EXTERNAL CATHETER WITH IMPROVED TACTILE FEEDBACK AND ASSOCIATED SYSTEMS AND METHODS - Patent application

Abstract

The embodiments relate to devices, systems, and methods for fluid collection. The fluid collection device may include a fluid-impermeable barrier defining at least a chamber and at least one opening extending through the fluid-impermeable barrier, and a permeable material disposed within the chamber. The fluid-impermeable barrier includes at least one foaming agent incorporated therein, the at least one foaming agent configured to increase flexibility of the fluid-impermeable barrier and maintain a selected geometric configuration. The fluid collection device may also include a conduit having an inlet and an outlet. The inlet is disposed within the chamber and the outlet extends through the opening in the fluid-impermeable barrier.

Description

[Technical field]

[0001] The present invention relates to external catheters and related systems and methods with improved tactile feedback. [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. 2018 / 228642 [Patent Document 2] U.S. Pat. No. 5,340,840 Summary of the Invention [Means for solving the problem]

[0006] The embodiments disclosed herein relate to a fluid collection system and a method for manufacturing the fluid collection system. In one embodiment, the fluid collection device may include a fluid-impermeable barrier at least partially defining a chamber, the fluid-impermeable barrier also defining an opening extending therethrough, the opening configured to be positioned adjacent to the urethra of a user. The fluid-impermeable barrier may include at least one foaming agent incorporated therein, the at least one foaming agent configured to increase the flexibility of the fluid-impermeable barrier and maintain a selected geometric configuration. The fluid collection device may further include a permeable material disposed within the chamber and a conduit having an inlet and an outlet. The inlet may be disposed within the chamber, and the outlet may extend through an opening in the fluid-impermeable barrier.

[0007] In one embodiment, the fluid collection system may include a fluid reservoir configured to hold a fluid and a fluid collection device fluidly coupled to the fluid reservoir. The fluid collection device may include a fluid impermeable barrier at least partially defining a chamber. In some embodiments, the fluid impermeable barrier may also define an opening extending therethrough, the opening configured to be positioned adjacent to the urethra of a user. The fluid impermeable barrier may include at least one foaming agent incorporated therein, the at least one foaming agent configured to increase the flexibility of the fluid impermeable barrier and maintain a selected geometric configuration. The fluid collection device may also include a permeable material disposed within the chamber. In some embodiments, the fluid collection system may also include a conduit having an inlet and an outlet. The outlet may be fluidly coupled to the fluid reservoir, and the inlet may be disposed within the chamber. The fluid collection system may further include a vacuum source configured to draw fluid from the fluid collection device.

[0008] In one embodiment, a method of manufacturing a fluid collection device is disclosed. The method may include providing an ingredient mixture and forming the ingredient mixture into a fluid impermeable barrier. In some embodiments, the fluid impermeable barrier at least partially defines a chamber and an opening extending through the fluid impermeable barrier, the opening configured to be positioned adjacent to the urethra of a user. The fluid impermeable barrier may include at least one foaming agent incorporated therein, the at least one foaming agent configured to increase the flexibility of the fluid impermeable barrier and maintain a selected geometric configuration. The method may also include incorporating the fluid impermeable barrier into the fluid collection device. The fluid collection device may further include a permeable material disposed within the chamber and a conduit including an inlet and an outlet, the inlet being disposed within the chamber and the outlet extending through the opening in the fluid impermeable barrier.

[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] 1 illustrates an isometric view of a female fluid collection device, according to one embodiment. [Figure 2B] 2B is a cross-sectional view of the fluid collection device of FIG. 2A. [Figure 3A] FIG. 1 is a cross-sectional view of a male urine collection assembly according to one embodiment. [Figure 3B]FIG. 1 illustrates an isometric view of a male urine collection assembly, according to one embodiment. [Figure 3C] FIG. 3C is a cross-sectional view of the male urine collection assembly of FIG. 3B. [Figure 4] 1 is a flow diagram of a method for manufacturing a fluid collection device, according to one embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0012] The embodiments disclosed herein relate to fluid collection systems and related methods. The devices and systems disclosed herein are configured to collect fluids from an individual. The fluids collected by the fluid collection device may include at least one of urine, vaginal secretions, penile secretions, reproductive fluids, blood, sweat, or other bodily fluids. Many users of the fluid collection device are over 65 years old, have limited mobility, and often rely on wheelchairs as their primary means of transportation. Many users also have medical conditions that may require them to be in a seated or supine position for extended periods of time. Due to this immobility, the fluid collection device may be placed in the wearer's groin and anatomical contours in an area proximal to the user's urethra and remain there for extended periods of time. Thus, users and caregivers may benefit from the fluid collection device, which may improve the tactile quality of the device and / or enable a more comfortable experience using the device without affecting the system's functionality, allowing the user and / or caregiver to use the urine collection system to collect fluids more comfortably than other comparable devices and / or systems.

[0013] In many embodiments described herein, the addition of at least one foaming agent to a component of the fluid collection system may increase the range of feel and / or deflection of the component. In some embodiments, the material properties and functionality of the component may remain unaffected by the addition of a foaming agent while at the same time significantly increasing the comfort level of the user. Traditional methods of altering the tactile user experience have attempted to change the material type, thickness, and / or shape. The fluid collection system embodiments described herein allow for a moderate component thickness while at the same time allowing for an effectively soft feel for the benefit of the user and / or caregiver.

[0014] 1A is a block diagram of a fluid collection system 10, according to one embodiment. The fluid collection system 10 may be included in the embodiments of the fluid collection system described herein. The system 10 includes a fluid (e.g., urine) collection device 12 (e.g., any of the fluid collection assemblies disclosed herein), a fluid collection container 14 (or reservoir), and a vacuum source 16 (or pump). The fluid collection device 12, the fluid collection container 14, and the vacuum source 16 may be fluidly coupled to one another via one or more conduits 18. For example, the fluid collection device 12 may be operably coupled to one or more of the fluid collection container 14 or the vacuum source 16 via the conduit 18. In some embodiments, the vacuum source 16 may be directly coupled to the fluid collection container 14. Fluid (e.g., urine or other bodily fluids) collected in the fluid collection assembly 12 may be removed from the fluid collection assembly 12 via a conduit 18 coupled to the fluid collection device 12. Suction force may be introduced into the chamber of the fluid collection device 12 via the inlet of the conduit 18 in response to suction (eg, vacuum) force applied at the outlet of the conduit 18 .

[0015] The suction force may be applied to the outlet of the conduit 18 directly or indirectly by the vacuum source 16. The suction force may be applied indirectly via the fluid collection container 14. For example, the outlet of the conduit 18 may be disposed within or fluidly coupled to an interior region of the fluid collection container 14, and an additional conduit 18 may extend from the fluid collection container 14 to the vacuum source 16. Thus, the vacuum source 16 may apply suction to the fluid collection assembly 12 via the fluid collection container 14. The suction force may be applied directly via the vacuum source 16. For example, the outlet of the conduit 18 may be disposed within the vacuum source 16 (e.g., a pump). The additional tube 18 may extend from the vacuum source 16 to a point outside the fluid collection device 12, such as the fluid collection container 14. In such an example, the vacuum source 16 may be disposed between the fluid collection device 12 and the fluid collection container 14.

[0016] The fluid collection container 14 may be sized and shaped to hold fluid therein. The fluid 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 conduit 18 may extend from the fluid collection device 12 and be attached to the fluid collection container 14 at a first point thereon. An additional conduit 18 may be attached to the fluid collection container 14 at a second point thereon and may extend and be attached to the vacuum source 16. Thus, a vacuum (e.g., suction) may be drawn through the fluid collection container 14 to the fluid collection device 12. Fluid, such as urine, may be evacuated from the fluid collection device 12 via the conduit 18 using the vacuum source 16.

[0017] The vacuum source 16 or pump 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 vacuum source 16 may provide a vacuum or suction to remove fluid from the fluid collection device 12. In some examples, the vacuum source 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 vacuum source 16.

[0018] Many embodiments of the fluid 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 fluid collection system 100, according to some embodiments. The fluid collection system 100 may include a fluid collection device 102 configured to receive fluid (e.g., urine) from a user. The fluid collection device 102 may be removably attached to a fluid collection container 104 of the fluid collection system 100. The fluid collection container 104 may be integrated into a housing 106, which may also include a vacuum device (e.g., a pump) therein. The fluid collection system 100 may further include a collection conduit 108 and a suction conduit 110. The collection conduit 108 may be disposed between the fluid collection device 102 and the fluid collection container 104. The collection conduit 108 may fluidly connect an interior volume of the fluid collection container 104 to the fluid collection device 102. A suction conduit 110 may couple the suction and / or exhaust of the pump to the fluid collection container 104. A pump disposed within the housing 106 may be in fluid communication with the interior volume of the fluid collection container 104 via the suction conduit 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 the pressure within the container 104.

[0019] The fluid collection device 102 may be positioned at least near the urethral opening. The fluid collection devices shown in Figures 1B-2B are examples of female fluid collection devices 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 August 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). Figures 3A-3C are examples of male fluid collection devices configured to collect fluid(s) from a male. Further 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.

[0020] In some embodiments, the collection conduit 108, the suction conduit 110, and / or other tubes of the fluid 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 conduit 108 may include silicone or latex. In some embodiments, the collection conduit 108 may be constructed of any suitable material that is impermeable to fluids such that fluids may be drawn from the fluid collection device 102 into the collection conduit 108. In some embodiments, the collection conduit 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.

[0021] The fluid 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 conduit 108 and an outlet coupled to a vacuum port that is coupled to a vacuum source. 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.

[0022] 2A is an isometric view of a fluid collection device 200, according to one embodiment. The fluid collection device 200 may include a fluid impermeable barrier 202, an opening 204, a chamber 206, an opening 208 in the fluid impermeable barrier 202, and a permeable material 210 disposed within the chamber 206 in the fluid impermeable barrier 202. A conduit 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 within the fluid collection device 200. The fluid impermeable barrier 202 temporarily stores bodily fluids within the chamber 206.

[0023] In some embodiments, the fluid impermeable barrier 202 may be formed of a thermoplastic elastomer. Thermoplastic elastomers include a class of copolymers that include materials that have both thermoplastic and elastomeric properties. In some embodiments, the thermoplastic elastomer of the fluid impermeable barrier 202 may include at least one of polyethylene, polypropylene, polyamide, and polyvinyl chloride. 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] To promote user comfort, the fluid impermeable barrier 202 may include at least one foaming agent incorporated therein, the at least one foaming agent configured to increase the flexibility of the fluid impermeable barrier 202 and maintain a selected geometric configuration. The at least one foaming agent may also reduce the weight of the fluid collection device 200. The weight reduction correlates with the use of less thermoplastic elastomer in the fluid impermeable barrier 202, which may translate into cost savings during manufacturing. In some embodiments, the weight reduction may include a weight reduction of about 15% to about 25% compared to a fluid impermeable barrier 202 including only a thermoplastic elastomer. In some embodiments, the weight reduction may include a weight reduction of about 19%. This weight reduction may correspond to about 2 to 4 grams of the fluid impermeable barrier 202 prior to assembly into the fluid collection device 200.

[0025] In some embodiments, the fluid impermeable barrier 202 may include less than 10% by volume of at least one foaming agent. In some embodiments, the fluid impermeable barrier 202 may include about 0.4% to about 5% by volume of at least one foaming agent. The amount of foaming agent may be selected depending on the desired properties of the fluid collection device 200 and manufacturing considerations. The inclusion of the foaming agent may reduce the processing temperature and may reduce the density of the fluid impermeable barrier 202 while producing a uniform cell structure. In some embodiments, the specific gravity of the fluid impermeable barrier 202 may be less than 0.85. In some embodiments, the specific gravity of the fluid impermeable barrier 202 may be between 0.45 and 0.85. In other embodiments, the specific gravity of the fluid impermeable barrier 202 may be between 0.65 and 0.75.

[0026] In some embodiments, the at least one effervescent agent included in the fluid impermeable barrier 202 may include sodium bicarbonate. Sodium bicarbonate is the monosodium salt of carbonic acid. In its unrefined state, sodium bicarbonate appears as an odorless white crystalline powder or mass. Sodium bicarbonate decomposes at about 228° F. (about 50° C.). In some embodiments, the at least one effervescent agent included in the fluid impermeable barrier 202 may include an azide compound. Azides are represented by the formula N 3 - The anion of the compound may be an azide. The azide compound included in the fluid impermeable barrier 202 as a blowing agent may include an inorganic azide, such as sodium azide, or an organic azide, such as an aryl azide and / or an alkyl azide. The blowing agent may be included in the fluid impermeable barrier 202 to reduce weight and improve flexibility while maintaining the inherent properties of the thermoplastic elastomer and reduce the amount of resin used in the manufacturing method of the fluid collection device, which is described in more detail below.

[0027] In some embodiments, the opening 204 of the fluid collection apparatus 200 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.

[0028] The fluid collection device 200 may be positioned adjacent to a user's urethra, and bodily fluids may enter the chamber 206 of the fluid collection device 200 via the opening 204. The fluid collection device 200 may be configured to receive fluid(s) into the chamber 206 via the opening 204. In use, the opening 204 may have an elongated shape, extending 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). The opening 204 of the fluid impermeable barrier 202 may exhibit a length measured along a longitudinal axis of the fluid collection device 200. In other words, the fluid impermeable barrier 202 may define a cylindrical shape with an opening extending longitudinally therethrough.

[0029] The fluid collection device 200 may include at least one permeable material 210 disposed within the chamber 206. The permeable material 210 may cover at least a portion (e.g., all) of the opening 204. The permeable material 210 may be exposed to an environment outside the chamber 206 through the opening 204. The permeable material 210 may be configured to wick and / or allow fluid flow through the opening 204, thereby preventing fluid from leaking out of the chamber 206. The permeability properties referred to herein may be wicking, capillary action, diffusion, or another similar property or process, and are referred to herein as "permeability" and / or "porosity." Such "wicking" and "permeability" properties may not include absorption of fluid into the permeable material 210. In other words, absorption or dissolving of bodily fluids into the material may not occur substantially until 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 permeable material 210 to be, for example, less than about 30% by weight of the dry weight of the permeable 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 permeable material 210.

[0030] In one embodiment, the permeable material 210 may include at least one absorbent or absorbing material. The permeable material 210 disposed within the chamber 206 may include any material capable of wicking and / or flowing fluid. For example, the permeable 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 wicking material, or combinations thereof. For example, the permeable material 210 may include a body of spun nylon fibers and an outer woven gauze layer encasing the body of spun nylon fibers. Forming the permeable material 210 from gauze, soft cloth, and / or smooth cloth may reduce chafing caused by the urine collection assembly 200. In some embodiments, the permeable material 210 may at least substantially and / or completely fill a portion of the chamber 206 that may not be occupied by the conduit 212. The conduit 212 may be at least partially disposed within the chamber 206. The conduit 212 may be used to remove fluid from the chamber 206. The conduit 212 may be in fluid communication with the opening 208 of the fluid collection device 200. The conduit 212 may include an inlet (shown in FIG. 2B) disposed within the chamber 206 and an outlet (not shown) disposed downstream of the inlet. The outlet may be operably coupled to a fluid collection container (e.g., the fluid collection container 104). Thus, the conduit 212 may fluidly couple the chamber 206 to the fluid collection container (as shown in FIG. 1A or FIG. 1B).

[0031] In some embodiments, the opening 208 of the fluid impermeable barrier 202 can be appropriately sized to receive the conduit 212. The conduit 212 can be disposed within the chamber 206 through the opening 208. The opening 208 can be sized and shaped to form at least a substantially fluid-tight seal with the conduit 212, thereby substantially preventing the fluid(s) from escaping the chamber 206 through the opening 208. As shown in FIG. 2A, an inlet of the conduit 212 can extend through the opening 208 into the chamber 206. In the illustrated embodiment, the conduit 212 is at least partially disposed within the chamber 206. Fluid collected in the fluid collection device 200 can be removed from the chamber 206 through the conduit 212.

[0032] 2B is a cross-sectional view of the fluid collection device of FIG. 2A, according to one embodiment. In some embodiments, the fluid collection device 200 may include a connector 214 disposed within the chamber 206. The connector 214 may be disposed within the chamber 206 where urine is collected and couples the conduit 212 to the chamber 206. In some embodiments, the connector 214 may be disposed within the permeable material 210. In some embodiments, the permeable material 210 fills the chamber 206 within the fluid impermeable barrier 202. In some embodiments, the inlet 216 of the conduit 212 may be coupled to the connector 214. The connector 214 may be sized and shaped to form at least a substantially fluid-tight seal with the conduit 212. The connector 214 may also be coupled to the fluid impermeable barrier 202 in some embodiments. The connector 214 and the fluid impermeable barrier 202 may be coupled in a manner that forms a fluid-tight seal, thereby substantially preventing the fluid(s) from leaking from the chamber 206.

[0033] In some embodiments, the connector 214 may have a higher Shore hardness than the fluid impermeable barrier 202. In some embodiments, the connector 214 may include a different material than the fluid impermeable barrier 202, where the material has a higher Shore hardness than the material included in the fluid impermeable barrier 202. In some embodiments, the material of the connector 214 and the fluid impermeable barrier 202 may be the same, but the connector 214 may have a different density, hardness, or porosity than the fluid impermeable barrier 202. The connector 214 may provide a strong bond between the conduit 212 and other components of the fluid collection device. In some embodiments, the connector 214 may be disposed within the chamber 206 and may be disposed within the permeable material 210. The connector 214 may not include a foaming agent because the connector 214 is not intended to contact the skin of a user.

[0034] In some embodiments, the fluid impermeable barrier 202 may be overmolded onto the connector 214. Overmolding involves a multi-shot injection molding process that produces a single final product from two or more different thermoplastics. To produce the overmolding, the connector 214 may be injection molded, including a material with a higher Shore hardness. The connector 214 may then be placed in an overmolding tool or an overmolding cavity within the same tool. The molten material that forms the fluid impermeable barrier 202 is then injected into, onto, and / or around the connector 214. After the molten material cools, the connector 214 and the fluid impermeable barrier 202 may be chemically and / or mechanically bonded.

[0035] In some embodiments, the fluid impermeable barrier 202 and the connector 214 may be two-shot (i.e., dual shot, multi-shot, or double shot) molded. In some embodiments, the connector 214 may be injected into a mold to form a substrate around which the fluid impermeable barrier 202 is molded. The substrate (e.g., connector) is solidified and cooled before being transferred to a second chamber of the mold. Once the connector is in place, the material that forms the fluid impermeable barrier 202 may be injected and bonded to the connector to form a bond. The material that forms the fluid impermeable barrier 202 is then cooled, and the fluid impermeable barrier 202 and the connector 214 are formed together.

[0036] 3A is a cross-sectional view of a male urine collection assembly 300, according to one embodiment. In other words, the urine collection assembly 300 is designed to collect fluid(s) from a male user. In some embodiments, the urine collection assembly 300 may include a fluid-impermeable barrier 302 shaped and configured to be placed around the penis of a user. The fluid-impermeable barrier 302 may be tubular or cup-shaped. The fluid-impermeable barrier 302 may define an opening 304 extending therethrough and configured for at least a portion of the penis to be placed therethrough.

[0037] The fluid impermeable barrier 302 at least partially defines a chamber 306 within the urine collection assembly 300. The fluid impermeable barrier 302 temporarily stores the fluid(s) within the chamber 306. The fluid impermeable barrier 302 may be formed of any suitable fluid impermeable material(s) to substantially prevent urine from passing therethrough.

[0038] The fluid impermeable barrier 302 at least partially defines the chamber 306. For example, an inner surface of the fluid impermeable barrier 302 at least partially defines a perimeter of the chamber 306. Similar to the embodiment described above with reference to FIGS. 2A-2B, in some embodiments, the fluid impermeable barrier 302 may include less than 10% by volume of at least one foaming agent. In some embodiments, the fluid impermeable barrier 302 may include about 0.4% to about 5% by volume of at least one foaming agent. The amount of foaming agent may be selected depending on the desired properties of the fluid collection device 300 and manufacturing considerations.

[0039] The urine collection assembly 300 may include at least one permeable material 308. The permeable material 308 may be configured to wick fluid up through the opening 304, thereby preventing fluid from leaking out of the chamber 306. The permeable material 308 may include any material that may wick fluid up. For example, the permeable material 308 may include a fabric, such as gauze (such as silk, linen, or cotton gauze), another soft fabric, or another smooth fabric. Forming the permeable material 308 from gauze, a soft fabric, and / or a smooth fabric may reduce chafing caused by the urine collection assembly 300. The permeable material 308 may not completely fill the chamber 306 because the chamber 306 is configured to have an open space to receive at least a portion of the penis. The urine collection assembly 300 may include multiple layers of permeable material 308.

[0040] The urine collection assembly 300 may include a reservoir 310. The reservoir 310 may be a substantially unoccupied portion of the chamber 306. The fluid(s) in the chamber 306 may flow through a permeable material 308 to the reservoir 310. The reservoir 310 may hold the fluid(s) therein. In some embodiments, the reservoir 310 may be disposed at a distal end 312 of the urine collection assembly 300 and an opening may be present at a proximal end 314 of the urine collection assembly. The proximal end 314 may include a base 316, which may be sized, shaped, and made of a material to be bonded to the skin surrounding the penis and for at least the urethral opening of the penis to extend therethrough. The base 316 may include an opening 304. In some embodiments, the base 316 may include a rigid structure configured to maintain the fluid impermeable membrane 302 in a particular position and / or at a particular angle relative to the individual's body (e.g., the skin surrounding the penis).

[0041] The fluid impermeable barrier 302 also includes at least a portion of a tube 318 disposed therein, e.g., at least partially disposed in the reservoir 310. In one example, the tube 318 may extend from a first opening 320 in the distal region 312 to a proximal region 314 at least proximal to the opening 304. The proximal region 314 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 304 of the fluid impermeable barrier 302 and contact the patient's skin. Fluid may be removed from the chamber 306 and / or reservoir 310 via the tube 318. The first opening 320 may be sized and shaped to form at least a substantially fluid-tight seal with the tube 318, thereby substantially preventing fluid(s) from leaking from the chamber 306 via the first opening 320.

[0042] 3B and 3C are isometric and cross-sectional views, respectively, of a male urine collection assembly 350, according to one embodiment. The urine collection assembly 350 includes a sheath 352 and a base 354. The sheath 352 includes a fluid impermeable barrier 356 formed at least in part from a first panel 358 attached to a second panel 360. However, in other embodiments, the first panel 358 and the second panel 360 may be integrally formed with one another. The fluid impermeable barrier 356 also defines a chamber 362 between the first panel 358 and the second panel 360, defines an opening 364 at a proximal end region 366 and the base 354 of the sheath 352, and defines an outlet 368 at a distal end region 370 of the sheath 352. The sheath 352 also includes at least one permeable material 372 disposed within the chamber 362. The base 354 is permanently attached to a proximal end region 366 of the sheath 352 .

[0043] In some embodiments, a permeable material 372 may be disposed within the chamber and between the first panel 358 and the second panel 360. An opening 364 may be formed in and extend through the fluid impermeable barrier 356, thereby allowing bodily fluids to enter the chamber 362 from outside the urine collection assembly 350. The opening 364 may be configured to receive a user's penis, which may extend into the chamber 362.

[0044] The fluid impermeable barrier 356 defines an outlet 368 sized to receive the tube 374. The tube 374 may be at least partially disposed within the chamber 362 or otherwise in fluid communication with the chamber 362 via the outlet 368. The outlet 368 may be sized and shaped to form at least a substantially fluid-tight seal with the tube 374, thereby substantially preventing bodily fluids from escaping the chamber 362. The inlet 376 of the tube 374 may be located at or near the distal end region 370 of the sheath 352, which is expected to be a gravimetric low point of the chamber 362 when worn by a user. Locating the inlet 376 at or near the distal end region 370 of the sheath 352 allows the tube 374 to receive more bodily fluids than if the inlet 376 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 retained within the permeable material 372 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 permeable material 372 is saturated with bodily fluids. Thus, the inlet 376 may be located in the fluid collection assembly 350 at a location that is expected to be a gravimetric low point of the urine collection assembly 350 when worn by a user.

[0045] Similar to the embodiments described above, in some embodiments, the sheath 352 and / or the fluid impermeable barrier 356 may also include less than 10% by volume of at least one foaming agent. In some embodiments, the fluid impermeable barrier 356 may include between about 0.4% and about 5% by volume of at least one foaming agent. The amount of foaming agent content may be selected depending on the desired properties of the fluid collection device 350 and manufacturing considerations.

[0046] FIG. 4 is a flow diagram of a method 400 of manufacturing a fluid collection device, according to one embodiment. Method 400 includes an operation 410 of providing a feedstock mixture. In some embodiments, the feedstock mixture may include at least one thermoplastic elastomer and at least one blowing agent. In some embodiments, the feedstock mixture may include injection molding pellets. Operation 410 may include mixing an appropriate ratio of thermoplastic elastomer and blowing agent to provide an appropriate ratio to generate a desired tactile feedback quality in the fluid impermeable barrier of the fluid collection device. In some embodiments, the feedstock mixture may include less than 10% blowing agent. In some embodiments, the feedstock mixture may include about 1% to about 5% blowing agent. In some embodiments, the blowing agent may be included in the thermoplastic elastomer injection molding pellets. In other embodiments, the blowing agent may be included as an injection molding pellet and mechanically mixed with the thermoplastic elastomer injection molding pellets.

[0047] In some embodiments, the method 400 may further include an operation 420 of forming the feedstock mixture into a fluid-impermeable barrier. In some embodiments, forming the feedstock mixture in operation 420 may include injection molding the feedstock mixture. Plastic injection molding may include a process of melting plastic pellets (e.g., injection molding pellets including thermoplastic elastomers and / or blowing agents) that, once sufficiently malleable, are injected under pressure into a mold cavity, such as the fluid-impermeable barrier 202 described above, and allowed to fill and solidify to produce the final product shape. In some embodiments, the pellets may be fed into a hopper where they may be melted, compressed, and injected into a mold runner system. In some embodiments, the injection molding of operation 420 may include heating the feedstock mixture above 250° F. to form a hot resin. The hot resin may be injected into a mold cavity and, upon cooling, a part is formed. In some embodiments, an ejector pin may facilitate removing the part from the mold.

[0048] In some embodiments, forming the feedstock mixture in operation 420 may include extruding the feedstock mixture. In some embodiments, similar to injection molding, the extrusion may include a molten feedstock mixture. In some embodiments, the extrusion of operation 420 may include heating the feedstock mixture above 250° F. to form a hot resin. The hot resin may then be forced through a die to form the feedstock into the final product shape (e.g., the fluid impermeable barrier 202). The shape of the die determines the shape of the product. The extrudate is then cooled to form a solid shape.

[0049] In some embodiments, the product may include the fluid-impermeable barrier of any of the above embodiments. The fluid-impermeable barrier may at least partially define a chamber and an opening extending therethrough, the opening configured to be positioned adjacent to the urethra of a user. In some embodiments, the fluid-impermeable barrier may include at least one foaming agent incorporated therein, the at least one foaming agent configured to increase the flexibility of the fluid-impermeable barrier and maintain a selected geometric configuration. In some embodiments, forming the ingredient mixture into the fluid-impermeable barrier includes forming the fluid-impermeable barrier into an arcuate shape that conforms to the vaginal and perineal areas of the wearer.

[0050] In some embodiments, the method 400 may also include an operation 430 of incorporating a fluid impermeable barrier into the fluid collection apparatus. The fluid collection apparatus may further include a permeable material disposed within the chamber and a conduit including an inlet and an outlet. The inlet may be disposed within the chamber and the outlet may extend through an opening in the fluid impermeable barrier. In some embodiments, the fluid collection apparatus may further include a connector disposed within the chamber, the inlet of the conduit being coupled to the connector, where the connector comprises a higher Shore hardness than the fluid impermeable barrier. The fluid impermeable barrier may be overmolded onto the connector.

[0051] 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.

[0052] 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.

[0053] 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 at least partially defining a chamber, the fluid-impermeable barrier also defining an opening extending therethrough, the opening configured to be positioned adjacent to a user's urethra, the fluid-impermeable barrier including at least one foaming agent incorporated therein, the at least one foaming agent configured to increase flexibility of the fluid-impermeable barrier and maintain a selected geometric configuration; a permeable material disposed within the chamber; a conduit including an inlet and an outlet, the inlet being disposed within the chamber and the outlet extending through an opening in the fluid impermeable barrier; A fluid collection device comprising:

2. The fluid collection device of claim 1 , wherein the fluid impermeable barrier comprises a thermoplastic elastomer.

3. 3. The fluid collection device of claim 2, wherein the thermoplastic elastomer comprises at least one of polyethylene, polypropylene, polyamide, and polyvinyl chloride.

4. 4. The fluid collection device of claim 1, wherein the fluid impermeable barrier comprises less than 10% by volume of the at least one foaming agent.

5. The fluid collection device of any of claims 1 to 4, wherein the fluid impermeable barrier comprises from about 0.4% to about 5% by volume of the at least one foaming agent.

6. 6. The fluid collection device of claim 1, wherein the fluid impermeable barrier comprises a specific gravity of less than 0.

85.

7. The fluid collection device of claim 1 , wherein the at least one effervescent agent comprises sodium bicarbonate.

8. The fluid collection apparatus of claim 1 , wherein the at least one foaming agent comprises an azide compound.

9. a fluid reservoir configured to hold a fluid; a fluid collection device fluidly coupled to the fluid reservoir, a fluid-impermeable barrier at least partially defining a chamber, the fluid-impermeable barrier also defining an opening extending therethrough, the opening configured to be positioned adjacent to a user's urethra, the fluid-impermeable barrier including at least one foaming agent incorporated therein, the at least one foaming agent configured to increase flexibility of the fluid-impermeable barrier and maintain a selected geometric configuration; and a fluid collection device comprising a permeable material disposed within the chamber; a conduit including an inlet and an outlet, the outlet fluidly coupled to the fluid reservoir and the inlet disposed within the chamber; a vacuum source fluidly coupled to one or more of the fluid reservoir or the fluid collection device via the conduit and configured to draw fluid from the fluid collection device; A fluid collection system comprising:

10. 10. The fluid collection device of claim 9, wherein the fluid impermeable barrier comprises a thermoplastic elastomer.

11. 11. The fluid collection device of claim 9 or 10, wherein the fluid impermeable barrier comprises less than 10% by volume of a foaming agent.

12. 12. The fluid collection system of claim 9, further comprising a connector disposed within the chamber, the inlet of the conduit being coupled to the connector, the connector comprising a higher Shore hardness than the fluid impermeable barrier.

13. The fluid collection device of claim 12 , wherein the fluid impermeable barrier is overmolded onto the connector.

14. 14. A fluid collection device according to any of claims 9 to 13, wherein the fluid impermeable barrier defines a cylindrical shape with an opening extending longitudinally therethrough.

15. 1. A method of manufacturing a fluid collection device, comprising: Providing a feedstock mixture; forming the ingredient mixture into a fluid-impermeable barrier, the fluid-impermeable barrier at least partially defining a chamber and an opening extending therethrough, the opening configured to be positioned adjacent to a urethra of a user, the fluid-impermeable barrier including at least one foaming agent incorporated therein, the at least one foaming agent configured to increase flexibility of the fluid-impermeable barrier and maintain a selected geometric configuration; incorporating the fluid impermeable barrier into the fluid collection apparatus, the fluid collection apparatus further comprising a permeable material disposed within the chamber and a conduit including an inlet and an outlet, the inlet being disposed within the chamber and the outlet extending through an opening in the fluid impermeable barrier; A method comprising:

16. 16. The method of claim 15, wherein forming the ingredient mixture into a fluid impermeable barrier comprises forming the fluid impermeable barrier into an arcuate shape that conforms to the vaginal and perineal area of ​​the wearer.

17. 17. The method of claim 15 or 16, wherein forming the feedstock mixture into a fluid impermeable barrier comprises injection molding the feedstock mixture.

18. 20. The method of claim 17, wherein injection molding the feedstock mixture includes heating the feedstock mixture above 250°F.

19. 19. The method of any of claims 15 to 18, wherein the raw mix comprises less than 10% of the at least one blowing agent.

20. 20. The method of any of claims 15-19, wherein forming the feed mixture into a fluid impermeable barrier comprises extruding the feed mixture.

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