Male external catheter including a nonwoven material and a spacer fabric

Abstract

An exemplary fluid collection device includes a fluid-impermeable barrier and a base. The fluid-impermeable barrier at least partially defines a chamber within the fluid collection device. The base is secured to the fluid-impermeable barrier and at least partially defines a chamber and an opening in fluid communication with the chamber. The base includes at least a first layer including at least a nonwoven fabric that extends at least partially between a proximal end region and a distal end region of the fluid collection device. The base may also include a second layer secured to the first layer and at least partially defines the chamber. The second layer includes a fluid-permeable multi-layer fabric that is positioned at least partially between the first layer and the chamber and extends at least partially between the proximal end region and the distal end region.

Description

[Background technology]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 238,477, filed August 30, 2021, the disclosure of which is incorporated herein by reference in its entirety.

[0002] A person or animal may have limited or impaired mobility, making the normal process of urination difficult or impossible. For example, a person may experience or have a disability that impairs mobility. A person may have restricted mobility conditions, such as those experienced by pilots, drivers, and workers in hazardous areas. Additionally, urine collection may be required for monitoring purposes or clinical testing.

[0003] To address some of these conditions, such as incontinence, urinary catheters, such as Foley catheters, can be used. Unfortunately, urinary catheters can be uncomfortable and painful and can lead to complications such as infection. Additionally, bedpans, which are containers used for the excretion of bedridden patients, are sometimes used. However, bedpans can be uncomfortable, prone to spills, and prone to other hygiene issues. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] International Publication No. 2021 / 155206 Summary of the Invention [Means for solving the problem]

[0005] Disclosed herein are embodiments of fluid collection devices and systems. In one embodiment, the fluid collection device includes a fluid-impermeable barrier and a base secured to the fluid-impermeable barrier. The fluid-impermeable barrier at least partially defines a chamber within the fluid collection device and extends at least partially between a proximal end region of the fluid collection device and a distal end region of the fluid collection device. The base at least partially defines the chamber and an opening in fluid communication with the chamber. The base includes at least a first layer including at least a nonwoven fabric extending at least partially between the proximal end region and the distal end region.

[0006] In one embodiment, a method of manufacturing a fluid collection device is disclosed. The method includes securing a first layer to a second layer to form a base, the first layer including at least a nonwoven fabric, and the second layer including a fluid-impermeable multi-layer. The method also includes securing the fluid-impermeable barrier to the base to form a chamber within the fluid collection device, the chamber being at least partially defined by the fluid-impermeable barrier and the second layer and in fluid communication with an opening, the opening being at least partially defined by the base and sized to receive at least a portion of the penis.

[0007] Features from any of the disclosed embodiments may be used in combination with each other without limitation. Furthermore, other features and advantages of the present disclosure will become apparent to those skilled in the art upon consideration of the following detailed description and accompanying drawings.

[0008] The drawings illustrate several embodiments of the present disclosure, with the same reference numerals referring to the same or similar elements or features in different views or embodiments shown in the drawings. [Brief explanation of the drawings]

[0009] [Figure 1] FIG. 1 is a block diagram of a fluid collection system according to one embodiment. [Figure 2A] FIG. 1 is a top view of a fluid collection device according to one embodiment. [Figure 2B] FIG. 2B is a bottom view of the fluid collection device of FIG. 2A. [Figure 3A] 3A is a cross-sectional view of the fluid collection device of FIG. 2A taken along line 3A-3A of FIG. 2A. [Figure 3B] 2B is a top view of the base of the fluid collection device of FIG. 2A with the fluid-impermeable barrier removed, according to one embodiment. [Figure 3C] 3C is an exploded view of the base of the fluid collection device of FIG. 3B, according to one embodiment. [Figure 4] 1 is a flow diagram of a method for manufacturing a fluid collection device according to one embodiment. [Figure 5] 1 is a cross-sectional view of a portion of a base of a fluid collection device according to one embodiment. [Figure 6] 1 is a cross-sectional view of a portion of a base of a fluid collection device according to one embodiment. [Figure 7] 1 is a cross-sectional view of a portion of a base of a fluid collection device according to one embodiment. [Figure 8] 1 is a cross-sectional view of a portion of a base of a fluid collection device according to one embodiment. [Figure 9] 1 is a cross-sectional view of a portion of a base of a fluid collection device according to one embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0010] Disclosed herein are embodiments of fluid collection devices, systems, and methods for using them. The fluid collection devices disclosed herein are configured to collect fluid from an individual. Fluids collected by the fluid collection device may include urine, penile secretions, reproductive fluids, blood, sweat, or other bodily fluids. The fluid collection devices described herein can be used within a fluid collection system. An exemplary fluid collection device includes a male external catheter fluid collection device configured to cover a user in a hospital or at home. In some embodiments, the fluid collection device includes an integrated device having a fluid-impermeable barrier secured to a base that includes an adhesive. The fluid collection devices described herein can be configured for use by users with either a protruding penis or a buried penis, where the penis is covered by excess skin in the pubic region or scrotum. The base of the fluid collection device can include an opening sized to receive the penis to position at least a portion of the penis within a chamber between the fluid-impermeable barrier and the base of the fluid collection device. The opening of the fluid collection device can also be positioned above the buried penis. Whether the user's penis is protruding or buried, the adhesive on the base can form an effective seal against the user to prevent unwanted leakage of fluid discharged from the fluid collection device. Conventional male external catheters are typically not suitable for use with average, small, and buried penises. Conventional male external catheters are also typically ineffective for use by patients lying in a hospital bed, as they are prone to leakage in this position. The configuration of at least one, some, or all of the embodiments of the fluid collection device described herein provides the technical effect of providing effective use and fluid collection by users with small or buried penises and in various body positions (e.g., prone or sitting). In some embodiments, the base may include one or more layers of nonwoven material and a layer of three-dimensional (3D) fabric. The fluid collection device is also configured to be secured to a conduit for connecting the fluid collection device to a vacuum source to remove fluid discharged from the fluid collection device.

[0011] The nonwoven material in the base can provide breathability to the fluid collection device so that a vacuum pressure of about 0 mmHg (0 Pa) to about 20 mmHg (2666.45 Pa) can be maintained on the fluid collection device for extended periods of time to extract fluid (e.g., urine) from the fluid collection device. The nonwoven material can include an inner surface of the base that at least partially defines a chamber and can provide skin-contact comfort to the area surrounding the user's penis. In some embodiments, the chamber is defined by and positioned between the nonwoven material and a fluid-impermeable barrier. In some embodiments, the nonwoven material can include a multi-layer or multi-part material having fibers or filaments that join or secure the fabric sheet or web structure.

[0012] The 3D fabric can be configured to keep the base dry during application and use of the fluid collection device, such that embodiments of the fluid collection device can remain in place on the user for up to approximately 3-5 days. Accordingly, in some embodiments, the 3D fabric can include a fluid-permeable multi-layer or multi-part fabric including a spacer material between two spaced-apart layers. The 3D fabric can at least partially include a multi-layer fluid-impermeable fabric. For example, the 3D fabric can include two woven fabric layers spaced apart and connected by spacer threads or yarns, such as fibers. The fibers connecting the two woven fabric layers can include polyester or nylon fibers. The 3D fabric can include polyester spacer mesh fabric and / or scuba fabric. Examples of 3D fabrics can include one or more of a 3D spacer mesh, a 3D spacer fabric, a spacer fabric, a 3D air spacer mesh, an air spacer fabric, a neoprene scuba fabric, a sandwich scuba fabric, or any combination thereof.

[0013] The 3D fabric can be configured to capture fluid (e.g., urine) from a user and allow the fluid to flow to ports and / or conduits for removal from the fluid collection device. The 3D fabric can also be configured to support the urine collection device in a substantially planar, predetermined shape even when a vacuum is applied to the interior region of the urine collection device. The 3D fabric can also prevent the fluid collection device from bending or twisting, thus preventing fluid removal from being restricted by a fluid collection device that bends or twists under the application of a vacuum source. Accordingly, embodiments of the fluid collection devices disclosed herein are suitable for use by a user in any one of a standing, sitting, or prone position. Exemplary fluid collection devices for use in the systems and methods herein are described in more detail below.

[0014] In some embodiments, the fluid collection device includes a male external catheter manufactured to include a waterproof and / or microporous polyethylene / polypropylene nonwoven fabric, a spacer fabric, a polyethylene film, and a mating tube secured together by welding with a low-traumatic gel adhesive. In at least one, some, or all of the fluid collection device embodiments described herein, the waterproof and / or microporous polyethylene / polypropylene nonwoven fabric and the spacer fabric provide the technical effect of continuously capturing and draining urine from the fluid collection device, while also including a wicking material that keeps the fluid collection device dry and cool under vacuum. The polyethylene film is transparent in at least one, some, or all of the fluid collection device embodiments described herein, resulting in the technical effect of allowing a user or caregiver to view the user's skin while the fluid collection device is in use.

[0015] FIG. 1 is a block diagram of a fluid collection system 10 according to one embodiment. The system 10 includes a fluid collection device 12 (e.g., any of the fluid collection devices disclosed herein), a fluid reservoir 14, and a vacuum source 16. The fluid collection device 12, the fluid reservoir 14, and the vacuum source 16 can be fluidly coupled to one another via one or more conduits 17. For example, the fluid collection device 12 can be operably coupled to one or more of the fluid reservoir 14 or the vacuum source 16 via the conduit 17. Fluid (e.g., urine or other bodily fluid) collected within the fluid collection device 12 can be removed from the fluid collection device 12 via the conduit 17 secured to the fluid collection device 12. A suction force can be introduced into a chamber of the fluid collection device 12 via an inlet of the conduit 17 in response to suction (e.g., vacuum) force applied to an outlet of the conduit 17.

[0016] The suction force can be applied directly or indirectly to the outlet of the conduit 17 by the vacuum source 16. The suction force can be applied indirectly via the fluid reservoir 14. For example, the outlet of the conduit 17 can be located within the fluid reservoir 14, and the additional conduit 17 can extend from the fluid reservoir 14 to the vacuum source 16. Thus, the vacuum source 16 can apply suction to the fluid collection device 12 via the fluid reservoir 14. The suction force can be applied directly via the vacuum source 16. For example, the outlet of the conduit 17 can be located within the vacuum source 16. The additional conduit 17 can extend from the vacuum source 16 to a point outside the fluid collection device 12, for example, to the fluid reservoir 14. In such an example, the vacuum source 16 can be located between the fluid collection device 12 and the fluid reservoir 14.

[0017] The fluid reservoir 14 is sized and shaped to hold fluid therein. The fluid reservoir 14 may include a bag (e.g., a drainage bag), a bottle or cup (e.g., a collection jar), or any other enclosed container for storing bodily fluids, such as urine. In some examples, a conduit 17 may extend from the fluid collection device 12 and be attached to the fluid reservoir 14 at a first point within the fluid reservoir 14. An additional conduit 17 may be attached to the fluid reservoir 14 at a second point on the fluid reservoir 14 and may extend to and be attached to a vacuum source 16. Thus, a vacuum (e.g., suction) may be drawn through the fluid collection device 12 via the fluid reservoir 14. Fluids, such as urine, may be evacuated from the fluid collection device 12 using the vacuum source 16.

[0018] The vacuum source 16 may include one or more of a manual vacuum pump, an electric vacuum pump, a diaphragm pump, a centrifugal pump, a positive displacement pump, a magnetic drive pump, a peristaltic pump, or any pump configured to generate a vacuum. The vacuum source 16 may provide a vacuum or suction force to remove fluid from the fluid collection device 12. In some examples, the vacuum source 16 may be powered by one or more power cords (e.g., connected to a power socket), one or more batteries, or a manual power source (e.g., a manual vacuum pump). In some examples, the vacuum source 16 may be sized and shaped to fit outside, on, or inside the fluid collection device 12. For example, the vacuum source 16 may include one or more miniature pumps or one or more micropumps. The vacuum sources disclosed herein may include one or more switches, buttons, plugs, remote controls, or any other device suitable for activating the vacuum source 16.

[0019] 2A and 2B, a fluid collection device 200 having a proximal end region 216 and a distal end region 218 may include a fluid-impermeable barrier 202 (shown in a top view in FIG. 2A ) and a base 210 (shown in a bottom view in FIG. 2B ). The fluid collection device 200 may be generally bag-shaped. In some embodiments, the fluid-impermeable barrier 202 is substantially planar and substantially rectangular. In other embodiments, the fluid-impermeable barrier 202 may include other geometric shapes and configurations. The fluid-impermeable barrier 202 may include a longitudinal length that is greater than the lateral width of the fluid-impermeable barrier 202. In some embodiments, the fluid-impermeable barrier 202 can include a longitudinal length of about 10 cm to about 25 cm, about 10 cm to about 15 cm, about 12.5 cm to about 17.5 cm, about 15 cm to about 20 cm, about 17.5 cm to about 22.5 cm, about 20 cm to about 25 cm, at least about 10 cm, at least about 12.5 cm, at least about 15 cm, at least about 17.5 cm, at least about 20 cm, at least about 22.5 cm, or at least 25 cm. In some embodiments, the fluid-impermeable barrier 202 can include a lateral width of about 5 cm to about 15 cm, about 5 cm to about 8.5 cm, about 7 cm to about 10.5 cm, about 9 cm to about 12.5 cm, about 11 cm to about 14.5 cm, less than about 14.5 cm, less than about 12.5 cm, less than about 10.5 cm, or less than about 8.5 cm.

[0020] The fluid-impermeable barrier 202 may comprise a substantially flexible, fluid-impermeable material, such as a fluid-impermeable polymer (e.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, polycarbonate, etc.), a polyurethane film, a thermoplastic elastomer, oil, other suitable material, or a combination thereof. In some embodiments, the fluid-impermeable barrier comprises a paper-like or pouch-like fluid-impermeable material, or a fluid-impermeable fabric. In at least one, some, or all embodiments, the fluid-impermeable barrier 202 comprises a substantially clear or transparent polyethylene or polyurethane film effective to provide the technical effect of allowing a user or caregiver to view the patient's skin while the fluid collection device 200 is in use. In some embodiments, the fluid-impermeable barrier 202 may comprise a thickness of about 0.03 to about 0.3 mm, about 0.03 to about 0.1 mm, about 0.04 to about 0.1 mm, about 0.05 to about 0.2 mm, or about 0.06 to about 3 mm.

[0021] The fluid-impermeable barrier 202 can be secured to the base 210 by, for example, ultrasonic welding, heat welding, radio frequency welding, microwave welding, heat staking, threading or seaming, adhesives, or a combination thereof. With reference to FIG. 2B , the base can at least partially define an opening 218 or a through-hole extending therethrough. The opening 218 may be positioned proximate or near the proximal end region 216 of the fluid collection device 200. In some embodiments, the opening 218 extends through both the first layer 312 and the second layer 314 of the base 210 such that the opening 218 is at least partially defined by both the first layer 312 and the second layer 314 (shown in FIGS. 3A-3C and described in more detail below). The opening 218 is sized and dimensioned to receive at least a portion of the penis. In some embodiments, opening 218 is generally circular and comprises a diameter of about 3.5 cm to about 9 cm, about 3.8 cm to about 5 cm, about 5 cm to about 6.4 cm, about 6.4 cm to about 7.6 cm, about 7.6 cm to about 8.9 cm, about 3.8 cm, about 5.1 cm, about 6.4 cm, or about 7.6 cm.

[0022] The fluid collection apparatus 200 may also include a fixation element 230 according to one embodiment. The fixation element 230 may be secured to the proximal end region 216 of the fluid collection apparatus 200. For example, the fixation element 230 may be secured to the proximal end region 216 of the base 210 by ultrasonic welding, heat welding, radio frequency welding, microwave welding, heat staking, threading or seaming, adhesive, or a combination thereof. In some embodiments, the fixation element 230 is directly connected to the base 210. The fixation element 230 may extend at least partially (e.g., entirely) around the opening 218. For example, the fixation element 230 may be a generally annular fixation element 230. The fixation element 230 and the base 210 are connected such that, when the fixation element 230 is secured to a user, the fixation element 230 forms at least a partial seal between the chamber 316 (shown in FIG. 3A ) and the ambient environment outside the fluid collection apparatus 200. When the fixation element 230 forms a seal, fluids positioned within the chamber or expelled into the chamber 316 by a urethra implanted in the user below the chamber 316 remain within the chamber 316 for removal through the aperture 222.

[0023] The fixation element 230 may include an adhesive surface 232 configured to adhere the fixation element 230 to the user's skin surrounding the penis. The adhesive surface 232 of the fixation element 230 may be positioned such that the adhesive surface 232 adheres only to the user's skin surrounding the penis, effective to allow the fluid collection device to cover either a protruding or buried penis. The adhesive surface 232 may be positioned on the fixation element 230 generally opposite the base 210 and / or port 220 of the fluid collection device 200. The adhesive surface 232 may be positioned at least partially (e.g., entirely) around the opening 218. The adhesive surface 232 may comprise one or more of a silicone gel adhesive, an acrylate / acrylic adhesive, an acrylate / acrylic gel adhesive, a hydrogel adhesive, or any combination thereof. A degree peel test For stainless steel or low-density polyethylene in testing, the adhesive strength of adhesive surface 232 is about 0.25 lb / in to about 3 lb / in (about 0.004 kg / mm ​​to about 0.053 kg / mm), about 0.4 to about 2.5 lb / in (about 0.007 kg / mm ​​to about 0.044 kg / mm), about 0.4 lb / in to about 1 lb / in (about 0.007 kg / mm ​​to about 0.017 kg / mm), about 1 lb / in to about 1.5 lb / in (about 0.017 kg / mm ​​to about 0.026 kg / mm), about 1.5 lb / in to about 2 lb / in (about 0.026 kg / mm ​​to about 0.035 kg / mm), about 2 lb / in to about 2.5 lb / in (about 0.035 kg / mm), and g / mm to about 0.044 kg / mm), at least about 0.4 lb / in (about 0.007 kg / mm), at least about 1 lb / in (about 0.017 kg / mm), at least about 1.5 lb / in (about 0.026 kg / mm), at least about 2 lb / in (about 0.035 kg / mm), at least about 2.5 lb / in (about 0.044 kg / mm), less than about 0.4 lb / in (about 0.007 kg / mm), less than about 1 lb / in (about 0.017 kg / mm), less than about 1.5 lb / in (about 0.026 kg / mm), less than about 2 lb / in (about 0.035 kg / mm), or less than about 2.5 lb / in (about 0.044 kg / mm).

[0024] The fluid collection device 200 may also include a port 220 secured to or connected to the base 210 at the distal end region 218. The port 220 may define or otherwise include an aperture 222 configured to receive or secure a tube or conduit effective to provide fluid communication between the chamber 316 and a vacuum source. In some embodiments, the port 220 includes a protruding port sized and dimensioned to be inserted into a tube or conduit to provide a friction fit between the port 220 and the tube or conduit. In some embodiments, the port 220 may include a mating tube made of polyethylene. In some embodiments, the port 220 may be formed of any suitable fluid-impermeable material, such as a fluid-impermeable polymer (e.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, polycarbonate, thermoplastic elastomer, polyvinyl chloride, ethylene vinyl acetate, polytetrafluoroethylene, etc.), a metal film, natural rubber, other suitable materials, or a combination thereof. The port 220 can be positioned between the fluid-impermeable barrier 202 and the base 210 and is in fluid communication with the chamber 316. In some embodiments, the port 220 is between the fluid-impermeable barrier 202 and the base 210 and is welded to at least one of the fluid-impermeable barrier 202 and the base 210.

[0025] When worn by the user 50, the fluid collection device 200 may include a tube or conduit (not shown) removably or securely secured to the port 220 of the fluid collection device 200. The conduit may comprise a flexible material such as plastic tubing (e.g., medical tubing). Such plastic tubing may include tubing materials such as thermoplastic elastomers, polyvinyl chloride, ethylene vinyl acetate, polytetrafluoroethylene, etc. In some embodiments, the conduit may comprise silicone or latex. The conduit provides fluid communication between an interior region of the fluid collection device 200 (e.g., chamber 316), a fluid reservoir (not shown), and / or a portable vacuum source (not shown). For example, the conduit may directly or indirectly fluidly couple the interior region of the fluid collection device to the fluid reservoir or the portable vacuum source.

[0026] Turning now to FIG. 3A, a cross-sectional view of the fluid collection device 200 of FIG. 2A taken along line 3A-3A is shown, according to one embodiment. The base 210 of the fluid collection device 200 can at least partially define a chamber 316 (interior region) that is sized and dimensioned to receive at least a portion (e.g., a majority) of a user's penis therein. In some embodiments, the chamber 316 is defined by and positioned directly between the fluid-impermeable barrier 202 and the base 210 (e.g., second layer 314). The chamber 316 and / or base 210 can include substantially all of the dimensions of the fluid-impermeable barrier 202 described above. In some embodiments, the base 210 is approximately rectangular and / or substantially planar. The base 210 of at least one, some, or all of the embodiments includes a wicking material, which provides the technical effect of capturing and continuously draining urine to the port 220 while keeping the fluid collection device dry and cool under vacuum applied through the port 220.

[0027] FIG. 3B shows the base 210 separated from the fluid-impermeable barrier 202, and FIG. 3C shows an exploded view of the base 210. In some embodiments, the base 210 includes at least a first layer 312 comprising at least a nonwoven fabric and a second layer 314 comprising a 3D fabric or material. The second layer 314 is positioned at least partially between the first layer 312 and the chamber 316. For example, substantially all of the first layer 312 can be spaced from the chamber 316 by the second layer 314. In some embodiments, the first layer 312 and the second layer 314 can extend at least partially between the proximal end region 216 and the distal end region 218 of the fluid collection device 200. The first layer 312 and the second layer 314 can be secured to one another by, for example, ultrasonic welding, heat welding, radio frequency welding, microwave welding, heat staking, threading or seaming, adhesive, or a combination thereof. In some embodiments, the second layer 314 is secured directly to the first layer 312, and the fluid-impermeable barrier 202 is secured directly to the first layer 312 with the second layer 314 positioned between the first layer 312 and the fluid-impermeable barrier 202. Looking at the cross-sectional view of FIG. 3A , the first layer 312 may be generally U-shaped (with a flat bottom), and the second layer 314 may fit within a channel formed between two side walls of the first layer 312. In these and other embodiments, the fluid-impermeable barrier 202 may be secured to two side walls of the first layer 312 generally opposite the bottom of the first layer 312, such that a chamber 316 is defined by the fluid-impermeable barrier 202, the second layer 314, and a portion of each of the two side walls of the first layer 312. In other embodiments, the sidewalls are not present in the first layer 312 and the fluid impermeable barrier 202 is secured to the periphery or perimeter of the first layer.

[0028] The nonwoven fabric of the first layer 312 may comprise a sheet or web structure bonded together by entangling fibers or filaments and / or by perforating a film. The sheet or web structure of the nonwoven fabric layers of the first layer 312 may be bonded together mechanically, thermally, or chemically. In some embodiments, the first layer may comprise a waterproof microporous polyethylene / polypropylene fabric. The nonwoven fabric of the first layer 312 may comprise a flat or tufted porous sheet made directly from discrete fibers, molten plastic, and / or plastic film. In some embodiments, the nonwoven fabric of the first layer 312 may comprise one or more of BERRY™ spunbond polypropylene nonwoven fabric, spunbond polyester woven fabric, and spunbond meltblown spunbond polypropylene nonwoven fabric. A first layer 312 comprising at least a nonwoven fabric can provide skin contact comfort during application of the fluid collection device 200. For example, in some embodiments, when the first layer 312 is pressed against the area around the penis or other body parts, the nonwoven fabric can provide a comfortable, soft interface to those areas or body parts. A first layer 312 including at least a nonwoven fabric can also be configured to provide breathability and / or waterproofness to the base 210, allowing the fluid collection device 200 to maintain a vacuum in a closed system under vacuum operation to remove fluid from the fluid collection device 200. Any embodiment of the first layer 312 including at least a nonwoven fabric described herein can be configured to provide ventilation to the chamber 316 when a vacuum force is applied to or drawn on the chamber 316 through the aperture 222.For example, the first layer 312 may have a pressure of, for example, about 0 mmHg to about 15 mmHg (about 2000 Pa), about 15 mmHg to about 30 mmHg (about 4000 Pa), about 0 mmHg to about 10 mmHg (about 1333 Pa), about 10 mmHg to about 20 mmHg (about 2666 Pa), about 20 mmHg to about 30 mmHg, at least about 5 mmHg (about 667 Pa), at least about 10 mmHg, at least about 15 mmHg, or at least about The aperture 222 can be configured to provide venting to the chamber 316 when a vacuum force of between about 0 mmHg and about 30 mmHg is drawn on the chamber 316 through the aperture 222, such as a vacuum force of at least about 20 mmHg, at least about 25 mmHg (about 3333 Pa), less than about 5 mmHg, less than about 10 mmHg, less than about 15 mmHg, less than about 20 mmHg, less than about 25 mmHg, or less than about 30 mmHg.

[0029] One or more embodiments of the first layer 312, including at least the nonwoven fabric described herein, may include pores. The pores may be generally uniformly distributed throughout the first layer 312 or may be substantially isolated within one or more of the portions of the first layer 312a, 312b, 312c, or 312d described in more detail below. The pores in the first layer 312 may be sized to between about 0.1 μm and about 5 μm, between about 0.1 μm and about 1 μm, between about 1 μm and about 2 μm, between about 2 μm and about 3 μm, between about 3 μm and about 4 μm, between about 4 μm and about 5 μm, at least about 0.1 μm, at least about 1 μm, at least about 2 μm, at least about 3 μm, at least about 4 μm, or less than about 1 μm, less than about 2 μm, less than about 3 μm, less than about 4 μm, or less than about 5 μm.

[0030] In some embodiments, the first layer 312 comprises one or more of spunbond polypropylene and / or meltblown polypropylene. In embodiments in which the first layer 312 comprises one or more of spunbond polypropylene or meltblown polypropylene, the first layer 312 may include a density of about 10 grams per square meter (gsm) to about 30 gsm, about 12 gsm to about 25 gsm, about 12 gsm to about 18.5 gsm, about 18.5 gsm to about 25 gsm, about 10 gsm to about 20 gsm, about 20 gsm to about 30 gsm, about 10 gsm to about 15 gsm, about 15 gsm to about 20 gsm, about 20 gsm to about 25 gsm, about 25 gsm to about 30 gsm, at least about 10 gsm, at least about 15 gsm, at least about 20 gsm, at least about 25 gsm, less than about 15 gsm, less than about 20 gsm, less than about 25 gsm, or less than about 30 gsm.

[0031] In some embodiments, the first layer 312, which includes at least a nonwoven fabric, can include multiple portions or layers. Each portion of the first layer can include a nonwoven material. For example, with reference to FIG. 6 , the first layer 312a can include a first outer portion 612a and a first inner portion 612b. In some examples, the first inner portion 612b can be adjacent to and / or interface with the second layer 314. The first outer portion 612a can define at least a portion of the outer surface of the base 210. In some embodiments, an additional layer can cover the first outer portion 612a and define at least a portion of the outer surface of the base 210. The materials of the first outer portion 612a and first inner portion 612b of the first layer 312a can vary according to different embodiments. In some examples, the first layer 312a includes a spunbond fabric including polyethylene and polypropylene. An embodiment of the first layer 312a comprising a spunbond fabric comprising polyethylene and polypropylene may include a first outer portion 612a and a first inner portion 612b. For example, in some embodiments, the first outer portion 612a comprises a polyethylene microporous film, and the first inner portion 612b comprises nonwoven polypropylene. The polyethylene microporous film of the first outer portion 612a may comprise a nonwoven polyethylene microporous film.

[0032] 7, in some embodiments, the first layer 312b may include a first outer portion 712a, a first inner portion 712c, and a first intermediate portion 712b between the first inner portion 712c and the first outer portion 712a. In some embodiments, each of the first inner portion 712c, the first outer portion 712a, and the first intermediate portion 712b may include a nonwoven material. In some embodiments, each of the first inner portion 712c and the first outer portion 712a may include a nonwoven material. The first inner portion 712c may be adjacent to or interface with the second layer 314. The first outer portion 712a may define at least a portion of the outer surface of the base 210. In some embodiments, an additional layer may cover the first outer portion 712a and define at least a portion of the outer surface of the base 210. Similar to the first layer 312a, the first layer 312b may include a spunbond fabric including polyethylene and polypropylene. For example, the first layer 312b may include a first inner portion 712c having a nonwoven polypropylene material, a first outer portion 712a having a polypropylene material (such as a nonwoven polypropylene material), and a first middle portion 712b having polyethylene (such as a nonwoven polyethylene) between the first inner portion 712c and the first outer portion 712a.

[0033] Embodiments of the first layer 312a or 312b comprising a spunbond fabric comprising polyethylene and polypropylene also may have a thickness of about 20 gsm to about 60 gsm, about 60 gsm to about 80 gsm, about 80 gsm to about 100 gsm, about 20 gsm to about 30 gsm, about 30 gsm to about 40 gsm, about 40 gsm to about 50 gsm, about 50 gsm to about 60 gsm, about 60 gsm to about 70 gsm, about 70 gsm to about 80 gsm, about 80 gsm to about 90 gsm, about 90 gsm to about 100 gsm, or at least They may have a density of from about 20 gsm to about 100 gsm, such as about 20 gsm, at least about 30 gsm, at least about 40 gsm, at least about 50 gsm, at least about 60 gsm, at least about 70 gsm, at least about 80 gsm, at least about 90 gsm, at least about 100 gsm, less than about 20 gsm, less than about 30 gsm, less than about 40 gsm, less than about 50 gsm, less than about 60 gsm, less than about 70 gsm, less than about 80 gsm, less than about 90 gsm, or less than about 100 gsm.

[0034] 6, in some embodiments, the material of the first layer 312a can include a polyester material and a polyethylene material. For example, the first layer 312a can include a first outer portion 612a including a polyethylene material (such as a non-woven polyethylene material) and a first inner portion 612b including a polyester material (such as a non-woven polyester material). In embodiments of the first layer 312a comprising a polyester material and a polyethylene material, the first layer 312a may have a thickness of from about 20 gsm to about 60 gsm, from about 60 gsm to about 80 gsm, from about 80 gsm to about 100 gsm, from about 100 gsm to about 120 gsm, from about 20 gsm to about 30 gsm, from about 30 gsm to about 40 gsm, from about 40 gsm to about 50 gsm, from about 50 gsm to about 60 gsm, from about 60 gsm to about 70 gsm, from about 70 gsm to about 80 gsm, from about 80 gsm to about 90 gsm, from about 90 gsm to about 100 gsm, from about 100 gsm to about 110 gsm, from about 110 gsm to about 120 gsm, or at least about 20 gsm. The density may include a density of from about 20 gsm to about 120 gsm, such as 0 gsm, at least about 30 gsm, at least about 40 gsm, at least about 50 gsm, at least about 60 gsm, at least about 70 gsm, at least about 80 gsm, at least about 90 gsm, at least about 100 gsm, at least about 110 gsm, at least about 120 gsm, less than about 20 gsm, less than about 30 gsm, less than about 40 gsm, less than about 50 gsm, less than about 60 gsm, less than about 70 gsm, less than about 80 gsm, less than about 90 gsm, less than about 100 gsm, less than about 110 gsm, or less than about 120 gsm.

[0035] In some embodiments, the material of the first layer 312a may include a spunbond fabric including a cellulose material and a polyethylene material. For example, the first layer 312a may be spunbonded and may include a first outer portion 612a including a polyethylene material and a first inner portion 612b including a cellulose material. In some embodiments, only one of the first outer portion 612a including a polyethylene material and the first inner portion 612b including a cellulose material is spunbonded. In some embodiments, both the first outer portion 612a including a polyethylene material and the first inner portion 612b including a cellulose material are spunbonded.

[0036] 7, in some embodiments, the first layer 312b can include spunbond polypropylene and meltblown polypropylene. The nonwoven polypropylene can be produced by a meltblown process and, in some examples, can include only polypropylene. The first outer portion 712a and the first inner portion 712c can both include spunbond polypropylene, and the first middle portion 712b can include meltblown polypropylene between the first inner portion 712c and the first outer portion 712a. In embodiments of the first layer 312b comprising spunbond polypropylene and meltblown polypropylene, the density of the first layer may be from about 10 gsm to about 60 gsm, from about 10 gsm to about 35 gsm, from about 35 gsm to about 60 gsm, from about 10 gsm to about 20 gsm, from about 20 gsm to about 30 gsm, from about 30 gsm to about 40 gsm, from about 40 gsm to about 50 gsm, from about 50 gsm to about 60 gsm, at least about 10 gsm, at least about 20 gsm, at least about 30 gsm, at least about 40 gsm, at least about 50 gsm, at least about 60 gsm, less than about 20 gsm, less than about 30 gsm, less than about 40 gsm, less than about 50 gsm, or less than about 60 gsm.

[0037] In some embodiments, the first layer 312 may comprise one or more of nonwoven spunbond polypropylene, nonwoven polyethylene, and / or nonwoven meltblown polypropylene. Looking first to FIG. 8 in the drawings, according to some embodiments, the first layer 312c may comprise a first outer portion 812a, a first inner portion 812d, a first intermediate portion 812c, and a second intermediate portion 812b. The first inner portion 812d may be adjacent to and interface with the second layer 314. The first outer portion 812a may define at least a portion of the outer surface of the base 210. In some embodiments, an additional layer may cover the first outer portion 812a and define at least a portion of the outer surface of the base 210. The first inner portion 812d may comprise nonwoven spunbond polypropylene, and the first outer portion 812a may comprise nonwoven polyethylene. The first intermediate portion 812c can be adjacent to the first inner portion 812d and can include nonwoven meltblown polypropylene. The second intermediate portion 812b can be between the first intermediate portion 812c and the first outer portion 812a and can include nonwoven spunbond polypropylene. The first layer 312c may include a density of about 20 gsm to about 90 gsm, such as about 25 gsm to about 85 gsm, about 20 gsm to about 55 gsm, about 55 gsm to about 90 gsm, about 25 gsm to about 35 gsm, about 35 gsm to about 45 gsm, about 45 gsm to about 55 gsm, about 55 gsm to about 65 gsm, about 65 gsm to about 75 gsm, about 75 gsm to about 85 gsm, at least about 20 gsm, at least about 30 gsm, at least about 40 gsm, at least about 50 gsm, at least about 60 gsm, at least about 70 gsm, at least about 80 gsm, less than about 25 gsm, less than about 35 gsm, less than about 45 gsm, less than about 55 gsm, less than about 65 gsm, less than about 75 gsm, less than about 85 gsm, or less than about 95 gsm.

[0038] In some embodiments, the first layer 312 may include one or more of nonwoven spunbond polypropylene, nonwoven polyethylene, and / or nonwoven meltblown polypropylene. Looking first to FIG. 9 in the drawings, according to some embodiments, the first layer 312d may include a first outer portion 912a, a first inner portion 912e, a first intermediate portion 912d, a second intermediate portion 912c, and a third intermediate portion 912b. The first inner portion 912e may be adjacent to and interface with the second layer 314. The first outer portion 912a may define at least a portion of the outer surface of the base 210. In some embodiments, an additional layer may cover the first outer portion 912a and define at least a portion of the outer surface of the base 210. The first outer portion 912a can comprise nonwoven polyethylene, and the first inner portion can comprise nonwoven spunbond polypropylene. The first intermediate portion 912d can be adjacent to or interface with the first inner portion 912e and can comprise nonwoven meltblown polypropylene. The second intermediate portion 912c can be adjacent to the first intermediate portion 912d and can comprise nonwoven spunbond polypropylene. The third intermediate portion 912b can be positioned between the second intermediate portion 912c and the first outer portion 912a and can comprise meltblown polypropylene.

[0039] 3A in the drawings, the base 210 of the fluid collection device 200 includes a second layer 314 that can define at least a portion of a chamber 316. The second layer 314 can include a 3D or multi-layer fluid-permeable fabric positioned at least partially between the first layer 312 and the chamber 316. In some embodiments, the chamber 316 is positioned between and at least partially defined by the fluid-impermeable barrier 202 and the second layer 314. The 3D fabric of the second layer 314 can include two woven fabric layers spaced apart and connected by spacer yarns or threads, such as fibers. The fibers connecting the two woven fabric layers can include polyester or nylon fibers. The 3D fabric of the second layer 314 can include a polyester spacer mesh fabric and / or scuba fabric. In some embodiments, the second layer 314 may include a second inner portion including one or more of nonwoven polyester, polypropylene, and / or polyethylene, and a second outer portion including one or more of polyester or nylon. The 3D fabric may be fluid permeable and may be configured to acquire fluid (e.g., urine) from a user and / or direct fluid to the apertures 222 for removal from the fluid collection device 200. The second layer 314 including the 3D fabric may then provide urine acquisition capabilities to the fluid collection device 200 and aid in the drainage or removal of fluid from the fluid collection device 200 under vacuum force. For example, when a user is wearing the fluid collection device 200, urine may enter the chamber 316 and then flow through the second layer 314 to the apertures 222 for removal from the fluid collection device 200. In some embodiments, the second layer 314 may be able to wick urine and / or allow the transport of urine to the apertures 222. The permeability property referred to herein may be wicking, capillary action, diffusion, or other similar property or process, and is referred to herein as "permeability" and / or "wicking." Such "wicking" can eliminate absorption into the wicking material.While no absorption is desirable, the term "substantially no absorption" may allow for a nominal amount of fluid absorption (e.g., absorbency) into the wicking material of the second layer 314, such as less than about 30% by weight, less than about 20% by weight, less than about 10% by weight, less than about 7% by weight, less than about 5% by weight, less than about 3% by weight, less than about 2% by weight, less than about 1% by weight, or less than about 0.5% by weight of the dry weight of the second layer 314. In one embodiment, the second layer 314 may include at least one absorbent or absorbing material. The second layer 314 may include a unidirectional fluid transfer fabric.

[0040] The 3D fabric can also be configured to support the base 210 of the fluid collection device 200 in a predetermined, generally planar shape. For example, in some embodiments, when a vacuum is applied to the chamber 316 of the base 210 through the port 220, the 3D fabric of the second layer 314 is configured to support the base 210 in a generally planar shape. The second layer 314, including the 3D fabric, can then prevent or reduce fluid restriction that may occur if the fluid collection device twists when a vacuum is drawn on the chamber. The second layer 314 can also provide a relatively dry condition to the user, thus enabling longer-term application of the fluid collection device 200, such as for about three to about five days. Examples of the second layer 314 can include a 3D spacer mesh, a 3D spacer fabric, a spacer fabric, a 3D air spacer mesh, an air spacer fabric, a neoprene scuba fabric, a sandwich scuba fabric, or any combination thereof.

[0041] The second layer 314 can comprise a thickness of about 0.5 mm to about 10 mm, about 1 mm to about 6 mm, about 1.5 mm to about 4.5 mm, about 4.5 mm to about 8.5 mm, about 6 mm to about 10 mm, about 1 mm to about 3 mm, about 3 mm to about 5 mm, about 5 mm to about 7 mm, about 7 mm to about 9 mm, at least about 0.5 mm, at least about 1 mm, at least about 2 mm, at least about 3 mm, at least about 4 mm, at least about 5 mm, at least about 6 mm, at least about 7 mm, at least about 8 mm, at least about 9 mm, less than about 1 mm, less than about 2 mm, less than about 3 mm, less than about 4 mm, less than about 5 mm, less than about 6 mm, or less than about 7 mm.

[0042] In some embodiments, the second layer 314 may include multiple layers or portions. For example, turning first to FIG. 5 in the drawings, the second layer 314a may include a second outer portion 514a and at least a second inner portion 514c. The second inner portion 514c may at least partially define the chamber 316 such that the chamber 316 is at least partially (e.g., directly) positioned between the fluid-impermeable barrier 202 and the second inner portion 514c. In a more specific example, the second layer 314a may include a second outer portion 514a, a second inner portion 514c, and an intermediate portion 514b disposed between and / or connecting the second inner portion 514c and the second outer portion 514a. In some embodiments, the intermediate portion 514b may include a fiber or fibrous material. For example, the fabric of the intermediate portion 514b may include a spacer yarn connecting the second outer portion 514a and the second inner portion 514c.

[0043] In some embodiments, the second layer 314 includes a spacer fabric configured to capture fluid and aid in evacuating the fluid from the fluid collection device 200 under vacuum. The spacer fabric may also act as a support material to help maintain the shape of the fluid collection device 200. The spacer fabric of the second layer 314 may include a second inner portion 514c, a second outer portion 514a, and a middle portion 514b of fibers connecting the second inner portion 514c and the second outer portion 514a. In some embodiments, the spacer fabric of the second layer 314 may include a polyester spacer fabric. For example, at least the second inner portion 514c and the second outer portion 514a of the second layer 314 may include and / or consist essentially of a polyester material. In some examples of the second layer 314 including a spacer fabric having polyester or other materials, the second inner portion 514c can include an inner mesh portion having holes or openings of a first size, and the second outer portion 514a can include an outer mesh portion having holes of a second size smaller than the holes in the inner mesh portion having the first size. In some examples of the second layer 314 including a spacer fabric having polyester or other materials, the second inner portion 514c can include a polyester woven fabric, and the second outer portion 514a can include a polyester mesh material having multiple holes or openings. In some examples of the second layer 314 including a spacer fabric having polyester or other materials, the second inner portion 514c can include a cotton woven fabric, and the second outer portion can include a polyester mesh having multiple holes or openings.

[0044] The second layer 314 including the spacer fabric may be about 150 gsm to about 300 gsm, about 190 gsm to about 260 gsm, about 150 gsm to about 190 gsm, about 190 gsm to about 230 gsm, about 230 gsm to about 260 gsm, about 260 gsm to about 300 gsm, about 190 gsm to about 200 gsm, about 200 gsm to about 210 gsm, about 210 gsm to about 220 gsm, about 230 gsm to about 240 gsm, about 240 gsm to about 250 gsm, about 250 gsm The density may include a density of at least about 190 gsm, at least about 200 gsm, at least about 210 gsm, at least about 220 gsm, at least about 230 gsm, at least about 240 gsm, at least about 250 gsm, at least about 260 gsm, less than about 190 gsm, less than about 200 gsm, less than about 210 gsm, less than about 220 gsm, less than about 230 gsm, less than about 240 gsm, less than about 250 gsm, or less than about 260 gsm.

[0045] In some embodiments, second layer 314 includes scuba fabric. The scuba fabric of second layer 314 may include a neoprene or polychloroprene material. In some embodiments, the scuba fabric includes a polyester-spandex knit fabric. For example, the scuba fabric of second layer 314 may include about 10% to about 25% by weight of a neoprene or polychloroprene material. The scuba fabric of second layer 314 may include one or more of second inner portion 514c, second outer portion 514a, or an intermediate portion 514b connecting second inner portion 514c and second outer portion 514a. In some embodiments, second outer portion 514a includes a polyester fabric, second inner portion 514c includes a polyester fabric, and intermediate portion 514b includes a scuba fabric including neoprene. In some embodiments, at least one (e.g., both) of the second outer portion 514a and the second inner portion 514c comprises scuba fabric. When the second outer portion 514a and the second inner portion 514c comprise scuba fabric, the middle portion 514b may include fibers such as spacer yarns connecting the second outer portion 514b and the second inner portion 514c.

[0046] In some embodiments, the second outer portion 514a comprises a polyester fabric, the second inner portion 514c comprises a cotton fabric, and the intermediate portion 514b comprises a scuba fabric including neoprene. In some embodiments, at least one (e.g., both) of the second outer portion 514a and the intermediate portion 514b can comprise a scuba fabric, and the second inner portion 514c can comprise a cotton fabric. When the second outer portion 514a comprises a scuba fabric and the second inner portion 514c comprises a cotton fabric, the intermediate portion 514b can include a fiber such as a spacer yarn connecting the second outer portion 514a and the second inner portion 514c.

[0047] The second layer 314 comprising scuba fabric may be about 225 gsm to about 400 gsm, about 250 gsm to about 380 gsm, about 250 gsm to about 300 gsm, about 300 gsm to about 350 gsm, about 350 gsm to about 400 gsm, about 250 gsm to about 260 gsm, about 260 gsm to about 270 gsm, about 270 gsm to about 280 gsm, about 280 gsm to about 3 ... Approximately 290gsm, approximately 290gsm to approximately 300gsm, approximately 300gsm to approximately 310gsm, approximately 310gsm to approximately 320gsm, approximately 320gsm to approximately 330gsm, approximately 330gsm to approximately 340gsm, approximately 350gsm, approximately 350gsm to approximately 360gsm, approximately 360gsm to approximately 370gsm, approximately 370gsm to approximately 380gsm, at least approximately 250gsm, at least The density may include a density of at least about 260 gsm, at least about 270 gsm, at least about 280 gsm, at least about 290 gsm, at least about 300 gsm, at least about 310 gsm, at least about 320 gsm, at least about 330 gsm, at least about 340 gsm, at least about 350 gsm, at least about 360 gsm, at least about 370 gsm, at least about 380 gsm, less than about 250 gsm, less than about 260 gsm, less than about 270 gsm, less than about 280 gsm, less than about 290 gsm, less than about 300 gsm, less than about 310 gsm, less than about 320 gsm, less than about 330 gsm, less than about 340 gsm, less than about 350 gsm, less than about 360 gsm, less than about 370 gsm, or less than about 380 gsm.

[0048] The various embodiments of the first layer 312 and second layer 314 described herein can be combined without limitation in the base 210 of the fluid collection device 200. For example, the embodiment of the second layer 314a described herein can be combined with any one or more of the embodiments of the first layer 312a, 312b, 312c, or 312d.

[0049] FIG. 4 is a flow diagram of a method 400 for manufacturing a fluid collection device according to one embodiment. In one embodiment, method 400 includes operation 410 of securing a first layer to a second layer to form a base. The base formed in operation 410 may include any base described herein, such as a base having at least a first layer including a nonwoven fabric and a second layer including a fluid-permeable multi-layer. Method 400 may also optionally include operation 420 of forming an opening in the base sized to receive at least a portion of the penis, the opening extending through the first and second layers at a proximal end region of the fluid collection device. Method 400 may also include operation 430 of positioning a port at a distal end region of the fluid collection device, the port defining an aperture configured to be fluidly coupled to the tube effective to provide fluid communication between the chamber and the tube. The method 400 may also include an operation 440 of securing the fluid-impermeable barrier to the base to form a chamber within the fluid collection device that is at least partially defined by the fluid-impermeable barrier and the second layer and that is in fluid communication with an opening that is at least partially defined by the base.

[0050] In some embodiments, operation 410 may include welding the first layer to the second layer by at least one of heat welding, radio frequency welding, or microwave welding. The first layer and / or second layer of the base may include any of the first layer and / or second layer described herein. In some embodiments, operation 440 includes welding a fluid-impermeable barrier to the base by at least one of heat welding, radio frequency welding, or microwave welding. The fluid-impermeable barrier may include any of the fluid-impermeable barriers described herein.

[0051] Operations 410, 420, 430, and 440 of method 400 are for illustrative purposes. For example, operations 410, 420, 430, and 440 of the method may be performed in a different order, divided into multiple operations, modified, supplemented, or combined. In one embodiment, one or more of operations 410, 420, 430, and 440 of method 400 may be omitted from method 400. Any of operations 410, 420, 430, and 440 of method 400 may include using any of the fluid collection devices or systems disclosed herein.

[0052] Also described herein is a method of collecting fluid, according to one embodiment. The method includes the act of positioning a base of a fluid collection device over or around the urethra of a user's penis. The fluid collection device may include any fluid collection device described herein. In some embodiments, the act may include positioning the base around the urethra of a user's penis by inserting at least a portion of the penis into an opening in the base. In some embodiments, the act includes positioning an opening in the base over the urethra of a penis implanted in the user. The method also includes the act of securing the fluid collection device to a user. This act may include securing adhesive on the base to at least a portion of the skin surrounding the user's penis. The method may also include the act of receiving fluid from the urethra into a chamber of the fluid collection device. The method also includes the act of applying a suction force, via something secured to the chamber, effective to draw fluid from the chamber.

[0053] While various aspects and embodiments have been disclosed herein, other aspects and embodiments are contemplated. The various aspects and embodiments disclosed herein are for purposes of illustration and are not intended to be limiting.

[0054] Terms of degree (e.g., "about," "substantially," "nearly," etc.) indicate structurally or functionally insignificant variations. Structurally or functionally insignificant variations are known to those of skill in the art. For example, in some embodiments, those of skill in the art will understand that structurally or functionally insignificant variations can include changing the amount modified by the term of degree by ±10%, ±5%, or ±2%. In one example, when a term of degree is used to modify a shape, the term of degree indicates that the shape modified by the term of degree has the appearance of the disclosed shape. For example, the term of degree can be used to indicate that the shape has rounded corners instead of sharp corners, curved edges instead of straight edges, may have one or more protrusions extending from an edge, is rectangular, is the same shape as the disclosed shape, etc.

Claims

1. 1. A fluid collection device comprising: a fluid-impermeable barrier at least partially defining a chamber within the fluid collection device, at least a portion of the fluid-impermeable barrier being substantially planar and extending at least partially between a proximal end region of the fluid collection device and a distal end region of the fluid collection device; a base secured to the fluid-impermeable barrier and at least partially defining the chamber and an opening in fluid communication with the chamber sized to receive at least a portion of a penis, at least a portion of the base being substantially planar and including at least a first layer including at least a nonwoven fabric extending at least partially between the proximal end region and the distal end region, the first layer including a first inner portion and a first outer portion, the opening being positioned adjacent to the proximal end region; Equipped with The fluid collection device further comprises a port positioned proximate the distal end region of the fluid collection device, the port defining an aperture configured to fluidly couple to the tube effective to provide fluid communication between the chamber and the tube.

2. 10. The fluid collection device of claim 1, the first outer portion is at least a portion of an outer surface of the base; the first outer portion is a breathable, waterproof, microporous nonwoven fabric; The fluid collection device further characterized in that the fluid impermeable barrier faces the opening.

3. 2. The fluid collection device of claim 1, wherein the base includes a second layer secured to the first layer and at least partially defining the chamber, the second layer including a fluid-permeable multi-layer fabric positioned at least partially between the first layer and the chamber and extending at least partially between the proximal end region and the distal end region, the first outer portion of the first layer positioned on the fluid collection device at least adjacent to a user, the first inner portion of the first layer positioned adjacent to the second layer, and the opening extending through both the first layer and the second layer.

4. 4. The fluid collection device of claim 3, the first layer is welded to the second layer by at least one of thermal welding, radio frequency welding, or microwave welding; the nonwoven fabric of the first layer comprises a spunbond fabric comprising polyethylene and polypropylene, the first layer having a density of about 20 gsm to about 100 gsm; The first inner portion is The first outer portion comprises a polyethylene microporous film, or The first inner portion is 1. A fluid collection device comprising a nonwoven polypropylene material, the first outer portion comprising a nonwoven polypropylene material, and the first layer comprising a first intermediate portion between the first inner portion and the first outer portion comprising polyethylene.

5. 4. The fluid collection device of claim 3, wherein the first inner portion comprises a nonwoven polyester material, the first outer portion comprises a polyethylene material, and the first layer has a density of about 20 gsm to about 120 gsm.

6. 4. The fluid collection device of claim 3, wherein the first layer comprises a spunbond fabric, the first inner portion comprises a cellulosic material, and the first outer portion comprises polyethylene.

7. 4. The fluid collection device of claim 3, wherein the first inner portion and the first outer portion comprise spunbond polypropylene, the first layer further comprises an intermediate portion between the first inner portion and the first outer portion comprising meltblown polypropylene, and the first layer comprises a density of about 10 gsm to about 60 gsm.

8. 4. The fluid collection device of claim 3, wherein the first inner portion comprises spunbond polypropylene, the first outer portion comprises nonwoven polyethylene, and the first layer further comprises a first intermediate portion adjacent to the first inner portion, the first intermediate portion comprising meltblown polypropylene, a second intermediate portion adjacent to the first intermediate portion, the second intermediate portion comprising spunbond polypropylene, and a third intermediate portion between the second intermediate portion and the first outer portion, the third intermediate portion comprising meltblown polypropylene.

9. 4. The fluid collection device of claim 3, wherein the first inner portion comprises spunbond polypropylene, the first outer portion comprises nonwoven polyethylene, the first layer further comprises a first intermediate portion adjacent the first inner portion comprising meltblown polypropylene, and a second intermediate portion between the first intermediate portion and the first outer portion comprising spunbond polypropylene, and the first layer comprises a density of about 25 gsm to about 85 gsm.

10. 4. The fluid collection device of claim 3, the first layer is configured to provide ventilation to the chamber when a vacuum of about 0 mmHg to about 10 mmHg (about 1333 Pa), or about 10 mmHg to about 20 mmHg (about 2666 Pa), is drawn on the chamber through the aperture; A fluid collection device, wherein the first layer comprises a porous layer having pores of about 0.1 μm to about 1 μm, about 1 μm to about 2 μm, or about 2 μm to about 3 μm.

11. 4. The fluid collection device of claim 3, the second layer includes a spacer fabric including a second inner portion, a second outer portion, and an intermediate portion connecting the second inner portion and the second outer portion; the fluid collection device the spacer fabric of the second layer comprising a polyester spacer fabric; the second inner portion comprising an inner mesh portion having holes of a first size; and the second outer portion comprising an outer mesh portion having holes of a second size smaller than the holes of the first size; the second inner portion comprising a polyester fabric and the second outer portion comprising a polyester mesh; or the second inner portion comprising a cotton fabric, and the second outer portion comprising a polyester mesh. and the second layer having a density of about 190 gsm to about 260 gsm. A fluid collection device comprising:

12. 4. The fluid collection device of claim 3, the second layer comprises a polyester-spandex knit fabric; The second layer is a second inner portion comprising the polyester-spandex knit fabric and a second outer portion comprising the polyester-spandex knit fabric; or a second inner portion comprising a cotton fabric, and a second outer portion comprising said polyester-spandex knit fabric. and the second layer having a density of about 250 gsm to about 380 gsm. A fluid collection device comprising:

13. 4. The fluid collection device of claim 3, wherein the second layer comprises: a second inner portion comprising one or more of nonwoven polyester, polypropylene, or polyethylene; a second outer portion comprising one or more of polyester or nylon; 10. A fluid collection device comprising:

14. 4. The fluid collection device of claim 3, the second layer has a thickness of about 1.5 mm to about 4.5 mm; a second inner portion of the second layer at least partially defines the chamber; A fluid collection device, wherein the first outer portion of the first layer at least partially defines an outer surface of the fluid collection device.

15. 4. The fluid collection device of claim 3, further comprising an adhesive secured to the first outer portion of the first layer and surrounding the opening, the adhesive configured to adhere to the user's skin around the user's penis; A fluid collection device, wherein the adhesive comprises one or more of a silicone gel adhesive, an acrylate / acrylic adhesive, an acrylate / acrylic gel adhesive, a hydrogel adhesive, or any combination thereof.

16. 1. A method of manufacturing a fluid collection device, the method comprising: securing a first layer to a second layer to form a base having at least a substantially planar portion, the first layer comprising at least a nonwoven fabric and the second layer comprising a fluid-permeable multi-layer; securing the fluid-impermeable barrier to the base to form a chamber defined at least in part by the second layer and a fluid-impermeable barrier having a substantially planar portion, the chamber being in fluid communication with an opening defined at least in part by the base and sized to receive at least a portion of a penis, the fluid collection device having a proximal end region and a distal end region, the base and the fluid-impermeable barrier extending from the proximal end region of the fluid collection device to the distal end region of the fluid collection device; forming the opening in the base, the opening extending through the first layer and the second layer at the proximal end region of the fluid collection device; and positioning a port at the distal end region of the fluid collection device, the port defining an aperture configured to be fluidly coupled to the tube effective to provide fluid communication between the chamber and the tube.

17. 17. The method of claim 16, the first layer is at least a portion of an outer surface of the base; the first layer is a breathable, waterproof, microporous nonwoven fabric; The method, wherein the step of securing the fluid-impermeable barrier to the base includes positioning the fluid-impermeable barrier and the opening opposite each other.

18. 17. The method of claim 16, wherein securing a first layer to a second layer to form a base includes welding the first layer to the second layer by at least one of heat welding, radio frequency welding, or microwave welding; securing a fluid-impermeable barrier to the base includes welding the fluid-impermeable barrier to the base by at least one of heat welding, radio frequency welding, or microwave welding; the nonwoven fabric of the first layer comprises a spunbond fabric comprising polyethylene and polypropylene; The method, wherein the first layer has a density of about 20 gsm to about 100 gsm.

19. 20. The method of claim 18, wherein the first inner portion of the first layer comprises nonwoven polypropylene and the first outer portion of the first layer comprises a microporous film of polypropylene.

20. 20. The method of claim 18, wherein a first inner portion of the first layer comprises a nonwoven polypropylene material, a first outer portion of the first layer comprises a nonwoven polypropylene material, and a first middle portion of the first layer comprises polyethylene between the first inner portion and the first outer portion.

21. 17. The method of claim 16, wherein a first inner portion of the first layer comprises a nonwoven polyester material and a first outer portion of the first layer comprises a polyethylene material, and wherein the first layer has a density of about 20 gsm to about 120 gsm.

22. 17. The method of claim 16, wherein the first layer comprises a spunbond fabric, a first inner portion of the first layer comprises a cellulosic material, and a first outer portion of the first layer comprises polyethylene.

23. 17. The method of claim 16, wherein the first inner portion of the first layer and the first outer portion of the first layer comprise spunbond polypropylene, the first layer further comprising an intermediate portion between the first inner portion and the first outer portion comprising meltblown polypropylene, and the first layer comprises a density of about 10 gsm to about 60 gsm.

24. 17. The method of claim 16, wherein a first inner portion of the first layer comprises spunbond polypropylene, a first outer portion of the first layer comprises nonwoven polyethylene, a first intermediate portion of the first layer comprises meltblown polypropylene adjacent to the first inner portion, a second intermediate portion of the first layer comprises spunbond polypropylene adjacent to the first intermediate portion, and a third intermediate portion of the first layer comprises meltblown polypropylene between the second intermediate portion and the first outer portion.

25. 17. The method of claim 16, wherein a first inner portion of the first layer comprises spunbond polypropylene, a first outer portion of the first layer comprises nonwoven polyethylene, a first middle portion of the first layer comprises meltblown polypropylene adjacent the first inner portion, a second middle portion of the first layer comprises spunbond polypropylene between the first middle portion and the first outer portion, and the first layer comprises a density of about 25 gsm to about 85 gsm.

26. 17. The method of claim 16, wherein the first layer is configured to provide ventilation to the chamber when a vacuum of about 0 mmHg to about 10 mmHg (about 1333 Pa), or about 10 mmHg to about 20 mmHg (about 2666 Pa), is drawn on the chamber through the aperture, and the first layer comprises a porous layer having pores of about 0.1 μm to about 1 μm, about 1 μm to about 2 μm, or about 2 μm to about 3 μm.

27. 17. The method of claim 16, wherein the second layer comprises a spacer fabric including a second inner portion, a second outer portion, and an intermediate portion connecting the second inner portion and the second outer portion.

28. 28. The method of claim 27, wherein the spacer fabric of the second layer comprises a polyester spacer fabric; the second inner portion includes an inner mesh portion having holes of a first size, and the second outer portion includes an outer mesh portion having holes of a second size that are smaller than the holes of the first size.

29. 28. The method of claim 27, wherein the second inner portion comprises a polyester fabric and the second outer portion comprises a polyester mesh.

30. 28. The method of claim 27, wherein the second inner portion comprises a cotton fabric and the second outer portion comprises a polyester mesh.

31. 28. The method of claim 27, wherein the second layer has a density of about 190 gsm to about 260 gsm.

32. 17. The method of claim 16, wherein the second layer comprises a polyester-spandex knit fabric, the second layer having a density of from about 250 gsm to about 380 gsm.

33. 33. The method of claim 32, wherein the second layer comprises a second inner portion comprising the polyester-spandex knit fabric and a second outer portion comprising the polyester-spandex knit fabric.

34. 33. The method of claim 32, wherein the second layer comprises a second inner portion comprising a cotton fabric and a second outer portion comprising the polyester-spandex knit fabric.

35. 17. The method of claim 16, wherein the second layer comprises: a second inner portion comprising one or more of nonwoven polyester, polypropylene, or polyethylene; a second outer portion comprising one or more of polyester or nylon; A method comprising:

36. 17. The method of claim 16, further comprising the step of securing an adhesive to a first outer portion of the first layer to at least partially surround the opening, the adhesive configured to adhere to the user's skin around the user's penis, and wherein the second layer has a thickness of about 1.5 mm to about 4.5 mm.

Images