Male fluid collection assemblies and systems, methods of use and methods of manufacture

Abstract

An exemplary fluid collection assembly includes a sheath and a port. The sheath includes a fluid-impermeable barrier that at least partially defines a chamber and at least one porous material disposed within the chamber. The port is located in a distal region and includes a first portion defining an inlet and a second portion defining an outlet and configured to attach to a catheter. The first portion includes an upper portion fixed to a lower portion such that the inlet is disposed between the upper and lower portions. The upper portion has an upper proximal end, and the lower portion has a lower proximal end, the lower proximal end being spaced apart from the upper proximal end.

Description

Background Technology

[0001] In many situations, a person's or animal's mobility may be limited or impaired, making the routine process of urination difficult or even impossible. For example, a person may experience or have a disability that affects their mobility. A person may be in environments that restrict movement, as experienced by pilots, drivers, and those working in hazardous areas. Furthermore, urine collection is sometimes necessary for monitoring purposes or for clinical testing.

[0002] Urinary catheters (such as Foley catheters) can be used to address some of these situations, such as urinary incontinence. However, unfortunately, catheters can cause discomfort, pain, and may lead to complications such as infections. Additionally, bedpans are sometimes used as receivers for bedridden patients (such as those in healthcare facilities) to use the toilet. However, bedpans are prone to causing discomfort, leaks, and other hygiene problems.

[0003] Men who suffer the most severe consequences of urinary incontinence (such as discomfort, rashes, and ulcers) are typically older and often bedridden. They also require ongoing assistance to maintain hygiene. These patients often exhibit the following characteristics: penile size typically decreases with age, skin folds containing fatty tissue cause penile retraction, and the penis usually points upwards when supine, making it difficult for the patient to access and operate the device. Urine collection devices should be designed with these characteristics in mind.

[0004] Existing solutions are typically designed for standing or sitting positions (e.g., cup and funnel), with the urinary outlet facing the distal end of the penis. Other designs (such as condom-style catheters) are difficult for patients to operate, often missize, and cannot be reliably secured in place.

[0005] Therefore, there is a need for a device that can collect urine from humans or animals (especially males) comfortably and with minimal pollution to the user and / or surrounding area. Summary of the Invention

[0006] The embodiments disclosed herein relate to male fluid collection assemblies, systems including the same, methods of manufacturing the same, and methods of using the same. In one embodiment, a fluid collection assembly is disclosed. The fluid collection assembly includes a sheath and a port. The sheath includes a fluid-impermeable barrier comprising a proximal region and a distal region extending from the proximal region, the proximal region defining an opening, and the fluid-impermeable barrier at least partially defining a chamber. The sheath also includes at least one porous material disposed within the chamber. The port is disposed in the distal region and includes a first portion defining an inlet and a second portion defining an outlet and configured to attach to a catheter. The first portion includes an upper portion and a lower portion, wherein the inlet is 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 spaced apart from the upper proximal end.

[0007] In one embodiment, a fluid collection assembly is disclosed. The fluid collection assembly includes a sheath and a port. The sheath includes a fluid-impermeable barrier comprising a proximal region and a distal region extending from the proximal region, the proximal region defining an opening, and the fluid-impermeable barrier at least partially defining a chamber. The sheath also includes at least one porous material disposed within the chamber. The port is disposed in the distal region and includes a first portion defining an inlet toward the proximal region of the fluid-impermeable barrier, and a second portion defining an outlet and configured to attach to a catheter. The first portion includes an upper portion and a lower portion, wherein the inlet is disposed between the upper portion and the lower portion, the upper portion having an upper proximal end, the lower portion having a lower proximal end spaced apart from the upper proximal end, and the second portion extending proximally from the first portion toward the proximal region of the fluid-impermeable barrier.

[0008] In one embodiment, a system is disclosed. The system may include any fluid collection assembly 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 one embodiment, a method of manufacturing a fluid collection assembly is disclosed. The method may include: providing a fluid-impermeable barrier comprising a first panel and a second panel. The method may further include: providing a port comprising a first portion defining an inlet and a second portion defining an outlet and configured to attach to a conduit. The first portion may include an upper portion and a lower portion, wherein the inlet is 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 spaced apart from the upper proximal end. The method may further 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 disposed between the first panel and the second panel on the first portion of the port, the fluid-impermeable barrier at least partially defining a chamber. The method may further include: disposing at least one porous material in the chamber.

[0010] In one 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 different from the first panel. The method may further include: providing a port including a first portion defining an inlet and a second portion defining an outlet and configured to attach to a conduit. The first portion may include an upper portion and a lower portion, wherein the inlet is 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 spaced apart from the upper proximal end. The method may further include: attaching the first panel to the second panel to form a sheath having a proximal region defining an opening and a distal region, wherein the port is disposed in the distal region such that the inlet of the first portion of the port is oriented within the chamber toward the proximal region of the fluid-impermeable barrier, and the outlet of the second portion of the port extends proximally from the first portion through the fluid-impermeable barrier toward the proximal region of the fluid-impermeable barrier. The method may further include: distributing at least one porous material within the chamber.

[0011] Features from any of the disclosed embodiments can be combined with each other without limitation. Furthermore, other features and advantages of this disclosure will become apparent to those skilled in the art when considered in conjunction with the following detailed description and accompanying drawings. Attached Figure Description

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

[0013] Figure 1A and Figure 1BThese are, respectively, isometric top and bottom views of a fluid collection assembly according to one embodiment.

[0014] Figure 1C and Figure 1D These are schematic cross-sectional views of the fluid collection assembly taken along the CC plane and DD plane according to any embodiment.

[0015] Figure 1E yes Figure 1A and Figure 1B An exploded isometric view of the fluid collection assembly shown.

[0016] Figure 1F According to one embodiment Figure 1A The isometric top view of the port shown.

[0017] Figure 1G It is based on one implementation method along Figure 1A The diagram shows a cross-sectional view of the port cut off by the 1F-1F plane.

[0018] Figure 2 This is an isometric top view of the port according to one embodiment.

[0019] Figure 3A This is a cross-sectional schematic diagram of a fluid collection assembly according to one embodiment.

[0020] Figure 3B yes Figure 3A An isometric top view of the port of the fluid collection component and a portion of the porous material.

[0021] Figure 4 This is a schematic cross-sectional view of the distal region of a fluid collection assembly according to one embodiment.

[0022] Figure 5 This is a schematic cross-sectional view of the distal region of a fluid collection assembly according to one embodiment.

[0023] Figures 6A to 6B This is a flowchart of a method for manufacturing a fluid collection assembly according to one embodiment.

[0024] Figure 7 This is a block diagram of a system for fluid collection according to one embodiment. Detailed Implementation

[0025] The embodiments disclosed herein relate to male fluid collection components, systems including the same, methods of manufacturing the same, and methods of using the same. An exemplary fluid collection component 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 within 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 a future time. The base defines an opening that aligns with the opening when the base is attached to the sheath. The base is configured to be secured to an area surrounding an individual penis, with the opening positioned above the penis.

[0026] The port is located in the distal region and includes a first portion defining an inlet and a second portion defining an outlet and configured to attach to a conduit. The first portion includes an upper portion and a lower portion, wherein the inlet is located between the upper and lower portions, the upper portion having an upper proximal end and the lower portion having a lower proximal end, the lower proximal end being laterally spaced from the upper proximal end. The upper and lower proximal ends may be located at substantially equidistant from the inlet, such that the upper and lower proximal ends are substantially aligned (e.g., the upper proximal end is directly above the lower proximal end). The upper and lower proximal ends may be located on upper and lower tabs or upper and lower disks of the first portion of the port. The dimensions of the upper and lower tabs and / or the upper and lower disks may be substantially equal or the same. The spaced arrangement of the upper proximal end and the lower proximal end of the first portion of the port produces the following technical effect: during use, the inlet is kept open by suppressing the fluid from sealing or blocking the inlet by applying a vacuum to the inlet.

[0027] In many embodiments, all edges of the port are rounded. This absence of sharp edges in the port provides the technical effect of preventing painful contact with the patient during use. In many embodiments, the port is formed of a more flexible and bendable material than conventional ports, such as silicone or polyurethane. The port can also be configured to orient the vacuum catheter to which it is attached toward the patient's head or another location chosen by the patient or caregiver. This configuration of the fluid collection assembly reduces the risk of twisting or kinking of the vacuum catheter when guided back toward the head of the bed (where the fluid collection container is located). In many embodiments, the port inlet can be positioned at a low point of the fluid collection assembly during use.

[0028] An exemplary method of using the fluid collection assembly includes securing the base to a region surrounding the penis of an individual. The base is disposed on the individual such that the penis extends through or adjacent to an orifice defined by the base (e.g., in the case of an unimpregnated penis). The sheath may also be attached to the base if it is not already attached thereto. For example, the sheath may be attached to the base before, during, or after securing the base to the region surrounding the penis. After securing the base to the region surrounding the penis and attaching the sheath to the base, the individual may expel bodily fluids from the penis. The bodily fluids may include urine or sweat. The bodily fluids enter a chamber of the sheath. The porous material may receive at least a portion of the bodily fluids entering the chamber and guide the bodily fluids toward the fluid outlet. The method may include removing the bodily fluids from the chamber through the fluid outlet, for example, when a vacuum force is applied to the outlet via a vacuum source in fluid communication with the chamber. Although the fluid collection components disclosed herein are described as male fluid collection components for the penis, it should be noted that the fluid collection components may also be female fluid collection components for collecting bodily fluids from females, urostomy bags, and / or wound care products.

[0029] Figure 1A and Figure 1B These are, respectively, isometric top and bottom views of a fluid collection assembly 100 according to one embodiment. Figure 1C and Figure 1D These are schematic cross-sectional views of the fluid collection assembly 100 taken along the CC plane and DD plane according to any embodiment. Figure 1E This is an exploded view of the fluid collection assembly 100. The fluid collection assembly 100 includes a sheath 102 and a base 104. In one embodiment, the sheath 102 includes a fluid-impermeable barrier 106, which is formed at least partially by a first panel 108 attached to a second panel 110. In one embodiment, as shown, the first panel 108 and the second panel 110 are distinct sheets. The fluid-impermeable barrier 106 also defines a chamber 112, an opening 114, and a fluid outlet 118 located between the first panel 108 and the second panel. The sheath 102 also includes at least one porous material 122 disposed within the chamber 112. The base 104 includes an orifice 124. The base 104 is attachable to a proximal region 160 of the fluid-impermeable barrier 106 such that the orifice 124 is aligned with the opening 114.

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

[0031] The fluid-impermeable barrier 106 can be formed of any suitable fluid-impermeable material, such as fluid-impermeable polymers (e.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, polyurethane, polyethylene, polyvinyl chloride, polycarbonate, etc.), metal films, natural rubber, other suitable materials, or combinations thereof. Thus, the fluid-impermeable barrier 106 substantially prevents bodily fluids from passing through it. In one example, the fluid-impermeable barrier 106 can be air-permeable and fluid-impermeable, thereby preventing leakage when a vacuum force is applied to it while allowing air to flow through chamber 112 (i.e., chamber 112 is maintained at approximately atmospheric pressure, thereby preventing vacuum forces from causing hickeys or kinking of conduit 142). In such an example, the fluid-impermeable barrier 106 can be formed of a hydrophobic material defining a plurality of pores. At least one or more portions of the outer surface 127 of the fluid-impermeable barrier 106 can be formed of a soft and / or smooth material, thereby reducing friction.

[0032] In one embodiment, the fluid-impermeable barrier 106 is formed of polyurethane, for example, solely of polyurethane. Clinical trials have shown that forming the fluid-impermeable barrier 106 with polyurethane improves the functionality of the fluid collection assembly 100. For example, the fluid-impermeable barrier 106 formed of polyurethane can exhibit greater flexibility than when formed of other materials. The increased flexibility of the fluid-impermeable barrier 106 formed of polyurethane makes it easier to attach the fluid collection assembly 100 to and maintain attachment to an individual. The increased flexibility of the fluid-impermeable barrier 106 formed of polyurethane also helps to allow the fluid collection assembly 100 to conform to the individual and / or be placed under the individual's clothing, thereby improving patient comfort. The increased flexibility of the fluid-impermeable barrier 106 prevents or at least inhibits uncomfortable pressure from corners (if present) formed in the fluid-impermeable barrier 106 on the individual using the fluid collection assembly 100, thereby making the fluid collection assembly 100 more comfortable to use. Polyurethane can also remain flexible when welded or otherwise formed therein as a seal. It has also been found that individuals using the fluid collection assembly 100 perceive the fluid-impermeable barrier 106, formed of polyurethane, as smoother than fluid-impermeable barriers 106 formed of other materials. The smoother feel of the polyurethane-formed fluid-impermeable barrier 106 makes wearing the fluid collection assembly 100 more comfortable. It has also been found that the polyurethane-formed fluid-impermeable barrier 106 is quieter when bent (e.g., wrinkled, creased, etc.) than fluid-impermeable barriers 106 formed of other materials. This improved quietness of the fluid-impermeable barrier 106 allows for more discreet use of the fluid collection assembly 100. For example, movement of an individual using the fluid collection assembly 100 is likely to cause the fluid-impermeable barrier 106 to bend. The polyurethane-formed fluid-impermeable barrier 106 allows for greater individual movement without generating noise in the fluid-impermeable barrier 106. Finally, it has been found that the fluid impermeable barrier 106 containing polyurethane can be welded to a variety of materials, thereby facilitating the attachment of the base 104, the vent 134 and the port 130 to the fluid impermeable barrier 106.

[0033] In one embodiment, at least one of the first panel 108 or the second panel 110 is formed of a fluid-impermeable material that is at least partially transparent, such as polyethylene, polypropylene, polyurethane, polycarbonate, or polyvinyl chloride. Forming at least one of the first panel 108 or the second panel 110 of a fluid-impermeable material that is at least partially transparent allows a person (e.g., a medical professional) to examine the penis. In some embodiments, both the first panel 108 and the second panel 110 are formed of a fluid-impermeable material that is at least partially transparent. For example, some conventional fluid collection assemblies that include a sheath and a base allow the sheath to be reversibly removed from the base after the base has been secured to the area surrounding the penis. Removing the sheath from the base allows a person to examine the penis. However, configuring the sheath to be removable from the base may allow leakage to occur between the sheath and the base. As previously described, the sheath 102 may optionally be permanently attached to the base 104, which substantially prevents leakage between the sheath 102 and the base 104 when the base 104 is properly attached to the sheath 102 (e.g., wrinkles are not allowed to form between the sheath 102 and the base 104). Selecting at least one of the first panel 108 or the second panel 110 to be formed of at least partially transparent, fluid-impermeable material allows for examination of the penis without removing the entire fluid collection assembly 100 from the area surrounding the penis. For example, the chamber 112 may include a penis receiving region 131 configured to receive the penis when an individual's penis is inserted into the chamber 112. The penis receiving region 131 may be defined by at least a 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 disposed in the chamber 112 such that when the penis is inserted into the chamber 112 through the opening 114, the porous material is not located between the penis and at least a portion of the transparent portion of the first panel 108 and / or the second panel 110. The porous material 122 is generally opaque, so the portion defining the penis receiving area 131 in at least a portion of the transparent material of the first panel 108 and / or the second panel 110 forms a window, thereby allowing a person to observe the penis receiving area 131 and examine the penis.

[0034] In one embodiment, the second panel 110 is at least partially formed of a partially transparent material and forms a window allowing a person to observe the penis receiving area 131. Furthermore, a porous material 122 is located between the penis receiving area 131 and at least a portion of the first panel 108. This embodiment can help maintain the dignity of the individual using the fluid collection assembly 100. For example, during use, the second panel 110 is typically adjacent to the individual, such as adjacent to the thigh and / or perineum. Therefore, the second panel 110 is typically obscured during use, and the penis cannot be observed by the person until the sheath 102 is lifted away from the individual. Meanwhile, the first panel 108 can be positioned away from the individual and is more easily seen than the second panel 110. However, a person (e.g., a passerby, visitor, etc.) cannot see the penis through the first panel 108 because the porous material 122 is opaque and / or the first panel 108 is formed of an opaque material. Therefore, in such an embodiment, unless such an examination is required, the first panel 108 and / or the porous material 122 prevent the person from seeing the penis, thereby protecting the dignity of the individual using the fluid collection assembly 100. In one embodiment, the first panel 108 is formed of at least partially transparent material and forms a window that allows a person to see the penis receiving area 131. Furthermore, a porous material 122 may be located 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 operation of lifting the sheath 102 to observe the penis receiving area 131, but since passersby may also see the penis receiving area 131, the dignity of the individual using the fluid collection assembly 100 may not be maintained.

[0035] As previously described, in one or more embodiments, 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 embodiment, as shown, the first panel 108 and the second panel 110 are attached together along at least a portion of their outer edges (e.g., top edge 136 and side edge 138). In such embodiments, the first panel 108 and the second panel 110 are attached using any suitable technique, such as adhesives, stitching, heat sealing, pulse heating, direct heating, radio frequency (“RF”) welding, ultrasonic (“US”) welding, or any other technique. In a particular embodiment, the first panel 108 and the second panel 110 are attached together using pulse heating because pulse heating is rapid and efficient in attaching polyurethane panels together. As will be discussed in more detail below, forming a fluid-impermeable barrier 106 from the first panel 108 and the second panel 110 can increase the manufacturing speed of the fluid collection assembly 100, especially when the first panel 108 and the second panel 110 are attached together using a non-stitching technique.

[0036] In one 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, the one or more vents 134 extending across the one or more orifices 132. The vents 134 are configured to allow air to flow through them while preventing water (a major component of bodily fluids) from flowing through them. The vents 134 facilitate airflow through the chamber 112. For example, as previously described, a vacuum may be provided to the chamber 112 by a vacuum source. The vacuum can draw air through the vents 134, causing air to flow from the vents 134 towards the fluid outlet 118. The airflow from the vents 134 helps to move bodily fluids toward the fluid outlet 118. The vents 134 also prevent the vacuum applied to the chamber 112 from rupturing small superficial blood vessels located in or around the penis (e.g., creating a hickey) or otherwise damaging the penis or the area around the penis. Vent 134 may comprise a porous hydrophobic material. In some embodiments, vent 134 may be covered by a hydrophilic material (e.g., a wicking material). Vacuum prevents liquid from leaving the fluid collection assembly 100 through vent 134 (especially in humid conditions), while air can still enter the fluid collection assembly 100 through vent 134. In some embodiments, the vent may also be completely uncovered by any material. The pores defined by the porous hydrophobic material may be interconnected, thereby allowing air to flow through vent 134. The hydrophobic properties of the porous hydrophobic material prevent water from flowing through vent 134. In one embodiment, vent 134 may comprise a porous polytetrafluoroethylene (“PTFE”) layer. Porous PTFE layers are considered very effective in allowing air to flow through them while preventing water from flowing through them, even when the porous PTFE layer is exposed to acidic body fluids. However, porous PTFE is difficult to weld to other materials (e.g., polyurethane). Therefore, the porous PTFE layer may be attached to a substrate. The substrate may contain a porous material or define one or more channels therethrough. The substrate may be selected to be readily attachable to the porous PTFE layer and the fluid-impermeable barrier 106. For example, the substrate may be selected to be formed of polyvinyl chloride (PVC) because PVC is readily attachable to both the porous PTFE layer and the fluid-impermeable barrier 106.

[0037] In one embodiment, an orifice 132 is formed in a first panel 108 of a fluid-impermeable barrier 106, and a vent 134 is attached to the first panel 108 of the fluid-impermeable barrier 106. In such an embodiment, the orifice 132 and the vent 134 are unlikely to be covered and in contact with an individual's skin. Covering the orifice 132 and the vent 134 with skin prevents or at least inhibits the flow of air through the portion of the orifice 132 and the vent 134 covered by skin. Furthermore, an individual may find the vent 134 uncomfortable in contact with their skin; therefore, placing the vent 134 on the first panel 108 makes the fluid collection assembly 100 more comfortable to wear. In one embodiment, the vent 134 is attached to the interior of the first panel 108 to prevent the edges of the vent 134 from rubbing against or otherwise irritating the individual's skin.

[0038] In one embodiment, as shown, at least one orifice 132 is formed on a portion of the fluid-impermeable barrier 106 located at or adjacent to the top edge 136 of the fluid-impermeable barrier 106, and at least one vent 134 is attached to that portion. The top edge 136 of the fluid-impermeable barrier 106 may include the edge of the fluid-impermeable barrier 106 located above the opening 114 when the individual is standing and the fluid collection assembly 100 is allowed to hang freely in the pubic region of the individual. The orifice 132 is formed at or near the top edge 136 and the vent 134 is attached to allow air flowing through the vent 134 to pass through the penis (thus keeping the penis dry) and to inhibit the accumulation of bodily fluids near the top edge 136. In one embodiment, as shown, at least one orifice 132 is formed on a portion of the fluid-impermeable barrier 106 located at or adjacent to the side edge 138 of the fluid-impermeable barrier 106, and at least one vent 134 is attached to that portion. The side edges 138 of the fluid-impermeable barrier 106 may include edges of the fluid-impermeable barrier 106 extending from or adjacent to the top edge 136. Typically, air preferentially flows along a path extending from the vent 134 toward the fluid outlet 118. When the vent 134 is spaced apart from and / or located at or near the top edge 136, the preferential airflow from these vents 134 may result in less airflow through at least some portions of the chamber 112 adjacent to the side edges 138. Positioning the orifice 132 and the vent 134 at or near the side edges 138 increases airflow through the portions of the chamber 112 adjacent to the side edges 138, thereby preventing or at least inhibiting the accumulation of bodily fluids in these portions of the chamber 112.

[0039] An opening 114, defined by a fluid-impermeable barrier 106, provides an entry path for fluid into chamber 112 when the penis is implanted, and allows the penis to enter chamber 112 (e.g., penis receiving area 131) when the penis is not implanted. The opening 114 may be defined by a fluid-impermeable barrier 106 (e.g., the 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, extending from the outer surface 127 to the inner surface 126, thereby allowing bodily fluids to enter chamber 112 from the outside of the fluid collection assembly 100.

[0040] In one embodiment, the second panel 110 defines the entire opening 114. For example, the opening 114 may be a cut defined by the second panel 110, spaced apart from the outer periphery (e.g., edge) of the second panel 110. In such an example, the second panel 110 may have a shape substantially corresponding to the shape of the first panel 108, thereby facilitating attachment of the first panel 108 to the second panel 110 along its outer periphery. It also allows the first panel 108 and the second panel 110 to lie substantially flat when the penis is not located in the chamber 112 and the sheath 102 is placed on a flat surface. The ability of the first panel 108 and the second panel 110 to lie substantially flat allows for more discreet wearing of the fluid collection assembly 100 and inhibits the accumulation of bodily fluids at the individual. However, in some embodiments, the opening 114 is not spaced apart from the outer periphery of the second panel 110. In such embodiments, the opening 114 may be a cut extending inward from at least one outer periphery of the second panel 110. Other examples of forming an opening 114 in the second panel 110 are disclosed in International Patent Application No. PCT / US2021 / 039866, filed June 30, 2021, the disclosure of which is incorporated herein by reference in its entirety.

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

[0042] In one embodiment, the fluid-impermeable barrier 106 is generally bullet-shaped. As used herein, the fluid-impermeable barrier 106 is generally bullet-shaped when the proximal region 160 of the fluid-impermeable barrier 106 has a substantially constant first width and the distal region 162 of the fluid-impermeable barrier 106 has a second width smaller than the first width. The first and second widths can be measured perpendicular to the longitudinal axis 140 and can be greater than the thickness of the sheath 102 when it is placed on a flat surface. The generally bullet-shaped fluid-impermeable barrier 106 facilitates the operation of the fluid collection assembly 100 and makes the sheath 102 more comfortable. The reduced second width also directs bodily fluid toward the fluid outlet 118 and port 130.

[0043] In one embodiment, the second width of the distal region 162 may vary (e.g., decrease) along the length of the distal region 162, and the second width is measured perpendicular to the longitudinal axis 140. In one example, the second width of the distal region 162 may decrease at a constant rate from the proximal region 160 toward the fluid outlet 118 (e.g., from the proximal region 160 to the fluid outlet 118). The constant rate of decrease in the second width can straighten the side edge 138 of the fluid-impermeable barrier 106 defining the distal region 162. The straight side edge 138 may form a corner at the junction between the proximal region 160 and the distal region 162, which may uncomfortablely compress an individual. In one example, the second width of the distal region 162 may decrease at a varying rate (e.g., an increasing rate) from the proximal region 160 toward the fluid outlet 118 (e.g., from the proximal region 160 to the fluid outlet 118). The varying rate of decrease in the second width causes the side edge 138 of the fluid-impermeable barrier 106 defining the distal region 162 to bend, for example, convexly bend. The curved side edge 138 prevents the formation of corners that could compress an individual, thus making the fluid collection assembly 100 more comfortable than if the side edge 138 of the distal region 162 were straight. However, it should be noted that when the side edge 138 of the distal region 162 is straight rather than curved, the airflow through the distal region 162 may be more uniform.

[0044] It should be noted that the fluid impermeable barrier 106 may take on a shape other than a generally bullet-shaped form. In one example, the fluid impermeable barrier 106 may take on a generally rectangular shape, as discussed in more detail in International Patent Application No. PCT / US2021 / 039866, filed June 30, 2021, the disclosure of which is incorporated herein by reference as stated above. In one example, the fluid impermeable barrier 106 may take on a generally triangular shape, a semi-elliptical shape, or any other suitable shape.

[0045] The fluid-impermeable barrier 106 may also at least partially limit the fluid outlet 118. The fluid outlet 118 may be formed by the unattached portions of the first panel 108 and the second panel 110.

[0046] Figure 1F This is an isometric top view of the port shown, and Figure 1G It is based on one implementation method along Figure 1E The diagram shows a cross-sectional view of port 130 taken from the 1G-1G plane. Port 130 includes a first portion 144 and a second portion 146. The first portion 144 and the second portion 146 may be integrally formed together (e.g., presenting a single-piece structure) or may comprise a multi-piece structure consisting of two or more pieces fixed together. Thus, in some embodiments, the fluid collection assembly disclosed herein may be formed from a first panel and a second panel integrally formed together (e.g., presenting a single-piece structure), which eliminates at least some edges and simplifies the manufacture of such fluid collection assemblies.

[0047] The first portion 144 may be attached to or configured to be attached to the fluid-impermeable barrier 106, and optionally is at least partially disposed within the chamber 112. The second portion 146 is configured to be attached to the conduit 142. The first portion 144 defines an inlet 148, and the second portion 146 defines an outlet 150 of port 130, which is located downstream of inlet 148. Port 130 also defines a passage 152 extending from inlet 148 to outlet 150. It should be noted that inlet 148 refers to the inlet of passage 152, and is not necessarily the inlet of port 130. In one example, when port 130 does not include slot 156, inlet 148 can be the inlet of both port 130 and passage 152. In one example, as shown, when port 130 includes slot 156, inlet 148 may not be the inlet of port 130 because slot 156 forms the inlet of port 130.

[0048] The first portion 144 of port 130 can be attached to the fluid-impermeable barrier 106 using any suitable technique. In one embodiment, the first portion 144 is disposed between the first panel 108 and the second panel 110 before being attached to the fluid-impermeable barrier 106. In such an embodiment, the first portion 144 is adjacent to and can be attached to the inner surface 126 of the fluid-impermeable barrier 106. In one embodiment, the first portion 144 can be attached to the fluid-impermeable barrier 106 using at least one of adhesives, pulse heating, direct heating, US soldering, RF soldering, any other attachment technique disclosed herein, or any other suitable attachment technique.

[0049] Port 130 may be formed of a more flexible and bendable material than conventional ports of the fluid collection assembly. For example, the material of port 130 may include polymers (e.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, polycarbonate, etc.), polyurethane, thermoplastic elastomers (TPE), rubber, thermoplastic polyurethane, other suitable materials, or combinations thereof. The port may be flexible, allowing it to bend or flex when positioned against a wearer's body and preventing injury to the wearer. Example materials for port 130 may include, but are not limited to, a fluid-impermeable barrier comprising at least one of Versaflex CL 2000X TPE, Dynaflex G6713TPE, or Silpuran 6000 / 05 A / B silicone.

[0050] In some embodiments, at least the second portion 146 exhibits greater rigidity than the fluid-impermeable barrier 106. The second portion 146 may exhibit greater rigidity than the fluid-impermeable barrier 106 because at least one of the following occurs: the second portion 146 exhibits a thickness greater than the fluid-impermeable barrier 106; or at least a portion of the second portion 146 is formed of a material exhibiting a Young's modulus (i.e., elastic modulus) greater than the Young's modulus (i.e., elastic modulus) of the material forming at least a portion of the fluid-impermeable barrier 106. This increased rigidity of the second portion 146 relative to the fluid-impermeable barrier 106 allows for the attachment of the second portion 146 to the conduit 142 using techniques that might be difficult or impossible to implement when the conduit 142 is directly attached to the fluid-impermeable barrier 106. In one example, the conduit 142 may be attached to the second portion 146 using an interference fit, which might be difficult or impossible to achieve when the conduit 142 is directly attached to the fluid-impermeable barrier 106. In such an example, the surface of the second portion 146 configured to abut the conduit 142 is tapered. The tapered surface of the second portion 146 facilitates insertion of the second portion 146 into the conduit 142 when the second portion 146 forms a male connector, and facilitates insertion of the conduit 142 into the second portion 146 when the second portion 146 forms a female connector. The tapered surface of the second portion 146 also allows control over the strength of the interference fit between the second portion 146 and the conduit 142 by controlling how much the second portion 146 is inserted into the conduit 142 or how much the conduit 142 is inserted into the second portion 146. In one example (not shown), the surface of the second portion 146 is configured to threadedly attach to the conduit 142, which may be difficult or impossible when the conduit 142 is directly attached to the fluid-impermeable barrier 106. In such an example, the second portion 146 may include one or more helically extending ridges extending from the surface of the second portion 146 that contacts or is closest to the conduit 142. It should be noted that the threaded surface of the second portion 146 and / or the threads may be tapered. In one example (not shown), the surface of the second portion 146 that contacts or is closest to the catheter 142 may include a circumferentially extending ridge. It should be noted that the surface of the second portion 146 including the ridge and / or the ridge may be tapered.

[0051] In one embodiment, at least the second portion 146 exhibits greater rigidity than the conduit 142. The second portion 146 may exhibit greater rigidity than the conduit 142 because at least one of the following occurs: the second portion 146 exhibits a thickness greater than the conduit 142, or at least a portion of the second portion 146 is formed of a material exhibiting a Young's modulus greater than the Young's modulus of the material forming at least a portion of the conduit 142. The increased rigidity of the second portion 146 prevents the channel 152 from collapsing. For example, it has been found that, in certain situations, directly attaching the conduit 142 to the fluid-impermeable barrier 106 may cause at least partial collapse of the portion of the conduit 142 attached to the fluid-impermeable barrier 106 when a strong vacuum is applied to the chamber 112. However, the increased rigidity of the port 130 prevents such collapse.

[0052] In one embodiment, the first portion 144 exhibits greater rigidity than the fluid-impermeable barrier 106 and / or conduit 142. For example, the first portion 144 may exhibit rigidity comparable to that of the second portion 146. The increased rigidity of the first portion 144 prevents collapse of the inlet 148, any portion of the channel 152 defined therein, and the groove 156. The increased rigidity of the first portion 144 also makes it easier to attach the port 130 to the first portion 144, as pressure can be applied to the first portion 144 during attachment without substantially deforming it.

[0053] The first portion 144 may have a shape different from that of the second portion 146. For example, the first portion 144 may have a first elongated shape extending in a direction generally perpendicular to the longitudinal axis 140, and the second portion 146 may have a second elongated shape (e.g., a generally cylindrical shape) extending generally parallel to the longitudinal axis 140. The first elongated shape of the first portion 144 can enhance the attachment between the first portion 144 and the fluid-impermeable barrier 106 by increasing the surface area of ​​the first portion 144 attached to the fluid-impermeable barrier 106. The first elongated shape of the first portion 144 also prevents or at least inhibits torsion of the sheath 102. Examples of the first elongated shape include a generally rectangular cross-sectional shape with rounded corners and edges, a generally oval cross-sectional shape, a generally elliptical cross-sectional shape, or a generally rhomboid cross-sectional shape with rounded edges and corners. In one specific example, the first elongated shape is a generally elliptical cross-sectional shape to eliminate sharp edges at the port that could potentially harm the wearer. In one specific example, the first elongated shape includes rounded corners because rounded corners are less likely to cause uncomfortable pressure on the individual than sharp corners. The second elongated shape of the second part 146, which extends generally parallel to the longitudinal axis 140, can facilitate attachment to the catheter 142.

[0054] The first portion 144 may exhibit a first maximum thickness, and the second portion 146 may exhibit a second maximum thickness. As discussed in more detail elsewhere, the sheath 102 is configured to lie substantially flat when positioned on a flat surface, thereby allowing the fluid collection assembly 100 to be worn covertly, preventing or at least inhibiting the accumulation of bodily fluid in the chamber 112, and allowing the fluid collection assembly 100 to be used for penile burial. It should be noted that “substantially flat” allows for deviations that do not normally prevent the covert wearing of the fluid collection assembly 100, still inhibit the accumulation of bodily fluid, and allow the fluid collection assembly 100 to be used for penile burial, such as deviations caused by slight bulges or ripples formed in the port 130, the vent 134, or in the fluid-impermeable barrier 106. Typically, the port 130 is configured to minimize the first and second maximum thicknesses, thereby preventing or at least inhibiting the ability of the sheath 102 to lie flat. The second maximum thickness is typically determined by the need to attach the conduit 142 to the second portion 146. For example, the second maximum thickness may need to be slightly larger than the inner diameter of the conduit 142 when the second portion 146 is a male connector, and slightly larger than the outer diameter of the conduit 142 when the second portion 146 is a female connector. In a specific example, the second portion 146 is a male connector because the second maximum thickness of the second portion 146 is less when it is a male connector than when it is a female connector. It should be noted that when the second portion 146 is a male connector, the adverse effect of the second portion 146 on the flattening capability of the sheath 102 is smaller than when the conduit 142 is directly attached to the fluid-impermeable barrier 106, because the second maximum thickness can be smaller than the outer diameter of the conduit 142.

[0055] Typically, the first maximum thickness of the first portion 144 is substantially equal to or less than the second maximum thickness to minimize the adverse effect of the first portion 144 on the ability of the sheath 102 to lie flat. In one example, when the second maximum thickness is located at or near the intersection between the first portion 144 and the second portion 146, the first maximum thickness may be substantially equal to the second maximum thickness to prevent the formation of corners that could uncomfortably compress the individual. When the outer surface 154 of the second portion 146 is tapered, the second maximum thickness may be located at or near the intersection between the first portion 144 and the second portion 146.

[0056] In one embodiment, the first maximum thickness of the first portion 144 is greater than the total thickness of the fluid-impermeable barrier 106 (e.g., the combined thickness of the first 108 and the second panel 110) and the porous material 122. This increased thickness of the first maximum thickness of the first portion 144 relative to the total 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 important to note that the high flexibility of the fluid-impermeable barrier 106, particularly when the fluid-impermeable barrier 106 is formed of polyurethane, minimizes the percentage of the sheath 102 not lying flat near the port 130. Furthermore, the first portion 144 has at least one of the following characteristics: it is spaced apart from the opening 114, thereby preventing the first maximum thickness from affecting the ability of the fluid collection assembly 100 to be used for penile burial; it is located at the point of maximum airflow, which inhibits fluid buildup; or the first maximum thickness is less than the maximum thickness of the conduit 142, thereby making the conduit 142 more detrimental to the concealed use capability of the fluid collection assembly 100 than the port 130. In one example, the first maximum thickness may be approximately 500% (i.e., 5 times greater) or less, approximately 400% or less, approximately 300% or less, approximately 200% or less, or approximately 150% or less than the total thickness of the fluid-impermeable barrier 106 and the porous material 122. It should be noted that the first maximum thickness may be greater than the total thickness of the fluid-impermeable barrier 106 and the porous material 122 to make the inlet 148 sufficiently large to remove bodily fluid from the chamber 112, and may be determined by the size of the conduit 142.

[0057] In one embodiment, a first portion 144 of port 130 may define a slot 156 different from that of inlet 148. Slot 156 is disposed upstream of inlet 148. For example, inlet 148 may present dimensions comparable to the corresponding dimensions (e.g., width and / or thickness) of channel 152 at or near the intersection of first portion 144 and second portion 146. The dimensions of inlet 148 are comparable to the corresponding dimensions of channel 152 when the difference between the dimensions of inlet 148 and channel 152 is at most about ±10% or at most about ±5%. For example, as shown, inlet 148 presents a width substantially the same as the width of channel 152 at the intersection of first portion 144 and second portion 146. Slot 156 presents a maximum dimension larger than the corresponding dimension of inlet 148 and is not comparable to the corresponding dimension of channel 152 at the intersection of first portion 144 and second portion 146. For example, as shown in the figure, the slot 156 defined by the first portion 144 exhibits a maximum dimension (i.e., width) significantly larger than the corresponding width of the inlet 148 and the corresponding width of the channel 152 at the intersection of the first portion 144 and the second portion 146. It should be noted that the wider width of the first portion 144 relative to the second portion 146 allows the first portion 144 to define the slot 156.

[0058] The slot 156 facilitates the flow of bodily fluid through chamber 112, into port 130, and through port 130. For example, compared to a substantially similar port 130 without the slot 156 (i.e., inlet 148 is the inlet of port 130), the wider dimension of the slot 156 relative to inlet 148 makes it easier for bodily fluid to enter port 130. The wider width of the slot 156 relative to inlet 148 also allows airflow to be distributed over a larger proportion of chamber 112 compared to a substantially similar port 130 without the slot 156. The wider dimension of the slot 156 relative to inlet 148 increases the unoccupied volume of port 130 compared to port 130 without the slot 156. The larger volume of port 130 allows port 130 to deliver fluid to its outlet. In other words, the slot 156 can form a fluid reservoir. Furthermore, it has been found that the slot 156 reduces turbulence of bodily fluid flowing through port 130 compared to port 130 without the slot 156. The reduced turbulence allows bodily fluids to flow through port 130 at a higher rate than when port 130 does not include slot 156, thereby suppressing oversaturation of bodily fluids in the porous material 122. The reduction in bodily fluid turbulence caused by slot 156 is particularly beneficial to the operation of the fluid collection assembly 100 when the second portion 146 forms a male connector. For example, forming the second portion 146 as a male connector reduces the lateral dimension (e.g., diameter) of channel 152, which limits the rate at which bodily fluids are removed from chamber 112. The reduction in bodily fluid turbulence through port 130 caused by slot 156 helps mitigate this problem.

[0059] In one embodiment, the dimensions of the channel 156 remain substantially constant. Maintaining the dimensions of the channel 156 substantially constant maximizes its volume, and consequently, the volume of the port 130, which can serve as a fluid reservoir. However, maintaining the dimensions of the channel 156 substantially constant may create a step at the intersection of the inlet 148 and the channel 156, potentially increasing turbulence of the fluid flowing through the port 130 compared to the absence of a step between the inlet 148 and the channel 156. In one embodiment, as shown, the dimensions of the channel 156 may taper along at least a portion of its length (e.g., measured parallel to the longitudinal axis 140). In other words, the dimensions of the channel 156 may vary along at least a portion of its length. The tapered dimensions of the channel 156 prevent or at least reduce the step at the intersection of the inlet 148 and the channel 156. Therefore, the tapered dimensions reduce turbulence of the fluid flowing through the port 130 compared to maintaining the dimensions of the channel 156 substantially constant. It should be noted that the tapered dimensions of the tank 156 reduce the volume of bodily fluids that can be temporarily stored in the tank 156, thereby reducing the volume of the port 130.

[0060] Due to the flexibility of the fluid impermeable barrier 106, the sheath 102 can be bent to present a generally L-shape or U-shape, which can cause the fluid impermeable barrier 106 to extend across the inlet of port 130 (e.g., across slot 156, or across inlet 148 when port 130 does not include slot 156). For example, during use, the fluid collection assembly 100 may be positioned on the individual such that the fluid collection assembly 100 extends generally from the pubic region of the individual toward the feet of the individual. However, in many hospitals, a vacuum source is located behind the individual's bed such that when the individual is lying in bed, the catheter 142 extends from the fluid outlet 118 toward the individual's head. Therefore, the catheter 142 may cause the sheath 102 to bend and present the aforementioned generally L-shape or U-shape. It has been found that when the sheath 102 is bent and presents a generally L-shape or U-shape, the fluid impermeable barrier 106 can block the inlet of port 130, thereby preventing or inhibiting the entry of bodily fluids into port 130.

[0061] Therefore, the first portion 144 of 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. An inlet 148 may be disposed between the upper portion 144a and the lower portion 144b of the first portion 144 of port 130. According to one embodiment, the proximal ends 157a and 157b are substantially aligned and spaced apart from each other between the first panel 108 and the second panel 108. For example, assuming the lateral dimension of the fluid collection assembly 100 extends from the first panel 108 to the second panel approximately perpendicular to the longitudinal axis 140, the proximal ends 157a and 157b are substantially spaced apart from each other laterally. The proximal ends 157a and 157b may be aligned such that they terminate at substantially equal distances from the inlet 148 or the body of the first portion 144. In some embodiments, the proximal ends 157a, 157b are aligned to terminate at substantially equal distances from the inlet 148, but the tabs 148a, 148b are offset from each other. In other words, in a side view (e.g., Figure 1C In the cross-sectional view, the proximal ends 157a and 157b are substantially aligned, but when port 130 is viewed from above or below, the tabs 148a and 148b are at least partially offset from each other. This alignment of the two spaced-apart proximal ends 157a and 157b produces the following technical effect: when a vacuum force is applied to chamber 112 through port 130, the inlet 148 and / or slot 156 remain open and unobstructed. In other words, the longitudinal alignment of the two spaced-apart proximal ends 157a and 157b inhibits or prevents the first panel 108 and the second panel 110 from closing above the inlet 148 and / or slot 156 when a vacuum force is applied to chamber 112 through port 130.

[0062] In some embodiments of the fluid collection assembly 100, port 130 includes an upper tab 158a extending from upper portion 144a into chamber 112 and to upper proximal end 157a, and a lower tab 158b extending from lower portion 144a into chamber 112 and to lower proximal end 157b. The spaced-apart tabs 158a, 158b extending from the first portion 144 increase the possibility of forming a pathway allowing bodily fluid to flow into port 130, even when the sheath 102 is bent and presents a generally L-shaped or U-shaped form. In other words, the spaced-apart tabs 158a, 158b allow bodily fluid to continue flowing into port 130 when sheath 102 is bent and / or increase the rate at which bodily fluid can flow into port 130.

[0063] The two tabs 158a and 158b may extend from the first portion 144 by a distance of about 2 mm or more, about 3 mm or more, about 4 mm or more, about 5 mm or more, about 6 mm or more, about 7 mm or more, about 8 mm or more, about 9 mm or more, about 1 cm or more, about 1.25 cm or more, about 1.5 cm or more, or within the range of about 1 mm to about 3 mm, about 2 mm to about 4 mm, about 3 mm to about 5 mm, about 4 mm to about 6 mm, about 5 mm to about 7 mm, about 6 mm to about 8 mm, about 7 mm to about 9 mm, about 8 mm to about 1 cm, about 9 mm to about 1.25 cm, or about 1 cm to about 1.5 cm. Two tabs 158a, 158b (e.g., proximal ends 157a, 157b of the two tabs 158a, 158b) may be spaced apart by a distance of approximately 5 mm or greater, approximately 6 mm or greater, approximately 7 mm or greater, approximately 8 mm or greater, approximately 9 mm or greater, approximately 1 cm or greater, approximately 1.25 cm or greater, approximately 1.5 cm or greater, 2 cm or greater, or approximately 5 mm to approximately 2 cm, approximately 5 mm to approximately 1 cm, approximately 1 cm to approximately 1.5 cm, approximately 1.5 cm to approximately 2 cm, approximately 5 mm to approximately 7 mm, approximately 6 mm to approximately 8 mm, approximately 8 mm to approximately 1 cm, approximately 9 mm to approximately 1.1 cm, approximately 1 cm to approximately 1.2 cm, approximately 1.1 cm to approximately 1.3 cm, approximately 1.2 cm to approximately 1.4 cm, approximately 1.3 cm to approximately 1.5 cm, approximately 1.4 cm to approximately 1.6 cm, approximately 1.5 cm to approximately 1.7 cm, or approximately 1.6 cm to approximately 1.8 cm. The range is approximately 1 cm to approximately 1.7 cm to approximately 1.9 cm or approximately 1.8 cm to approximately 2 cm.

[0064] Generally, as the distance by which the two tabs 158a and 158b extend from the first portion 144 increases, the ability of the two tabs 158a and 158b to allow fluid to continue flowing into the port 130 and / or to increase the rate at which fluid can flow into the port 130 is improved when the sheath 102 is bent. However, increasing the distance by which the two tabs 158a and 158b extend from the first portion 144 increases the likelihood that the two tabs 158a and 158b will uncomfortably compress the individual, for example, when the sheath 102 is bent. The likelihood of the two tabs 158a and 158b uncomfortably compressing the individual can be reduced by using porous material 122 to cushion the two tabs 158a and 158b. When the tab 158 is formed on the side of the first portion 144 adjacent to the first panel 108 and the porous material 122 is configured to be located between the tab 158 and the second panel 110, the two tabs 158a and 158b can be cushioned by the porous material 122. The porous material 122 located between the two tabs 158a, 158b also provides a network for water molecule bonding and introduces this network into port 130 to remove fluid from chamber 112. The porous material 122 located between the two tabs 158a, 158b also prevents fluid from being drawn into the space between the two tabs 158a, 158b and into port 130 through the impermeable barrier 106. In some embodiments, each of the two tabs 158a, 158b extends at least partially into the porous material 122. In some embodiments, at least a portion (e.g., all) of the end of the distal region 172 of the porous material 122 lies between the two tabs 158a, 158b. When the porous material 122 is located between the two tabs 158a, 158b and / or the two tabs 158a, 158b extend into the porous material 122, the porous material 122 may be disposed near (e.g., adjacent to) the first portion 144 of the port 130 and / or extend into the groove 156 of the port 130. In these and other embodiments, the upper proximal end 157a (e.g., upper tab 158a) and the lower proximal end 157b (e.g., lower tab 158b) of the first portion 144 of the port 130 may be disposed between the first panel 108 and the second panel 110.

[0065] In one embodiment, the two tabs 158a and 158b may be formed of the same material as the rest of the port 130. In such an embodiment, the port 130 may have a monolithic structure (e.g., a single-piece structure), which makes the manufacture of the port 130 more efficient. In another embodiment, the two tabs 158a and 158b may be different from the rest of the port 130 (e.g., formed of a different material). In such an embodiment, the manufacture of the port 130 may be more difficult because it requires forming multiple pieces (instead of one) and attaching the two pieces together.

[0066] See you again Figure 1A-1E The fluid outlet 118 and port 130 may be located at or near the distal region 162 of the sheath 102, which is intended to be the lowest point of gravity in the chamber 112 when worn by a user. Positioning the fluid outlet 118 and port 130 at or near the distal region 162 of the sheath 102 allows the conduit 142 to receive more bodily fluid and reduces the likelihood of accumulation (e.g., accumulation of bodily fluid can lead to microbial growth and odor), for example, due to capillary forces, bodily fluid may be contained within the porous material 122. However, bodily fluid may tend to flow in the direction of gravity, especially when at least a portion of the porous material 122 is saturated with bodily fluid. Therefore, the fluid outlet 118 and port 130 may be located in the fluid collection assembly 100 at a position intended to be the lowest point of gravity when worn by a user.

[0067] As previously described, the sheath 102 includes at least one porous material 122 disposed within the chamber 112. The porous material 122 can guide bodily fluids to one or more selected areas of the chamber 112, for example, away from the penis and toward the fluid outlet 118. Therefore, the porous material 122 can facilitate the removal of bodily fluids from the chamber 112 and prevent the penis from coming into contact with a moist material, which can lead to penile skin deterioration and / or make the fluid collection assembly 100 more uncomfortable to wear. The porous material 122 can also reduce the flow of urine from the penis.

[0068] In one embodiment, the porous material 122 includes a wicking material configured to wick bodily fluids away from the opening 114, thereby preventing the fluids from escaping from the chamber 112. Such "wicking" may not include the adsorption of fluid into the wicking material. In other words, after the material is exposed to a fluid and removed from the fluid after a period of time, substantially no fluid is adsorbed into the material. While adsorption is undesirable, the term "substantially no adsorption" allows a nominal amount of fluid to be adsorbed into the wicking material (e.g., adsorbently), for example, less than about 30 wt%, 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%. The wicking material may also wick fluid generally toward the interior of the chamber 112, as discussed in more detail below. In one embodiment, the porous material 122 is configured to adsorb or absorb bodily fluids. Similar to wicking materials, such adsorption or absorption materials can remove bodily fluids from the opening 114, thereby preventing bodily fluids from escaping from the chamber 112.

[0069] The porous material 122 can be formed from any suitable porous material. For example, the porous material 122 can be formed from nylon (e.g., spun nylon fibers), polyester, polyurethane, polyethylene, polypropylene, other porous polymers, hydrophobic foams, open-cell foams, wool, silk, linen, cotton (e.g., cotton gauze), felt, other fabrics, coated porous materials (e.g., waterproofing coated porous materials), any other suitable porous materials, or combinations thereof. In some embodiments, the porous material 122 may comprise two or more layers of fluid-permeable material. For example, the porous material 122 may comprise a fluid-permeable membrane covering at least a portion (e.g., all) of a fluid-permeable body (e.g., a support), wherein both the fluid-permeable membrane and the fluid-permeable body are disposed within the chamber 112. The fluid-permeable membrane may be configured to draw any fluid from the openings 114 / 124 core, thereby preventing fluid from escaping from the chamber 112. In some embodiments, at least one of the fluid-permeable membrane or the fluid-permeable support comprises nylon configured to draw fluid from the openings 114 / 124 core. The materials of fluid-permeable membranes and fluid-permeable supports may also include natural fibers. In such examples, the materials may have a coating to prevent or limit fluid adsorption into the material, such as a waterproofing coating.

[0070] The fluid-permeable membrane can also wick fluid generally toward the interior of chamber 112 and / or the fluid-permeable support. The fluid-permeable membrane can comprise any fluid-wicking material. For example, the fluid-permeable membrane can comprise fabrics such as gauze (e.g., silk, linen, polymer-based materials such as polyester, or cotton gauze), other soft fabrics (e.g., knitted plain weave or the like), or other smooth fabrics (e.g., rayon, satin, or the like). Forming the fluid-permeable membrane from gauze, soft fabrics, and / or smooth fabrics can reduce friction caused by the fluid collection assembly 100. In many embodiments, the porous material 122 includes a fluid-permeable support and a fluid-permeable wicking membrane, the fluid-permeable support comprising a porous spun nylon fiber structure, and the fluid-permeable wicking membrane comprising gauze that at least partially surrounds or covers the spun nylon fiber structure. For example, the porous material 122 can comprise gauze or other wicking fabric configured to contact the user's skin in chamber 112 and / or the penile receiving area 131. In some embodiments, the gauze or other wicking fabric is covered with a layer of spun nylon fiber material. In some implementations, gauze or other wicking fabric covers the side of the spun nylon fiber material of the basic plane facing the user's skin.

[0071] In some embodiments that include a fluid-permeable membrane (e.g., gauze) covering a fluid-permeable support (e.g., spun nylon fibers), each of the two tabs 158a, 158b extends at least partially into the fluid-permeable support. In some embodiments, at least a portion (e.g., all) of the end of the fluid-permeable support located in the distal region 172 is disposed between the two tabs 158a, 158b, and the fluid-permeable membrane is not located between the two tabs 158a, 158b. When the fluid-permeable support of the porous material 122 is located between the two tabs 158a, 158b and / or the two tabs 158a, 158b extend into the fluid-permeable support of the porous material 122, the fluid-permeable support of the porous material 122 may be disposed near (e.g., adjacent to) the first portion 144 of the port 130 and / or extend into the groove 156 of the port 130.

[0072] In one embodiment, the porous material 122 may be a sheet (e.g., a multilayer sheet). The porous material 122 is a sheet when it satisfies at least one of the following: it is generally planar when placed on a flat surface, does not define a cavity (e.g., is not tubular), or its length and width are greater than its thickness. Forming the porous material 122 as a sheet facilitates the manufacture of the fluid collection assembly 100. For example, forming the porous material 122 as a sheet makes the first panel 108, the second panel 110, and the porous material 122 each a sheet. During the manufacture 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 example, the porous material 122 may have a shape of the same size as the first panel 108 and the second panel 110, or more preferably slightly smaller than the dimensions of the first panel 108 and the second panel 110. Thus, the first panel 108 and the second panel 110 can be attached together along their outer edges (e.g., upper edge 136 and side edge 138), and the porous material 12 can also be attached 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, thereby preventing the porous material 122 from forming a channel through the fluid-impermeable barrier 106 (through which bodily fluids could leak). Furthermore, attaching the porous material 122 to the first panel 108 and / or the second panel 110 prevents significant movement of the porous material 122 within the chamber 112, for example, preventing the porous material 122 from accumulating near the fluid outlet 118. In one example, the porous material 122 may be attached to the first panel 108 or the second panel 110 before or after the first panel 108 is attached to the second panel 110 (e.g., by adhesive). In another example, the porous material 122 may simply be disposed within 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 fixed to each other (e.g., the fluid-permeable support and the fluid-permeable membrane are movable within the chamber). In one embodiment, as further discussed below, the porous material 122 may take the form of something other than a sheet, such as a hollow, generally cylindrical shape.

[0073] The porous material 122 may have a shape that substantially corresponds to the fluid-impermeable barrier 106, such that the porous material 122 partially or substantially completely occupies the entire chamber 112. For example, as shown, the porous material 122 may have a generally bullet-shaped form. The porous material 122 may have a generally bullet-shaped form when it includes a proximal portion 170 corresponding to the proximal region 160 and a distal portion 172 extending from the proximal portion 170 corresponding to the distal region 162. The proximal portion 170 may have a substantially constant first width, and the distal portion 172 may have a second width smaller than the first width. The second width may be constant or variable (e.g., varying at a constant or variable ratio). The porous material 122 may also have a shape other than a generally bullet-shaped form, such as a generally rectangular shape, a generally semi-elliptical shape, or any other suitable shape.

[0074] Other examples of porous materials are disclosed in International Patent Application No. PCT / US2022 / 014285, filed January 28, 2022, the disclosure of which is incorporated herein by reference in its entirety.

[0075] Typically, when the penis is not in the penile receiving area 131 and the sheath 102 rests on a flat surface, the sheath 102 is substantially flat. The sheath 102 is substantially flat because the fluid-impermeable barrier 106 is formed by the first panel 108 and the second panel 110, rather than by a generally tubular fluid-impermeable barrier. Furthermore, as previously mentioned, the porous material 122 may be a sheet, which also makes the sheath 102 substantially flat. It should be noted that the sheath 102 is described as substantially flat because at least one of the porous materials 122 may form a slight bulge within the sheath 102 based on the thickness of the porous material 122, the port 130 may also cause a bulge around it, or the base 104 may exert a pull on the portion of the sheath 102 surrounding it. It should also be noted that the sheath 102 may also be compliant, and therefore the sheath 102 may not be substantially flat during use, as the sheath 102 may rest on a non-flat surface (e.g., between the testicles, perineum and / or thighs) during use, and the sheath 102 may conform to the shape of such surfaces.

[0076] When the penis is not in the penis receiving area 131 and the sheath 102 rests on a flat surface, the sheath 102 can be substantially flat, allowing the fluid collection assembly 100 to be used for both buried and unburied penises. For example, when the fluid collection assembly 100 is used for buried penis, the penis does not extend into the penis receiving area 131, allowing the sheath 102 to rest relatively flat on the orifice 124. When the sheath 102 is resting relatively flat on the orifice 124, the porous material 122 extends across the orifice and is very close to the buried penis. Thus, the porous material 122 prevents or inhibits the accumulation of bodily fluids drained from the buried penis on the individual's skin, because the porous material 122 will receive and remove at least a large portion of the bodily fluids that would otherwise accumulate on the individual's skin. Therefore, the individual's skin remains dry, thereby improving the comfort of using the fluid collection assembly 100 and preventing skin atrophy. However, unlike other conventional fluid collection components configured for burying the penis, the fluid collection component 100 can still be used with an unburied penis, as the unburied penis can still be received in the penis receiving area 131, even when the penis is fully erect. Furthermore, the sheath 102, being substantially flat, allows the fluid collection component 100 to be used more discreetly than when the sheath 102 is not substantially flat, thus avoiding potentially embarrassing situations.

[0077] When the sheath 102 is substantially flat, the porous material 122 can substantially occupy the entire chamber 112, and the penile receiving area 131 is collapsed (for illustrative purposes, in...). Figure 1C and Figure 1D (Indicated as not collapsed). In other words, the sheath 102 may not define an area that is never occupied by the porous material 12. When the porous material 122 substantially occupies the entire chamber 112, bodily fluids drained into the chamber 112 are unlikely to accumulate over a long period of time, as accumulation of bodily fluids can lead to hygiene problems, odors, and / or keep the individual's skin in contact with bodily fluids, resulting in discomfort and skin degeneration.

[0078] As previously described, the first panel 108, the second panel 110, and the porous material 122 can be selected to be relatively flexible. The first panel 108, the second panel 110, and the porous material 122 are relatively flexible when they cannot maintain their shape when unsupported. The flexibility of the first panel 108, the second panel 110, and the porous material 122 allows the sheath 102 to be substantially flat as described above. The flexibility of the first panel 108, the second panel 110, and the porous material 122 also allows the sheath 102 to conform to the shape of the penis, even if the size and shape of the penis change (e.g., during erection), and minimizes unoccupied space in the chamber 112 where bodily fluids may accumulate.

[0079] As previously described, the fluid collection assembly 100 may optionally include a base 104 configured to connect to the skin surrounding the penis (e.g., mons pubis, thigh, testis, and / or perineum) and allow the penis to be placed through it. For example, the base 104 may define an orifice 124 configured to allow the penis to be placed through it. The base 104 may be flexible, thereby enabling it to conform to any shape of the skin surface and reducing traction on the skin surface. The base 104 is configured to attach to the area surrounding the penis (e.g., mons pubis) but not to the thigh, as attaching the base 104 to the thigh could cause uncomfortable traction on the base 104 during individual movement. In one 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 attach to the mons pubis, and the secondary attachment portion 176 is configured to attach to a region of the penis other than the mons pubis (e.g., the upper part of the testis). The primary attachment portion 174 may be generally rectangular or trapezoidal in shape. The primary attachment portion 174 may extend further from the orifice 124 than the secondary attachment portion 176 because the mons pubis is less sensitive and has a larger area than other regions of the penis. The secondary attachment portion 176 may include one or more concave side edges 178. The concave side edges 178 may help prevent the secondary attachment portion 176 from attaching to the individual's thigh. It should be noted that any corners of the base 104 may be rounded to prevent or at least inhibit the base 104 from uncomfortably compressing the individual.

[0080] Base 104 can present except Figure 1E Shapes other than those shown. For example, base 104 may be approximately partially triangular, having three vertices and edges extending between the vertices. The vertices may be rounded to prevent base 104 from pressing in and injuring an individual. Orifice 124 may be located off-center and closer to one of the vertices than the others. Other examples of shapes that base 104 may form are disclosed in PCT application PCT / US2021 / 015787, filed January 29, 2021, the disclosure of which is incorporated herein by reference in its entirety.

[0081] In one embodiment (not shown), the orifice 124 may be generally circular. In another embodiment, as shown, the orifice 124 may be non-circular. The non-circular shape of the orifice 124 may be selected to correspond to at least one of the following: corresponding to the cross-sectional shape of the base of the penis and / or better conforming to the area surrounding the penis, either of which can limit the leakage and accumulation of bodily fluids. For example, as shown, the orifice 124 may be generally bell-shaped. The generally bell-shaped shape includes a concave top edge 180 (relative to the interior of the orifice 124) and a concave bottom edge 182 opposite to the concave top edge 180. The generally bell-shaped shape also includes two convex side edges 184 extending between the top edge 180 and the bottom edge 182. Any corners between the top edge 180, the top edge 182, and the side edges 184 may be rounded. The two convex side edges 184 cause a variation in the width of the orifice 124. For example, the two convex side edges 184 make the width of the opening 124 near the top edge 180 smaller than the width of the opening 124 near the bottom edge 182. The generally bell-shaped shape of the opening 124 allows it to correspond to the shape of the base of the penis, thereby preventing leakage of bodily fluids from the chamber 112 and inhibiting fluid buildup. The opening 124 may also have other non-circular shapes, such as a generally triangular shape, a generally trapezoidal shape, a generally hippopede shape, or any other suitable non-circular shape.

[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 individual's skin 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, which is configured to be easily removed from the adhesive layer and to prevent the adhesive layer from unintentionally attaching to other objects. The substrate may be formed of a fluid-impermeable material to prevent leakage of bodily fluids from the chamber 112 through the base 104.

[0083] In one embodiment, the entire base 104 is attached to the sheath 102, which enhances the attachment strength between the sheath 102 and the base 104. In another embodiment, as shown, only the defining orifice 124 of the base 104 or the inner portion adjacent to the orifice 124 is attached to the sheath 102. Attaching only the inner portion of the base 104 to the sheath 102 is sufficient to keep the base 104 attached to the sheath 102 during use. Attaching only the inner portion of the base 104 to the sheath 102 allows the outer portion of the base 104 (e.g., the portion of the base 104 other than the inner portion) to be easily operated by the user of the fluid collection assembly 100, thereby making it easier to attach the base 104 to an individual.

[0084] In one embodiment, the base 104 may be attached to the second panel 110 prior to the attachment of the second panel 110 to the first panel 108, thereby facilitating attachment of the base 104 to the sheath 102, for example using ultrasonic (US) welding, radio frequency (RF) welding, and pulse heating. Attaching the base 104 to the second panel 110 prior to setting (e.g., securing) the fluid-permeable support 122 in the chamber 112 may make securing the fluid-permeable support 122 in the chamber 112 difficult, as the base 104 may create an obstruction. In one example, as shown, 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 porous material gaps 198 may be generally aligned with each other, such that the base gaps 196 and porous material gaps 198 are adjacent to each other. The base gap 196 and the porous material gap 198 allow the opposing portions of the fluid-impermeable barrier 106, which are generally aligned with the base gap 196 and the porous material gap 198, to be attached together (e.g., using US welding, RF welding, pulse heating, direct heating, thermoforming, etc.). Attaching the opposing portions of the fluid-impermeable barrier 106 together secures the fluid-permeable support 122 within the chamber 112. In a particular example, as shown, the base gap 196 and the porous material gap 198 may be formed in the following portions of the base 104 and the fluid-permeable support 122, which are adjacent to or located above the portion of the orifice 124 furthest from the fluid outlet 118 (e.g., further from the fluid outlet 118). This arrangement of the base gap 196 and the porous material gap 198 allows the fluid-permeable support 122 to remain extended across the orifice 124. The example disclosed in Base 104 is in International Application PCT / US22 / 14285, filed on January 28, 2022, the disclosure of which is incorporated herein by reference in its entirety.

[0085] See you again Figure 1A-1E As previously described, the fluid collection assembly 100 includes a conduit 142. The conduit 142 may comprise a flexible material, such as a plastic tube (e.g., a medical tube). This plastic tube may comprise a tube of thermoplastic elastomer, polyvinyl chloride, ethylene vinyl acetate, polytetrafluoroethylene, etc. In some examples, the conduit 142 may comprise silicone or latex. In some examples, the conduit 142 may include one or more resilient portions, for example, by having one or more of a diameter or wall thickness that allows the conduit to be flexible.

[0086] As will be described in more detail below, conduit 142 is configured to connect to one or more of a fluid storage container (not shown) and a vacuum source (not shown), and extend at least partially between them. In one example, conduit 142 is configured to connect directly to a vacuum source (not shown). In such an example, conduit 142 may extend from 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, conduit 142 is configured to connect indirectly to at least one of a fluid storage container (not shown) and a vacuum source (not shown). In some examples, the conduit is secured to the wearer's skin with a tubing fixation device, such as the STATLOCK® tubing fixation device provided by CR Bard, Inc., including, but not limited to, the devices disclosed in U.S. Patent Nos. 6,117,163, 6,123,398, and 8,211,063, the disclosures of which are incorporated herein by reference in their entirety.

[0087] The inlet and outlet of conduit 142 are configured to fluidly connect (e.g., directly or indirectly) a vacuum source (not shown) to chamber 112. When the vacuum source ( Figure 7 When a vacuum is applied in the conduit 142, bodily fluids in the chamber 112 can be drawn into the inlet 148 and extracted from the fluid collection assembly 100 through the conduit 142. In some examples, the conduit 142 may be frosted or opaque (e.g., black) to obscure the visibility of the bodily fluids therein.

[0088] In some examples, the vacuum source may be located remotely from the fluid collection device. In such examples, conduit 142 may be fluidly connected to a fluid storage container, which may be positioned 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 chamber 112. The bodily fluids may accumulate or otherwise collect in chamber 112 (e.g., received into porous material 122). At least a portion of the bodily fluids may be aspirated through the interior of conduit 142 via an inlet. The bodily fluids may be removed from the fluid collection assembly 100 by a vacuum / vacuum extraction provided by a vacuum source. During operation, even if bodily fluids are introduced into and subsequently removed from chamber 112, the vent 134 maintains the pressure in chamber 112 substantially at atmospheric pressure.

[0090] As previously described, the fluid collection assembly 100 is formed of a first panel 108 and a second panel 110, which may be different sheets, allowing the first panel to be at least partially opaque and the second panel at least partially transparent. However, forming the first panel 108 and the second panel 110 from different sheets can create edges that can cause patient discomfort and require significant manufacturing work (e.g., welding or other attachment techniques) to attach the first panel 108 to the second panel 110. Therefore, in some embodiments, the fluid collection assembly disclosed herein may be formed from a first panel and a second panel integrally molded together (e.g., as a single piece), thereby eliminating at least some edges and simplifying the manufacture of such a fluid collection assembly.

[0091] This article also discloses other port configurations that prevent or inhibit panels 108 and 110 from blocking port entrances. Figure 2 An isometric top view of port 230 according to one embodiment is shown. Port 230 may be used in fluid collection assembly 100 (e.g., port 230 may replace port 130 in fluid collection assembly 100). Unless otherwise stated, port 230 may include any aspect of port 130, such as material and spacing between proximal ends.

[0092] Port 230 includes a first portion 244 and a second portion 246. The first portion 244 may be attached to or configured to be attached to a fluid-impermeable barrier 106, and optionally is at least partially disposed within chamber 112. The second portion 246 is configured to be attached to conduit 142. The first portion 244 defines an inlet (not shown), and the second portion 246 defines an outlet 250 of port 230, located downstream of the inlet. Port 230 also defines a channel (not shown) extending from the inlet to the outlet 250. It should be noted that the inlet refers to the inlet of the channel, and not necessarily the inlet of port 230. In one example, when port 230 does not include the slot 256, the inlet can be the inlet of both port 230 and the channel. In another example, when port 230 includes the slot 256, the inlet may not be the inlet of port 230, because the slot 256 forms the inlet of port 230.

[0093] The first portion 244 of port 230 may be attached to the fluid-impermeable barrier 106 using any suitable techniques described above for port 130. Port 230 (e.g., the first portion 244 and the second portion 246) may include any materials and / or physical properties described above for port 130. The second portion 246 may include any shape and / or construction described above for the second portion 146.

[0094] The shape of the first portion 244 may differ from that of the second portion 246 and also from that of the first portion 144 of the port 130. The first portion 244 may include two spaced-apart discs 244a and 244b (e.g., the upper portion of the upper disc 244a and the lower portion of the lower disc 244b). The two spaced-apart discs 244a and 244b may be generally planar and arranged parallel to the longitudinal axis 140, and may be generally circular or elliptical in shape. The shape of the two spaced-apart discs 244a and 244b eliminates sharp edges on the port 230 that could potentially cause injury to the wearer. The second elongated shape of the second portion 246, extending parallel to the longitudinal axis 140, facilitates attachment to the catheter 142. The first portion 244 and the second portion 246 may include any thickness described above in relation to the first portion 144 and the second portion 146.

[0095] In some embodiments, port 230 includes one or more opposing supports 258 extending between an upper disk 244a and a lower disk 244b, such that the upper disk 244a and the lower disk 244b are spaced apart from each other. At least some of the one or more supports 258 may be positioned midway (e.g., substantially in the middle) between the proximal ends 257a, 257b and the opposing distal ends of the two disks 244a, 244b. In one example, one or more supports 258 begin midway (e.g., substantially in the middle) between the proximal ends 257a, 257b and the opposing distal ends of the two disks 244a, 244b and then extend to at least a first portion 244 attached to a second portion 246. In some embodiments, one or more supports 258 are configured to extend from a first end of the support 258 (e.g., ... Figure 2 (as shown) extends to the opposite second end of the support member 258 ( Figure 2 (Not visible in the middle), and the second portion 246 is disposed between the first end and the opposite second end of the support member 258. Except for the second portion 246 located therebetween, the support member 258 may extend continuously between the first and second ends of the support member 258. Therefore, the opening leading to the slot 256 may be disposed opposite to the second portion 246 and / or the support member 258. One or more support members 258 may be arcuate or curved to match the periphery of the two disks 244a, 244b.

[0096] In these and other embodiments, one or more supports 258 may at least partially define a groove 256 different from the inlet of the second portion 246. For example, one or more supports 258, the upper disk 244a, and the lower disk 244b may define a groove 256 located upstream of the inlet of the second portion. The dimensions of the groove 256 and the inlet of port 230 may include the dimensions, characteristics, and advantages of the inlet 148 and groove 156 associated with port 130 described above. In one embodiment, as shown, the dimensions of the groove 256 may taper along at least a portion of its length (e.g., measured parallel to the longitudinal axis 140). In other words, the dimensions of the groove 256 may vary over at least a portion of its length. The tapering dimensions of the groove 256 may prevent or at least reduce the step at the intersection of the inlet and the groove 256. Therefore, compared to the groove 256 maintaining a substantially constant dimension, the tapering dimensions may reduce turbulence of fluid flowing through port 230. It should be noted that the tapered dimensions of the tank 256 reduce the volume of bodily fluids that can be temporarily stored in the tank 256 and thus in the port 230.

[0097] In some embodiments, one or more support members 258 include two opposing support columns. The two opposing support columns may be positioned midway (e.g., substantially in the middle) between the proximal ends 257a, 257b and the opposing distal ends of the two disks 244a, 244b.

[0098] The first portion 244 of port 230 may include an upper disk 244a having an upper proximal end 257a and a lower disk 244b having a lower proximal end 257b. An inlet may be disposed between the upper disk 244a and the lower disk 244b of the first portion 244 of port 230. According to one embodiment, the proximal ends 257a, 257b are substantially aligned and spaced apart from each other (e.g., by one or more supports 258). For example, the proximal ends 257a, 257b may terminate at substantially equal distances from the inlet. In some embodiments, the upper disk 244a and the lower disk 244b are substantially identical in size and / or shape. The alignment of the two spaced-apart proximal ends 257a, 257b produces the technical effect that when a vacuum force is applied to chamber 112 through port 230, the inlet and / or slot 256 remains open and unobstructed. In other words, the longitudinal alignment of the two spaced-apart proximal ends 257a, 257b inhibits or prevents the first panel 108 and the second panel 110 from closing above the inlet and / or slot 256 when a vacuum force is applied to the chamber 112 through port 230. The spaced-apart proximal ends 257a, 257b increase the possibility of forming a channel that allows bodily fluid to flow to port 230, even when the sheath 102 is bent and presents a generally L-shaped or U-shaped form. In other words, the spaced-apart proximal ends 257a, 257b allow bodily fluid to continue flowing into port 230 and / or increase the rate at which bodily fluid flows into port 230 when the sheath 102 is bent.

[0099] The distance between the two disks 244a, 244b (e.g., the proximal ends 257a, 257b of the two disks 244a, 244b) may be about 5 mm or greater, about 6 mm or greater, about 7 mm or greater, about 8 mm or greater, about 9 mm or greater, about 1 cm or greater, about 1.25 cm or greater, about 1.5 cm or greater, 2 cm or greater, or within the following ranges: 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, or about 1.6 cm to about 1.8 cm. 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 of the two disks 244a, 244b uncomfortably compressing an individual can be reduced by cushioning the two disks 244a, 244b with porous material 122. In some embodiments, each of the two disks 244a, 244b extends at least partially into the porous material 122. In some embodiments, at least a portion (e.g., all) of the end of the distal region 172 of the porous material 122 is disposed between the two disks 244a, 244b. When the porous material 122 is disposed between the two disks 244a, 244b and / or the two disks 244a, 244b extend into the porous material 122, the porous material 122 may be disposed close to (e.g., adjacent to) one or more supports 258 of the port 230 and / or extend into the groove 256 of the port 230. In these and other embodiments, the upper disk 244a and the lower disk 244b of the first portion 244 of port 230 may be disposed between the first panel 108 and the second panel 110.

[0101] In some implementations, the second portion of the port may be tilted relative to the longitudinal axis of the fluid collection assembly. Figure 3A A cross-sectional schematic diagram of the fluid collection assembly 300, and Figure 3B for Figure 3A An isometric top view of the port 330 and a portion of the porous material 122 of the fluid collection assembly 300. Unless otherwise stated, the fluid collection assembly 300 may include any aspect of the fluid collection assembly 100.

[0102] According to one embodiment, the fluid collection assembly 300 includes a port 330. Unless otherwise stated, the port 330 may include any aspect of ports 130, 230. For example, the port 330 may include a first portion having an upper disk 344a including an upper proximal end 357a, a lower disk 344b including a lower proximal end (not visible), and a support 358. The upper disk 344a, upper proximal end 357a, lower disk 344b, lower proximal end, and support 358 of the port 330 may include any aspect of the upper disk 244a, upper proximal end 257a, lower disk 244b, lower proximal end 257b, and one or more supports 258 of the port 230. Since a second portion 346 extends from the upper disk 344a in the port 330, in some embodiments, the support 358 extends from a first end of the support 348 (e.g., ...). Figure 3B As shown, the support 358 extends continuously to the opposite second end of the support 348 (not visible in Figure 3). The support 358 may be arc-shaped or curved to match the periphery of the two disks 344a, 344b.

[0103] In some embodiments, at least one (e.g., both) of the two disks 344a, 344b extends at least partially into the porous material 122. In some embodiments, the upper disk 344a extends into the porous material 122 such that a portion of the porous material 122 is disposed between the upper disk 344a and the first panel 108. In some embodiments, the upper disk 344a may be fixed to and / or disposed adjacent to the first panel 108. In some embodiments, at least a portion (e.g., all) of the end of the distal region 172 of the porous material 122 is disposed between the two disks 344a, 344b. When the porous material 122 is disposed between the two disks 344a, 344b and / or the two disks 344a, 344b extend into the porous material 122, the porous material 122 may be disposed near (e.g., adjacent to) one or more supports 358 of the port 330 and / or extend into a slot of the port 330. In some embodiments, the porous material 122 extends into the slot of port 330 to abut the support 358 (e.g., substantially filling the slot of port 330 and / or filling the space between the upper disk 344a and the lower disk 344b). In these and other embodiments, the upper disk 344a and the lower disk 344b of port 330 may be disposed between the first panel 108 and the second panel 110. In these and other embodiments, port 330, the first panel 108, and the porous material 122 may be configured such that there is substantially no void space between the first panel 108 and the upper disk 344a and / or the porous material 122 in chamber 112.

[0104] In some embodiments, the second portion 346 is inclined from the first portion 344 toward the proximal region of the sheath 102. For example, the second portion 346 may be secured to the upper disk 344a and may include an inlet configured as an opening on the upper disk 344a. The second portion 346 may be inclined proximally from the upper disk 344a toward the proximal region of the sheath 102. This configuration of the second portion 346 allows the catheter 142 to be oriented toward the bedside (where a vacuum source is typically located) during use, thereby preventing kinking of the catheter 142. The second portion 346 may be inclined relative to the upper disk 344a at approximately 10º to approximately 80º, approximately 10º to approximately 45º, approximately 45º to approximately 80º, approximately 10º to approximately 20º, approximately 20º to approximately 30º, approximately 30º to approximately 40º, approximately 40º to approximately 50º, approximately 50º to approximately 60º, approximately 60º to approximately 70º, or approximately 70º to approximately 80º.

[0105] Figure 4 This is a schematic cross-sectional view of the distal region of a fluid collection assembly 400 according to one embodiment. Unless otherwise stated, the fluid collection assembly may include any aspect of fluid collection assemblies 100 and 300. The fluid collection assembly 400 may include a fluid-impermeable barrier 106 and a porous material 122. In the fluid collection assembly 400, the porous material 122 may be disposed or fixed to a second panel 110 of the fluid-impermeable barrier 106 instead of the first panel 108.

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

[0107] The first portion 444 of port 430 may be attached to the fluid-impermeable barrier 106 using any suitable techniques described above related to port 130. Port 430 (e.g., the first portion 444 and the second portion 446) may include any materials and / or physical properties described above related to port 130. Although in Figure 4Not visible in the foreground, port 430 may include tabs 158a, 158b and / or disks 244a, 244b of ports 130, 230 and their proximal ends. Porous material 122 may be disposed relative to the first portion 444 of port 430 as described in the embodiments of ports 130, 230 above. In some embodiments, the first portion 444 includes a fitting having two tabs 158a, 158b extending from the inlet of the fitting in the first portion 444. The second portion 446 of port 430 may be angled and / or bent from the first portion 444 toward the proximal region of the fluid-impermeable barrier 106. In some embodiments, the second portion 446 is at least partially bent or angled within chamber 112. This configuration of the second portion 446 allows the conduit 142 to be oriented toward the head of the bed (where the vacuum source is typically located) during use, thereby preventing kinking of the conduit 142.

[0108] In some embodiments, a first portion 444 of port 430 may be disposed on the upper surface of porous material 122, and a second portion 446 may be bent or angled within or outside chamber 112 to orient conduit 142 toward the head of the bed. For example, in some embodiments, the first portion 444 may pass through a permeable membrane of porous material 122 and be disposed adjacent to a permeable support (e.g., spun nylon) of porous material 122. In some embodiments, porous material 122 may be disposed adjacent to first panel 108. In these and other embodiments, port 430 may be attached or secured at first panel 108 to fluid-impermeable barrier 106. The first portion 444 of port 430 may be at least partially disposed in chamber 112. The second portion 446 is configured to attach to conduit 142. The first portion 444 defines an inlet, and the second portion 446 defines an outlet of port 430, the outlet of port 430 being downstream of the inlet. Port 430 also defines a passage extending from the inlet to the outlet. The second portion 446 of port 430 may be angled and / or bent from the first portion 444 toward the proximal region of the fluid-impermeable barrier 106. This configuration of the second portion 446 allows the conduit 142 to be oriented toward the bedside (where the vacuum source is typically located) during use, thereby preventing kinking of the conduit 142.

[0109] Figure 5 This is a schematic cross-sectional view of the distal region of a fluid collection assembly 500 according to one embodiment. Unless otherwise stated, the fluid collection assembly may include any aspect of fluid collection assemblies 100, 300, and 400. The fluid collection assembly 500 may include a fluid-impermeable barrier 106 and a porous material 122. In the fluid collection assembly 500, the porous material 122 may be disposed or fixed to a second panel 110 of the fluid-impermeable barrier 106 instead of the first panel 108.

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

[0111] The first portion 544 of port 530 may be attached to the fluid-impermeable barrier 106 using any suitable techniques described above as relating to port 130. Port 530 (e.g., the first portion 544 and the second portion 546) may include any materials and / or physical properties described above as relating to port 130. Although in Figure 4 Not visible in the foreground, port 530 may include tabs 158a, 158b and / or disks 244a, 244b of ports 130, 230 and their proximal ends. Porous material 122 may be disposed relative to the first portion 544 of port 530 as described in the embodiments of ports 130, 230. In some embodiments, the first portion 544 includes a fitting having two tabs 158a, 158b extending from the inlet of the fitting in the first portion 544. The second portion 546 of port 530 may be angled and / or bent from the first portion 544 toward the proximal region of the fluid-impermeable barrier 106. In some embodiments, the second portion 546 is at least partially bent or angled within chamber 112. In some embodiments, port 530 includes an elbow connector 550 rotatably secured to the second portion 546 outside chamber 112. Elbow connector 550 is configured to allow a portion of the second portion 546 to rotate, thereby preventing kinking of the conduit 142 when it is secured to the second portion 546. Elbow connector 550 may be included on the second portion of ports 130, 230, 330, 430 described herein.

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

[0113] Figure 6A This is a flowchart of a method 600 for manufacturing a fluid collection assembly according to one embodiment. Method 600 can be used to manufacture at least some of the fluid collection assemblies and / or fluid collection systems disclosed herein. In one embodiment, method 600 includes action 605: providing a fluid-impermeable barrier, which, according to one embodiment, includes a first panel and a second panel. Method 600 may also include action 610: providing a port, the port including a first portion defining an inlet and a second portion defining an outlet and configured to be attached to a conduit. The first portion may include an upper portion and a lower portion, the inlet being disposed between the upper and lower portions, the upper portion having an upper proximal end, the lower portion having a lower proximal end, the lower proximal end being spaced apart from the upper proximal end. Method 600 may also include action 615: attaching the first panel (e.g., the periphery of the first panel) to the second panel (e.g., the periphery of the second panel) to form a sheath having: (1) a proximal region defining an opening, and (2) a distal region having an upper proximal end and a lower proximal end disposed between the first and second panels on the first portion of the port, the fluid-impermeable barrier at least partially defining a chamber. Method 600 may further include action 620: disposing of at least one porous material in the chamber. In some embodiments, disposing of 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, method 600 further includes the action of rotatably securing the elbow connector to a second portion of the port outside the chamber. The actions of method 600 are for illustrative purposes only and may be performed in different orders, broken down into multiple actions, modified, supplemented, or combined. In one example, one or more actions of method 600 may be omitted from method 600.

[0114] Figure 6BThis is a flowchart of a method 650 for manufacturing a fluid collection assembly according to one embodiment. Method 650 can be used to manufacture at least some of the fluid collection assemblies and / or fluid collection systems disclosed herein. Method 650 includes action 655: providing a fluid-impermeable barrier, according to one embodiment, a first panel and a second panel different from the first panel. Method 650 may also include action 660: providing a port, the port including a first portion defining an inlet and a second portion defining an outlet and configured to attach to a conduit. The first portion may include an upper portion and a lower portion, wherein the inlet is 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 spaced apart from the upper proximal end. Method 650 may further include action 665: attaching a first panel (e.g., the outer periphery of the first panel) to a second panel (e.g., the outer periphery of the second panel) to form a sheath having a proximal region and a distal region defining an opening, wherein a port is disposed in the distal region such that an inlet of a first portion of the port is oriented in the chamber toward the proximal region of a fluid-impermeable barrier, and an outlet of a second portion of the port is inclined or bent from the first portion through the fluid-impermeable barrier toward the proximal region of the fluid-impermeable barrier.

[0115] Method 650 may further include action 670: disposing of at least one porous material in the chamber. In some embodiments, action 670 includes: positioning at least one porous material in the chamber as an inlet at least near a first portion of the port. In some embodiments, step 670 includes disposing of the at least one porous material in the chamber such that the inlet of the first portion of the port is embedded in the at least one porous material. In some embodiments, method 650 may include the action of rotatably securing an elbow connector outside the chamber to a second portion of the port.

[0116] The actions in method 650 are for illustrative purposes only and may be performed in different orders, broken down into multiple actions, modified, supplemented, or combined. In one example, one or more actions of method 650 may be omitted from method 650.

[0117] Figure 7This is a block diagram of a system 707 for fluid collection according to one embodiment. System 707 includes a fluid collection assembly 700, a fluid storage container 709, and a vacuum source 711. The fluid collection assembly 700 may include any fluid collection assembly disclosed herein. The fluid collection assembly 700, the fluid storage container 709, and the vacuum source 711 are fluidly connected to each other via one or more conduits 742. For example, the fluid collection assembly 700 may be operatively connected to one or more of the fluid storage container 709 or the vacuum source 711 via conduits 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 conduits 742 extending into the fluid collection assembly 700. In response to a vacuum force (e.g., a vacuum pressure) applied to the outlet of the conduit 742, a vacuum force may be introduced into the chamber of the fluid collection assembly 700 via the inlet of the conduit 742.

[0118] Vacuum force can be applied directly or indirectly to the outlet of conduit 742 by vacuum source 711. Vacuum force can also be applied indirectly via fluid storage container 709. For example, the outlet of conduit 742 can be located within fluid storage container 709, and an additional conduit 742 can extend from fluid storage container 709 to vacuum source 711. Therefore, vacuum source 711 can apply a vacuum to fluid collection assembly 700 via fluid storage container 709. Vacuum force can also be applied directly by vacuum source 711. For example, the outlet of conduit 742 can be located within vacuum source 711. An additional conduit 742 can extend from vacuum source 711 to a point outside fluid collection assembly 700 (e.g., extending to fluid storage container 709). In such an example, vacuum source 711 can be located between fluid collection assembly 700 and fluid storage container 709.

[0119] The fluid storage container 709 is sized and shaped to hold fluid therein. The fluid storage container 709 may include a bag (e.g., a drainage bag), a bottle or cup (e.g., a collection can), or any other closed container for storing bodily fluids. In some examples, a catheter 742 may extend from the fluid collection assembly 700 and be attached to the fluid storage container 709 at a first point within the fluid storage container 709. An additional catheter 742 may be attached to the fluid storage container 709 at a second point and may extend and be attached to a vacuum source 711. Therefore, a vacuum (e.g., a vacuum) can be drawn through the fluid storage container 709 through the fluid collection assembly 700. The vacuum source 711 can be used to drain fluids such as urine from the fluid collection assembly 700.

[0120] Vacuum source 711 may include one or more of the following: a manual vacuum pump, an electric vacuum pump, a diaphragm pump, a centrifugal pump, a positive displacement pump, a magnetically driven pump, a peristaltic pump, or any pump configured to generate a vacuum. Vacuum source 711 can provide a vacuum or evacuation to remove fluid from fluid collection assembly 700. In some examples, vacuum source 711 may be powered by one or more of the following: a power cord (e.g., connected to a power outlet), one or more batteries, or even a manual power source (e.g., a manually operated vacuum pump). In some examples, the size and shape of vacuum source 711 may be configured to be mounted outside, on, or inside fluid collection assembly 700. For example, vacuum source 711 may include one or more miniature pumps or one or more micro-pumps. Vacuum source 711 disclosed herein may include one or more of the following: a switch, a button, a plug, a remote control, or any other device suitable for activating vacuum source 711.

[0121] It should be noted that the embodiments disclosed above relate to a fluid collection assembly configured to collect bodily fluids from males. However, it should be noted that such a fluid collection assembly can also be used to collect bodily fluids from females, since the female urethral opening is functionally similar to a buried penis.

[0122] While several aspects and implementations have been disclosed herein, other aspects and implementations are conceivable. The various aspects and implementations disclosed herein are for illustrative purposes only and are not intended to be limiting.

[0123] Degree terms (e.g., "about," "basically," "roughly," etc.) indicate a change that is not significant in structure or function. In one example, when a degree term is included with a term indicating quantity, the degree term is interpreted as ±10%, ±5%, or +2% of the term indicating quantity. In one example, when a degree term is used to modify a shape, the degree term indicates that the shape modified by the degree term has the appearance of the disclosed shape. For example, a degree term 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 from it, be oblong, be the same as the disclosed shape, etc.

Claims

1. A fluid collection assembly, comprising: Sheath, which includes: A fluid-impermeable barrier comprising a proximal region and a distal region extending from the proximal region, the proximal region defining an opening, and the fluid-impermeable barrier at least partially defining a chamber; and At least one porous material disposed in the chamber; and A port, disposed in the distal region, the port including a first portion defining an inlet and a second portion defining an outlet, the outlet being configured to attach to a conduit, wherein the first portion includes an upper portion and a lower portion, wherein the inlet is disposed between the upper portion and the lower portion, the upper portion having an upper proximal end, the lower portion having a lower proximal end, the lower proximal end being spaced apart from the upper proximal end.

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

3. The fluid collection assembly according to claim 1, wherein, The first portion of the port includes: Upper disk, including the upper proximal end; The lower disk includes the lower proximal end; and One or more opposing supports extend between the upper disk and the lower disk, such that the upper disk and the lower disk are spaced apart from each other.

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

5. The fluid collection assembly according to any one of claims 1 to 4, wherein, The fluid-impermeable barrier includes a first panel and a second panel, wherein at least one porous material is disposed between the first panel and the second panel, and the upper proximal end and the lower proximal end of the first portion of the port are disposed between the first panel and the second panel.

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

7. The fluid collection assembly according to any one of claims 1 to 5, wherein, The second portion slopes from the first portion toward the proximal region of the sheath.

8. The fluid collection assembly according to any one of claims 1 to 5, wherein, The second portion extends through the fluid-impermeable barrier, and the fluid collection assembly includes an elbow connector that is rotatably fixed to the second portion outside the chamber.

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

10. The fluid collection assembly according to any one of claims 1 to 5, wherein, The first portion is an elongated shape generally perpendicular to the longitudinal axis of the fluid collection assembly, and includes rounded edges and corners on all edges and corners of the first portion, wherein the second portion slopes from the first portion toward the proximal region of the sheath.

11. The fluid collection assembly according to any one of claims 1 to 5, wherein, The first portion is an elongated shape generally perpendicular to the longitudinal axis of the fluid collection assembly, and includes rounded edges and corners on all edges and corners of the first portion. The second portion extends through the fluid-impermeable barrier, and the fluid collection assembly includes an elbow connector rotatably fixed to the second portion outside the chamber.

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

13. A fluid collection assembly, comprising: Sheath, which includes: A fluid-impermeable barrier comprising a proximal region and a distal region extending from the proximal region, the proximal region defining an opening, and the fluid-impermeable barrier at least partially defining a chamber; and At least one porous material disposed in the chamber; and A port, disposed in the distal region, includes a first portion and a second portion, the first portion defining an inlet oriented toward the proximal region of the fluid-impermeable barrier, the second portion defining an outlet configured to attach to a conduit, wherein the first portion includes an upper portion and a lower portion, wherein the inlet is disposed between the upper portion and the lower portion, the upper portion having an upper proximal end, the lower portion having a lower proximal end spaced apart from the upper proximal end, and the second portion extending proximally from the first portion toward the proximal region of the fluid-impermeable barrier.

14. The fluid collection assembly of claim 13, wherein, The at least one porous material is positioned at least near the inlet of the first portion of the port.

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

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

17. The fluid collection assembly according to any one of claims 13 to 16, wherein, The second portion extends through the fluid-impermeable barrier, and the fluid collection assembly includes an elbow connector that is rotatably fixed to the second portion outside the chamber.

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

19. The fluid collection assembly according to any one of claims 13 to 18, wherein, The second portion slopes and / or bends from the first portion toward the proximal region of the fluid-impermeable barrier.

20. A system comprising: The fluid collection assembly according to any one of claims 1 to 19; A vacuum source configured to apply a vacuum force; Fluid storage containers; as well as At least one conduit is connected to the outlet and is in fluid communication with the vacuum source and the fluid storage container.

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

22. The method according to claim 20, wherein, Providing 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 according to claim 20 or 21, further comprising: The elbow connector is rotatably fixed to the second part of the port from the outside of the chamber.

24. A method of manufacturing a fluid collection assembly, the method comprising: Provides a fluid-impermeable barrier, a first panel, and a second panel different from the first panel; A port is provided, the port including a first portion defining an inlet and a second portion defining an outlet, the outlet being configured to be attached to a conduit, wherein the first portion includes an upper portion and a lower portion, wherein the inlet is disposed between the upper portion and the lower portion, the upper portion having an upper proximal end, the lower portion having a lower proximal end, the lower proximal end being spaced apart from the upper proximal end; The first panel is attached to the second panel to form a sheath having a proximal region and a distal region, the proximal region defining an opening, wherein a port is disposed in the distal region such that the inlet of the first portion of the port is oriented in the chamber toward the proximal region of the fluid-impermeable barrier, and the outlet of the second portion of the port extends proximally from the first portion through the fluid-impermeable barrier toward the proximal region of the fluid-impermeable barrier. as well as At least one porous material is disposed within the cavity.

25. The method according to claim 23, wherein, Providing at least one porous material in the chamber includes: positioning the at least one porous material in the chamber at least close to the inlet of the first portion of the port.

26. The method according to claim 24, wherein, The inlet arrangement in the chamber, which brings the at least one porous material at least close to the first portion of the port, comprises: disposing the at least one porous material in the chamber such that the inlet of the first portion of the port is embedded in the at least one porous material.

27. The method according to any one of claims 23 to 25, further comprising: The elbow connector is rotatably fixed to the second part of the port from the outside of the chamber.

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