Male fluid collection assembly and system, method of use and method of manufacture thereof

Abstract

An exemplary fluid collection assembly includes a sheath and a base. The sheath includes a fluid impermeable barrier having a proximal region and a distal region extending from the proximal region. The proximal region exhibits a first width and the distal region exhibits a second width less than the first width. The proximal region defines an opening and the distal region defines a fluid outlet. The fluid impermeable barrier defines a chamber. The sheath also includes at least one porous material disposed within the chamber. The base can be attached to the sheath or can be configured to be attached to the sheath. The base defines an opening that is aligned with the opening when the base is attached to the sheath. The base is configured to be secured to a region about an individual's penis with the opening positioned over the penis.

Description

[Background technology]

[0001] In various circumstances, humans or animals may experience limited or reduced mobility, making the typical urination process difficult or impossible. For example, humans may suffer or have a disability that results in reduced mobility. Human mobility conditions may be limited, such as those experienced by pilots, drivers, and workers in hazardous areas. In addition, urine collection may be required for monitoring purposes or clinical trials.

[0002] 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. In addition, bedpans, which are containers used for the excretion of bedridden patients, are sometimes used in medical facilities. Bedpans are prone to discomfort, leakage, and other hygiene issues.

[0003] Men who suffer the most serious consequences of urinary incontinence, such as discomfort, rash, and pain, are typically elderly and often bedridden. They also require ongoing assistance to maintain hygiene. Common characteristics of these patients include that they typically sleep supine, that penile size often decreases with age, that the penis is often retracted and pointing upwards in the supine position due to the bulging of the skin, including adipose tissue, and that it is difficult for the patient to reach the penis and operate the device. Urine collection devices should be designed with reference to these characteristics.

[0004] Available solutions are typically for use in an erect position, with the outlet facing the distal end of the penis (such as cups and funnels). Other designs, such as condom-style catheters, are difficult for the patient to manipulate, too often have dimensional incompatibility, and do not stay in place reliably. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] US Patent Application Publication No. 2019 / 247222 [Patent Document 2] International Publication No. 2021 / 155206 [Patent Document 3] US Patent Application Publication No. 2021 / 121318 [Patent Document 4] International Publication No. 2022 / 006256 Summary of the Invention [Problem to be solved by the invention]

[0006] Thus, there is a need for a device that allows for the comfortable collection of urine from humans or animals, particularly males, with minimal contamination of the user and / or surrounding area. [Means for solving the problem]

[0007] The embodiments disclosed herein are directed to a male fluid collection assembly, a system including the male fluid collection assembly, a method of manufacturing the male fluid collection assembly, and a method of using the male fluid collection assembly. In one embodiment, a fluid collection assembly is disclosed. The fluid collection assembly includes a sheath. The sheath includes a fluid impermeable barrier including a proximal region and a distal region extending from the proximal region. The proximal region exhibits a first width and the distal region exhibits a second width less than the first width. The proximal region defines an opening and the distal region defines a fluid outlet. The fluid impermeable barrier defines at least a chamber. The sheath also includes at least one porous material disposed within the chamber. The fluid collection assembly also includes a base configured to be secured or secured to the proximal region of the sheath. The base is configured to be attached to the skin surrounding the penis. The base defines an opening corresponding to the opening of the sheath.

[0008] In one embodiment, a system is disclosed. The system includes a fluid collection assembly. The fluid collection assembly includes a sheath. The sheath includes a fluid impermeable barrier including a proximal region and a distal region extending from the proximal region. The proximal region exhibits a first width and the distal region exhibits a second width less than the first width. The proximal region defines an opening and the distal region defines a fluid outlet. The fluid impermeable barrier defines at least a chamber. The sheath also includes at least one porous material disposed within the chamber. The fluid collection assembly also includes a base configured to be secured or secured to the proximal region of the sheath. The base is configured to be attached to the skin surrounding the penis. The base defines an opening corresponding to the opening of the sheath. The system also includes a vacuum source configured to apply a vacuum force, a fluid containment vessel, and at least one conduit connected to the outlet and in fluid communication with the vacuum source and the fluid containment vessel.

[0009] In one embodiment, a method of manufacturing a fluid collection assembly is disclosed. The method includes attaching a base to a fluid impermeable barrier of a sheath. The sheath includes a fluid impermeable barrier including a proximal region and a distal region extending from the proximal region. The proximal region exhibits a first width and the distal region exhibits a second width less than the first width. The proximal region defines an opening and the distal region defines a fluid outlet. The fluid impermeable barrier defines at least a chamber. The base is configured to be attached to the skin around the penis. The base defines an opening that corresponds to the opening of the sheath after attachment of the base to the fluid impermeable barrier. The method also includes disposing at least one porous material within the chamber.

[0010] In one embodiment, a method of using a system for collecting bodily fluids from an individual is disclosed. The method includes attaching a base to the skin around the penis. The base is configured to be secured or secured to a sheath. The sheath includes a fluid-impermeable barrier including a proximal region and a distal region extending from the proximal region. The proximal region exhibits a first width and the distal region exhibits a second width less than the first width. The proximal region defines an opening and the distal region defines a fluid outlet. The fluid-impermeable barrier defines at least a chamber. The sheath also includes at least one porous material disposed within the chamber.

[0011] Without limitation, features from any of the disclosed embodiments may be used in combination with each other. In addition, 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.

[0012] The drawings illustrate several embodiments of the present disclosure, and in different views or embodiments shown in the drawings, the same reference numbers refer to the same or similar elements or features. [Brief description of the drawings]

[0013] [Figure 1A] 1A and 1B are isometric top and bottom views, respectively, of a fluid collection assembly according to one embodiment. [Figure 1B] 1A and 1B are isometric top and bottom views, respectively, of a fluid collection assembly according to one embodiment. [Figure 1C] 1A-1D are cross-sectional schematic diagrams of a fluid collection assembly taken along planes CC and DD, respectively, according to optional embodiments. [Figure 1D] 1A-1D are cross-sectional schematic diagrams of a fluid collection assembly taken along planes CC and DD, respectively, according to optional embodiments. [Figure 1E] FIG. 2 is an exploded isometric view of the fluid collection assembly shown in FIGS. 1A and 1B. [Figure 1F] FIG. 1B is a cross-sectional view of the port taken along plane 1F-1F shown in FIG. 1A according to one embodiment. [Figure 1G] 1 is a cross-sectional schematic diagram of a porous material according to one embodiment. [Figure 1H] FIG. 2 is a top view of a base according to one embodiment. [Figure 1I] 2 is a cross-sectional schematic view of a base according to one embodiment. [Diagram 2] 1 is a cross-sectional schematic diagram of a fluid collection assembly including a first panel and a second panel integrally formed with one another according to one embodiment. [Figure 3A] 1A-1C are cross-sectional schematic diagrams illustrating how a substantially similar fluid collection assembly according to one embodiment can be used for buried and non-buried penises. [Figure 3B] 1A-1C are cross-sectional schematic diagrams illustrating how a substantially similar fluid collection assembly according to one embodiment can be used for buried and non-buried penises. [Figure 4] FIG. 1 is a block diagram of a system for fluid collection according to one embodiment. [Diagram 5] 1 is a flow diagram of a method for collecting fluid according to one embodiment. [Figure 6] 1 is a flow diagram of a method for manufacturing a fluid collection assembly according to one embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0014] The embodiments disclosed herein are directed to a male fluid collection assembly, a system including a male fluid collection assembly, a method of manufacturing a male fluid collection assembly, and a method of using a male fluid collection assembly. An exemplary fluid collection assembly includes a sheath and a base. The sheath includes a fluid impermeable barrier having a proximal region and a distal region extending from the proximal region. The proximal region exhibits a first width and the distal region exhibits a second width less than the first width. The proximal region defines an opening and the distal region defines a fluid outlet. The fluid impermeable barrier defines a chamber. The sheath also includes at least one porous material disposed within the chamber. The base can be attached (e.g., permanently attached) to the sheath or the base can be configured to be secured to the sheath at some future time. The base defines an opening that is aligned with the opening when the base is attached to the sheath. The base is configured to be secured to a region around the penis of an individual with the opening positioned over the penis.

[0015] An exemplary method of using the fluid collection assembly includes securing a base to an area around the penis of the individual. The base is positioned on the individual such that the penis extends through an opening defined by the base (e.g., the penis is not embedded) or is adjacent to such an opening (e.g., the penis is embedded). If the sheath is not already attached to the base, the sheath can also be attached to the base. For example, the sheath can be attached to the base before, during, or after securing the base to the area around the penis. After the base is secured to the area around the penis and the sheath is attached to the base, the individual can expel bodily fluids from the penis. The bodily fluids can include urine or sweat. The bodily fluids enter a chamber of the sheath. The porous material can receive at least a portion of the bodily fluids entering the chamber and direct the bodily fluids toward the fluid outlet. The method can include removing the bodily fluids from the chamber through the fluid outlet when a vacuum force is applied to the outlet, for example via a vacuum source in fluid communication with the chamber. It should be noted that although the fluid collection assembly disclosed herein is discussed as a male fluid collection assembly for use on the penis, the fluid collection assembly can also be a female fluid collection assembly for use to collect bodily fluids from a woman.

[0016] 1A and 1B are isometric top and bottom views, respectively, of a fluid collection assembly 100 according to one embodiment. FIGS. 1C and 1D are cross-sectional schematic views of the fluid collection assembly 100 taken along planes CC and DD, respectively, according to any embodiment. FIG. 1E is an exploded view of the fluid collection assembly 100. The fluid collection assembly 100 includes a sheath 102 and a base 104. In one embodiment, the sheath 102 includes a fluid-impermeable barrier 106 formed at least in part from a first panel 108 attached to a second panel 110. In one embodiment, as shown, the first panel 108 and the second panel 110 are separate sheets. The fluid-impermeable barrier 106 also defines a chamber 112 between the first panel 108 and the second panel, an opening 114, and a fluid outlet 118. The sheath 102 also includes at least one porous material 122 disposed within the chamber 112. The base 104 includes an opening 124. The base 104 is attached to a proximal region 160 of the fluid impermeable barrier 106, with the opening 124 aligned with the opening 114.

[0017] The inner surface 126 of the fluid-impermeable barrier 106 (e.g., the inner surfaces of the first panel 108 and the second panel 110) at least partially defines a chamber 112 within the fluid collection assembly 100. The fluid-impermeable barrier 106 temporarily contains bodily fluids within the chamber 112.

[0018] The fluid-impermeable barrier 106 can be formed from any suitable fluid-impermeable material, such as a fluid-impermeable polymer (e.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, polyurethane, polyethylene, polyvinyl chloride, polycarbonate, etc.), a metal film, natural rubber, another suitable material, or a combination thereof. Thus, the fluid-impermeable barrier 106 substantially prevents bodily fluids from passing through the fluid-impermeable barrier 106. In one example, the fluid-impermeable barrier 106 can be air-permeable and fluid-impermeable, thus allowing air flow through the chamber 112 while preventing leakage when a vacuum force is applied to the chamber 112 (i.e., the chamber 112 maintains approximately atmospheric pressure, thereby preventing bruising or kinking of the conduit 142 due to the vacuum force). In such an example, the fluid-impermeable barrier 106 can be formed from a hydrophobic material defining a plurality of pores. At least one or more portions of at least the outer surface 127 of the fluid impermeable barrier 106 may be formed from a soft and / or smooth material, thereby reducing abrasion.

[0019] In one embodiment, the fluid impermeable barrier 106 is formed from polyurethane, e.g., formed exclusively from polyurethane. In clinical trials, forming the fluid impermeable barrier 106 from polyurethane has been found to improve the functionality of the fluid collection assembly 100. For example, when formed from polyurethane, the fluid impermeable barrier 106 may exhibit greater flexibility than when the fluid impermeable barrier 106 is formed from another material. The increased flexibility of the fluid impermeable barrier 106 when formed from polyurethane may make it easier to attach the fluid collection assembly 100 to an individual and to maintain the fluid collection assembly 100 attached to the individual. The increased flexibility of the fluid impermeable barrier 106 when formed from polyurethane may also help enable the fluid collection assembly 100 to conform to an individual and / or fit under an individual's clothing, thereby increasing patient comfort. The increased flexibility of the fluid impermeable barrier 106 prevents or at least inhibits any corners formed in the fluid impermeable barrier 106 from digging in uncomfortably into the individual using the fluid collection assembly 100, thereby making the fluid collection assembly 100 more comfortable to use. Polyurethane can also remain flexible when welded or have a seal when otherwise formed. It has also been found that individuals using the fluid collection assembly 100 describe the fluid impermeable barrier 106 formed from polyurethane as being smoother than when the fluid impermeable barrier 106 is formed from other materials. The smoother feel of the fluid impermeable barrier 106 formed from polyurethane makes the fluid collection assembly 100 more comfortable to wear. It has also been found that forming the fluid impermeable barrier 106 from polyurethane allows the fluid impermeable barrier 106 to bend (e.g., crinkle, wrinkle, etc.) more gently than if the fluid impermeable barrier 106 was formed from another material. The improved acoustic quietness of the fluid impermeable barrier 106 may allow for a more discreet use of the fluid collection assembly 100. For example, when an individual using the fluid collection assembly 100 moves, the fluid impermeable barrier 106 is likely to flex.Forming the fluid impermeable barrier 106 from polyurethane allows for greater movement of the individual without substantial noise being generated by the fluid impermeable barrier 106. Finally, it has been found that a fluid impermeable barrier 106 comprising polyurethane can be welded to a variety of materials, thereby facilitating attachment of the base 104, vent 134, and port 130 to the fluid impermeable barrier 106.

[0020] In one embodiment, at least one of the first panel 108 or the second panel 110 is formed from an at least partially transparent, fluid impermeable material, such as polyethylene, polypropylene, polyurethane, polycarbonate, or polyvinyl chloride. Forming at least one of the first panel 108 or the second panel 110 from an at least partially transparent, fluid impermeable material allows a human (e.g., a physician) to inspect the penis. In some embodiments, both the first panel 108 and the second panel 110 are formed from an at least partially transparent, fluid impermeable material. For example, some conventional fluid collection assemblies including a sheath and a base may allow the sheath to be reversibly detached from the base after the base is secured to an area around the penis. Removing the sheath from the base allows a human to inspect the penis. However, configuring the sheath to be detachable from the base may allow leakage between the sheath and the base. As discussed above, the sheath 102 can be permanently attached to the base 104, and when the base 104 is properly attached to the sheath 102 (e.g., preventing wrinkles from forming between the sheath 102 and the base 104), leakage between the sheath 102 and the base 104 is substantially prevented. Selecting at least one of the first panel 108 or the second panel 110 to be formed from an at least partially transparent impermeable material allows for inspection of the penis without removing the entire fluid collection assembly 100 from the area around the penis. For example, the chamber 112 can include a penis receiving area 131 configured to receive the individual's penis when the penis extends into the chamber 112. The penis receiving area 131 can be defined by at least the porous material 122 and at least a portion of the at least partially transparent material of the first panel 108 and / or the second panel 110. In other words, the porous material 122 is positioned within the chamber 112, but such that when the penis is inserted into the chamber 112 through the opening 114, the porous material is not positioned between the penis and at least a portion of the transparent portions of the first panel 108 and / or second panel 110.The porous material 122 is generally not transparent, such that the at least partially transparent material of the first panel 108 and / or second panel 110 that defines the penis receiving area 131 forms a window that allows a human to view the penis receiving area 131 and inspect the penis.

[0021] In one embodiment, the second panel 110 is at least partially formed from an at least partially transparent material and forms a window that allows a human to view the penis receiving area 131. Additionally, the porous material 122 is positioned between the penis receiving area 131 and at least a portion of the first panel 108. Such an embodiment can help maintain the dignity of an individual using the fluid collection assembly 100. For example, during use, the second panel 110 is generally adjacent to the individual, e.g., adjacent to the thigh and / or perineum. Thus, the second panel 110 is generally obscured during use, and a human cannot view the penis without first lifting the sheath 102 away from the individual. Meanwhile, the first panel 108 can face away from the individual and be more easily viewed than the second panel 110. However, because the porous material 122 is not transparent and / or the first panel 108 is formed from an opaque material, a human (e.g., a passerby, a visitor, etc.) cannot view the penis through the first panel 108. Thus, in such an embodiment, the first panel 108 and / or the porous material 122 prevent a human from viewing the penis unless such an examination is required, thereby preserving the dignity of the individual using the fluid collection assembly 100. In one embodiment, the first panel 108 is formed at least partially from a transparent material and forms a window that allows a human to view the penis receiving area 131. Additionally, the porous material 122 is positioned between the penis receiving area 131 and at least a portion of the second panel 110. In such an embodiment, the human does not have to perform the additional action of lifting the sheath 102 to view the penis receiving area 131, but passersby can also view the penis receiving area 131, thereby not preserving the dignity of the individual using the fluid collection assembly 100.

[0022] As discussed above, at least a portion of the first panel 108 and at least a portion of the second panel 110 are attached to one another. In one embodiment, as shown, the first panel 108 and the second panel 110 are affixed to one another along at least a portion of their outer edges (e.g., top edge 136 and side edges 138). In such an embodiment, the first panel 108 and the second panel 110 are affixed to one another using any suitable technique, such as adhesives, sewing, heat sealing, impulse heating, direct heating, radio frequency ("RF") welding, ultrasonic ("US") welding, or any other technique. In certain embodiments, the first panel 108 and the second panel 110 are affixed to one another using impulse heating, as impulse heating is rapid and effective at affixing polyurethane panels to one another. As discussed in more detail below, forming the fluid-impermeable barrier 106 from the first panel 108 and the second panel 110 can improve the manufacturing speed of the fluid collection assembly 100, particularly when the first panel 108 and the second panel 110 are attached to one another using techniques other than sewing.

[0023] In one embodiment, the fluid-impermeable barrier 106 defines one or more orifices 132 extending therethrough. The sheath 102 includes one or more vents 134 attached to the fluid-impermeable barrier 106, the one or more vents 134 extending across the one or more orifices 132. The vents 134 are configured to allow air to flow through the vents 134 while preventing water (a major component of bodily fluids) from flowing through the vents 134. The vents 134 facilitate the flow of air through the chamber 112. For example, as discussed above, a vacuum can be provided to the chamber 112 from a vacuum source. The vacuum can draw air through the vents 134, thereby enabling the flow of air from the vents 134 to the fluid outlet 118. The flow of air from the vents 134 helps move bodily fluids toward the fluid outlet 118. The vent 134 also prevents a vacuum applied to the chamber 112 from rupturing tiny superficial blood vessels in the penis or the area around the penis (e.g., causing bruising) or otherwise damaging the penis or the area around the penis.

[0024] The vent 134 may include a porous hydrophobic material. The pores defined by the porous hydrophobic material may be interconnected, thereby allowing air to flow through the vent 134. The hydrophobic nature of the porous hydrophobic material may prevent water from flowing through the vent 134. In one example, the average size of the pores of the porous hydrophobic material (e.g., the average maximum lateral dimension of the pores) can be about 1 μm or more, about 5 μm or more, about 10 μm or more, about 20 μm or more, about 30 μm or more, about 40 μm or more, about 50 μm or more, about 60 μm or more, about 80 μm or more, about 100 μm or more, about 125 μm or more, about 150 μm or more, about 175 μm or more, about 200 μm or more, about 250 μm or more, about 300 μm or more, about 400 μm or more, about 500 μm or more, about 1 mm or less, about 750 μm or less, about 500 μm or less, or about 1 μm to about 10 μm, about 5 μm to about 20 μm. The thickness can be selected to be within the range of about 10 μm, about 10 μm to about 30 μm, about 20 μm to about 40 μm, about 30 μm to about 50 μm, about 40 μm to about 60 μm, about 50 μm to about 80 μm, about 60 μm to about 100 μm, about 80 μm to about 125 μm, about 100 μm to about 150 μm, about 125 μm to about 175 μm, about 150 μm to about 200 μm, about 175 μm to about 250 μm, about 200 μm to about 300 μm, about 250 μm to about 400 μm, about 300 μm to about 500 μm, about 400 μm to about 750 μm, or about 500 μm to about 1 mm. In one example, the porous hydrophobic material can exhibit a contact angle with water greater than 90°, such as in the range of about 90° to about 110°, about 100° to about 120°, about 110° to about 130°, about 120° to about 140°, about 130° to about 150°, about 140° to about 160°, about 150° to about 170°, or about 160° to about 180°. Generally, the size of the pores depends on the hydrophobicity of the porous hydrophobic material, and vice versa. For example, increasing the hydrophobicity of the porous hydrophobic material can increase the size of the pores.

[0025] In one embodiment, the vent 134 may include a porous polytetrafluoroethylene ("PTFE") layer. The porous PTFE layer is currently believed to be extraordinarily effective at preventing water from flowing through while allowing air to flow therethrough, even when the porous PTFE layer is exposed to acidic body fluids. However, porous PTFE is difficult to weld to other materials, such as polyurethane. Thus, the porous PTFE layer may be attached to a substrate. The substrate may include a porous material or may define one or more passageways through the substrate. The substrate may be selected to be easily attached to the porous PTFE layer and the fluid-impermeable barrier 106. For example, the substrate may be selected to be formed from polyvinyl chloride, since polyvinyl chloride is easily attached to the porous PTFE layer and the fluid-impermeable barrier 106.

[0026] In one embodiment, the orifice 132 is formed in the first panel 108 of the fluid impermeable barrier 106, and the vent 134 is attached to the first panel 108. In such an embodiment, the orifice 132 and the vent 134 are less likely to be covered by an individual's skin and contact the skin. Covering the orifice 132 and the vent 134 with the skin may prevent, or at least inhibit, air flow through the covered portions of the orifice 132 and the vent 134. Furthermore, an individual may find it uncomfortable to have the vent 134 contact the skin, and therefore locating the vent 134 in the first panel 108 may make the fluid collection assembly 100 more comfortable to wear. In one embodiment, the vent 134 is attached to the inside of the first panel 108 to prevent the edges of the vent 134 from rubbing or otherwise irritating the individual's skin.

[0027] In one embodiment, as shown, at least one of the orifices 132 is formed in a portion of the fluid impermeable barrier 106 located at or near an upper edge 136 of the fluid impermeable barrier 106, and at least one of the vents 134 is attached to such portion. The upper edge 136 of the fluid impermeable barrier 106 can include an edge of the fluid impermeable barrier 106 that is located above the opening 114 when the individual is standing, allowing the fluid collection assembly 100 to hang freely from the individual's pubic region. By forming the orifices 132 at or near the upper edge 136 and attaching the vents 134, air flowing through the vents 134 is directed over the penis (thereby keeping the penis dry) and inhibits bodily fluids from pooling near the upper edge 136. In one embodiment, as shown, at least one of the orifices 132 is formed in a portion of the fluid impermeable barrier 106 located at or near a side edge 138 of the fluid impermeable barrier 106, and at least one of the vents 134 is attached to such portion. The side edge 138 of the fluid impermeable barrier 106 may include an edge of the fluid impermeable barrier 106 extending from or near the top edge 136. Generally, air preferentially flows in a path extending from the vents 134 toward the fluid outlet 118. When the vents 134 are spaced from the side edge 138 and / or located at or near the top edge 136, the preferential air flow from these vents 134 may minimize air flow through at least some of the portions of the chamber 112 adjacent the side edge 138. Positioning the orifice 132 and the vent 134 at or near the side edge 138 can increase the flow of air through the portion of the chamber 112 adjacent the side edge 138, thereby preventing or at least inhibiting the accumulation of bodily fluids in such portion of the chamber 112.

[0028] In one embodiment, the orifices 132 and vents 134 can have an elongated shape. In one example, the orifices 132 and vents 134 located at or near the top edge 136 can have an elongated shape that is generally parallel to the top edge 136 and / or generally perpendicular to the longitudinal axis 140 of the fluid collection assembly 100. In such an example, the elongated shape of the orifices 132 and vents 134 causes air to preferentially flow through a greater percentage of the chamber 112 than would be the case if the orifices 132 and vents 134 did not have an elongated shape and / or were oriented in a different direction. In one example, the orifices 132 and vents 134 located at or near the side edges 138 can have an elongated shape that is generally parallel to the side edges 138 and / or generally perpendicular to the longitudinal axis 140 of the fluid collection assembly 100. In such an example, the elongated shape of the orifice 132 and the vent 134 allows air to flow preferentially through a greater proportion of the chamber 112 (e.g., a portion of the chamber 112 adjacent the side edge 138) than would occur if the orifice 132 and the vent 134 did not have an elongated shape and / or were facing in a different direction.

[0029] The opening 114 defined by the fluid-impermeable barrier 106 provides an entry path for fluid to enter the chamber 112 when the penis is buried and allows the penis to enter the chamber 112 (e.g., the penis receiving area 131) when the penis is not buried. The opening 114 can be defined by the fluid-impermeable barrier 106 (e.g., an inner edge of the fluid-impermeable barrier 106). For example, the opening 114 can be formed in and extend through the fluid-impermeable barrier 106 from the outer surface 127 to the inner surface 126, thereby allowing bodily fluids to enter the chamber 112 from outside the fluid collection assembly 100.

[0030] In one embodiment, the second panel 110 defines the entirety of the opening 114. For example, the opening 114 is a cutout defined by the second panel 110 and is spaced from the periphery (e.g., an edge) of the second panel 110. In such an example, the second panel 110 can assume a shape that substantially corresponds to the shape of the first panel 108, which can facilitate attaching the first panel 108 to the second panel 110 along their periphery. Also, when the penis is not located within the chamber 112 and the sheath 102 is resting on a flat surface, the first panel 108 and the second panel 110 can be substantially flat. Allowing the first panel 108 and the second panel 110 to be substantially flat can make the fluid collection assembly 100 less noticeable to wear and can reduce pooling of bodily fluids on an individual. However, in some embodiments, the opening 114 is not spaced from the periphery of the second panel 110. In such embodiments, the opening 114 may be a cutout extending inwardly from at least one perimeter of the second panel 110. Other examples of forming the opening 114 in the second panel 110 are disclosed in International Patent Application No. PCT / US2021 / 039866, filed June 30, 2021, the disclosure of which is incorporated herein by reference in its entirety.

[0031] As discussed above, the fluid impermeable barrier 106 includes a proximal region 160 and a distal region 162 that extends from the proximal region 160, for example, to the fluid outlet 118 (e.g., port 130). The proximal region 160 can define the opening 114, and the distal region 162 can define the fluid outlet 118. Both the proximal region 160 and the distal region 162 define the chamber 112.

[0032] In one embodiment, the fluid impermeable barrier 106 exhibits a generally bullet-shaped shape. As used herein, the fluid impermeable barrier 106 exhibits a generally bullet-shaped shape when the proximal region 160 of the fluid impermeable barrier 106 exhibits a substantially constant first width and the distal region 162 of the fluid impermeable barrier 106 exhibits a second width that is smaller than the first width. The first and second widths may be measured perpendicular to the longitudinal axis 140 and may be greater than a thickness of the sheath 102 when the sheath 102 is positioned on a flat surface. The generally bullet-shaped shape of the fluid impermeable barrier 106 facilitates operation of the fluid collection assembly 100 while making the sheath 102 more comfortable. For example, the substantially constant first width maintains contact with the upper thigh of an individual, thereby maintaining the position of the fluid collection assembly 100. The substantially constant first width also allows the penis to become erect more easily because the sheath 102 falls between the individual's thighs and inhibits the erect penis from lifting the portion of the sheath 102 that falls between the thighs. Reducing the second width allows the sheath 102 to become thinner, thereby allowing the portion of the sheath 102 that is less likely to receive the penis to sag between the individual's thighs. This sagging allows gravity to assist in moving bodily fluids toward the fluid outlet 118. Reducing the second width also directs bodily fluids toward the fluid outlet 118 and the port 130.

[0033] In one embodiment, the second width of the distal region 162 can vary (e.g., decrease) along the length of the distal region 162 measured perpendicular to the longitudinal axis 140. In one example, the second width of the distal region 162 can decrease at a constant rate from the proximal region 160 toward the fluid outlet 118 (e.g., to the fluid outlet 118). The constant decrease in the second width straightens the side edges 138 of the fluid impermeable barrier 106 that define the distal region 162. The straight side edges 138 may form corners at the intersection between the proximal region 160 and the distal region 162, which may dig in uncomfortably to an individual. In one example, the second width of the distal region 162 can decrease at a variable rate (e.g., an increasing rate) from the proximal region 160 toward the fluid outlet 118 (e.g., to the fluid outlet 118). The variable rate decrease in the second width causes the side edges 138 of the fluid impermeable barrier 106 that define the distal region 162 to be curved, e.g., convexly curved. The curved side edges 138 can prevent the formation of corners that can dig into an individual, thereby making the fluid collection assembly 100 more comfortable than if the side edges 138 of the distal region 162 were straight. However, it should be noted that when the side edges 138 of the distal region 162 are straight rather than curved, air flow through the distal region 162 can be more uniform.

[0034] It should be noted that the fluid-impermeable barrier 106 can also assume a shape other than a generally bullet-shaped shape. In one example, the fluid-impermeable barrier 106 can assume a generally rectangular shape, as discussed in more detail in International Patent Application No. PCT / US2021 / 039866, filed June 30, 2021, the disclosure of which was previously incorporated by reference herein. In one example, the fluid-impermeable barrier 106 can assume a generally triangular shape, a semi-elliptical shape, or any other suitable shape.

[0035] The fluid impermeable barrier 106 defines a fluid outlet 118. The fluid outlet 118 can be formed from portions of the first panel 108 and the second panel 110 that are not attached to one another. In an embodiment, not shown, the fluid outlet 118 is configured to be directly attached to the conduit 142. In such an embodiment, the conduit 142 can be at least partially disposed within the chamber 112 or can be otherwise in fluid communication with the chamber 112 through the fluid outlet 118. The fluid outlet 118 can be sized and shaped to form at least a substantially liquid-tight seal with the conduit 142, thereby substantially preventing bodily fluids from leaking from the chamber 112. The conduit 142 can be attached to the fluid outlet 118 (e.g., the first panel 108 and the second panel 110) by joining the conduit 142 to the fluid outlet 118 using adhesives, welding, an interference or friction fit, or other methods. Attaching the conduit 142 to the fluid outlet 118 can prevent leakage and can prevent the conduit 142 from being inadvertently removed from the fluid outlet 118. In one example, the conduit 142 can be attached to the fluid outlet 118 in the same manufacturing step as the first panel 108 and the second panel 110 are attached to one another. In one embodiment, as shown, the fluid outlet 118 is configured to be indirectly attached to the conduit 142. In such an embodiment, the sheath 102 can include a port 130 attached directly to the fluid impermeable barrier 106, the port 130 configured to be attached to the conduit 142.

[0036] FIG. 1F is a cross-sectional view of the port 130 taken along the plane 1F-1F shown in FIG. 1E according to one embodiment. The port 130 includes a first portion 144 and a second portion 146. The first portion 144 is configured to be attached to the fluid impermeable barrier 106 and optionally configured to be at least partially disposed within the chamber 112. The second portion 146 is configured to be attached to the conduit 142. The first portion 144 defines an inlet 148 and the second portion 146 defines an outlet 150 of the port 130 located downstream from the inlet 148. The port 130 also defines a channel 152 extending from the inlet 148 to the outlet 150. It should be noted that the inlet 148 refers to the inlet of the channel 152 and not necessarily the inlet of the port 130. In one example, the inlet 148 can be the inlet of both the port 130 and the channel 152 when the port 130 does not include a sink 156. In one example, as shown, when the port 130 includes a sink 156 , the inlet 148 need not be an inlet to the port 130 because the sink 156 forms the inlet to the port 130 .

[0037] The first portion 144 of the port 130 may be attached to the fluid impermeable barrier 106 using any suitable technique. In one embodiment, the first portion 144 is disposed between the first panel 108 and the second panel 110 prior to attaching the first portion 144 to the fluid impermeable barrier 106. In such an embodiment, the first portion 144 abuts and is attached to the inner surface 126 of the fluid impermeable barrier 106. In one embodiment, the first portion 144 is attached to the fluid impermeable barrier 106 using at least one of an adhesive, impulse heating, direct heating, US welding, RF welding, any other attachment technique disclosed herein, or another other suitable attachment technique.

[0038] At least the second portion 146 exhibits a stiffness greater than the fluid-impermeable barrier 106. The second portion 146 can exhibit a stiffness greater than the fluid-impermeable barrier 106 because at least a portion of the second portion 146 exhibits a thickness greater than the fluid-impermeable barrier 106 or because at least a portion of the second portion 146 is formed from a material that exhibits a Young's modulus (i.e., elastic modulus) greater than the Young's modulus of a material forming at least a portion of the fluid-impermeable barrier 106. Increasing the stiffness of the second portion 146 relative to the fluid-impermeable barrier 106 allows the second portion 146 to be attached to the conduit 142 using techniques that may be difficult or impossible to perform when the conduit 142 is attached directly to the fluid-impermeable barrier 106. In one example, the conduit 142 can be attached to the second portion 146 using an interference fit that may be difficult or impossible to perform when the conduit 142 is attached directly to the fluid-impermeable barrier 106. In such an example, the surface of the second portion 146 configured to abut the conduit 142 is tapered. Tapering the surface of the second portion 146 can make it easier to insert the second portion 146 into the conduit 142 when the second portion 146 forms a male connector, or easier to receive the conduit 142 into the second portion 146 when the second portion 146 forms a female connector. Tapering the surface of the second portion 146 also allows for control of the strength of the interference fit between the second portion 146 and the conduit 142 by controlling how far the second portion 146 is inserted into the conduit 142 or how far the conduit 142 is inserted into the second portion 146. In one example, not shown, the surface of the second portion 146 is configured to be attached to the conduit 142 with a threaded fastening, which may be difficult or impossible to achieve when the conduit 142 is attached directly to the fluid impermeable barrier 106. In such examples, second portion 146 may include one or more helically extending ridges extending from a surface of second portion 146 that contacts or is closest to conduit 142. It should be noted that a surface of second portion 146 that includes a thread and / or the threads may be tapered.In one example, although not shown, a surface of second portion 146 that contacts or is closest to conduit 142 may include a circumferentially extending ridge. It should be noted that the surface of second portion 146 that includes the ridge and / or the ridge may also be tapered.

[0039] In one embodiment, at least the second portion 146 exhibits a stiffness greater than that of the conduit 142. The second portion 146 can exhibit a stiffness greater than that of the conduit 142 because at least a portion of the second portion 146 exhibits a thickness greater than that of the conduit 142 or because at least a portion of the second portion 146 is formed from a material exhibiting a Young's modulus greater than that of a material forming at least a portion of the conduit 142. Increasing the stiffness of the second portion 146 prevents the collapse of the channel 152. For example, it has been found that in certain circumstances, attaching the conduit 142 directly to the fluid-impermeable barrier 106 may cause the portion of the conduit 142 attached to the fluid-impermeable barrier 106 to at least partially collapse when a strong vacuum is applied to the chamber 112. However, increasing the stiffness of the port 130 prevents such collapse.

[0040] In one embodiment, the first portion 144 exhibits a greater stiffness than the fluid impermeable barrier 106 and / or the conduit 142. For example, the first portion 144 can exhibit a stiffness comparable to that of the second portion 146. Increasing the stiffness of the first portion 144 prevents collapse of the inlet 148, the portion of the channel 152 defined by the inlet 148, and the sink 156. Increasing the stiffness of the first portion 144 can also make it easier to attach the port 130 to the first portion 144 because pressure can be applied to the first portion 144 without substantially deforming the first portion 144 during the attachment process.

[0041] The first portion 144 can have a different shape than the second portion 146. For example, the first portion 144 can have a first elongated shape extending in a direction generally perpendicular to the longitudinal axis 140, and the second portion 146 can have a second elongated shape (e.g., a generally cylindrical shape) extending generally parallel to the longitudinal axis 140. The first elongated shape of the first portion 144 can enhance the attachment between the first portion 144 and the fluid-impermeable barrier 106 by increasing the surface area of ​​the first portion 144 that is attached to the fluid-impermeable barrier 106. The first elongated shape of the first portion 144 also prevents, or at least inhibits, twisting of the sheath 102. Examples of the first elongated shape include a generally rectangular cross-sectional shape, a generally elliptical cross-sectional shape, a generally oval cross-sectional shape, or a generally diamond cross-sectional shape. In a particular example, the first elongated shape is a generally diamond cross-sectional shape. Because the relatively sharp corners of the generally diamond shaped cross-sectional shape spaced farthest from the second portion 146, as compared to more rounded corners, facilitate attachment of the fluid impermeable barrier 106 to the first portion 144 without forming gaps between the first portion 144, the first panel 108, and the second panel 110. In certain instances, the first elongated shape includes rounded corners because rounded corners are less likely to dig into an individual uncomfortably than sharp corners. The second elongated shape of the second portion 146 extending parallel to the longitudinal axis 140 can facilitate attachment to the conduit 142.

[0042] The first portion 144 can exhibit a first maximum thickness and the second portion 146 can exhibit a second maximum thickness. As discussed in more detail below, the sheath 102 is configured to be substantially flat when placed on a flat surface, thereby allowing the fluid collection assembly 100 to be worn unobtrusively, preventing or at least inhibiting the accumulation of bodily fluids in the chamber 112, and allowing the fluid collection assembly 100 to be used with a buried penis. It is noted that "substantially flat" generally allows for tolerances that do not prevent the fluid collection assembly 100 from being worn unobtrusively, yet inhibits the accumulation of bodily fluids, allows the fluid collection assembly 100 to be used with a buried penis, and allows for tolerances caused by minor bulges or waves formed in the port 130, vent 134, or fluid impermeable barrier 106, for example. Generally, the port 130 is configured to minimize the first maximum thickness and the second maximum thickness, thereby preventing or at least inhibiting the ability of the sheath 102 to flatten. The second maximum thickness is generally dictated by the need to attach the conduit 142 to the second portion 146. For example, the second maximum thickness may need to be slightly larger than the inner diameter of the conduit 142 when the second portion 146 is a male connector, and may need to be slightly larger than the outer diameter of the conduit 142 when the second portion 146 is a female connector. In a particular example, the second maximum thickness of the second portion 146 is a male connector because the second maximum thickness of the second portion 146 is smaller when the second portion 146 is a male connector than when the second portion 146 is a female connector. It should be noted that when the second portion 146 is a male connector, the second maximum thickness can be less than the outer diameter of the conduit 142, so that the second portion 146 does not adversely affect the ability of the sheath 102 to flatten as much as it would if the conduit 142 were directly attached to the fluid-impermeable barrier 106.

[0043] Generally, the first maximum thickness of the first portion 144 is substantially less than or equal to the second maximum thickness so that the first portion 144 has a minimal adverse effect on the ability of the sheath 102 to flatten. In one example, the first maximum thickness can be substantially equal to the second maximum thickness when the second maximum thickness is located at or near the intersection between the first portion 144 and the second portion 146 to prevent the formation of corners that may dig in uncomfortably into an individual. When the outer surface 154 of the second portion 146 is tapered, the second maximum thickness can be located at or near the intersection between the first portion 144 and the second portion 146.

[0044] In one embodiment, the first maximum thickness of the first portion 144 is greater than the collective thickness of the fluid impermeable barrier 106 and the porous material 122 (e.g., the collective thickness of the first panel 108 and the second panel 110). Increasing the thickness of the first maximum thickness of the first portion 144 relative to the collective thickness of the fluid impermeable barrier 106 and the porous material 122 prevents the sheath 102 from flattening at or near the port 130. However, it should be noted that by making the fluid impermeable barrier 106 more flexible, particularly when the fluid impermeable barrier 106 is formed from polyurethane, the percentage of the sheath 102 adjacent the port 130 that does not flatten is minimized. Additionally, the first portion 144 is at least one of spaced from the opening 114 to prevent the first maximum thickness from affecting the ability of the fluid collection assembly 100 to be used with a buried penis, located at a point where air flow is greatest to inhibit pooling of bodily fluids, or the first maximum thickness is less than the maximum thickness of the conduit 142, whereby the conduit 142 has a more adverse effect on the ability of the fluid collection assembly 100 to be used unobtrusively than the port 130. In one example, the first maximum thickness can be about 500% or less (i.e., 5 times greater), about 400% or less, about 300% or less, about 200% or less, or about 150% or less greater than the collective thickness of the fluid impermeable barrier 106 and the porous material 122. It should be noted that the first maximum thickness may be greater than the collective thickness of the fluid-impermeable barrier 106 and the porous material 122 to allow the inlet 148 to be large enough to remove bodily fluid from the chamber 112, which may depend on the size of the conduit 142.

[0045] In one embodiment, the first portion 144 of the port 130 can define a sink 156 separate from the inlet 148. The sink 156 is positioned upstream from the inlet 148. For example, the inlet 148 can exhibit dimensions (e.g., width and / or thickness) equivalent to corresponding dimensions of the channel 152 at or near the intersection of the first portion 144 and the second portion 146. The dimensions of the inlet 148 are equivalent to the corresponding dimensions of the channel 152 when the dimensions of the inlet 148 differ from the dimensions of the channel 152 by at most about ±10% or at most about ±5%. For example, as shown, the inlet 148 exhibits a width substantially the same as the width of the channel 152 at the intersection of the first portion 144 and the second portion 146. The sink 156 exhibits a maximum dimension that is larger than the corresponding dimension of the inlet 148 and is not equivalent to the corresponding dimension of the channel 152 at the intersection of the first portion 144 and the second portion 146. For example, as shown, sink 156 defined by first portion 144 exhibits a maximum dimension (i.e., width) that is significantly greater than the corresponding width of inlet 148 and the corresponding width of channel 152 at the intersection of first portion 144 and second portion 146. Note that the greater width of first portion 144 compared to second portion 146 enables first portion 144 to define sink 156.

[0046] The sink 156 facilitates the flow of bodily fluids through the chamber 112 into and through the port 130. For example, the wider dimensions of the sink 156 compared to the inlet 148 allow bodily fluids to enter the port 130 more easily than a substantially similar port 130 that does not include the sink 156 (i.e., the inlet 148 is the inlet to the port 130). The wider width of the sink 156 compared to the inlet 148 also distributes the airflow over a larger percentage of the chamber 112 than a substantially similar port 130 that does not include the sink 156. The wider dimensions of the sink 156 compared to the inlet 148 increases the unoccupied volume of the port 130 than would be the case if the port 130 did not include the sink 156. The increased volume of the port 130 allows the port 130 to receive and retain a larger volume of bodily fluids, as the port 130 can temporarily contain bodily fluids in addition to the porous material 122, thereby preventing the porous material 122 from becoming oversaturated with bodily fluids. In other words, the sink 156 can form a fluid reservoir. It has also been found that the sink 156 reduces turbulence of bodily fluid flowing through the port 130 compared to when the port 130 did not include the sink 156. The reduced turbulence allows bodily fluid to flow through the port 130 faster than when the port 130 did not include the sink 156, thereby reducing oversaturation of the bodily fluid in the porous material 122. The reduced turbulence of bodily fluid by the sink 156 can facilitate operation of the fluid collection assembly 100, particularly when the second portion 146 forms a male connector. For example, forming the second portion 146 as a male connector reduces the lateral dimensions (e.g., diameter) of the channel 152, which limits the rate at which bodily fluid is removed from the chamber 112. The reduced turbulence of bodily fluid flowing through the port 130 by the sink 156 helps to alleviate this problem.

[0047] In one embodiment, the dimensions of the sink 156 are maintained substantially constant. Maintaining the dimensions of the sink 156 substantially constant maximizes the volume of the sink 156, which in turn maximizes the volume of the port 130 that can be a fluid reservoir. However, maintaining the dimensions of the sink 156 substantially constant may result in a step at the intersection of the inlet 148 and the sink 156, which may result in more turbulent flow of bodily fluids through the port 130 than would be the case if there were no step between the inlet 148 and the sink 156. In one embodiment, as shown, the dimensions of the sink 156 may taper along at least a portion of the length of the sink 156 (e.g., measured parallel to the longitudinal axis 140). In other words, the dimensions of the sink 156 may vary along at least a portion of its length. Tapering the dimensions of the sink 156 may prevent or at least reduce a step at the intersection of the inlet 148 and the sink 156. Thus, the tapered dimension may result in less turbulence in the bodily fluid flowing through port 130 than would be the case if the dimensions of sink 156 were kept substantially constant. It should be noted that the tapered dimension of sink 156 reduces the volume of bodily fluid that may be temporarily contained within sink 156, and therefore within port 130.

[0048] The flexibility of the fluid impermeable barrier 106 may cause the sheath 102 to bend and assume a generally L- or U-shape such that the fluid impermeable barrier 106 extends across the inlet of the port 130 (e.g., across the sink 156, or across the inlet 148 when the port 130 does not include the sink 156). For example, during use, the fluid collection assembly 100 may be positioned on an individual such that the fluid collection assembly 100 extends generally from the individual's pubic region toward the individual's feet. However, in many hospitals, the vacuum source is positioned behind the individual's bed, such that when the individual is lying in bed, the conduit 142 extends from the fluid outlet 118 toward the individual's head. Thus, the conduit 142 may cause the sheath 102 to bend and assume a generally L- or U-shape. It has been found that when the sheath 102 is bent to assume a generally L- or U-shape, the fluid impermeable barrier 106 may block the entrance to the port 130, thereby preventing or inhibiting bodily fluids from entering the port 130. Thus, in some embodiments, the port 130 may include at least one tab 158 extending from the first portion 144 into the chamber 112.

[0049] The tabs 158 extending from the first portion 144 increase the likelihood that a passageway will be formed that allows bodily fluid to flow into the ports 130, even when the sheath 102 is bent to assume a generally L- or U-shape. In other words, the tabs 158 may allow bodily fluid to continue to flow into the ports 130 and / or increase the rate at which bodily fluid can flow into the ports 130 when the sheath 102 is bent.

[0050] Tab 158 can extend from first portion 144 a distance of about 2 mm or more, about 3 mm or more, about 4 mm or more, about 5 mm or more, about 6 mm or more, about 7 mm or more, about 8 mm or more, about 9 mm or more, about 1 cm or more, about 1.25 cm or more, about 1.5 cm or more, or within the range of about 1 mm to about 3 mm, about 2 mm to about 4 mm, about 3 mm to about 5 mm, about 4 mm to about 6 mm, about 5 mm to about 7 mm, about 6 mm to about 8 mm, about 7 mm to about 9 mm, about 8 mm to about 1 cm, about 9 mm to about 1.25 cm, or about 1 cm to about 1.5 cm. Generally, the ability of tab 158 to allow bodily fluid to continue to flow into port 130 when sheath 102 is bending and / or to increase the rate at which bodily fluid can flow into port 130 improves as the distance tab 158 extends from first portion 144 increases. However, increasing the distance that tab 158 extends from first portion 144 increases the likelihood that tab 158 will dig in uncomfortably into an individual, for example, when sheath 102 is bent. The likelihood that tab 158 will dig in uncomfortably into an individual can be mitigated by cushioning tab 158 with porous material 122. When tab 158 is formed on the side of first portion 144 adjacent first panel 108 and porous material 122 is configured to be positioned between tab 158 and second panel 110, tab 158 can be cushioned by porous material 122.

[0051] In one embodiment, the tab 158 may be formed from the same material as the rest of the port 130. In such an embodiment, the port 130 may exhibit a unitary (e.g., unitary) construction, which may make manufacturing the port 130 more efficient. In one embodiment, the tab 158 may be separate (e.g., formed from a different material) from the rest of the port 130. In such an embodiment, manufacturing the port 130 may be more difficult because manufacturing the port 130 requires forming two separate pieces (rather than one) and attaching them to one another.

[0052] 1A-1E, the fluid outlet 118 and the port 130 can be located at or near the distal region 162 of the sheath 102 that is expected to be the gravimetric lowest point of the chamber 112 when worn by a user. Locating the fluid outlet 118 and the port 130 at or near the distal region 162 of the sheath 102 allows the conduit 142 to receive more bodily fluids and reduces the likelihood of pooling (e.g., pooling of bodily fluids that can cause bacterial growth and foul odors) than if the fluid outlet 118 and the port 130 were located elsewhere. For example, bodily fluids pool in the porous material 122 due to capillary forces. However, bodily fluids can preferentially flow in the direction of gravity, especially when at least a portion of the porous material 122 is saturated with bodily fluids. Accordingly, the fluid outlet 118 and the port 130 can be located in the fluid collection assembly 100 at a location that is expected to be the low weight point in the fluid collection assembly 100 when worn by a user.

[0053] As previously discussed, the sheath 102 includes at least one porous material 122 disposed within the chamber 112. The porous material 122 can direct bodily fluids to one or more selected areas of the chamber 112, for example, away from the penis and toward the fluid outlet 118. Thus, the porous material 122 can facilitate removal of bodily fluids from the chamber 112 and can form a padding layer that prevents the penis from hitting the wet material, which can cause irritation of the skin of the penis and / or make the fluid collection assembly 100 more uncomfortable to wear. The porous material 122 can also attenuate the flow of urine from the penis.

[0054] In one embodiment, the porous material 122 includes a wicking configured to wick bodily fluid away from the opening 114, thereby preventing the bodily fluid from escaping the chamber 112. Such "wicking" does not include absorption of fluid into the wicking. In other words, after the material is exposed to the fluid for a period of time and removed from the fluid, there is substantially no absorption of the fluid into the material. Although absorption is not desired, the term "substantially no absorption" can allow for absorption (e.g., absorbency) of a nominal amount of fluid into the wicking, such as less than about 30% by weight of the dry weight of the wicking, less than 20% by weight, less than 15% by weight, less than 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 wicking. The wicking can also wick fluid generally toward the interior of the chamber 112, as discussed in more detail below. In one embodiment, the porous material 122 is configured to adsorb or absorb bodily fluid. Similar to wicking materials, such absorbent or absorbing materials can transport bodily fluids away from opening 114 , thereby preventing the bodily fluids from leaking out of chamber 112 .

[0055] The porous material 122 can be formed from any suitable porous material. For example, the porous material 122 can be formed from nylon (e.g., spun nylon fibers), polyester, polyurethane, polyethylene, polypropylene, other porous polymers, hydrophobic foams, open cell foams, wool, silk, flax, cotton (e.g., cotton gauze), felt, other fabrics, coated porous materials (e.g., water repellent coated porous materials), any other suitable porous materials, or combinations thereof.

[0056] FIG. 1G is a cross-sectional schematic diagram of the porous material 122 according to one embodiment. The porous material 122 includes a first layer 164 and a second layer 166. The first layer 164 and the second layer 166 can be woven materials. The porous material 122 also includes a plurality of fibers 168, which form a layer between the first layer 164 and the second layer 166. The first layer 164, the second layer 166, and the plurality of fibers 168 each define a plurality of pores, which allow for transport of bodily fluids and circulation of air through the porous material 122. The pores defined by the plurality of fibers 168 can be at least one of larger pores or more pores, which reduces the possibility of dried bodily fluids clogging the porous material 122. The presence of the plurality of fibers 168 also enhances the feel of the porous material 122 against the penis and provides a cushioning effect to the penis. The plurality of fibers 168 may also prevent the porous material from collapsing due to vacuum forces.

[0057] In one embodiment, the plurality of fibers can space the first layer 164 a distance d from the second layer 166. The distance d can be selected based on the number of fibers forming the plurality of fibers 168 and the density at which the plurality of fibers 168 are packed. For example, the distance d can be selected to be about 0.25 mm or more, about 0.5 mm or more, about 0.75 mm or more, about 1 mm or more, about 1.5 mm or more, about 2 mm or more, about 3 mm or more, about 4 mm or more, about 5 mm or more, about 6 mm or more, about 8 mm or more, about 10 mm or more, about 12.5 mm or more, about 15 mm or more, or within a range of about 0.25 mm to about 0.75 mm, about 0.5 mm to about 1 mm, about 0.75 mm to about 1.5 mm, about 1 mm to about 2 mm, about 1.5 mm to about 3 mm, about 2 mm to about 4 mm, about 3 mm to about 5 mm, about 4 mm to about 6 mm, about 5 mm to about 8 mm, about 6 mm to about 10 mm, about 8 mm to about 12.5 mm, or about 10 mm to about 15 mm. The thickness of the distance d can be selected to adjust the absorbency of the porous material 122. For example, increasing the thickness can increase the volume of the plurality of fibers 168 and / or the porosity defined by the plurality of fibers 168, thereby increasing the amount of bodily fluid that can be received by and at least partially contained within the porous material 122.

[0058] The first layer 164, the second layer 166, and the plurality of fibers 168 may be formed from any suitable material, such as a hydrophobic material, a hydrophilic material, polyester, cotton, or any other porous material disclosed herein. In one embodiment, one or more of the first layer 164, the second layer 166, or the plurality of fibers 168 may be formed from a hydrophobic material that inhibits bodily fluids from being stored in the porous material 122, thereby facilitating the removal of bodily fluids from the chamber 112. In one embodiment, the first layer 164, the second layer 166, or one or more of the plurality of fibers 168 may be formed from a hydrophilic material that allows bodily fluids to be temporarily stored in the porous material 122, thereby limiting the amount of bodily fluids that may pool around the skin of the individual. In one embodiment, two or more of the first layer 164, the second layer 166, or the plurality of fibers 168 may be formed from different materials. In such an embodiment, the first layer 164 may define the penis receiving area 131 or may otherwise be located closer to the penis receiving area 131 than the second layer 166. The first layer 164 may be formed from a hydrophobic material and the plurality of fibers 168 may be formed from a hydrophilic material. In such a configuration, bodily fluids may be drawn through the first layer 164 and temporarily contained within the plurality of fibers 168. However, the first layer 164 may remain substantially dry due to its hydrophobicity, thereby enabling the porous material 122 to provide a dry feeling to the penis. In one embodiment, at least one of the first layer 164 or the second layer 166 is formed from a fabric (e.g., a fabric gauze) and the plurality of fibers 168 is formed from nylon fibers (e.g., spun nylon fibers).

[0059] In one embodiment, although not shown, the porous material 122 can be formed from two layers rather than three layers as shown in FIG. 1G. For example, the porous material 122 can be formed from a fluid-permeable membrane and a fluid-permeable support. The fluid-permeable support can define the penis receiving area 131 or can be otherwise located closer to the penis receiving area 131 than the fluid-permeable support. The fluid-permeable membrane can be configured and / or constructed to wick bodily fluids away from the penis receiving area 131, thereby minimizing the amount of bodily fluids present within the penis receiving area 131 or otherwise contacting the individual's skin. It is also noted that the fluid-permeable membrane can be configured to adsorb or absorb bodily fluids, thereby minimizing the amount of bodily fluids present within the penis receiving area 131 or otherwise contacting the individual's skin. The fluid-permeable membrane can be formed from any of the porous materials disclosed herein. For example, the fluid-permeable membrane can be formed from a fabric, such as gauze (e.g., silk, linen, or cotton gauze), another soft fabric, another smooth fabric, a woven or nonwoven material (e.g., spun nylon fibers), or any other suitable porous material. Forming the fluid-permeable membrane from gauze, a soft fabric, and / or a smooth fabric (or any of the other porous materials 122 disclosed herein that may contact the penis) can reduce chafing caused by the fluid collection assembly 100.

[0060] The fluid-permeable support is configured to support the fluid-permeable membrane, since the fluid-permeable membrane may be formed from a material that is relatively collapsible, thin, or otherwise easily deformed. For example, the fluid-permeable support may be positioned such that the fluid-permeable membrane is disposed between the fluid-permeable support and the fluid-impermeable barrier 106. Thus, the fluid-permeable support may support and maintain the position of the fluid-permeable membrane. The fluid-permeable support may include any of the fluid-permeable membrane materials disclosed hereinabove. For example, the fluid-permeable membrane material may be utilized in a denser or stiffer form than the fluid-permeable membrane when used as a fluid-permeable support. The fluid-permeable support may be formed from any fluid-permeable material that does not deform as much as the fluid-permeable membrane. For example, the fluid-permeable support may include a porous polymer (e.g., nylon, polyester, polyurethane, polyethylene, polypropylene, etc.) structure or an open-cell foam. In some examples, the fluid-permeable support may be formed from a natural material, such as cotton, wool, silk, or a combination thereof. In such examples, the material may have a coating to prevent or limit absorption of fluid into the material, such as a water repellent coating, In some examples, the fluid permeable support may be formed from cloth, felt, gauze, or combinations thereof.

[0061] In one embodiment, the porous material 122 may include a single layer (e.g., one of the first layer 164, the second layer 166, a layer formed from a plurality of fibers 168, a fluid-permeable membrane, a fluid-permeable support, or another porous layer). In one embodiment, the porous material 122 may be formed from four or more layers.

[0062] Examples of other materials from which the porous material 122 can be formed are disclosed in U.S. Provisional Patent Application No. 63 / 134,754, filed January 7, 2021, U.S. Provisional Patent Application No. 63 / 241,575, filed September 8, 2021, and U.S. Provisional Patent Application No. 63 / 247,491, filed September 23, 2021, the disclosures of each of which are incorporated by reference in their entirety into this application.

[0063] In one embodiment, the porous material 122 can be a sheet (e.g., a multi-layer sheet). The porous material 122 is a sheet when it is at least one of substantially planar when placed on a flat surface, does not define a cavity (e.g., is not tubular), and exhibits a length and width that is greater than its thickness. Forming the porous material 122 as a sheet can facilitate manufacturing of the fluid collection assembly 100. For example, forming the porous material 122 as a sheet can enable each of the first panel 108, the second panel 110, and the porous material 122 to be sheets. During manufacturing of the fluid collection assembly 100, the first panel 108, the second panel 110, and the porous material 122 can be stacked and then attached to one another in the same manufacturing step. For example, the porous material 122 can exhibit a shape that is the same size as the size of the first panel 108 and the second panel 110, or more preferably, slightly smaller. Thus, the porous material 122 may be attached to the first panel 108 and the second panel 110 by attaching the first panel 108 and the second panel 110 to one another along their outer edges (e.g., the top edge 136 and the side edges 138). The porous material 122 may be slightly smaller than the first panel 108 and the second panel 110 such that the first panel 108 and / or the second panel 110 extends around the porous material 122, so that the porous material 122 does not form a passageway through the fluid-impermeable barrier 106 through which bodily fluids may leak. Attaching the porous material 122 to the first panel 108 and / or the second panel 110 may also prevent the porous material 122 from significantly moving within the chamber 112, for example, preventing the porous material 122 from bunching up near the fluid outlet 118. In one example, the porous material 122 can be attached (eg, with an adhesive) to the first panel 108 or the second panel 110 before or after the first panel 108 is attached to the second panel 110.In one example, rather than attaching the porous material 122 to at least one of the first panel 108 or the second panel 110, the porous material 122 may simply be disposed within the chamber 112. In one embodiment, as discussed in more detail below, the porous material 122 may assume a shape other than a sheet, such as a hollow generally cylindrical shape.

[0064] The porous material 122 can exhibit a shape that generally corresponds to the shape of the fluid-impermeable barrier 106 such that the porous material 122 partially or substantially completely occupies all of the chamber 112. For example, as shown, the porous material 122 can exhibit a generally bullet-shaped shape. The porous material 122 can exhibit a generally bullet-shaped shape when the porous material 122 includes a proximal portion 170 corresponding to the proximal region 160 and a distal portion 172 extending from the proximal portion 170 and corresponding to the distal region 162. The proximal portion 170 can exhibit a substantially constant first width, and the distal portion 172 can exhibit a second width that is smaller than the first width. The second width can be constant or can vary (e.g., vary at a constant or variable rate). The porous material 122 can also exhibit a shape other than a generally bullet-shaped shape, such as a generally rectangular shape, a generally semi-elliptical shape, or any other suitable shape.

[0065] Generally, when the penis is not located in the penis receiving area 131 and the sheath 102 is located on a flat surface, the sheath 102 is substantially flat. The sheath 102 is substantially flat because the fluid impermeable barrier 106 is formed from the first panel 108 and the second panel 110 rather than a generally tubular fluid impermeable barrier. Additionally, as discussed above, the porous material 122 can be a sheet, which also makes the sheath 102 substantially flat. It is noted that although the sheath 102 is described as being substantially flat, depending on the thickness of the porous material 122, at least one of the porous materials 122 may form a slight bulge in the sheath 102, which may result in a bulge around the port 130 or a portion of the sheath 102 being pulled around the base 104. It should also be noted that the sheath 102 is flexible and therefore during use, the sheath 102 may be positioned on a non-flat surface (e.g., it may be positioned on the testicles, the perineum, and / or between the thighs) and the sheath 102 may conform to the surfaces of these shapes, so the sheath 102 may not be substantially flat during use.

[0066] When the penis is not located within the penis receiving area 131 and the sheath 102 is located on a flat surface, the sheath 102 is allowed to be substantially flat, allowing the fluid collection assembly 100 to be used with buried and non-buried penises. For example, when the fluid collection assembly 100 is used with a buried penis, the penis does not extend into the penis receiving area 131, causing the sheath 102 to be relatively flat across the opening 124. When the sheath 102 is relatively flat across the opening 124, the porous material 122 extends across the opening and is in close contact with the buried penis. Thus, the porous material 122 prevents or inhibits bodily fluids drained from the buried penis from contacting and pooling on the individual's skin, as the porous material 122 receives and removes at least a majority of the bodily fluids that would otherwise contact and pool on the individual's skin. Thus, the individual's skin remains dry, thereby improving the comfort of using the fluid collection assembly 100 and preventing skin irritation. However, unlike other conventional fluid collection assemblies configured for use with a buried penis, the fluid collection assembly 100 can also be used with a non-buried penis because the non-buried penis can still be received within the penis receiving area 131, even when the penis is fully erect. Additionally, allowing the sheath 102 to be substantially flat allows the fluid collection assembly 100 to be used more discreetly than if the sheath 102 were not substantially flat, thereby avoiding a potentially embarrassing scenario.

[0067] When the sheath 102 is substantially flat, the porous material 122 can occupy substantially all of the chamber 112, with the penis receiving area 131 being collapsed (shown uncollapsed for illustrative purposes in FIGS. 1C and 1D). In other words, the sheath 102 does not define an area that is not always occupied by the porous material 122. When the porous material 122 occupies substantially all of the chamber 112, bodily fluids that are drained into the chamber 112 are less likely to accumulate for an extended period of time, as this may cause hygiene issues, odor, and / or leave the individual's skin in contact with the bodily fluids, which may cause discomfort and skin irritation.

[0068] As discussed above, the first panel 108, the second panel 110, and the porous material 122 can be selected to have a relatively high degree of flexibility. The first panel 108, the second panel 110, and the porous material 122 have a relatively high degree of flexibility when the first panel 108, the second panel 110, and the porous material 122, respectively, cannot maintain their shape without support. As discussed above, the flexibility of the first panel 108, the second panel 110, and the porous material 122 can allow the sheath 102 to become substantially flat. The flexibility of the first panel 108, the second panel 110, and the porous material 122 can also allow the sheath 102 to conform to the shape of the penis even as the penis changes size and shape (e.g., erection), minimizing unoccupied space in the chamber 112 where bodily fluids may accumulate.

[0069] As discussed above, the fluid collection assembly 100 includes a base 104 configured to be coupled to the skin surrounding the penis (e.g., the mons pubis, thighs, testicles, and / or perineum) through which the penis is positioned. For example, the base 104 can define an opening 124 configured such that the penis is positioned through the opening 124. The base 104 can be flexible, thereby allowing the base 104 to conform to the shape of the skin surface and reduce pulling of the base 104 on the skin surface.

[0070] 1H is a top view of the base 104 according to one embodiment. Rather than being attached to the thigh, where attachment of the base 104 to the thigh could cause the base 104 to pull uncomfortably when an individual moves, the base 104 is configured to be attached to the area around the penis (e.g., the mons pubis). In one example, the base 104 can include a primary attachment portion 174 and a secondary attachment portion 176. The primary attachment portion 174 is configured to be attached to the mons pubis, and the secondary attachment portion 176 is configured to be attached to the area around the penis, excluding the mons pubis (e.g., the top of the testes). The primary attachment portion 174 can be generally rectangular or trapezoidal in shape. Because the mons pubis is larger and less sensitive than other areas around the penis, the primary attachment portion 174 can extend farther from the opening 124 than the secondary attachment portion 176. The secondary attachment portion 176 can include one or more concave side edges 178. The concave side edges 178 can help prevent the secondary attachment portion 176 from attaching to an individual's thigh. It should be noted that any corners of the base 104 can be rounded to prevent, or at least inhibit, the base 104 from digging uncomfortably into the individual.

[0071] The base 104 can have shapes other than that shown in FIG. 1H. For example, the base 104 can have a generally partial triangular shape having three vertices and edges extending between each vertex. The vertices can be rounded to prevent the base 104 from digging into and injuring an individual. The opening 124 can be off-center and located closer to one of the vertices than the other vertex. Other examples of shapes that the base 104 can be formed into are disclosed in PCT Application No. PCT / US2021 / 015787, filed Jan. 29, 2021, the disclosure of which is incorporated herein by reference in its entirety.

[0072] In one embodiment, not shown, the opening 124 can have a generally circular shape. In one embodiment, as shown, the opening 124 can have a shape other than circular. The non-circular shape of the opening 124 can be selected to at least one of correspond to the cross-sectional shape of the base of the penis and / or better conform to the area around the penis, either of which can limit leakage or pooling of bodily fluids. For example, as shown, the opening 124 can have a generally bell-shaped shape. The generally bell-shaped shape includes a concave (relative to the interior of the opening 124) upper edge 180 and a concave lower edge 182 opposite the concave upper edge 180. The generally bell-shaped shape also includes two convex side edges 184 extending between the upper edge 180 and the lower edge 182. Any corners between the upper edge 180, the lower edge 182, and the side edges 184 can be rounded. The two convex side edges 184 vary the width of the opening 124. For example, the two convex side edges 184 make the width of the opening 124 near the top edge 180 smaller than the width of the opening 124 near the bottom edge 182. The generally bell-shaped shape of the opening 124 can enable the opening 124 to correspond to the shape of the base of the penis, thereby preventing bodily fluids from leaking from the chamber 112 and reducing pooling of bodily fluids. The opening 124 can take on other non-circular shapes, such as a generally triangular shape, a generally trapezoidal shape, a generally hippopede shape, or any other suitable non-circular shape.

[0073] 1I is a cross-sectional schematic diagram of a base 104 according to one embodiment. The base 104 includes a substrate 186 having a top surface 188 and a bottom surface 190. The top surface 188 is closer to the sheath 102 than the bottom surface 190, which is closer to the individual's skin than the top surface 188. The base 104 can also include an adhesive layer 192 disposed on at least a portion of the bottom surface 190. The adhesive layer 192 is configured to attach the base 104 to the skin around the penis. The base 104 can also include a release liner 194 configured to be easily removed from the adhesive layer 192, the release liner 194 being configured to prevent the adhesive layer 192 from being inadvertently attached to an object.

[0074] The substrate 186 can be formed from a fluid-impermeable material to prevent bodily fluids from leaking through the base 104 and out of the chamber 112. For example, the substrate 186 can be formed from any of the fluid-impermeable materials disclosed herein. In a particular example, the substrate 186 can be formed from a hydrophobic porous material, such as a hydrophobic woven or nonwoven material. The hydrophobicity of the hydrophobic porous material, along with its small pores, can prevent bodily fluids from flowing through the porous material. It is noted that the hydrophobic porous material can allow air to flow through the porous material, which can make the fluid collection assembly 100 more comfortable to wear.

[0075] In one embodiment, the substrate 186 exhibits a thickness of about 2 mm or less, about 1.5 mm or less, about 1 mm or less, about 0.75 mm or less, about 0.5 mm or less, about 0.3 mm or less, about 0.2 mm or less, about 0.1 mm or less, about 0.05 mm or less, or in the range of about 0.05 mm to about 0.2 mm, about 0.1 mm to about 0.3 mm, about 0.2 mm to about 0.5 mm, about 0.3 mm to about 0.75 mm, about 0.5 mm to about 1 mm, about 0.75 mm to about 1.5 mm, or about 1 to about 2 mm. Forming the substrate 186 to exhibit any of the above thicknesses allows the substrate 186 to be sufficiently flexible to conform to the shape and contours of the skin surrounding the penis. For example, the shape and contours of the skin surrounding the penis may vary from person to person, and configuring the substrate 186 to be a thin film may allow the base 104 to conform to the shape and contours of the skin surrounding the penis while preventing the formation of gaps between the base 104 and the skin through which bodily fluids may leak. Additionally, the thin substrate 186 may be attached to an individual's skin without pulling, or substantially without pulling, the individual's skin, making the fluid collection assembly 100 more comfortable to use over extended periods of time. It should be noted that decreasing the thickness of the substrate may also decrease the amount that the fluid collection assembly 100 pulls on the skin, e.g., a substrate exhibiting a thickness of approximately 2 mm will pull on the skin more than a substantially similar substrate exhibiting a thickness of approximately 0.5 mm.

[0076] The adhesive layer 192 may be formed from any adhesive capable of securely attaching the substrate 186 to the skin surrounding the penis. In one example, the adhesive layer 192 may be formed from a silicone-based adhesive, such as a silicone gel adhesive. A silicone-based adhesive, such as Medical Silicone Tape 2475P available from 3M, has been found to secure the fluid collection assembly 100 to the skin surrounding the penis for at least 24 hours, even immediately after wiping the skin surface. In one example, the adhesive layer 192 may be formed from an acrylic gel adhesive or a hydrogel.

[0077] In one embodiment, the base 104 is at least partially transparent (e.g., the substrate 186 and the adhesive layer 192 are formed from at least partially transparent materials). In such an embodiment, a human (e.g., a physician) can inspect the skin surrounding the penis, for example, to determine the health of the skin. Additionally, the human can detect gaps between the base 104 and the individual's skin through which bodily fluids may leak. After detecting the gap, the human can remove the gap or replace the fluid collection assembly 100 to prevent leakage and to prevent deterioration of the skin caused by skin contact with bodily fluids.

[0078] As discussed above, the base 104 is configured to be attached (e.g., permanently attached) to the sheath 102. For example, the base 104 is configured to be attached to the sheath 102 when the fluid collection assembly 100 is provided with the base 104 attached to the sheath 102, or when the base 104 is provided unattached to the sheath 102 but configured to be attached to the sheath 102 at some point in the future. The base 104 can be attached to the sheath 102 using any suitable technique. For example, the base 104 can be attached to the sheath 102 using adhesives, sewing, heat sealing, impulse heating, RF welding, or US welding.

[0079] In one embodiment, the base 104 is permanently attached to the sheath 102. The base 104 is permanently attached to the sheath 102 when it cannot be removed from the sheath 102 without damaging at least one of the sheath 102 or the base 104, using a blade to separate the sheath 102 from the base 104, using a chemical to break down an adhesive that attaches the sheath 102 to the base 104, and / or using heat to melt or soften an adhesive or attachment (e.g., ultrasonic welding) that attaches the sheath 102 to the base 104. In one embodiment, the base 104 is attached to the sheath 102 using a non-permanent attachment.

[0080] In one embodiment, all of the base 104 is attached to the sheath 102, which may enhance the attachment between the sheath 102 and the base 104. In one embodiment, as shown, only an inner portion of the base 104 that defines or is adjacent to the opening 124 is attached to the sheath 102. Attaching only the inner portion of the base 104 to the sheath 102 may be sufficient to keep the base 104 attached to the sheath 102 during use. Attaching only the inner portion of the base 104 to the sheath 102 may allow an outer portion of the base 104 (e.g., portions of the base 104 other than the inner portion) to be easily handled by a user of the fluid collection assembly 100, making it easier to attach the base 104 to an individual.

[0081] In one embodiment, the base 104 can be attached to the second panel 110 before attaching the second panel 110 to the first panel 108, which facilitates attaching the base 104 to the sheath 102 using, for example, US welding, RF welding, and impulse heating. Attaching the base 104 to the second panel 110 before securing the porous material 122 within the chamber 112 can make it difficult to secure the porous material 122 within the chamber 112 as the base 104 may get in the way. In one example, as shown, the base 104 and the porous material 122 can define one or more base gaps 196 and one or more porous material gaps 198, respectively. The base gaps 196 and the porous material gaps 198 can be generally aligned with one another such that the base gaps 196 and the porous material gaps 198 are adjacent to one another. The base gap 196 and the porous material gap 198 allow opposing portions of the fluid impermeable barrier 106 that are generally aligned with the base gap 196 and the porous material gap 198 to be attached to one another (e.g., using US welding, RF welding, impulse heating, direct heating, heat staking, etc.). Attaching the opposing portions of the fluid impermeable barrier 106 to one another can secure the porous material 122 within the chamber 112. In a particular example, as shown, the base gap 196 and the porous material gap 198 can be formed within portions of the base 104 and the porous material 122 adjacent to or above (e.g., spaced farther from) the fluid outlet 118 of the opening 124. Positioning the base gap 196 and the porous material gap 198 in such a manner can maintain the porous material 122 extending across the opening 124.

[0082] 1A-1D , as previously discussed, the fluid collection assembly 100 includes a conduit 142. The conduit 142 may include a flexible material, such as plastic tubing (e.g., medical tubing). Such plastic tubing may include thermoplastic elastomer, polyvinyl chloride, ethylene vinyl acetate, polytetrafluoroethylene, and the like tubing. In some examples, the conduit 142 may include silicone or latex. In some examples, the conduit 142 may include one or more elastic portions, such as by having one or more of a diameter or wall thickness that allows the conduit to be flexible.

[0083] As described in more detail below, the conduit 142 is coupled to one or more of a fluid containment vessel (not shown) and a vacuum source (not shown) and is configured to extend at least partially between the fluid containment vessel (not shown) and the vacuum source (not shown). In one example, the conduit 142 is configured to be directly connected to the vacuum source (not shown). In such examples, the conduit 142 can extend at least 1 foot, at least 2 feet, at least 3 feet, or at least 6 feet from the fluid impermeable barrier 106. In another example, the conduit 142 is configured to be indirectly connected to at least one of the fluid containment vessel (not shown) and the vacuum source (not shown). In some examples, the conduit is secured to the wearer's skin by a catheter securement device, such as a STATLOCK® catheter securement device available from CRBard, Inc., including but not limited to those disclosed in U.S. Pat. Nos. 6,117,163, 6,123,398, and 8,211,063, the disclosures of which are all incorporated herein by reference in their entirety.

[0084] The inlet and outlet of the conduit 142 are configured to fluidly couple (e.g., directly or indirectly) a vacuum source (not shown) to the chamber 112. When the vacuum source (FIG. 4) applies a vacuum / vacuum into the conduit 142, bodily fluids in the chamber 112 can be drawn into the inlet 148 and out of the fluid collection assembly 100 via the conduit 142. In some examples, the conduit 142 can be matte or opaque (e.g., black) to obscure the visibility of bodily fluids in the conduit 142.

[0085] In some examples, the vacuum source can be located remotely from the fluid collection device. In such examples, the conduit 142 can be fluidly connected to a fluid containing container, which can be disposed between the vacuum source and the fluid collection assembly 100.

[0086] During operation, a man using the fluid collection assembly 100 can expel bodily fluids (e.g., urine) into the chamber 112. The bodily fluids can pool or otherwise collect (e.g., received within the porous material 122) within the chamber 112. At least a portion of the bodily fluids can be drawn into the interior of the conduit 142 via the inlet. The bodily fluids can be extracted from the fluid collection assembly 100 via a vacuum / vacuum provided by a vacuum source. During operation, the vent 134 can maintain the pressure within the chamber 112 substantially at atmospheric pressure, even when bodily fluids are introduced into and subsequently removed from the chamber 112.

[0087] As discussed above, the fluid collection assembly 100 can be formed from the first panel 108 and the second panel 110 that are separate sheets, thereby allowing the first panel to be at least partially opaque and the second panel to be at least partially transparent. However, forming the first panel 108 and the second panel 110 from separate sheets can result in edges that may cause discomfort to the patient and require a significant amount of manufacturing (e.g., welding or other attachment techniques) to attach the first panel 108 to the second panel 110. Thus, in some embodiments, the fluid collection assemblies disclosed herein can be formed from first and second panels that are integrally formed with one another (e.g., exhibiting a unitary structure), thereby eliminating at least some of the edges and simplifying the manufacturing of such fluid collection assemblies. For example, FIG. 2 is a cross-sectional schematic diagram of a fluid collection assembly 200 including a first panel 208 and a second panel 210 that are integrally formed with one another according to one embodiment. Except as otherwise disclosed herein, the fluid collection assembly 200 can be the same as or substantially similar to any of the fluid collection assemblies disclosed herein. For example, the fluid collection assembly 200 includes a sheath 202 and a base (not shown). The sheath 202 defines at least a chamber 212, an opening (not shown), and a fluid outlet (not shown). The fluid collection assembly 200 also includes at least one porous material 222 disposed within the chamber 212.

[0088] As discussed above, the first panel 208 and the second panel 210 are integrally formed with one another. Thus, the first panel 208 and the second panel 210 are different regions of the fluid impermeable barrier 206, rather than different sheets attached to one another. The first panel 208 is the region of the fluid impermeable barrier 206 adjacent the porous material 222, and the second panel 210 is the region of the fluid impermeable barrier 206 adjacent the penis receiving area 231 (shown uncollapsed for illustrative purposes).

[0089] In one embodiment, as shown, the first panel 208 and the second panel 210 are formed from thin-walled tubes, such as thin-walled tubes formed using a blown film extrusion process. Forming the first panel 208 and the second panel 210 from thin-walled tubes eliminates the need to attach the longitudinal edges of the first panel 208 and the second panel 210 to one another. However, portions of the first panel 208 and the second panel 210 forming their proximal and distal end regions may need to be attached to one another using any of the techniques disclosed herein. Thus, forming the first panel 208 and the second panel 210 from thin-walled tubes makes manufacturing the fluid collection assembly 200 more efficient since fewer portions of the first panel 208 and the second panel 210 need to be attached to one another. Additionally, forming the first panel 208 and the second panel 210 from a thin-walled tube reduces the number of edges that can dig into an individual as compared to if the first panel 208 and the second panel 210 were formed from two separate sheets.

[0090] In one embodiment, the first panel 208 and the second panel 210 are formed from a single folded sheet. Forming the first panel 208 and the second panel 210 from a single folded sheet eliminates the need to attach one of the longitudinal edges of the first panel 208 and the second panel 210 to one another. However, the portions of the first panel 208 and the second panel 210 that form the proximal end region, the distal end region, and the portion opposite the fold may need to be attached to one another using any of the attachment techniques disclosed herein. Thus, forming the first panel 208 and the second panel 210 from a single folded sheet makes the manufacture of the fluid collection assembly 200 more efficient and reduces the number of edges that are formed, as compared to forming the first panel 208 and the second panel 210 from two separate sheets. It should be noted that in either embodiment, when the penis is not positioned within the chamber 212, the first panel 208 and the second panel 210 can still be substantially flat.

[0091] In one embodiment, an opening can be formed in the second panel 210. For example, a cutout can be formed in the second panel 210 that is spaced from or extends inwardly from an outer edge of the second panel 210 (e.g., an outer edge of a thin-walled tube or a single folded sheet).

[0092] As discussed above, the fluid collection assembly disclosed herein can be used for buried and non-buried penises. Figures 3A and 3B are cross-sectional schematic diagrams illustrating how a substantially similar fluid collection assembly according to an embodiment can be used for buried and non-buried penises. Referring to Figure 3A, a first individual 301a has a buried penis 303a (shown diagrammatically as a slight protuberance). A fluid collection assembly 300a is attached to the first individual 301a. The fluid collection assembly 300a is shown as being substantially the same as the fluid collection assembly 100 shown in Figures 1A-1I. However, it should be noted that the fluid collection assembly 300a can comprise any of the fluid collection assemblies disclosed herein. The fluid collection assembly 300a is attached to the first individual 301a such that the opening of the base 304a and the opening of the sheath 302a are adjacent to the buried penis 303a. Because the fluid collection assembly 300a is substantially flat, the porous material 322a is generally adjacent to the opening and can be spaced from the buried penis 303a by only the thickness of the base 304a, thereby allowing little space for bodily fluids to pool before being received by the porous material 322a. It should be noted that the distance the porous material 322a can be spaced from the buried penis 303a can be less than the thickness of the base 304a (e.g., the porous material 322a bulges into the opening) or slightly more than the thickness of the base 304a (e.g., the testicles 305a bulge and push the porous material 322a away from the opening 314a or the porous material 322a assumes a non-sheet-like shape).

[0093] 3B, a second individual 301b has a non-implanted penis 303b. A fluid collection assembly 300b, the same or substantially the same as fluid collection assembly 300a, is attached to the second individual 301b. The fluid collection assembly 300b is attached to the second individual 301b such that the penis 303b extends through an opening in the base 304b and an opening in the sheath 302b. Due to the flexibility of the fluid collection assembly 300b, the penis 303b can be received within the sheath 302b.

[0094] 4 is a block diagram of a system 407 for fluid collection according to one embodiment. The system 407 includes a fluid collection assembly 400, a fluid containment vessel 409, and a vacuum source 411. The fluid collection assembly 400 can include any of the fluid collection assemblies disclosed herein. The fluid collection assembly 400, the fluid containment vessel 409, and the vacuum source 411 can be fluidly coupled to one another via one or more conduits 442. For example, the fluid collection assembly 400 can be operably coupled to one or more of the fluid containment vessel 409 or the vacuum source 411 via the conduit 442. Bodily fluids (e.g., urine or other bodily fluids) collected within the fluid collection assembly 400 can be removed from the fluid collection assembly 400 via the conduit 442 that projects into the fluid collection assembly 400. In response to a vacuum (e.g., vacuum) force applied to an outlet of the conduit 442, a vacuum force can be introduced into a chamber of the fluid collection assembly 400 via an inlet of the conduit 442.

[0095] The vacuum force can be applied directly or indirectly by the vacuum source 411 to the outlet of the conduit 442. The vacuum force can be applied indirectly via the fluid containment vessel 409. For example, the outlet of the conduit 442 can be disposed within the fluid containment vessel 409, and the additional conduit 442 can extend from the fluid containment vessel 409 to the vacuum source 411. Accordingly, the vacuum source 411 can apply a vacuum to the fluid collection assembly 400 via the fluid containment vessel 409. The vacuum force can be applied directly via the vacuum source 411. For example, the outlet of the conduit 442 can be disposed within the vacuum source 411. The additional conduit 442 can extend from the vacuum source 411 to a location outside the fluid collection assembly 400, for example to the fluid containment vessel 409. In such an example, the vacuum source 411 can be disposed between the fluid collection assembly 400 and the fluid containment vessel 409.

[0096] The fluid containment vessel 409 is sized and shaped to hold a fluid therein. The fluid containment vessel 409 may include a bag (e.g., a drainage bag), a bottle or cup (e.g., a collection jar), or any other enclosed container for containing bodily fluids. In some examples, a conduit 442 may extend from the fluid collection assembly 400 and may be attached to the fluid containment vessel 409 at a first location within the conduit 442. An additional conduit 442 may be attached to the fluid containment vessel 409 at a second location thereof and may extend to and be attached to the vacuum source 411. In response, a vacuum (e.g., vacuum) may be drawn on the fluid collection assembly 400 through the fluid containment vessel 409. The vacuum source 411 may be used to evacuate fluid, such as urine, from the fluid collection assembly 400.

[0097] The vacuum source 411 can include one or more of a manual vacuum pump, an electric vacuum pump, a membrane 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 411 can provide a vacuum or vacuum to draw fluid from the fluid collection assembly 400. In some examples, the vacuum source 411 can be powered by one or more of a power cord (e.g., connected to a power socket), one or more batteries, or even a manual power source (e.g., a manual vacuum pump). In some examples, the vacuum source 411 can be sized and shaped to fit outside, on, or within the fluid collection assembly 400. For example, the vacuum source 411 can include one or more miniature pumps or one or more micropumps. The vacuum sources 411 disclosed herein can include one or more of a switch, a button, a plug, a remote control, or any other device suitable for activating the vacuum source 411.

[0098] 5 is a flow diagram of a method 500 of collecting fluid according to one embodiment. The method 500 of collecting fluid may use any of the fluid collection assemblies and / or fluid collection systems disclosed herein. The method 500 may include an operation 510 which depicts "positioning an opening of the fluid collection assembly adjacent to or about the penis." Operation 510 may be followed by an operation 520 which depicts "receiving bodily fluid from the penis into a chamber of the fluid collection assembly."

[0099] Operations 510 and 520 of method 500 are for illustrative purposes. For example, operations 510 and 520 of method 500 may be performed in a different order, split into multiple operations, modified, supplemented, or combined. In one example, one or more of operations 510 or 520 of method 500 may be omitted from method 500.

[0100] Operation 510 indicates "positioning an opening of the fluid collection assembly adjacent or around the penis." Operation 510 of positioning the opening of the fluid collection assembly can include utilizing any of the fluid collection assemblies or systems disclosed herein. In some examples, operation 510 can include positioning the opening such that a porous material of the fluid collection assembly extends across the opening, thereby allowing the porous material to abut or be positioned proximate to the buried penis. In some examples, operation 510 can include positioning a base of the fluid collection assembly over the buried penis such that the male urethra is positioned adjacent to an opening of the base and an opening of the sheath. In such examples, operation 510 can include positioning a sheath of the male fluid collection assembly around the non-buried penis such that at least a portion of the penis is positioned through the opening of the sheath and into the chamber of the fluid collection assembly.

[0101] Operation 520 indicates "receiving bodily fluid from the penis into the chamber of the fluid collection assembly." In some examples, receiving bodily fluid from the penis into the chamber of the fluid collection assembly includes receiving the bodily fluid through an opening in the fluid collection assembly. Receiving bodily fluid from the penis into the chamber of the fluid collection assembly can include at least one of wicking, absorbing, or adsorbing the bodily fluid from the opening using a porous material. In some examples, receiving bodily fluid from the penis into the chamber of the fluid collection assembly can include receiving the bodily fluid into a chamber of a sheath of the fluid collection assembly. Receiving bodily fluid from the penis into the chamber of the fluid collection assembly can include flowing the bodily fluid toward a portion of the chamber fluidly coupled to an inlet of a conduit in fluid communication with a vacuum source. For example, receiving bodily fluid from the penis into the chamber of the fluid collection assembly can include flowing the bodily fluid to a low weight point of the chamber via gravity, wicking, or vacuum force, or the like.

[0102] The method 500 can include applying a vacuum by a vacuum source effective to draw bodily fluid from the chamber through a conduit disposed within the chamber or otherwise in fluid communication with the chamber. The conduit can also be fluidly coupled to the vacuum source using any of the vacuum sources disclosed herein. Applying the vacuum by the vacuum source can include activating a vacuum source (e.g., a vacuum device) in fluid communication with an inlet of the conduit within the fluid collection assembly. In some examples, activating a vacuum source in fluid communication with an inlet of the conduit within the fluid collection assembly can include powering the vacuum source by one or more of flipping an on / off switch, pressing a button, plugging the vacuum source into a power outlet, placing batteries in the vacuum source, etc. In some examples, the vacuum source can include a manual vacuum pump, and applying the vacuum by the vacuum source can include manually operating a manual vacuum pump effective to draw bodily fluid from the chamber through a conduit disposed within the chamber and in fluid communication with the vacuum source.

[0103] In some examples, applying a vacuum by a vacuum source effective to draw bodily fluid from the chamber through a conduit disposed within the chamber and fluidly coupled to the vacuum source can be effective to remove at least a portion of the bodily fluid from the chamber of the fluid collection assembly. In some examples, applying a vacuum by a vacuum source effective to draw bodily fluid from the chamber through a conduit disposed within the chamber and fluidly coupled to the vacuum source can be effective to transfer at least a portion of the bodily fluid from the chamber to a fluid containing container (e.g., a bottle or bag).

[0104] In some examples, the vacuum source (e.g., a vacuum device) can be disposed on or within the fluid collection assembly, and applying a vacuum by the vacuum source can include activating the vacuum source. In some examples, the vacuum source can be remote from the fluid collection assembly, and applying a vacuum by the vacuum source can include activating the vacuum source.

[0105] In some examples, applying a vacuum by a vacuum source effective to draw bodily fluid from the chamber via a conduit disposed within the chamber and fluidly coupled to the vacuum source can include detecting humidity within the chamber (e.g., by one or more humidity sensors) and activating the vacuum source in response to the humidity to provide a vacuum within the chamber. Control of the vacuum source in response to a signal indicating that humidity or a humidity level is present within the chamber can be automatic, such as via a controller (e.g., a computer programmed to perform this operation), or can simply provide an indication that a humidity level is present that may require the removal of bodily fluid from the chamber of the fluid collection assembly. In the latter case, a user can receive an instruction (e.g., from a controller) and manually activate the vacuum pump.

[0106] In one example, the method 500 can include collecting the bodily fluid removed from the fluid collection assembly, such as in a fluid containment vessel spaced from the fluid collection assembly and fluidly coupled to the conduit. The fluid containment vessel can include any of the fluid containment vessels disclosed herein.

[0107] 6 is a flow diagram of a method 600 for manufacturing a fluid collection assembly according to one embodiment. Method 600 can be used to manufacture at least some of the fluid collection assemblies and / or fluid collection systems disclosed herein. Method 600 can include operation 610, which depicts "attaching a first panel and a second panel to one another along at least a portion of an edge thereof to form a sheath." Operation 610 can be followed by operation 620, which depicts "disposing at least one porous material within a chamber defined between the first panel and the second panel."

[0108] Operations 610, 620 of method 600 are for illustrative purposes. For example, operations 610, 620 of method 600 may be performed in a different order, split into multiple operations, modified, supplemented, or combined. In one example, one or more of operations 610, 620 of method 600 may be omitted from method 600. Either operations 610 or 620 may include using any of the fluid collection devices or systems disclosed herein.

[0109] Operation 610 indicates "attaching at least a portion of the first panel and at least a portion of the second panel to one another along at least a portion of their edges to form a sheath." In one example, when the first and second panels are separate sheets, operation 610 can include positioning the first and second panels adjacent to one another (e.g., overlapping one another). Positioning the first and second panels adjacent to one another forms a chamber between the first and second panels. After positioning the first and second panels, the first and second panels can be attached to one another, such as along at least a portion of their outer edges. For example, all of the outer edges of the first and second panels can be attached to one another, except for portions of their outer edges that define an opening configured to receive a penis (if the opening is not completely defined by one of the first or second panels) and a fluid outlet. In one example, the first and second panels are integrally formed with one another. In such an example, operation 610 can include attaching edges of the first and second panels that are not already attached. When the first and second panels are formed from thin-walled tubes, operation 610 can include attaching portions of the first and second panels that together form proximal and distal end regions thereof. When the first and second panels are formed from a single folded sheet, operation 610 can include attaching portions of the first and second panels that together form proximal and distal end regions thereof and attaching portions of the first and second panels opposite the fold.

[0110] The first and second panels can be attached to one another using any suitable technique. In one embodiment, the first and second panels are attached to one another by sewing the first and second panels together. In one embodiment, the first and second panels are attached to one another using a technique other than sewing, for example, via heat sealing, RF welding, or US welding. Attaching the first and second panels to one another using a technique other than sewing can increase the manufacturing speed of the fluid collection assembly formed during method 600. For example, heat sealing, RF welding, or US welding can be performed significantly faster than sewing the first and second panels together. Furthermore, heat sealing, RF welding, or US welding can form a better watertight seal when compared to sewing.

[0111] Operation 620 indicates "disposing at least one porous material within a chamber defined between the first and second panels." In one embodiment, prior to operation 610, the porous material may be attached to one of the first or second panels (e.g., by adhesive, heat sealing, RF welding, US welding, or any other suitable technique). In such an embodiment, positioning the first and second panels adjacent to one another also disposes the porous material within the chamber. In one embodiment, the porous material may be positioned between the first and second panels when the first and second panels are positioned adjacent to one another. In other words, the first panel, the porous material, and the second panel may form a laminate with the porous material positioned between the first and second panels. Operation 620 may also attach the porous material to the first and second panels when the first and second panels are attached to one another. Thus, the method 600 does not require separate operations of attaching the porous material to the first and second panels, thus making the method 600 more efficient and quicker.

[0112] In one embodiment, the porous material is placed in the chamber after the first and second panels are attached to each other. In one example, as discussed above, the porous material is attached to the first and second panels by attaching portions of the fluid impermeable barrier adjacent to one or more base gaps and one or more porous material gaps. In one example, the porous material can be attached to one or more of the first or second panels by adhesive, tape, or the like, or the porous material may not be attached to the first and second panels. Not attaching the porous material to the first and second panels can make the method 600 more efficient and quicker, but the porous material may move within the chamber, such as by bunching near the fluid outlet.

[0113] In one embodiment, the method 600 can include forming one or more of the first panel, the second panel, and the porous material. In one example, the method 600 can form the first and second panels, for example, by punching the first and second panels (including the openings, cutouts, or perforations defined thereby). As discussed above, punching the first and second panels and attaching the first and second panels to each other can be performed more quickly and easily than forming a single sheet into a cylinder. In one example, the porous material can also be punched from a sheet of porous material when the porous material assumes a sheet-like shape. In one example, the first and second panels can be formed using a blown film extrusion technique to form a thin-walled tube. In one example, at least one of the first panel, the second panel, or the porous material can be formed by techniques other than punching or blown film extrusion, although such techniques may be more complicated or time consuming. Examples of techniques other than punching and other than blown film extrusion include blade cutting, other extrusion techniques, molding (eg, injection molding), or any other suitable technique.

[0114] In one embodiment, the method 600 can include forming the base. In one example, the base can be formed by stamping the base from a sheet (e.g., a sheet including a substrate, at least one adhesive layer, and at least one release liner). The base can be formed by stamping, for example, because the base is formed from a thin film and the base may not include protrusions, such as ring-shaped protrusions, that define openings. Alternatively, the base can be formed by injection molding or any other suitable technique, although techniques other than stamping may be more time consuming.

[0115] In one embodiment, method 600 can include attaching (e.g., permanently attaching) the base to the sheath formed at least in part by operations 610 and 620. In one example, method 600 can include attaching the base to the sheath before providing the fluid collection assembly to an end user. In such an example, method 600 can include permanently attaching the base to the sheath and disposing the fluid collection assembly in a package after attaching the base to the sheath. In one example, method 600 can not include permanently attaching the base to the sheath before providing the fluid collection assembly to an end user. In such an example, method 600 can include disposing the fluid collection assembly in a package with the sheath and the base not attached to each other. The end user can remove the fluid collection assembly from the package and can permanently attach the base to the sheath after removing the fluid collection assembly from the package. For example, the end user can permanently attach the base to the sheath before, during, or after attaching the base to the skin surrounding the penis.

[0116] It should be noted that the above disclosed embodiments relate to fluid collection assemblies configured to collect bodily fluids from a male, however, such fluid collection assemblies may also be used to collect bodily fluids from a female, as the female urethral meatus is functionally similar to a buried penis.

[0117] 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.

[0118] Terms of degree (e.g., "about," "substantially," "generally," etc.) indicate structurally or functionally insignificant variations. In one example, when a term of degree is included with a term of quantity, the term of degree is interpreted to mean ±10%, ±5%, or +2% of the term of quantity. 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 can have rounded corners instead of sharp corners, curved edges instead of straight edges, one or more protrusions extending from an edge, an elongated shape, the same shape as the disclosed shape, etc.

Claims

1. a fluid impermeable barrier including a proximal region and a distal region extending from the proximal region, the proximal region including a plurality of proximal edges opposite the distal region, the plurality of proximal edges being attached to one another, the proximal region exhibiting a first width and the distal region exhibiting a second width less than the first width, the proximal region defining an opening, the fluid impermeable barrier defining at least a chamber and a fluid outlet; a port attached to the fluid outlet, the port including a first portion defining an inlet and a second portion defining an outlet, the first portion being configured to be attached to the fluid impermeable barrier and the second portion being configured to be attached to a conduit; at least one porous material disposed within the chamber; A sheath, a base configured to be secured or fixed to the proximal region of the sheath, the base configured to be attached to skin around the penis and defining an opening corresponding to the opening of the sheath; Equipped with 11. A fluid collection assembly comprising: a first portion having a first width and a second portion having a second width, the first portion being shaped such that the first width is greater than the second width, and the first portion exhibits a greater stiffness than the fluid impermeable barrier as well as the conduit.

2. 2. The fluid collection assembly of claim 1, wherein the fluid impermeable barrier comprises a first panel and a second panel attached to the first panel.

3. 2. The fluid collection assembly of claim 1, wherein the fluid impermeable barrier comprises a first panel and a second panel integrally formed with one another.

4. 10. The fluid collection assembly of claim 1, wherein the fluid impermeable barrier comprises polyurethane.

5. 2. The fluid collection assembly of claim 1, wherein the first width is substantially constant and the second width decreases from the proximal region toward the fluid outlet.

6. 6. The fluid collection assembly of claim 5, wherein the second width decreases at a substantially constant rate.

7. 2. The fluid collection assembly of claim 1, the fluid impermeable barrier defines one or more orifices extending therethrough; 11. The fluid collection assembly of claim 10, wherein the sheath further comprises one or more vents attached to the fluid impermeable barrier and covering the one or more orifices, the one or more vents configured to allow air to flow through the one or more vents and to substantially prevent water from flowing through the one or more vents.

8. 8. The fluid collection assembly of claim 7, wherein the one or more vents comprise a porous polytetrafluoroethylene layer attached to a substrate, the substrate being attached to the fluid-impermeable barrier.

9. 8. The fluid collection assembly of claim 7, wherein the one or more orifices and the one or more vents are elongated in shape.

10. 2. The fluid collection assembly of claim 1, wherein the at least one porous material exhibits a shape that generally corresponds to a shape of the first and second portions of the fluid impermeable barrier.

11. 11. The fluid collection assembly of claim 10, wherein the second portion exhibits the same maximum thickness as the first portion.

12. 11. The fluid collection assembly of claim 10, wherein the first portion exhibits a first width and the second portion exhibits a second width, the first width being at least two times greater than the second width.

13. 11. The fluid collection assembly of claim 10, wherein the first portion defines a sink upstream from the inlet, the sink exhibiting at least one of a width or a thickness greater than a corresponding width or thickness of the inlet.

14. The fluid collection assembly of claim 10, wherein the port includes at least one tab extending from the first portion into the chamber.

15. The fluid collection assembly of claim 1 , wherein the base comprises a nonwoven substrate.

16. The fluid collection assembly of claim 1 , wherein the base defines one or more base gaps therein.

17. 17. The fluid collection assembly of claim 16, wherein the at least one porous material defines one or more porous material gaps extending therethrough, the one or more porous material gaps being generally aligned with the one or more base gaps.

18. 20. The fluid collection assembly of claim 17, wherein opposing portions of the fluid-impermeable barrier generally aligned with the one or more base gaps and the one or more porous material gaps are attached to one another.

19. 2. The fluid collection assembly of claim 1, wherein the base includes an inner region adjacent the opening and an outer region spaced from the opening by the inner region, the inner region being attached to the fluid-impermeable barrier and the outer region not being attached to the fluid-impermeable barrier.

20. 10. The fluid collection assembly of claim 1, wherein the base includes one or more recessed edges.

21. A fluid collection assembly according to claim 1; a vacuum source configured to apply a vacuum force; A fluid storage container; at least one conduit connected to the outlet and in fluid communication with the vacuum source and the fluid containing vessel; A system comprising:

22. 1. A method of manufacturing a fluid collection assembly, comprising: affixing together a plurality of proximal edges of a fluid impermeable barrier of a sheath, the sheath including a fluid impermeable barrier including a proximal region and a distal region extending from the proximal region, the proximal edge being located opposite the distal region, the proximal region exhibiting a first width, the distal region exhibiting a second width less than the first width, the proximal region defining an opening, the fluid impermeable barrier defining at least a chamber and a fluid outlet, the base being configured to be attached to the skin surrounding the penis, the base defining an opening corresponding to the opening of the sheath after attachment of the base to the fluid impermeable barrier; attaching a port to the fluid outlet, the port including a first portion defining an inlet and a second portion defining an outlet, the first portion being configured to be attached to the fluid impermeable barrier and the second portion being configured to be attached to a conduit, the first portion being shaped such that the first width is greater than the second width, and the first portion being stiffer than the fluid impermeable barrier as well as the conduit; attaching a base to the fluid impermeable barrier of the sheath; and disposing at least one porous material within the chamber.

23. 23. The method of claim 22, providing the fluid impermeable barrier including a first panel and a second panel separate from the first panel; and attaching a perimeter of the first panel to a perimeter of the second panel; The method, wherein attaching the base to the fluid impermeable barrier includes attaching the base to the second panel.

24. 24. The method of claim 23, wherein attaching the base to the first panel is performed prior to attaching at least a portion of the perimeter of the first panel to the perimeter of the second panel.

25. 23. The method of claim 22, providing the base and the at least one porous material, the base including one or more base gaps, the at least one porous material including one or more porous material gaps, the one or more base gaps and the one or more porous material gaps being generally aligned following placement of the at least one porous material within the chamber; and attaching opposing portions of the fluid impermeable barrier adjacent the one or more porous material gaps to one another.

26. 1. A method of using a system for collecting bodily fluid from an individual, comprising: The method includes attaching a base to the skin surrounding the penis, the base being fixed or configured to be fixed to a sheath, the sheath being: a fluid impermeable barrier including a proximal region and a distal region extending from the proximal region, the proximal region including a proximal edge opposite the distal region attached to one another, the proximal region exhibiting a first width and the distal region exhibiting a second width less than the first width, the proximal region defining an opening, the fluid impermeable barrier defining at least a chamber and a fluid outlet; a port attached to the fluid outlet, the port including a first portion defining an inlet and a second portion defining an outlet, the first portion being configured to be attached to the fluid impermeable barrier and the second portion being configured to be attached to a conduit, the first portion being shaped such that the first width is greater than the second width, the first portion being stiffer than the fluid impermeable barrier as well as the conduit; and at least one porous material disposed within the chamber. A method comprising:

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