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

Abstract

An exemplary fluid collection assembly includes a sheath including a chamber and a fluid permeable body disposed in the chamber. The sheath includes a fluid impermeable barrier including a proximal end region, a distal end region, a first panel, a second panel attached to the first panel and defining an opening at the proximal end region of the fluid impermeable barrier, and a fluid outlet at the distal end region. The fluid permeable body includes a fluid permeable support and a fluid permeable membrane. The fluid permeable membrane comprises a wicking material and is arranged such that the fluid permeable membrane is arranged to contact the penis within the chamber when the penis passes through the opening.

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. The sheath includes a fluid-impermeable barrier, the fluid-impermeable barrier including a proximal region, a distal region extending from the proximal region, a first panel, a second panel, and a fluid outlet located in the distal region, the second panel being attached to the first panel and defining an opening in the proximal region of the fluid-impermeable barrier, the opening being sized to receive at least a portion of the penis through the opening. The fluid-impermeable barrier at least partially defines a chamber. The fluid collection assembly includes a fluid-permeable body disposed in the chamber. The fluid-permeable body includes a fluid-permeable support and a fluid-permeable membrane, the fluid-permeable membrane including a wicking material. The fluid-permeable membrane is configured such that the fluid-permeable support is located between the fluid-permeable membrane and one of the first panel or the second panel. 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 cavity). The fluid-permeable membrane is configured to contact the penis within the cavity when the penis extends through the opening. The fluid collection assembly also includes a port extending through the fluid outlet. The port includes a first portion defining an inlet located adjacent to the fluid-permeable support such that the fluid-permeable membrane is not present between the inlet and the fluid-permeable support. The port includes a second portion defining an outlet located outside the cavity and configured to attach to a catheter.

[0007] In one embodiment, a method of manufacturing a fluid collection assembly includes: providing a fluid-impermeable barrier including a first panel and a second panel, the second panel defining an opening. The opening is sized to receive at least a portion of a penis passing through it. The method further includes: attaching the outer periphery of the first panel to the outer periphery of the second panel to form a sheath having a proximal region including the opening, a distal region extending from the proximal region, and a fluid outlet located in the distal region, the fluid-impermeable barrier at least defining a chamber. The method further includes: disposing a fluid-permeable body having a fluid-permeable support and a fluid-permeable membrane including a wicking material within the chamber, such that the fluid-permeable membrane is configured to contact the penis within the chamber when the penis extends through the opening, and a port extends through the fluid outlet, wherein a first portion of the port defines an inlet disposed adjacent to the fluid-permeable support such that the fluid-permeable membrane is absent between the inlet and the fluid-permeable support, and a second portion of the port defines an outlet located outside the chamber and configured to connect to a conduit.

[0008] 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

[0009] 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.

[0010] Figure 1A and Figure 1B These are, respectively, isometric top and bottom views of a fluid collection assembly according to one embodiment.

[0011] Figure 1C and Figure 1D These are schematic cross-sectional views of the fluid collection assembly taken along the 1C-1C plane and the 1D-1D plane according to any embodiment.

[0012] Figure 1E yes Figure 1A An exploded isometric view of the fluid collection assembly shown.

[0013] Figure 2A This is an isometric top view of a fluid collection assembly according to one embodiment.

[0014] Figure 2B and Figure 2CThese are schematic cross-sectional views of a fluid collection assembly taken along the 2B-2B plane and the 2C-2C plane, respectively, according to one embodiment.

[0015] Figure 2D According to one embodiment Figure 2A An exploded isometric view of the fluid collection assembly shown.

[0016] Figure 2E This is a cross-sectional schematic diagram of a fluid collection assembly according to one embodiment.

[0017] Figure 3 This is a block diagram of a system for fluid collection according to one embodiment.

[0018] Figure 4 This is a flowchart of a method for collecting fluid according to one embodiment. Detailed Implementation

[0019] 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, a fluid-permeable body, and a base. The sheath includes a fluid-impermeable barrier having a proximal region and a distal region extending from the proximal region. The proximal region defines an opening, and the distal region defines a fluid outlet. The fluid-impermeable barrier at least partially defines a chamber. In some embodiments, the fluid-permeable body (e.g., a porous material) is disposed within the chamber. The fluid-permeable body may include a fluid-permeable support and a fluid-permeable membrane. The fluid-permeable membrane includes a wicking material and is disposed adjacent to (e.g., fixed to) the fluid-permeable support such that the fluid-permeable membrane is configured to contact the penis within the chamber when the penis extends through the opening. The fluid-permeable membrane and the fluid-impermeable barrier of the sheath can close over two sides of the fluid-permeable support, thereby preventing or inhibiting the escape of air and vacuum through the matrix. The fluid collection assembly may further include a conduit having an inlet disposed in the chamber adjacent to the fluid permeable through a support. The 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 orifice aligned 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, wherein the orifice is located above the penis.

[0020] The fluid-permeable membrane includes a wicking material and is disposed adjacent to (e.g., fixed to) the fluid-permeable support such that the fluid-permeable membrane is configured to contact the penis within the cavity when the penis extends through the opening. This configuration of the fluid-permeable membrane to contact the penis produces the following technical effects: providing a more comfortable contact for the penis and enabling more effective vacuum-assisted wicking. The fluid-impermeable barrier of the fluid-permeable membrane and the sheath can close on the sides of the fluid-permeable support, thereby inhibiting or preventing the escape of air and vacuum through the matrix. This configuration of the fluid-permeable support and the fluid-permeable membrane produces the following technical effects: more efficient removal of fluid from the cavity by allowing fluid in the fluid-permeable support to be drawn into the catheter, even when the inlet of the catheter is upward relative to the rest of the fluid-permeable support.

[0021] Example methods of using the fluid collection assembly include: 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 (e.g., in the case of an unimpregnated penis) or adjacent to an orifice defined by the base (e.g., in the case of an impregnated 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, blood, 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, wound care devices, ostomy bags, etc.

[0022] 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 1EThis 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. In some embodiments, the fluid-impermeable barrier 106 is formed from the first and second panels integrally molded together (e.g., presenting a single-piece structure). 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 a fluid-permeable body, which includes a fluid-permeable support 122 and a fluid-permeable membrane 123 disposed within the chamber 112. The base 104 includes an orifice 124. The base 104 is attached to the proximal region 160 of the fluid-impermeable barrier 106, such that the orifice 124 is aligned with the opening 114.

[0023] 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.

[0024] 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.

[0025] In one embodiment, the fluid-impermeable barrier 106 is formed of polyurethane, for example, solely of polyurethane. Forming the fluid-impermeable barrier 106 with polyurethane can improve the functionality of the fluid collection assembly 100. For example, the fluid-impermeable barrier 106, when formed of polyurethane, can exhibit greater flexibility than when formed of other materials. The increased flexibility of the polyurethane-formed fluid-impermeable barrier 106 makes it easier to attach the fluid collection assembly 100 to and maintain attachment to the individual. The increased flexibility of the polyurethane-formed fluid-impermeable barrier 106 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, thus 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.

[0026] 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 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). At least one of the first panel 108 or the second panel 110 is formed of a fluid-impermeable material that allows for penile examination 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 fluid-permeable body (e.g., a fluid-permeable membrane 123) 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, a fluid-permeable body (e.g., a fluid-permeable membrane 123) may be disposed in the chamber 112 such that when the penis is inserted into the chamber 112 through the opening 114, the fluid-permeable body 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 fluid-permeable body is generally opaque, so the portion of the at least partially transparent material of the first panel 108 and / or the second panel 110 defining the penis receiving area 131 forms a window, thereby allowing a person to observe the penis receiving area 131 and examine the penis.

[0027] 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 fluid-permeable body is located between the penis receiving area 131 and at least a portion of the first panel 108. This embodiment helps 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 near 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 fluid-permeable body 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 fluid-permeable body 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 fluid-permeable body 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.

[0028] As previously described, at least a portion of the first panel 108 and at least a portion of the second panel 110 are 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 an embodiment, the first panel 108 and the second panel 110 are attached using any suitable technique, such as adhesive, 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. In some embodiments, the first panel 108 and the second panel 110 are formed integrally together (e.g., presenting a single-piece structure).

[0029] In one embodiment, the fluid-impermeable barrier 106 defines one or more orifices 132 extending therethrough. In one embodiment, the sheath 102 includes one or more vents 134 attached to the fluid-impermeable barrier 106, the one or more vents 134 extending across the one or more orifices 132. The vents 134 are configured to allow air to flow through 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 can be provided to the chamber 112 by a vacuum source. The vacuum can draw air through the vents 134, thereby causing air to flow from the vents 134 to 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.

[0030] The vent 134 may comprise a porous hydrophobic material. In some embodiments, the vent 134 may be covered with a hydrophilic material (e.g., a wicking material). A vacuum prevents liquid from leaving the fluid collection assembly 100 through the vent 134 (especially in humid conditions), while air can still enter the fluid collection assembly 100 through the vent 134. In some embodiments, the vent may also be completely uncovered. The pores defined by the porous hydrophobic material may be interconnected, thereby allowing air to flow through the vent 134. The hydrophobic properties of the porous hydrophobic material prevent water from flowing through the vent 134. In one example, the average pore size (e.g., the average maximum lateral dimension of the pores) of the porous hydrophobic material can be selected as about 1 μm or greater, about 5 μm or greater, about 10 μm or greater, about 20 μm or greater, about 30 μm or greater, about 40 μm or greater, about 50 μm or greater, about 60 μm or greater, about 80 μm or greater, about 100 μm or greater, about 125 μm or greater, about 150 μm or greater, about 175 μm or greater, about 200 μm or greater, about 250 μm or greater, about 300 μm or greater, about 400 μm or greater, about 500 μm or greater, about 1 mm or less, about 750 μm or less, about 500 μm or less, or about 1 μm to about 10 μm, about 5 μm to about 20 μm, about 10 μm to about 30 μm, about 20 μm to about 40 μm. The range is approximately 1 μm, approximately 30 μm to approximately 50 μm, approximately 40 μm to approximately 60 μm, approximately 50 μm to approximately 80 μm, approximately 60 μm to approximately 100 μm, approximately 80 μm to approximately 125 μm, approximately 100 μm to approximately 150 μm, approximately 125 μm to approximately 175 μm, approximately 150 μm to approximately 200 μm, approximately 175 μm to approximately 250 μm, approximately 200 μm to approximately 300 μm, approximately 250 μm to approximately 400 μm, approximately 300 μm to approximately 500 μm, approximately 400 μm to approximately 750 μm, or approximately 500 μm to approximately 1 mm. In one example, the contact angle between the porous hydrophobic material and water can be greater than 90°, for example, in the range of about 90° to about 110°, about 100° to about 120°, about 110° to about 130°, about 120° to about 140°, about 130° to about 150°, about 140° to about 160°, about 150° to about 170°, or about 160° to 180°. Typically, the pore size depends on the hydrophobicity of the porous hydrophobic material, and vice versa. For example, increasing the hydrophobicity of the porous hydrophobic material allows for an increase in pore size.

[0031] In one embodiment, the vent 134 may comprise a porous polytetrafluoroethylene (“PTFE”) layer. Porous PTFE layers are considered highly effective in allowing air to flow through while preventing water flow, even when exposed to acidic body fluids. However, porous PTFE is difficult to weld to other materials, such as polyurethane. Therefore, the porous PTFE layer may be attached to a substrate. The substrate may comprise a porous material or define one or more channels therethrough. The substrate may be selected to facilitate attachment 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.

[0032] 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.

[0033] 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.

[0034] In one embodiment, the orifice 132 and vent 134 may be elongated. In one example, the orifice 132 and vent 134 located at or near the top edge 136 may be elongated, generally parallel to the top edge 136 and / or generally perpendicular to the longitudinal axis 140 of the fluid collection assembly 100. In such an example, the elongated shape of the orifice 132 and vent 134 allows air to preferentially flow through a larger proportion of the chamber 112 compared to when the orifice 132 and vent 134 are not elongated and / or are oriented differently. In one example, the orifice 132 and vent 134 located at or near the side edge 138 may be elongated, generally parallel to the side edge 138 and / or generally parallel to the longitudinal axis 140 of the fluid collection assembly 100. In such an example, the elongated shape of the orifice 132 and vent 134, compared to when the orifice 132 and vent 134 are not elongated and / or are oriented differently, allows air to preferentially flow through a larger proportion of the chamber 112 (e.g., a portion of the adjacent side edge 138 of the chamber 112).

[0035] 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 is formed in and extends 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.

[0036] In one embodiment, the second panel 110 defines the entire opening 114. For example, the opening 114 is 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.

[0037] 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.

[0038] 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. For example, the substantially constant first width maintains contact with the upper thigh of the individual, thereby holding the fluid collection assembly 100 in place. Furthermore, the substantially constant first width makes it easier for the penis to become erect because the substantially constant first width inhibits the sheath 102 from falling between the individual's thighs and inhibits the erection of the penis from lifting the portion of the sheath 102 that has fallen between the thighs. The reduced second width makes the sheath 102 thinner, allowing the portion of the sheath 102 that is less likely to receive the penis to fall between the individual's thighs. This descent allows gravity-assisted movement of the fluid toward fluid outlet 118. The reduced second width also directs the fluid toward fluid outlet 118 and port 130.

[0039] 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 causes the side edge 138 of the fluid-impermeable barrier 106 defining the distal region 162 to be straight. 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.

[0040] 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.

[0041] Fluid is impermeable to barrier 106, which defines fluid outlet 118. Fluid outlet 118 may be formed from the unattached portions of the first panel 108 and the second panel 110. In one embodiment (not shown), fluid outlet 118 is configured to be directly attached to conduit 142. In such an embodiment, conduit 142 may be at least partially disposed in chamber 112, or otherwise in fluid communication with chamber 112 via fluid outlet 118. The size and shape of fluid outlet 118 may be configured to form at least a substantially fluid seal with conduit 142, thereby substantially preventing the leakage of bodily fluids from chamber 112. Conduit 142 may be attached to fluid outlet 118 using adhesives, welding, interference fits, or friction fits (e.g., to the first panel 108 and the second panel 110), or otherwise combined with fluid outlet 118. Attaching conduit 142 to fluid outlet 118 prevents leakage and prevents unintentional detachment of conduit 142 from fluid outlet 118. In one example, conduit 142 may be attached to fluid outlet 118 in the same manufacturing step as attaching the first panel 108 and the second panel 110 together. In one embodiment, as shown, fluid outlet 118 is configured to be indirectly attached to conduit 142. In such an embodiment, sheath 102 may include port 130, which is directly attached to fluid-impermeable barrier 106 and configured to be attached to conduit 142.

[0042] As previously described, the sheath 102 also includes a fluid-permeable body comprising a fluid-permeable support 122 and a fluid-permeable membrane 123 disposed within the chamber 112. At least one of the fluid-permeable support 122 and / or the fluid-permeable membrane 123 can guide bodily fluids to one or more selected areas of the chamber 112, such as an inlet 130a away from the penis and toward the fluid outlet 118 and / or port 130. Thus, the fluid-permeable support 122 and the fluid-permeable membrane 123 can facilitate the removal of bodily fluids from the chamber 112. The fluid-permeable membrane 123 is configured to contact the penis within the chamber 112 when the penis passes through the openings 114 / 124. Therefore, in some embodiments, the fluid-permeable support 122 may be located between and bordering the fluid-permeable membrane 123 and one of the first panel 108 or the second panel 110 of the fluid-impermeable barrier 106. The fluid-permeable membrane 123 and / or the fluid-permeable support 122 can also slow down the flow of urine from the penis.

[0043] In one embodiment, fluid may be wicked through support 122, comprising a wicking material configured to wick bodily fluid away from opening 114, thereby preventing fluid from escaping from chamber 112. Such "wicking" may not include the adsorption of fluid into the wicking material. In other words, there is essentially no fluid adsorbed into the material after it has been exposed to and removed from the fluid for a period of time. While adsorption is undesirable, the term "essentially no adsorption" allows a nominal amount of fluid to be adsorbed into the wicking material (e.g., adsorbent), 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 chamber 112, as will be discussed in more detail below. In one embodiment, fluid can be configured through support 122 to adsorb or absorb bodily fluids. Similar to wicking materials, such adsorbing or absorbing materials can remove bodily fluids from opening 114, thereby preventing bodily fluids from escaping from chamber 112.

[0044] The fluid-permeable support 122 may be formed of any suitable porous material. For example, the fluid-permeable support 122 may be formed of nylon (e.g., spun nylon fibers), polyester, polyurethane, polyethylene, polypropylene, other porous polymers, hydrophobic foam, open-cell foam, wool, silk, linen, cotton (e.g., cotton gauze), felt, other fabrics, coated porous materials (e.g., waterproof coating porous materials), any other suitable porous materials, or combinations thereof.

[0045] In some embodiments (not shown), the fluid-permeable support 122 includes a first layer and a second layer, the second layer comprising a textile material. The fluid-permeable support 122 may also include a plurality of fibers forming a layer between the first and second layers of the fluid-permeable support 122. Each of the first layer, the second layer, and the plurality of fibers of the fluid-permeable support 122 may define a plurality of pores, thereby allowing the transport of bodily fluids and the circulation of air through the fluid-permeable support 122. The pores defined by the plurality of fibers may be at least one of being larger or more numerous, thereby reducing the likelihood of dried bodily fluids clogging the fluid-permeable support 122. The plurality of fibers in the fluid-permeable support 122 also prevent the porous material from collapsing due to vacuum forces.

[0046] The first layer, second layer, and plurality of fibers of the fluid-permeable support 122 can be formed of any suitable material, such as hydrophobic materials, hydrophilic materials, polyester, cotton, or any other porous material disclosed herein. In one embodiment, one or more of the first layer, second layer, or plurality of fibers of the fluid-permeable support 122 are formed of a hydrophobic material, which inhibits the storage of bodily fluids in the fluid-permeable support 122, thereby facilitating the removal of bodily fluids from the chamber 112. In one embodiment, one or more of the first layer, second layer, or plurality of fibers of the fluid-permeable support 122 are formed of a hydrophilic material, which allows the fluid-permeable support 122 to temporarily store bodily fluids therein, thereby limiting the amount of bodily fluids accumulating around the individual's skin. In one embodiment, two or more of the first layer, second layer, or plurality of fibers of the fluid-permeable support 122 are formed of different materials. According to one embodiment, the first layer may be formed of a hydrophobic material, while the plurality of fibers may be formed of a hydrophilic material. This configuration allows bodily fluids to be drawn through the first layer and temporarily stored in multiple fibers of the fluid-permeable support 122. However, due to the hydrophobicity of the first layer, it remains essentially dry, thus allowing fluids to permeate through the support 122 and providing a dry sensation to the penis.

[0047] In such an embodiment, the fluid-permeable membrane 123 may define the penile receiving region 131, or otherwise be closer to the penile receiving region 131 than the fluid-permeable support 122. The composition and / or structure of the fluid-permeable membrane 123 may be configured to draw bodily fluids away from the core of the penile receiving region 131, thereby minimizing the amount of bodily fluids present in the penile receiving region 131 or on the individual's skin. It should also be noted that the fluid-permeable membrane 123 may also be configured to adsorb or absorb bodily fluids to minimize the amount of bodily fluids present in the penile receiving region 131 or on the individual's skin. The fluid-permeable membrane 123 may be formed from any porous material disclosed herein. For example, the fluid-permeable membrane 123 may be formed from fabrics, such as gauze (e.g., silk, linen, or cotton gauze), other soft fabrics, other smooth fabrics, woven or non-woven materials (e.g., spun nylon fibers), or any other suitable porous material. A fluid-permeable membrane 123, formed from gauze, soft fabric, and / or smooth fabric (or any other porous material disclosed herein that may come into contact with the penis), can reduce friction caused by the fluid collection assembly 100.

[0048] Since the fluid-permeable membrane 123 can be formed of a relatively foldable, fragile, or otherwise easily deformable material, the fluid-permeable support 122 is configured to support the fluid-permeable membrane 123. For example, the fluid-permeable support 122 can be configured to be positioned between the fluid-permeable membrane 123 and the fluid-impermeable barrier 106. In this way, the fluid-permeable support 122 can support and maintain the position of the fluid-permeable membrane 123. Figure 1A-1E In the illustrated fluid collection assembly, a fluid-permeable support 122 is disposed adjacent to (e.g., fixed to) a first panel 108, such that the fluid-permeable support 122 is located between a fluid-permeable membrane 123 and the first panel 108. The fluid-permeable membrane 123 may be configured to typically contact the penis on the opposite side of openings 114 / 124 within chamber 112 when the penis passes through openings 114 / 124, wherein the penis is located between the fluid-permeable membrane 123 and a second panel 110. The fluid-permeable support 122 may be formed of any fluid-permeable material that is less deformable than the fluid-permeable membrane 123. For example, the fluid-permeable support 122 may comprise a porous polymer structure (e.g., nylon, polyester, polyurethane, polyethylene, polypropylene, etc.) or an open-cell foam. In some examples, the fluid-permeable support 122 may be formed of natural materials such as cotton, wool, silk, or combinations thereof. In such examples, the material may have a coating to prevent or limit fluid adsorption into the material, such as a waterproofing coating.

[0049] Examples of other materials that can form fluid-permeable support 122 are disclosed in U.S. Provisional Patent Application No. 63 / 134,754, filed January 7, 2021; U.S. Provisional Patent Application No. 63 / 241,575, filed September 8, 2021; and U.S. Provisional Patent Application No. 63 / 247,491, filed September 23, 2021, the disclosures of which are incorporated herein by reference in their entirety.

[0050] In one embodiment, the fluid-permeable support 122 and / or the fluid-permeable membrane 123 may be sheets (e.g., multilayer sheets). The fluid-permeable support 122 and / or the fluid-permeable membrane 123 is a sheet when it satisfies at least one of the following: is generally planar when placed on a flat surface, does not define a cavity (e.g., is not tubular), or has a length and width greater than its thickness. Forming the fluid-permeable support 122 and / or the fluid-permeable membrane 123 as a sheet facilitates the manufacture of the fluid collection assembly 100. For example, forming the fluid-permeable support 122 and / or the fluid-permeable membrane 123 as a sheet makes the first panel 108, the second panel 110, and the fluid-permeable support 122 each a sheet. During the manufacturing process of the fluid collection assembly 100, the first panel 108, the second panel 110, the fluid-permeable support 122, and / or the fluid-permeable membrane 123 may be stacked and then attached to each other in the same manufacturing step. For example, the fluid-permeable support 122 and / or the fluid-permeable membrane 123 may have the same dimensions 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 may be attached together along their outer edges (e.g., top edge 136 and side edge 138), and the fluid-permeable support 122 and / or the fluid-permeable membrane 123 may also be attached to the first panel 108 and the second panel 110. The fluid-permeable support 122 and / or the fluid-permeable membrane 123 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 fluid-permeable support 122 and / or the fluid-permeable membrane 123, thereby preventing the fluid-permeable support 122 and / or the fluid-permeable membrane 123 from forming a channel through the fluid-impermeable barrier 106 (through which bodily fluids may leak). Furthermore, attaching the fluid-permeable support 122 and / or the fluid-permeable membrane 123 to the first panel 108 and / or the second panel 110 prevents significant movement of the fluid-permeable support 122 and / or the fluid-permeable membrane 123 within the chamber 112, for example, preventing the fluid-permeable support 122 and / or the fluid-permeable membrane 123 from accumulating near the fluid outlet 118. In one example, the fluid-permeable support 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 fluid-permeable support 122 and / or the fluid-permeable membrane 123 may be disposed solely within the chamber 112 without attaching the fluid-permeable support 122 and / or the fluid-permeable membrane 123 to at least one of the first panel 108 or the second panel 110.In one embodiment, the fluid-permeable support 122 and / or the fluid-permeable membrane 123 may take on shapes other than sheets, such as hollow, generally cylindrical shapes.

[0051] The fluid-permeable support 122 and / or the fluid-permeable membrane 123 may have a shape substantially corresponding to the fluid-impermeable barrier 106, such that the fluid-permeable support 122 and / or the fluid-permeable membrane 123 partially or substantially completely occupy the entire chamber 112. For example, as shown, the fluid-permeable support 122 and / or the fluid-permeable membrane 123 may have a generally bullet-shaped form. The fluid-permeable support 122 and / or the fluid-permeable membrane 123 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 fluid-permeable support 122 and / or the fluid-permeable membrane 123 may also take on shapes other than a generally bullet-shaped form, such as a generally rectangular shape, a generally semi-elliptical shape, or any other suitable shape.

[0052] 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 fluid-permeable support 122 and / or the fluid-permeable membrane 123 may be sheet material, 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 fluid-permeable support 122 and / or the fluid-permeable membrane 123 may form a slight bulge in the sheath 102 based on the thickness of the fluid-permeable support 122 and / or the fluid-permeable membrane 123, 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.

[0053] 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 penises, 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, fluid can extend across the orifice through the membrane 123 and is very close to the buried penis. Thus, the fluid permeable support 122 and / or the fluid permeable membrane 123 prevent or inhibit the accumulation of bodily fluids drained from the buried penis on the individual's skin, because the fluid permeable support 122 and / or the fluid permeable membrane 123 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.

[0054] When the sheath 102 is substantially flat, the fluid-permeable support 122 and / or the fluid-permeable membrane 123 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 fluid-permeable support 122 and / or the fluid-permeable membrane 123. When the fluid-permeable support 122 and / or the fluid-permeable membrane 123 substantially occupy the entire chamber 112, bodily fluids discharged into the chamber 112 are unlikely to accumulate over a longer period of time, as accumulation of bodily fluids can lead to hygiene problems, odor, and / or keep the individual's skin in contact with bodily fluids, resulting in discomfort and skin degeneration.

[0055] As previously described, the first panel 108, the second panel 110, the fluid-permeable support 122, and / or the fluid-permeable membrane 123 may be selected to be relatively flexible. The first panel 108, the second panel 110, the fluid-permeable support 122, and / or the fluid-permeable membrane 123 are relatively flexible when they cannot maintain their shape when unsupported. The flexibility of the first panel 108, the second panel 110, the fluid-permeable support 122, and / or the fluid-permeable membrane 123 allows the sheath 102 to be substantially flat as described above. The flexibility of the first panel 108, the second panel 110, the fluid-permeable support 122, and / or the fluid-permeable membrane 123 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 fluid may accumulate.

[0056] return Figure 1D The fluid-permeable support 122 may include a first surface intersecting with the first panel 108, a second surface opposite the first surface and intersecting with the fluid-permeable membrane 123, and two side surfaces extending between the first and second surfaces. At least one of the fluid-permeable membrane 123, the first panel 108, or the second panel 110 may cover the two side surfaces of the fluid-permeable support 122 such that the fluid-permeable support 122 is generally not exposed within the chamber 122 (e.g., substantially the entire fluid-permeable support 122 is covered within the chamber 112 by the first panel 108, the second panel 110, and / or the fluid-permeable membrane 123). This configuration prevents air from escaping through the fluid-permeable support 122 and instead directs almost all suction to draw fluid through the fluid-permeable membrane 123 into the permeable support 122, and subsequently to the inlet 130a for removal from the chamber.

[0057] As previously described, the fluid collection assembly 100 includes a base 104 configured to connect to and allow placement of the penis through the skin surrounding the penis (e.g., mons pubis, thigh, testis, and / or perineum). For example, the base 104 may define an orifice 124 configured to allow placement of the penis through it. The base 104 may be flexible, allowing it to conform to any shape of the skin surface and reducing strain on the skin surface. The base 104 is configured to attach to a region surrounding the penis (e.g., mons pubis) but not to the thigh, as attaching the base 104 to the thigh could cause uncomfortable strain 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.

[0058] 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.

[0059] 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.

[0060] 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.

[0061] 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.

[0062] 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.

[0063] Port 130 includes a first portion disposed within fluid collection assembly 100 and a second portion disposed outside fluid collection assembly 100. Therefore, port 130 may extend through fluid outlet 118. For example, the first portion of port 130 may optionally be at least partially disposed within chamber 112. The second portion is configured to attach to conduit 142 (e.g., a fitting) in fluid communication with a vacuum source or pump. The first portion defines inlet 130a, and the second portion defines outlet 130b of port 130 downstream of inlet 130a. Port 130 also defines a channel or conduit extending from inlet 130a to outlet 130b. Inlet 130a may be disposed in a distal region 172 of fluid-permeable support 122.

[0064] In some embodiments, inlet 130a is positioned at least adjacent to fluid-permeable support 122, and no fluid-permeable membrane 123 exists between inlet 130a and fluid-permeable support 122. For example, inlet 130a may be oriented to intersect with a portion of fluid-permeable support 122. In some embodiments, fluid-permeable support 122 includes an opening or recess configured to receive inlet 130a therein, such that inlet 130a is adjacent to or intersectes with fluid-permeable support 122, while inlet does not intersect with fluid-permeable membrane 123. In some embodiments, inlet 130a is disposed on a sidewall of a first portion of port 130, and the first portion of port 130 includes a covered end 130c disposed adjacent to fluid-permeable membrane 123.

[0065] In some embodiments (not shown), an inlet 130a is located at the end of port 130 and is situated on the upper surface of the fluid-permeable support 122 at the junction with the first panel 108. In other words, port 130 may extend through the first panel 108 such that inlet 130a is positioned on the surface of the fluid-permeable support at the junction with the first panel 108. In these and other embodiments, port 130 may include a disc disposed near inlet 130a, and the disc may be located between the fluid-permeable support 122 and the first panel 108. Alternatively, the disc may be fixed to the outer surface of the first panel 108, with inlet 130 aligned with outlet 108. In these and other embodiments, a distal region 172 of the fluid-permeable support 122 may extend to the distal junction or seal between the first panel 108 and the second panel 110, and a fluid-permeable membrane 123 terminates before the distal junction of the first panel 108 and the second panel 110. The distal region 162 of the fluid-impermeable barrier 106 may consist only of a fluid-permeable support 122 directly disposed (e.g., fixed) between the first panel 108 and the second panel 110, and the fluid-permeable membrane 123 may not be present in the distal region 162 of the fluid-impermeable barrier 106. The distal end of the fluid-permeable membrane 123 may be fixed to the second panel 110, and the fluid-permeable support 122 may extend distally beyond the distal end of the fluid-permeable membrane 123.

[0066] In some implementations, port 130 may be configured similarly to port 280 (shown in...). Figure 2EThe inlet 280a is positioned at the end of the first portion of the port 280, and the fluid-permeable end 172a of the support 122 in the distal region 172 is positioned therethrough. The first panel 108 and the second panel 110 may be sealed or attached such that the fluid-permeable end 172a of the support 123 in the distal region 172 only intersects with the fluid-impermeable barrier 106 and the inlet 280a (e.g., the end 172a is not exposed in the chamber 112).

[0067] By positioning the inlet 130a adjacent to or at the interface of the fluid-permeable support 122, and by eliminating the presence of a fluid-permeable membrane 123 between the inlet 130a and the fluid-permeable support 122, the technical effect of improving fluid transport from the fluid-permeable support 122 into the inlet port 130 for removal from the chamber 112 is achieved. In some embodiments, at least a second portion of the port 130 is inclined and / or bent relative to the longitudinal axis of the fluid collection assembly from the first portion toward the proximal region 160 of the fluid-impermeable barrier 106. In the fluid collection assembly 100, the port 130 is generally inclined from the inlet 130a via the fluid outlet 118 and at least partially toward the proximal region 160 of the fluid-impermeable barrier 106. The orientation and configuration of the port 130 result in reduced kinking that may occur in the conduit 142 attached to the port 130, and allow the conduit 142 to be oriented toward the bedside where the fluid collection tank may be placed. This allows for the use of fewer vacuum lines (e.g., conduit 142) and also reduces the lifting of the bottom of the fluid collection assembly 100, which improves fluid flow within the fluid collection assembly.

[0068] See you again Figure 1A-1D 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.

[0069] 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 at least one foot, at least two feet, at least three feet, or at least six feet or longer. 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.

[0070] 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 3 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.

[0071] 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.

[0072] During operation, a male using the fluid collection assembly 100 may discharge bodily fluids (e.g., urine) into chamber 112. The fluids may accumulate or otherwise be collected in chamber 112 (e.g., fluid may be received through support 122). At least a portion of the fluids may be aspirated through the interior of conduit 142 via an inlet. The 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, vent 134 maintains the pressure in chamber 112 substantially at atmospheric pressure.

[0073] In some embodiments, the fluid-permeable support 122 and the fluid-permeable membrane 123 may be disposed on or fixed to the second panel 110 (e.g., a panel or side thereof including components comprising fluid openings 114 / 124). See also Figure 2A-2D , Figure 2AIt is an isometric top view of the fluid collection assembly, wherein the fluid permeable support 122 and the fluid permeable membrane 123 are disposed on or fixed to the second panel 110. Figure 2B and Figure 2C These are schematic cross-sectional views of the fluid collection assembly 200 taken along the 2B-2B plane and the 2C-2C plane, respectively. Figure 2D yes Figure 2A An exploded isometric view of the fluid collection assembly shown. Unless otherwise stated or described, the fluid collection assembly 200 may include any aspect of the fluid collection assembly 100 described above.

[0074] In some embodiments of the fluid collection assembly 200, the fluid-permeable support 122 is disposed adjacent to (e.g., fixed to) the second panel 110 (e.g., or on the side of the assembly defining the openings 114 / 124) such that the fluid-permeable support 122 is located between the fluid-permeable membrane 123 and the second panel 110. In this configuration, the fluid-permeable membrane 123 is configured to contact the penis in the chamber 112 when the penis passes through the openings 114 / 124, wherein the penis is located between the fluid-permeable membrane 123 and the first panel 108. This configuration and arrangement of the fluid-permeable support 122 and the fluid-permeable membrane 123 produces the technical effect of directing more urine to the fluid-permeable support 122 for removal from the fluid collection assembly 200.

[0075] The port 230 of the fluid collection assembly 200 may be similar to the port 130 of the fluid collection assembly 100. For example, the port 230 may include a first portion disposed within the fluid collection assembly 100 and a second portion disposed outside the fluid collection assembly 100. Thus, the port 230 may extend through the fluid outlet 118. For example, the first portion of the port 230 may optionally be at least partially disposed within the chamber 112. The second portion of the port 230 is configured to attach to a conduit 142 (e.g., a fitting) in fluid communication with a vacuum source or pump. The first portion of the port defines an inlet 230a, and the second portion defines an outlet 130b of the port 230, the outlet being downstream of the inlet 230a. In these and other embodiments, the inlet 230a is disposed at the end of the first portion of the port 230. The port 230 also defines a channel or conduit extending from the inlet 130a to the outlet 130b. The inlet 230a may be disposed in the distal region 172 of the fluid-permeable support 122.

[0076] In some embodiments, inlet 230a is configured to be at least adjacent to or at the interface with fluid-permeable support 122, such that there is no fluid-permeable membrane 123 between inlet 230a and fluid-permeable support 122. For example, a first portion of port 230 may pass through an opening or hole 121 in fluid-permeable membrane 123, such that inlet 230a interfaces with or abuts against a surface of fluid-permeable support 122. More specifically, inlet 230a may interface with or abut against the same generally surface of fluid-permeable support 122 that interfaces with fluid-permeable membrane 123.

[0077] Setting inlet 230a adjacent to fluid-permeable support 122 produces the technical effect of improving fluid transport from fluid-permeable support 122 into port 230 for removal from chamber 112. In some embodiments, at least a second portion of port 230 is inclined and / or bent relative to the longitudinal axis of the fluid collection assembly from the first portion toward the proximal region 160 of fluid-impermeable barrier 106. In fluid collection assembly 100, port 130 generally extends from inlet 230a through fluid outlet 118 and is at least partially inclined toward the proximal region 160 of fluid-impermeable barrier 106. The orientation and configuration of port 230 produce the technical effect of reducing kinking that may occur in the conduit 142 fixed to port 230.

[0078] In some embodiments, port 230 may include a disc disposed near inlet 230a, the disc being located between the fluid-permeable support 122 and the first panel 108. Alternatively, the disc of port 230 may be fixed to the outer surface of the first panel 108, with inlet 130 aligned with outlet 108. In these and other embodiments of the fluid collection assembly 200, the distal region 172 of the fluid-permeable support 122 may extend to the distal intersection or seal between the first panel 108 and the second panel 110, while the fluid-permeable membrane 123 terminates before the distal intersection of the first panel 108 and the second panel 110. The distal region 162 of the fluid-impermeable barrier 106 of the fluid collection assembly 200 may consist only of the fluid-permeable support 122 directly disposed (e.g., fixed) between the first panel 108 and the second panel 110, and the fluid-permeable membrane 123 may not be present in the distal region 162 of the fluid-impermeable barrier 106. The distal end of the fluid-permeable membrane 123 can be fixed to the first panel 108, and the fluid-permeable support 122 can extend distally beyond the distal end of the fluid-permeable membrane 123.

[0079] Back Figure 2CThe fluid-permeable support 122 may include a first surface intersecting with the second panel 110, a second surface opposite the first surface and intersecting with the fluid-permeable membrane 123, and two side surfaces extending between the first and second surfaces. At least one of the fluid-permeable membrane 123, the first panel 108, or the second panel 110 may cover the two side surfaces of the fluid-permeable support 122 such that the fluid-permeable support 122 is generally not exposed within the chamber 122 (e.g., the fluid-permeable support 122 is substantially entirely covered within the chamber 112 by the first panel 108, the second panel 110, and / or the fluid-permeable membrane 123). This configuration prevents air from escaping through the fluid-permeable support 122 and instead directs substantially all suction to draw fluid through the fluid-permeable membrane 123 into the permeable support 122, and subsequently to the inlet 130a for removal from the chamber.

[0080] In some implementations, the ports of the fluid collection assembly may be curved. Figure 2E This is a cross-sectional schematic diagram of a fluid collection assembly 250 according to one embodiment. Unless otherwise stated, the fluid collection assembly 250 may include any aspect of the fluid collection assembly 200. In some embodiments, the fluid collection assembly 250 may include a port 280 having an inlet 280a disposed near the end of the fluid-permeable support 122 in the distal region 172. A first portion of the port 280 may extend distally from the inlet 280a, then bend or angle proximally and extend through the fluid outlet 118. In some embodiments, the first portion of the port 280a extends through an opening in the fluid-permeable membrane 123. In some embodiments, the first portion of the port 280 extends beyond the end of the fluid-permeable membrane 123. The first panel 108 and the second panel 110 may be sealed or attached such that the end 172a of the fluid-permeable support 123 in the distal region 172 intersects only with the fluid-impermeable barrier 106 and the inlet 280a (e.g., the end 172a is not exposed in the chamber 112).

[0081] Figure 3This is a block diagram of a system 307 for fluid collection according to one embodiment. System 307 includes a fluid collection assembly 300, a fluid storage container 309, and a vacuum source 311. The fluid collection assembly 300 may include any fluid collection assembly disclosed herein. The fluid collection assembly 300, the fluid storage container 309, and the vacuum source 311 may be fluidly connected to each other via one or more conduits 342. For example, the fluid collection assembly 300 may be operatively connected to one or more of the fluid storage container 309 or the vacuum source 311 via conduits 342. Bodily fluids (e.g., urine or other bodily fluids) collected in the fluid collection assembly 300 may be removed from the fluid collection assembly 300 via conduits 342 extending into the fluid collection assembly 300. In response to a vacuum force (e.g., a vacuum pressure) applied to the outlet of the conduit 342, a vacuum force may be introduced into the chamber of the fluid collection assembly 300 via the inlet of the conduit 342.

[0082] Vacuum force can be applied directly or indirectly to the outlet of conduit 342 by vacuum source 311. Vacuum force can also be applied indirectly via fluid storage container 309. For example, the outlet of conduit 342 can be located within fluid storage container 309, and an additional conduit 342 can extend from fluid storage container 309 to vacuum source 311. Therefore, vacuum source 311 can apply a vacuum to fluid collection assembly 300 via fluid storage container 309. Vacuum force can also be applied directly by vacuum source 311. For example, the outlet of conduit 342 can be located within vacuum source 311. An additional conduit 342 can extend from vacuum source 311 to a point outside fluid collection assembly 300, such as extending to fluid storage container 309. In such an example, vacuum source 311 can be located between fluid collection assembly 300 and fluid storage container 309.

[0083] The fluid storage container 309 is sized and shaped to hold fluid therein. The fluid storage container 309 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 342 may extend from the fluid collection assembly 300 and be attached to the fluid storage container 309 at a first point within the fluid storage container 309. An additional catheter 342 may be attached to the fluid storage container 309 at a second point and may extend and be attached to a vacuum source 311. Therefore, a vacuum (e.g., a vacuum) can be drawn through the fluid storage container 309 through the fluid collection assembly 300. The vacuum source 311 can be used to drain fluids such as urine from the fluid collection assembly 300.

[0084] Vacuum source 311 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 311 can provide a vacuum or a vacuum to remove fluid from fluid collection assembly 300. In some examples, vacuum source 311 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 311 may be configured to be disposed outside, on, or inside fluid collection assembly 300. For example, vacuum source 311 may include one or more miniature pumps or one or more micro-pumps. Vacuum source 311 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 311.

[0085] Figure 4 This is a flowchart of a method 400 for manufacturing a fluid collection assembly according to one embodiment. Method 400 can form any fluid collection assembly disclosed herein. Method 400 may include action 405, which is described as “providing a fluid-impermeable barrier including a first panel and a second panel, the first panel defining an opening sized to receive at least a portion of a penis through the opening.” Method 400 may include action 410, which is described as “attaching the outer periphery of the first panel to the outer periphery of the second panel to form a sheath having a proximal region including the opening, a distal region extending from the proximal region, and a fluid outlet located in the distal region, the fluid-impermeable barrier at least defining a chamber.” Method 400 may include action 415, which is described as "arranging a fluid permeable body in a chamber having a fluid permeable support and a fluid permeable membrane including a wicking material, such that the fluid permeable membrane is configured to contact the penis in the chamber when the penis extends through the opening, and a port extends through a fluid outlet, wherein a first portion of the port defines an inlet, the inlet being configured adjacent to the fluid permeable support such that there is no fluid permeable membrane between the inlet and the fluid permeable support, and a second portion of the port defines an outlet located outside the chamber and configured to be attached to a catheter."

[0086] In some embodiments, action 415 includes setting (e.g., fixing) a fluid-permeable support such that it is positioned between a fluid-permeable membrane and a second panel, wherein the fluid-permeable membrane is configured to contact the penis within a chamber when the penis extends through the opening, wherein the penis is located between the fluid-permeable membrane and the first panel. In these and other embodiments, method 400 may include setting (e.g., fixing) a port including a fluid outlet to a distal region, the port including a first portion and a second portion, the first portion defining an inlet at least adjacent to the fluid-permeable support, and the second portion defining an outlet located outside the chamber, the second portion being configured to attach to a catheter. In these and other embodiments, at least the second portion of the port may be tilted and / or bent relative to the longitudinal axis of the fluid collection assembly from the first portion toward the proximal region.

[0087] In some embodiments, action 415 includes setting (e.g., securing) a fluid-permeable support to a first panel such that the fluid-permeable support is positioned between a fluid-permeable membrane and the first panel, the fluid-permeable membrane being configured to contact the penis in a chamber when the penis extends through the opening, wherein the penis is positioned between the fluid-permeable membrane and a second panel. In these and other embodiments, method 400 may include securing a port including a fluid outlet to a distal region, the port including a first portion and a second portion, the first portion defining an inlet positioned at least adjacent to the fluid-permeable support, the second portion defining an outlet located outside the chamber, the first portion extending through the fluid-permeable membrane, and the second portion being configured to attach to a conduit. In these and other embodiments, at least the second portion of the port may be inclined and / or bent relative to the longitudinal axis of the fluid collection assembly from the first portion toward the proximal region. In some embodiments, method 400 further includes setting an inlet on the surface of the fluid-permeable support at the interface with the fluid-permeable membrane. In some embodiments, method 400 further includes setting an inlet near the end of the fluid-permeable support in the distal region.

[0088] In some embodiments, method 400 further includes the action of covering the interface surface of the fluid-permeable support and the two sides of the fluid-permeable support with a fluid-permeable membrane.

[0089] The actions in method 400 are for illustrative purposes and can be performed in different orders, broken down into multiple actions, modified, supplemented, or combined. In one example, one or more actions of method 400 may be omitted from method 400.

[0090] 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.

[0091] 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.

[0092] 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: A sheath comprising a fluid-impermeable barrier including a proximal region, a distal region extending from the proximal region, a first panel, a second panel, and a fluid outlet located in the distal region, the second panel being attached to the first panel and defining an opening in the proximal region of the fluid-impermeable barrier, the opening being sized to receive at least a portion of the penis through the opening, the fluid-impermeable barrier at least defining a chamber. A fluid-permeable body disposed in the chamber and comprising: Fluid can pass through the support; and A fluid-permeable membrane comprising a wicking material and configured such that a fluid-permeable support is disposed between the fluid-permeable membrane and one of a first panel or a second panel, the fluid-permeable membrane being configured to contact the penis in the chamber when the penis extends through the opening; and The port extends through the fluid outlet and includes: (1) a first portion defining an inlet disposed adjacent to the fluid-permeable support such that no fluid-permeable membrane exists between the inlet and the fluid-permeable support; and (2) a second portion defining an outlet located outside the chamber and configured to be attached to a catheter.

2. The fluid collection assembly according to claim 1, wherein, The fluid-permeable support is located between the fluid-permeable membrane and the first panel, wherein the fluid-permeable membrane is configured to contact the penis in the chamber when the penis extends through the opening, wherein the penis is located between the fluid-permeable membrane and the second panel.

3. The fluid collection assembly according to claim 2, wherein, At least the second portion of the port is inclined and / or bent relative to the longitudinal axis of the fluid collection assembly from the first portion toward the proximal region.

4. The fluid collection assembly according to any one of claims 2 or 3, wherein, The inlet is located on the sidewall of the first portion of the port, and the covered end of the first portion is located adjacent to the fluid-permeable membrane.

5. The fluid collection assembly according to claim 2, wherein: The inlet is located at the end of the first portion and adjacent to the end of the fluid-permeable support in the distal region; as well as The port extends distally from the inlet, then bends and / or tilts to extend proximally.

6. The fluid collection assembly according to claim 1, wherein, The fluid-permeable support is located between the fluid-permeable membrane and the second panel, wherein the fluid-permeable membrane is configured to contact the penis in the chamber when the penis extends through the opening, wherein the penis is located between the fluid-permeable membrane and the first panel.

7. The fluid collection assembly according to claim 6, wherein, The first portion of the port extends through a pore in the fluid-permeable membrane, such that the inlet is disposed adjacent to the fluid-permeable support, and there is no fluid-permeable membrane between the inlet and the fluid-permeable support.

8. The fluid collection assembly according to claim 7, wherein, At least the second portion of the port is inclined and / or bent relative to the longitudinal axis of the fluid collection assembly from the first portion toward the proximal region, and the inlet is disposed on the surface of the fluid-permeable support at the interface with the fluid-permeable membrane.

9. The fluid collection assembly according to claim 6, wherein: The inlet is located adjacent to the end of the support in the distal region where the fluid can pass through; and The port extends distally from the inlet, then bends and / or tilts to extend proximally.

10. The fluid collection assembly according to any one of claims 5 to 9, wherein, The fluid-permeable membrane and the fluid-permeable support each include an opening aligned with the opening in the second panel and sized to receive at least a portion of the penis passing through it.

11. The fluid collection assembly according to any one of claims 1 to 10, wherein, The fluid-permeable membrane includes gauze material or wicking fabric material.

12. The fluid collection assembly according to any one of claims 1 to 11, wherein, The fluid is permeable to the support, which includes a porous spun fiber structure.

13. The fluid collection assembly of claim 12, wherein, The fluid is permeable to the support, which comprises a porous spun nylon fiber structure.

14. The fluid collection assembly according to any one of claims 1 to 13, wherein: The fluid-permeable support includes a first surface that intersects with one of the first panel or the second panel, a second surface that is opposite to the first surface and intersects with the fluid-permeable membrane, and two side surfaces that extend between the first surface and the second surface. as well as The fluid-permeable membrane, the second panel, and / or at least one of the second panels cover the two sides of the fluid-permeable support, such that the fluid-permeable support is substantially entirely covered in the chamber by the first panel, the second panel, and / or the fluid-permeable membrane, and the fluid-permeable support is not exposed in the chamber.

15. A system comprising: The fluid collection assembly according to any one of claims 1 to 14; 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.

16. A method of manufacturing a fluid collection assembly, the method comprising: A fluid-impermeable barrier is provided, the fluid-impermeable barrier including a first panel and a second panel, the second panel defining an opening sized to receive at least a portion of the penis through the opening; The outer periphery of the first panel is attached to the outer periphery of the second panel to form a sheath having a proximal region including the opening, a distal region extending from the proximal region, and a fluid outlet located in the distal region, the fluid being impermeable to a barrier that at least defines a chamber. as well as A fluid-permeable body having a fluid-permeable support and a fluid-permeable membrane including a wicking material is disposed in the chamber such that the fluid-permeable membrane is configured to contact the penis in the chamber when the penis extends through the opening, and a port extends through the fluid outlet, wherein a first portion of the port defines an inlet disposed adjacent to the fluid-permeable support such that the fluid-permeable membrane is not present between the inlet and the fluid-permeable support, and a second portion of the port defines an outlet located outside the chamber and configured to be attached to a catheter.

17. The method according to claim 16, wherein, The fluid-permeable body disposed in the chamber includes: The fluid-permeable support is configured such that it is located between the fluid-permeable membrane and the first panel, wherein the fluid-permeable membrane is configured to contact the penis in the chamber when the penis extends through the opening, wherein the penis is located between the fluid-permeable membrane and the second panel.

18. The method according to claim 17, wherein, At least the second portion of the port is inclined and / or bent relative to the longitudinal axis of the fluid collection assembly from the first portion toward the proximal region.

19. The method according to claim 17 or claim 18, wherein, The inlet is located on the sidewall of the first portion of the port, and the covered end of the first portion is located adjacent to the fluid-permeable membrane.

20. The method of claim 17, wherein: The inlet is located at the end of the first portion and adjacent to the end of the fluid-permeable support in the distal region; as well as The port extends distally from the inlet, then bends and / or tilts to extend proximally.

21. The method according to claim 16, wherein, The fluid-permeable body disposed in the chamber includes: The fluid-permeable support is configured such that it is located between the fluid-permeable membrane and the second panel, wherein the fluid-permeable membrane is configured to contact the penis in the chamber when the penis extends through the opening, wherein the penis is located between the fluid-permeable membrane and the first panel.

22. The method according to claim 21, wherein, The first portion extends through the fluid via pores in the membrane.

23. The method according to claim 22, wherein, At least the second portion of the port is inclined and / or bent relative to the longitudinal axis of the fluid collection assembly from the first portion toward the proximal region, and the inlet is disposed on the surface of the fluid-permeable support at the interface with the fluid-permeable membrane.

24. The method according to claim 21, wherein, The inlet is located adjacent to the fluid permeable through the end of the support in the distal region, and the port extends distally from the inlet, then bends and / or tilts to extend proximally.

25. The method according to any one of claims 20 to 24, wherein, The fluid-permeable support and the fluid-permeable membrane each include an opening aligned with the opening in the second panel and sized to receive at least a portion of the penis passing through it.

26. The method according to any one of claims 16 to 25, wherein, The fluid-permeable membrane includes gauze material or wicking fabric material.

27. The method according to any one of claims 16 to 26, wherein, The fluid is permeable to the support, which includes a porous spun fiber structure.

28. The method according to claim 27, wherein, The fluid is permeable to the support, which comprises a porous spun nylon fiber structure.

29. The method according to any one of claims 16 to 28, wherein, The fluid-permeable body is disposed in the chamber such that the fluid-permeable support is substantially entirely covered in the chamber by the first panel, the second panel and / or the fluid-permeable membrane, and the fluid-permeable support is not exposed in the chamber.

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