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

Abstract

An example of a fluid collection assembly includes a sheath containing a chamber and a fluid-permeable body positioned within the chamber. The sheath includes a fluid-impermeable barrier comprising a proximal region, a distal region, a first panel, a second panel attached to the first panel and defining an opening in the proximal region of the fluid-impermeable barrier, and a fluid outlet in the distal region. The fluid-permeable body includes a fluid-permeable support and a fluid-permeable membrane. The fluid-permeable membrane includes a wicking material and is positioned so as to contact the penis within the chamber as the penis extends through the opening.

Description

Background Art

[0001] In various situations, the mobility of humans or animals may be limited or impaired, which may result in normal urination becoming difficult or impossible. For example, a person may experience or have a disability that impairs mobility. A person may have restricted movement conditions such as those experienced by pilots, drivers, and workers in hazardous areas. Furthermore, urine collection may be required for monitoring purposes or clinical testing.

[0002] Urethral catheters such as Foley catheters can be used to address some of these situations such as incontinence. Unfortunately, however, urethral catheters may cause discomfort and pain, and may lead to complications such as infectious diseases. Furthermore, bedpans, which are containers used for excretion of bedridden patients in medical facilities and the like, may also be used. However, bedpans may be prone to discomfort, spillage, and other hygienic problems.

[0003] Men who suffer from the most serious effects of urinary incontinence, such as discomfort, rashes, and bedsores, are generally elderly and often bedridden. They also require continuous care to maintain hygiene. Common characteristics of such patients include decrease in penis size with aging, penile retraction due to sagging skin including adipose tissue, the penis often pointing upward in a supine position, and that patients have difficulty reaching the penis and operating the device. Urine collection devices should be designed in consideration of these characteristics.

[0004] Available solutions are generally for use in standing or sitting positions (such as cup- and funnel-shaped ones), with a urine discharge port on the opposite side of the distal end of the penis. Other designs, such as condom catheters, are difficult for patients to operate, often cause dimensional incompatibility, and are difficult to be securely worn.

[0005] Therefore, there is a need for a device that can collect urine from people or animals, particularly males, in a comfortable manner and with minimal contamination of the user and / or surrounding area. [Overview of the Initiative] [Means for solving the problem]

[0006] Embodiments disclosed herein relate to a male fluid collection assembly, a system comprising the same, a method for manufacturing the same, and a method for using the same. In the embodiments, a fluid collection assembly is disclosed. The fluid collection assembly includes a sheath. The sheath includes a fluid-impermeable barrier including a proximal region, a distal region extending from the proximal region, a first panel, a second panel attached to the first panel defining an opening in the proximal region of the fluid-impermeable barrier that is sized to allow at least a portion of the penis to pass through, and a fluid outlet in the distal region. The fluid-impermeable barrier defines at least partially a chamber. The fluid collection assembly includes a fluid-permeable body disposed within the chamber. The fluid-permeable body includes a fluid-permeable support and a fluid-permeable membrane comprising a wicking material. The fluid-permeable membrane is positioned such that the fluid-permeable support is positioned between the fluid-permeable membrane and one of the first or second panels. In some embodiments, the fluid-permeable support, fluid-permeable membrane, and fluid-impermeable barrier are not fixed to each other (for example, the fluid-permeable support and fluid-permeable membrane are movable within the chamber). The fluid-permeable membrane is positioned to contact the penis within the chamber as 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 positioned 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 positioned outside the chamber and configured to be attached to a conduit.

[0007] In an embodiment, a method for manufacturing a fluid collection assembly includes providing a fluid-impermeable barrier comprising a first panel and a second panel defining an opening. The opening is sized to allow at least a portion of the penis to pass through. The method also 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 containing the opening, a distal region extending from the proximal region, and a fluid outlet in the distal region, wherein the fluid-impermeable barrier defines at least a chamber. The method also includes positioning a fluid-permeable body having a fluid-permeable support and a fluid-permeable membrane comprising a wicking material within a chamber, wherein the fluid-permeable membrane is positioned within the chamber to contact the penis as the penis extends through the opening, and a port extends through a fluid outlet, wherein a first portion of the port defines an inlet positioned 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 positioned outside the chamber and configured to be attached to a conduit.

[0008] Features from any of the disclosed embodiments may be used in combination with each other without limitation. In addition, other features and advantages of this disclosure will become apparent to those skilled in the art by considering the following detailed description and accompanying drawings.

[0009] The drawings illustrate several embodiments of the present disclosure, and the same reference numerals refer to the same or similar elements or features in different drawings or in embodiments shown in the drawings. [Brief explanation of the drawing]

[0010] [Figure 1A] These are isometric views from the top and bottom of the fluid collection assembly, respectively, according to the embodiment. [Figure 1B] These are isometric views from the top and bottom of the fluid collection assembly, respectively, according to the embodiment. [Figure 1C]These are schematic cross-sectional views of a fluid collection assembly cut along planes 1C-1C and 1D-1D, respectively, according to an arbitrary embodiment. [Figure 1D] These are schematic cross-sectional views of a fluid collection assembly cut along planes 1C-1C and 1D-1D, respectively, according to an arbitrary embodiment. [Figure 1E] Figure 1A is an exploded isometric view of the fluid collection assembly shown. [Figure 2A] This is an isometric view from above of the fluid collection assembly according to the embodiment. [Figure 2B] These are schematic cross-sectional views of the fluid collection assembly according to the embodiment, cut along planes 2B-2B and 2C-2C, respectively. [Figure 2C] These are schematic cross-sectional views of the fluid collection assembly according to the embodiment, cut along planes 2B-2B and 2C-2C, respectively. [Figure 2D] This is an exploded isometric view of the fluid collection assembly shown in Figure 2A, according to an embodiment. [Figure 2E] This is a cross-sectional view of a fluid collection assembly according to an embodiment. [Figure 3] This is a block diagram of a fluid collection system according to an embodiment. [Figure 4] This is a flowchart of a fluid collection method according to an embodiment. [Modes for carrying out the invention]

[0011] Embodiments disclosed herein relate to male fluid collection assemblies, systems comprising the same, methods for manufacturing the same, and methods for using the same. An example of a fluid collection assembly 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 defines a chamber, at least partially. In some embodiments, the fluid-permeable body (e.g., a porous material) is placed 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 positioned adjacent to (e.g., fixed to) the fluid-permeable support so that the fluid-permeable membrane is positioned to contact the penis within the chamber as the penis extends through the opening. The fluid-permeable membrane and the fluid-impermeable barrier of the sheath may cover the sides of the fluid-permeable support so as to prevent or inhibit the escape of air and vacuum through the matrix. The fluid collection assembly may also include a conduit positioned within a chamber and having an inlet adjacent to a fluid-permeable support. The base may be attached to the sheath (e.g., permanently) or configured to be fixed to the sheath at some point in the future. The base defines an aperture that aligns with the opening when attached to the sheath. The base is configured to be fixed to the area around the individual's penis with the aperture positioned above the penis.

[0012] The fluid-permeable membrane contains wicking material and is positioned adjacent to (e.g., fixed to) the fluid-permeable support so that the fluid-permeable membrane is positioned to contact the penis within the chamber as the penis extends through the opening. Positioning the fluid-permeable membrane to contact the penis results in the technical benefits of a more comfortable contact for the penis and the possibility of a more effective vacuum-assisted wicking action. The fluid-impermeable barrier of the fluid-permeable membrane and sheath can cover the sides of the fluid-permeable support so that air and vacuum escape through the matrix is ​​inhibited or prevented. This configuration of the fluid-permeable support and fluid-permeable membrane results in the technical benefit of more effective fluid removal from the chamber, as it allows fluid within the fluid-permeable support to be drawn into the conduit even when the conduit inlet is located above the rest of the fluid-permeable support.

[0013] One example of how to use a fluid collection assembly involves securing the base to an area around the individual's penis. The base is positioned relative to the individual such that the penis extends through an aperture defined by the base (e.g., the penis is not embedded) or is adjacent to the aperture (e.g., the penis is embedded). If the sheath is not yet attached to the base, it can be attached to the base. For example, the sheath can be attached to the base before, during, or after securing the base to the area around the penis. After the base is secured to the area around the penis and the sheath is attached to the base, the individual can drain bodily fluids from their penis. The bodily fluids may include urine, blood, or sweat. The bodily fluids enter the chamber of the sheath. A porous material can receive at least some of the bodily fluids entering the chamber and guide the fluids toward the fluid outlet. The method may include removing the bodily fluids from the chamber through the fluid outlet when a vacuum force is applied to the outlet, for example, via a vacuum source that is in fluid communication with the chamber. The fluid collection assemblies disclosed herein are described as male fluid collection assemblies used with the penis, but it should be noted that the fluid collection assemblies may also be female fluid collection assemblies used to collect bodily fluids from women, wound care devices, ostomy bags, etc.

[0014] Figures 1A and 1B are isometric top and bottom views of the fluid collection assembly 100 according to an embodiment, respectively. Figures 1C and 1D are schematic cross-sectional views of the fluid collection assembly 100 cut along planes CC and DD, respectively, according to either embodiment. Figure 1E is an exploded view of the fluid collection assembly 100. The fluid collection assembly 100 includes a sheath 102 and a base 104. In an embodiment, the sheath 102 includes a fluid impermeable barrier 106 at least partially formed from a first panel 108 attached to a second panel 110. In an embodiment, as shown, the first panel 108 and the second panel 110 are different sheets. In some embodiments, the fluid impermeable barrier 106 is formed from first and second panels that are integrally formed (e.g., showing a single-piece structure). The fluid impermeable barrier 106 also defines a chamber 112, an opening 114, and a fluid outlet 118 between the first panel 108 and the second panel. The sheath 102 also includes a fluid-permeable body comprising a fluid-permeable support 122 and a fluid-permeable membrane 123, which are located within the chamber 112. The base 104 includes an aperture 124. The base 104 is attached to the proximal region 160 of the fluid-impermeable barrier 106 so that the aperture 124 aligns with the opening 114.

[0015] The inner surfaces 126 of the fluid-impermeable barrier 106 (e.g., the inner surfaces of the first and second panels 108, 110) at least partially define the chamber 112 within the fluid collection assembly 100. The fluid-impermeable barrier 106 temporarily stores bodily fluids within the chamber 112.

[0016] The fluid-impermeable barrier 106 can be formed from any suitable fluid-impermeable material, such as a fluid-impermeable polymer (e.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, polyurethane, polyethylene, polyvinyl chloride, polycarbonate, etc.), a metal film, natural rubber, another suitable material, or a combination thereof. Thus, the fluid-impermeable barrier 106 substantially prevents bodily fluids from passing through it. In one example, the fluid-impermeable barrier 106 can be permeable and fluid-impermeable, thereby preventing leakage while allowing airflow through the chamber 112 when a vacuum force is applied (i.e., the chamber 112 is maintained at approximately atmospheric pressure, so that the vacuum force does not cause suction marks or bend the conduit 142). In such an example, the fluid-impermeable barrier 106 can be formed from a hydrophobic material defining multiple pores. At least one portion of at least the outer surface 127 of the fluid-impermeable barrier 106 can be formed from a soft and / or smooth material, thereby reducing abrasion.

[0017] In this embodiment, the fluid-impermeable barrier 106 is formed from polyurethane, for example, solely from polyurethane. Forming the fluid-impermeable barrier 106 from polyurethane can improve the functionality of the fluid collection assembly 100. For example, the fluid-impermeable barrier 106 can exhibit greater flexibility when formed from polyurethane than when formed from another material. The increased flexibility of the fluid-impermeable barrier 106 formed from polyurethane makes it easier to attach the fluid collection assembly 100 to an individual and maintain that attachment. The increased flexibility of the fluid-impermeable barrier 106 formed from polyurethane also helps the fluid collection assembly 100 conform to the individual's body shape and / or tuck under their clothing, thereby improving patient comfort. The increased flexibility of the fluid-impermeable barrier 106 prevents, or at least minimizes, any corners formed within the fluid-impermeable barrier 106 from pressing uncomfortably against the individual using the fluid collection assembly 100, thereby making the use of the fluid collection assembly 100 more comfortable. Polyurethane can also maintain its flexibility even when welded or otherwise formed with seals. Furthermore, it has been found that individuals using the fluid collection assembly 100 report that the fluid-impermeable barrier 106 feels smoother when it is made of polyurethane than when it is made of other materials. The smoother feel of the fluid-impermeable barrier 106 made of polyurethane makes wearing the fluid collection assembly 100 more comfortable. It has also been found that forming the fluid-impermeable barrier 106 from polyurethane allows for quieter bending (e.g., creasing, folding) of the fluid-impermeable barrier 106 than when it is made from other materials. The improved quietness of the fluid-impermeable barrier 106 allows for more discreet use of the fluid collection assembly 100. For example, the movement of an individual using the fluid collection assembly 100 is likely to cause the fluid-impermeable barrier 106 to bend.By forming the fluid-impermeable barrier 106 from polyurethane, it becomes possible for the fluid-impermeable barrier 106 to remain silent even when an individual moves relatively large. Finally, it has been found that the polyurethane-containing fluid-impermeable barrier 106 can be welded to various materials, thereby facilitating the attachment of the base 104, vent 134, and port 130 to the fluid-impermeable barrier 106.

[0018] In some embodiments, at least one of the first panel 108 or the second panel 110 is formed from at least partially transparent fluid-impermeable material such as polyethylene, polypropylene, polyurethane, polycarbonate, or polyvinyl chloride. By forming at least one of the first panel 108 or the second panel 110 from at least partially transparent fluid-impermeable material, a person (e.g., a medical professional) can examine the penis. In some embodiments, both the first panel 108 and the second panel 110 are formed from at least partially transparent fluid-impermeable material. For example, some conventional fluid collection assemblies including a sheath and a base may allow the sheath to be reversibly removed from the base after the base has been fixed in the area around the penis. By removing the sheath from the base, a person can examine the penis. However, if the sheath is configured to be removable from the base, leakage may occur between the sheath and the base. As described above, the sheath 102 can be permanently attached to the base 104, and if the base 104 is properly attached to the sheath 102 (for example, so that no wrinkles are formed between the sheath 102 and the base 104), leakage between the sheath 102 and the base 104 is substantially prevented. By selecting to form at least one of the first panel 108 or the second panel 110 from at least partially transparent, impermeable material, it becomes possible to inspect the penis without removing the entire fluid collection assembly 100 from the area around the penis. For example, the chamber 112 may include a penis receiving area 131 configured to receive the individual's penis as the penis extends into the chamber 112. The penis receiving area 131 can 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, when the penis is inserted into the chamber (112) through the opening (114), the fluid-permeable body (e.g., fluid-permeable membrane 123) can be positioned within the chamber (112) such that the fluid-permeable body is not located between the penis and at least a portion of the transparent section of the first panel (108) and / or the second panel (110). The fluid-permeable body is generally not transparent, so the portion of the at least partially transparent material of the first panel (108) and / or the second panel (110) that defines the penis receiving area (131) forms a window, which allows a person to look inside the penis receiving area (131) and inspect the penis.

[0019] In an embodiment, the second panel 110 is formed from a material that is at least partially transparent, forming a window that allows a person to see inside the penis receiving area 131. Furthermore, the fluid-permeable body is positioned between the penis receiving area 131 and at least a portion of the first panel 108. Such an embodiment can help preserve the dignity of the person using the fluid collection assembly 100. For example, during use, the second panel 110 is generally adjacent to the person, for example, adjacent to the thigh and / or perineum. Therefore, the second panel 110 is generally difficult to see during use, and the person cannot see the penis unless they first lift the sheath 102 away from themselves. On the other hand, the first panel 108 faces away from the person and may be easier to see than the second panel 110. However, because the fluid-permeable body is not transparent and / or the first panel 108 is formed from an opaque material, a person (e.g., a passerby, visitor, etc.) cannot see the penis through the first panel 108. Therefore, in such embodiments, the first panel 108 and / or fluid-permeable body prevent a person from seeing the penis except when such inspection is necessary, thereby preserving the dignity of the person using the fluid collection assembly 100. In embodiments, the first panel 108 is formed from a material that is at least partially transparent and forms a window that allows a person to see inside the penis receiving area 131. Furthermore, the fluid-permeable body may be positioned between the penis receiving area 131 and at least a portion of the second panel 110. In such embodiments, a person can see inside the penis receiving area 131 without the additional action of lifting the sheath 102, but passersby can also see inside the penis receiving area 131, which may compromise the dignity of the person using the fluid collection assembly 100.

[0020] As described above, at least a portion of the first panel 108 and at least a portion of the second panel 110 are attached to each other. In embodiments, as shown in the figures, the first and second panels 108, 110 are attached to each other along at least a portion of their outer edges (e.g., the top edge and side edges 136, 138). In such embodiments, the first and second panels 108, 110 are attached using any suitable technique such as adhesive, suture, heat seal, impulse heating, direct heating, high-frequency ("RF") welding, ultrasonic ("US") welding, or any other technique. In certain embodiments, the first and second panels 108 are attached to each other using impulse heating, as impulse heating allows polyurethane panels to be attached to each other quickly and effectively. As will be described in more detail later, the manufacturing speed of the fluid collection assembly 100 can be improved by forming the fluid-impermeable barrier 106 from a first panel 108 and a second panel 110, particularly when the first panel 108 and the second panel 110 are attached to each other using techniques other than sutures. In some embodiments, the first panel 108 and the second panel 110 are formed integrally (e.g., showing a single-piece structure).

[0021] In an embodiment, the fluid-impermeable barrier 106 defines one or more orifices 132 extending therethrough. In an embodiment, the sheath 102 includes one or more vents 134 attached to the fluid-impermeable barrier 106 and extending across the one or more orifices 132. The vent 134 is configured to allow air to flow therethrough while preventing water, which is the main component of body fluids, from flowing therethrough. The vent 134 facilitates air flow through the chamber 112. For example, as described above, vacuum can be supplied to the chamber 112 from a vacuum source. The vacuum draws air through the vent 134, thereby allowing air flow from the vent 134 to the fluid outlet 118. Air flow from the vent 134 helps move body fluid toward the fluid outlet 118. The vent 134 also prevents the vacuum applied to the chamber 112 from rupturing small superficial blood vessels (e.g., causing suction marks) or otherwise damaging the penis or the area surrounding the penis.

[0022] The vent 134 may include a porous hydrophobic material. In some embodiments, the vent 134 may be covered with a hydrophilic material such as a wicking material. The vacuum can prevent liquid from leaving the fluid collection assembly 100 through the vent 134 (especially when wet), while air can still enter the fluid collection assembly 100 through the vent 134. In some embodiments, the vent may not be covered with any material. The pores defined by the porous hydrophobic material are interconnected, thereby allowing airflow through the vent 134. The hydrophobicity of the porous hydrophobic material can 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 porous hydrophobic materials is approximately 1 μm or more, approximately 5 μm or more, approximately 10 μm or more, approximately 20 μm or more, approximately 30 μm or more, approximately 40 μm or more, approximately 50 μm or more, approximately 60 μm or more, approximately 80 μm or more, approximately 100 μm or more, approximately 125 μm or more, approximately 150 μm or more, approximately 175 μm or more, approximately 200 μm or more, approximately 250 μm or more, approximately 300 μm or more, approximately 400 μm or more, approximately 500 μm or more, approximately 1 mm or less, approximately 750 μm or less, approximately 500 μm or less, or approximately 1 μm to approximately 10 μm, approximately 5 μm or less The thickness can be selected to be approximately 20 μm, approximately 10 μm to approximately 30 μm, approximately 20 μm to approximately 40 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, a porous hydrophobic material can have a contact angle with water greater than 90°, and can be in the range of approximately 90° to 110°, 100° to 120°, 110° to 130°, 120° to 140°, 130° to 150°, 140° to 160°, 150° to 170°, or 160° to 180°. Generally, the size of the pores depends on the hydrophobicity of the porous hydrophobic material, and vice versa.For example, by increasing the hydrophobicity of porous hydrophobic materials, it becomes possible to increase the size of the pores.

[0023] In embodiments, the vent 134 may include a porous polytetrafluoroethylene ("PTFE") layer. Porous PTFE layers are currently considered highly effective in that they allow air to flow through them while preventing water from flowing through them, even when the porous PTFE layer is exposed to acidic bodily fluids. However, porous PTFE is difficult to weld to other materials such as polyurethane. Therefore, the porous PTFE layer can be attached to a substrate. The substrate may contain a porous material or define one or more passages through which it flows. The substrate can be selected to be easily attached to the porous PTFE layer and the fluid-impermeable barrier 106. For example, since polyvinyl chloride can be easily attached to the porous PTFE layer and the fluid-impermeable barrier 106, the substrate can be selected to be formed from polyvinyl chloride.

[0024] In an embodiment, the orifice 132 is formed in the first panel 108 of the fluid-impermeable barrier 106, and the vent 134 is mounted on the first panel 108. In such an embodiment, the orifice 132 and vent 134 are unlikely to be covered by or in contact with an individual's skin. Covering the orifice 132 and vent 134 with skin may prevent or at least restrict airflow through the portion of the orifice 132 and vent 134 covered by the skin. Furthermore, contact between the vent 134 and the skin may cause discomfort to the individual, and therefore positioning the vent 134 on the first panel 108 may make the fitting of the fluid collection assembly 100 more comfortable. In an embodiment, the vent 134 is mounted on the inside of the first panel 108 so that its edges do not rub against or otherwise irritate an individual's skin.

[0025] In the embodiment, as shown in the figure, at least one of the orifices 132 is formed in a portion of the fluid-impermeable barrier 106 on or near the upper edge 136 of the fluid-impermeable barrier 106, and at least one of the vents 134 is attached to that portion. The upper edge 136 of the fluid-impermeable barrier 106 may include the edge of the fluid-impermeable barrier 106 above the opening 114 when the individual is standing and the fluid collection assembly 100 is allowed to hang freely from the individual's pubic area. By forming the orifice 132 on or near the upper edge 136 and attaching the vent 134, air flowing through the vent 134 passes over the penis (thus keeping the penis dry), and the accumulation of bodily fluids near the upper edge 136 is suppressed. In the embodiment, as shown in the figure, at least one of the orifices 132 is formed in a portion of the impermeable barrier 106 located on or near the side edge 138 of the impermeable barrier 106, and at least one of the vents 134 is attached to that portion. The side edge 138 of the impermeable barrier 106 may include the edge of the impermeable barrier 106 extending from or near the upper edge 136. Generally, air preferentially flows through the path extending from the vents 134 toward the fluid outlet 118. If the vents 134 are located away from the side edge 138 and / or near the upper edge 136, the preferential airflow from these vents 134 may minimize airflow in at least some of the portions of the chamber 112 adjacent to the side edge 138. By positioning the orifice 132 and vent 134 on or near the side edge 138, the airflow through the portion of the chamber 112 adjacent to the side edge 138 can be increased, thereby preventing or at least suppressing the accumulation of bodily fluids in such portions of the chamber 112.

[0026] In some embodiments, the orifice 132 and vent 134 may exhibit an elongated shape. In one example, the orifice 132 and vent 134 on or near the upper edge 136 may exhibit an elongated shape that is substantially parallel to the upper edge 136 and / or substantially 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 flow preferentially through a larger proportion of the chamber 112 compared to when the orifice 132 and vent 134 do not exhibit an elongated shape and / or are oriented in a different direction. In one example, the orifice 132 and vent 134 on or near the side edge 138 may exhibit an elongated shape that is substantially parallel to the side edge 138 and / or substantially parallel to the longitudinal axis 140 of the fluid collection assembly 100. In such examples, the elongated shape of the orifice 132 and vent 134 allows air to preferentially flow through a larger proportion of the chamber 112 (e.g., the portion of the chamber 112 adjacent to the side edge 138) compared to when the orifice 132 and vent 134 do not have an elongated shape and / or are oriented in a different direction.

[0027] The opening 114, defined by the fluid-impermeable barrier 106, provides an entry route for bodily fluids into the chamber 112 when the penis is buried, and allows the penis to enter the chamber 112 (e.g., the penis receiving area 131) when the penis is not buried. The opening 114 can be defined by the fluid-impermeable barrier 106 (e.g., the inner edge of the fluid-impermeable barrier 106). For example, the opening 114 is formed in the fluid-impermeable barrier 106 and extends through the fluid-impermeable barrier 106 from the outer surface 127 to the inner surface 126, thereby allowing bodily fluids to enter the chamber 112 from outside the fluid collection assembly 100.

[0028] In some embodiments, the second panel 110 defines the entire opening 114. For example, the opening 114 is a notch defined by the second panel 110, spaced apart from its outer periphery (e.g., edge). In such examples, the second panel 110 can have a shape substantially corresponding to the shape of the first panel 108, thereby facilitating the attachment of the first panel 108 to the second panel 110 along their outer periphery. Also, when the penis is not in the chamber 112 and the sheath 102 is lying on a plane, the first panel 108 and the second panel 110 can lie substantially flat. The ability of the first and second panels 108, 110 to lie substantially flat allows the fluid collection assembly 100 to be attached more discreetly, and the accumulation of bodily fluids on the individual can be suppressed. 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 notch extending inward from at least one outer periphery of the second panel 110. Other examples of forming the opening 114 in the second panel 110 are disclosed in International Patent Application PCT / US2021 / 039866, filed on 30 June 2021, which is incorporated herein by reference in its entirety.

[0029] As described above, the fluid-impermeable barrier 106 includes a proximal region 160 and a distal region 162 extending from the proximal region 160 to, for example, a fluid outlet 118 (e.g., port 130). The proximal region 160 can define the opening 114, and the distal region 162 can define the fluid outlet 118. Both the proximal region 160 and the distal region 162 define the chamber 112.

[0030] In embodiments, the fluid-impermeable barrier 106 exhibits a generally bullet shape. As used herein, the fluid-impermeable barrier 106 exhibits a generally bullet shape when the proximal region 160 of the fluid-impermeable barrier 106 exhibits a substantially constant first width and the distal region 162 of the fluid-impermeable barrier 106 exhibits a second width smaller than the first width. The first and second widths can be measured perpendicular to the longitudinal axis 140 and may be greater than the thickness of the sheath 102 when it is lying on a plane. The generally bullet shape of the fluid-impermeable barrier 106 facilitates the operation of the fluid collection assembly 100 while making the sheath 102 more comfortable. For example, the substantially constant first width maintains contact with the upper part of the individual's thigh, thereby maintaining the position of the fluid collection assembly 100. Also, the substantially constant first width facilitates penile erection. This is because the virtually constant first width prevents the sheath 102 from hanging down between the individual's thighs, and prevents the erect penis from lifting the portion of the sheath 102 that hangs down between the thighs. The reduced second width thins the sheath 102, thereby allowing the portion of the sheath 102 that is less likely to accept the penis to hang down between the individual's thighs. This hanging down allows gravity to move the bodily fluids toward the fluid outlet 118. The reduced second width also collects the bodily fluids toward the fluid outlet 118 and port 130.

[0031] In one embodiment, the second width of the distal region 162 can vary (e.g., decrease) along the length of the distal region 162, measured perpendicular to the longitudinal axis 140. In one example, the second width of the distal region 162 can decrease at a constant rate from the proximal region 160 toward the fluid outlet 118 (e.g., up to that point). The constant rate at which the second width decreases causes the side edge 138 of the fluid-impermeable barrier 106 defining the distal region 162 to become straight. The straight side edge 138 may form a corner at the intersection of the proximal and distal regions 160, 162, which may press against an individual in an uncomfortable way. In one example, the second width of the distal region 162 can decrease at a variable (e.g., increase) rate from the proximal region 160 toward the fluid outlet 118 (e.g., up to that point). The variable rate at which the second width decreases causes the side edges 138 of the fluid-impermeable barrier 106 defining the distal region 162 to curve, for example, convexly. The curved side edges 138 can prevent the formation of corners that may press against an individual, thereby making the fluid collection assembly 100 more comfortable than if the side edges 138 of the distal region 162 were straight. However, it should be noted that if the side edges 138 of the distal region 162 were straight rather than curved, the airflow through the distal region 162 may be more uniform.

[0032] It should be noted that the fluid-impermeable barrier 106 can take on shapes other than generally bullet-shaped. For example, the fluid-impermeable barrier 106 can take on a generally rectangular shape, as described in more detail in International Patent Application PCT / US2021 / 039866, filed on 30 June 2021, which is incorporated herein by reference. For example, the fluid-impermeable barrier 106 can take on a generally triangular shape, a semi-elliptical shape, or any other suitable shape.

[0033] A fluid-impermeable barrier 106 defines a fluid outlet 118. The fluid outlet 118 can be formed from portions of the first panel 108 and the second panel 110 that are not attached to each other. In an embodiment not shown, the fluid outlet 118 is configured to be directly attached to a conduit 142. In such an embodiment, the conduit 142 can be positioned at least partially within the chamber 112 or otherwise in fluid communication with the chamber 112 through the fluid outlet 118. The fluid outlet 118 is sized and shaped to form at least a substantially fluid-tight seal with respect to the conduit 142, thereby substantially preventing bodily fluids from escaping from the chamber 112. The conduit 142 can be attached to the fluid outlet 118 (for example, to the first and second panels 108, 110) by bonding the fluid outlet 118 to the fluid outlet 118 by adhesive, welding, interference fit or friction fit or by other means. By attaching the conduit 142 to the fluid outlet 118, leakage can be prevented and the conduit 142 can be prevented from accidentally detaching from the fluid outlet 118. In one example, the conduit 142 can be attached to the fluid outlet 118 in the same manufacturing step of attaching the first and second panels 108, 110 to each other. In an embodiment, as shown, the fluid outlet 118 is configured to be indirectly attached to the conduit 142. In such an embodiment, the sheath 102 may include a port 130 that is directly attached to the fluid impermeable barrier 106 and configured to be attached to the conduit 142.

[0034] As described above, the sheath 102 also includes a fluid-permeable body comprising a fluid-permeable support 122 and a fluid-permeable membrane 123 positioned 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, for example, away from the penis and toward the inlet 130a of 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 positioned to contact the penis within the chamber 112 as the penis extends through the opening 114 / 124. Thus, in some embodiments, the fluid-permeable support 122 can be positioned between and in contact with the fluid-permeable membrane 123 and one of the first panel 108 or second panel 110 of the fluid-impermeable barrier 106. The fluid-permeable membrane 123 and / or fluid-permeable support 122 can also restrict the flow of urine from the penis.

[0035] In embodiments, the fluid-permeable support 122 includes a wicking material configured to draw body fluid away from the opening 114, thereby preventing the body fluid from escaping from the chamber 112. Such “wicking action” may not involve the absorption of fluid into the wicking material. In other words, after the material is exposed to the fluid and then removed from the fluid some time later, substantially no absorption of fluid into the material occurs. While no absorption is desirable, the term “substantially no absorption” may allow for a nominal amount of fluid absorption (e.g., absorbency) into the wicking material, e.g., less than about 30% by weight, less than 20% by weight, less than 15% by weight, less than 10% by weight, less than about 7% by weight, less than about 5% by weight, less than about 3% by weight, less than about 2% by weight, less than 1% by weight, or less than about 0.5% by weight of the dry weight of the wicking material. The wicking material can also draw the fluid generally into the interior of the chamber 112, as will be described in more detail later. In embodiments, the fluid-permeable support 122 is configured to adsorb or absorb body fluid. Similar to wicking materials, such adsorbent or absorbent materials can draw body fluid away from the opening 114, thereby preventing the body fluid from escaping from the chamber 112.

[0036] The fluid-permeable support 122 can be formed from any suitable porous material. For example, the fluid-permeable support 122 can be formed from nylon (e.g., spun nylon fibers), polyester, polyurethane, polyethylene, polypropylene, other porous polymers, hydrophobic foam, open-cell foam, wool, silk, flax, cotton (e.g., cotton gauze), felt, other fabrics, coated porous materials (e.g., water-repellent coated porous materials), any other suitable porous material, or a combination thereof.

[0037] In some embodiments (not shown), the fluid-permeable support 122 includes a first layer and a second layer comprising a woven 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. The first layer, the second layer, and the plurality of fibers of the fluid-permeable support 122 can each define a plurality of pores, thereby enabling the transport of bodily fluids and the circulation of air through the fluid-permeable support 122. The pores defined by the plurality of fibers can be at least one of the following: larger or more numerous, thereby reducing the likelihood of dry bodily fluids clogging the fluid-permeable support 122. In addition, the plurality of fibers of the fluid-permeable support 122 can prevent the porous material from collapsing due to vacuum forces.

[0038] The first layer, second layer, and multiple fibers of the fluid permeable support 122 can be formed from any suitable material, such as a hydrophobic material, a hydrophilic material, polyester, cotton, or any other porous material disclosed herein. In an embodiment, one or more of the first layer, second layer, or multiple fibers of the fluid permeable support 122 are formed from a hydrophobic material that suppresses the accumulation of bodily fluids inside the fluid permeable support 122, thereby facilitating the removal of bodily fluids from the chamber 112. In an embodiment, one or more of the first layer, second layer, or multiple fibers of the fluid permeable support 122 are formed from a hydrophilic material that allows the fluid permeable support 122 to temporarily store bodily fluids, thereby limiting the amount of bodily fluids that accumulate around an individual's skin. In an embodiment, two or more of the first layer, second layer, or multiple fibers of the fluid permeable support 122 are formed from different materials. According to an embodiment, the first layer can be formed from a hydrophobic material, and the multiple fibers can be formed from a hydrophilic material. Such a configuration may draw bodily fluids through the first layer and temporarily store them in the multiple fibers of the fluid-permeable support 122. However, the first layer can remain substantially dry due to its hydrophobicity, thereby making the fluid-permeable support 122 feel dry against the penis.

[0039] In such embodiments, the fluid-permeable membrane 123 may define the penile receptacle 131 or be located closer to the penile receptacle 131 than the fluid-permeable support 122. The fluid-permeable membrane 123 may be configured and / or structured to draw bodily fluids away from the penile receptacle 131, thereby minimizing the amount of bodily fluid present in the penile receptacle 131 or otherwise on the individual's skin. It should be noted that the fluid-permeable membrane 123 may also be configured to adsorb or absorb bodily fluids to minimize the amount of bodily fluid present in the penile receptacle 131 or otherwise 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), another soft fabric, another smooth fabric, a woven or nonwoven material (e.g., spun nylon fiber), or any other suitable porous material. By forming a fluid-permeable membrane 123 from gauze, a soft fabric, and / or a smooth fabric (or any of the other porous materials disclosed herein that may come into contact with the penis), friction caused by the fluid collection assembly 100 can be reduced.

[0040] The fluid permeable support 122 is configured to support the fluid permeable membrane 123 because the fluid permeable membrane 123 may be formed from a material that is relatively foldable, fragile, or otherwise easily deformed. For example, the fluid permeable support 122 can be positioned so that it is located between the fluid permeable membrane 123 and the fluid impermeable barrier 106. Thus, the fluid permeable support 122 can support the fluid permeable membrane 123 and maintain its position. In the fluid collection assembly shown in Figures 1A to 1E, the fluid permeable support 122 is positioned adjacent to (e.g., fixed to) the first panel 108 so that the fluid permeable support 122 is positioned between the fluid permeable membrane 123 and the first panel 108. The fluid-permeable membrane 123 can be positioned so as the penis extends through the opening 114 / 124, the penis is positioned between the fluid-permeable membrane 123 and the second panel 110, and is in contact with the penis in the chamber 112, generally on the opposite side of the opening 114 / 124. The fluid-permeable support 122 can be formed from any fluid-permeable material that is less deformable than the fluid-permeable membrane 123. For example, the fluid-permeable support 122 may include 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 can be formed from natural materials such as cotton, wool, silk, or a combination thereof. In such examples, the material may have a coating, such as a water-repellent coating, to prevent or limit the absorption of fluid into the material.

[0041] Examples of other materials that can form the fluid-permeable support 122 are disclosed in U.S. Provisional Patent Application No. 63 / 134,754 filed 7 January 2021, U.S. Provisional Patent Application No. 63 / 241,575 filed 8 September 2021, and U.S. Provisional Patent Application No. 63 / 247,491 filed 23 September 2021, each of which is incorporated herein by reference as a whole.

[0042] In embodiments, the fluid-permeable support 122 and / or the fluid-permeable membrane 123 may be a sheet (e.g., a multilayer sheet). The fluid-permeable support 122 and / or the fluid-permeable membrane 123 is a sheet if it is substantially planar when laid on a plane, does not define cavities (e.g., is not tubular), or its length and width are 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, by forming the fluid-permeable support 122 and / or the fluid-permeable membrane 123 as a sheet, the first panel 108, the second panel 110, and the fluid-permeable support 122 can each be made into a sheet. During the manufacturing 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 can 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 can have the same size as the first panel 108 and the second panel 110, or more preferably slightly smaller. Therefore, the fluid permeable support 122 and / or the fluid permeable membrane 123 can also be attached to the first panel 108 and the second panel 110 by attaching them to each other along their outer edges (e.g., top edge 136 and side edge 138). The fluid-permeable support 122 and / or fluid-permeable membrane 123 can be made slightly smaller than the first panel 108 and / or second panel 110 so that the fluid-permeable support 122 and / or fluid-permeable membrane 123 does not form a passage through the fluid-impermeable barrier 106 that could cause leakage of bodily fluids.Furthermore, by attaching the fluid-permeable support 122 and / or fluid-permeable membrane 123 to the first panel 108 and / or second panel 110, it is possible to prevent the fluid-permeable support 122 and / or fluid-permeable membrane 123 from moving significantly within the chamber 112, for example, from solidifying together near the fluid outlet 118. In one example, the fluid-permeable support 122 can 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., via an adhesive). In one example, the fluid-permeable support 122 and / or fluid-permeable membrane 123 may simply be placed within the chamber 112 without attaching the fluid-permeable support 122 and / or fluid-permeable membrane 123 to at least one of the first panel 108 or the second panel 110. In this embodiment, the fluid-permeable support 122 and / or fluid-permeable membrane 123 can have a shape other than a sheet, such as a hollow, generally cylindrical shape.

[0043] The fluid-permeable support 122 and / or fluid-permeable membrane 123 can exhibit a shape that roughly corresponds to the shape of the fluid-impermeable barrier 106, such that the fluid-permeable support 122 and / or fluid-permeable membrane 123 partially or substantially completely occupies all of the chamber 112. For example, as shown in the figure, the fluid-permeable support 122 and / or fluid-permeable membrane 123 can exhibit a roughly bullet shape. The fluid-permeable support 122 and / or fluid-permeable membrane 123 exhibits a roughly bullet shape when it includes a proximal portion 170 corresponding to a proximal region 160 and a distal region 172 extending from the proximal portion 170 and corresponding to a distal region 162. The proximal portion 170 can exhibit a substantially constant first width, and the distal portion 172 can exhibit a second width smaller than the first width. The second width can be constant or can vary (e.g., at a constant or variable rate). The fluid-permeable support 122 and / or fluid-permeable membrane 123 can have a shape other than a generally bullet shape, for example, a generally rectangular shape, a generally semi-elliptical shape, or any other suitable shape.

[0044] In general, the sheath 102 is substantially flat when the penis is not within the penile receiving area 131 and when the sheath 102 is lying on a plane. The sheath 102 is substantially flat because the fluid-impermeable barrier 106 is formed from the first panel 108 and the second panel 110 rather than being a generally tubular fluid-impermeable barrier. Furthermore, as previously stated, the fluid-permeable support 122 and / or fluid-permeable membrane 123 may be a sheet, which also makes the sheath 102 substantially flat. Note that the sheath 102 is described as substantially flat because, depending on the thickness of the fluid-permeable support 122 and / or fluid-permeable membrane 123, at least one of the fluid-permeable support 122 and / or fluid-permeable membrane 123 may form a slight bulge in the sheath 102, the port 130 may create a bulge around it, or the base 104 may pull on the surrounding portion of the sheath 102. Furthermore, it should be noted that the sheath 102 may be adaptable, and therefore may be placed on a non-flat surface during use (for example, lying between the testes, perineum, and / or thighs), and may conform to the shape of these surfaces, meaning that the sheath 102 may not be substantially flat during use.

[0045] The fluid collection assembly 100 can be used with both buried and unburied penises because the sheath 102 can be substantially flat when the penis is not within the penis receiving area 131 and when the sheath 102 is placed on a plane. For example, when the fluid collection assembly 100 is used with a buried penis, the penis does not extend into the penis receiving area 131, thereby allowing the sheath 102 to lie relatively flat across the aperture 124. When the sheath 102 lies relatively flat across the aperture 124, the fluid permeable membrane 123 extends across the aperture and is in close proximity to the buried penis. Therefore, the fluid permeable support 122 and / or fluid permeable membrane 123 receive and remove at least a substantial amount of bodily fluid that would otherwise accumulate against the individual's skin, thus preventing or inhibiting the accumulation of bodily fluid discharged from a buried penis against 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 deterioration. However, unlike other conventional fluid collection assemblies configured for use with a retracted penis, the fluid collection assembly 100 can still be used with a non-retracted penis, as it can still accommodate a non-retracted penis within the penis receiving area 131 even when the penis is fully erect. Furthermore, the ability of the sheath 102 to be substantially flat allows for more discreet use of the fluid collection assembly 100 than if the sheath 102 were substantially non-flat, thereby avoiding situations that might be embarrassing.

[0046] If the sheath 102 is substantially flat, the fluid-permeable support 122 and / or fluid-permeable membrane 123 can occupy substantially the entire chamber 112, and the penis receiving area 131 is in a collapsed state (shown as uncollapsed for illustrative purposes in Figures 1C and 1D). In other words, the sheath 102 may not define an area that is not always occupied by the fluid-permeable support 122 and / or fluid-permeable membrane 123. If the fluid-permeable support 122 and / or fluid-permeable membrane 123 occupies substantially the entire chamber 112, it is unlikely that bodily fluids discharged into the chamber 112 will accumulate for a long period of time, as the accumulation of bodily fluids can cause sanitary problems, generate odors, and / or cause discomfort and skin deterioration as the individual's skin remains in contact with the bodily fluids.

[0047] As mentioned above, the first panel 108, the second panel 110, the fluid-permeable support 122, and / or the fluid-permeable membrane 123 can 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 if they cannot maintain their shape when they are not supported. As mentioned above, 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. 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 when the size and shape of the penis changes (e.g., when erect), minimizing unoccupied space within the chamber 112 where bodily fluids may accumulate.

[0048] Returning to Figure 1D, the fluid-permeable support 122 may include a first surface in contact with the first panel 108, a second surface opposite the first surface and in contact with the fluid-permeable membrane 123, and two sides 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 sides of the fluid-permeable support 122, so that the fluid-permeable support 122 is not largely exposed within the chamber 122 (for example, substantially all of the 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 substantially all suction force to draw fluid from the fluid-permeable membrane 123 into the fluid-permeable support 122, and then directs the fluid to be drawn into the inlet 130a and removed from the chamber.

[0049] As described above, the fluid collection assembly 100 includes a base 104 configured to be attached to the skin surrounding the penis (e.g., the pubic region, thigh, testes, and / or perineum) and to which the penis is positioned. For example, the base 104 may define an aperture 124 configured therein to which the penis is positioned. The base 104 may be flexible, thereby allowing it to conform to any shape of the skin surface and reducing the pulling of the base 104 on the skin surface. The base 104 may be configured to be attached to an area surrounding the penis (e.g., the pubic region) without being attached to the thigh, as attaching the base 104 to the thigh may cause uncomfortable pulling when the individual moves. In one example, the base 104 may include a main attachment portion 174 and a secondary attachment portion 176. The main attachment portion 174 is configured to be attached to the pubic area, and the secondary attachment portion 176 is configured to be attached to the area around the penis excluding the pubic area (e.g., the upper part of the testicles). The main attachment portion 174 may have a generally rectangular or trapezoidal shape. The main attachment portion 174 may extend further from the aperture 124 than the secondary attachment portion 176, as the pubic area is less sensitive and wider than other areas around the penis. The secondary attachment portion 176 may include one or more concave lateral edges 178. The concave lateral edges 178 can help prevent the secondary attachment portion 176 from attaching to the individual's thigh. It should be noted that the corners of the base 104 are all rounded to prevent or at least prevent the base 104 from pressing uncomfortably against the individual.

[0050] The base 104 can have a shape other than the one shown in Figure 1E. For example, the base 104 can have a generally partially triangular shape having three vertices and sides extending between each vertex. The vertices can be rounded to prevent the base 104 from digging into and injuring an individual. The aperture 124 may be located off-center and closer to one vertex than the others. Other examples of shapes that the base 104 can form are disclosed in PCT application PCT / US2021 / 015787, filed on 29 January 2021, which is incorporated herein by reference in its entirety.

[0051] In embodiments not shown, the aperture 124 may have a generally circular shape. In embodiments, as shown, the aperture 124 may have a non-circular shape. The non-circular shape of the aperture 124 can be selected to correspond to the cross-sectional shape of the base of the penis and / or to fit well with the area around the penis, either or both of which can limit leakage and accumulation of bodily fluids. For example, as shown, the aperture 124 may have a generally bell shape. The generally bell shape includes a concave upper edge 180 (relative to the interior of the aperture 124) and a concave lower edge 182 opposite the concave upper edge 180. The generally bell shape also includes two convex side edges 184 extending between the upper and lower edges 180, 182. Any corners between the upper edge, lower edge, and side edges 180, 182, 184 can be rounded. The two convex side edges 184 vary the width of the aperture 124. For example, the two convex lateral edges 184 make the width of the aperture 124 near the upper edge 180 smaller than the width of the aperture 124 near the lower edge 182. The generally bell shape of the aperture 124 allows it to conform to the shape of the base of the penis, thereby preventing bodily fluids from leaking out of the chamber 112 and suppressing the accumulation of bodily fluids. The aperture 124 can exhibit other non-circular shapes such as generally triangular, generally trapezoidal, generally lemniscate, or any other suitable non-circular shape.

[0052] The base 104 may include a substrate having an upper and a lower surface. The upper surface is closer to the sheath 102 than the lower surface, and the lower surface is closer to the individual's skin than the upper surface. The base 104 may also include an adhesive layer located on at least a portion of the lower 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 configured to be easily removed from the adhesive layer and to prevent the adhesive layer from accidentally adhering to an object. The substrate may be formed from a fluid-impermeable material to prevent bodily fluids from leaking from the chamber 112 through the base 104.

[0053] In one embodiment, the entire base 104 is attached to the sheath 102, thereby reinforcing the attachment between the sheath 102 and the base 104. In another embodiment, as shown in the figure, only the inner portion of the base 104 that defines or is adjacent to the aperture 124 is attached to the sheath 102. Attaching only the inner portion of the base 104 to the sheath 102 may be sufficient to maintain 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 user of the fluid collection assembly 100 to easily handle the outer portion of the base 104 (e.g., the portion of the base 104 other than the inner portion), thereby facilitating the attachment of the base 104 to the individual.

[0054] In one embodiment, the base 104 can be attached to the second panel 110 before the second panel 110 is attached to the first panel 108, thereby facilitating attachment of the base 104 to the sheath 102 using, for example, US welding, RF welding, and impulse heating. If the base 104 is attached to the second panel 110 before the fluid permeable support 122 is positioned (e.g., fixed) in the chamber 112, the base 104 may get in the way, making it difficult to fix the fluid permeable support 122 in the chamber 112. In one example, as shown in the figure, the base 104 and the fluid permeable support 122 can each define one or more base gaps 196 and one or more porous material gaps 198. The base gaps 196 and porous material gaps 198 can be aligned with each other so 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 opposing portions of the fluid-impermeable barrier 106 that are generally aligned with the base gap 196 and the porous material gap 198 to be attached to each other (e.g., using US welding, RF welding, impulse heating, direct heating, heat staking, etc.). By attaching the opposing portions of the fluid-impermeable barrier 106 to each other, the fluid-permeable support 122 can be fixed within the chamber 112. In a particular example, as shown in the figure, the base gap 196 and the porous material gap 198 can be formed on portions of the base 104 and the fluid-permeable support 122 that are adjacent to or above the portion of the aperture 124 furthest from the fluid outlet 118 (e.g., further away from the fluid outlet 118). Such positioning of the base gap 196 and the porous material gap 198 allows the fluid-permeable support 122 to remain extended across the aperture 124. An example of the base 104 is disclosed in International Application No. PCT / US22 / 14285, filed on 28 January 2022, which is incorporated herein by reference in its entirety.

[0055] Port 130 includes a first portion located within the fluid collection assembly 100 and a second portion located outside the fluid collection assembly 100. Thus, port 130 can extend through the fluid outlet 118. For example, the first portion of port 130 can optionally be located at least partially within the chamber 112. The second portion is configured to be attached to a conduit 142 (e.g., a tube) that fluid-connects to a vacuum source or pump. The first portion defines an inlet 130a, and the second portion defines an outlet 130b of port 130, downstream of the inlet 130a. Port 130 also defines a channel or conduit extending from the inlet 130a to the outlet 130b. The inlet 130a can be located within the distal region 172 of the fluid-permeable support 122.

[0056] In some embodiments, the inlet 130a is positioned at least adjacent to the fluid permeable support 122, and the fluid permeable membrane 123 is not present between the inlet 130a and the fluid permeable support 122. For example, the inlet 130a can be oriented to contact a portion of the fluid permeable support 122. In some embodiments, the fluid permeable support 122 includes an opening or recess configured to receive the inlet 130a therein, such that the inlet is positioned adjacent to or in contact with the fluid permeable support 122 without contacting the fluid permeable membrane 123. In some embodiments, the inlet 130a is positioned on the side wall of a first portion of the port 130, and the first portion of the port 130 includes a covered end portion 130c positioned adjacent to the fluid permeable membrane 123.

[0057] In some embodiments (not shown), the inlet 130a is positioned at the end of the port 130, and the inlet 130a is positioned on the upper surface of the fluid permeable support 122 in contact with the first panel 108. In other words, the port 130 extends through the first panel 108, and the inlet 130a can be positioned relative to the surface of the fluid permeable support in contact with the first panel 108. In these and other embodiments, the port 130 may include a disk positioned adjacent to the inlet 130a, and the disk can be positioned between the fluid permeable support 122 and the first panel 108. Furthermore or alternatively, the disk can be fixed to the outer surface of the first panel 108 with the inlet 130 aligned with the outlet 108. In these and other embodiments, 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, and the fluid-permeable membrane 123 may terminate before the distal intersection between the first panel 108 and the second panel 110. The distal region 162 of the fluid-impermeable barrier 106 may then include only the fluid-permeable support 122 directly positioned (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 this distal end of the fluid-permeable membrane 123.

[0058] In some embodiments, port 130 can be configured similarly to port 280 (shown in Figure 2E) such that the inlet 280a is located at the end of the first portion of port 280 and positioned adjacent to the terminal portion 172a of the fluid permeable support 122 in the distal region 172. The first panel 108 and the second panel 110 can be sealed or fitted such that the terminal portion 172a of the fluid permeable support 123 in the distal region 172 is in contact only with the fluid impermeable barrier 106 and the inlet 280a (for example, the terminal portion 172a is not exposed within the chamber 112).

[0059] By positioning the inlet 130a adjacent to or in contact with the fluid permeable support 122 such that the fluid permeable membrane 123 is not present between the inlet 130a and the fluid permeable support 122, the technical effect is obtained in that fluid transfer from the fluid permeable support 122 to the port 130 is improved and removed from the chamber 112. In some embodiments, at least a second portion of the port 130 is angled and / or curved with respect 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 angled from the inlet 130a through the fluid outlet 118 toward the proximal region 160 of the fluid impermeable barrier 106, at least partially. The orientation and configuration of the port 130 result in the technical effect of reducing any bending that may occur in the conduit 142 fixed to the port 130 and orienting the conduit 142 toward the head of the bed where the fluid collection canister is likely to be positioned. This makes it possible to reduce the number of vacuum tubes (e.g., conduit 142) used, and also reduces the lifting of the bottom of the fluid collection assembly 100, thereby improving the fluid flow in the fluid collection assembly.

[0060] Returning to Figures 1A to 1D, as previously mentioned, the fluid collection assembly 100 includes a conduit 142. The conduit 142 may be made of a flexible material such as a plastic tube (e.g., a medical tube). Such plastic tubes may include thermoplastic elastomers, polyvinyl chloride, ethylene vinyl acetate, polytetrafluoroethylene, and the like. In some examples, the conduit 142 may be made of silicone or latex. In some examples, the conduit 142 may include one or more elastic parts, for example, by having one or more of a diameter or wall thickness that allows the conduit to be flexible.

[0061] As will be described in more detail later, the conduit 142 is configured to be attached to one or more of a fluid reservoir (not shown) and a vacuum source (not shown), and to extend at least partially between them. In one example, the conduit 142 is configured to be directly connected to a vacuum source (not shown). In such an example, the conduit 142 may extend from the fluid-impermeable barrier 106 for at least 1 foot, at least 2 feet, at least 3 feet, or at least 6 feet or more. In another example, the conduit 142 is configured to be indirectly connected to at least one of the fluid reservoir (not shown) and the vacuum source (not shown). In some examples, the conduit is fixed to the wearer's skin using a catheter fixation device, such as a STATLOCK® catheter fixation device available from CRBard, Inc., including, but not limited to, those disclosed in U.S. Patents 6,117,163, 6,123,398, and 8,211,063. All of these disclosures are incorporated herein by reference as a whole.

[0062] The inlet and outlet of the conduit 142 are configured to fluid-couple (e.g., directly or indirectly) a vacuum source (not shown) to the chamber 112. When the vacuum source (Figure 3) applies vacuum / vacuum pressure to the conduit 142, bodily fluids in the chamber 112 may be drawn into the inlet 148 and out of the fluid collection assembly 100 through the conduit 142. In some examples, the conduit 142 can be made frosted or opaque (e.g., black) to prevent visibility of the bodily fluids within it.

[0063] In some examples, the vacuum source can be located far from the fluid collection device. In such examples, the conduit 142 can be fluidly connected to a fluid storage container that can be located between the vacuum source and the fluid collection assembly 100.

[0064] During operation, a man using the fluid collection assembly 100 can discharge bodily fluids (e.g., urine) into the chamber 112. The bodily fluids may accumulate in the chamber 112 or be collected in the chamber 112 in other ways (e.g., received in the fluid-permeable support 122). At least some of the bodily fluids may be drawn into the conduit 142 through the inlet. The bodily fluids may be drawn out of the fluid collection assembly 100 via the vacuum / vacuum pressure supplied by the vacuum source. During operation, even if bodily fluids flow into the chamber 112 and then are removed from the chamber 112, the vent 134 can substantially maintain the pressure inside the chamber 112 at atmospheric pressure.

[0065] In some embodiments, the fluid-permeable support 122 and the fluid-permeable membrane 123 may be positioned or fixed on a second panel 110 (e.g., a panel or side of the assembly including the fluid openings 114 / 124). Referring to Figures 2A to 2D, Figure 2A is an isometric view from above of a fluid collection assembly in which the fluid-permeable support 122 and the fluid-permeable membrane 123 are positioned or fixed on a second panel 110. Figures 2B and 2C are schematic cross-sectional views of the fluid collection assembly 200 cut along planes 2B-2B and 2C-2C, respectively, and Figure 2D is an exploded isometric view of the fluid collection assembly shown in Figure 2A. Unless otherwise noted or stated, the fluid collection assembly 200 may include any embodiment of the fluid collection assembly 100 described above.

[0066] In some embodiments of the fluid collection assembly 200, the fluid permeable support 123 is positioned adjacent to (e.g., fixed to) the second panel 110 (e.g., or a side of the assembly defining the opening 114 / 124), and the fluid permeable support 122 is positioned between the fluid permeable membrane 123 and the second panel 110. In this configuration, the fluid permeable membrane 123 is positioned to contact the penis within the chamber 112 when the penis extends through the opening 114 / 124, with the penis between the fluid permeable membrane 123 and the first panel 108. This configuration and positioning of the fluid permeable support 122 and the fluid permeable membrane 123 may result in the technical effect of guiding more urine into the fluid permeable support 122 for removal from the fluid collection assembly 200.

[0067] Port 230 of fluid collection assembly 200 can be similar to port 130 of fluid collection assembly 100. For example, port 230 may include a first portion located within fluid collection assembly 100 and a second portion located outside fluid collection assembly 100. Thus, port 230 may extend through fluid outlet 118. For example, the first portion of port 230 may optionally be located at least partially within chamber 112. The second portion of port 230 is configured to be attached to a conduit 142 (e.g., a tube) that fluid-connects to a vacuum source or pump. The first portion of the port defines an inlet 230a, and the second portion defines an outlet 130b of port 230, which is downstream of inlet 230a. In these and other embodiments, inlet 230a is located at the end of the first portion of port 230. Port 230 also defines a channel or conduit extending from inlet 130a to outlet 130b. The inlet 230a can be located within the distal region 172 of the fluid-permeable support 122.

[0068] In some embodiments, the inlet 230a is positioned at least adjacent to or in contact with the fluid permeable support 122 such that the fluid permeable membrane 123 is not present between the inlet 230a and the fluid permeable support 122. For example, a first portion of the port 230 may extend through an opening or hole 121 in the fluid permeable membrane 123 such that the inlet 230a is in contact with or abuts against a surface of the fluid permeable support 122. More specifically, the inlet 230a may be in contact with or abut against the same generally general surface of the fluid permeable support 122 that is in contact with the fluid permeable membrane 123.

[0069] By positioning the inlet 230a adjacent to the fluid-permeable support 122, a technical benefit is obtained in which the fluid transfer from the fluid-permeable support 122 to the port 230 for removal from the chamber 112 is improved. In some embodiments, at least a second portion of the port 230 is angled and / or curved with respect 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 angled at least partially toward the proximal region 160 of the fluid-impermeable barrier 106, generally from the inlet 230a through the fluid outlet 118. The orientation and configuration of the port 230 result in a technical benefit in which any bending that may occur in the conduit 142 fixed to the port 230 is reduced.

[0070] In some embodiments, the port 230 may include a disk positioned adjacent to the inlet 230a, the disk of which may be positioned between the fluid-permeable support 122 and the first panel 108. Alternatively, the disk of the port 230 may be fixed to the outer surface of the first panel 108 with the inlet 130 aligned with the 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, and the fluid-permeable membrane 123 may terminate before the distal intersection between 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 include only a fluid-permeable support 122 that is directly positioned (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 first panel 108, and the fluid-permeable support 122 may extend distally beyond this distal end of the fluid-permeable membrane 123.

[0071] Referring to Figure 2C, the fluid-permeable support 122 may include a first surface in contact with the second panel 110, a second surface opposite the first surface and in contact with the fluid-permeable membrane 123, and two sides 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 sides of the fluid-permeable support 122, so that the fluid-permeable support 122 is not largely exposed within the chamber 122 (for example, substantially all of the 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 substantially all suction force to draw fluid from the fluid-permeable membrane 123 into the fluid-permeable support 122, and then directs the fluid to be drawn into the inlet 130a and removed from the chamber.

[0072] In some embodiments, the ports of the fluid collection assembly can be curved. Figure 2E is a schematic cross-sectional view of a fluid collection assembly 250 according to an embodiment. Unless otherwise specified, the fluid collection assembly 250 can include any form of the fluid collection assembly 200. In some embodiments, the fluid collection assembly 250 can include a port 280 having an inlet 280a positioned adjacent to the end of the fluid permeable support 122 in the distal region 172. A first portion of the port 280 can extend distally from the inlet 280a, then curve or angle to extend proximal, 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 can be sealed or mounted such that the terminal portion 172a of the fluid-permeable support 123 in the distal region 172 is in contact only with the fluid-impermeable barrier 106 and the inlet 280a (for example, the terminal portion 172a is not exposed within the chamber 112).

[0073] Figure 3 is a block diagram of a system 307 for fluid collection according to an embodiment. The 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 of the fluid collection assemblies disclosed herein. The fluid collection assembly 300, the fluid storage container 309, and the vacuum source 311 can be fluidly connected to each other via one or more conduits 342. For example, the fluid collection assembly 300 can be operably coupled to one or both of the fluid storage container 309 or the vacuum source 311 via the conduits 342. Body fluids (e.g., urine or other body fluids) collected in the fluid collection assembly 300 can be removed from the fluid collection assembly 300 via the conduits 342 protruding into the fluid collection assembly 300. A vacuum force can be introduced into the chamber of the fluid collection assembly 300 via the inlet of the conduits 342 in response to a vacuum force (e.g., vacuum pressure) applied to the outlet of the conduits 342.

[0074] A vacuum force can be applied directly or indirectly to the outlet of the conduit 342 by the vacuum source 311. The vacuum force can also be applied indirectly via the fluid storage container 309. For example, the outlet of the conduit 342 can be located within the fluid storage container 309, and an additional conduit 342 can extend from the fluid storage container 309 to the vacuum source 311. Thus, the vacuum source 311 can apply a vacuum to the fluid collection assembly 300 via the fluid storage container 309. Alternatively, the vacuum force can be applied directly by the vacuum source 311. For example, the outlet of the conduit 342 can be located within the vacuum source 311. An additional conduit 342 can extend from the vacuum source 311 to a point outside the fluid collection assembly 300, such as the fluid storage container 309. In such an example, the vacuum source 311 can be located between the fluid collection assembly 300 and the fluid storage container 309.

[0075] The fluid storage container 309 is sized and shaped to hold a fluid within it. The fluid storage container 309 may include a bag (e.g., a drainage bag), a bottle or cup (e.g., a collection bottle), or a sealed container for storing any other bodily fluids. In some examples, a conduit 342 may extend from the fluid collection assembly 300 and be attached to the fluid storage container 309 at a first point. An additional conduit 342 may be attached to the fluid storage container 309 at a second point and extend to a vacuum source 311. Thus, a vacuum (e.g., vacuum pressure) can be drawn from the fluid collection assembly 300 through the fluid storage container 309. Fluids such as urine can be discharged from the fluid collection assembly 300 using the vacuum source 311.

[0076] The 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. The vacuum source 311 can supply vacuum to remove fluid from the fluid collection assembly 300. In some examples, the 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 manual power (e.g., a manually operated vacuum pump). In some examples, the vacuum source 311 may be sized and shaped to fit outside, on top of, or inside the fluid collection assembly 300. For example, the vacuum source 311 may include one or more miniaturized pumps or one or more micropumps. The 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 the vacuum source 311.

[0077] Figure 4 is a flowchart of a method 400 for manufacturing a fluid collection assembly according to an embodiment. Method 400 can form any of the fluid collection assemblies disclosed herein. Method 400 may include operation 405, which describes "providing a fluid-impermeable barrier comprising a first panel and a second panel defining an opening, the opening being sized to allow at least a portion of the penis to pass through." Method 400 may include operation 410, which describes "attaching the outer periphery of the first panel to the outer periphery of the second panel to form a sheath having a proximal region containing an opening, a distal region extending from the proximal region, and a fluid outlet in the distal region. The fluid-impermeable barrier defines at least a chamber." Method 400 may include operation 415, which describes "positioning a fluid permeable body having a fluid permeable support and a fluid permeable membrane including a wicking material within a chamber such that the fluid permeable membrane is positioned to contact the penis within the chamber as the penis extends through the opening; a port extending through a fluid outlet, with a first portion of the port defining an inlet positioned 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 defining an outlet positioned outside the chamber and configured to be attached to a conduit."

[0078] In some embodiments, operation 415 includes positioning (e.g., fixing) the fluid permeable support so that it is positioned between the fluid permeable membrane and the second panel, and the fluid permeable membrane is positioned so that it contacts the penis in the chamber with the penis positioned between the fluid permeable membrane and the first panel as the penis extends through the opening. In these and other embodiments, method 400 may include positioning (e.g., fixing) a port including a fluid outlet in a distal region, the port including a first portion defining an inlet positioned at least adjacent to the fluid permeable support and a second portion defining an outlet positioned outside the chamber, the second portion being configured to be attached to a conduit. In these and other embodiments, at least the second portion of the port may be angled and / or curved with respect to the longitudinal axis of the fluid collection assembly from the first portion toward the proximal region.

[0079] In some embodiments, operation 415 includes positioning (e.g., fixing) the fluid permeable support to the first panel such that the fluid permeable support is positioned between the fluid permeable membrane and the first panel, and the fluid permeable membrane is positioned so that it contacts the penis in the chamber with the penis positioned between the fluid permeable membrane and the second panel as the penis extends through the opening. In these and other embodiments, method 400 may include an operation to fix a port including a fluid outlet in the distal region, the port including a first portion defining an inlet positioned at least adjacent to the fluid permeable support and a second portion defining an outlet positioned outside the chamber, the first portion extending through the fluid permeable membrane and the second portion being configured to be attached to a conduit. In these and other embodiments, at least the second portion of the port may be angled and / or curved with respect to the longitudinal axis of the fluid collection assembly from the first portion toward the proximal region. In some embodiments, method 400 further includes an operation to position the inlet on a surface of the fluid permeable support in contact with the fluid permeable membrane. In some embodiments, method 400 further includes the operation of positioning the inlet adjacent to the terminal portion of the fluid permeable support in the distal region.

[0080] In some embodiments, method 400 further includes covering the contact surface of the fluid permeable support and two sides of the fluid permeable support with a fluid permeable film.

[0081] The actions of Method 400 are for illustrative purposes only and can be performed in a different order, divided into multiple actions, modified, supplemented, or combined. In one example, one or more actions of Method 400 can be omitted from Method 400.

[0082] It should be noted that the embodiments disclosed above relate to fluid collection assemblies configured to collect bodily fluids from males. However, it should also be noted that since the female urethral opening is functionally similar to that of a buried penis, such fluid collection assemblies can also be used to collect bodily fluids from females.

[0083] While various aspects and embodiments are disclosed herein, other aspects and embodiments are also conceivable. The various aspects and embodiments disclosed herein are for illustrative purposes only and are not intended to limit the scope of the invention.

[0084] Degree terms (e.g., "approximately," "substantially," "generally," etc.) indicate variations that are not structurally or functionally significant. In one example, when a degree term is used together with a quantity term, the degree term is interpreted to mean ±10%, ±5%, or +2% of the quantity term. 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 curved corners instead of sharp corners, curved edges instead of straight edges, one or more projections extending from there, be rectangular, or be the same as the disclosed shape.

Claims

1. A fluid collection assembly, 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 attached to the first panel defining an opening in the proximal region of the fluid-impermeable barrier that is sized to allow at least a portion of the penis to pass through, and a fluid outlet in the distal region, wherein the fluid-impermeable barrier defines at least a chamber, A fluid-permeable body disposed within the chamber, A fluid-permeable support, A fluid permeable membrane comprising a wicking material, wherein the fluid permeable support is positioned to be located between the fluid permeable membrane and one of the first panel or the second panel, and is positioned to contact the penis within the chamber as the penis extends through the opening, A fluid-permeable body including, A port extending through the fluid outlet, comprising: (1) a first portion defining an inlet positioned adjacent to the fluid permeable support such that the fluid permeable membrane is not present between the inlet and the fluid permeable support; and (2) a second portion defining an outlet positioned outside the chamber and configured to be attached to a conduit, A fluid collection assembly characterized by including the following:

2. A fluid collection assembly according to claim 1, wherein the fluid permeable support is positioned between the fluid permeable membrane and the first panel, and the fluid permeable membrane is positioned so as the penis extends through the opening, the penis is positioned between the fluid permeable membrane and the second panel and is in contact with the penis within the chamber.

3. A fluid collection assembly according to claim 2, characterized in that at least the second portion of the port is angled and / or curved with respect to the longitudinal axis of the fluid collection assembly from the first portion toward the proximal region.

4. A fluid collection assembly according to claim 2 or 3, characterized in that the inlet is located on the side wall of the first portion of the port, and the covered end portion of the first portion is located adjacent to the fluid permeable membrane.

5. A fluid collection assembly according to claim 2, The inlet is located at the end of the first portion and is positioned adjacent to the terminal end of the fluid permeable support in the distal region. A fluid collection assembly characterized in that the port extends distally from the inlet, and then curves and / or forms an angle to extend proximal.

6. A fluid collection assembly according to claim 1, wherein the fluid permeable support is positioned between the fluid permeable membrane and the second panel, and the fluid permeable membrane is positioned so as the penis extends through the opening, the penis is positioned between the fluid permeable membrane and the first panel and is in contact with the penis within the chamber.

7. A fluid collection assembly according to claim 6, wherein the first portion of the port extends through a pore in the fluid permeable membrane, thereby positioning the inlet adjacent to the fluid permeable support, and the fluid permeable membrane is not present between the inlet and the fluid permeable support.

8. A fluid collection assembly according to claim 7, wherein at least the second portion of the port is angled and / or curved with respect to the longitudinal axis of the fluid collection assembly toward the proximal region from the first portion, and the inlet is positioned on the surface of the fluid permeable support in contact with the fluid permeable membrane.

9. A fluid collection assembly according to claim 6, The inlet is positioned adjacent to the terminal end of the fluid-permeable support in the distal region, A fluid collection assembly characterized in that the port extends distally from the inlet, and then curves and / or forms an angle to extend proximal.

10. A 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 that is aligned with the opening of the second panel and is sized to allow at least a portion of the penis to pass through.

11. A fluid collection assembly according to any one of claims 1 to 10, wherein the fluid permeable membrane comprises a gauze material or a wicking cloth material.

12. A fluid collection assembly according to any one of claims 1 to 11, wherein the fluid permeable support comprises a porous spun fiber structure.

13. A fluid collection assembly according to claim 12, wherein the fluid permeable support comprises a porous spun nylon fiber structure.

14. A fluid collection assembly according to any one of claims 1 to 13, The fluid-permeable support includes a first surface in contact with one of the first panel or the second panel, a second surface on the opposite side of the first surface in contact with the fluid-permeable film, and two sides extending between the first surface and the second surface. A fluid collection assembly characterized in that at least one of the fluid permeable membrane, the second panel, and / or the second panel covers the two sides of the fluid permeable support, so that substantially the entire fluid permeable support is covered within the chamber by the first panel, the second panel, and / or the fluid permeable membrane, and the fluid permeable support is not exposed within the chamber.

15. It is a system, A fluid collection assembly according to any one of claims 1 to 14, A vacuum source configured to apply a vacuum force, Fluid storage container and Connected to the outlet and in fluid communication with the vacuum source and the fluid storage container, at least one conduit, A system characterized by including

16. A method for manufacturing a fluid collection assembly, To provide a fluid-impermeable barrier including a first panel and a second panel defining an opening, wherein the opening is sized to allow at least a portion of the penis to pass through, 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 in the distal region, wherein the fluid impermeable barrier defines at least the chamber. Positioning a fluid-permeable body having a fluid-permeable support and a fluid-permeable membrane including a wicking material within the chamber, wherein the fluid-permeable membrane is positioned to contact the penis within the chamber as the penis extends through the opening, and a port extends through the fluid outlet, the first portion of the port defining an inlet positioned adjacent to the fluid-permeable support such that the fluid-permeable membrane is not present between the inlet and the fluid-permeable support, and the second portion of the port defining an outlet positioned outside the chamber and configured to be attached to a conduit, A method characterized by including

17. The method according to claim 16, wherein positioning the fluid permeable body within the chamber is A method comprising positioning the fluid permeable support such that the fluid permeable support is positioned between the fluid permeable membrane and the first panel, and positioning the fluid permeable membrane so that it contacts the penis within the chamber when the penis extends through the opening and the penis is positioned between the fluid permeable membrane and the second panel.

18. A method according to claim 17, characterized in that at least the second portion of the port is angled and / or curved with respect to the longitudinal axis of the fluid collection assembly from the first portion toward the proximal region.

19. A method according to claim 17 or 18, characterized in that the inlet is located on the side wall of the first portion of the port, and the covered end portion of the first portion is located adjacent to the fluid permeable membrane.

20. The method according to claim 17, The inlet is located at the end of the first portion and is positioned adjacent to the terminal end of the fluid permeable support in the distal region. A method characterized in that the port extends distally from the inlet, and then curves and / or forms an angle to extend proximal.

21. The method according to claim 16, wherein positioning the fluid permeable body within the chamber is A method characterized by positioning the fluid permeable support such that the fluid permeable support is positioned between the fluid permeable membrane and the second panel, and positioning the fluid permeable membrane so that when the penis extends through the opening, the penis is positioned between the fluid permeable membrane and the first panel and in contact with the penis within the chamber.

22. A method according to claim 21, characterized in that the first portion extends through the pores of the fluid permeable membrane.

23. A method according to claim 22, characterized in that at least the second portion of the port is angled and / or curved with respect to the longitudinal axis of the fluid collection assembly from the first portion toward the proximal region, and the inlet is positioned on the surface of the fluid permeable support in contact with the fluid permeable membrane.

24. A method according to claim 21, characterized in that the inlet is positioned adjacent to the terminal portion of the fluid permeable support in the distal region, and the port extends distally from the inlet, and then curves and / or extends proximal at an angle.

25. A method according to any one of claims 20 to 24, characterized in that the fluid permeable support and the fluid permeable membrane each include an opening that is aligned with the opening of the second panel and is sized to allow at least a portion of the penis to pass through.

26. A method according to any one of claims 16 to 25, characterized in that the fluid permeable membrane comprises a gauze material or a wicking cloth material.

27. A method according to any one of claims 16 to 26, characterized in that the fluid-permeable support comprises a porous spun fiber structure.

28. A method according to claim 27, characterized in that the fluid-permeable support comprises a porous spun nylon fiber structure.

29. A method according to any one of claims 16 to 28, characterized in that positioning a fluid permeable body within the chamber includes positioning the fluid permeable body within the chamber such that substantially all of the fluid permeable support is covered within the chamber by the first panel, the second panel, and / or the fluid permeable membrane, and the fluid permeable support is not exposed within the chamber.

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