Male fluid collection assemblies and systems, methods of using, and methods of manufacturing the same

Abstract

An example fluid collection assembly includes a sheath and a port. The sheath includes a fluid impermeable barrier at least partially defining a chamber and at least one porous material disposed in the chamber. The port is positioned at the distal region and includes a first part defining an inlet and a second part defining an outlet and configured to be attached to a conduit. The first part includes an upper portion secured to a lower portion such that the inlet is disposed between the upper portion and the lower portion. The upper portion has an upper proximal end and the lower portion has a lower proximal end that is spaced from the upper proximal end.

Description

MALE FLUID COLLECTION ASSEMBLIES AND SYSTEMS, METHODS OF USING, AND METHODS OF MANUFACTURING THE SAMEBACKGROUND

[0001] In various circumstances, a person or animal may have limited or impaired mobility such that typical urination processes are challenging or impossible. For example, a person may experience or have a disability that impairs mobility. A person may have restricted travel conditions such as those experienced by pilots, drivers, and workers in hazardous areas. Additionally, sometimes urine collection is needed for monitoring purposes or clinical testing.

[0002] Urinary catheters, such as a Foley catheter, can be used to address some of these circumstances, such as incontinence. Unfortunately, however, urinary catheters can be uncomfortable, painful, and can lead to complications, such as infections. Additionally, bed pans, which are receptacles used for the toileting of bedridden patients, such as those in a health care facility, are sometimes used. Bed pans, however, can be prone to discomfort, spills, and other hygiene issues.

[0003] Males who suffer the most severe consequences of urinary incontinence, such as discomfort, rashes, and sores are typically elderly and often bedbound. They also require continuous assistance to maintain hygiene. Characteristics often found in these patients: the size of the penis often decreases with age, skin rolls containing fat tissue cause the penis to recede, often pointing upward while in a laying position, patients have difficulty reaching the penis and manipulating devices. A urine capture device should be designed with reference to these characteristics.

[0004] Available solutions are typically for use while standing up or seated (such as cups and funnels), with a urine discharge port opposite to the distal end of the penis. Other designs such as condom-style catheters are difficult for patients to manipulate, too often they are dimensionally incompatible; and they do not stay on reliably.

[0005] Thus, there is a need for a device capable of collecting urine from a person or animal, particularly a male, comfortably and with minimal contamination of the user and / or the surrounding area.SUMMARY

[0006] Embodiments disclosed herein are directed to male fluid collection assemblies, systems including the same, methods of manufacturing the same, and methods of using the same. In an embodiment, a fluid collection assembly is disclosed. The fluidcollection assembly includes a sheath and a port. The sheath includes a fluid impermeable barrier including a proximal region and a distal region extending from the proximal region, the proximal region defining an opening, the fluid impermeable barrier at least partially defining a chamber. The sheath also includes at least one porous material disposed in the chamber. The port is positioned at the distal region and includes a first part defining an inlet and a second part defining an outlet and configured to be attached to a conduit. The first part includes an upper portion and a lower portion with the inlet disposed between the upper portion and the lower portion, the upper portion having an upper proximal end and the lower portion having a lower proximal end that is spaced from the upper proximal end.

[0007] In an embodiment, a fluid collection assembly is disclosed. The fluid collection assembly includes a sheath and a port. The sheath includes a fluid impermeable barrier including a proximal region and a distal region extending from the proximal region, the proximal region defining an opening, the fluid impermeable barrier at least partially defining a chamber. The sheath also includes at least one porous material disposed in the chamber. The port is positioned at the distal region and includes a first part defining an inlet oriented towards the proximal region of the fluid impermeable barrier and a second part defining an outlet and configured to be attached to a conduit. The first part includes an upper portion and a lower portion with the inlet disposed between the upper portion and the lower portion, the upper portion having an upper proximal end and the lower portion having a lower proximal end that is spaced from the upper proximal end, the second part extending proximally from the first part towards the proximal region of the fluid impermeable barrier.

[0008] In an embodiment, a system is disclosed. The system may include any of the fluid collection assemblies described herein, a vacuum source configured to apply a vacuum force, a fluid storage container, and at least one conduit connected to the outlet and in fluid communication with the vacuum source and the fluid storage container.

[0009] In an embodiment, a method of manufacturing a fluid collection assembly is disclosed. The method may include providing a fluid impermeable barrier including a first panel and a second panel. The method also may include providing a port including a first part defining an inlet and a second part defining an outlet and configured to be attached to a conduit. The first part may include an upper portion and a lower portion with the inlet disposed between the upper portion and the lower portion, the upper portion having an upper proximal end and the lower portion having a lower proximal end that isspaced from the upper proximal end. The method also may include attaching the first panel to the second panel to form a sheath having (1) a proximal region defining an opening and (2) a distal region having the upper proximal end and the lower proximal end on the first part of the port disposed between the first panel and the second panel, the fluid impermeable barrier at least partially defining a chamber. The method also may include disposing at least one porous material in the chamber.

[0010] In an embodiment, a method of manufacturing a fluid collection assembly is disclosed. The method may include providing a fluid impermeable barrier a first panel and a second panel that is distinct from the first panel. The method also may include providing a port including a first part defining an inlet and a second part defining an outlet and configured to be attached to a conduit. The first part may include an upper portion and a lower portion with the inlet disposed between the upper portion and the lower portion, the upper portion having an upper proximal end and the lower portion having a lower proximal end that is spaced from the upper proximal end. The method also may include attaching the first panel to the second panel to form a sheath having a proximal region defining an opening and a distal region with the port positioned at the distal region such that the inlet of the first part of the port is oriented inside the chamber towards the proximal region of the fluid impermeable barrier and the outlet of the second part of the port extends proximally from the first part through the fluid impermeable barrier towards the proximal region of the fluid impermeable barrier. The method also may include disposing at least one porous material in the chamber.

[0011] Features from any of the disclosed embodiments may be used in combination with one another, without limitation. In addition, other features and advantages of the present disclosure will become apparent to those of ordinary skill in the art through consideration of the following detailed description and the accompanying drawings.BRIEF DESCRIPTION OF THE DRAWINGS

[0012] The drawings illustrate several embodiments of the present disclosure, wherein identical reference numerals refer to identical or similar elements or features in different views or embodiments shown in the drawings.

[0013] FIGS. 1A and IB are isometric top and bottom views, respectively, of a fluid collection assembly, according to an embodiment.

[0014] FIGS. 1C and ID are cross-sectional schematics of the fluid collection assembly taken along planes C-C and D-D, respectively, according to any embodiment.

[0015] FIG. IE is an exploded isometric view of the fluid collection assembly shown in FIGS. 1A and IB.

[0016] FIG. IF is an isometric top view of the port shown in FIG. 1A, according to an embodiment.

[0017] FIG. 1G is a cross-sectional schematic of the port taken along plane IF- IF shown in FIG. 1A, according to an embodiment.

[0018] FIG. 2 is an isometric top view of a port, according to an embodiment.

[0019] FIG. 3A is a cross-sectional schematic of a fluid collection assembly, according to an embodiment.

[0020] FIG. 3B is an isometric top view of the port and a portion of the porous material of the fluid collection assembly of FIG. 3A.

[0021] FIG. 4 is a cross-sectional schematic of a distal region of a fluid collection assembly, according to an embodiment.

[0022] FIG. 5 is a cross-sectional schematic of a distal region of a fluid collection assembly, according to an embodiment.

[0023] FIGS. 6A-6B are flow diagrams of methods to manufacture fluid collection assemblies, according to an embodiment.

[0024] FIG. 7 is a block diagram of a system for fluid collection, according to an embodiment.DETAILED DESCRIPTION

[0025] Embodiments disclosed herein are directed to male fluid collection assemblies, systems including the same, methods of manufacturing the same, and methods of using the same. An example fluid collection assembly includes a sheath and a port. The sheath includes a fluid impermeable barrier having a proximal region and a distal region extending from the proximal region. 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 in the chamber. A base may be attached (e.g., permanently attached) to the sheath or the base may be configured to be secured to the sheath at some time period in the future. The base defines an aperture 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 a penis of an individual with the aperture positioned over the penis.

[0026] The port is positioned at the distal region and includes a first part defining an inlet and a second part defining an outlet and configured to be attached to a conduit. Thefirst part includes an upper portion and a lower portion with the inlet disposed between the upper portion and the lower portion, the upper portion having an upper proximal end and the lower portion having a lower proximal end that is spaced laterally from the upper proximal end. The upper and lower proximal ends may be positioned at a substantially equal distance from the inlet such that the upper and lower proximal ends are substantially aligned (e.g., the upper proximal end is positioned directly over the lower proximal end). The upper and lower proximal ends may be positioned on upper and lower tabs or upper and lower discs of the first part of the port. The upper and lower tabs and / or the upper and lower discs may be sized substantially equal or the same. This spaced apart positioning positioning of the upper and lower proximal ends of the first part of the port results in the technical effect of keeping the inlet open during use by inhibiting the fluid impermeable barrier from sealing or blocking the inlet when a vacuum is applied to the inlet.

[0027] In many embodiments, all edges of the port are rounded. This configuration of the port where sharp edges are absent results in the technical effect of preventing painful contact with the patient during use. In many embodiments, the port is formed from a softer, more pliable material than conventional ports, such as a silicone material or a polyurethane material. The port also may be configured to orient a vacuum conduit to which the port is attached towards the head of the patient or a different positioned selected by the patient or the caregiver. This configuration of the fluid collection assembly reduces the risk of the vacuum conduit being twisted or kinked as the vacuum conduit is directed back towards the head of the bed where a fluid collection canister is positioned. The inlet of the port of many embodiments may be positioned at the low point of the fluid collection assembly during use.

[0028] An example method of using the fluid collection assembly includes securing the base to the region about the penis of an individual. The base is positioned on the individual such that the penis extends through (e.g., the penis is not buried) or is adjacent to (e.g., the penis is buried) the aperture defined by the base. If sheath is not already attached to the base, the sheath may also be attached to the base. For example, the sheath may be attached to the base before, during, or after securing the base to the region about the penis. After the base is secured to the region about the penis and the sheath is attached to the base, the individual may discharge bodily fluids from the penis. The bodily fluids may include urine or sweat. The bodily fluids enter the chamber of the sheath. The porous material may receive at least some of the bodily fluids that enter thechamber and direct the bodily fluids towards the fluid outlet. The method may include removing the bodily fluids from the chamber through the fluid outlet, for instance, when a vacuum force is applied to the outlet via a vacuum source that is in fluid communication with the chamber. Although the fluid collection assemblies disclosed herein are discussed as being male fluid collection assemblies that are used with penises, it is noted that the fluid collection assemblies may be female fluid collection assemblies that are used to collect bodily fluids from females, urostomy pouches, and / or wound care.

[0029] FIGS. 1A and IB are isometric top and bottom views, respectively, of a fluid collection assembly 100, according to an embodiment. FIGS. 1C and ID are cross- sectional schematics of the fluid collection assembly 100 taken along planes C-C and D- D, respectively, according to any embodiment. FIG. IE is an exploded view of the fluid collection assembly 100. The fluid collection assembly 100 includes a sheath 102 and a base 104. In an embodiment, the sheath 102 includes a fluid impermeable barrier 106 that is at least partially formed from a first panel 108 attached to a second panel 110. In an embodiment, as illustrated, the first panel 108 and the second panel 110 are distinct 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 1 18. The sheath 102 also includes at least one porous material 122 disposed in the chamber 112. The base 104 includes an aperture 124. The base 104 may be attached to the proximal region 160 of the fluid impermeable barrier 106 such that the aperture 124 is aligned with the opening 114.

[0030] The inner surfaces 126 of the fluid impermeable barrier 106 (e.g., inner surfaces of the first and second panels 108, 110) at least partially defines the chamber 112 within the fluid collection assembly 100. The fluid impermeable barrier 106 temporarily stores the bodily fluids in the chamber 112.

[0031] The fluid impermeable barrier 106 may be formed of any suitable fluid impermeable material(s), such as a fluid impermeable polymer (e.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, polyurethane, polyethylene, polyvinyl chloride, a polycarbonate, etc.), a metal film, natural rubber, another suitable material, or combinations thereof. As such, the fluid impermeable barrier 106 substantially prevents the bodily fluids from passing through the fluid impermeable barrier 106. In an example, the fluid impermeable barrier 106 may be air permeable and fluid impermeable thus preventing leaks while allowing air flow through the chamber 112 when a vacuum force is applied thereto (i.e., the chamber 112 remains at about atmospheric pressure thereby preventing the vacuum force from causing a hickie orkinking the conduit 142). In such an example, the fluid impermeable barrier 106 may be formed of a hydrophobic material that defines a plurality of pores. At least one or more portions of at least an outer surface 127 of the fluid impermeable barrier 106 may be formed from a soft and / or smooth material, thereby reducing chaffing.

[0032] In an embodiment, the fluid impermeable barrier 106 is formed from polyurethane, such as formed only from polyurethane. It has been found in clinical trials that forming the fluid impermeable barrier 106 from polyurethane improves the functionality of the fluid collection assembly 100. For example, the fluid impermeable barrier 106 may exhibit a flexibility when formed from polyurethane that is greater than when the fluid impermeable barrier 106 is formed from another material. The increased flexibility of the fluid impermeable barrier 106 formed from the polyurethane makes it easier to attach the fluid collection assembly 100 to the individual and maintain the fluid collection assembly 100 attached to the individual. The increased flexibility of the fluid impermeable barrier 106 formed from the polyurethane also help allow the fluid collection assembly 100 to conform to the individual and / or fit underneath the clothing of the individual thereby increasing patient comfort. The increased flexibility of the fluid impermeable barrier 106 prevents or at least inhibits corners formed in the fluid impermeable barrier 106, if present, from uncomfortably pressing into the individual using the fluid collection assembly 100 thereby making the fluid collection assembly 100 more comfortable to use. The polyurethane may also remain flexible when welded or otherwise have seals formed therein. It has also been found that individuals using the fluid collection assembly 100 describe the fluid impermeable barrier 106 formed from polyurethane as being more smooth 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 wearing the fluid collection assembly 100 more comfortable. It has also been found that forming the fluid impermeable barrier 106 from the polyurethane allows the fluid impermeable barrier 106 to be bent (e.g., crumpled, wrinkled, etc.) more quietly than if the fluid impermeable barrier 106 was formed from another material. The improved quietness of the fluid impermeable barrier 106 allows the fluid collection assembly 100 to be used more discreetly. For example, movement of an individual using the fluid collection assembly 100 is likely to cause the fluid impermeable barrier 106 to bend. Forming the fluid impermeable barrier 106 from polyurethane allows the individual to move more substantially without the fluid impermeable barrier 106 generating noise. Finally, it has been found that the fluid impermeable barrier 106 thatincludes polyurethane is able to be welded to a variety of materials thereby facilitating attachment of the base 104, the vents 134, and the port 130 to the fluid impermeable barrier 106.

[0033] In an 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 person (e.g., medical practitioner) to examiner the penis. In some embodiments, both the first panel 108 and the second panel 110 are formed from at least partially transparent fluid impermeable material. For example, some conventional fluid collection assemblies that include a sheath and a base may allow the sheath to be reversibly detached from the base after the base is secured to the region about the penis. Detaching the sheath from the base allows the person to examine the penis. However, configuring the sheath to be detachable from the base may allow leaks between the sheath and the base. As previously discussed, the sheath 102 may optionally be permanently attached to the base 104, which substantially prevents leaks between the sheath 102 and the base 104 when the base 104 is appropriately attached to the sheath 102 (e.g., no wrinkles were allowed to form between the sheath 102 and base 104). 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 the penis to be examined without detaching the entire fluid collection assembly 100 from the region about the penis. For example, the chamber 112 may include a penis receiving area 131 that is configured to receive the penis of the individual when the penis extends into the chamber 112. The penis receiving area 131 may 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 in the chamber 112 such that the porous material is not positioned between the penis and at least a portion of the transparent portion of the first panel 108 and / or second panel 110 when the penis is inserted into the chamber 112 through the opening 114. The porous material 122 is generally not transparent and, thus, the portion of the at least partially transparent material of the first panel 108 and / or the second panel 110 that defines the penis receiving area 131 forms a window which allows the person to view into the penis receiving area 131 and examine the penis.

[0034] In an embodiment, the second panel 110 is at least partially formed from the at least partially transparent material and forms the window that allows the person to view into the penis receiving area 131. Further, 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 may help maintain the dignity of the individual using the fluid collection assembly 100. For example, during use, the second panel 110 is generally adjacent to the individual, such as adjacent to the thighs and / or perineum. Thus, the second panel 110 is generally obscured during use and a person cannot view the penis without first lifting the sheath 102 away from the individual. Meanwhile, the first panel 108 may face away from the individual and be more easily viewable than the second panel 110. However, a person (e.g., a passerby, a visitor, etc.) cannot view the penis through the first panel 108 because the porous material 122 is not transparent and / or the first panel 108 is formed from a nontransparent material. Thus, in such an embodiment, the first panel 108 and / or the porous material 122 prevent person(s) from viewing the penis unless such examination is necessary, thereby preserving the dignity of the individual using the fluid collection assembly 100. In an embodiment, the first panel 108 is formed from the at least partially transparent material and forms the window that allows the person to view into the penis receiving area 131. Further, the porous material 122 may be positioned between the penis receiving area 131 and at least a portion of the second panel 110. In such an embodiment, the person does not need to perform the additional act of lifting the sheath 102 to view into the penis receiving area 131 but may not maintain the dignity of the individual using the fluid collection assembly 100 since passersby may also view into the penis receiving area 131.

[0035] As previously discussed, at least a portion of the first panel 108 and at least a portion of the second panel 110 may be attached together in one or more embodiments. In an embodiment, as shown, the first and second panels 108, 110 are attached together along at least a portion of the outer edges thereof e.g., the top and lateral edges 136, 138). In such an embodiment, the first and second panels 108, 110 are attached using any suitable technique, such as with an adhesive, sewing, heat sealing, impulse heating, direct heating, radio frequency (“RF”) welding, ultrasonic (“US”) welding, or any other technique. In a particular embodiment, the first and second panels 108 are attached together using impulse heating since impulse heating is quick and is effective at attaching polyurethane panels together. As will be discussed in more detail below, forming the fluid impermeable barrier 106 from the first panel 108 and the second panel 110 mayimprove the rate of manufacturing the fluid collection assembly 100, especially when the first panel 108 and the second panel 110 are attached together using a non-sewing technique.

[0036] In an embodiment, the fluid impermeable barrier 106 may define one or more orifices 132 extending therethrough. The sheath 102 may optionally include one or more vents 134 attached to the fluid impermeable barrier 106 that extend across the one or more orifices 132. The vents 134 are configured to allow air to flow therethrough while preventing water (a major constituent of bodily fluids) from flowing therethrough. The vents 134 facilitate air flow through the chamber 112. For example, as previously discussed, a vacuum may be provided to the chamber 112 from a vacuum source. The vacuum may pull air through the vents 134, thereby allowing air flow from the vents 134 to the fluid outlet 118. The air flow from the vents 134 helps move bodily fluids towards the fluid outlet 118. The vents 134 also prevent the vacuum applied to the chamber 112 from bursting small superficial blood vessels (e.g., cause a hickie) in or otherwise damage the penis or the area about the penis. The vents 134 may include a porous hydrophobic material. In some embodiments, the vents 134 may be covered by a hydrophilic material such as wicking material. The vacuum may prevent (especially when wet) liquid from exit the fluid collection assembly 100 from the vents 134, while air can still enter the fluid collection assembly 100 through the vents 134. In some embodiments, the vents may also be covered by no material at all. The pores defined by the porous hydrophobic material may be interconnected thereby allowing air to flow through the vents 134. The hydrophobic properties of the porous hydrophobic material may prevent water from flowing through the vents 134. In an embodiment, the vents 134 may include a porous polytetrafluoroethylene (“PTFE”) layer. It is currently believed that the porous PTFE layer is exceptionally effectively at allowing air to flow therethrough while preventing water from flow therethrough even when the porous PTFE layer is exposed to acidic bodily fluids. However, porous PTFE is difficult to weld to other materials, such as polyurethane. As such, the porous PTFE layer may be attached to a substrate. The substrate may include a porous material or define one or more passageways therethrough. 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 may be easily attached to the porous PTFE layer and attached to the fluid impermeable barrier 106.

[0037] In an embodiment, the orifices 132 are formed in and the vents 134 are attached to the first panel 108 of the fluid impermeable barrier 106. In such an embodiment, the orifices 132 and the vents 134 are unlikely to be covered by and contact the skin of the individual. Covering the orifices 132 and the vents 134 with the skin may prevent or at least inhibit air flow through the portions of the orifices 132 and the vents 134 at are covered by the skin. Further, an individual may find the vents 134 contacting the skin to be uncomfortable and, thus, disposing the vents 134 on the first panel 108 may make the fluid collection assembly 100 more comfortable to wear. In an embodiment, the vents 134 are attached to an interior of the first panel 108 to prevent the edges of the vents 134 from rubbing or otherwise irritating the skin of the individual.

[0038] In an embodiment, as illustrated, at least one of the orifices 132 is formed in and at least one of the vents 134 is attached to a portion of the fluid impermeable barrier 106 that is at or near to top edge 136 of the fluid impermeable barrier 106. The top edge 136 of the fluid impermeable barrier 106 may include an edge of the fluid impermeable barrier 106 that is above the opening 114 when the individual is standing and the fluid collection assembly 100 is allowed to freely hang from the pubic region of the individual. Forming the orifices 132 and attaching the vents 1 4 at or near the top edge 136 causes air flowing through the vents 134 to pass over the penis (thereby keeping the penis dry) and inhibits pooling of the bodily fluids near the top edge 136. In an embodiment, as illustrated, at least one of the orifices 132 is formed in and at least one of the vents 134 is attached to a portion of the fluid impermeable barrier 106 that is at or near to a lateral edge 138 of the fluid impermeable barrier 106. The lateral edge 138 of the fluid impermeable barrier 106 may include an edge of the fluid impermeable barrier 106 that extends from or near the top edge 136. Generally, air preferentially flows in a path extending from the vents 134 towards the fluid outlet 118. When the vents 134 are spaced from the lateral edges 138 and / or at or near the top edge 136, the preferential air flow from these vents 134 may cause at least some of the portions of the chamber 112 adjacent to the lateral edges 138 to have minimal air flow therethrough. Positioning the orifices 132 and the vents 134 at or near the lateral edges 138 may increase the air flow through the portions of the chamber 112 adjacent to the lateral edges 138 thereby preventing or at least inhibiting pooling of bodily fluids in such portions of the chamber 112.

[0039] The opening 114 defined by the fluid impermeable barrier 106 provides an ingress route for fluids to enter the chamber 112 when the penis is a buried penis andallow the penis to enter the chamber 112 (e.g., the penis receiving area 131) when the penis is not buried. The opening 114 may be defined by the fluid impermeable barrier 106 (e.g., an inner edge of the fluid impermeable barrier 106). For example, the opening 114 may be formed in and extend through the fluid impermeable barrier 106, from the outer surface 127 to the inner surface 126, thereby enabling bodily fluids to enter the chamber 112 from outside of the fluid collection assembly 100.

[0040] In an embodiment, the second panel 110 defines the entirety of the opening 114. For example, the opening 114 may be a cutout defined by the second panel 110 that is spaced from the outer periphery (e.g., edges) of the second panel 110. In such an example, the second panel 110 may exhibit a shape that substantially corresponds to the shape of the first panel 108 which may facilitate attaching the first panel 108 to the second panel 110 along the outer periphery thereof. It also allows the first panel 108 and the second panel 110 to lie substantially flat when the penis is not in the chamber 112 and the sheath 102 is lying on a flat surface. The ability of the first and second panels 108, 110 to lie substantially flat may make wearing the fluid collection assembly 100 more discrete and inhibit pooling of bodily fluids against the individual. However, in some embodiments, the opening 1 14 is not spaced from the outer periphery of the second panel 110. In such embodiments, the opening 114 may be a cutout extending inwardly from at least one outer periphery 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 on June 30, 2021, the disclosure of which is incorporated herein, in its entirety, by this reference.

[0041] As previously discussed, the fluid impermeable barrier 106 includes a proximal region 160 and a distal region 162 extending from the proximal region 160, for example, to the fluid outlet 118 (e.g., to the port 130). The proximal region 160 may define the opening 114 and the distal region 162 may define the fluid outlet 118. Both the proximal region 160 and the distal region 162 define the chamber 112.

[0042] In an embodiment, the fluid impermeable barrier 106 exhibits a generally bullet shape. As used, herein, the fluid impermeable barrier 106 exhibits the generally bullet 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 less than the first width. The first and second widths may be measured perpendicularly to the longitudinal axis 140 and may be greater than a thickness of the sheath 102 when the sheath 102 lies on a flat surface. Thegenerally bullet shape of the fluid impermeable barrier 106 facilitates operation of the fluid collection assembly 100 while making the sheath 102 more comfortable. The decreased second width also funnels the bodily fluids towards the fluid outlet 118 and the port 130.

[0043] In an embodiment, the second width of the distal region 162 may vary (e.g., decrease) along a length of the distal region 162 measured perpendicularly to the longitudinal axis 140. In an example, the second width of the distal region 162 may decrease at a constant rate from the proximal region 160 towards e.g., to) the fluid outlet 118. The constant rate at which the second width decreases may cause the lateral edges 138 of the fluid impermeable barrier 106 that defines the distal region 162 to be straight. The straight lateral edges 138 may form corners at the intersection between the proximal and distal regions 160, 162 that may uncomfortably press into the individual. In an example, the second width of the distal region 162 may decrease at a variable (e.g., increasing) rate from the proximal region 160 towards (e.g., to) the fluid outlet 118. The variable rate at which the second width decreases causes the lateral edges 138 of the fluid impermeable barrier 106 that defines the distal region 162 to be curved, such as convexly curved. The curved lateral edges 138 may prevent the formation of comers that may press into the individual thereby making the fluid collection assembly 100 more comfortable than if the lateral edges 138 of the distal region 162 were straight. However, it is noted that the air flow through the distal region 162 may be more uniform when the lateral edges 138 of the distal region 162 are straight instead of curved.

[0044] It is noted that the fluid impermeable barrier 106 may exhibit a shape other than the generally bullet shape. In an example, the fluid impermeable barrier 106 may exhibit a generally rectangular shape, as discussed in more detail in International Patent Application No. PCT / US2021 / 039866 filed on June 30, 2021, the disclosure of which was previously incorporated herein. In an example, the fluid impermeable barrier 106 may exhibit a generally triangular shape, a semi-oval shape, or any other suitable shape.

[0045] The fluid impermeable barrier 106 also may at least partially define a fluid outlet 118. The fluid outlet 118 may be formed from a portion of the first panel 108 and the second panel 110 that are not attached together.

[0046] FIG. IF is an isometric top view of the port shown and FIG. 1G is a cross- sectional view of the port 130 taken along plane 1G-1G shown in FIG. IE, according to an embodiment. The port 130 includes a first part 144 and a second part 146. The first part 144 and the second part 146 may be integrally formed together (e.g., exhibit singlepiece construction) or may include a multipiece construction having two or more pieces secured together. As such, in some embodiments, the fluid collection assemblies disclosed herein may be formed from first and second panels that are integrally formed together (e.g., exhibit single piece construction) which may eliminate at least some of the edges and simplify manufacturing of such fluid collection assemblies.

[0047] The first part 144 may be attached or configured to be attached to the fluid impermeable barrier 106 and, optionally, to be at least partially disposed in the chamber 112. The second part 146 is configured to attach to the conduit 142. The first part 144 defines an inlet 148 and the second part 146 defines an outlet 150 of the port 130 that is downstream from the inlet 148. The port 130 also defines a channel 152 extending from the inlet 148 to the outlet 150. It is noted that the inlet 148 refers to the inlet of the channel 152 and not necessarily the inlet of the port 130. In an example, the inlet 148 may be the inlet of both the port 130 and the channel 152 when the port 130 does not include a sink 156. In an example, as illustrated, the inlet 148 may not be the inlet of the port 130 when the port 130 includes sink 156 since the sink 156 forms the inlet of the port 130.

[0048] The first part 144 of the port 130 may be attached to the fluid impermeable barrier 106 using any suitable technique. In an embodiment, the first part 144 is disposed between the first and second panels 108, 110 before attaching the first part 144 to the fluid impermeable barrier 106. In such an embodiment, the first part 144 abuts and may be attached to the inner surface 126 of the fluid impermeable barrier 106. In an embodiment, the first part 144 may be 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.

[0049] The port 130 may be formed of a softer, more pliable material than conventional ports of fluid collection assemblies. For example, the material of the port 130 may include polymer (e.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, a polycarbonate, etc.), polyurethane, thermoplastic elastomer (TPE), rubber, thermoplastic polyurethane, another suitable material, or combinations thereof. The port may be flexible, thereby enabling the port to bend or curve when positioned against the body of a wearer and prevent injury to the wearer. Example materials of the port 130 may include, but are not limited to, a fluid impermeable barrier including at leastone of Versaflex CL 2000X TPE, Dynaflex G6713 TPE, or Silpuran 6000 / 05 A / B silicone.

[0050] In some embodiments, at least the second part 146 exhibits a rigidity that is greater than the fluid impermeable barrier 106. The second part 146 may exhibit a rigidity that is greater than the fluid impermeable barrier 106 because at least one of second part 146 exhibits a thickness that is greater than the fluid impermeable barrier 106 or at least a portion of the second part 146 is formed from a material exhibiting a Young’s modulus (i.e., modulus of elasticity) that is greater than a Young’s modulus of a material forming at least a portion of the fluid impermeable barrier 106. The increased rigidity of the second part 146 relative to the fluid impermeable barrier 106 allows the second part 146 to be attached to the conduit 142 using techniques that may be difficult or impossible to do when the conduit 142 is directly attached to the fluid impermeable barrier 106. In an example, the conduit 142 may be attached to the second part 146 using an interference fit which may be difficult or impossible to do when the conduit 142 is directly attached to the fluid impermeable barrier 106. In such an example, a surface of the second part 146 that is configured to abut the conduit 142 is tapered. The tapered surface of the second part 146 may make inserting the second part 146 into the conduit 142 easier when the second part 146 forms a male connector and may make receiving the conduit 142 into the second part 146 easier when the second part 146 forms a female connector. The tapered surface of the second part 146 also allows the strength of the interference fit between the second part 146 and the conduit 142 to be controlled by controlling how much the second part 146 is inserted into the conduit 142 or how much the conduit 142 is inserted into the second part 146. In an example, not shown, a surface of the second part 146 is configured to be threadedly attached to the conduit 142 which may be difficult or impossible to do when the conduit 142 is directly attached to the fluid impermeable barrier 106. In such an example, the second part 146 may include one or more helically extending ridges extending from a surface of the second part 146 that contacts or is closest to the conduit 142. It is noted that the surface of the second part 146 that includes the threads and / or the threads may be tapered. In an example, not shown, a surface of the second part 146 that contacts or is closest to the conduit 142 may include circumferentially extending ridges. It is noted that the surface of the second part 146 that includes the ridges and / or the ridges may be tapered.

[0051] In an embodiment, at least the second part 146 exhibits a rigidity that is greater than the conduit 142. The second part 146 may exhibit a rigidity that is greaterthan the conduit 142 because at least one of the second part 146 exhibits a thickness that is greater than the conduit 142 or at least a portion of the second part 146 is formed from a material exhibiting a Young’s modulus that is greater than a Young’s modulus of a material forming at least a portion of the conduit 142. The increased rigidity of the second part 146 prevents collapse of the channel 152. For example, it has been found that, in certain circumstances, directly attaching the conduit 142 to the fluid impermeable barrier 106 may cause the portions 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, the increased rigidity of the port 130 prevents such collapse.

[0052] In an embodiment, the first part 144 exhibits a rigidity that is greater than the fluid impermeable barrier 106 and / or the conduit 142. For example, the first part 144 may exhibit a rigidity that is comparable to the second part 146. The increased rigidity of the first part 144 prevents collapse of the inlet 148, any portions of the channel 152 defined thereby, and the sink 156. The increased rigidity of the first part 144 may also make attaching the port 130 to the first part 144 easier since pressure may be applied to the first part 144 during the attachment process substantially without deforming the first part 144.

[0053] The first part 144 may exhibit a shape that is different than the second part 146. For example, the first part 144 may exhibit a first elongated shape that extend in a direction that is generally perpendicular to the longitudinal axis 140 and the second part 146 may exhibit a second elongated shape (e.g., generally cylindrical shape) that extends generally parallel to the longitudinal axis 140. The first elongated shape of the first part 144 may strengthen the attachment between the first part 144 and the fluid impermeable barrier 106 by increasing the surface area of the first part 144 that is attached to the fluid impermeable barrier 106. The first elongated shape of the first part 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 with rounded comers and edges, a generally oval cross-sectional shape, a generally elliptical cross-sectional shape, or a generally diamond cross-sectional shape with rounded edges and comers. In a particular example, the first elongated shape is a generally elliptical cross-sectional shape to eliminate sharp edges on the port that may injure the wearer. In a particular example, the first elongated shape included rounded comers since the rounded comers are less likely to uncomfortably press into the individual than sharp corners. The second elongated shape of the secondpart 146 that extends parallel to the longitudinal axis 140 may facilitate attachment to the conduit 142.

[0054] The first part 144 may exhibit a first maximum thickness and the second part 146 may exhibit a second maximum thickness. As discussed in more detail elsewhere, the sheath 102 is configured to lie substantially flat when disposed on a flat surface which allows the fluid collection assembly 100 to be worn discretely, prevents or at least inhibits pooling of bodily fluids in the chamber 112, and allows the fluid collection assembly 100 to be used with buried penises. It is noted that “substantially flat” allows for deviations that generally do not prevent the fluid collection assembly 100 from being worn discretely, still inhibits pooling of bodily fluids, and allows the fluid collection assembly 100 to be used by a buried penis, such as deviations caused by the port 130, the vents 134, or minor bulges or waves formed in the fluid impermeable barrier 106. 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 lay flat. The second maximum thickness is generally dictated by the need to attach the conduit 142 to the second part 146. For example, the second maximum thickness may need to be slightly greater than the inner diameter of the conduit 142 when the second part 146 is a male connector and greater than the outer diameter of the conduit 142 when the second part 146 is a female connector. In a particular example, the second part 146 is a male connector since the second maximum thickness of the second part 146 is smaller when the second part 146 is a male connector than when the second part 146 is a female connector. It is noted that, when the second part 146 is a male connector, the second part 146 has less of an adverse effect on the ability of the sheath 102 to lay flat than if the conduit 142 is directly attached to the fluid impermeable barrier 106 since the second maximum thickness may be less than an outer diameter of the conduit 142.

[0055] Generally, the first maximum thickness of the first part 144 is substantially equal to or less than the second maximum thickness to minimize the adverse effect that the first part 144 has on the ability of the sheath 102 to lay flat. In an example, when the second maximum thickness is at or near an intersection between the first and second parts 144, 146, the first maximum thickness may be substantially equal to the second maximum thickness to prevent formation of comers that may press uncomfortably into the individual. The second maximum thickness may be at or near the intersection between the first and second parts 144, 146 when the outer surface 154 of the second part 146 is tapered.

[0056] In an embodiment, the first maximum thickness of the first part 144 is greater than a collective thickness of the fluid impermeable barrier 106 (e.g., the collective thickness of the first and second panels 108, 110) and the porous material 122. The increased thickness of the first maximum thickness of the first part 144 relative to the collective thickness of the fluid impermeable barrier 106 and the porous material 122 prevents the sheath 102 from lying flat at or near the port 130. However, it is noted that the high flexibility of the fluid impermeable barrier 106, especially when the fluid impermeable barrier 106 is formed from polyurethane, minimizes the percentage of the sheath 102 adjacent to the port 130 that does not lie flat. Further, the first part 144 is at least one of spaced from the opening 114 which prevents the first maximum thickness from affecting the ability of the fluid collection assembly 100 to be used with a buried penis, is located at the greatest air flow which inhibits pooling of bodily fluids, or the first maximum thickness is less than the maximum thickness of the conduit 142 thereby causing the conduit 142 to more adversely affect the ability to use the fluid collection assembly 100 discretely than the port 130. In an example, the first maximum thickness may be greater than the collective thickness of the fluid impermeable barrier 106 and the porous material 122 by about 500% (i.e., 5 times greater) or less, about 400% or less, about 300% or less, about 200% or less, or about 150% or less. It is noted that the first maximum thickness may be larger than the collective thickness of the fluid impermeable barrier 106 and the porous material 122 to allow the inlet 148 to be sufficiently large to remove the bodily fluids from the chamber 112 and may be dictated by the size of the conduit 142.

[0057] In an embodiment, the first part 144 of the port 130 may define a sink 156 that is distinct from the inlet 148. The sink 156 is positioned upstream from the inlet 148. For example, the inlet 148 may exhibit dimension(s) e.g., width and / or thickness) that is comparable to corresponding dimension(s) of the channel 152 are or near the intersection of the first part 144 and the second part 146. The dimension(s) of the inlet 148 are comparable to the corresponding dimension(s) of the channel 152 when the dimension(s) of the inlet 148 differ from the dimension(s) of the channel 152 by at most about ±10% or at most about ±5%. For example, as illustrated, the inlet 148 exhibits a width that is substantially the same as the width of the channel 152 at the intersection of the first and second parts 144, 146. The sink 156 exhibits a maximum dimension that is greater than a corresponding dimension(s) of the inlet 148 and is not comparable to a corresponding dimension(s) of the channel 152 at the intersection of the first and second parts 144, 146.For example, as illustrated, the sink 156 defined by the first part 144 exhibits a maximum dimension (i.e., width) that is significantly greater than the corresponding width of the inlet 148 and the corresponding width of the channel 152 at the intersection of the first and second parts 144, 146. It is noted that the wider width of the first part 144 relative to the second part 146 allows the first part 144 to define the sink 156.

[0058] The sink 156 facilitates flow of the bodily fluids through the chamber 112, into the port 130, and through the port 130. For example, the wider dimension(s) of the sink 156 relative to the inlet 148 makes it easier for the bodily fluids to enter the port 130 than a substantially similar port 130 that does not include the sink 156 (i.e., the inlet 148 is the inlet of the port 130). The wider width of the sink 156 relative to the inlet 148 also distributes the air flow to a greater percentage of the chamber 112 than a substantially similar port 130 that does not include the sink 156. The wider dimension(s) of the sink 156 relative to the inlet 148 increases the unoccupied volume of the port 130 than if the port 130 did not include the sink 156. The greater volume of the port 130 allows the port 130 to funnel fluid to the outlet of the port 130. In other words, the sink 156 may form a fluid reservoir. Also, it has been found that the sink 156 decreases turbulent flow of the bodily fluids flowing through the port 1 0 than if the port 1 0 did not include the sink 156. The decreased turbulent flow allows the bodily fluids to flow through the port 130 at a greater rate than if the port 130 did not include the sink 156 thereby inhibiting oversaturation of the bodily fluids in the porous material 122. The decreased turbulent flow of the bodily fluids caused by the sink 156 may especially facilitate the operation of the fluid collection assembly 100 when the second part 146 forms a male connector. For example, forming the second part 146 as a male connector decreases the lateral dimension(s) (e.g., diameter) of the channel 152 which causes the lateral dimensions of the second part 146 to limit the rate at which bodily fluids are removed from the chamber 112. The decreased turbulent flow of the bodily fluids through the port 130 caused by the sink 156 helps mitigate this issue.

[0059] In an embodiment, the dimension(s) of the sink 156 are maintained substantially constant. Maintaining the dimension(s) of the sink 156 substantially constant maximizes the volume of the sink 156, and by extension the volume of the port 130, that may be a fluid reservoir. However, maintaining the dimension(s) of the sink 156 substantially constant may cause a step to form at the intersection of the inlet 148 and the sink 156 which may increase turbulent flow of the bodily fluids flowing through the port 130 than if there was not step between the inlet 148 and the sink 156. In anembodiment, as illustrated, the dimension(s) of the sink 156 may be tapered along at least a portion of the length ( .g., measured parallel to the longitudinal axis 140) of the sink 156. In other words, the dimension(s) of the sink 156 may vary along at least a portion of the length thereof. The tapered dimension(s) of the sink 156 may prevent or at least decrease the step at the intersection of the inlet 148 and the sink 156. Thus, the tapered dimension(s) may decrease turbulent flow of the bodily fluids flowing through the port 130 than if the dimension(s) of the sink 156 where maintained substantially constant. It is noted that the tapered dimension(s) of the sink 156 decreases the volume of bodily fluids that may be temporarily stored in the sink 156 and, by extension, the port 130.

[0060] Due to the flexibility of the fluid impermeable barrier 106, the sheath 102 may bend to exhibit a generally L- or U-shape which may cause the fluid impermeable barrier 106 to extend across the inlet of the port 130 (e.g. , extend across the sink 156 or 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 the individual such that the fluid collection assembly 100 generally extends from the pubic region of the individual towards the feet of the individual. However, in many hospitals, the vacuum source is positioned behind the bed of the individual such that the conduit 142 extends from the fluid outlet 1 18 towards the head of the individual when the individual is lying on the bed. As such, the conduit 142 may cause the sheath 102 to bend and exhibit the generally L- or U-shape. It has been found that the fluid impermeable barrier 106 may obstruct the inlet of the port 130 thereby preventing or inhibiting bodily fluids entering the port 130 when the sheath 102 bends and exhibits the generally L- or U-shape.

[0061] As such, the first part 144 of the port 130 may include an upper portion 144a having an upper proximal end 157a and a lower portion 144b having a lower proximal end 157b. The inlet 148 may be disposed between the upper portion 144a and the lower portion 144b of the first part 144 of the port 130. The proximal ends 157a, 157b are substantially aligned and spaced from one another between the first panel 108 and the second panel 108, according to an embodiment. For example, assuming a lateral dimension of the fluid collection assembly 100 extends generally perpendicular to the longitudinal axis 140 from the first panel 108 to the second panel, the proximal ends 157a, 157b are spaced substantially laterally from one another. The proximal ends 157a, 157b may be aligned such that the proximal ends 157a, 157b terminate at substantially an equal distance from the inlet 148 or the body of the first part 144. In some embodiments, the proximal ends 157a, 157b are aligned to terminate at substantially an equal distancefrom the inlet 148, but the tabs 148a, 148b are offset from one another. In other words, the proximal ends 157a, 157b are generally aligned in a side view (such as the cross- sectional view of FIG. 1C), but the tabs 148a, 148b are at least partially offset from one another when the port 130 is viewed from above or below the port 130. Alignment of the two spaced apart proximal ends 157a, 157b results in the technical effect of keeping the inlet 148 and / or the sink 156 open and unobstructed when a vacuum force is applied to the chamber 112 through the port 130. In other words, the longitudinal alignment of the two spaced apart proximal ends 157a, 157b inhibits or prevents the first panel 108 and the second panel 110 from closing over the inlet 148 and / or the sink 156 when a vacuum force applied to the chamber 112 through the port 130.

[0062] In some embodiments of the fluid collection assembly 100, the port 130 includes an upper tab 158a extending into the chamber 112 from the upper portion 144a to the upper proximal end 157a and a lower tab 158b extending into the chamber 112 from the lower portion 144a to the lower proximal end 157b. The spaced apart two tabs 158a, 158b extending from the first part 144 increases the likelihood that a passageway is formed that allows bodily fluids to flow to the port 130 even when the sheath 102 bends and exhibits the generally L- or U-shape. In other words, the spaced apart two tabs 1 8a, 158b may allow bodily fluids to continue to flow into the port 130 and / or increase the rate at which the bodily fluids may flow into the port 130 when the sheath 102 is bent.

[0063] The two tabs 158a, 158b may extend from the first part 144 by a distance that is 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 in ranges 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. The two tabs 158a, 158b (e.g., the proximal ends 157a, 157b of the two tabs 158a, 158b) may be spaced by a distance that is 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, 2 cm or more, or in ranges of about 5 mm to about 2 cm, about 5 mm to about 1 cm, about 1 cm to about 1.5 cm, about 1.5 cm to about 2 cm, about 5 mm to about 7 mm, about 6 mm to about 8 mm, about 8 mm to about 1 cm, about 9 mm to about 1.1 cm, about 1 cm to about 1.2 cm, about 1.1 cm to about 1.3 cm, about 1.2 cm to about 1.4 cm, about 1.3 cm to about 1.5 cm, about 1.4 cmto about 1.6 cm, about 1.5 cm to about 1.7 cm, about 1.6 cm to about 1.8 cm, about 1.7 cm to about 1.9 cm, or about 1.8 cm to about 2 cm.

[0064] Generally, the ability of the two tabs 158a, 158b to allow bodily fluids to continue to flow into the port 130 and / or increase the rate at which the bodily fluids may flow into the port 130 when the sheath 102 is bent is improved as the distance that the two tabs 158a, 158b extend from the first part 144 is increased. However, increasing the distance that the two tabs 158a, 158b extend from the first part 144 increases the likelihood that the two tabs 158a, 158b uncomfortably press into the individual, for example, when the sheath 102 is bent. The likelihood that the two tabs 158a, 158b uncomfortably press into the individual may be mitigated by cushioning the two tabs 158a, 158b with the porous material 122. The two tabs 158a, 158b may be cushioned by the porous material 122 when the tab 158 is formed on a side of the first part 144 adjacent to the first panel 108 and configuring the porous material 122 to be positioned between the tab 158 and the second panel 110. The porous material 122 between the two tabs 158a, 158b also may provide a network for water molecules to connect and bring that network into the port 130 for fluid removal from the chamber 112. The porous material 122 between the two tabs 158a, 1 8b also may inhibit the fluid impermeable barrier 106 from being vacuumed between the two tabs 158a, 158b and into the port 130. In some embodiments, each of the two tabs 158a, 158b extend at least partially into the porous material 122. In some embodiments, at least some (e.g., all) of the terminating end of distal region 172 of the porous material 122 is positioned between the two tabs 158a, 158b. With the porous material 122 positioned between the two tabs 158a, 158b and / or the two tabs 158a, 158b extending into the porous material 122, the porous material 122 may be positioned proximate to (e.g., abut) the first part 144 of the port 130 and / or extend into the sink 156 of the port 130. In these and other embodiments, the upper proximal end 157a (e.g., the upper tab 158a) and the lower proximal end 157b (e.g., the lower tab 158b) of the first part 144 of the port 130 may be disposed between the first panel 108 and the second panel 110.

[0065] In an embodiment, the two tabs 158a, 158b may be formed from the same material as the rest of the port 130. In such an embodiment, the port 130 may exhibit integral construction (e.g., single-piece construction) which may make manufacturing of the port 130 more efficient. In an embodiment, the two tabs 158a, 158b may be distinct (e.g., formed from a different material) from the rest of the port 130. In such an embodiment, manufacturing of the port 130 may be more difficult since manufacturing ofthe port 130 requires forming to pieces (instead of one) and attaching the two pieces together.

[0066] Referring back to FIGS. 1A-1E, the fluid outlet 118 and the port 130 may be located at or near the distal region 162 of the sheath 102 which is expected to be the gravimetrically low 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 enables the conduit 142 to receive more of the bodily fluids than if the fluid outlet 118 and the port 130 was located elsewhere and reduce the likelihood of pooling (e.g., pooling of the bodily fluids may cause microbe growth and foul odors). For instance, the bodily fluids in porous material 122 due to capillary forces. However, the bodily fluids may exhibit a preference to flow in the direction of gravity, especially when at least a portion of the porous material 122 is saturated with the bodily fluids. Accordingly, the fluid outlet 118 and the port 130 may be located in the fluid collection assembly 100 in a position expected to be the gravimetrically low point in the fluid collection assembly 100 when worn by a user.

[0067] As previously discussed, the sheath 102 includes at least one porous material 122 disposed in the chamber 112. The porous material 122 may direct the bodily fluids to one or more selected regions of the chamber 112, such as away from the penis and towards the fluid outlet 118. As such, the porous material 122 may facilitate the removal of the bodily fluids from the chamber 112 and form a layer that prevents the penis from resting against a damp material which may cause degradation of the skin of the penis and / or make the fluid collection assembly 100 more uncomfortable to wear. The porous material 122 may also blunt a stream of urine from the penis.

[0068] In an embodiment, the porous material 122 includes a wicking material configured to wick any bodily fluids away from the opening 114 thereby preventing the bodily fluids from escaping the chamber 112. Such “wicking” may not include absorption of fluid into the wicking material. Put another way, substantially no absorption of fluid into the material may take place after the material is exposed to the fluid and removed from the fluid for a time. While no absorption is desired, the term “substantially no absorption” may allow for nominal amounts of absorption of fluid into the wicking material (e.g., absorbency), such as less than about 30 wt% of the dry weight of the wicking material, less than 20 wt%, less than 15 wt%, less than 10 wt%, less than about 7 wt%, less than about 5 wt%, less than about 3 wt%, less than about 2 wt%, less than about 1 wt%, or less than about 0.5 wt% of the dry weight of the wicking material.The wicking material may also wick the fluid generally towards an interior of the chamber 112, as discussed in more detail below. In an embodiment, the porous material 122 is configured to adsorb or absorb the bodily fluids. Similar, to the wicking material, such adsorbing or absorbing material may move bodily fluids away from the opening 114 thereby preventing the bodily fluids from escaping the chamber 112.

[0069] The porous material 122 may be formed from any suitable porous material. For example, the porous material 122 may be formed from nylon (e.g. , spun nylon fibers), polyester, polyurethane, polyethylene, polypropylene, other porous polymers, hydrophobic foam, an open cell foam, wool, silk, linen, cotton (e.g., cotton gauze), felt, other fabrics, a coated porous material (e.g., a water repellent coated porous material), any other suitable porous materials, or combinations thereof. In some embodiments, the porous material 122 may include two or more layers of fluid permeable materials. For example, the porous material 122 may include a fluid permeable membrane covering at least a portion (e.g., all) of a fluid permeable body (e.g. support), with both the fluid permeable membrane and the fluid permeable body being disposed in the chamber 112. The fluid permeable membrane may be configured to wick any fluid away from the opening 1 14 / 124, thereby preventing the fluid from escaping the chamber 1 12. In some embodiments, at least one of the fluid permeable membrane or the fluid permeable support include nylon configured to wick fluid away from the opening 114 / 124. The material of the fluid permeable membrane and the fluid permeable support also may include natural fibers. 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.

[0070] The fluid permeable membrane may also wick the fluid generally towards an interior of the chamber 112 and / or the fluid permeable support. The fluid permeable membrane may include any material that may wick the fluid. For example, the fluid permeable membrane may include fabric, such as a gauze (e.g., a silk, linen, polymer based materials such as polyester, or cotton gauze), another soft fabric (e.g., jersey knit fabric or the like), or another smooth fabric (e.g., rayon, satin, or the like). Forming the fluid permeable membrane from gauze, soft fabric, and / or smooth fabric may reduce chaffing caused by the fluid collection assembly 100. In many embodiments, the porous material 122 includes a fluid permeable support including a porous spun nylon fiber structure and a fluid permeable wicking membrane including gauze at least partially enclosing or covering the spun nylon fiber structure. For example, the porous material 122 may include a gauze or other wicking fabric positioned to contact the skin of the userin the chamber 112 and / or the penis receiving area 131. In some embodiments, the gauze or other wicking fabric covers a layer of spun nylon fibers material. In some embodiments, the gauze or other wicking fabric covers the side of substantially planar spun nylon fibers material that is oriented towards the skin of the user.

[0071] In some embodiments including a fluid permeable membrane (e.g., gauze) covering a fluid permeable support (e.g., spun nylon fibers), each of the two tabs 158a, 158b extend at least partially into the fluid permeable support. In some embodiments, at least some (e.g., all) of the terminating end of the fluid permeable support at the distal region 172 is positioned between the two tabs 158a, 158b, and the fluid permeable membrane is not positioned between the two tabs 158a, 158b. With the fluid permeable support of the porous material 122 positioned between the two tabs 158a, 158b and / or the two tabs 158a, 158b extending into the fluid permeable support of the porous material 122, the fluid permeable support of the porous material 122 may be positioned proximate to (e.g., abut) the first part 144 of the port 130 and / or extend into the sink 156 of the port 130.

[0072] In an embodiment, the porous material 122 may be a sheet (e.g., a multi-layer sheet). The porous material 122 is a sheet when the porous material 122 at least one of is generally planar when lying on a flat surface, does not define a cavity (e.g., is not tubular), or exhibits a length and width that is greater than a thickness thereof. Forming the porous material 122 as a sheet may facilitate the manufacturing of the fluid collection assembly 100. For example, forming the porous material 122 as a sheet allows the first panel 108, the second panel 110, and the porous material 122 to each be sheets. During the manufacturing of the fluid collection assembly 100, the first panel 108, the second panel 110, and the porous material 122 may be stacked and then attached to each other in the same manufacturing step. For instance, the porous material 122 may exhibit a shape that is the same size or, more preferably, slightly smaller than the size of the first panel 108 and the second panel 110. As such, attaching the first panel 108 and the second panel 110 together along the outer edges (e.g. , top edges 136 and lateral edges 138) thereof may also attach the porous material 122 to the first panel 108 and the second panel 110. 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 extend around the porous material 122 such that the porous material 122 does not form a passageway through the fluid impermeable barrier 106 through which the bodily fluids may leak. Also, attaching the porous material 122 to the first panel 108 and / or the second panel 110 may preventthe porous material 122 from significantly moving in the chamber 112, such as preventing the porous material 122 from bunching together near the fluid outlet 118. In an example, the porous material 122 may be attached to the first panel 108 or the second panel 110 (e.g., via an adhesive) before or after attaching the first panel 108 to the second panel 110. In an example, the porous material 122 may merely be disposed in the chamber 112 without attaching the porous material 122 to at least one of the first panel 108 or the second panel 110. In some embodiments, the fluid permeable support, the fluid permeable membrane, and the fluid impermeable barrier are not secured to one another (e.g., the fluid permeable support and the fluid permeable membrane are movable within the chamber). In an embodiment, as will be discussed in more detail below, the porous material 122 may exhibit shapes other than a sheet, such as a hollow generally cylindrical shape.

[0073] The porous material 122 may 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 illustrated, the porous material 122 may exhibit a generally bullet shape. The porous material 122 may exhibit a generally bullet 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 that corresponds to the distal region 162. The proximal portion 170 may exhibit a substantially constant first width and the distal portion 172 may exhibit a second width that is less than the first width. The second width may be constant or vary (e.g., vary at a constant or variable rate). The porous material 122 may exhibit a shape other than the generally bullet shape, such as a generally rectangular shape, generally semi -oval shape, or any other suitable shape.

[0074] Other examples of porous material(s) are disclosed in International Patent Application No. PCT / US2022 / 014285 filed on lanuary 28, 2022, the disclosure of which is incorporated herein, in its entirety, by this reference.

[0075] Generally, the sheath 102 is substantially flat when the penis is not in the penis receiving area 131 and the sheath 102 is resting on a flat surface. The sheath 102 is substantially flat because the fluid impermeable barrier 106 is formed from the first panel 108 and the second panel 110 instead of a generally tubular fluid impermeable barrier. Further, as previously discussed, the porous material 122 may be a sheet, which also causes the sheath 102 to be substantially flat. It is noted that the sheath 102 is described as being substantially flat because at least one of the porous material 122 may cause aslight bulge to form in the sheath 102 depending on the thickness of the porous material 122, the port 130 may cause a bulge thereabout, or the base 104 may pull on portions of the sheath 102 thereabout. It is also noted that the sheath 102 may also be compliant and, as such, the sheath 102 may not be substantially flat during use since, during use, the sheath 102 may rest on a non-flat surface (e.g., may rest on the testicles, the perineum, and / or between the thighs) and the sheath 102 may conform to the surface of these shapes.

[0076] The ability of the sheath 102 to be substantially flat when the penis is not in the penis receiving area 131 and the sheath 102 is resting on a flat surface allows the fluid collection assembly 100 to be used with a buried and a non-buried penis. For example, when the fluid collection assembly 100 is being used with a buried penis, the penis does not extend into the penis receiving area 131 which causes the sheath 102 to lie relatively flat across the aperture 124. When the sheath 102 lies relatively flat across the aperture 124, the porous material 122 extends across the aperture and is in close proximity to the buried penis. As such, the porous material 122 prevents or inhibits pooling of bodily fluids discharged from the buried penis against the skin of the individual since the porous material 122 will receive and remove at least a significant portion of the bodily fluids that would otherwise pool against the skin of the individual. Thus, the skin of the individual remains dry thereby improving comfort of using the fluid collection assembly 100 and preventing skin degradation. However, unlike other conventional fluid collection assemblies that are configured to be used with buried penises, the fluid collection assembly 100 may still be used with a non-buried penis since the non-buried penis can still be received into the penis receiving area 131, even when the penis is fully erect. Additionally, the ability of the sheath 102 to be substantially flat allows the fluid collection assembly 100 to be used more discretely than if the sheath 102 was not substantially flat thereby avoiding possibly embarrassing scenarios.

[0077] When the sheath 102 is substantially flat, the porous material 122 may occupy substantially all of the chamber 112 and the penis receiving area 131 is collapsed (shown as being non-collapsed in FIGS. 1C and ID for illustrative purposes). In other words, the sheath 102 may not define a region that is constantly unoccupied by the porous material 122. When the porous material 122 occupies substantially all of the chamber 112, the bodily fluids discharged into the chamber 112 are unlikely to pool for significant periods of time since pooling of the bodily fluids may cause sanitation issues, cause an odor,and / or may cause the skin of the individual to remain in contact with the bodily fluids which may cause discomfort and skin degradation.

[0078] As previously discussed, the first panel 108, the second panel 110, and the porous material 122 may be selected to be relatively flexible. The first panel 108, the second panel 110, and the porous material 122 are relatively flexible when the first panel 108, the second panel 110, and the porous material 122, respectively, are unable to maintain their shape when unsupported. The flexibility of the first panel 108, the second panel 110, and the porous material 122 may allow the sheath 102 to be substantially flat, as discussed above. The flexibility of the first panel 108, the second panel 110, and the porous material 122 may also allow the sheath 102 to conform to the shape of the penis even when the size and shape of the penis changes (e.g., becomes erect) and to minimize any unoccupied spaces in the chamber 112 in which bodily fluids may pool.

[0079] As previously discussed, the fluid collection assembly 100 may optionally a base 104 that is configured to be coupled to the skin that surrounds the penis (e.g., mons pubis, thighs, testicles, and / or perineum) and have the penis disposed therethrough. For example, the base 104 may define an aperture 124 configured to have the penis positioned therethrough. The base 104 may he flexible, thereby allowing the base 104 to conform to any shape of the skin surface and mitigate the base 104 pulling the on skin surface. The base 104 is configured to be attached to the region about the penis (e.g., mons pubis) while not being attached to the thighs since attaching the base 104 to the thighs may cause the base 104 to uncomfortably pull when the individual moves. In an example, the base 104 may 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 region about the penis except for the mons pubis (e.g., an upper portion of the testicles). The primary attachment portion 174 may exhibit a generally rectangular or trapezoidal shape. The primary attachment portion 174 may extend further from the aperture 124 than the secondary attachment portion 176 since the mons pubis is less sensitive and larger than the other regions about the penis. The secondary attachment portion 176 may include one or more concave lateral edges 178. The concave lateral edges 178 may help prevent the secondary attachment portion 176 from being attached to the thighs of the individual. It is noted that any corners of the base 104 may be rounded to prevent or at least inhibit the base 104 uncomfortably pressing into the individual.

[0080] The base 104 may exhibit shapes other than the shape illustrated in FIG. IE. For example, the base 104 may exhibit a generally partially triangular shape having three apexes and edges extending between each of the apexes. The apexes may be rounded to prevent the base 104 from digging into and hurting the individual. The aperture 124 may be located off-center and closer to one of the apexes than the other apexes. Other examples of shapes that the base 104 may form are disclosed in PCT Application No. PCT / US2021 / 015787 filed on January 29, 2021, the disclosure of which is incorporated herein, in its entirety, by this reference.

[0081] In an embodiment, not shown, the aperture 124 may exhibit a generally circular shape. In an embodiment, as illustrated, the aperture 124 may exhibit a noncircular shape. The non-circular shape of the aperture 124 may be selected to at least one of correspond to the cross-sectional shape of a base of a penis and / or better conform to the region about the penis, either of which may limit leakage and pooling of the bodily fluids. For example, as illustrated, the aperture 124 may exhibit a generally bell-like shape. The generally bell-like shape includes a concave (relative to an interior of the aperture 124) top edge 180 and a concave bottom edge 182 opposite the concave top edge 180. The generally bell-like shape also includes two convex lateral edges 184 extending between the top and bottom edges 180, 182. Any corners between the top, bottom, and lateral edges 180, 182, 184 may be rounded. The two convex lateral edges 184 cause the width of the aperture 124 to vary. For example, the two convex lateral edges 184 cause a width of the aperture 124 near the top edge 180 to be smaller than a width of the aperture 124 near the bottom edge 182. The generally bell-like shape of the aperture 124 may allow the aperture 124 to correspond to the shape of the base of the penis which prevents bodily fluids leaking from the chamber 112 and inhibits pooling of the bodily fluids. The aperture 124 may exhibit other non-circular shapes, such as generally triangular shape, a generally trapezoidal shape, a generally hippopede shape, or any other suitable non- circular shape.

[0082] The base 104 may include a substrate having a top surface and a bottom surface. The top surface is closer to the sheath 102 than the bottom surface while the bottom surface is closer to the skin of the individual than the top surface. The base 104 may also include an adhesive layer disposed on at least a portion of the bottom surface. The adhesive layer is configured to attach the base 104 to the skin around the penis. The base 104 may also include a release liner 194 is configured to be easily removed from the adhesive layer and is configured to prevent the adhesive layer inadvertently becomingattached to an object. The substrate may be formed from a fluid impermeable material to prevent bodily fluids from leaking from the chamber 112 through the base 104.

[0083] In an embodiment, all of the base 104 is attached to the sheath 102 which may strengthen the attachment between the sheath 102 and the base 104. In an embodiment, as illustrated, only the inner portions of the base 104 defining or adjacent to the aperture 124 are attached to the sheath 102. Attaching only the inner portions of the base 104 to the sheath 102 may be sufficient to maintain the base 104 attached to the sheath 102 during use. Only attaching the inner portions of the base 104 to the sheath 102 may allow the outer portions of the base 104 (e.g., portions of the base 104 other than the inner portions) to be easily handled by a user of the fluid collection assembly 100 which, in turn, makes it easier to attach the base 104 to the individual.

[0084] In an embodiment, the base 104 may be attached to the second panel 110 before the second panel 110 is attached to the first panel 108 which facilitates attaching the base 104 to sheath 102, for example, using US welding, RF welding, and impulse heating. Attaching the base 104 to the second panel 110 before positioning (e.g., securing) the fluid permeable support 122 in the chamber 112 may cause difficulties securing the fluid permeable support 122 in the chamber 1 12 since the base 104 may be in the way. In an example, as illustrated, the base 104 and the fluid permeable support 122 may 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 may be generally aligned with each other such that the base gaps 196 and the porous material gaps 198 are adjacent to each other. The base gaps 196 and the porous material gaps 198 allows opposing portions of the fluid impermeable barrier 106 that are generally aligned with the base gaps 196 and the porous material gaps 198 to be attached together (e.g., using US welding, RF welding, impulse heating, direct heating, heat staking, etc.). Attaching the opposing portions of the fluid impermeable barrier 106 together may secure the fluid permeable support 122 in the chamber 112. In a particular example, as illustrated, the base gaps 196 and the porous material gaps 198 may be formed in portions of the base 104 and the fluid permeable support 122 that are adjacent to or above (e.g., further spaced from the fluid outlet 118) portions of the aperture 124 that are furthest spaced from the fluid outlet 118. Such positioning of the base gaps 196 and the porous material gaps 198 may keep the fluid permeable support 122 extending across the aperture 124. Examples of bases 104 are disclosed in International Application No. PCT / US22 / 14285 filed onJanuary 28, 2022, the disclosures of which are incorporated herein, in its entirety, by this reference.

[0085] Referring back to FIGS. 1A-1E, 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 a thermoplastic elastomer, polyvinyl chloride, ethylene vinyl acetate, polytetrafluoroethylene, etc., tubing. In some examples, the conduit 142 may include silicon or latex. In some examples, the conduit 142 may include one or more portions that are resilient, such as to by having one or more of a diameter or wall thickness that allows the conduit to be flexible.

[0086] As described in more detail below, the conduit 142 is configured to be coupled to, and at least partially extend between, one or more of the fluid storage container (not shown) and the vacuum source (not shown). In an example, the conduit 142 is configured to be directly connected to the vacuum source (not shown). In such an example, the conduit 142 may extend from the fluid impermeable barrier 106 by at least one foot, at least two feet, at least three feet, at least six feet, or at least eight feet. In another example, the conduit 142 is configured to be indirectly connected to at least one of the fluid storage container (not shown) and the vacuum source (not shown). In some examples, the conduit is secured to a wearer’s skin with a catheter securement device, such as a STATLOCK® catheter securement device available from C. R. Bard, Inc., including but not limited to those disclosed in U.S. Patent Nos. 6,117,163; 6,123,398; and 8,211,063, the disclosures of which are all incorporated herein by reference in their entirety.

[0087] The inlet and an outlet of the conduit 142 are configured to fluidly couple (e.g., directly or indirectly) the vacuum source (not shown) to the chamber 112. As the vacuum source (FIG. 7) applies a vacuum / vacuum in the conduit 142, the bodily fluids in the chamber 112 may be drawn into the inlet 148 and out of the fluid collection assembly 100 via the conduit 142. In some examples, the conduit 142 may be frosted or opaque (e.g., black) to obscure visibility of the bodily fluids therein.

[0088] In some examples, the vacuum source may be remotely located from the fluid collection device. In such examples, the conduit 142 may be fluidly connected to the fluid storage container, which may be disposed between the vacuum source and the fluid collection assembly 100.

[0089] During operation, a male using the fluid collection assembly 100 may discharge bodily fluids (e.g., urine) into the chamber 112. The bodily fluids may pool or otherwise be collected in the chamber 112 (e.g., received into the porous material 122). At least some of the bodily fluids may be pulled through the interior of the conduit 142 via the inlet. The bodily fluids may be drawn out of the fluid collection assembly 100 via the vacuum / vacuum provided by the vacuum source. During operation, the vents 134 may substantially maintain the pressure in the chamber 112 at atmospheric pressure even though bodily fluids are introduced into and subsequently removed from the chamber 112.

[0090] As previously discussed, the fluid collection assembly 100 is formed from the first panel 108 and the second panel 110 that may be distinct sheets which may allow the first panel to be at least partially opaque while the second panel is at least partially transparent. However, forming the first and second panels 108, 110 from distinct sheets may form edges that may cause patient discomfort and requires a significant amount of manufacturing (e.g., welding or other attachment technique) to attach the first panel 108 to the second panel 110. As such, in some embodiments, the fluid collection assemblies disclosed herein may be formed from first and second panels that are integrally formed together (e.g., exhibit single piece construction) which may eliminate at least some of the edges and simplify manufacturing of such fluid collection assemblies.

[0091] Other configurations of ports that prevent or inhibit the panels 108, 110 from blocking the inlet of the port are disclosed herein. FIG. 2 is an isometric top view of a port 230, according to an embodiment. The port 230 may be used with the fluid collection assembly 100 (e.g., the port 230 may replace the port 130 in the fluid collection assembly 100). Unless otherwise noted, the port 230 may include any aspect of the port 130, such as materials and space between proximal ends.

[0092] The port 230 includes a first part 244 and a second part 246. The first part 244 may be attached or configured to be attached to the fluid impermeable barrier 106 and, optionally, to be at least partially disposed in the chamber 112. The second part 246 is configured to attach to the conduit 142. The first part 244 defines an inlet (not visible) and the second part 246 defines an outlet 250 of the port 230 that is downstream from the inlet. The port 230 also defines a channel (not visible) extending from the inlet to the outlet 250. It is noted that the inlet refers to the inlet of the channel and not necessarily the inlet of the port 230. In an example, the inlet may be the inlet of both the port 230 and the channel when the port 230 does not include a sink 256. In an example, as theinlet may not be the inlet of the port 230 when the port 230 includes sink 256 since the sink 256 forms the inlet of the port 230.

[0093] The first part 244 of the port 230 may be attached to the fluid impermeable barrier 106 using any suitable technique described above in relation to the port 130. The port 230 (e.g., the first part 244 and the second part 246) may include any material and / or physical properties described above in relation to the port 130. The second part 246 may include any shapes and / or configurations of the second part 146 described above.

[0094] The first part 244 may exhibit a shape that is different than the second part 246, and also different than the first part 144 of the port 130. The first part 244 may include two spaced apart discs 244a, 244b (e.g., an upper portion that is an upper disc 244a and a lower portion that is a lower disc 244b). The two spaced apart discs 244a, 244b may be generally planar and positioned parallel to the longitudinal axis 140, the two spaced apart discs 244a, 244b may be generally circular or elliptical in shape. The shapes of the two spaced apart discs 244a, 244b eliminate sharp edges on the port 230 that may injure the wearer. The second elongated shape of the second part 246 that extends parallel to the longitudinal axis 140 may facilitate attachment to the conduit 142. The first part 244 and the second part 246 may include any thicknesses described above in relation to the first part 144 and the second part 146.

[0095] In some embodiments, the port 230 includes one or more opposing supports 258 extending between the upper disc 244a and the lower disc 244b such that the upper disc 244a and the lower disc 244b are spaced from one another. At least some of the one or more supports 258 may be positioned partway (e.g., substantially halfway) between the proximal ends 257a, 257b and the opposite distal ends of the two discs 244a, 244b. In an example, the one or more supports 258 begin partway e.g., substantially halfway) between the proximal ends 257a, 257b and the opposite distal ends of the two discs 244a, 244b, and then extends at least until the first part 244 attaches to the second part 246. In some embodiments, the one or more supports 258 are configured to extend from a first end (shown in FIG. 2) of the support 258 to the opposing second end (not visible in FIG. 2) of the support 258, with the second part 246 disposed between the first end and the opposing second end of the support 258. Besides the second part 256 being positioned therebetween, the support 258 may extend continuously between first end and the second end of the support 258. Accordingly, an opening leading into the sink 256 may be positioned opposite to the second part 246 and / or the support 258. The one or moresupports 258 may by arced or curved complementary to the perimeter of the two discs 244a, 244b.

[0096] In these and other embodiments, the one or more supports 258, then may at least partially define a sink 256 that is distinct from the inlet of the second part 246. For example, the one or more supports 258, the upper disc 244a, and the lower disc 244b may define the sink 256 that is positioned upstream from the inlet of the second part. The dimensions of the sink 256 and the inlet of the port 230 may include of the dimensions, attributes, and advantages of the inlet 148 and the sink 156 described above in relation to the port 130. In an embodiment, as illustrated, the dimension(s) of the sink 256 may be tapered along at least a portion of the length (e.g., measured parallel to the longitudinal axis 140) of the sink 256. In other words, the dimension(s) of the sink 256 may vary along at least a portion of the length thereof. The tapered dimension(s) of the sink 256 may prevent or at least decrease the step at the intersection of the inlet and the sink 256. Thus, the tapered dimension(s) may decrease turbulent flow of the bodily fluids flowing through the port 230 than if the dimension(s) of the sink 256 where maintained substantially constant. It is noted that the tapered dimension(s) of the sink 256 decreases the volume of bodily fluids that may be temporarily stored in the sink 256 and, by extension, the port 230.

[0097] In some embodiments, the one or more supports 258 include two opposing support posts. The two opposing support posts may be positioned partway e.g., substantially halfway) between the proximal ends 257a, 257b and the opposite distal ends of the two discs 244a, 244b.

[0098] The first part 244 of the port 230 may include the upper disc 244a having an upper proximal end 257a and the lower disc 244b having a lower proximal end 257b. The inlet may be disposed between the upper disc 244a and the lower disc 244b of the first part 244 of the port 230. The proximal ends 257a, 257b are substantially aligned and spaced from one another (by, for example, the one or more supports 258), according to an embodiment. For example, the proximal ends 257a, 257b may terminate at a substantially equal distance from the inlet. In some embodiments, the upper disc 244a and the lower disc 244b are sized and / or shaped substantially equal to one another. Alignment of the two spaced apart proximal ends 257a, 257b results in the technical effect of keeping the inlet and / or the sink 256 open and unobstructed when a vacuum force is applied to the chamber 112 through the port 230. In other words, the longitudinal alignment of the two spaced apart proximal ends 257a, 257b inhibits or prevents the first panel 108 and thesecond panel 110 from closing over the inlet and / or the sink 256 when a vacuum force applied to the chamber 112 through the port 230. The spaced apart proximal ends 257a, 257b increases the likelihood that a passageway is formed that allows bodily fluids to flow to the port 230 even when the sheath 102 bends and exhibits the generally L- or U- shape. In other words, the spaced apart proximal ends 257a, 257b may allow bodily fluids to continue to flow into the port 230 and / or increase the rate at which the bodily fluids may flow into the port 230 when the sheath 102 is bent.

[0099] The two discs 244a, 244b (e.g., the proximal ends 257a, 257b of the two discs 244a, 244b) may be spaced by a distance that is 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, 2 cm or more, or in ranges of about 5 mm to about 2 cm, about 5 mm to about 1 cm, about 1 cm to about 1.5 cm, about 1.5 cm to about 2 cm, about 5 mm to about 7 mm, about 6 mm to about 8 mm, about 8 mm to about 1 cm, about 9 mm to about 1.1 cm, about 1 cm to about 1.2 cm, about 1.1 cm to about 1.3 cm, about 1.2 cm to about 1.4 cm, about 1.3 cm to about 1.5 cm, about 1.4 cm to about 1.6 cm, about 1.5 cm to about 1.7 cm, about 1.6 cm to about 1.8 cm, about 1.7 cm to about 1.9 cm, or about 1 .8 cm to about 2 cm.

[0100] In some embodiments, the likelihood that the two discs 244a, 244b uncomfortably press into the individual may be mitigated by cushioning the two discs 244a, 244b with the porous material 122. In some embodiments, each of the two discs 244a, 244b extend at least partially into the porous material 122. In some embodiments, at least some (e.g., all) of the terminating end of distal region 172 of the porous material 122 is positioned between the two discs 244a, 244b. With the porous material 122 positioned between the two discs 244a, 244b and / or the two discs 244a, 244b extending into the porous material 122, the porous material 122 may be positioned proximate to (e.g., abut) the one or more supports 258 of the port 230 and / or extend into the sink 256 of the port 230. In these and other embodiments, the upper disc 244a and the lower disc 244b of the first part 244 of the port 230 may be disposed between the first panel 108 and the second panel 110.

[0101] In some embodiments, the second part of the port may be angled relative to the longitudinal axis of the fluid collection assembly. FIG. 3A is a cross-sectional schematic of a fluid collection assembly 300, and FIG. 3B is an isometric top view of the port 330 and a portion of the porous material 122 of the fluid collection assembly 300 ofFIG. 3A. Unless otherwise noted, the fluid collection assembly 300 may include any aspect of the fluid collection assembly 100.

[0102] The fluid collection assembly 300 includes the port 330, according to an embodiment. Unless otherwise noted, the port 330 may include any aspect of the ports 130, 230. For example, the port 330 may include a first part having an upper disc 344a including an upper proximal end 357a, a lower disc 344b including a lower proximal end (not visible), and a support 358. The upper disc 344a, upper proximal end 357a, lower disc 344b, lower proximal end, and support 358 of the port 330 may include any aspect of the upper disc 244a, upper proximal end 257a, lower disc 244b, lower proximal end 257b, and one or more supports 258 of the port 230. As the second part 346 extends from the upper disc 344a in the port 330, in some embodiments, the support 358 extends continuously from a first end (shown in FIG. 3B) of the support 348 to the opposing second end (not visible in FIG. 3) of the support 348. The support 358 may by arced or curved complementary to the perimeter of the two discs 344a, 344b.

[0103] In some embodiments, at least one (e.g. both) of the two discs 344a, 344b extend at least partially into the porous material 122. In some embodiments, the upper disc 344a extends into the porous material 122 such that a portion of the porous material 122 is positioned between the upper disc 344a and the firs panel 108. In some embodiments, the upper disc 344a may be secured and / or positioned adjacent to the first panel 108. In some embodiments, at least some (e.g., all) of the terminating end of distal region 172 of the porous material 122 is positioned between the two discs 344a, 344b. With the porous material 122 positioned between the two discs 344a, 344b and / or the two discs 344a, 344b extending into the porous material 122, the porous material 122 may be positioned proximate to (e.g., abut) the one or more supports 358 of the port 330 and / or extend into the sink of the port 330. In some embodiments, the porous material 122 extends into the sink of the port 330 to abut the support 358 (e.g., substantially fill the sink of the port 330 and / or fill the space between the upper disc 344a and the lower disc 344b). In these and other embodiments, the upper disc 344a and the lower disc 344b of the port 330 may be disposed between the first panel 108 and the second panel 110. In these and other embodiments, the port 330, the first panel 108 and the porous material 122 may be positioned such that there is substantially no void space in the chamber 112 between the first panel 108 and the upper disc 344a and / or the porous material 122.

[0104] In some embodiments, the second part 346 angles from the first part 344 towards the proximal region of the sheath 102. For example, the second part 346 may besecured to the upper disc 344a and may include an inlet configured as an opening on the upper disc 344a. The second part 346 may angle from the upper disc 344a proximally towards the proximal region of the sheath 102. This configuration of the second part 346 may orient the conduit 142 towards the head of the bed during use where the vacuum source is typically located, thereby preventing kinks in the conduit 142. The second part 346 may be angled relative to the upper disc 344a about 10° to about 80", about 10° to about 45°, about 45° to about 80°, about 10° to about 20°, about 20° to about 30°, about 30° to about 40°, about 40° to about 50°, about 50° to about 60°, about 60° to about 70°, or about 70° to about 80°.

[0105] FIG. 4 is a cross-sectional schematic of a distal region of a fluid collection assembly 400, according to an embodiment. Unless otherwise noted, the fluid collection assembly may include any aspect of the fluid collection assemblies 100, 300. The fluid collection assembly 400 may include the fluid impermeable barrier 106 and the porous material 122. In the fluid collection assembly 400, the porous material 122 may be positioned or secured to the second panel 110 rather than the first panel 108 of the fluid impermeable barrier 106.

[0106] The fluid collection assembly 400 may include a port 430. Unless otherwise noted, the port 430 may include any aspect of the ports 130, 230, 330. In some embodiments, the port 430 includes a first part 444 and a second part 446. The first part 444 may be attached or configured to be attached to the fluid impermeable barrier 106 and, optionally, to be at least partially disposed in the chamber 112. The second part 446 is configured to attach to the conduit 142. The first part 444 defines an inlet and the second part 446 defines an outlet of the port 430 that is downstream from the inlet. The port 430 also defines a channel extending from the inlet to the outlet.

[0107] The first part 444 of the port 430 may be attached to the fluid impermeable barrier 106 using any suitable technique described above in relation to the port 130. The port 430 (<?.g., the first part 444 and the second part 446) may include any material and / or physical properties described above in relation to the port 130. Though not visible in FIG. 4, the port 430 may include the tabs 158a, 158b, and / or the discs 244a, 244b and the proximal ends thereof of the ports 130, 230. The porous material 122 may be positioned relative to the first part 444 of the port 430 as described above in embodiments of the ports 130, 230. In some embodiments, the first part 444 includes a tube having the two tabs 158a, 158b extending from an inlet of the tube of the first part 444. The second part 446 of the port 430 may be angled and or curved from the first part 444 towards theproximal region of the fluid impermeable barrier 106. In some embodiments, second part 446 at least partially curves or angle within in the chamber 112. This configuration of the second part 446 may orient the conduit 142 towards the head of the bed during use where the vacuum source is typically located, thereby preventing kinks in the conduit 142.

[0108] In some embodiments, the first part of 444 of the port 430 may be positioned on an upper surface of the porous material 122, and the second part 446 may curve or angle within or outside the chamber 112 to orient the conduit 142 towards the head of the bed. For example, in some embodiments, the first part 444 may extend through a permeable membrane of the porous material 122 and be positioned adjacent to a permeable support (e.g. spun nylon) of the porous material 122. In some embodiments, the porous material 122 may be positioned adjacent to the first panel 108. In these and other embodiments, the port 430 may be attached or secured to the fluid impermeable barrier 106 at the first panel 108. The first part 444 of the port 430 may be at least partially disposed in the chamber 112. The second part 446 is configured to attach to the conduit 142. The first part 444 defines an inlet and the second part 446 defines an outlet of the port 430 that is downstream from the inlet. The port 430 also defines a channel extending from the inlet to the outlet. The second part 446 of the port 430 may be angled and or curved from the first part 444 towards the proximal region of the fluid impermeable barrier 106. This configuration of the second part 446 may orient the conduit 142 towards the head of the bed during use where the vacuum source is typically located, thereby preventing kinks in the conduit 142.

[0109] FIG. 5 is a cross-sectional schematic of a distal region of a fluid collection assembly 500, according to an embodiment. Unless otherwise noted, the fluid collection assembly may include any aspect of the fluid collection assemblies 100, 300, 400. The fluid collection assembly 500 may include the fluid impermeable barrier 106 and the porous material 122. In the fluid collection assembly 500, the porous material 122 may be positioned or secured to the second panel 110 rather than the first panel 108 of the fluid impermeable barrier 106.

[0110] The fluid collection assembly 500 may include a port 530. Unless otherwise noted, the port 530 may include any aspect of the ports 130, 230, 330, 430. In some embodiments, the port 530 includes a first part 544 and a second part 546. The first part 544 may be attached or configured to be attached to the fluid impermeable barrier 106 and, optionally, to be at least partially disposed in the chamber 112. The second part 546 is configured to attach to the conduit 142. The first part 544 defines an inlet and thesecond part 546 defines an outlet of the port 530 that is downstream from the inlet. The port 530 also defines a channel extending from the inlet to the outlet.

[0111] The first part 544 of the port 530 may be attached to the fluid impermeable barrier 106 using any suitable technique described above in relation to the port 130. The port 530 (e.g., the first part 544 and the second part 546) may include any material and / or physical properties described above in relation to the port 130. Though not visible in FIG. 4, the port 530 may include the tabs 158a, 158b, and / or the discs 244a, 244b and the proximal ends thereof of the ports 130, 230. The porous material 122 may be positioned relative to the first part 544 of the port 530 as described above in embodiments of the ports 130, 230. In some embodiments, the first part 544 includes a tube having the two tabs 158a, 158b extending from an inlet of the tube of the first part 544. The second part 546 of the port 530 may be angled and or curved from the first part 544 towards the proximal region of the fluid impermeable barrier 106. In some embodiments, second part 546 at least partially curves or angle within in the chamber 112. In some embodiments, the port 530 includes an elbow connector 550 rotatably secured to the second part 546 outside of the chamber 112. The elbow connector 550 is configured to allow a portion of the second part 546 to swivel, thereby preventing kinks in the conduit 142 when the conduit 142 is secured to the second part 546. The elbow connector 550 may be included on the second part of the ports 130, 230, 330, 430 described herein.

[0112] In some embodiments, the first part of 544 of the port 530 may be positioned on an upper surface of the porous material 122, and the second part 546 may curve or angle within to the elbow connector 550. For example, in some embodiments, the first part 544 may extend through a permeable membrane of the porous material 122 and be positioned adjacent to a permeable support (e.g. spun nylon) of the porous material 122. In some embodiments, the porous material 122 may be positioned adjacent to the first panel 108. In these and other embodiments, the port 530 may be attached or secured to the fluid impermeable barrier 106 at the first panel 108. The first part 544 of the port 530 may be at least partially disposed in the chamber 112. The second part 546 may be absent, and the first part 544 may be attached to the elbow connector 550.

[0113] FIG. 6A is a flow diagram of a method 600 to manufacture a fluid collection assembly, according to an embodiment. The method 600 may be used to manufacture at least some of the fluid collection assemblies and / or fluid collection systems disclosed herein. In an embodiment, the method 600 includes an act 605 of providing a fluid impermeable barrier including a first panel and a second panel, according to anembodiment. The method 600 also may include an act 610 of providing a port including a first part defining an inlet and a second part defining an outlet and configured to be attached to a conduit. The first part may include an upper portion and a lower portion with the inlet disposed between the upper portion and the lower portion, the upper portion having an upper proximal end and the lower portion having a lower proximal end that is spaced from the upper proximal end. The method 600 also may include an act 615 of attaching the first panel (e.g., an outer periphery of the first panel) to the second panel (e.g., an outer periphery of the second panel) to form a sheath having (1) a proximal region defining an opening and (2) a distal region having the upper proximal end and the lower proximal end on the first part of the port disposed between the first panel and the second panel, the fluid impermeable barrier at least partially defining a chamber. The method 600 also may include an act 620 of disposing at least one porous material in the chamber. In some embodiments, disposing at least one porous material in the chamber includes disposing the at least one porous material in the chamber between the upper proximal end and the lower proximal end of the port. In some embodiments, the method 600 also includes an act of rotatably securing an elbow connector to the second part of the port outside the chamber. Acts of the method 600 are for illustrative purposes and may be performed in different orders, split into multiple acts, modified, supplemented, or combined. In an example, one or more of the acts of the method 600 may be omitted from the method 600.

[0114] FIG. 6B is a flow diagram of a method 650 to manufacture a fluid collection assembly, according to an embodiment. The method 650 may be used to manufacture at least some of the fluid collection assemblies and / or fluid collection systems disclosed herein. The method 650 includes an act 655 of providing a fluid impermeable barrier a first panel and a second panel that is distinct from the first panel, according to an embodiment. The method 650 also may include an act 660 of providing a port including a first part defining an inlet and a second part defining an outlet and configured to be attached to a conduit. The first part may include an upper portion and a lower portion with the inlet disposed between the upper portion and the lower portion, the upper portion having an upper proximal end and the lower portion having a lower proximal end that is spaced from the upper proximal end. The method 650 also may include an act 665 of attaching the first panel (e.g., an outer periphery of the first panel) to the second panel (e.g., an outer periphery of the second panel) to form a sheath having a proximal region defining an opening and a distal region with the port positioned at the distal region suchthat the inlet of the first part of the port is oriented inside the chamber towards the proximal region of the fluid impermeable barrier and the outlet of the second part of the port is angled or curved from the first part through the fluid impermeable barrier towards the proximal region of the fluid impermeable barrier.

[0115] The method 650 also may include an act 670 of disposing at least one porous material in the chamber. In some embodiments, the act 670 includes disposing the at least one porous material in the chamber at least proximate to the inlet of the first part of the port. In some embodiments, the act 670 includes disposing the at least one porous material in the chamber such that the inlet of the first part of the port is embedded in the at least one porous material. In some embodiments, the method 650 may include an act of rotatably securing an elbow connector to the second part of the port outside the chamber.

[0116] Acts of the method 650 are for illustrative purposes and may be performed in different orders, split into multiple acts, modified, supplemented, or combined. In an example, one or more of the acts of the method 650 may be omitted from the method 650.

[0117] FIG. 7 is a block diagram of a system 707 for fluid collection, according to an embodiment. The system 707 includes a fluid collection assembly 700, a fluid storage container 709, and a vacuum source 71 1. The fluid collection assembly 700 may include any of the fluid collection assemblies disclosed herein. The fluid collection assembly 700, the fluid storage container 709, and the vacuum source 711 may be fluidly coupled to each other via one or more conduits 742. For example, fluid collection assembly 700 may be operably coupled to one or more of the fluid storage container 709 or the vacuum source 711 via the conduit 742. Bodily fluids (e.g., urine or other bodily fluids) collected in the fluid collection assembly 700 may be removed from the fluid collection assembly 700 via the conduit 742 which protrudes into the fluid collection assembly 700. Vacuum force may be introduced into the chamber of the fluid collection assembly 700 via the inlet of the conduit 742 responsive to vacuum (e.g., vacuum) force applied at the outlet of the conduit 742.

[0118] The vacuum force may be applied to the outlet of the conduit 742 by the vacuum source 711 either directly or indirectly. The vacuum force may be applied indirectly via the fluid storage container 709. For example, the outlet of the conduit 742 may be disposed within the fluid storage container 709 and an additional conduit 742 may extend from the fluid storage container 709 to the vacuum source 711. Accordingly, the vacuum source 711 may apply vacuum to the fluid collection assembly 700 via the fluid storage container 709. The vacuum force may be applied directly via the vacuum source711. For example, the outlet of the conduit 742 may be disposed within the vacuum source 711. An additional conduit 742 may extend from the vacuum source 711 to a point outside of the fluid collection assembly 700, such as to the fluid storage container 709. In such examples, the vacuum source 711 may be disposed between the fluid collection assembly 700 and the fluid storage container 709.

[0119] The fluid storage container 709 is sized and shaped to retain a fluid therein. The fluid storage container 709 may include a bag (e.g., drainage bag), a bottle or cup (e.g., collection jar), or any other enclosed container for storing the bodily fluids. In some examples, the conduit 742 may 742 extend from the fluid collection assembly 700 and attach to the fluid storage container 709 at a first point therein. An additional conduit 742 may attach to the fluid storage container 709 at a second point thereon and may extend and attach to the vacuum source 711. Accordingly, a vacuum (e.g., vacuum) may be drawn through fluid collection assembly 700 via the fluid storage container 709. Fluid, such as urine, may be drained from the fluid collection assembly 700 using the vacuum source 711.

[0120] The vacuum source 711 may include one or more of a manual vacuum pump, and electric vacuum pump, a diaphragm pump, a centrifugal pump, a displacement pump, a magnetically driven pump, a peristaltic pump, or any pump configured to produce a vacuum. The vacuum source 711 may provide a vacuum or vacuum to remove fluid from the fluid collection assembly 700. In some examples, the vacuum source 711 may be powered by one or more of a power cord (e.g., connected to a power socket), one or more batteries, or even manual power (e.g., a hand operated vacuum pump). In some examples, the vacuum source 711 may be sized and shaped to fit outside of, on, or within the fluid collection assembly 700. For example, the vacuum source 711 may include one or more miniaturized pumps or one or more micro pumps. The vacuum sources 711 disclosed herein may include one or more of a switch, a button, a plug, a remote, or any other device suitable to activate the vacuum source 711.

[0121] It is noted that the embodiments disclosed above relate to fluid collection assemblies configured to collection bodily fluids from a male. However, it is noted that such fluid collection assemblies may also be used to collection bodily fluids from a female since the urethral opening of the female is, functionally, similar to a buried penis.

[0122] 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.

[0123] Terms of degree (e.g., “about,” “substantially,” “generally,” etc.) indicate structurally or functionally insignificant variations. In an example, when the term of degree is included with a term indicating quantity, the term of degree is interpreted to mean ± 10%, ±5%, or +2% of the term indicating quantity. In an example, when the term of degree is used to modify a shape, the term of degree indicates that the shape being modified by the term of degree has the appearance of the disclosed shape. For instance, the term of degree may be used to indicate that the shape may have rounded corners instead of sharp corners, curved edges instead of straight edges, one or more protrusions extending therefrom, is oblong, is the same as the disclosed shape, etc.

Claims

CLAIMSWe claim:

1. A fluid collection assembly, comprising: a sheath including: a fluid impermeable barrier including a proximal region and a distal region extending from the proximal region, the proximal region defining an opening, the fluid impermeable barrier at least partially defining a chamber; and at least one porous material disposed in the chamber; and a port positioned at the distal region, the port including a first part defining an inlet and a second part defining an outlet that is configured to be attached to a conduit, wherein the first part includes an upper portion and a lower portion with the inlet disposed between the upper portion and the lower portion, the upper portion having an upper proximal end and the lower portion having a lower proximal end that is spaced from the upper proximal end.

2. The fluid collection assembly of claim 1, wherein: the upper portion includes an upper tab extending proximally into the chamber from the upper portion and including the upper proximal end; the lower portion includes a lower tab extending proximal into the chamber from the lower portion and including the lower proximal end; and the upper proximal end and the lower proximal end terminate at a substantially equal distance from the inlet of the first part.

3. The fluid collection assembly of claim 1, wherein the first part of the port includes: an upper disc including the upper proximal end; a lower disc including the lower proximal end; and one or more opposing supports extending between the upper disc and the lower disc such that the upper disc and the lower disc are spaced from one another.

4. The fluid collection assembly of any of claims 1-3, wherein the at least one porous material is disposed between the upper proximal end and the lower proximal end of the first part of the port.

5. The fluid collection assembly of any of claims 1-4, wherein the fluid impermeable barrier includes a first panel and a second panel with the at least one porous material disposed therebetween, the upper proximal end and the lower proximal end of the first part of the port being disposed between the first panel and the second panel.

6. The fluid collection assembly of any of claims 1-5, wherein the outlet of the second part is generally parallel to a longitudinal axis of the fluid collection assembly.

7. The fluid collection assembly of claim 1-5, wherein the second part angles from the first part towards the proximal region of the sheath.

8. The fluid collection assembly of claim 1-5, wherein the second part extends through the fluid impermeable barrier and the fluid collection assembly includes an elbow connector rotatably secured to the second part outside of the chamber.

9. The fluid collection assembly of any of claims 1-5, wherein the outlet of the second part is generally parallel to a longitudinal axis of the fluid collection assembly, and the first part is elongated generally perpendicular to the longitudinal axis and includes rounded edges and corners on all edges and corners of the first part.

10. The fluid collection assembly of any of claims 1-5, wherein the first part is elongated generally perpendicular to a longitudinal axis of the fluid collection assembly and includes rounded edges and comers on all edges and comers of the first part, and wherein the second part angles from the first part towards the proximal region of the sheath.1 1 . The fluid collection assembly of any of claims 1 -5, wherein the first part is elongated generally perpendicular to a longitudinal axis of the fluid collection assembly and includes rounded edges and comers on all edges and corners of the first part, the second part extends through the fluid impermeable barrier, and the fluid collection assembly includes an elbow connector rotatably secured to the second part outside of the chamber.

12. The fluid collection assembly of any of claims 1-11, wherein the port includes at least one of a silicone material and / or a polyurethane material.

13. A fluid collection assembly, comprising: a sheath including: a fluid impermeable barrier including a proximal region and a distal region extending from the proximal region, the proximal region defining an opening, the fluid impermeable barrier at least partially defining a chamber; and at least one porous material disposed in the chamber; and a port positioned at the distal region and including a first part defining an inlet oriented towards the proximal region of the fluid impermeable barrier and a second part defining an outlet that is configured to be attached to a conduit, wherein the first part includes an upper portion and a lower portion with the inlet disposed between the upperportion and the lower portion, the upper portion having an upper proximal end and the lower portion having a lower proximal end that is spaced from the upper proximal end, the second part extending proximally from the first part towards the proximal region of the fluid impermeable barrier.

14. The fluid collection assembly of claim 13, wherein the at least one porous material is disposed at least proximate to the inlet of the first part of the port.

15. The fluid collection assembly of claim 14, wherein the inlet of the first part of the port is embedded in the at least one porous material.

16. The fluid collection assembly of any of claims 13-15, wherein the fluid impermeable barrier includes a first panel and a second panel with the at least one porous material disposed therebetween, the inlet of the first part of the port being disposed between the first panel and the second panel.

17. The fluid collection assembly of any of claims 13-16, wherein the second part extends through the fluid impermeable barrier and the fluid collection assembly includes an elbow connector rotatably secured to the second part outside of the chamber.

18. The fluid collection assembly of any of claims 13-17, wherein the port includes at least one of a silicone material and / or a polyurethane material.

19. The fluid collection assembly of any of claims 13-18, wherein the second part angles and / or curves from the first part towards the proximal region of the fluid impermeable barrier.

20. A system, comprising: the fluid collection assembly of any one of claims 1-19; a vacuum source configured to apply a vacuum force; a fluid storage container; and at least one conduit connected to the outlet and in fluid communication with the vacuum source and the fluid storage container.

21. A method of manufacturing a fluid collection assembly, the method comprising: providing a fluid impermeable barrier including a first panel and a second panel; providing a port including a first part defining an inlet and a second part defining an outlet that is configured to be attached to a conduit, wherein the first part includes an upper portion and a lower portion with the inlet disposed between the upper portion and the lower portion, the upper portion having an upper proximal end and the lower portion having a lower proximal end that is spaced from the upper proximal end;attaching the first panel to the second panel to form a sheath having (1) a proximal region defining an opening and (2) a distal region having the upper proximal end and the lower proximal end on the first part of the port disposed between the first panel and the second panel, the fluid impermeable barrier at least partially defining a chamber; and disposing at least one porous material in the chamber.

22. The method of claim 20, wherein disposing at least one porous material in the chamber includes disposing the at least one porous material in the chamber between the upper proximal end and the lower proximal end of the port.

23. The method of either of claims 20 or 21, further comprising rotatably securing an elbow connector to the second part of the port outside the chamber.

24. A method of manufacturing a fluid collection assembly, the method comprising: providing a fluid impermeable barrier a first panel and a second panel that is distinct from the first panel; providing a port including a first part defining an inlet and a second part defining an outlet that is configured to be attached to a conduit, wherein the first part includes an upper portion and a lower portion with the inlet disposed between the upper portion and the lower portion, the upper portion having an upper proximal end and the lower portion having a lower proximal end that is spaced from the upper proximal end; attaching the first panel to the second panel to form a sheath having a proximal region defining an opening and a distal region with the port positioned at the distal region such that the inlet of the first part of the port is oriented inside the chamber towards the proximal region of the fluid impermeable barrier and the outlet of the second part of the port extends proximally from the first part through the fluid impermeable barrier towards the proximal region of the fluid impermeable barrier; and disposing at least one porous material in the chamber.

25. The method of claim 23, wherein disposing at least one porous material in the chamber includes disposing the at least one porous material in the chamber at least proximate to the inlet of the first part of the port.

26. The method of claim 24, wherein disposing the at least one porous material in the chamber at least proximate to the inlet of the first part of the port includes disposing the at least one porous material in the chamber such that the inlet of the first part of the port is embedded in the at least one porous material.

27. The method of any of claims 23-25, further comprising rotatably securing an elbow connector to the second part of the port outside the chamber.

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