Fluid collection device including a base fixing area, and related systems and methods

Abstract

The present invention provides an example fluid-impermeable barrier of a fluid collection device and a method of forming a fluid-impermeable barrier of a fluid collection device. The fluid-impermeable barrier includes an inner surface, a first end region, and a second end region, the inner surface at least partially defining a chamber, the first end region defining an orifice extending therethrough and including a first outer surface portion, the second end region being distal to the first end region and including a second outer surface portion, the second outer surface portion having a stronger adhesive strength than the first outer surface portion. The fluid-impermeable barrier also defines an opening that extends longitudinally along the fluid-impermeable barrier and is configured to be positioned adjacent to a female urethra.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Patent Application No. 62 / 864,656, filed on June 21, 2019, the disclosure of which is incorporated herein by reference in its entirety. Background Art

[0003] The mobility of an individual may be limited or impaired, making the typical urination process challenging or impossible. For example, the individual may have undergone surgery or suffer from a disability that impedes mobility. In another example, the individual may have limited mobility conditions, such as pilots, drivers, and workers working in hazardous areas. In addition, it may be necessary to collect fluid from an individual for monitoring purposes or clinical trials.

[0004] Bedpans and urinary catheters (such as Foley catheters) can be used to address some of these situations. However, bedpans and urinary catheters have several problems associated with them. For example, bedpans can easily cause discomfort, pressure sores, spillage, and other hygiene issues. Urinary catheters can cause discomfort, pain, and can lead to urinary tract infections.

[0005] Accordingly, users and manufacturers of fluid collection devices continue to seek new and improved devices, systems, and methods for collecting urine. Summary of the invention

[0006] Embodiments disclosed herein are fluid collection devices and methods of assembling fluid collection devices. In one embodiment, a fluid collection device includes a fluid-impermeable barrier and a fluid-permeable body. The fluid-impermeable barrier has an inner surface, a first end region, and a second end region, the inner surface at least partially defining a chamber, the first end region defining an orifice extending therethrough and including a first outer surface portion, the second end region distal to the first end region and including a second outer surface portion, the second outer surface portion having a stronger adhesive strength than the first outer surface portion. The fluid-impermeable barrier also defines an opening that extends longitudinally along the fluid-impermeable barrier and is configured to be positioned adjacent to a female urethra. The fluid-permeable body is at least partially positioned within the chamber to extend across at least a portion of the opening and is configured to wick fluid away from the opening.

[0007] In one embodiment, a fluid collection device includes a fluid-impermeable barrier and a fluid-permeable body. The fluid-impermeable barrier at least partially defines a chamber, an opening, and an orifice, the opening extending longitudinally along the fluid-impermeable barrier and configured to be positioned adjacent to a female urethra, and the orifice extending through the fluid-impermeable barrier. At least a portion of the fluid-impermeable barrier has a composition including oil and at least one of silicone rubber or a thermoplastic elastomer (TPE), the composition including about 60 oil phr to about 200 oil phr based on 100 parts per hundred rubber (phr) styrene block copolymer. The fluid-permeable body is at least partially positioned within the chamber to extend across at least a portion of the opening and is configured to wick fluid away from the opening.

[0008] In one embodiment, a method of forming a fluid impermeable barrier of a fluid collection device includes inserting a composition including at least one of silicone rubber or TPE into a barrier mold. The barrier mold includes a first mold portion having a first mold surface and a second portion having a second mold surface that is more polished than the first mold surface. The method also includes molding the composition in the barrier mold to form a fluid impermeable barrier, the fluid impermeable barrier having an inner surface, a first end region, a second end region, and an opening, the inner surface at least partially defining a chamber, the first end region having a first outer surface portion that is connected to the first mold surface, the second end region being distal to the first end region and having a second outer surface portion that is connected to the second mold surface, the opening extending longitudinally along the fluid impermeable barrier. The opening is configured to be positioned adjacent to a female urethra, and the second outer surface portion has a stronger bonding strength than the first outer surface portion.

[0009] In one embodiment, a method of forming a fluid-impermeable barrier of a fluid collection device includes inserting a composition into at least a portion of a barrier mold, the composition including at least one of a silicone rubber or a TPE and about 60 to about 200 phr of oil based on 100 phr of a styrenic block copolymer. The method also includes molding the composition in the barrier mold to form at least a portion of the fluid-impermeable barrier, the at least a portion of the fluid-impermeable barrier defining a chamber and an opening extending therethrough, the opening being configured to be positioned adjacent to a female urethra. The method also includes removing the fluid-impermeable barrier from the barrier mold.

[0010] The features of any of the disclosed embodiments may be used in combination with each other without limitation. In addition, other features and advantages of the present disclosure will become apparent to those of ordinary skill in the art by considering the following detailed description and accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] The drawings illustrate several embodiments of the present disclosure, wherein like reference numerals refer to the same or similar elements or features throughout the different views or embodiments shown in the drawings.

[0012] Figure 1A is an isometric view of a feminine fluid collection device according to one embodiment.

[0013] Figure 1B It is worn by female users Figure 1A Front view of a female fluid collection device.

[0014] Figure 1C yes Figure 1A Exploded view of a female fluid collection device.

[0015] Figure 2A and Figure 2B According to various embodiments, Figure 1A The line 2-2 is intercepted Figure 1A Cross-sectional view of a female fluid collection device.

[0016] Figure 3A is an isometric front view of a feminine fluid collection device according to a second embodiment.

[0017] Figure 3B yes Figure 3A Exploded view of a female fluid collection device.

[0018] Figure 3C yes Figure 3A Rear isometric view of a female fluid collection device.

[0019] Figure 4 is a flow chart of a method of forming a fluid impermeable barrier for a fluid collection device.

[0020] Figure 5 is a flow chart of a method of assembling a fluid collection device according to one embodiment.

[0021] Figure 6 is a flow chart of a method for collecting fluid according to an embodiment.

[0022] Figure 7 is a block diagram of a system for fluid collection according to an embodiment. DETAILED DESCRIPTION

[0023] Embodiments disclosed herein include fluid collection devices and methods of forming fluid collection devices. In female users, the fluid collection device performs better when a portion of the fluid impermeable barrier is at least partially positioned within the gluteal cleft of the wearer. However, the fluid impermeable barrier of conventional fluid collection devices may slip between the gluteal cleft, thereby reducing the efficiency of the fluid collection device. One or more embodiments of the fluid collection device described herein include a base fixing area having an improved outer surface, which promotes improved adhesion between at least a portion of the fluid impermeable barrier and the gluteal cleft. One or more embodiments of the fluid collection device described herein also include a fluid impermeable barrier having a longer longitudinal length, which further promotes at least partial adhesion of the fluid collection device within the gluteal cleft of larger or obese users. An exemplary fluid collection device for use with the systems and methods herein is described in more detail below.

[0024] In one embodiment, a fluid collection device includes a fluid-impermeable barrier and a fluid-permeable body. The fluid-impermeable barrier has an inner surface, a first end region, and a second end region, the inner surface at least partially defining a chamber, the first end region defining an orifice extending therethrough and including a first outer surface portion, the second end region distal to the first end region and including a second outer surface portion. The second outer surface portion has at least one of a stronger adhesive strength, a lower surface roughness, or a stronger viscosity than the first outer surface portion. Therefore, compared with conventional fluid collection devices, the second outer surface portion is more likely to remain fixed in the gluteal cleft. The fluid-impermeable barrier also defines an opening that extends longitudinally along the fluid-impermeable barrier and is configured to be positioned adjacent to a female urethra. The fluid-permeable body is at least partially positioned within the chamber to extend across at least a portion of the opening and is configured to wick fluid away from the opening.

[0025] In one embodiment, a fluid collection device includes a fluid-impermeable barrier and a fluid-permeable body. The fluid-impermeable barrier at least partially defines a chamber, an opening, and an orifice, the opening extending longitudinally along the fluid-impermeable barrier and configured to be positioned adjacent to a female urethra, and the orifice extending through the fluid-impermeable barrier. At least a portion of the fluid-impermeable barrier has a composition including oil and at least one of silicone rubber and a thermoplastic elastomer (TPE), the composition including about 60 oil phr to about 200 oil phr based on 100 parts per hundred rubber (phr) styrene block copolymer. Incorporating oil and at least one of silicone rubber or TPE into the fluid-impermeable barrier results in a softer material with more viscosity that is more likely to remain fixed within the gluteal cleft. The fluid-permeable body is at least partially positioned within the chamber to extend across at least a portion of the opening and is configured to wick fluid away from the opening.

[0026] In one embodiment, a method of forming a fluid-impermeable barrier of a fluid collection device includes inserting a composition including at least one of silicone rubber or TPE into a barrier mold. The barrier mold includes a first mold portion having a first mold surface and a second portion having a second mold surface that is more polished than the first mold surface. The method also includes molding the composition in the barrier mold to form a fluid-impermeable barrier, the fluid-impermeable barrier having an inner surface, a first end region, a second end region, and an opening, the inner surface at least partially defining a chamber, the first end region having a first outer surface portion that is in contact with the first mold surface, the second end region being distal to the first end region and having a second outer surface portion that is in contact with the second mold surface, and the opening extending longitudinally along the fluid-impermeable barrier. The opening is configured to be positioned adjacent to a female urethra. Because the second mold surface is more polished than the first mold surface, the second outer surface portion is also more highly polished than the first outer surface portion, and therefore has at least one of a stronger bond strength, a lower surface roughness, or a stronger viscosity than the first outer surface portion. Therefore, the second outer surface portion is more likely to remain fixed in the gluteal cleft than conventional fluid collection devices.

[0027] In one embodiment, a method of forming a fluid-impermeable barrier of a fluid collection device includes inserting a composition into at least a portion of a barrier mold, the composition including at least one of a silicone rubber or a TPE and about 60 to about 200 phr of oil based on 100 phr of a styrenic block copolymer. The method also includes molding the composition in the barrier mold to form at least a portion of the fluid-impermeable barrier, the at least a portion of the fluid-impermeable barrier defining a chamber and an opening extending therethrough, the opening being configured to be positioned adjacent to a female urethra. The method also includes removing the fluid-impermeable barrier from the barrier mold.

[0028] The fluid collection device disclosed herein is configured to collect fluid from an individual. The fluid collected by the fluid collection device may include urine. The fluid collected by the fluid collection device may also include at least one of vaginal secretions, penile secretions, reproductive fluids, blood, sweat, or other body fluids.

[0029] The fluid collection device described herein can be used in a fluid collection system. The fluid collection system may include a fluid collection device, a fluid storage container, and a portable vacuum source. The fluid (e.g., urine or other body fluids) collected in the fluid collection device can be removed from the fluid collection device via a catheter, which extends into the internal area of ​​the fluid collection device. For example, the first open end of the catheter can extend into the fluid collection device to reach a reservoir therein. The second open end of the catheter can extend into the fluid collection device or the portable vacuum source. In response to the suction (e.g., vacuum) force applied at the second end of the catheter, the suction force can be introduced into the internal area of ​​the fluid collection device via the first open end of the catheter. The suction force can be applied directly or indirectly to the second open end of the catheter by the portable vacuum source.

[0030] The fluid collection devices described herein may be shaped and sized to be positioned adjacent to an opening of a female urethra or to have a male urethra positioned therethrough (e.g., to accommodate a penis therein). For example, the fluid collection device may include a fluid-impermeable barrier that at least partially defines a chamber of the fluid collection device (e.g., an interior region of the fluid collection device). The fluid-impermeable barrier also defines an opening extending therethrough from an external environment. The opening may be positioned adjacent to a female urethra or to have a male urethra positioned therethrough. The fluid collection device may include a fluid-permeable body disposed within the fluid-impermeable barrier. A conduit may extend into the fluid collection device at a first end region, extending through one or more of the fluid-impermeable barrier, the fluid-permeable body, to a second end region of the fluid collection device. Exemplary fluid collection devices for use with the systems and methods herein are described in more detail below.

[0031] In some embodiments, the portable vacuum source may be disposed in or on the fluid collection device. In such embodiments, a conduit may extend from the fluid collection device and be attached to the portable vacuum source at a first point therein. An additional conduit may be attached to the portable vacuum source at a second point thereon and may extend out of the fluid collection device and may be attached to a fluid storage container. Thus, a vacuum (e.g., suction) may be drawn through the fluid collection device via the fluid storage container. The portable vacuum source may be used to drain fluids, such as urine, from the fluid collection device.

[0032] Figure 1A 1 is an isometric view of a fluid collection device 100 according to an embodiment. The fluid collection device 100 is an example of a female fluid collection device 100 configured to receive fluid from a female. The fluid collection device 100 includes a fluid impermeable barrier 102 having a first end region 125 and a second end region 127. The fluid impermeable barrier 102 at least partially defines a chamber 104 (e.g., an interior region, such as Figure 1C104 and 106. The fluid impermeable barrier 102 is substantially cylindrical between the first end region 125 and the second end region 127. In other embodiments, the fluid impermeable barrier 102 may include other shapes, such as one or more of a substantially flat surface, a triangle, or other suitable shapes. The opening 106 is formed in the fluid impermeable barrier 102 and extends longitudinally through the fluid impermeable barrier 102, thereby enabling fluid to enter the chamber 104 from the exterior of the fluid collection device 100. The opening 106 can be configured to be positioned adjacent to the female urethra.

[0033] The fluid collection device 100 can be positioned near the opening of the female urethra and urine can enter the interior area of ​​the fluid collection device 100 through the opening 106. The fluid collection device 100 is configured to receive the fluid into the chamber 104 through the opening 106. For example, the opening 106 can be shaped as an elongated shape that is configured to extend from a first location below the urethral opening (e.g., at or near the anus or vaginal opening) to a second location above the urethral opening (e.g., at or near the clitoris or pubic hair). The opening 106 can be shaped as an elongated shape because the space between the female's legs is relatively small when the female's legs are closed, thereby allowing the fluid to flow only along a path corresponding to the elongated shape of the opening 106. For example, the opening 106 can extend longitudinally along the fluid-impermeable barrier. The opening 106 in the fluid-impermeable barrier 102 can exhibit a width measured transverse to the longitudinal direction and can be at least about 10% of the circumference of the fluid collection device 100, such as about 25% to about 50%, about 40% to about 60%, about 50% to about 75%, about 65% to about 85%, or about 75% to about 100% of the circumference of the fluid collection device 100. The width of the opening 106 can exhibit a width greater than 50% of the circumference of the fluid collection device 100 because the vacuum (e.g., suction) through the conduit 108 pulls the fluid into the conduit 108. In some embodiments, the opening 106 can be vertically oriented (e.g., with its long axis parallel to the longitudinal axis of the device 100). In some embodiments (not shown), the opening 106 can be horizontally oriented (e.g., with its long axis perpendicular to the longitudinal axis of the device 100). In some embodiments, an inward boundary or edge 129 of the fluid-impermeable barrier 102 defines the opening 106. The edge 129 may include two opposing arcuate portions along the periphery or outer edge of the substantially cylindrical fluid-impermeable barrier 102. In one embodiment, the fluid-impermeable barrier 102 may be configured to be attached to an individual, such as adhesively attached (e.g., using a hydrogel adhesive) to the individual. According to one embodiment, a suitable adhesive is a hydrogel layer, such as those disclosed in U.S. Patent Application Publication No. 2017 / 0189225, the disclosure of which is incorporated herein by reference in its entirety.

[0034] The fluid-impermeable barrier 102 may also temporarily store the fluid in the chamber 104. For example, the fluid-impermeable barrier 102 may be formed of any suitable fluid-impermeable material, such as a fluid-impermeable polymer (e.g., silicone rubber, polypropylene, polyethylene, polyethylene terephthalate, polycarbonate, etc.), a polyurethane film, a TPE, an oil, a rubber, a thermoplastic polyurethane, other suitable materials, or a combination thereof. Thus, the fluid-impermeable barrier 102 substantially prevents the fluid from leaving the portion of the chamber 104 spaced apart from the opening 106. The fluid-impermeable barrier 102 is flexible, allowing the fluid collection device 100 to bend or curve when positioned against the wearer's body. One or more TPEs may be combined with at least one of silicone rubber and oil. In many embodiments, the fluid-impermeable barrier 102 may include a composition having at least silicone rubber and oil therein. The fluid-impermeable barrier 102 having the following amount of oil provides a fluid-impermeable barrier 102 having a softer outer surface 107, which has a stronger adhesive strength or viscosity than the fluid-impermeable barrier of a conventional fluid collection device.

[0035] For example, the work of adhesion of the fluid impermeable barrier 102 can vary according to different embodiments. The work of adhesion of the fluid impermeable barrier 102 can be from about 200 grams per second (gs) to about 3500 gs, from about 200 gs to about 1850 gs, from about 1850 gs to about 3500 gs, from about 200 gs to about 1025 gs, from about 1025 gs to about 1850 gs, from about 1850 gs to about 2675 gs, from about 2675 gs to about 3500 gs, from about 200 gs to about 800 gs, from about 600 gs to about 1200 gs, from about 1000 gs to about 1600 gs, from about 1400 gs to about 2000 gs, from about 1800 gs to about 2400 gs, from about 2200 gs to about gs, at least about 200 gs, at least about 600 gs, at least about 1000 gs, at least about 1400 gs, at least about 1800 gs, at least about 2200 gs, at least about 2600 gs, at least about 3000 gs, at least about 3400 gs, less than about 3500 gs, less than about 3100 gs, less than about 2700 gs, less than about 2300 gs, less than about 1900 gs, less than about 1500 gs, less than about 1100 gs, less than about 700 gs, or less than about 300 gs.

[0036] The viscosity of the fluid impermeable barrier 102 may also vary according to different embodiments. For example, the viscosity of the fluid impermeable barrier 102 may be from about 50 grams (g) to about 500g, from about 50g to about 275g, from about 275g to about 500g, from about 50g to about 100g, from about 100g to about 150g, from about 150g to about 200g, from about 200g to about 250g, from about 250g to about 300g, from about 300g to about 350g, from about 350g to about 400g, from about 400g to about 450g, or from about 450g to about 460g. 50g to about 500g, at least about 50g, at least about 100g, at least about 150g, at least about 200g, at least about 250g, at least about 300g, at least about 350g, at least about 400g, at least about 450g, less than about 100g, less than about 150g, less than about 200g, less than about 250g, less than about 300g, less than about 350g, less than about 400g, less than about 450g, or less than about 500g.

[0037] The type of oil in the fluid impermeable barrier 102 can vary according to different embodiments. In some embodiments, the fluid impermeable barrier 102 can include mineral oil. The amount of oil in the fluid impermeable barrier 102 can vary according to different embodiments. For example, the fluid impermeable barrier 102 can include a composition having a varying oil phr based on 100 phr of styrenic block copolymer, such as about 60 oil phr to about 200 oil phr, about 50 oil phr to about 100 oil phr, about 100 oil phr to about 150 oil phr, about 150 oil phr to about 200 oil phr, about 60 oil phr to about 80 oil phr, about 8 ... from about 120 oil phr to about 140 oil phr, from about 140 oil phr to about 160 oil phr, from about 160 oil phr to about 180 oil phr, from about 180 oil phr to about 200 oil phr, from about 60 oil phr to about 70 oil phr, from about 70 oil phr to about 80 oil phr, from about 80 oil phr to about 90 oil phr, from about 90 oil phr to about 100 oil phr, from about 100 oil phr to about 110 oil phr, from about 110 oil phr to about 120 oil phr, about 120 oil phr to about 130 oil phr, about 130 oil phr to about 140 oil phr, about 140 oil phr to about 150 oil phr, about 150 oil phr to about 160 oil phr, about 160 oil phr to about 170 oil phr, about 170 oil phr to about 180 oil phr, about 180 oil phr to about 190 oil phr, about 190 oil phr to about 200 oil phr, less than about 200 oil phr, In some examples, the material of fluid-impermeable barrier 102 may include a TPE material such as Versaflex 2000 or Dynaflex G6713 having oil mixed therein.

[0038] In one embodiment, the fluid impermeable barrier 102 may be breathable. In this embodiment, the fluid impermeable barrier 102 may be formed of a hydrophobic material defining a plurality of pores. In one embodiment, at least one or more portions of the outer surface of the fluid impermeable barrier 102 may be formed of a soft and / or smooth material to reduce abrasions. The fluid impermeable barrier 102 may include markers thereon, such as one or more markers for assisting a user in aligning the device 100 with the wearer. For example, a line on the fluid impermeable barrier 102 (e.g., opposite the opening 106) may allow a medical professional to align the opening 106 with the wearer's urethra. In an example, the marker may include one or more of an alignment reference line or a directional marker (such as a stripe or a #). Such markers may be positioned to align the device 100 with one or more anatomical features, such as the pubic bone, etc.

[0039] The fluid collection device 100 may include a fluid permeable body 120 or layer disposed in the chamber 104. The fluid permeable body 120 may cover at least a portion (e.g., all) of the opening 106 or extend across at least a portion (e.g., all) of the opening 106. The fluid permeable body 120 may be configured to wick away any fluid from the opening 106, thereby preventing the fluid from overflowing the chamber 104. The fluid permeable body 120 may also wick the fluid generally toward the interior of the chamber 104, as discussed in more detail below. A portion of the fluid permeable body 120 may define a portion of the outer surface of the fluid collection device 100. Specifically, the portion of the fluid permeable body 120 that defines a portion of the outer surface of the fluid collection device 100 may be a portion of the fluid permeable body 120 that is exposed by the opening 106 defined by the fluid impermeable barrier 102 that contacts the user. In addition, the portion of the fluid permeable device that defines a portion of the outer surface of the fluid collection device 100 may not be covered by gauze or other wicking material at the opening.

[0040] The fluid permeable body 120 may include any material that can wick fluid. The permeable properties referred to herein may be wicking, capillary action, diffusion, or other similar properties or processes, and are referred to herein as "permeable" and / or "wicking." Such "wicking" may exclude absorption into the wicking material.

[0041] The fluid-permeable body 120 may include a one-way fluid movement fabric. Thus, the fluid-permeable body 120 may remove fluid from the area surrounding the female urethra, thereby keeping the urethra dry. The fluid-permeable body 120 may allow fluid to flow generally toward the reservoir 122 (e.g., the void space formed within the chamber 104). Figure 2A and Figure 2B104). For example, the fluid-permeable body 120 may include a porous or fibrous material, such as a hydrophilic polyolefin. In some embodiments, the fluid-permeable body 120 consists of or is substantially composed of a porous or fibrous material, such as a hydrophilic polyolefin. Examples of polyolefins that can be used for the fluid-permeable body 120 include, but are not limited to, polyethylene, polypropylene, polyisobutylene, ethylene propylene rubber, ethylene propylene diene monomer, or a combination thereof. The porous or fibrous material can be extruded into a substantially cylindrical shape to fit within the chamber 104 of the fluid-impermeable barrier 102. The fluid-permeable body 120 may include varying densities or sizes. In addition, the fluid-permeable body 120 can be manufactured according to various manufacturing methods, such as molding, extrusion, or sintering.

[0042] In some embodiments, the fluid-permeable body 120 comprises a single porous body. That is, during use, the fluid-permeable body 120 extends from the conduit 108 to meet the fluid-impermeable barrier 102 and the opening 106. In some embodiments, the outer surface 109 (e.g., Figure 1C ) is substantially adjacent to the inner surface 103 of the fluid-impermeable barrier 106 (as shown in FIG. Figure 1C 106). A single fluid-permeable body 120 may be advantageous over conventional systems, which typically require an air-laid nonwoven pad covered by a ribbed fabric compression bandage, because the single fluid-permeable body 120 reduces the number of components in the fluid collection device 100, reduces assembly time for the fluid collection device 100, requires shelf life data for only a single component, and provides a single component that is latex-free. In some embodiments, at least a portion of the single porous material of the fluid-permeable body 120 extends continuously between the opening 106 and the reservoir 122 to wick any fluid from the opening 106 directly to the reservoir 122. In addition, because the fluid-impermeable barrier is flexible and the fluid-permeable body 120 is configured to wick fluid away from the body rather than absorb fluid from the body and retain fluid on the body, in some embodiments, the fluid collection device 100 has no sealing or buffer ring on the inward edge 129 defining the opening 106. In these and other embodiments, the fluid-permeable body 120 includes an outer surface 109 and a single layer or type of material between the openings 106 and the conduits 108 positioned within the fluid-permeable body 120 .

[0043] In other embodiments, the fluid-permeable body 120 may include two or more layers of fluid-permeable material, and does not include (or does not exist) more than two layers of material between the opening 106 and the conduit 108 positioned within the fluid-permeable body 120. For example, the fluid collection device 100 may include a fluid-permeable membrane that covers or wraps around at least a portion of a fluid-permeable support, wherein both the fluid-permeable membrane and the fluid-permeable support are disposed in the chamber 104. The fluid-permeable membrane may cover at least a portion (e.g., all) of the opening 106 or extend across at least a portion (e.g., all) of the opening. The fluid-permeable membrane may be configured to wick away any fluid from the opening 106, thereby preventing the fluid from overflowing the chamber 104. The permeable properties referred to herein may be wicking, capillary action, diffusion, or other similar properties or processes, and are referred to herein as "permeable" and / or "wicking". In some embodiments, at least one of the fluid-permeable membrane or the fluid-permeable support comprises nylon configured to wick away the fluid from the opening 106. The material of fluid permeable film and fluid permeable support member may also include natural fibers. In such examples, the material may have a coating that prevents or limits fluid absorption into the material, such as a waterproof coating. This "wicking" may not include the absorption of entering wicking materials. In other words, after the material is exposed to fluid and removed from the fluid for a period of time, the fluid is not absorbed into the material substantially. Although it is not desirable to absorb, the term "substantially non-absorbent" may allow the nominal amount of fluid to be absorbed into the wicking material (e.g., absorbency), such as less than about 10% by weight of the dry weight of the wicking material, less than about 7% by weight of the dry weight of the wicking material, 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.

[0044] The fluid permeable membrane can also wick the fluid generally toward the interior of the chamber 104, as discussed in more detail below. The fluid permeable membrane can include any material that can wick fluid. For example, the fluid permeable membrane can include a fabric such as gauze (e.g., silk, linen, polymer-based materials such as polyester or cotton gauze), another soft fabric (e.g., jersey, etc.), or another smooth fabric (e.g., rayon, satin, etc.). Forming the fluid permeable membrane from gauze, soft fabric, and / or smooth fabric can reduce abrasions caused by the fluid collection device 100. Other embodiments of fluid-permeable membranes, fluid-permeable supports, chambers, and their shapes and configurations are disclosed in the following patents: U.S. Patent Application No. 15 / 612,325 filed on June 2, 2017; U.S. Patent Application No. 15 / 260,103 filed on September 8, 2016; U.S. Patent Application No. 15 / 611,587 filed on June 1, 2017; PCT Patent Application No. PCT / US19 / 29608 filed on April 29, 2019, the disclosure of each patent application is incorporated herein by reference in its entirety. In many embodiments, the fluid-permeable body 120 includes a fluid-permeable support including a porous nylon structure (e.g., spun nylon fibers) and a fluid-permeable membrane including a gauze surrounding or covering the porous nylon structure.

[0045] Figure 1B 1 is a front view of the fluid collection device 100 in use on a female user 150. In use, the fluid permeable body 120 of the fluid collection device is positioned adjacent the urethra of the user 150. The fluid permeable body 120 is disposed within the chamber 104 of the fluid impermeable barrier 102 of the fluid collection device 100 (e.g., Figure 2A and Figure 2B 100) and is exposed to the urethra of the user 150 through the opening 106 in the fluid collection device 100. The fluid collection device 100 can be fixed to the user using any of a plurality of fixing devices. The fluid received from the urethra in the chamber 104 of the fluid collection device 100 can be removed through the catheter 108.

[0046] Figure 2A is along Figure 1A2-2 of . The fluid collection device 100 also includes a conduit 108 that is at least partially disposed in the chamber 104. The conduit 108 (e.g., a tube) includes an inlet 110 located at a second end region 127 of the fluid-impermeable barrier 102 and an outlet 112 located at a first end region 125 of the fluid-impermeable barrier 102 that is positioned downstream of the inlet 110. The conduit 108 provides fluid communication between an interior region of the chamber 104 and a fluid storage container (not shown) or a portable vacuum source (not shown). For example, the conduit 108 can directly or indirectly fluidly couple an interior region of the chamber 104 and / or the reservoir 122 to a fluid storage container or a portable vacuum source.

[0047] In the illustrated embodiment, the fluid-permeable body 120 defines an aperture 202 that extends through the fluid-permeable body 120 from a first body end 121 of the fluid-permeable body 120 to a second body end 123 of the fluid-permeable body 120 distal from the first body end 120. In other embodiments, the aperture 202 only partially extends from the first body end 121 of the fluid-permeable body 120 into the fluid-permeable body.

[0048] In the illustrated embodiment, the conduit 108 is at least partially disposed in the chamber 104 and interfaces with at least a portion of the aperture 202 of the fluid-permeable body 120. For example, the conduit 108 may extend from a first end region 125 (e.g., near the outlet 112) into the fluid-impermeable barrier 102, and may extend through the aperture 202 to a second end region 127 (e.g., opposite the first end region 125) to a point near the reservoir 122, such that the inlet 110 is in fluid communication with the reservoir 122. For example, in the illustrated embodiment, the inlet 110 is positioned in the reservoir 122. However, in other embodiments, the inlet 110 may be positioned flush with or behind the end of the fluid-permeable body 120 that partially defines the reservoir 122. Fluid collected in the fluid collection device 100 may be removed from the interior region of the chamber 104 via the conduit 108. The conduit 108 may include a flexible material, such as a plastic tubing (e.g., a medical tubing). Such plastic tubing may include tubing such as TPE, polyvinyl chloride, ethylene vinyl acetate, polytetrafluoroethylene, etc. In some embodiments, the catheter 108 may include silicone rubber or latex.

[0049] The fluid-impermeable barrier 102 can store fluid in a reservoir 122 therein. The reservoir 122 is an unoccupied portion of the chamber 104 and is free of other materials. In some embodiments, the reservoir 122 is at least partially defined by the fluid-permeable body 120 and the fluid-impermeable barrier 102. For example, in one embodiment, the reservoir 122 can be located in a portion of the chamber 104 closest to the inlet 110 (e.g., the second end region). Thus, in Figure 2A In some embodiments, the reservoir 122 is defined by the second body end 123 of the fluid-permeable body 120 and the second end region 127 of the fluid-impermeable barrier 122. However, the reservoir 122 may be located in the portion of the chamber 104 closest to the inlet 110 (e.g., the second end region). The reservoir 122 may also be located at a different location in the chamber 104. For example, the reservoir 122 may be located at the end of the chamber 104 closest to the outlet 112. In these and other embodiments, the conduit 108 may extend through the first region 125 of the fluid-impermeable barrier 102 to the reservoir 122 without extending through the fluid-permeable body 120. Therefore, in these and other embodiments, the fluid-permeable body 120 may be free of holes. In another embodiment, the fluid collection device 100 may include multiple reservoirs, such as a first reservoir located in the portion of the chamber 104 closest to the inlet 110 (e.g., the second end region) and a second reservoir located in the portion of the chamber 104 closest to the outlet 112 (e.g., the first end region). In another example, the fluid-permeable body 120 is separated from at least a portion of the conduit 108 , and the reservoir 122 may be the space between the fluid-permeable body 120 and the conduit 108 .

[0050] Other embodiments of reservoirs, fluid-impermeable barriers, fluid-permeable membranes, fluid-permeable bodies, chambers, and their shapes and configurations are disclosed in the following patents: U.S. patent application No. 15 / 612,325 filed on June 2, 2017; U.S. patent application No. 15 / 260,103 filed on September 8, 2016; and U.S. patent application No. 15 / 611,587 filed on June 1, 2017, the disclosure of each patent application is incorporated herein by reference in its entirety.

[0051] The fluid-impermeable barrier 102 and the fluid-permeable body 120 can be configured to have a conduit 108 at least partially disposed in the chamber 104. For example, the fluid-permeable body 120 can be configured to form a space, such as a hole 202, to accommodate the conduit 108. In another example, the fluid-impermeable barrier 102 can define an orifice 124 that is sized to receive the conduit 108 (e.g., at least one tube). The at least one conduit 108 can be disposed in the chamber 104 via the orifice 124. The orifice 124 can be configured to form an at least substantially fluid-tight seal against the conduit 108 or at least one tube, thereby substantially preventing fluid from escaping the chamber 104.

[0052] In some embodiments, the conduit 108 can extend through the fluid permeable body 120 and at least partially into the reservoir 122, such as Figure 2A In some embodiments, the conduit 108 may extend through the fluid-permeable body 120 and terminate at or before the second body end 123 of the fluid-permeable body 120, such that the conduit 108 does not extend into the reservoir 122 (or the conduit 108 is not present in the reservoir 122). For example, Figure 2B As shown, the end of the conduit 108 can be substantially flush or coplanar with the second body end 123 of the fluid-permeable body 120. In other embodiments, the end of the conduit 108 can be recessed from the second body end 123 of the fluid-permeable body 120. The end of the conduit 108 can also extend partially into the reservoir 122 (e.g., Figure 2A ) and is recessed from or flush with the second body end 123 of the fluid-permeable body (as shown in FIG. Figure 2B as shown).

[0053] When secured to the fluid collection device 100, the conduit 108 is configured to provide fluid communication with one or more of a fluid storage container (not shown) and a portable vacuum source (not shown) and extend at least partially between them. For example, the conduit 108 may be configured to be fluidly coupled to one or more of a fluid storage container and a portable vacuum source and extend at least partially between them. In one embodiment, the conduit 108 is configured to be directly connected to the portable vacuum source (not shown). In this example, the conduit 108 may extend at least one foot, at least two feet, at least three feet, or at least six feet from the fluid impermeable barrier 102. In another example, the conduit 108 is configured to be indirectly connected to at least one of a fluid storage container (not shown) or a portable vacuum source (not shown). In some examples, the conduit may be frosted or opaque (e.g., black) to obscure the visibility of the fluid therein. In some embodiments, the conduit is secured to the skin of the wearer with a conduit fixture, such as a conduit fixture available from CRBard, Inc. Catheter securing devices include, but are not limited to, those disclosed in US Pat. Nos. 6,117,163, 6,123,398, and 8,211,063, the disclosures of which are incorporated herein by reference in their entireties.

[0054] The inlet 110 and the outlet 112 are configured to provide fluid communication (e.g., directly or indirectly) between a portable vacuum source (not shown) and the chamber 104 (e.g., the reservoir 122). For example, the inlet 110 and the outlet 112 of the conduit 108 may be configured to fluidly couple the portable vacuum source directly or indirectly to the reservoir 122. In one embodiment, the inlet 110 and / or the outlet 112 may form a male connector. In another example, the inlet 110 and / or the outlet 112 may form a female connector. In one embodiment, the inlet 110 and / or the outlet 112 may include ribs configured to facilitate a secure connection. In one embodiment, the inlet 110 and / or the outlet 112 may form a tapered shape. In one embodiment, the inlet 110 and / or the outlet 112 may include a rigid or flexible material.

[0055] Positioning the inlet 110 at or near a gravitational low point of the chamber 104 enables the conduit to receive more fluid than if the inlet 110 were positioned elsewhere and reduces the likelihood of accumulation (e.g., accumulation of fluid that may lead to microbial growth and malodor). For example, the fluid in the fluid-permeable body 120 may flow in any direction due to capillary forces. However, the fluid may exhibit a preference to flow in the direction of gravity, particularly when at least a portion of the fluid-permeable body 120 is filled with fluid.

[0056] When the portable vacuum source applies vacuum / suction in conduit 108, fluid in chamber 104 (e.g., fluid in reservoir 122 such as positioned in first end region 125, second end region 127, or other intermediate location within chamber 104) can be introduced into inlet 110 via conduit 108 and drawn out of fluid collection device 100.

[0057] In one embodiment, the catheter 108 is configured to be inserted into at least the chamber 104. In this embodiment, the catheter 108 may include one or more markers 131 (e.g., Figure 1A 104 ), the one or more markers are configured to facilitate the insertion of the catheter 108 into the chamber 104. For example, the catheter 108 may include one or more markers located thereon, the one or more markers being configured to prevent over-insertion or under-insertion of the catheter 108, such as when the catheter 108 defines an inlet 110 configured to be disposed in or near the reservoir 122. In another embodiment, the catheter 108 may include one or more markers located thereon, the one or more markers being configured to facilitate proper rotation of the catheter 108 relative to the chamber 104. In an embodiment, the one or more markers may include lines, dots, stickers, or any other suitable markers. In an example, the catheter 108 may extend from a first end region (e.g., near the outlet 112) into the fluid-impermeable barrier 102, and may extend to a second end region (e.g., opposite the first end region) to a point near the reservoir 122, such that the inlet 110 is in fluid communication with the reservoir 122. In some embodiments (not shown), the conduit 108 may enter the second end region and the inlet 110 may be disposed in the second end region (e.g., disposed in the reservoir 122). Fluid collected in the fluid collection device 100 may be removed from the interior region of the chamber 104 via the conduit 108. The conduit 108 may include a flexible material, such as a plastic tubing (e.g., medical tubing), as disclosed herein. In some examples, the conduit 108 may include one or more resilient portions, such as being resilient by having one or more of a diameter or a wall thickness that allows the conduit to be flexible.

[0058] In one embodiment, one or more components of the fluid collection device 100 may include an antimicrobial material, such as an antibacterial material, where the fluid collection device may contact the wearer or the wearer's bodily fluids. The antimicrobial material may include an antimicrobial coating, such as furacillin or a silver coating. The antimicrobial material may inhibit microbial growth, such as microbial growth caused by the accumulation or stagnation of fluid. In one embodiment, one or more components of the fluid collection device 100 (e.g., the impermeable barrier 102, the conduit 108, etc.) may include an odor blocking material or an absorbent material, such as a cyclodextrin-containing material or a TPE polymer.

[0059] In any embodiments disclosed herein, the conduit 108 may include or be operably connected to: a flow meter (not shown) to measure the flow of fluid therein; one or more fixtures (e.g., a StatLock fixture, not shown) or accessories to secure the conduit 108 to one or more components of the systems or devices disclosed herein (e.g., a portable vacuum source or a fluid storage container); or one or more valves to control the flow of fluid in the systems and devices disclosed herein.

[0060] In one embodiment, at least a portion of the conduit 108 of the fluid collection device or system herein may be formed of at least partially opaque material, which at least partially opaque material can conceal the fluid present therein. For example, the first section of the conduit 108 disclosed herein may be formed of an opaque material or a translucent material, while the second section of the conduit 108 may be formed of a transparent material or a translucent material. In some embodiments, the first section may include a transparent or translucent material. Unlike an opaque or nearly opaque material, a translucent material allows a user of the device and system herein to visually identify fluid or problems that impede the flow of fluid within the conduit 108.

[0061] In any examples, systems, or devices disclosed herein, the system of the fluid collection device may include a moisture sensor (not shown) disposed within a chamber of the fluid collection device. In such examples, the moisture sensor may be operably coupled to a controller or directly coupled to a portable vacuum source and may provide an electrical signal indicating that moisture is detected or not detected in one or more portions of the chamber. The moisture sensor(s) may provide an indication of the presence of moisture, and in response thereto, the controller or portable vacuum device may indicate the start of suction into the chamber to remove fluid from the chamber. Suitable moisture sensors may include capacitive sensors, volume sensors, potentiometric sensors, resistive sensors, frequency domain reflectometry sensors, time domain reflectometry sensors, or any other suitable moisture sensor. In practice, the moisture sensor may detect moisture within the chamber and may provide a signal to the controller or portable vacuum source to activate the portable suction device.

[0062] In the attached figure go to FIG. 3A to FIG. 3C , FIG. 3A to FIG. 3C Various views of a fluid collection device 300 are provided according to one or more embodiments. Unless otherwise noted, the fluid collection device 300 may include any of the features described with respect to the fluid collection device 100. Figure 3C, the fluid collection device 300 includes a fluid impermeable barrier 302 having a first end region 325 extending from a first end 306 of the fluid impermeable barrier 302 and a second end region 327 extending from a second end 311 of the fluid impermeable barrier 302 toward the first end region 325. The first end region 325 includes a first outer surface portion 305 and an orifice 124, and the second end region includes a second outer surface portion 310.

[0063] The fluid impermeable barrier 302 may also include a longitudinal length L extending from the first end 306 to the second end 311. The first outer surface portion 305 may extend a first length L1 along the longitudinal length L, and the second outer surface portion 310 may extend a second length L2 along the longitudinal length L. The second length L2 may vary according to different embodiments. For example, the second length L2 may be at least about one-tenth of the longitudinal length L, at least about one-fifth of the longitudinal length L, at least about one-quarter of the longitudinal length L, at least about one-third of the longitudinal length L, at least about one-half of the longitudinal length L, about one-tenth to about one-half of the longitudinal length L, about one-fifth to about one-half of the longitudinal length L, about one-quarter to about one-half of the longitudinal length L, about one-third to about one-half of the longitudinal length L, about one-tenth of the longitudinal length L, about one-fifth of the longitudinal length L, about one-quarter of the longitudinal length L, about one-third of the longitudinal length L, about one-half of the longitudinal length L, about one-tenth of the longitudinal length L, about one-fifth of the longitudinal length L, about one-quarter of the longitudinal length L, about one-third of the longitudinal length L, about one-half of the longitudinal length L, less than about one-tenth of the longitudinal length L, less than about one-fifth of the longitudinal length L, less than about one-quarter of the longitudinal length L, less than about one-third of the longitudinal length L, or less than about one-half of the longitudinal length L.

[0064] The longitudinal length L of the fluid impermeable barrier 302 can vary according to different embodiments. In some embodiments, the fluid impermeable barrier 302 can include a longer longitudinal length compared to conventional fluid collection devices. A longer longitudinal length is advantageous over shorter conventional fluid collection devices because a longer fluid impermeable barrier 302 can make it easier to place and use the fluid collection device 300 on obese or larger patients. With specific reference to the fluid impermeable barrier 302, the fluid impermeable barrier 102 can also include any of the longitudinal lengths and transverse widths described with respect to the fluid impermeable barrier 302. The longitudinal length L of the fluid-impermeable barrier 302 may be from about 7.5 inches (about 19.0 cm) to about 20 inches (about 50.8 cm), from about 7.5 inches to about 15 inches (about 38.1 cm), from about 7.5 inches to about 13 inches (about 33.0 cm), from about 7.5 inches to about 11 inches (about 27.9 cm), from about 7.5 inches to about 9 inches (about 22.9 cm), from about 9 inches to about 20 inches, from about 9 inches to about 15 inches, from about 9 inches to about 13 inches (about 33.0 cm), from about 9 inches to about 11 inches, from about 10 inches (about 25.4 cm) to about 20 inches, about 10 inches to about 15 inches, about 10 inches to about 13 inches, about 10 inches to about 11 inches, at least about 7.5 inches, at least about 8 inches (about 20.3 cm), at least about 9 inches, at least about 10 inches, at least about 11 inches, at least about 12 inches (about 30.4 cm), at least about 13 inches, at least about 14 inches (about 35.6 cm), at least about 15 inches, at least about 20 inches, about 7.5 inches, about 8 inches, about 9 inches, about 10 inches, about 11 inches, about 12 inches, about 13 inches, about 14 inches, about 15 inches, or about 20 inches.

[0065] The fluid impermeable barrier 302 may also include a diameter or lateral width L w The transverse width L of the fluid-impermeable barrier wThe range of the invention is about 0.5 inches (about 1.3 cm) to about 2.0 inches (about 5.1 cm), about 0.5 inches to about 1.5 inches (about 3.8 cm), about 0.5 inches to about 1.25 inches (about 3.18 cm), about 0.5 inches to about 1.0 inches (about 2.5 cm), about 0.5 inches to about 0.75 inches (about 1.9 cm), about 0.75 inches to about 2.0 inches, about 0.75 inches to about 1.5 inches, about 0.75 inches to about 1.25 inches, about 0.75 inches to about 1.5 inches, about 0.75 inches to about 1.25 inches, about 0.75 inches to about 1.5 inches, about 0.75 inches to about 1.25 inches, about 0.75 inches to about 1.5 inches, about 0.75 inches to about 1.25 inches, about 0.75 inches to about 1.0 inches (about 2.5 cm), about 0.5 inches to about 0.75 inches to about 1.0 inches, about 0.75 inches to about 1.25 inches, about 0.75 inches to about 1.0 ... inch to about 1.0 inch, about 1.0 inch to about 2.0 inches, about 1.0 inch to about 1.5 inches, about 1.0 inch to about 1.25 inches, about 0.5 inch, about 0.75 inch, about 1 inch, about 1.25 inches, about 1.5 inches, about 1.75 inches (about 4.4 cm), about 2.0 inches, less than about 0.5 inch, less than about 0.75 inches, less than about 1 inch, less than about 1.25 inches, less than about 1.5 inches, less than about 1.75 inches, or less than about 2.0 inches.

[0066] In many embodiments, the first outer surface portion 305 of the first end region 325 has different properties than the second outer surface portion 310 of the second end region 327. The second outer surface portion 310 may include a base fixing area that is configured to improve the fixation of the fluid collection device 300 to the user. For example, the second outer surface portion 327 may have a lower surface roughness, stronger adhesion, and / or stronger adhesive strength than the first outer surface portion. In the illustrated embodiment, the transition between the first outer surface portion 305 of the first end region 325 and the second outer surface portion 310 of the second end region 327 is sharp or abrupt. However, in other embodiments, the transition between the first outer surface portion 305 of the first end region 325 and the second outer surface portion 310 of the second end region 327 is gradual, and the properties of the outer surface of the fluid-impermeable barrier 302 between the first outer surface portion 305 and the second outer surface portion 310 may be a gradual transition or change.

[0067] In one or more embodiments, the first end region 325 and the second end region 327 can include different compositions from each other, thereby causing the first outer surface portion 305 to have different properties than the second outer surface portion 310. For example, the composition of the second end region 327 can include more oil than the composition of the first end region 325, thereby causing the second outer surface portion 310 to be softer and / or have a stronger adhesive strength or viscosity than the first outer surface portion 305. The compositions of both the first end region 325 and the second end region 327 can also include other compositions as described above with respect to the fluid impermeable barrier 102. The amount of oil in the second end region 327 can vary according to different embodiments. For example, the second end region 327 may include a composition having a varying oil phr based on 100 phr of styrenic block copolymer, such as about 60 oil phr to about 200 oil phr, about 50 oil phr to about 100 oil phr, about 100 oil phr to about 150 oil phr, about 150 oil phr to about 200 oil phr, about 60 oil phr to about 80 oil phr, about 80 oil phr to about 100 oil phr, about 100 oil phr to about 150 oil phr, about 150 oil phr to about 200 oil phr, about 60 oil phr to about 80 oil phr, about 80 oil phr to about 100 oil phr, about 100 oil phr to about 150 oil phr from about 120 oil phr, from about 120 oil phr to about 140 oil phr, from about 140 oil phr to about 160 oil phr, from about 160 oil phr to about 180 oil phr, from about 180 oil phr to about 200 oil phr, from about 60 oil phr to about 70 oil phr, from about 70 oil phr to about 80 oil phr, from about 80 oil phr to about 90 oil phr, from about 90 oil phr to about 100 oil phr, from about 100 oil phr to about 110 oil phr, from about 1 10 oil phr to about 120 oil phr, about 120 oil phr to about 130 oil phr, about 130 oil phr to about 140 oil phr, about 140 oil phr to about 150 oil phr, about 150 oil phr to about 160 oil phr, about 160 oil phr to about 170 oil phr, about 170 oil phr to about 180 oil phr, about 180 oil phr to about 190 oil phr, about 190 oil phr to about 200 oil phr, less than about 200 oil phr, oil phr, less than about 180 oil phr, less than about 160 oil phr, less than about 140 oil phr, less than about 120 oil phr, less than about 100 oil phr, less than about 80 oil phr, less than about 60 oil phr, greater than about 200 oil phr, greater than about 180 oil phr, greater than about 160 oil phr, greater than about 140 oil phr, greater than about 120 oil phr, greater than about 100 oil phr, greater than about 80 oil phr, or greater than about 60 oil phr.

[0068] When the composition of the second end region 327 includes oil, the composition of the first end region 325 can have a lower oil content than the second end region 327. For example, the first end region 325 can include a composition that has no oil or has a varying oil phr based on 100 phr of styrenic block copolymer, such as from about 0 oil phr to about 150 oil phr, from about 1 oil phr to about 50 oil phr, from about 50 oil phr to about 100 oil phr, from about 100 oil phr to about 150 oil phr, from about 1 oil phr to about 20 oil phr, from about 20 oil phr to about 40 oil phr, from about 40 oil phr to about 60 oil phr, From about 60 oil phr to about 80 oil phr, from about 80 oil phr to about 100 oil phr, from about 100 oil phr to about 120 oil phr, from about 120 oil phr to about 140 oil phr, from about 140 oil phr to about 160 oil phr, less than about 160 oil phr, less than about 140 oil phr, less than about 120 oil phr, less than about 100 oil phr, less than about 80 oil phr, less than about 60 oil phr, less than about 40 oil phr, or less than about 20 oil phr.

[0069] In many embodiments, the second end region 327 can be more highly polished than the first end region 325, thereby causing the first outer surface portion 305 to have different properties than the second outer surface portion 310. The second end region 327 can have a lower surface roughness than the first end region 325, at least in part due to forming the fluid impermeable barrier 302 in a mold having a different surface finish. For example, the fluid impermeable barrier 302 can be molded in a barrier mold having a first mold portion that interfaces with the first outer surface portion 305 and a second mold portion that interfaces with the second outer surface portion 310, the second mold portion being more polished or having a smoother surface finish than the first mold portion. The resulting second outer surface portion 310 has a stronger bond strength, lower surface roughness, and / or greater tack than the first outer surface portion 305.

[0070] For example, in some embodiments, the second mold portion may include a surface having an Association of the Plastics Industry (SPI) grade of A1, A2, A3, B1, B2, or B3. Then, the corresponding second outer surface portion 310 may also include an SPI grade approximately equal to the surface of the second mold portion, thereby causing the second outer surface portion 310 to have an SPI grade of approximately A1, A2, A3, B1, B2, or B3. The first mold portion may include a surface having an SPI grade of C1, C2, C3, D1, D2, or D3. Then, the corresponding first outer surface portion 305 may also include an SPI grade approximately equal to the surface of the first mold portion, thereby causing the first outer surface portion 305 to have an SPI grade of C1, C2, C3, D1, D2, or D3.

[0071] In many embodiments, the second end region 327 may include an adhesive on the second outer surface portion 310, thereby causing the first outer surface portion 305 to have different properties than the second outer surface portion 310. The adhesive may be applied to the second outer surface portion 310 after the fluid impermeable barrier 302 is formed, and may include any adhesive suitable for use on the skin, such as a hydrogel adhesive. The resulting second outer surface portion 310 has a stronger bond strength and / or greater tack than the first outer surface portion 305.

[0072] In the attached figure go to Figure 4 , Figure 4 is a flow chart of a method 400 of forming a fluid impermeable barrier of a fluid collection device. The method 400 may optionally include an act 405 of mixing oil with at least one of silicone rubber or TPE to form a composition. The method also includes an act 410 of inserting the composition into a barrier mold. The method also includes an act 415 of molding the composition in the barrier mold to form the fluid impermeable barrier. The method also includes an act 420 of removing the fluid impermeable barrier from the barrier mold.

[0073] In some embodiments, method 400 includes an act 405 of mixing oil with at least one of silicone rubber or TPE to form a composition having a varying oil phr based on 100 phr of styrenic block copolymer, such as about 60 oil phr to about 200 oil phr, about 50 oil phr to about 100 oil phr, about 100 oil phr to about 150 oil phr, about 150 oil phr to about 200 oil phr, about 60 oil phr to about 80 oil phr, about 80 oil phr to about 100 oil phr, about 100 oil phr to about 120 oil phr, about 120 oil phr to about 140 oil phr, about 140 oil phr to about 160 oil phr, about 160 oil phr to about 180 oil phr, about 180 oil phr to about 200 oil phr, about 60 oil phr to about 70 oil phr, about 70 oil phr to about 80 oil phr, about 80 oil phr to about 90 oil phr, about 90 oil phr to about 100 oil phr, about 100 oil phr to about 110 oil phr, about 110 oil phr to about 120 oil phr, about 120 oil phr to about 130 oil phr, about 130 oil phr to about 140 oil phr, about 140 oil phr to about 150 oil phr, about 150 oil phr to about 160 oil phr, about 160 oil phr to about 170 oil phr, about 170 oil phr to about 180 oil phr, about 180 oil phr to about 190 oil phr, about 190 oil phr to about 200 oil phr, Less than about 200 oil phr, less than about 180 oil phr, less than about 160 oil phr, less than about 140 oil phr, less than about 120 oil phr, less than about 100 oil phr, less than about 80 oil phr, less than about 60 oil phr, greater than about 200 oil phr, greater than about 180 oil phr, greater than about 160 oil phr, greater than about 140 oil phr, greater than about 120 oil phr, greater than about 100 oil phr, greater than about 80 oil phr, or greater than about 60 oil phr.

[0074] In some embodiments, the action 405 of mixing oil with at least one of silicone rubber or TPE to form a composition includes mixing one or more ingredients to form a first composition and mixing the oil with at least one of silicone rubber or TPE to form a second composition, the second composition having a higher oil content than the first composition. Mixing the one or more ingredients to form the first composition may include mixing the oil with at least one of silicone rubber or TPE to form a first composition, wherein the first composition has a lower oil content than the second composition. Mixing at least one of silicone rubber or TPE with oil to form the first composition may include mixing the oil with at least one of silicone rubber or TPE to form the first composition, the first composition having a varying oil phr based on 100 phr of styrene block copolymer, such as from about 0 oil phr to about 150 oil phr, from about 1 oil phr to about 50 oil phr, from about 50 oil phr to about 100 oil phr, from about 100 oil phr to about 150 oil phr, from about 1 oil phr to about 20 oil phr, from about 20 oil phr to about 40 oil phr, From about 40 oil phr to about 60 oil phr, from about 60 oil phr to about 80 oil phr, from about 80 oil phr to about 100 oil phr, from about 100 oil phr to about 120 oil phr, from about 120 oil phr to about 140 oil phr, from about 140 oil phr to about 160 oil phr, less than about 160 oil phr, less than about 140 oil phr, less than about 120 oil phr, less than about 100 oil phr, less than about 80 oil phr, less than about 60 oil phr, less than about 40 oil phr, or less than about 20 oil phr.

[0075] Mixing the oil with at least one of the silicone rubber or the TPE to form the second composition may include mixing the oil with at least one of the silicone rubber or the TPE to form the second composition having a varying oil phr based on 100 phr of the styrenic block copolymer, such as about 60 oil phr to about 200 oil phr, about 50 oil phr to about 100 oil phr, about 100 oil phr to about 150 oil phr, about 150 oil phr to about 200 oil phr, about 60 oil phr to about 80 oil phr, phr, about 80 oil phr to about 100 oil phr, about 100 oil phr to about 120 oil phr, about 120 oil phr to about 140 oil phr, about 140 oil phr to about 160 oil phr, about 160 oil phr to about 180 oil phr, about 180 oil phr to about 200 oil phr, about 60 oil phr to about 70 oil phr, about 70 oil phr to about 80 oil phr, about 80 oil phr to about 90 oil phr, about 90 oil phr to about 100 oil phr, about 1 100 oil phr to about 110 oil phr, about 110 oil phr to about 120 oil phr, about 120 oil phr to about 130 oil phr, about 130 oil phr to about 140 oil phr, about 140 oil phr to about 150 oil phr, about 150 oil phr to about 160 oil phr, about 160 oil phr to about 170 oil phr, about 170 oil phr to about 180 oil phr, about 180 oil phr to about 190 oil phr, about 190 oil phr to about 200 oil phr hr, less than about 200 oil phr, less than about 180 oil phr, less than about 160 oil phr, less than about 140 oil phr, less than about 120 oil phr, less than about 100 oil phr, less than about 80 oil phr, less than about 60 oil phr, greater than about 200 oil phr, greater than about 180 oil phr, greater than about 160 oil phr, greater than about 140 oil phr, greater than about 120 oil phr, greater than about 100 oil phr, greater than about 80 oil phr, or greater than about 60 oil phr.

[0076] In an alternative embodiment of method 400, a composition including oil and at least one of silicone rubber or TPE may be provided that has been previously mixed together. Thus, method 400 may sometimes not include mixing the oil with at least one of silicone rubber or TPE. The composition including oil and at least one of silicone rubber or TPE may include, for example, a raw material including oil and at least one of silicone rubber or TPE.

[0077] In some embodiments, the act 410 of inserting the composition into the barrier mold may include inserting the composition comprising at least one of silicone rubber or TPE into the barrier mold. In these and other embodiments, the barrier mold into which the composition comprising at least one of silicone rubber or TPE is inserted may include a first mold portion having a first mold surface and a second portion having a second mold surface that is more polished than the first mold surface and / or has a lower surface roughness than the first mold surface. For example, the second mold surface may have an SPI grade of A1, A2, A3, B1, B2, or B3, and the first mold surface may have an SPI grade of C1, C2, C3, D1, D2, or D3. In some embodiments, the method 400 may also include inserting the composition into an injection mold for injection molding of a fluid-impermeable barrier. In some embodiments, the method 400 may also include inserting the composition into a liquid silicone rubber molding or a TPE rubber molding of the fluid-impermeable barrier.

[0078] In an embodiment of method 400, mixing oil with at least one of silicone rubber or TPE to form a composition includes: mixing one or more ingredients to form a first composition, and mixing oil with at least one of silicone rubber or TPE to form a second composition having a higher oil content than the first composition, and the action 410 of inserting the composition into the barrier mold may also include: inserting the first composition into a first mold portion of the barrier mold, and inserting the second composition into a second mold portion of the barrier mold.

[0079] In some embodiments, the act 410 of inserting the composition into the barrier mold may include inserting a composition including oil and at least one of silicone rubber or TPE into at least a portion of the barrier mold. In these and other embodiments, the act of inserting the composition including oil and at least one of silicone rubber or TPE into at least a portion of the barrier mold may also include inserting an additional composition into an additional portion of the barrier mold. The additional composition may include at least one of silicone rubber or TPE and also have a lower oil content than the composition. In these and other embodiments, inserting the additional composition into the additional portion of the barrier mold includes inserting the additional composition into an additional portion of the barrier mold having a first mold surface, and inserting the composition into at least a portion of the barrier mold includes inserting the composition into a portion of the barrier mold having a second mold surface that is more polished than the first mold surface.

[0080] The act 415 of molding the composition in a barrier mold to form a fluid impermeable barrier may include: one or more of heating and cooling the composition in the barrier mold to form the fluid impermeable barrier. In some embodiments, the act 415 of molding the composition in the barrier mold to form the fluid impermeable barrier may include: molding the composition in the barrier mold to form at least a portion of a defined chamber of the fluid impermeable barrier and an opening extending therethrough, wherein the opening is configured to be positioned adjacent to a female urethra. In embodiments of the method 400 in which two or more different compositions are formed, the act 415 of molding the composition in the barrier mold may include: molding the composition in the barrier mold to form a fluid impermeable barrier having a first end region and a second end region, the first end region comprising an additional or first composition having a lower oil content, the second end region being distal to the first end region and comprising a second composition or compositions having a higher oil content.

[0081] In embodiments of method 400 in which the barrier mold includes a first mold portion having a first mold surface and a second portion having a second mold surface that is more polished than the first mold surface and / or has a lower surface roughness than the first mold surface, the act 415 of molding the composition in the barrier mold to form a fluid-impermeable barrier may include molding the composition in the barrier mold to form a fluid-impermeable barrier having an inner surface, a first end region, a second end region, and an opening, the inner surface at least partially defining a cavity, the first end region having a first outer surface portion that interfaces with the first mold surface, the second end region being distal to the first end region and having a second outer surface portion that interfaces with the second mold surface, the opening extending longitudinally along the fluid-impermeable barrier. In these and other embodiments, the opening is configured to be positioned adjacent to the female urethra, and the second outer surface portion has a stronger bond strength than the first outer surface portion.

[0082] In some embodiments of method 400, method 400 may further include applying an adhesive to a second outer surface portion of the fluid-impermeable barrier after the fluid-impermeable barrier has been molded. The adhesive applied to the second outer surface portion may include any adhesive suitable for use on the skin, such as a hydrogel adhesive. According to one embodiment, a suitable adhesive is a hydrogel layer, such as those disclosed in U.S. Patent Application Publication No. 2017 / 0189225, the disclosure of which is incorporated herein by reference in its entirety. The resulting second outer surface portion has a stronger adhesive strength and / or greater tack than the first outer surface portion.

[0083] Acts 405, 410, 415, and 420 of method 400 are provided for illustration purposes. For example, acts 405, 410, and 415 of method 400 may be performed in a different order, divided into multiple acts, modified, supplemented, or combined. In an embodiment, one or more of acts 405, 410, and 415 of method 400 may be omitted from method 400. Any of acts 405, 410, and 415 may include forming any fluid-impermeable barrier disclosed herein.

[0084] Figure 5 is a flow chart of a method 500 of assembling a fluid collection device and / or fluid collection system disclosed herein, according to an embodiment. Method 500 may include action 505, which describes providing a fluid impermeable barrier. The fluid impermeable barrier at least partially defines a chamber and an opening extending therethrough. The opening is configured to be positioned adjacent to a female urethra or to have a male urethra positioned therethrough. The fluid permeable body may include a single porous hydrophilic polyolefin material extruded, molded, or sintered into a substantially cylindrical shape.

[0085] The method may include action 510, which describes inserting a substantially cylindrical fluid-permeable body into a chamber of a fluid-impermeable barrier. When the fluid-permeable body is inserted into the chamber of the fluid-impermeable barrier, the fluid-permeable body is connected to at least a portion of the fluid-impermeable barrier and covers at least a portion of the opening. The fluid-permeable body includes a single porous material that is substantially cylindrical and configured to wick away any fluid from the opening. In some embodiments, action 510 may include inserting the fluid-permeable body into the chamber of the fluid-impermeable barrier so that a reservoir is defined in the chamber by a second body end of the fluid-permeable body distal to the first body end and a second end region of the fluid-impermeable barrier distal to the orifice. In some embodiments, action 510 may include inserting a substantially cylindrical fluid-permeable body into the chamber of the fluid-impermeable barrier so that the fluid-permeable body and the conduit fill substantially the entire chamber.

[0086] The method may include action 515, which describes inserting an inlet of a conduit into the fluid-impermeable body. The conduit may be inserted into the fluid-impermeable body through an orifice defined by the fluid-impermeable barrier at a first end region of the fluid-impermeable barrier. In some embodiments, action 515 may include inserting the inlet of the conduit into a hole at the first body end, through the hole of the fluid-permeable body, through the second body end of the fluid-permeable body, and into the reservoir so that the conduit extends from the reservoir, through the fluid-permeable body, through the hole to the outside of the fluid-impermeable barrier.

[0087] The method may include an act 520 describing inserting an inlet of a conduit at least partially into a hole at a first body end of a fluid-permeable body. The hole at least partially extends through the fluid-permeable body and is defined by the fluid-permeable body. The conduit is connected to at least a portion of the fluid-permeable body.

[0088] Actions 505, 510, 515, and 520 of method 500 are provided for illustration purposes. For example, actions 505, 510, 515, and 520 of method 500 may be performed in a different order, divided into multiple actions, modified, supplemented, or combined. In one embodiment, one or more of actions 505, 510, 515, and 520 of method 500 may be omitted from method 500. Any of actions 505, 510, 515, and 520 may include using any fluid collection device disclosed herein.

[0089] Figure 6 is a flow chart of a method 600 for collecting fluid. The method 600 includes an act 605 of positioning a fluid permeable body of a fluid collection device adjacent to a female urethra of a user. The fluid permeable body is disposed within a chamber of a fluid impermeable barrier of the fluid collection device and is exposed to the female urethra of the user through an opening in the fluid collection device defined by the fluid impermeable barrier. The method 600 also includes an act 610 of securing the fluid collection device to the user. The method 600 also includes an act 615 of receiving fluid from the female urethra into the chamber of the fluid collection device. In some embodiments, the method 600 is an act of applying suction, the suction effective to draw fluid from the chamber via a conduit disposed in the chamber.

[0090] Actions 605, 610, and 615 of method 600 are for illustration purposes. For example, actions 605, 610, and 615 of method 600 may be performed in a different order, divided into multiple actions, modified, supplemented, or combined. In one embodiment, one or more of actions 605, 610, and 615 of method 600 may be omitted from method 600. Any of actions 605, 610, and 615 may include using any fluid collection device disclosed herein.

[0091] Figure 71 is a block diagram of a system 10 for fluid collection according to an embodiment. System 10 includes a fluid collection device 12, a fluid storage container 14, and a portable vacuum source 16. Fluid collection device 12 may include any fluid collection device described herein, such as fluid collection device 100. Fluid collection device 12, fluid storage container 14, and portable vacuum source 16 may be fluidly coupled to each other via one or more conduits 17. Conduit 17 may include any conduit described herein, such as conduit 108. Fluid collection device 12 may be operably coupled to one or more of fluid storage container 14 or portable vacuum source via conduit 17. Fluid (e.g., urine or other bodily fluid) collected in fluid collection device 12 may be removed from fluid collection device 12 via conduit 17, which extends into an interior region of fluid collection device 12. For example, a first open end of conduit 17 may extend into fluid collection device 12 to a reservoir therein. A second open end of conduit 17 may extend into fluid collection device 12 or portable vacuum source 16. In response to a suction (e.g., vacuum) force applied at the second end of the conduit 17, suction force may be introduced into the interior region of the fluid collection device 12 via the first open end of the conduit 17. The suction force may be applied to the second open end of the conduit 17 by the portable vacuum source 16 directly or indirectly.

[0092] The suction force may be applied indirectly via the fluid storage container 14. For example, the second open end of the conduit 17 may be disposed within the fluid storage container 14, and the additional conduit 17 may extend from the fluid storage container 14 to the portable vacuum source 16. Thus, the portable vacuum source 16 may apply suction to the fluid collection device 12 via the fluid storage container 14. The suction force may be applied directly via the fluid storage container 14. For example, the second open end of the conduit 17 may be disposed within the portable vacuum source 16. The additional conduit 17 may extend from the portable vacuum source 16 to a point outside the fluid collection device 12, such as to the fluid storage container 14. In such examples, the portable vacuum source 16 may be disposed between the fluid collection device 12 and the fluid storage container 14.

[0093] The fluid collection device 12 may be shaped and sized to be positioned adjacent to the female urethra. The fluid collection member of the fluid collection device 12 may include a fluid-impermeable barrier that at least partially defines a chamber of the fluid collection device 12 (e.g., an interior region of the fluid collection device member). As described in more detail above, the fluid collection device 12 may include a softer, thinner fluid-impermeable barrier than a conventional fluid collection device. The fluid-impermeable barrier also defines an opening extending therethrough from the external environment. The opening may be positioned on the fluid collection member to align adjacent to the female urethra. The fluid collection member of the fluid collection device 12 may include a fluid-permeable body disposed within the fluid-impermeable barrier. The fluid-permeable body may include a fluid-permeable membrane and a fluid-permeable support disposed within the fluid-permeable membrane. The conduit 17 may extend into the fluid collection device 12 at a first end region, pass through one or more of the fluid-impermeable barrier, the fluid-permeable membrane, or the fluid-permeable support, and extend to a second end region of the fluid collection member of the fluid collection device 12. An example fluid collection device used with the systems and methods herein is described in more detail below.

[0094] In some embodiments, the fluid storage container 14 may include a bag (e.g., a drainage bag), a bottle or cup (e.g., a collection can), or any other closed container for storing body fluids such as urine. In an example, a conduit 17 may extend from the fluid collection device 12 and be attached to the fluid storage container 14 at a first point therein. An additional conduit 17 may be attached to the fluid storage container 14 at a second point thereon and may extend and be attached to a portable vacuum source 16. For example, the fluid storage container 14 may include a container fluidly coupled to a first conduit segment that is also fluidly coupled to a fluid collection member of the fluid collection device 12. The container may be fluidly coupled to a second segment of the conduit 17 that is also fluidly coupled to the portable vacuum source. In such examples, the portable vacuum source 16 may provide vacuum / suction to the fluid collection member through the container to provide suction in the chamber of the fluid collection member. Thus, a vacuum (e.g., suction) may be drawn through the fluid collection device 12 via the fluid storage container 14. As the fluid is drained from the chamber, the fluid may travel through the first section of the conduit to a fluid storage container where the fluid may be retained. A portable vacuum source 16 may be used to drain fluid, such as urine, from the fluid collection device 12 .

[0095] In some embodiments, portable vacuum source 16 may be disposed in or on fluid collection device 12. In such examples, conduit 17 may extend from the fluid collection device and be attached to portable vacuum source 16 at a first point therein. Additional conduit 17 may be attached to portable vacuum source 16 at a second point thereon and may extend out of fluid collection device 12 and may be attached to fluid storage container 14. Thus, a vacuum (e.g., suction) may be drawn through fluid collection device 12 via fluid storage container 14.

[0096] The portable vacuum source 16 may include one or more of a manual vacuum pump and 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 portable vacuum source 16 may provide a vacuum or suction to remove fluid from the fluid collection member of the fluid collection device 12. In some embodiments, the portable vacuum source 16 may be powered by one or more of a power cord (e.g., connected to an electrical outlet), one or more batteries, or even a manual power source (e.g., a manual vacuum pump). In an example, the portable vacuum source 16 may be sized and shaped to fit on the outside of the fluid collection device 12, on the fluid collection device, or within the fluid collection device. For example, the portable vacuum source 16 may include one or more small pumps or one or more micro pumps. The portable vacuum source 16 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 portable vacuum source 16. It should be understood that the portable vacuum source 16 disclosed herein can provide a portable device for providing suction or vacuum that allows the devices and systems herein to be used outside of a hospital or nursing facility environment where a vacuum line is plumbed into a patient room or where there is a large (e.g., larger or heavier than a patient can carry) vacuum source. For example, the portable vacuum source can be small and light enough for a user (e.g., a patient) or a support person (e.g., a nurse) to carry during transportation of the user.

[0097] As used herein, the term "about" or "substantially" refers to an allowable deviation of ±10% or ±5% of the term modified by "about" or "substantially". In addition, the term "less than", "or smaller", "greater than", "more than" or "or more" includes (as an endpoint) the value modified by the term "less than", "or smaller", "greater than", "more than" or "or more".

[0098] While various aspects and embodiments have been disclosed herein, other aspects and embodiments are also contemplated. The various aspects and embodiments disclosed herein are for purposes of illustration and are not intended to be limiting.

Claims

1. A fluid collection device, comprising: a fluid impermeable barrier, the fluid impermeable barrier being substantially cylindrical and having an inner surface, at least partially defining a chamber, a first end region, and a second end region, the inner surface including a first outer surface portion and defining an orifice extending therethrough, the second end region being distal to the first end region and including a second outer surface portion, the second outer surface portion having a greater adhesive strength than the first outer surface portion, the fluid impermeable barrier further defining an opening extending longitudinally along the fluid impermeable barrier and configured to be positioned adjacent a female urethra, wherein at least some of the second outer surface portions are positioned to be at least partially secured in a gluteal cleft; as well as A fluid permeable body is substantially cylindrical and is at least partially positioned within the chamber to extend across at least a portion of the opening, a portion of the fluid permeable body defines a portion of the outer surface of the fluid collection device, and the fluid permeable body is configured to wick fluid away from the opening.

2. The fluid collection device according to claim 1, characterized in that: The second outer surface portion comprises a lower surface roughness than the first outer surface portion.

3. The fluid collection device according to claim 1, characterized in that: the fluid impermeable barrier comprises a first end located at the first end region and a second end located at the second end region; and The second outer surface portion extends less than halfway from the second end toward the first end.

4. The fluid collection device according to claim 1, characterized in that: the fluid impermeable barrier comprises a first end at the first end region and a second end at the second end region, and a longitudinal length extending from the first end to the second end; and The second outer surface portion extends less than one third of the longitudinal length from the second end toward the first end.

5. The fluid collection device according to any one of claims 1 to 4, characterized in that: The first and second end regions of the fluid-impermeable barrier include at least one silicone rubber or a thermoplastic elastomer, and the second end region of the fluid-impermeable barrier has a higher oil content than the first end region.

6. The fluid collection device according to any one of claims 1 to 4, characterized in that: Further comprising a conduit comprising an inlet and an outlet, wherein at least a portion of the conduit extends through the aperture in the first end region and into the chamber, the fluid permeable body being configured to wick fluid from the opening to the inlet.

7. The fluid collection device according to any one of claims 1 to 4, characterized in that: The second end region includes an adhesive on the second outer surface portion.

8. The fluid collection device according to any one of claims 1 to 4, characterized in that: The fluid-impermeable barrier includes a first end at the first end region and a second end at the second end region, and a longitudinal length extending from the first end to the second end, the longitudinal length being at least about 20 cm.

9. The fluid collection device according to any one of claims 1 to 4, characterized in that: The second end region comprises a portion of the fluid impermeable barrier having a composition comprising oil and at least one of silicone rubber or a thermoplastic elastomer, the composition comprising from about 60 oil phr to about 200 oil phr based on 100 parts per hundred rubber (phr) styrene block copolymer.

10. The fluid collection device according to claim 9, characterized in that: The first end region includes an additional portion of the fluid-impermeable barrier, the additional portion of the fluid-impermeable barrier having an additional composition including at least one of silicone rubber or a thermoplastic elastomer and having a lower oil content than the portion of the fluid-impermeable barrier having the composition including the oil and at least one of the silicone rubber or the thermoplastic elastomer.

11. The fluid collection device according to claim 9, characterized in that: The second outer surface portion has a stronger adhesiveness than the first outer surface portion.

12. A method of forming a fluid impermeable barrier of a fluid collection device according to claim 1, the method comprising: inserting a composition including at least one of a silicone rubber or a thermoplastic elastomer into a barrier mold including a first mold portion having a first mold surface and a second portion having a second mold surface that is more polished than the first mold surface; as well as The composition is molded in the barrier mold to form a fluid-impermeable barrier, the fluid-impermeable barrier being substantially cylindrical and having an inner surface at least partially defining a chamber, a first end region having a first outer surface portion that is in contact with the first mold surface, a second end region that is distal to the first end region and has a second outer surface portion that is in contact with the second mold surface, the opening extending longitudinally along the fluid-impermeable barrier, the opening being configured to be positioned adjacent to a female urethra, and the second outer surface portion having a stronger adhesive strength than the first outer surface portion.

13. The method according to claim 12, characterized in that Further including: At least one of the silicone rubber or the thermoplastic elastomer is mixed with oil to form the composition.

14. The method according to claim 12, characterized in that Further including: mixing a portion of at least one of the silicone rubber or the thermoplastic elastomer with oil to form a second composition, the second composition having a higher oil content than the first composition, wherein inserting the composition including at least one of the silicone rubber or the thermoplastic elastomer into the barrier mold comprises: inserting the first composition into the first mold portion of the barrier mold; as well as The second composition is inserted into the second mold portion of the barrier mold.

15. The method according to any one of claims 12 to 14, characterized in that Further including: An adhesive is applied to the second outer surface portion of the fluid impermeable barrier.

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