacuum pump). The vacuum sources disclosed herein may include one or more of a switch, a button, a plug, a remote control, or any other device suitable for activating the pump 16.

[0019] Many embodiments of the urine collection system described herein are configured to be worn by a user, placed on a surface such as a table, and / or secured or attachable to a wheelchair. FIG. 1B is an isometric view of a urine collection system 100, according to some embodiments. The urine collection system 100 may include a urine collection assembly 102 configured to receive fluid (e.g., urine) from a user. The urine collection assembly 102 may be removably attached to a urine collection container 104 of the urine collection system 100. The urine collection container 104 may be integrated into a housing 106, which may also include a pump therein. The urine collection system 100 may further include a collection tube 108 and a suction tube 110. The collection tube 108 may be disposed between the urine collection assembly 102 and the urine collection container 104. The collection tube 108 may fluidly connect an interior volume of the urine collection container 104 to the urine collection assembly 102. A suction tube 110 may connect the suction and / or discharge of the pump to the urine collection container 104. A pump disposed within the housing 106 may be in fluid communication with the interior volume of the urine collection container 104 via the suction tube 110. The housing 106 may also be configured to store or house internal electrical and mechanical components. For example, the housing may include a pump (not shown in FIG. 1B) configured to regulate pressure within the container 104.

[0020] The urine collection assembly 102 may be positioned at least near the urethral opening. The urine collection assemblies shown in FIGS. 1B-2B are examples of female fluid collection assemblies configured to collect fluid(s) from a female (e.g., collect urine from a female urethra). Further examples of female fluid collection assemblies are disclosed in U.S. Patent No. 10,390,989, issued Aug. 27, 2019, the disclosure of which is incorporated herein by this reference in its entirety. However, the fluid collection assemblies, systems, and methods disclosed herein may include male fluid collection assemblies and / or devices shaped, sized, and otherwise configured to collect fluid(s) from a male (e.g., collect urine from a male urethra). Examples of male fluid collection assemblies are disclosed in U.S. Provisional Patent Application No. 63 / 067,542, filed August 19, 2020, and U.S. Patent Application No. 16 / 433,773, filed June 6, 2019, the disclosures of which are hereby incorporated by reference in their entireties into this specification.

[0021] In some embodiments, the collection tube 108, the suction tube 110, and / or other tubes of the urine collection system 100 may include a flexible material, such as a tubular body of material (e.g., medical tubing). Such tubular bodies of material may include thermoplastic elastomers, polyvinyl chloride, ethylene vinyl acetate, polytetrafluoroethylene, flexible metals, ceramics, and composite tubular bodies, and the like. The collection tube 108 may include silicone or latex. In some embodiments, the collection tube 108 may be constructed of any suitable material that is impermeable to fluids such that fluids may be drawn from the urine collection assembly 102 into the collection tube 108. In some embodiments, the collection tube 108 may include one or more portions that are resilient, for example, by having one or more diameters or wall thicknesses that allow the collection tube 108 to be flexible.

[0022] A urine collection container 104 may be integrated into the housing 106. In some embodiments, the container 104 may include at least an inlet coupled to a collection tube 108, an outlet coupled to a drainage tube and a vacuum port coupled to a pump. In some embodiments, the container 104 may be opaque or transparent depending on different embodiments and may include a rectangular front or back profile, as shown in FIG. 1B.

[0023] 2A is a cross-sectional view of a urine collection assembly 200, according to one embodiment. The urine collection assembly 200 may include a fluid impermeable barrier 202, at least one opening 204, a chamber 206, a fluid outlet 208, and a porous material 210 disposed within the chamber 206 in the fluid impermeable barrier 202. A tube 212 may be at least partially disposed within the chamber 206. An inner surface of the fluid impermeable barrier 202 at least partially defines the chamber 206 in the urine collection assembly 200. The fluid impermeable barrier 202 temporarily stores bodily fluids within the chamber 206. The fluid impermeable barrier 202 may be formed of any suitable fluid impermeable material(s), such as a fluid impermeable polymer (e.g., silicone rubber, thermoplastic polyurethane, polyolefin, polyvinyl chloride, etc.), a metal film, natural latex rubber, other suitable materials, or a combination thereof. Thus, the fluid impermeable barrier 202 substantially prevents bodily fluids from passing through the fluid impermeable barrier 202. In some examples, the fluid impermeable barrier 202 may be tubular (ignoring openings), such as a substantially cylindrical (as shown), oval, prismatic, or flat tube. During use, the fluid impermeable barrier 202 may come into contact with the wearer. The fluid impermeable barrier 202 may be sized and shaped to fit in the intergluteal cleft between the legs of a female user.

[0024] The opening 204 may provide an entry path for fluid to enter the chamber 206. The opening 204 may be defined by the fluid impermeable barrier 202, for example, by an inner edge of the fluid impermeable barrier 202. For example, the opening 204 may be formed in and extend through the fluid impermeable barrier 202, thereby allowing fluid(s) to enter the chamber 206 from outside the urine collection assembly 200. The opening 204 may be an elongated hole in the fluid impermeable barrier 202. For example, the opening 204 may be defined as a notch in the fluid impermeable barrier 202. The opening 204 may be positioned and formed to be disposed adjacent the female urethra.

[0025] The urine collection assembly 200 may be positioned near the female urethra such that bodily fluids can enter a chamber of the fluid collection assembly 200 via an opening 204. The fluid collection assembly 200 may be configured to receive the fluid(s) into a chamber 206 via the opening 204. In use, the opening 204 may have an elongated shape and extend from a first location below the urethral opening (e.g., at or near the anal or vaginal opening) to a second location above the urethral opening (e.g., at or near the top of the vaginal opening, or pubic hair).

[0026] The opening 204 may have an elongated shape due to the relatively small space between the woman's legs when she closes her legs, thereby allowing the flow of the fluid(s) only along a path corresponding to the elongated shape of the opening 204 (e.g., a longitudinally extending opening). The opening 204 in the fluid impermeable barrier 202 may exhibit a length measured along the longitudinal axis of the urine collection assembly 200, which may be at least about 10% of the length of the urine collection assembly 200, such as 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 95% of the length of the urine collection assembly 200. In some embodiments, the opening 204 may be vertical (e.g., having a major axis parallel to the longitudinal axis of the assembly 200). In other non-limiting examples (not shown), the opening 204 may be horizontal (e.g., having a major axis perpendicular to the longitudinal axis of the assembly 200). In some embodiments, the fluid impermeable barrier 202 may be configured to be attached to an individual, for example, to be affixed to the individual (e.g., using a hydrogel, medical grade silicone, or acrylic adhesive). An example of a suitable adhesive is a hydrogel layer.

[0027] The urine collection assembly 200 includes at least one porous material 210 disposed within the chamber 206. The porous material 210 may cover at least a portion (e.g., all) of the opening 204. The porous material 210 may be exposed to an environment external to the chamber 206 through the opening 204. The porous material 210 may be configured to wick fluid and / or allow fluid flow from the opening 204, thereby preventing fluid from escaping from the chamber 206. The permeability property referred to herein may be wicking, capillary action, diffusion, or another similar property or process, and is referred to herein as "permeability" and / or "wicking". Such "wicking" and "permeability" properties may not include absorption of fluid into the porous material 210. In other words, absorption or dissolving of bodily fluids into the material may not occur substantially for some time after the material is exposed to and removed from the bodily fluid. While no absorption or solubility is desired, the term "substantially not absorbed" may allow for a nominal amount of absorption and / or solubility (e.g., absorbency) of bodily fluids into the porous material 210 to be, for example, less than about 30% by weight of the dry weight of the porous material 210, 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 dry weight of the porous material 210.

[0028] In one embodiment, the porous material 210 may include at least one absorbent or absorbing material. The porous material 210 disposed within the chamber 206 may include any material capable of wicking and / or flowing fluid. For example, the porous material 210 may be formed from nylon (e.g., spun nylon fibers), polyester, polyethylene, polypropylene, wool, silk, linen, cotton (e.g., cotton gauze), felt, other woven and porous polymers, hydrophobic foam, open cell foam polyurethane, coated porous materials (e.g., hydrophobically coated porous materials, materials with affinity for certain substances), polymer sintered particles from polyethylene, polypropylene, polytetrafluoroethylene (PTFE), elastomeric particles, any other suitable porous material, or combinations thereof. For example, the porous material 210 may include a body of spun nylon fibers and an outer woven gauze layer or other permeable membrane that encases the body of spun nylon fibers. Forming the porous material 210 from gauze, soft cloth, and / or smooth cloth may reduce chafing caused by the urine collection assembly 200. In some embodiments, the porous material 210 may at least substantially and / or completely fill the portion of the chamber 206 that may not be occupied by the tube 212.

[0029] The tube 212 may be at least partially disposed within the chamber 206. The tube 212 may be used to remove fluid from the chamber 206. The tube 212 may be in fluid communication with the fluid outlet 208 of the fluid collection assembly 200. The tube 212 may include a tube inlet 218 disposed within the chamber 206 and a tube outlet (not shown) disposed downstream of the tube inlet 218. The tube outlet may be operably coupled to a urine collection container (e.g., the urine collection container 104). Thus, the tube 212 may fluidly couple the chamber 206 with the urine collection container (as shown in FIG. 1A or FIG. 1B).

[0030] In some embodiments, the fluid impermeable barrier 202 may define a first opening 216 of a suitable size to receive the tube 212. The tube 212 may be disposed in the chamber 206 through the first opening 216. The first opening 216 may be sized and shaped to form at least a substantially fluid-tight seal with the tube 212, thereby substantially preventing the fluid(s) from escaping the chamber 206 through the first opening 216. The first opening may include a fluid outlet 208. As shown in FIG. 2A, the inlet 218 of the tube 212 may extend through the first opening 216 into the chamber 206. In the illustrated embodiment, the tube 212 is at least partially disposed within the chamber 206. Fluid collected in the fluid collection assembly 200 may be removed from the chamber 206 through the tube 212.

[0031] The urine collection assembly 200 may include a reservoir 219 disposed within the chamber 206. The reservoir 219 may be a substantially unoccupied portion of the chamber 206. The reservoir 219 may be at least partially defined between the fluid impermeable barrier 202 and one or both of a porous material 210 and a tube inlet 218 disposed within the chamber 206. Fluid within the chamber 206 may flow through the porous material 210 to the reservoir 219. The reservoir 219 may hold fluid therein. In some embodiments, the reservoir 219 may temporarily hold fluid until the fluid within the reservoir 219 is removed to the tube 212. Although depicted in an end region in FIG. 2A, the reservoir 219 may be located in any portion of the chamber 206. The reservoir 219 may be located in a portion of the chamber 206 designed to be located at a gravimetrically low point of the fluid collection device when the device is worn.

[0032] In some embodiments, the inlet 218 of the tube 212 may be located within the reservoir 219 of the urine collection assembly 200 as shown. In other embodiments, the inlet 218 may be behind the reservoir 219 or flush with the porous material 210. In general, the inlet 218 of the tube 212 may be configured within the urine collection assembly 200 to effect fluid extraction. By locating the inlet 218 of the tube 212 at or near a location that is expected to be a gravimetrically low point of the chamber 206 when worn by a user, the tube 212 may receive more fluid(s) than if the inlet 218 were located elsewhere, reducing the chance of retention (e.g., retention of fluid(s) may cause microbial growth and odors).

[0033] The fluid collection assembly 200 may include a urinalysis device 220. The urinalysis device 220 may be disposed within the urine collection assembly 200. In some embodiments, the urinalysis device 220 may be a basic diagnostic tool used to determine pathological changes in a user's urine. In some embodiments, a standard urine test strip may be included. In some embodiments, the urinalysis device 220 may include a test strip. A standard urine test strip may include about 10 different chemical pads or reagents that react (change color) when dipped into a urine sample and removed. Tests can often be read in as little as 60 to 120 seconds after dipping, although certain tests require longer times. Regular testing of urine with multi-parameter strips is the first step in the diagnosis of a wide range of diseases. Analysis includes testing for the presence of one or more proteins, glucose, ketones, hemoglobin, bilirubin, urobilinogen, acetone, nitrites, or white blood cells, as well as testing for pH and specific gravity, or testing for infection by various pathogens.

[0034] In some embodiments, the test strip may include a ribbon made of plastic or paper about 5 millimeters wide. The plastic strip may include a pad impregnated with a chemical that reacts with compounds present in the urine to produce a characteristic color. In the case of a paper strip, the reactants may be absorbed directly onto the paper. Paper strips may be specific for a single reaction (e.g., pH measurement), while the padded strip may perform multiple measurements simultaneously.

[0035] There are strips that serve different purposes, for example qualitative strips that simply determine whether a sample is positive or negative, or semi-quantitative strips that, in addition to giving a positive or negative reaction, also provide an estimate of a quantitative result, in the latter case the color reaction is approximately proportional to the concentration of the substance being tested in the sample. The result is read by comparing the color of the pad to a color scale provided by the manufacturer, and no additional equipment is required.

[0036] In some embodiments, the urinalysis device 220 may be configured to extend longitudinally across the at least one opening 204. The urinalysis device 220 may be configured to include a finite width that is less than the width of the at least one opening 204 such that the urinalysis device 220 does not obstruct the opening 204 and / or reduce the ingress of urine through the opening 204 towards the chamber 206. In some embodiments, the urinalysis device 220 may be disposed within the chamber 206. In some embodiments, the urinalysis device 220 may be disposed within the at least one porous material 210. In other embodiments, the urinalysis device 220 may be disposed in front of the porous material 210 relative to the at least one opening 204.

[0037] FIG. 2B is a cross-sectional view of a urine collection assembly, according to one embodiment. In some embodiments, the fluid impermeable barrier 202 may include a second opening 222 appropriately sized to receive the urinalysis device 220. The urinalysis device 220 may be disposed within the chamber 206 through the second opening 222. The second opening 222 may be sized and shaped to form at least a substantially fluid-tight seal with the urinalysis device 220, thereby substantially preventing fluid(s) from leaking from the chamber 206 through the second opening 222. As shown in FIG. 2B, the urinalysis device 220 may extend into the chamber 206 through the second opening 222. The urinalysis device 220 may extend across at least one opening 204. In some embodiments, the second opening 222 may be disposed near the fluid outlet 208. In the illustrated embodiment, the urinalysis device 220 is disposed at least partially within the chamber 206.

[0038] In some embodiments, the urinalysis device 220 may be placed within the tube 212. In some embodiments, the tube 212 may provide a convenient location for a caregiver to remove and analyze the device 220. In some embodiments, the tube 212 may include an opening into which the urinalysis device 220 may be withdrawn and / or inserted and saturated.

[0039] 3 is an exploded view of another example urine collection assembly 300, according to an embodiment. In some embodiments, the urine collection assembly 300 may include a fluid impermeable barrier 302 shaped to be positioned at least near the urethra of a user. The urine collection assembly 300 may include a conduit 304 in fluid communication with the urine collection assembly 300, the conduit 304 configured to couple to a urine collection container (not shown). The urine collection assembly 300 may also include an opening 306. Urine may pass through the opening 306 and into a chamber 308 disposed within the urine collection assembly 300. The chamber 308 may include a porous material 310. In some embodiments, a urine testing device 312 may be disposed within the urine collection assembly 300. In some embodiments, the urine testing device 312 may be disposed within the conduit 304. In some embodiments, the fluid impermeable barrier 302 may include an opening 314. The urine testing device 312 may be configured to be withdrawn through the opening 314. The urine testing device 312 may be configured to extend longitudinally across the opening 306 of the urine collection assembly 300 .

[0040] In some embodiments, the opening 314 may be located on the outer surface 316 of the fluid impermeable barrier 302. The opening 314 may be located in an area convenient for a user and / or caregiver to access. In some embodiments, the urinalysis device 312 may include a pull tab 318. The pull tab 318 may include a portion of the urinalysis device 312 that extends beyond the fluid impermeable barrier 302 to provide a portion of the device that can be grasped to remove the urinalysis device 312 from the urine collection assembly 300. In some embodiments, the pull tab 318 may be configured to prevent the urinalysis device 312 from slipping through the opening 314 completely into the chamber and / or into the fluid impermeable barrier 302. In some embodiments, the pull tab 318 may include a textured surface to enhance a user or caregiver's grip. In some embodiments, the urinalysis device 312 may be configured to analyze at least one of calcium, blood, glucose, bilirubin, urobilinogen, ketones, white blood cells, creatinine, microalbumin, pH, ascorbic acid, and / or protein.

[0041] 4A is a cross-sectional view of a male urine collection assembly 400, according to one embodiment. In other words, the urine collection assembly 400 is designed to collect fluid(s) from a male user. In some embodiments, the urine collection assembly 400 may include a fluid-impermeable barrier 402 shaped and configured to be placed around the penis of a user. The fluid-impermeable barrier 402 may be tubular or cup-shaped. The fluid-impermeable barrier 402 may define an opening 404 extending through the fluid-impermeable barrier 402 and configured for at least a portion of the penis to be placed therethrough.

[0042] The fluid-impermeable barrier 402 at least partially defines a chamber 406 within the urine collection assembly 400. The fluid-impermeable barrier 402 temporarily stores fluid(s) within the chamber 406. The fluid-impermeable barrier 402 may be formed of any suitable fluid-impermeable material(s) to substantially prevent urine from passing through the fluid-impermeable barrier 402. The fluid-impermeable barrier 402 at least partially defines the chamber 406. For example, an inner surface of the fluid-impermeable barrier 402 at least partially defines a perimeter of the chamber 406.

[0043] The urine collection assembly 400 may include at least one porous material 408. The porous material 408 may be configured to wick fluid up from the opening 404, thereby preventing fluid from leaking out of the chamber 406. The porous material 408 may include any material that may wick fluid up. For example, the porous material 408 may include a fabric, such as gauze (such as silk, linen, or cotton gauze), another soft fabric, or another smooth fabric. Forming the porous material 408 from gauze, a soft fabric, and / or a smooth fabric may reduce chafing caused by the urine collection assembly 400. The porous material 408 may not completely fill the chamber 406 because the chamber 406 is configured to have an open space to receive at least a portion of the penis. The urine collection assembly 400 may include multiple layers of the porous material 408.

[0044] The urine collection assembly 400 may include a reservoir 410. The reservoir 410 may be a substantially unoccupied portion of the chamber 406. The fluid(s) in the chamber 406 may flow through a porous material 408 to the reservoir 410. The reservoir 410 may hold the fluid(s) therein. In some embodiments, the reservoir 410 may be disposed at a distal end 412 of the urine collection assembly 400 and an opening may be present at a proximal end 414 of the urine collection assembly. The proximal end 414 may include a base 416, which may be sized, shaped, and made of a material to be bonded to the skin surrounding the penis and to allow at least the urethral opening of the penis to pass therethrough. The base 416 may include an opening 404. In some embodiments, the base 416 may include a rigid structure configured to maintain the fluid impermeable membrane 402 in a particular position and / or at a particular angle relative to the individual's body (e.g., the skin surrounding the penis).

[0045] The fluid impermeable barrier 402 also includes at least a portion of a tube 418 disposed therein, e.g., at least partially disposed in the reservoir 410. In one example, the tube 418 may extend from a first opening 420 in the distal region 412 to a proximal region 414 at least proximal to the opening 404. The proximal region 414 may be disposed near or on the skin surrounding the penis (e.g., on the penis or the surrounding pubic area). Thus, when a patient lies on his back, fluid (e.g., urine) may collect near the opening 404 of the fluid impermeable barrier 402 and contact the patient's skin. Fluid may be removed from the chamber 406 and / or reservoir 410 via the tube 418. The first opening 420 may be sized and shaped to form at least a substantially fluid-tight seal with the tube 418, thereby substantially preventing fluid(s) from leaking from the chamber 406 via the first opening 420.

[0046] In some embodiments, the urine collection assembly 400 may further include a urine testing device 422. In some embodiments, the urine testing device 422 may include a test strip. In some embodiments, the urine testing device 422 may be configured to extend across the chamber 406 and / or the reservoir 410. The urine testing device 422 may be configured to include a finite width that is less than the width of the chamber 406 such that the urine testing device 422 does not impede the flow of urine into the tube 418 and / or reduce the ingress of urine through the opening 404 toward the chamber 406. In some embodiments, the urine testing device 422 may be disposed within the chamber 406. In some embodiments, the urine testing device 422 may be disposed within the at least one porous material 408. In other embodiments, the urine testing device 422 may be disposed at the distal end 412 of the urine collection assembly 400.

[0047] In some embodiments, the fluid impermeable barrier 402 may include a second opening 424. The urinalysis device 422 may be configured to be withdrawn through the second opening 424. The urinalysis device 422 may be configured to extend across the reservoir 410, distal to the porous material 408 and proximal to the tube 418.

[0048] In some embodiments, the second opening 424 may be located on an exterior surface of the fluid impermeable barrier 402. The second opening 424 may be located in an area that is convenient for a user and / or caregiver to access. In some embodiments, the urine testing device 422 may include a pull tab 426. The pull tab 426 may include a portion of the urine testing device 422 that extends beyond the fluid impermeable barrier 402 to provide a portion of the device that can be grasped to remove the urine testing device 422 from the urine collection assembly 400. In some embodiments, the pull tab 426 may be configured to prevent the urine testing device 422 from slipping through the second opening 424 completely into the chamber and / or into the fluid impermeable barrier 402.

[0049] 4B and 4C are isometric and cross-sectional views, respectively, of a male urine collection assembly 450, according to one embodiment. The urine collection assembly 450 includes a sheath 452 and a base 454. The sheath 452 includes a fluid impermeable barrier 456 formed at least in part from a first panel 458 attached to a second panel 460. However, in other embodiments, the first panel 458 and the second panel 460 may be integrally formed with one another. The fluid impermeable barrier 456 also defines a chamber 462 between the first panel 458 and the second panel 460, defines an opening 464 at a proximal end region 466 and the base 454 of the sheath 452, and defines an outlet 468 at a distal end region 470 of the sheath 452. The sheath 452 also includes at least one porous material 472 disposed within the chamber 462. The base 454 is permanently attached to a proximal end region 466 of the sheath 452 .

[0050] In some embodiments, the porous material 472 may be disposed within the chamber between the first panel 458 and the second panel 460. An opening 464 may be formed in and extend through the fluid impermeable barrier 456, thereby allowing bodily fluids to enter the chamber 462 from outside the urine collection assembly 450. The opening 464 may be configured to receive a user's penis, which may extend into the chamber 462.

[0051] The fluid impermeable barrier 456 defines an outlet 468 sized to receive the tube 474. The tube 474 may be at least partially disposed within the chamber 462 or otherwise in fluid communication with the chamber 462 via the outlet 468. The outlet 468 may be sized and shaped to form at least a substantially fluid-tight seal with the tube 474, thereby substantially preventing bodily fluids from escaping the chamber 462. The inlet 476 of the tube 474 may be located at or near the distal end region 470 of the sheath 452, which is expected to be a gravimetric low point of the chamber 462 when worn by a user. Locating the inlet 476 at or near the distal end region 470 of the sheath 452 allows the tube 474 to receive more bodily fluids than if the inlet 476 were located elsewhere, reducing the possibility of retention (e.g., retention of bodily fluids can cause microbial growth and foul odors). For example, bodily fluids are within the porous material 472 by capillary forces. However, bodily fluids may have a tendency to flow in the direction of gravity, especially when at least a portion of the porous material 472 is saturated with bodily fluids. Thus, the inlet 476 may be located in the fluid collection assembly 450 at a location that is expected to be a gravimetric low point of the urine collection assembly 450 when worn by a user.

[0052] In some embodiments, the urine collection assembly 450 includes an opening 478 in the outer surface 480 of the fluid impermeable barrier 456. The urine collection assembly 450 may further include a urinalysis device 482. In some embodiments, the urinalysis device 482 may include a test strip. The urinalysis device 482 may be configured to extend across the chamber 462 toward the distal end region 470 of the sheath 452. The urinalysis device 482 may be configured to include a finite width that is less than the width of the chamber 462 such that the urinalysis device 482 does not impede the flow of urine into the tube 474 and / or reduce the ingress of urine through the opening 464 toward the chamber 462. In some embodiments, the urinalysis device 482 may be disposed within the chamber 462. In some embodiments, the urinalysis device 482 may be disposed within the at least one porous material 472.

[0053] The urinalysis device 482 may be configured to be pulled through an opening 478 in the outer surface 480 of the fluid impermeable barrier 456. As with the previously disclosed assemblies, the opening 478 may be located in an area convenient for a user and / or caregiver to access. In some embodiments, the urinalysis device 482 may include a pull tab 484. The pull tab 484 may include a portion of the urinalysis device 482 that extends beyond the outer surface 480 of the fluid impermeable barrier 456, thereby providing a portion of the device that can be grasped to remove the urinalysis device 482 from the urine collection assembly 450. In some embodiments, the pull tab 484 may be configured to prevent the urinalysis device 482 from slipping through the opening 478 completely into the chamber 462 and / or into the fluid impermeable barrier 456.

[0054] FIG. 5 is a flow diagram of a method 500 of collecting a urine test sample, according to one embodiment. Method 500 includes an operation 510 of placing a urine collection assembly adjacent to a urethral opening of a user. In some embodiments, the urine collection assembly may include a fluid impermeable barrier defining at least a chamber, at least one opening, and a fluid outlet. The urine collection assembly may further include at least one porous material disposed within the chamber, and a urine testing device disposed within the chamber. In some embodiments, the urine testing device may be disposed within the at least one porous material. Method 500 may further include an operation 520 of receiving urine from the urethral opening into a chamber of the urine collection assembly. Method 500 also includes an operation 530 of saturating the urine testing device with urine. Method 500 may also include an operation 540 of withdrawing the urine testing device from within the urine collection assembly. In some embodiments, the urine testing device may be withdrawn immediately after the urine testing device is saturated. In other embodiments, the urine collection assembly may be replaced and discarded after the urine testing device is withdrawn. In some embodiments, withdrawing the urinalysis device may include withdrawing a test strip through an opening in a fluid impermeable barrier. The urinalysis device may be withdrawn manually, typically by a user or a caregiver. Typically, the urinalysis device is withdrawn manually and read or placed in a machine / computer for further analysis.

[0055] In some embodiments, the method 500 may further include an operation 550 of reading the urinalysis test strip by comparing the color sample on the urinalysis test strip to a color chart. In some embodiments, the urinalysis device may be read by an automated urinalysis analyzer. The method 500 may further include applying suction with a pump effective to draw urine from the chamber through the conduit and collect the urine in a urine collection container. The urine collection container may include either a reusable container or a disposable container.

[0056] The method operations for collecting fluid from a user described above are for illustrative purposes. For example, the method operations for collecting fluid from a user and the method operations for collecting a urine test sample may be performed in a different order, split into multiple operations, modified, supplemented, or combined. In an embodiment, one or more of the method operations for collecting fluid from a user may be omitted from the method. Any of the method operations for collecting a urine test sample from a user may include using any of the urine collection systems disclosed herein.

[0057] As used herein, the terms "about" or "substantially" refer to an acceptable variation of the term modified by "about" or "substantially" up to ±10% or ±5%. Additionally, the terms "less than," "or less than," "greater than," "greater than," or "or more than" include the value modified by the terms "less than," "or less than," "greater than," or "or more than" as endpoints.

[0058] While various aspects and embodiments have been disclosed herein, other aspects and embodiments are contemplated, and the various aspects and embodiments disclosed herein are intended to be illustrative and not limiting.

Claims

1. a fluid impermeable barrier defining at least a chamber, at least one opening, and a fluid outlet; a conduit including a first end disposed within the chamber; at least one porous material disposed within the chamber; a urinalysis device disposed within the fluid collection assembly; 1. A urine collection assembly comprising:

2. 10. The urine collection assembly of claim 1, wherein the fluid impermeable barrier includes an opening, and the urine testing device is configured to be withdrawn through the opening.

3. The urine collection assembly of claim 2 , wherein the opening is located near the fluid outlet.

4. A urine collection assembly according to claim 1 , wherein the urine testing device extends across the at least one opening.

5. A urine collection assembly according to claim 1 , wherein the urine testing device is disposed within the chamber.

6. 4. A urine collection assembly according to claim 1, wherein the urine testing device is disposed within the at least one porous material.

7. A urine collection assembly according to claim 1 , wherein the urine testing device is disposed within the conduit.

8. 8. The urine collection assembly of claim 1, wherein the urine testing device is configured to analyze at least one of calcium, blood, glucose, bilirubin, urobilinogen, ketones, white blood cells, creatinine, microalbumin, pH, ascorbic acid, and protein.

9. 9. A urine collection assembly according to claim 1, wherein the urine testing device comprises a urine testing test strip.

10. 10. A urine collection assembly according to any preceding claim, wherein the urine testing device includes a pull tab.

11. a urine collection assembly including at least one opening configured to be positioned at least proximate to the user's urethra; a conduit in fluid communication with the urine collection assembly; A urine testing device; a urine collection container having an interior region in fluid communication with the conduit; a pump in fluid communication with the urine collection container and the urine collection assembly, the pump configured to pump urine from the urine collection assembly and collect the urine in the urine collection container via the conduit; A urine collection system comprising:

12. The urine collection system of claim 11 , wherein the urine testing device is disposed within the urine collection assembly.

13. 13. The urine collection system of claim 11 or 12, wherein the urine collection assembly further comprises a fluid impermeable barrier having an opening, and wherein the urine testing device is configured to be withdrawn through the opening.

14. 14. A urine collection system according to any of claims 11 to 13, wherein the urine testing device is disposed within the conduit.

15. 14. The urine collection system of claim 11, wherein the urine testing device includes a pull tab.

16. 14. A urine collection system according to any of claims 11 to 13, wherein the urine testing device extends across the at least one opening.

17. 1. A method of collecting a urine test sample, comprising: Positioning a urine collection assembly adjacent to a urethral opening, said urine collection assembly comprising: a fluid impermeable barrier defining at least a chamber, at least one opening, and a fluid outlet; at least one porous material disposed within the chamber; and a urinalysis device disposed within the chamber; and receiving urine from the urethral opening into the chamber of the urine collection assembly; saturating the urinalysis device with urine; withdrawing the urine testing device from within the urine collection assembly; A method comprising:

18. 20. The method of claim 17, wherein the urinalysis device includes a urinalysis test strip, the method further comprising reading the urinalysis test strip by comparing a color sample on the urinalysis test strip to a color chart.

19. 19. The method of claim 17 or 18, further comprising applying suction with a pump effective to draw one or more bodily fluids from the chamber through a conduit and depositing the one or more bodily fluids in a urine collection container.

20. 20. The method of any of claims 17 to 19, wherein the urinalysis device is disposed within the at least one porous material.

21. 21. The method of any of claims 17 to 20, comprising withdrawing the urine testing device through an opening in the fluid impermeable barrier.

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