External catheter with urinalysis function and related system and method

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 an external catheter with a urine test function, and related systems and methods.

Background Art

[0002] Individuals may have limited or impaired mobility, making the normal urination process difficult or impossible. For example, an individual may have undergone surgery that impairs mobility or have a disability. In another example, an individual may have restricted movement conditions such as those experienced by pilots, drivers, and workers in hazardous areas. Additionally, fluid collection from an individual may be required for monitoring purposes or clinical trials.

[0003] Bedpans and urethral catheters, such as Foley catheters, can be used to address some of these situations. However, bedpans and urethral catheters have several associated problems. For example, bedpans can be uncomfortable, prone to spills, and pose other hygiene issues. Urethral catheters can be uncomfortable, painful, and may cause urinary tract infections. Conventional fluid collection devices may also be limited in use when the patient is lying supine in bed.

[0004] Therefore, 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

Patent Document 2

Patent Document 3

[0006] Embodiments disclosed herein relate to a urine collection system, a urine test, and a method of using the urine collection system. In one embodiment, the urine collection assembly may include at least a chamber, at least one opening, and a fluid-impermeable barrier defining a fluid outlet. The urine collection assembly may further include a conduit having a first end located within the chamber, at least one porous material located within the chamber, and a urine test device located within the fluid collection assembly.

[0007] In one embodiment, the urine collection system may include a urine collection assembly, a conduit that is in fluid communication with the urine collection assembly, a urine testing device, a urine collection container including an internal region that is in fluid communication with the conduit, and a pump that is 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 store the urine in the urine collection container via the conduit.

[0008] In one embodiment, a method for collecting a urine test sample is disclosed. This method may include positioning a urine collection assembly adjacent to the user's urethral opening. The urine collection assembly may include at least a chamber, at least one opening, and a fluid-impermeable barrier defining a fluid outlet. The urine collection assembly may further include at least one porous material placed within the chamber, and a urine testing device placed within the chamber. This method may also include receiving urine from the urethral opening into the chamber of the urine collection assembly, saturating the urine testing device with urine, and withdrawing the urine testing 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 this disclosure will become apparent to those skilled in the art by considering the following detailed description and accompanying drawings.

[0010] The drawings illustrate several embodiments of the present disclosure, and the same reference numerals refer to the same or similar elements or features in different figures or embodiments shown in the drawings. [Brief explanation of the drawing]

[0011] [Figure 1A] This is a block diagram of a portable fluid collection system according to one embodiment. [Figure 1B] This is an isometric view of a fluid collection system according to one embodiment. [Figure 2A] This is a cross-sectional view of a female urine collection assembly according to one embodiment. [Figure 2B] This is a cross-sectional view of a female urine collection assembly according to one embodiment. [Figure 3] This is an exploded view of a female urine collection assembly according to one embodiment. [Figure 4A] This is a cross-sectional view of a male urine collection assembly according to one embodiment. [Figure 4B] This is an isometric view of a male urine collection assembly according to one embodiment. [Figure 4C] Figure 4B is a cross-sectional view of a male urine collection assembly. [Figure 5] This is a flowchart illustrating a method for collecting urine test samples according to one embodiment. [Modes for carrying out the invention]

[0012] Embodiments disclosed herein relate to urine collection systems and related 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 urine samples for examination, treatment, or diagnosis. Therefore, users and / or caregivers can benefit from urine collection systems that allow for the provision of urine samples without extensive disassembly of the system, enabling them to conveniently collect fluids and urine samples using the urine collection system.

[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 storage container or disassembly of the system which could lead to leakage or spillage. Embodiments of the urine collection system described herein allow for both the collection of urine drawn from a urine collection assembly adjacent to the user's urethral opening and the convenient drawing of urine test samples 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 urine testing device is placed in the fluid collection assembly and can be drawn out through the opening for sampling. In some embodiments, the urine testing device may be configured to analyze at least one of calcium, blood, glucose, bilirubin, urobilinogen, ketones, leukocytes, creatinine, microalbumin, pH, ascorbic acid, and protein when requested by the user or instructed 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 an embodiment of the fluid collection systems 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 each other 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. The fluid (e.g., urine or other body fluid) 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 the chamber of the urine collection assembly 12 via the inlet of the tube 18 in response to a suction (e.g., vacuum) force applied at the outlet of the tube 18.

[0016] The suction force may be applied directly or indirectly by the pump 16 to the outlet of the tube 18. The suction force may be applied indirectly via the urine collection container 14. For example, the outlet of the tube 18 may be disposed within the interior region of the urine collection container 14 or may be fluidly coupled, 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. The suction force 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 can be sized and shaped to hold fluid therein. The urine collection container 14 can include a bag (e.g., a drainage bag), a bottle or cup (e.g., a collection jar), or any other enclosed container for storing body fluid(s) such as urine. In some examples, the tube 18 can 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 can be attached to the urine collection container 14 at a second point thereon and extend to and be attached to the pump 16. Thus, a vacuum (e.g., suction) can be drawn into the urine collection assembly 12 through the urine collection container 14. Fluid such as urine can be discharged from the urine collection assembly 12 using the pump 16.

[0018] The pump 16 or vacuum source can include one or more of a manual vacuum pump, and an electric vacuum pump, diaphragm pump, centrifugal pump, positive displacement pump, magnetic drive pump, peristaltic pump, or any other pump configured to generate a vacuum. The pump 16 can supply a vacuum or suction to remove fluid from the urine collection assembly 12. In some examples, the pump 16 can 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 source disclosed herein can include one or more of a switch, button, plug, remote control, or any other device suitable for operating the pump 16.

[0019] Many embodiments of the urine collection systems described herein are configured to be worn by a user, placed on a surface such as a table, and / or fixed to or attached to a wheelchair. Figure 1B is an isometric view of a urine collection system 100 according to several 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 detachably 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. The urine collection system 100 may further include a collection tube 108 and a suction tube 110. The collection tube 108 may be positioned between the urine collection assembly 102 and the urine collection container 104. The collection tube 108 may fluidly connect the internal volume of the urine collection container 104 to the urine collection assembly 102. The suction tube 110 can connect the pump's suction and / or discharge to the urine collection container 104. A pump located within the housing 106 may be in fluid communication with the internal volume of the urine collection container 104 via the suction tube 110. The housing 106 may also be configured to house or accommodate internal electrical and mechanical components. For example, the housing may include a pump (not shown in Figure 1B) configured to regulate the pressure inside the container 104.

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

[0021] In some embodiments, the collection tube 108, the suction tube 110, and / or other tubes of the urine collection system 100 may include flexible materials such as material tubular bodies (e.g., medical tubing). Such material tubular bodies may include thermoplastic elastomers, polyvinyl chloride, ethylene vinyl acetate, polytetrafluoroethylene, flexible metals, ceramics, and composite material tubular bodies. The collection tube 108 may include silicone or latex. In some embodiments, the collection tube 108 may be constructed of any suitable material that does not allow fluid to pass through, thereby allowing fluid to 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 resilient portions, for example, by having one or more diameters or wall thicknesses that allow the collection tube 108 to be flexible.

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

[0023] Figure 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 disposed at least partially within the chamber 206. The 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 fluid-impermeable polymers (e.g., silicone rubber, thermoplastic polyurethane, polyolefin, polyvinyl chloride, etc.), metal films, natural latex rubber, other suitable materials, or a combination thereof. Therefore, the fluid-impermeable barrier 202 substantially prevents bodily fluids from passing through it. In some examples, the fluid-impermeable barrier 202 may be tubular (ignoring the opening), for example substantially cylindrical (illustrated), 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 the gluteal 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 a fluid-impermeable barrier 202, for example, by the inner edge of the fluid-impermeable barrier 202. For example, the opening 204 may be formed within the fluid-impermeable barrier 202 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 also be an elongated hole within the fluid-impermeable barrier 202. For example, the opening 204 may be defined as a notch within the fluid-impermeable barrier 202. The opening 204 may be positioned and formed to be adjacent to the female urethra.

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

[0026] The opening 204 may have an elongated shape because the space between the woman's legs is relatively small when the woman closes her legs, thereby allowing only fluid flow along a path corresponding to the elongated shape of the opening 204 (e.g., an opening extending longitudinally). The opening 204 of the fluid-impermeable barrier 202 may have 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, 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 95% of the length of the urine collection assembly 200. In some embodiments, the opening 204 may be vertical (e.g., having a principal 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 principal 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, by being adhered 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 placed 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 the environment outside the chamber 206 through the opening 204. The porous material 210 may be configured to draw fluid up from the opening 204 and / or allow fluid flow, thereby preventing fluid from leaking out of the chamber 206. 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.” Such “wicking” and “permeability” properties may not include the absorption of fluid into the porous material 210. In other words, the absorption or solubility of bodily fluids into the material may not substantially occur for some time after the material has been exposed to and removed from the bodily fluids. While it is desirable that there be no absorption or solubility, the term “substantially unabsorbable” may be acceptable if the nominal amount of absorption and / or solubility of body fluids into the porous material 210 (e.g., absorbency) is less than, for example, 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 absorbent material. The porous material 210 placed within the chamber 206 may include any material that can draw up and / or flow fluids. 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 textiles and porous polymers, hydrophobic foams, open-cell foam polyurethanes, coated porous materials (e.g., hydrophobic coated porous materials, materials with affinity for specific substances), polymer sintered particles from polyethylene, polypropylene, polytetrafluoroethylene (PTFE), elastomer particles, any other suitable porous material, or a combination thereof. For example, the porous material 210 may include a body of spun nylon fibers and an outer textile gauze layer or other permeable membrane surrounding the body of spun nylon fibers. Forming the porous material 210 from gauze, a soft cloth, and / or a smooth cloth can reduce abrasion caused by the urine collection assembly 200. In some embodiments, the porous material 210 can at least substantially and / or completely fill portions of the chamber 206 that may not be occupied by the tube 212.

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

[0030] In some embodiments, the fluid-impermeable barrier 202 may define a first opening 216 of a size appropriate for receiving a tube 212. The tube 212 may be positioned within the chamber 206 through the first opening 216. The first opening 216 is sized and shaped to form at least substantially a fluid-tight seal with respect to the tube 212, thereby substantially preventing fluid(s) from leaking out of the chamber 206 through the first opening 216. The first opening may include a fluid outlet 208. As shown in Figure 2A, the inlet 218 of the tube 212 may extend into the chamber 206 through the first opening 216. In the illustrated embodiment, the tube 212 is positioned at least partially within the chamber 206. The 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 located 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 a fluid-impermeable barrier 202 and one or both of a porous material 210 and a tube inlet 218 located within the chamber 206. Fluid in the chamber 206 may flow through the porous material 210 into the reservoir 219. The reservoir 219 may hold fluid within it. In some embodiments, the reservoir 219 may temporarily hold fluid until the fluid in the reservoir 219 is removed into the tube 212. The reservoir 219 is depicted in the end region of Figure 2A, but may be located in any portion of the chamber 206. The reservoir 219 may be located in a portion of the chamber 206 that is designed to be located at a gravimetrically low point of the fluid collection device when the device is installed.

[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 the figure. In other embodiments, the inlet 218 may be located behind the reservoir 219 or flush with the porous material 210. Generally, the inlet 218 of the tube 212 may be configured within the urine collection assembly 200 to allow for effective fluid extraction. By positioning the inlet 218 of the tube 212 at or near a location that is expected to be a gravimetrically low point in the chamber 206 when the user is wearing it, the tube 212 can accept more fluid(s) than if the inlet 218 were located elsewhere, reducing the possibility of stagnation (for example, fluid(s) stagnation can lead to microbial growth and foul odor).

[0033] The fluid collection assembly 200 may include a urine testing device 220. The urine testing device 220 may be located within the urine collection assembly 200. In some embodiments, the urine testing device 220 may be a basic diagnostic tool used to determine pathological changes in the user's urine. In some embodiments, standard urine test strips may be included. In some embodiments, the urine testing device 220 may include test strips. Standard urine test strips may contain about 10 different chemical pads or reagents that react (change color) when dipped in a urine sample and removed. Tests can often be read in as little as 60 to 120 seconds after dipping, although certain tests may take longer. Regular testing of urine with multi-parameter strips is the first step in diagnosing a wide range of diseases. Analysis may include testing for the presence of one or more proteins, glucose, ketones, hemoglobin, bilirubin, urobilinogen, acetone, nitrite, or leukocytes, 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, approximately 5 millimeters wide. A 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 reactant can be absorbed directly into the paper. While a paper strip may be specific to a single reaction (e.g., pH measurement), a strip with a pad can perform multiple measurements simultaneously.

[0035] There are strips for various purposes, such as qualitative strips that simply determine whether a sample is positive or negative, or semi-quantitative strips that, in addition to showing 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 test substance in the sample. Results are 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 urine testing device 220 may be configured to extend longitudinally across at least one opening 204. The urine testing device 220 may be configured to have a finite width smaller than the width of at least one opening 204 so that it does not obstruct the opening 204 and / or reduces the entry of urine through the opening 204 toward the chamber 206. In some embodiments, the urine testing device 220 may be located inside the chamber 206. In some embodiments, the urine testing device 220 may be located inside at least one porous material 210. In other embodiments, the urine testing device 220 may be located in front of the porous material 210 with respect to at least one opening 204.

[0037] Figure 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 of appropriate size to receive a urine test device 220. The urine test device 220 may be positioned within the chamber 206 through the second opening 222. The second opening 222 may be sized and shaped to form at least substantially a fluid-tight seal to the urine test device 220, thereby substantially preventing fluid(s) from leaking out of the chamber 206 through the second opening 222. As shown in Figure 2B, the urine test device 220 may extend into the chamber 206 through the second opening 222. The urine test device 220 may extend across at least one opening 204. In some embodiments, the second opening 222 may be positioned near a fluid outlet 208. In the illustrated embodiment, the urine test device 220 is positioned at least partially within the chamber 206.

[0038] In some embodiments, the urine testing device 220 may be located inside the tube 212. In some embodiments, the tube 212 may provide a convenient location for a caregiver to remove the device 220 for analysis. In some embodiments, the tube 212 may include an opening into which the urine testing device 220 can be drawn out and / or inserted and saturated.

[0039] Figure 3 is an exploded view of another example of a urine collection assembly 300 according to one embodiment. In some embodiments, the urine collection assembly 300 may include a fluid-impermeable barrier 302 shaped to be positioned at least near the user's urethra. The urine collection assembly 300 may include a conduit 304 that is in fluid communication with the urine collection assembly 300, and the conduit 304 is configured to connect to a urine collection container (not shown). The urine collection assembly 300 may also include an opening 306. Urine can pass through the opening 306 into a chamber 308 located 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 located within the urine collection assembly 300. In some embodiments, the urine testing device 312 may be located 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 drawn out 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 access by the user and / or caregiver. In some embodiments, the urine testing device 312 may include a pull tab 318. The pull tab 318 may include a portion of the urine testing device 312 that extends beyond the fluid-impermeable barrier 302, thereby providing a portion of the device that can be grasped to remove the urine testing device 312 from the urine collection assembly 300. In some embodiments, the pull tab 318 may be configured to prevent the urine testing device 312 from slipping through the opening 314 and entering the chamber and / or the fluid-impermeable barrier 302 completely. In some embodiments, the pull tab 318 may include a textured surface to enhance the grip of the user or caregiver. In some embodiments, the urine testing device 312 may be configured to analyze at least one of the following: calcium, blood, glucose, bilirubin, urobilinogen, ketones, leukocytes, creatinine, microalbumin, pH, ascorbic acid, and / or protein.

[0041] Figure 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 configured to be positioned around the user's penis. 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, configured so that at least a portion of the penis is placed through it.

[0042] The fluid-impermeable barrier 402 at least partially defines the 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, the inner surface of the fluid-impermeable barrier 402 at least partially defines the periphery of the chamber 406.

[0043] The urine collection assembly 400 may include at least one porous material 408. The porous material 408 is configured to draw fluid up from the opening 404, thereby preventing the fluid from leaking out of the chamber 406. The porous material 408 may include any material that is capable of drawing up fluid. For example, the porous material 408 may include textiles, such as gauze (silk, linen, or cotton gauze), another soft cloth, or another smooth cloth. Forming the porous material 408 from gauze, a soft cloth, and / or a smooth cloth may reduce the abrasion caused by the urine collection assembly 400. The porous material 408 may not completely fill the chamber 406, as the chamber 406 is configured to have an empty space to accommodate 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. Fluid(s) in the chamber 406 may flow through the porous material 408 to the reservoir 410. The reservoir 410 may hold the fluid(s) within it. In some embodiments, the reservoir 410 may be located at the distal end 412 of the urine collection assembly 400, with an opening located at the proximal end 414 of the urine collection assembly. The proximal end 414 may include a base 416, which is bonded to the skin surrounding the penis and is sized and shaped such that at least the urethral opening of the penis passes through it, and may be made of such material. 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 at a specific position and / or angle relative to the individual's body (e.g., the skin around the penis).

[0045] The fluid-impermeable barrier 402 also includes at least a portion of a tube 418 that is positioned therein, for example, at least partially 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 close to the opening 404. The proximal region 414 may be positioned near or on the skin around the penis (e.g., on the penis or the surrounding genital area). Thus, when the patient lies supine, fluid (e.g., urine) may collect near the opening 404 of the fluid-impermeable barrier 402 and come into contact with the patient's skin. The fluid can 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 substantially a fluid-tight seal with respect to the tube 418, thereby substantially preventing the fluid(s) from leaking out of the chamber 406 through 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 reservoir 410. The urine testing device 422 may be configured to have a finite width smaller than the width of the chamber 406, so that the urine testing device 422 does not obstruct the flow of urine into the tube 418 and / or reduce the entry of urine into the chamber 406 through the opening 404. In some embodiments, the urine testing device 422 may be located inside the chamber 406. In some embodiments, the urine testing device 422 may be located inside at least one porous material 408. In other embodiments, the urine testing device 422 may be located 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 urine test device 422 may be configured to be drawn out through the second opening 424. The urine test 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 the outer surface of the fluid-impermeable barrier 402. The second opening 424 may be located in an area convenient for access by the user and / or caregiver. 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, thereby providing 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 passing through the second opening 424 and entering the chamber and / or the fluid-impermeable barrier 402 completely.

[0049] Figures 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, at least partially formed 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 formed integrally with each other. The fluid-impermeable barrier 456 also defines a chamber 462 between the first panel 458 and the second panel 460, defines an opening 464 in the proximal end region 466 of the sheath 452 and the base 454, and defines an outlet 468 in the 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 the proximal end region 466 of the sheath 452.

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

[0051] A fluid-impermeable barrier 456 defines an outlet 468 sized to receive a tube 474. The tube 474 is at least partially located within the chamber 462, or otherwise can be in fluid communication with the chamber 462 via the outlet 468. The outlet 468 is sized and shaped to form at least substantially a fluid-tight seal with respect to the tube 474, thereby substantially preventing body fluids from leaking out of the chamber 462. The inlet 476 of the tube 474 may be located in or near the distal end region 470 of the sheath 452, which is expected to be a gravimetrically low point in the chamber 462 when fitted by the user. By locating the inlet 476 in or near the distal end region 470 of the sheath 452, the tube 474 can receive more body fluids than if the inlet 476 were located elsewhere, reducing the possibility of stagnation (for example, stagnation of body fluids can cause microbial growth and foul odor). For example, body fluids are contained within the porous material 472 by capillary forces. However, bodily fluids may tend to flow in the direction of gravity, especially if at least a portion of the porous material 472 is saturated with bodily fluids. Therefore, the inlet 476 may be located within the fluid collection assembly 450 at a position that is expected to be a gravimetrically low point of the urine collection assembly 450 when worn by the 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 urine testing device 482. In some embodiments, the urine testing device 482 may include a test strip. The urine testing device 482 may be configured to extend across the chamber 462 toward the distal end region 470 of the sheath 452. The urine testing device 482 may be configured to include a finite width less than the width of the chamber 462 so that the urine testing device 482 does not obstruct the flow of urine into the tube 474 and / or reduce the entry of urine toward the chamber 462 through the opening 464. In some embodiments, the urine testing device 482 may be located inside the chamber 462. In some embodiments, the urine testing device 482 may be located inside at least one porous material 472.

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

[0054] Figure 5 is a flow chart of a method 500 for collecting a urine test sample according to one embodiment. Method 500 includes an action 510 to position a urine collection assembly adjacent to the user's urethral opening. In some embodiments, the urine collection assembly may include at least a chamber, at least one opening, and a fluid-impermeable barrier defining a fluid outlet. The urine collection assembly may further include at least one porous material placed within the chamber, and a urine test device placed within the chamber. In some embodiments, the urine test device may be placed within at least one porous material. Method 500 may further include an action 520 to receive urine from the urethral opening into the chamber of the urine collection assembly. Method 500 also includes an action 530 to saturate the urine test device with urine. Method 500 may also include an action 540 to withdraw the urine test device from within the urine collection assembly. In some embodiments, the urine test device may be withdrawn immediately after the urine test device has been saturated. In other embodiments, the urine collection assembly may be replaced and discarded after the urine test device has been withdrawn. In some embodiments, withdrawing the urine test device may involve withdrawing a test strip through an opening in a fluid-impermeable barrier. The urine test device can typically be withdrawn manually by the user or caregiver. Typically, the urine test device is withdrawn manually and read, or placed in a machine / computer for further analysis.

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

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

[0057] As used herein, the terms “about” or “substantially” refer to an acceptable variation in the term that is modified by “about” or “substantially” by up to ±10% or ±5%. Furthermore, the terms “less than,” “or less,” “greater than,” “greater than,” or “or more” include, as endpoints, values ​​modified by the terms “less than,” “or less,” “greater than,” or “greater than.”

[0058] While various aspects and embodiments are disclosed herein, other aspects and embodiments are conceivable. The various aspects and embodiments disclosed herein are for illustrative purposes only and are not intended to limit the scope of the invention.

Claims

1. A urine collection assembly, 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 placed within the chamber, A urine testing device is placed within the aforementioned urine collection assembly, Equipped with, A urine collection assembly comprising a fluid-impermeable barrier including an opening, wherein the urine testing device is configured to be drawn out through the opening, and the urine testing device is at least partially located within the at least one porous material.

2. The urine collection assembly according to claim 1, wherein the opening is located near the fluid outlet.

3. The urine collection assembly according to claim 1, wherein the urine testing device extends at least partially across the at least one opening.

4. The urine collection assembly according to claim 1, wherein the urine testing device is at least partially located within the chamber.

5. The urine collection assembly according to claim 1, wherein the urine testing device is at least partially located within the conduit.

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

7. The urine collection assembly according to claim 1, wherein the urine testing device includes a urine test strip.

8. The urine collection assembly according to claim 1, wherein the urine testing device includes a pull tab configured to prevent the urine testing device from slipping through the opening and entering the urine collection assembly completely.

9. A urine collection assembly, A chamber, at least one opening configured to be positioned at least in close proximity to the user's urethra, and a fluid-impermeable barrier defining a fluid outlet, A conduit including a first end disposed within the chamber, At least one porous material placed within the chamber, A urine testing device disposed within the urine collection assembly, wherein the fluid-impermeable barrier includes an opening, the urine testing device is configured to be drawn out through the opening, and the urine testing device is at least partially disposed within the at least one porous material, A urine collection assembly including, A conduit that communicates fluid with the aforementioned urine collection assembly, A urine collection container having an internal region that is in fluid communication with the aforementioned conduit, A pump that is in fluid communication with the urine collection container and the urine collection assembly, the pump configured to draw up urine from the urine collection assembly and store the urine in the urine collection container via the conduit, A urine collection system equipped with the following features.

10. The urine collection system according to claim 9, wherein the urine testing device is located within the urine collection assembly.

11. The urine collection system according to claim 9, wherein the urine testing device includes a pull tab configured to prevent the urine testing device from slipping through the opening and entering the urine collection assembly completely.

12. The urine collection system according to claim 9, wherein the urine testing device extends at least partially across the at least one opening.

13. A method for collecting urine test samples, The urine collection assembly is positioned adjacent to the urethral opening, wherein the urine collection assembly is 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, The invention includes a urine testing device, which is at least partially disposed within the chamber and at least partially disposed within the at least one porous material. To receive urine from the urethral opening into the chamber of the urine collection assembly, The urine testing device is saturated with urine, To withdraw the urine testing device from the urine collection assembly, Methods that include...

14. The method according to claim 13, wherein the urine testing device includes a urine test strip, and the method further comprises reading the urine test strip by comparing a color sample on the urine test strip with a color chart.

15. The method according to claim 13, further comprising applying suction using a pump effective for aspirating one or more bodily fluids from the chamber via a conduit, and storing the one or more bodily fluids in a urine collection container.

16. The method according to claim 13, wherein withdrawing the urine testing device includes withdrawing the device through an opening in the fluid-impermeable barrier.

17. A urine collection assembly, 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 placed within the chamber, A urine testing device is placed within the aforementioned urine collection assembly, Equipped with, The urine testing device comprises a urine collection assembly, at least partially disposed within the at least one porous material.

18. The urine collection assembly according to claim 17, wherein the urine testing device is configured to analyze at least one of calcium, blood, glucose, bilirubin, urobilinogen, ketones, leukocytes, creatinine, microalbumin, pH, ascorbic acid, and protein.

19. The urine collection assembly according to claim 17, wherein the urine testing device includes a urine test strip.

20. The urine collection assembly according to claim 17, wherein the fluid-impermeable barrier includes an opening, and the urine testing device includes a pull tab configured to prevent the urine testing device from slipping through the opening and entering the urine collection assembly completely.

21. The urine collection assembly according to claim 17, wherein the fluid-impermeable barrier includes an opening, and the urine testing device is configured to be withdrawn through the opening.

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