WO2025038088A1 - Ensembles et systèmes de collecte de fluide mâle, procédés d'utilisation, et procédés pour les fabriquer - Google Patents
Ensembles et systèmes de collecte de fluide mâle, procédés d'utilisation, et procédés pour les fabriquer Download PDFInfo
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- WO2025038088A1 WO2025038088A1 PCT/US2023/030373 US2023030373W WO2025038088A1 WO 2025038088 A1 WO2025038088 A1 WO 2025038088A1 US 2023030373 W US2023030373 W US 2023030373W WO 2025038088 A1 WO2025038088 A1 WO 2025038088A1
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- Prior art keywords
- fluid
- fluid permeable
- panel
- permeable membrane
- penis
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
- A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Colostomy devices
- A61F5/451—Genital or anal receptacles
- A61F5/453—Genital or anal receptacles for collecting urine or other discharge from male member
Definitions
- a person or animal may have limited or impaired mobility such that typical urination processes are challenging or impossible.
- a person may experience or have a disability that impairs mobility.
- a person may have restricted travel conditions such as those experienced by pilots, drivers, and workers in hazardous areas. Additionally, sometimes urine collection is needed for monitoring purposes or clinical testing.
- Urinary catheters such as a Foley catheter
- urinary catheters can be uncomfortable, painful, and can lead to complications, such as infections.
- bed pans which are receptacles used for the toileting of bedridden patients, such as those in a health care facility, are sometimes used. Bed pans, however, can be prone to discomfort, spills, and other hygiene issues.
- Embodiments disclosed herein are directed to male fluid collection assemblies, systems including the same, methods of manufacturing the same, and methods of using the same.
- a 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 and defining an opening in the proximal region of the fluid impermeable barrier sized to receive at least a portion of a penis therethrough, and a fluid outlet at the distal region.
- the fluid impermeable barrier at least partially defines a chamber.
- the fluid collection assembly includes a fluid permeable body disposed in the chamber.
- the fluid permeable body includes a fluid permeable support and a fluid permeable membrane including a wicking material.
- the fluid permeable membrane is disposed such that the fluid permeable support is positioned between the fluid permeable membrane and one of the first panel or the second panel.
- the fluid permeable support, the fluid permeable membrane, and the fluid impermeable barrier are not secured to one another e.g., the fluid permeable support and the fluid permeable membrane are movable within the chamber).
- the fluid permeable membrane is positioned to contact the penis in the chamber when the penis extends through the opening.
- the fluid collection assembly also includes a port extending through the fluid outlet.
- the port includes a first part defining an inlet positioned adjacent to the fluid permeable support such that the fluid permeable membrane is absent between the inlet and the fluid permeable support.
- the port includes a second part defining an outlet positioned outside the chamber and configured to attach to a conduit.
- a method of manufacturing a fluid collection assembly includes providing a fluid impermeable barrier including a first panel and a second panel defining an opening.
- the opening is sized to receive at least a portion of a penis therethrough.
- the method also includes attaching an outer periphery of the first panel to an 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 at the distal region, the fluid impermeable barrier at least defining a chamber.
- the method also includes positioning a fluid permeable body having a fluid permeable support and a fluid permeable membrane including a wicking a material in the chamber such that the fluid permeable membrane is positioned to contact the penis in the chamber when the penis extends through the opening, and a port extends through the fluid outlet with a first part of the port defining an inlet that is positioned adjacent to the fluid permeable support such that the fluid permeable membrane is absent between the inlet and the fluid permeable support, a second part of the port defining an outlet positioned outside the chamber and configured to attach to a conduit.
- FIGS. 1A and IB are isometric top and bottom views, respectively, of a fluid collection assembly, according to an embodiment.
- FIGS. 1C and ID are cross-sectional schematics of the fluid collection assembly taken along planes 1C-1C and ID-ID, respectively, according to any embodiment.
- FIG. IE is an exploded isometric view of the fluid collection assembly shown in FIG. 1A.
- FIG. 2A is an isometric top view of a fluid collection assembly, according to an embodiment.
- FIGS. 2B and 2C are cross-sectional schematics of the fluid collection assembly taken along planes 2B-2B and 2C-2C, respectively, according to an embodiment.
- FIG. 2D is an exploded isometric view of the fluid collection assembly shown in FIG. 2A, according to an embodiment.
- FIG. 2E is a cross-sectional schematic of a fluid collection assembly, according to an embodiment.
- FIG. 3 is a block diagram of a system for fluid collection, according to an embodiment.
- FIG. 4 is a flow diagram of a method to collect fluid, according to an embodiment.
- Embodiments disclosed herein are directed to male fluid collection assemblies, systems including the same, methods of manufacturing the same, and methods of using the same.
- An example fluid collection assembly includes a sheath, a fluid permeable body, and a base.
- the sheath includes a fluid impermeable barrier having a proximal region and a distal region extending from the proximal region.
- the proximal region defines an opening and the distal region defines a fluid outlet.
- the fluid impermeable barrier at least partially defines a chamber.
- the fluid permeable body e.g., porous material
- the fluid permeable body may include a fluid permeable support and a fluid permeable membrane.
- the fluid permeable membrane includes a wicking material and is disposed adjacent (e.g. , secured to) the fluid permeable support such that the fluid permeable membrane is positioned to contact the penis in the chamber when the penis extends through the opening.
- the fluid permeable membrane and the fluid impermeable barrier of the sheath may close over the sides of the fluid permeable support so that air and the vacuum escaping through the matrix is prevented or inhibited.
- the fluid collection assembly also may include a conduit having an inlet disposed in the chamber adjacent the fluid permeable support.
- the base may be attached (e.g., permanently attached) to the sheath or the base may be configured to be secured to the sheath at some time period in the future.
- the base defines an aperture that is aligned with the opening when the base is attached to the sheath.
- the base is configured to be secured to a region about a penis of an individual with the aperture positioned over the penis.
- the fluid permeable membrane includes a wicking material and is positioned adjacent to (e.g., secured to) the fluid permeable support such that the fluid permeable membrane is positioned to contact the penis in the chamber when the penis extends through the opening. Positioning the fluid permeable membrane to contact the penis results in the technical effect of a more comfortable contact for the penis and the possibility of a more effective vacuum-assisted wicking action.
- the fluid permeable membrane and the fluid impermeable barrier of the sheath may close over the sides of the fluid permeable support so that air and the vacuum escaping through the matrix is inhibited or prevented.
- An example method of using the fluid collection assembly includes securing the base to the region about the penis of an individual.
- the base is positioned on the individual such that the penis extends through (e.g., the penis is not buried) or is adjacent to e.g. , the penis is buried) the aperture defined by the base.
- the sheath may also be attached to the base.
- the sheath may be attached to the base before, during, or after securing the base to the region about the penis.
- the individual may discharge bodily fluids from the penis.
- the bodily fluids may include urine, blood, or sweat.
- the bodily fluids enter the chamber of the sheath.
- the porous material may receive at least some of the bodily fluids that enter the chamber and direct the bodily fluids towards the fluid outlet.
- the method may include removing the bodily fluids from the chamber through the fluid outlet, for instance, when a vacuum force is applied to the outlet via a vacuum source that is in fluid communication with the chamber.
- FIGS. 1A and IB are isometric top and bottom views, respectively, of a fluid collection assembly 100, according to an embodiment.
- FIGS. 1C and ID are cross- sectional schematics of the fluid collection assembly 100 taken along planes C-C and D- D, respectively, according to any embodiment.
- FIG. IE is an exploded view of the fluid collection assembly 100.
- the fluid collection assembly 100 includes a sheath 102 and a base 104.
- the sheath 102 includes a fluid impermeable barrier 106 that is at least partially formed from a first panel 108 attached to a second panel 110.
- the first panel 108 and the second panel 110 are distinct sheets.
- the fluid impermeable barrier 106 is formed from first and second panels that are integrally formed together (e.g., exhibit single piece construction).
- the fluid impermeable barrier 106 also defines a chamber 112 between the first panel 108 and the second panel, an opening 114, and a fluid outlet 118.
- the sheath 102 also includes a fluid permeable body including a fluid permeable support 122 and a fluid permeable membrane 123 disposed in 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 such that the aperture 124 is aligned with the opening 114.
- the inner surfaces 126 of the fluid impermeable barrier 106 ( ⁇ ?.g., inner surfaces of the first and second panels 108, 110) at least partially defines the chamber 112 within the fluid collection assembly 100.
- the fluid impermeable barrier 106 temporarily stores the bodily fluids in the chamber 112.
- the fluid impermeable barrier 106 may be formed of any suitable fluid impermeable material(s), such as a fluid impermeable polymer ( ⁇ ?.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, polyurethane, polyethylene, polyvinyl chloride, a polycarbonate, etc.), a metal film, natural rubber, another suitable material, or combinations thereof. As such, the fluid impermeable barrier 106 substantially prevents the bodily fluids from passing through the fluid impermeable barrier 106.
- a fluid impermeable polymer ⁇ ?.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, polyurethane, polyethylene, polyvinyl chloride, a polycarbonate, etc.
- the fluid impermeable barrier 106 may be air permeable and fluid impermeable thus preventing leaks while allowing air flow through the chamber 112 when a vacuum force is applied thereto (i.e., the chamber 112 remains at about atmospheric pressure thereby preventing the vacuum force from causing a hickie or kinking the conduit 142).
- the fluid impermeable barrier 106 may be formed of a hydrophobic material that defines a plurality of pores. At least one or more portions of at least an outer surface 127 of the fluid impermeable barrier 106 may be formed from a soft and/or smooth material, thereby reducing chaffing.
- the fluid impermeable barrier 106 is formed from polyurethane, such as formed only from polyurethane. Forming the fluid impermeable barrier 106 from polyurethane may improve the functionality of the fluid collection assembly 100. For example, the fluid impermeable barrier 106 may exhibit a flexibility when formed from polyurethane that is greater than when the fluid impermeable barrier 106 is formed from another material. The increased flexibility of the fluid impermeable barrier 106 formed from the polyurethane makes it easier to attach the fluid collection assembly 100 to the individual and maintain the fluid collection assembly 100 attached to the individual.
- the increased flexibility of the fluid impermeable barrier 106 formed from the polyurethane also help allow the fluid collection assembly 100 to conform to the individual and/or fit underneath the clothing of the individual thereby increasing patient comfort.
- the increased flexibility of the fluid impermeable barrier 106 prevents or at least inhibits corners formed in the fluid impermeable barrier 106, if present, from uncomfortably pressing into the individual using the fluid collection assembly 100 thereby making the fluid collection assembly 100 more comfortable to use.
- the polyurethane may also remain flexible when welded or otherwise have seals formed therein. It has also been found that individuals using the fluid collection assembly 100 describe the fluid impermeable barrier 106 formed from polyurethane as being more smooth than when the fluid impermeable barrier 106 is formed from other materials.
- the smoother feel of the fluid impermeable barrier 106 formed from polyurethane makes wearing the fluid collection assembly 100 more comfortable. It has also been found that forming the fluid impermeable barrier 106 from the polyurethane allows the fluid impermeable barrier 106 to be bent (e.g., crumpled, wrinkled, etc.) more quietly than if the fluid impermeable barrier 106 was formed from another material. The improved quietness of the fluid impermeable barrier 106 allows the fluid collection assembly 100 to be used more discreetly. For example, movement of an individual using the fluid collection assembly 100 is likely to cause the fluid impermeable barrier 106 to bend.
- the fluid impermeable barrier 106 Forming the fluid impermeable barrier 106 from polyurethane allows the individual to move more substantially without the fluid impermeable barrier 106 generating noise. Finally, it has been found that the fluid impermeable barrier 106 that includes polyurethane is able to be welded to a variety of materials thereby facilitating attachment of the base 104, the vents 134, and the port 130 to the fluid impermeable barrier 106.
- At least one of the first panel 108 or the second panel 110 is formed from an at least partially transparent fluid impermeable material, such as polyethylene, polypropylene, polyurethane, polycarbonate, or polyvinyl chloride. Forming at least one of the first panel 108 or the second panel 110 from an at least partially transparent fluid impermeable material allows a person (e.g., medical practitioner) to examiner the penis. In some embodiments, both the first panel 108 and the second panel 110 are formed from at least partially transparent fluid impermeable material. For example, some conventional fluid collection assemblies that include a sheath and a base may allow the sheath to be reversibly detached from the base after the base is secured to the region about the penis.
- Detaching the sheath from the base allows the person to examine the penis.
- configuring the sheath to be detachable from the base may allow leaks between the sheath and the base.
- the sheath 102 may be permanently attached to the base 104, which substantially prevents leaks between the sheath 102 and the base 104 when the base 104 is appropriately attached to the sheath 102 (e.g., no wrinkles were allowed to form between the sheath 102 and base 104).
- Selecting at least one of the first panel 108 or the second panel 110 to be formed from an at least partially transparent impermeable material allows the penis to be examined without detaching the entire fluid collection assembly 100 from the region about the penis.
- the chamber 112 may include a penis receiving area 131 that is configured to receive the penis of the individual when the penis extends into the chamber 112.
- the penis receiving area 131 may be defined by at least the fluid permeable body (e.g., the 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.
- the fluid permeable body e.g., the fluid permeable membrane 123
- the fluid permeable body may be positioned in the chamber 112 such that the fluid permeable body is not positioned between the penis and at least a portion of the transparent portion of the first panel 108 and/or second panel 110 when the penis is inserted into the chamber 112 through the opening 114.
- the fluid permeable body is generally not transparent and, thus, the portion of the at least partially transparent material of the first panel 108 and/or the second panel 110 that defines the penis receiving area 131 forms a window which allows the person to view into the penis receiving area 131 and examine the penis.
- the second panel 110 is at least partially formed from the at least partially transparent material and forms the window that allows the person to view into the penis receiving area 131. Further, the fluid permeable body is positioned between the penis receiving area 131 and at least a portion of the first panel 108. Such an embodiment may help maintain the dignity of the individual using the fluid collection assembly 100.
- the second panel 110 is generally adjacent to the individual, such as adjacent to the thighs and/or perineum.
- the second panel 110 is generally obscured during use and a person cannot view the penis without first lifting the sheath 102 away from the individual.
- the first panel 108 may face away from the individual and be more easily viewable than the second panel 110.
- the first panel 108 prevent person(s) from viewing the penis unless such examination is necessary, thereby preserving the dignity of the individual using the fluid collection assembly 100.
- the first panel 108 is formed from the at least partially transparent material and forms the window that allows the person to view into the penis receiving area 131.
- the fluid permeable body may be positioned between the penis receiving area 131 and at least a portion of the second panel 110.
- the person does not need to perform the additional act of lifting the sheath 102 to view into the penis receiving area 131 but may not maintain the dignity of the individual using the fluid collection assembly 100 since passersby may also view into the penis receiving area 131.
- first and second panels 108, 110 are attached together.
- the first and second panels 108, 110 are attached together along at least a portion of the outer edges thereof (e.g., the top and lateral edges 136, 138).
- the first and second panels 108, 110 are attached using any suitable technique, such as with an adhesive, sewing, heat sealing, impulse heating, direct heating, radio frequency (“RF”) welding, ultrasonic (“US”) welding, or any other technique.
- the first and second panels 108 are attached together using impulse heating since impulse heating is quick and is effective at attaching polyurethane panels together.
- forming the fluid impermeable barrier 106 from the first panel 108 and the second panel 110 may improve the rate of manufacturing the fluid collection assembly 100, especially when the first panel 108 and the second panel 110 are attached together using a non-sewing technique.
- the first panel 108 and the second panel 110 are integrally formed together (e.g., exhibit single piece construction).
- the fluid impermeable barrier 106 defines one or more orifices 132 extending therethrough.
- the sheath 102 includes one or more vents 134 attached to the fluid impermeable barrier 106 that extend across the one or more orifices 132.
- the vents 134 are configured to allow air to flow therethrough while preventing water (a major constituent of bodily fluids) from flowing therethrough.
- the vents 134 facilitate air flow through the chamber 112.
- a vacuum may be provided to the chamber 112 from a vacuum source. The vacuum may pull air through the vents 134, thereby allowing air flow from the vents 134 to the fluid outlet 118.
- vents 134 helps move bodily fluids towards the fluid outlet 118.
- the vents 134 also prevent the vacuum applied to the chamber 112 from bursting small superficial blood vessels (e.g., cause a hickie) in or otherwise damage the penis or the area about the penis.
- the vents 134 may include a porous hydrophobic material.
- the vents 134 may be covered by a hydrophilic material such as wicking material.
- the vacuum may prevent (especially when wet) liquid from exit the fluid collection assembly 100 from the vents 134, while air can still enter the fluid collection assembly 100 through the vents 134.
- the vents may also be covered by no material at all.
- the pores defined by the porous hydrophobic material may be interconnected thereby allowing air to flow through the vents 134.
- the hydrophobic properties of the porous hydrophobic material may prevent water from flowing through the vents 134.
- the average size of the pores (e.g., the average maximum lateral dimension of the pores) of the porous hydrophobic material may be selected to be about 1 pm or greater, about 5 pm or greater, about 10 pm or greater, about 20 pm or greater, about 30 pm or greater, about 40 pm or greater, about 50 pm or greater, about 60 pm or greater, about 80 pm or greater, about 100 pm or greater, about 125 pm or greater, about 150 pm or greater, about 175 pm or greater, about 200 pm or greater, about 250 pm or greater, about 300 pm or greater, about 400 pm or greater, about 500 pm or greater, about 1 mm or less, about 750 pm or less, about 500 pm or less, or in ranges of about 1 pm to about 10 pm, about 5 pm to about 20 pm, about 10 pm to about 30 pm, about 20 pm to about 40 pm, about 30 pm to about 50 pm, about 40 pm to about 60 pm, about 50 pm to about 80 pm, about 60 pm to about 100 pm, about 80 pm to about 125 pm, about 100 pm to about 150 pm,
- the porous hydrophobic material may exhibit a contact angle with water that is greater than 90°, such as in ranges of about 90° to about 110°, about 100° to about 120°, about 110° to about 130°, about 120° to about 140°, about 130° to about 150°, about 140° to about 160°, about 150° to about 170°, or about 160° to 180°.
- the size of the pores is dependent on the hydrophobicity of the porous hydrophobic material and vice versa. For example, increasing the hydrophobicity of the porous hydrophobic material allows the size of the pores to be increased.
- the vents 134 may include a porous polytetrafluoroethylene (“PTFE”) layer. It is currently believed that the porous PTFE layer is exceptionally effectively at allowing air to flow therethrough while preventing water from flow therethrough even when the porous PTFE layer is exposed to acidic bodily fluids. However, porous PTFE is difficult to weld to other materials, such as polyurethane. As such, the porous PTFE layer may be attached to a substrate.
- the substrate may include a porous material or define one or more passageways therethrough.
- the substrate may be selected to be easily attached to the porous PTFE layer and the fluid impermeable barrier 106.
- the substrate may be selected to be formed from polyvinyl chloride since polyvinyl chloride may be easily attached to the porous PTFE layer and attached to the fluid impermeable barrier 106.
- the orifices 132 are formed in and the vents 134 are attached to the first panel 108 of the fluid impermeable barrier 106.
- the orifices 132 and the vents 134 are unlikely to be covered by and contact the skin of the individual. Covering the orifices 132 and the vents 134 with the skin may prevent or at least inhibit air flow through the portions of the orifices 132 and the vents 134 at are covered by the skin. Further, an individual may find the vents 134 contacting the skin to be uncomfortable and, thus, disposing the vents 134 on the first panel 108 may make the fluid collection assembly 100 more comfortable to wear.
- the vents 134 are attached to an interior of the first panel 108 to prevent the edges of the vents 134 from rubbing or otherwise irritating the skin of the individual.
- At least one of the orifices 132 is formed in and at least one of the vents 134 is attached to a portion of the fluid impermeable barrier 106 that is at or near to top edge 136 of the fluid impermeable barrier 106.
- the top edge 136 of the fluid impermeable barrier 106 may include an edge of the fluid impermeable barrier 106 that is above the opening 114 when the individual is standing and the fluid collection assembly 100 is allowed to freely hang from the pubic region of the individual.
- Forming the orifices 132 and attaching the vents 134 at or near the top edge 136 causes air flowing through the vents 134 to pass over the penis (thereby keeping the penis dry) and inhibits pooling of the bodily fluids near the top edge 136.
- at least one of the orifices 132 is formed in and at least one of the vents 134 is attached to a portion of the fluid impermeable barrier 106 that is at or near to a lateral edge 138 of the fluid impermeable barrier 106.
- the lateral edge 138 of the fluid impermeable barrier 106 may include an edge of the fluid impermeable barrier 106 that extends from or near the top edge 136.
- air preferentially flows in a path extending from the vents 134 towards the fluid outlet 118.
- the vents 134 are spaced from the lateral edges 138 and/or at or near the top edge 136, the preferential air flow from these vents 134 may cause at least some of the portions of the chamber 112 adjacent to the lateral edges 138 to have minimal air flow therethrough.
- Positioning the orifices 132 and the vents 134 at or near the lateral edges 138 may increase the air flow through the portions of the chamber 112 adjacent to the lateral edges 138 thereby preventing or at least inhibiting pooling of bodily fluids in such portions of the chamber 112.
- the orifices 132 and the vents 134 may exhibit an elongated shape.
- the orifices 132 and the vents 134 at or near the top edge 136 may exhibit an elongated shape that is generally parallel to the top edge 136 and/or generally perpendicular to a longitudinal axis 140 of the fluid collection assembly 100.
- the elongated shape of the orifices 132 and the vents 134 cause the air to preferentially flow through a greater percentage of the chamber 112 than if the orifices 132 and the vents 134 did not exhibit an elongated shape and/or were oriented differently.
- the orifices 132 and the vents 134 at or near the lateral edge 138 may exhibit an elongated shape that is generally parallel to the lateral edge 138 and/or generally parallel to the longitudinal axis 140 of the fluid collection assembly 100.
- the elongated shape of the orifices 132 and the vents 134 may cause the air to preferentially flow through a greater percentage of the chamber 112 (e.g., the portions of the chamber 112 adjacent to the lateral edges 138) than if the orifices 132 and the vents 134 did not exhibit an elongated shape and/or were oriented differently.
- the opening 1 14 defined by the fluid impermeable barrier 106 provides an ingress route for fluids to enter the chamber 112 when the penis is a buried penis and allow the penis to enter the chamber 112 (e.g., the penis receiving area 131) when the penis is not buried.
- the opening 114 may be defined by the fluid impermeable barrier 106 (e.g., an inner edge of the fluid impermeable barrier 106).
- the opening 114 is formed in and extends through the fluid impermeable barrier 106, from the outer surface 127 to the inner surface 126, thereby enabling bodily fluids to enter the chamber 112 from outside of the fluid collection assembly 100.
- the second panel 110 defines the entirety of the opening 114.
- the opening 114 is a cutout defined by the second panel 110 that is spaced from the outer periphery (e.g., edges) of the second panel 110.
- the second panel 110 may exhibit a shape that substantially corresponds to the shape of the first panel 108 which may facilitate attaching the first panel 108 to the second panel 110 along the outer periphery thereof. It also allows the first panel 108 and the second panel 110 to lie substantially flat when the penis is not in the chamber 112 and the sheath 102 is lying on a flat surface.
- the ability of the first and second panels 108, 110 to lie substantially flat may make wearing the fluid collection assembly 100 more discrete and inhibit pooling of bodily fluids against the individual.
- the opening 114 is not spaced from the outer periphery of the second panel 110.
- the opening 114 may be a cutout extending inwardly from at least one outer periphery of the second panel 110.
- Other examples of forming the opening 114 in the second panel 110 are disclosed in International Patent Application No. PCT/US2021/039866 filed on June 30, 2021, the disclosure of which is incorporated herein, in its entirety, by this reference.
- the fluid impermeable barrier 106 includes a proximal region 160 and a distal region 162 extending from the proximal region 160, for example, to the fluid outlet 118 (e.g., to the port 130).
- the proximal region 160 may define the opening 114 and the distal region 162 may define the fluid outlet 118. Both the proximal region 160 and the distal region 162 define the chamber 112.
- the fluid impermeable barrier 106 exhibits a generally bullet shape.
- the fluid impermeable barrier 106 exhibits the generally bullet shape when the proximal region 160 of the fluid impermeable barrier 106 exhibits a substantially constant first width and the distal region 162 of the fluid impermeable barrier 106 exhibits a second width that is less than the first width.
- the first and second widths may be measured perpendicularly to the longitudinal axis 140 and may be greater than a thickness of the sheath 102 when the sheath 102 lies on a flat surface.
- the generally bullet shape of the fluid impermeable barrier 106 facilitates operation of the fluid collection assembly 100 while making the sheath 102 more comfortable.
- the substantially constant first width maintains contact with the upper portions of the thighs of the individual thereby maintaining the position of the fluid collection assembly 100.
- the substantially constant first width makes it easier for the penis to become erect since the substantially constant first width inhibits the sheath 102 falling between the thighs of the individual and the erect penis from lifting the portions of the sheath 102 that fell between the thighs.
- the decreased second width makes the sheath 102 thinner thereby allowing the portions of the sheath 102 that are less likely to receive the penis to drop between the thighs of the individual. This drop allows gravity to assist in moving the bodily fluids towards the fluid outlet 118.
- the decreased second width also funnels the bodily fluids towards the fluid outlet 118 and the port 130.
- the second width of the distal region 162 may vary e.g., decrease) along a length of the distal region 162 measured perpendicularly to the longitudinal axis 140.
- the second width of the distal region 162 may decrease at a constant rate from the proximal region 160 towards (e.g. , to) the fluid outlet 118.
- the constant rate at which the second width decreases causes the lateral edges 138 of the fluid impermeable barrier 106 that defines the distal region 162 to be straight.
- the straight lateral edges 138 may form comers at the intersection between the proximal and distal regions 160, 162 that may uncomfortably press into the individual.
- the second width of the distal region 162 may decrease at a variable (e.g., increasing) rate from the proximal region 160 towards e.g., to) the fluid outlet 118.
- the variable rate at which the second width decreases causes the lateral edges 138 of the fluid impermeable barrier 106 that defines the distal region 162 to be curved, such as convexly curved.
- the curved lateral edges 138 may prevent the formation of comers that may press into the individual thereby making the fluid collection assembly 100 more comfortable than if the lateral edges 138 of the distal region 162 were straight.
- the air flow through the distal region 162 may be more uniform when the lateral edges 138 of the distal region 162 are straight instead of curved.
- the fluid impermeable barrier 106 may exhibit a shape other than the generally bullet shape.
- the fluid impermeable barrier 106 may exhibit a generally rectangular shape, as discussed in more detail in International Patent Application No. PCT/US2021/039866 filed on lune 30, 2021 , the disclosure of which was previously incorporated herein.
- the fluid impermeable barrier 106 may exhibit a generally triangular shape, a semi-oval shape, or any other suitable shape.
- the fluid impermeable barrier 106 defines a fluid outlet 118.
- the fluid outlet 118 may be formed from a portion of the first panel 108 and the second panel 110 that are not attached together.
- the fluid outlet 118 is configured to be directly attached to a conduit 142.
- the conduit 142 may be at least partially disposed in the chamber 112 or otherwise in fluid communication with the chamber 112 through the fluid outlet 118.
- the fluid outlet 118 may be sized and shaped to form an at least substantially fluid tight seal against the conduit 142, thereby substantially preventing the bodily fluids from escaping the chamber 112.
- the conduit 142 may be attached to the fluid outlet 118 (e.g., to the first and second panels 108, 110) using an adhesive, a weld, an interference or friction fit, or otherwise bonding the fluid outlet 118 to the fluid outlet 118.
- Attaching the conduit 142 to the fluid outlet 118 may prevent leaks and may prevent the conduit 142 from inadvertently becoming detached from the fluid outlet 118.
- the conduit 142 may be attached to the fluid outlet 118 in the same manufacturing step that attaches the first and second panels 108, 110 together.
- the fluid outlet 118 is configured to be indirectly attached to the conduit 142.
- 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.
- the sheath 102 also includes a fluid permeable body including the fluid permeable support 122 and the fluid permeable membrane 123 disposed in the chamber 112. At least one of the fluid permeable support 122 and/or the fluid permeable membrane 123 may direct the bodily fluids to one or more selected regions of the chamber 112, such as away from the penis and towards the fluid outlet 118 and/or the inlet 130a of the port 130. As such, the fluid permeable support 122 and the fluid permeable membrane 123 may facilitate the removal of the bodily fluids from the chamber 112.
- the fluid permeable membrane 123 is positioned to contact the penis in the chamber 112 when the penis extends through the opening 114/124.
- the fluid permeable support 122 may be positioned between and interface the fluid permeable membrane 123 and one of the first panel 108 or the second panel 110 of the fluid impermeable barrier 106.
- the fluid permeable membrane 123 and/or the fluid permeable support 122 may also blunt a stream of urine from the penis.
- the fluid permeable support 122 includes a wicking material configured to wick bodily fluids away from the opening 114 thereby preventing the bodily fluids from escaping the chamber 112.
- wicking may not include absorption of fluid into the wicking material. Put another way, substantially no absorption of fluid into the material may take place after the material is exposed to the fluid and removed from the fluid for a time.
- the term “substantially no absorption” may allow for nominal amounts of absorption of fluid into the wicking material (e.g., absorbency), such as less than about 30 wt% of the dry weight of the wicking material, less than 20 wt%, less than 15 wt%, less than 10 wt%, less than about 7 wt%, less than about 5 wt%, less than about 3 wt%, less than about 2 wt%, less than about 1 wt%, or less than about 0.5 wt% of the dry weight of the wicking material.
- the wicking material may also wick the fluid generally towards an interior of the chamber 112, as discussed in more detail below.
- the fluid permeable support 122 is configured to adsorb or absorb the bodily fluids. Similar, to the wicking material, such adsorbing or absorbing material may move bodily fluids away from the opening 114 thereby preventing the bodily fluids from escaping the chamber 112.
- the fluid permeable support 122 may be formed from any suitable porous material.
- the fluid permeable support 122 may be formed from nylon (e.g., spun nylon fibers), polyester, polyurethane, polyethylene, polypropylene, other porous polymers, hydrophobic foam, an open cell foam, wool, silk, linen, cotton (e.g., cotton gauze), felt, other fabrics, a coated porous material (e.g., a water repellent coated porous material), any other suitable porous materials, or combinations thereof.
- the fluid permeable support 122 includes a first layer and a second layer including a woven material.
- the fluid permeable support 122 also may include a plurality of fibers forming a layer between the first layer and the second layer of the fluid permeable support 122.
- Each of the first layer, the second layer, and the plurality of fibers of the fluid permeable support 122 may define a plurality of pores, thereby allowing transport of the bodily fluids and air circulation through the fluid permeable support 122.
- the pores defined by the plurality of fibers may be at least one of larger or more numerous, thereby decreasing the likelihood that dried bodily fluids clog the fluid permeable support 122.
- the plurality of fibers in the fluid permeable support 122 may also prevent the vacuum force from collapsing the porous material.
- the first layer, the second layer, and the plurality of fibers the fluid permeable support 122 may be formed from any suitable material, such as a hydrophobic material, a hydrophilic material, polyester, cotton, or any other porous material disclosed herein.
- one or more of the first layer, the second layer, or the plurality of fibers the fluid permeable support 122 are formed from a hydrophobic material that inhibits the fluid permeable support 122 from storing the bodily fluids therein which may facilitate removal of the bodily fluids from the chamber 112.
- one or more of the first layer, and second layer, or the plurality of fibers the fluid permeable support 122 are formed from a hydrophilic material which allows the fluid permeable support 122 to temporarily store the bodily fluids therein thereby limiting the quantity of bodily fluids that pool around the skin of the individual.
- two or more of the first layer, the second layer, or the plurality of fibers the fluid permeable support 122 are formed from different materials.
- the first layer may be formed from a hydrophobic material while the plurality of fibers are formed from a hydrophilic material, according to an embodiment. Such a configuration may cause the bodily fluids to be pulled through the first layer and temporarily stored in the plurality of fibers of the fluid permeable support 122.
- the first layer may remain substantially dry due to the hydrophobicity thereof which allows the fluid permeable support 122 to feel dry to the penis.
- the fluid permeable membrane 123 may define the penis receiving area 131 or may otherwise be closer to the penis receiving area 131 than the fluid permeable support 122.
- the fluid permeable membrane 123 may be composed and/or structured to wick bodily fluids away from the penis receiving area 131, thereby minimizing the quantity of bodily fluids that are present in the penis receiving area 131 or otherwise present against the skin of the individual.
- the fluid permeable membrane 123 may also be configured to adsorb or absorb the bodily fluids to minimize the quantity of bodily fluids that are present in the penis receiving area 131 or otherwise present against the skin of the individual.
- the fluid permeable membrane 123 may be formed from any of the porous materials disclosed herein.
- the fluid permeable membrane 123 may be formed from fabric, such as a 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. Forming the fluid permeable membrane 123 from gauze, soft fabric, and/or smooth fabric (or any of the other porous materials disclosed herein that may contact the penis) may reduce chaffing caused by the fluid collection assembly 100.
- the fluid permeable support 122 is configured to support the fluid permeable membrane 123 since the fluid permeable membrane 123 may be formed from a relatively foldable, flimsy, or otherwise easily deformable material.
- the fluid permeable support 122 may be positioned such that the fluid permeable support 122 is disposed between the fluid permeable membrane 123 and the fluid impermeable barrier 106. As such, the fluid permeable support 122 may support and maintain the position of the fluid permeable membrane 123.
- the fluid permeable support 122 is positioned adjacent to (e.g., secured to) the first panel 108 such that the fluid permeable support 122 is positioned between the fluid permeable membrane 123 and the first panel 108.
- the fluid permeable membrane 123 may be positioned to contact the penis in the chamber 112 generally opposite to the opening 114/124, with the penis between the fluid permeable membrane 123 and the second panel 110 when the penis extends through the opening 114/124.
- the fluid permeable support 122 may be formed from any fluid permeable material that is less deformable than the fluid permeable membrane 123.
- the fluid permeable support 122 may include a porous polymer (e.g., nylon, polyester, polyurethane, polyethylene, polypropylene, etc.) structure or an open cell foam.
- the fluid permeable support 122 may be formed from a natural material, such as cotton, wool, silk, or combinations thereof.
- the material may have a coating to prevent or limit absorption of fluid into the material, such as a water repellent coating.
- the fluid permeable support 122 and/or the fluid permeable membrane 123 may be a sheet (e.g., a multi-layer sheet).
- the fluid permeable support 122 and/or the fluid permeable membrane 123 may be a sheet (e.g., a multi-layer sheet).
- the fluid permeable membrane 122 and/or the fluid permeable membrane 123 is a sheet when the fluid permeable support 122 and/or the fluid permeable membrane 123 at least one of is generally planar when lying on a flat surface, does not define a cavity (e.g., is not tubular), or exhibits a length and width that is greater than a thickness thereof.
- Forming the fluid permeable support 122 and/or the fluid permeable membrane 123 as a sheet may facilitate the manufacturing of the fluid collection assembly 100. For example, forming the fluid permeable support 122 and/or the fluid permeable membrane 123 as a sheet allows the first panel 108, the second panel 1 10, and the fluid permeable support 122 to each be sheets.
- the first panel 108, the second panel 110, the fluid permeable support 122, and/or the fluid permeable membrane 123 may be stacked and then attached to each other in the same manufacturing step.
- first panel 108 and the second panel 110 may exhibit a shape that is the same size or, more preferably, slightly smaller than the size of the first panel 108 and the second panel 110.
- attaching the first panel 108 and the second panel 110 together along the outer edges e.g., top edges 136 and lateral edges 138) thereof may also attach the fluid permeable support 122 and/or the fluid permeable membrane 123 to the first panel 108 and the second panel 110.
- the fluid permeable support 122 and/or the fluid permeable membrane 123 may be slightly smaller than the first panel 108 and the second panel 110 such that the first panel 108 and/or the second panel 110 extend around the fluid permeable support 122 and/or the fluid permeable membrane 123 such that the fluid permeable support 122 and/or the fluid permeable membrane 123 does not form a passageway through the fluid impermeable barrier 106 through which the bodily fluids may leak.
- attaching the fluid permeable support 122 and/or the fluid permeable membrane 123 to the first panel 108 and/or the second panel 110 may prevent the fluid permeable support 122 and/or the fluid permeable membrane 123 from significantly moving in the chamber 112, such as preventing the fluid permeable support 122 and/or the fluid permeable membrane 123 from bunching together near the fluid outlet 118.
- the fluid permeable support 122 may be attached to the first panel 108 or the second panel 110 (e.g., via an adhesive) before or after attaching the first panel 108 to the second panel 110.
- the fluid permeable support 122 and/or the fluid permeable membrane 123 may merely be disposed in the chamber 112 without attaching the fluid permeable support 122 and/or the fluid permeable membrane 123 to at least one of the first panel 108 or the second panel 110.
- the fluid permeable support 122 and/or the fluid permeable membrane 123 may exhibit shapes other than a sheet, such as a hollow generally cylindrical shape.
- the fluid permeable support 122 and/or the fluid permeable membrane 123 may exhibit a shape that generally corresponds to the shape of the fluid impermeable barrier 106 such that the fluid permeable support 122 and/or the fluid permeable membrane 123 partially or substantially completely occupies all of the chamber 112.
- the fluid permeable support 122 and/or the fluid permeable membrane 123 may exhibit a generally bullet shape.
- the fluid permeable support 122 and/or the fluid permeable membrane 123 may exhibit a generally bullet shape when the fluid permeable support 122 and/or the fluid permeable membrane 123 includes a proximal portion 170 corresponding to the proximal region 160 and a distal portion 172 extending from the proximal portion 170 that corresponds to the distal region 162.
- the proximal portion 170 may exhibit a substantially constant first width and the distal portion 172 may exhibit a second width that is less than the first width.
- the second width may be constant or vary e.g., vary at a constant or variable rate).
- the fluid permeable support 122 and/or the fluid permeable membrane 123 may exhibit a shape other than the generally bullet shape, such as a generally rectangular shape, generally semi-oval shape or any other suitable shape.
- the sheath 102 is substantially flat when the penis is not in the penis receiving area 131 and the sheath 102 is resting on a flat surface.
- the sheath 102 is substantially flat because the fluid impermeable barrier 106 is formed from the first panel 108 and the second panel 110 instead of a generally tubular fluid impermeable barrier.
- the fluid permeable support 122 and/or the fluid permeable membrane 123 may be a sheet, which also causes the sheath 102 to be substantially flat.
- the sheath 102 is described as being substantially flat because at least one of the fluid permeable support 122 and/or fluid permeable membrane 123 may cause a slight bulge to form in the sheath 102 depending on the thickness of the fluid permeable support 122 and/or the fluid permeable membrane 123, the port 130 may cause a bulge thereabout, or the base 104 may pull on portions of the sheath 102 thereabout.
- the sheath 102 may also be compliant and, as such, the sheath 102 may not be substantially flat during use since, during use, the sheath 102 may rest on a non-flat surface (e.g., may rest on the testicles, the perineum, and/or between the thighs) and the sheath 102 may conform to the surface of these shapes.
- a non-flat surface e.g., may rest on the testicles, the perineum, and/or between the thighs
- the sheath 102 may conform to the surface of these shapes.
- the ability of the sheath 102 to be substantially flat when the penis is not in the penis receiving area 131 and the sheath 102 is resting on a flat surface allows the fluid collection assembly 100 to be used with a buried and a non-buried penis.
- the penis does not extend into the penis receiving area 131 which causes the sheath 102 to lie relatively flat across the aperture 124.
- the fluid permeable membrane 123 extends across the aperture and is in close proximity to the buried penis.
- the fluid permeable support 122 and/or the fluid permeable membrane 123 prevents or inhibits pooling of bodily fluids discharged from the buried penis against the skin of the individual since the fluid permeable support 122 and/or the fluid permeable membrane 123 will receive and remove at least a significant portion of the bodily fluids that would otherwise pool against the skin of the individual.
- the skin of the individual remains dry thereby improving comfort of using the fluid collection assembly 100 and preventing skin degradation.
- the fluid collection assembly 100 may still be used with a non-buried penis since the non-buried penis can still be received into the penis receiving area 131, even when the penis is fully erect.
- the ability of the sheath 102 to be substantially flat allows the fluid collection assembly 100 to be used more discretely than if the sheath 102 was not substantially flat thereby avoiding possibly embarrassing scenarios.
- the fluid permeable support 122 and/or the fluid permeable membrane 123 may occupy substantially all of the chamber 112 and the penis receiving area 131 is collapsed (shown as being non-collapsed in FIGS. 1C and ID for illustrative purposes). In other words, the sheath 102 may not define a region that is constantly unoccupied by the fluid permeable support 122 and/or the fluid permeable membrane 123.
- the bodily fluids discharged into the chamber 112 are unlikely to pool for significant periods of time since pooling of the bodily fluids may cause sanitation issues, cause an odor, and/or may cause the skin of the individual to remain in contact with the bodily fluids which may cause discomfort and skin degradation.
- the first panel 108, the second panel 110, the fluid permeable support 122, and/or the fluid permeable membrane 123 may be selected to be relatively flexible.
- the first panel 108, the second panel 110, the fluid permeable support 122, and/or the fluid permeable membrane 123 are relatively flexible when the first panel 108, the second panel 110, the fluid permeable support 122, and/or the fluid permeable membrane 123, respectively, are unable to maintain their shape when unsupported.
- the flexibility of the first panel 108, the second panel 110, the fluid permeable support 122, and/or the fluid permeable membrane 123 may allow the sheath 102 to be substantially flat, as discussed above.
- the flexibility of the first panel 108, the second panel 110, the fluid permeable support 122, and/or the fluid permeable membrane 123 may also allow the sheath 102 to conform to the shape of the penis even when the size and shape of the penis changes (e.g., becomes erect) and to minimize any unoccupied spaces in the chamber 112 in which bodily fluids may pool.
- the fluid permeable support 122 may include a first surface interfacing the first panel 108, a second surface opposite to the first surface and interfacing the fluid permeable membrane 123, and two sides extending between the first surface and the second surface. 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 such that the fluid permeable support 122 is generally not exposed within the chamber 122 (e.g. , substantially all of the fluid permeable support 122 is covered in the chamber 112 by the first panel 108, the second panel 110, and/or the fluid permeable membrane 123). This configuration prevents air from escaping through the fluid permeable support 122, and instead directs substantially all suction to pull fluid through the fluid permeable membrane 123 into the fluid permeable support 122, and then to the inlet 130a for removal from the chamber.
- the fluid collection assembly 100 includes a base 104 that is configured to be coupled to the skin that surrounds the penis (e.g., mons pubis, thighs, testicles, and/or perineum) and have the penis disposed therethrough.
- the base 104 may define an aperture 124 configured to have the penis positioned therethrough.
- the base 104 may be flexible, thereby allowing the base 104 to conform to any shape of the skin surface and mitigate the base 104 pulling the on skin surface.
- the base 104 is configured to be attached to the region about the penis (e.g., mons pubis) while not being attached to the thighs since attaching the base 104 to the thighs may cause the base 104 to uncomfortably pull when the individual moves.
- the base 104 may include a primary attachment portion 174 and a secondary attachment portion 176.
- the primary attachment portion 174 is configured to be attached to the mons pubis and the secondary attachment portion 176 is configured to be attached to the region about the penis except for the mons pubis (e.g. , an upper portion of the testicles).
- the primary attachment portion 174 may exhibit a generally rectangular or trapezoidal shape.
- the primary attachment portion 174 may extend further from the aperture 124 than the secondary attachment portion 176 since the mons pubis is less sensitive and larger than the other regions about the penis.
- the secondary attachment portion 176 may include one or more concave lateral edges 178.
- the concave lateral edges 178 may help prevent the secondary attachment portion 176 from being attached to the thighs of the individual. It is noted that any corners of the base 104 may be rounded to prevent or at least inhibit the base 104 uncomfortably pressing into the individual.
- the base 104 may exhibit shapes other than the shape illustrated in FIG. IE.
- the base 104 may exhibit a generally partially triangular shape having three apexes and edges extending between each of the apexes.
- the apexes may be rounded to prevent the base 104 from digging into and hurting the individual.
- the aperture 124 may be located off-center and closer to one of the apexes than the other apexes.
- Other examples of shapes that the base 104 may form are disclosed in PCT Application No. PCT/US2021/015787 filed on January 29, 2021, the disclosure of which is incorporated herein, in its entirety, by this reference.
- the aperture 124 may exhibit a generally circular shape.
- the aperture 124 may exhibit a noncircular shape.
- the non-circular shape of the aperture 124 may be selected to at least one of correspond to the cross-sectional shape of a base of a penis and/or better conform to the region about the penis, either of which may limit leakage and pooling of the bodily fluids.
- the aperture 124 may exhibit a generally bell-like shape.
- the generally bell-like shape includes a concave (relative to an interior of the aperture 124) top edge 180 and a concave bottom edge 182 opposite the concave top edge 180.
- the generally bell-like shape also includes two convex lateral edges 184 extending between the top and bottom edges 180, 182. Any comers between the top, bottom, and lateral edges 180, 182, 184 may be rounded.
- the two convex lateral edges 184 cause the width of the aperture 124 to vary. For example, the two convex lateral edges 184 cause a width of the aperture 124 near the top edge 180 to be smaller than a width of the aperture 124 near the bottom edge 182.
- the generally bell-like shape of the aperture 124 may allow the aperture 124 to correspond to the shape of the base of the penis which prevents bodily fluids leaking from the chamber 112 and inhibits pooling of the bodily fluids.
- the aperture 124 may exhibit other non-circular shapes, such as generally triangular shape, a generally trapezoidal shape, a generally hippopede shape, or any other suitable noncircular shape.
- the base 104 may include a substrate having a top surface and a bottom surface. The top surface is closer to the sheath 102 than the bottom surface while the bottom surface is closer to the skin of the individual than the top surface.
- the base 104 may also include an adhesive layer disposed on at least a portion of the bottom surface. The adhesive layer is configured to attach the base 104 to the skin around the penis.
- the base 104 may also include a release liner 194 is configured to be easily removed from the adhesive layer and is configured to prevent the adhesive layer inadvertently becoming attached 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.
- all of the base 104 is attached to the sheath 102 which may strengthen the attachment between the sheath 102 and the base 104.
- only the inner portions of the base 104 defining or adjacent to the aperture 124 are attached to the sheath 102. Attaching only the inner portions of the base 104 to the sheath 102 may be sufficient to maintain the base 104 attached to the sheath 102 during use. Only attaching the inner portions of the base 104 to the sheath 102 may allow the outer portions of the base 104 (c.g., portions of the base 104 other than the inner portions) to be easily handled by a user of the fluid collection assembly 100 which, in turn, makes it easier to attach the base 104 to the individual.
- the base 104 may be attached to the second panel 110 before the second panel 110 is attached to the first panel 108 which facilitates attaching the base 104 to sheath 102, for example, using US welding, RF welding, and impulse heating. Attaching the base 104 to the second panel 110 before positioning (e.g., securing) the fluid permeable support 122 in the chamber 112 may cause difficulties securing the fluid permeable support 122 in the chamber 112 since the base 104 may be in the way.
- the base 104 and the fluid permeable support 122 may define one or more base gaps 196 and one or more porous material gaps 198, respectively.
- the base gaps 196 and the porous material gaps 198 may be generally aligned with each other such that the base gaps 196 and the porous material gaps 198 are adjacent to each other.
- the base gaps 196 and the porous material gaps 198 allows opposing portions of the fluid impermeable barrier 106 that are generally aligned with the base gaps 196 and the porous material gaps 198 to be attached together (e.g., using US welding, RF welding, impulse heating, direct heating, heat staking, etc.). Attaching the opposing portions of the fluid impermeable barrier 106 together may secure the fluid permeable support 122 in the chamber 112.
- the base gaps 196 and the porous material gaps 198 may be formed in portions of the base 104 and the fluid permeable support 122 that are adjacent to or above (e.g., further spaced from the fluid outlet 118) portions of the aperture 124 that are furthest spaced from the fluid outlet 118. Such positioning of the base gaps 196 and the porous material gaps 198 may keep the fluid permeable support 122 extending across the aperture 124. Examples of bases 104 are disclosed in International Application No. PCT/US22/14285 filed on January 28, 2022, the disclosures of which are incorporated herein, in its entirety, by this reference.
- the port 130 includes a first part disposed in the fluid collection assembly 100 and a second part disposed outside of the fluid collection assembly 100. Accordingly, the port 130 may extend through the fluid outlet 118.
- the first part of the port 130 may optionally be at least partially disposed in the chamber 112.
- the second part is configured to attach to the conduit 142 (e.g. tube) in fluid communication with a vacuum source or pump.
- the first part defines the inlet 130a and the second part defines an outlet 130b of the port 130 that is downstream from the inlet 130a.
- the port 130 also defines a channel or conduit extending from the inlet 130a to the outlet 130b.
- the inlet 130a may be disposed in the distal region 172 of the fluid permeable support 122.
- the inlet 130a is positioned at least adjacent to the fluid permeable support 122, and the fluid permeable membrane 123 is absent between the inlet 130a and the fluid permeable support 122.
- the inlet 130a may be oriented to interface a portion of the fluid permeable support 122.
- the fluid permeable support 122 includes an opening or recess configured to receive the inlet 130a therein to dispose the inlet 130a adjacent to or interfacing the fluid permeable support 122 without the inlet interfacing the fluid permeable membrane 123.
- the inlet 130a is disposed on a sidewall of the first part of the port 130, and the first part of the port 130 includes a covered terminating end 130c disposed adjacent to the fluid permeable membrane 123.
- the inlet 130a is positioned at the terminating end of the port 130, and the inlet 130a is positioned on a top surface of the fluid permeable support 122 that interfaces the first panel 108.
- the port 130 may extend through the first panel 108 to position the inlet 130a against a surface of the fluid permeable support that interfaces the first panel 108.
- the port 130 may include a disc disposed proximate to the inlet 130a, and the disc may be positioned between the fluid permeable support 122 and the first panel 108. Additionally or alternatively, the disc may be secured to the outer surface of the first panel 108 with the inlet 130 aligned with outlet 108.
- the distal region 172 of the fluid permeable support 122 may extend to a distal intersection or seal between the first panel 108 and the second panel 110, while the fluid permeable membrane 123, while the fluid permeable membrane 123 terminates prior to the distal intersection of the first panel 108 and the second panel 110.
- the distal region 162 of the fluid impermeable barrier 106 may include only the fluid permeable support 122 positioned (e.g., secured) directly between the first panel 108 and the second panel 110, and the fluid permeable membrane 123 may be absent from the distal region 162 of the fluid impermeable barrier 106.
- a distal terminating end of the fluid permeable membrane 123 may be secured to the second panel 110 and the fluid permeable support 122 may extend distally beyond this distal terminating end of the fluid permeable membrane 123.
- the port 130 may be configured similar to the port 280 (shown in FIG. 2E) such that the inlet 280a is disposed at an end of the first part of the port 280 and positioned adjacent to a terminating end 172a of the fluid permeable support 122 in the distal region 172.
- the first panel 108 and the second panel 110 may be sealed or attached such that the terminating end 172a of the fluid permeable support 123 in the distal region 172 interfaces only the fluid impermeable barrier 106 and the inlet 280a (e.g., the terminating end 172a is not exposed in the chamber 112).
- the inlet 130a adjacent to or interfacing with the fluid permeable support 122 with the fluid permeable membrane 123 absent between the inlet 130a and the fluid permeable support 122 results in the technical effect of improved fluid transfer from the fluid permeable support 122 into the port 130 for removal from the chamber 112.
- at least the second part of the port 130 angles and/or curves relative to a longitudinal axis of the fluid collection assembly from the first part towards the proximal region 160 of the fluid impermeable barrier 106.
- the port 130 angles generally from the inlet 130a through the fluid outlet 118 and at least partially towards the proximal region 160 of the fluid impermeable barrier 106.
- the orientation and configuration of the port 130 results in the technical effect of reducing kinks that may occur in the conduit 142 secured to the port 130, as well as orienting the conduit 142 towards the head of the bed where a fluid collection canister is likely to be positioned. This enables the use of less vacuum tubing (e.g. conduit 142), and also reduces the lifting up of the bottom of the fluid collection assembly 100 which improves fluid flow in the fluid collection assembly.
- the fluid collection assembly 100 includes a conduit 142.
- the conduit 142 may include a flexible material such as plastic tubing e.g., medical tubing). Such plastic tubing may include a thermoplastic elastomer, polyvinyl chloride, ethylene vinyl acetate, polytetrafluoroethylene, etc., tubing.
- the conduit 142 may include silicon or latex.
- the conduit 142 may include one or more portions that are resilient, such as to by having one or more of a diameter or wall thickness that allows the conduit to be flexible.
- the conduit 142 is configured to be coupled to, and at least partially extend between, one or more of the fluid storage container (not shown) and the vacuum source (not shown).
- the conduit 142 is configured to be directly connected to the vacuum source (not shown).
- the conduit 142 may extend from the fluid impermeable barrier 106 by at least one foot, at least two feet, at least three feet, or at least six feet, or more.
- the conduit 142 is configured to be indirectly connected to at least one of the fluid storage container (not shown) and the vacuum source (not shown).
- the conduit is secured to a wearer’s skin with a catheter securement device, such as a STATLOCK® catheter securement device available from C. R. Bard, Inc., including but not limited to those disclosed in U.S. Patent Nos. 6,117,163; 6,123,398; and 8,211,063, the disclosures of which are all incorporated herein by reference in their entirety.
- a catheter securement device such as a STATLOCK® catheter securement device available from C. R. Bard, Inc.
- the inlet and an outlet of the conduit 142 are configured to fluidly couple (e.g., directly or indirectly) the vacuum source (not shown) to the chamber 112.
- the vacuum source FIG. 3
- the bodily fluids in the chamber 112 may be drawn into the inlet 148 and out of the fluid collection assembly 100 via the conduit 142.
- the conduit 142 may be frosted or opaque (e.g., black) to obscure visibility of the bodily fluids therein.
- the vacuum source may be remotely located from the fluid collection device.
- the conduit 142 may be fluidly connected to the fluid storage container, which may be disposed between the vacuum source and the fluid collection assembly 100.
- a male using the fluid collection assembly 100 may discharge bodily fluids e.g., urine) into the chamber 112.
- the bodily fluids may pool or otherwise be collected in the chamber 112 (e.g., received into the fluid permeable support 122). At least some of the bodily fluids may be pulled through the interior of the conduit 142 via the inlet.
- the bodily fluids may be drawn out of the fluid collection assembly 100 via the vacuum/vacuum provided by the vacuum source.
- the vents 134 may substantially maintain the pressure in the chamber 112 at atmospheric pressure even though bodily fluids are introduced into and subsequently removed from the chamber 112.
- the fluid permeable support 122 and the fluid permeable membrane 123 may be disposed on or secured to the second panel 1 10 (e.g., the panel or side of the assembly including the fluid opening 114/124).
- FIGS. 2A-2D FIG. 2A is an isometric top view of a fluid collection assembly having the fluid permeable support 122 and the fluid permeable membrane 123 may be disposed on or secured to the second panel 110.
- FIGS. 2B and 2C are cross-sectional schematics of the fluid collection assembly 200 taken along planes 2B-2B and 2C-2C, respectively, and
- FIG. 2D is an exploded isometric view of the fluid collection assembly shown in FIG. 2A.
- the fluid collection assembly 200 may include any aspect of the fluid collection assembly 100 described above.
- the fluid permeable support 123 is positioned adjacent to (e.g. , secured to) the second panel 110 (e.g., or the side of the assembly defining the opening 114/124) such that the fluid permeable support 122 is positioned between the fluid permeable membrane 123 and the second panel 110.
- the fluid permeable membrane 123 is positioned to contact the penis in the chamber 112 with the penis between the fluid permeable membrane 123 and the first panel 108 when the penis extends through the opening 114/124.
- This configuration and positioning of the fluid permeable support 122 and the fluid permeable membrane 123 may result in the technical effect of directing more urine into the fluid permeable support 122 for removal from the fluid collection assembly 200.
- the port 230 of the fluid collection assembly 200 may be similar to the port 130 of the fluid collection assembly 100.
- the port 230 may include a first part disposed in the fluid collection assembly 100 and a second part disposed outside of the fluid collection assembly 100. Accordingly, the port 230 may extend through the fluid outlet 118.
- the first part of the port 230 may optionally be at least partially disposed in the chamber 112.
- the second part of the port 230 is configured to attach to the conduit 142 (e.g. tube) in fluid communication with a vacuum source or pump.
- the first part of the port defines the inlet 230a and the second part defines an outlet 130b of the port 230 that is downstream from the inlet 230a.
- the inlet 230a is disposed at an end of the first part of the port 230.
- the port 230 also defines a channel or conduit extending from the inlet 130a to the outlet 130b.
- the inlet 230a may be disposed in the distal region 172 of the fluid permeable support 122.
- the inlet 230a is positioned at least adjacent to or interfacing with the fluid permeable support 122 such that the fluid permeable membrane 123 is absent between the inlet 230a and the fluid permeable support 122.
- the first part of the port 230 may extend through an opening or hole 121 in the fluid permeable membrane 123 such that the inlet 230a interfaces or abuts a surface of the fluid permeable support 122. More particularly, the inlet 230a may interface or abut the same general surface of the fluid permeable support 122 that interfaces the fluid permeable membrane 123.
- the inlet 230a adjacent to the fluid permeable support 122 results in the technical effect of improved fluid transfer from the fluid permeable support 122 into the port 230 for removal from the chamber 112.
- at least the second part of the port 230 angles and/or curves relative to a longitudinal axis of the fluid collection assembly from the first part towards the proximal region 160 of the fluid impermeable barrier 106.
- the port 130 angles generally from the inlet 230a through the fluid outlet 118 and at least partially towards the proximal region 160 of the fluid impermeable barrier 106.
- the port 230 may include a disc disposed proximate to the inlet 230a, and the disc may be positioned between the fluid permeable support 122 and the first panel 108. Additionally or alternatively, the disc of the port 230 may be secured to the outer surface of the first panel 108 with the inlet 130 aligned with outlet 108.
- the distal region 172 of the fluid permeable support 122 may extend to a distal intersection or seal between the first panel 108 and the second panel 110, while the fluid permeable membrane 123, while the fluid permeable membrane 123 terminates prior to the distal intersection of the first panel 108 and the second panel 110.
- the distal region 162 of the fluid impermeable barrier 106 of the fluid collection assembly 200 may include only the fluid permeable support 122 positioned (e.g., secured) directly between the first panel 108 and the second panel 110, and the fluid permeable membrane 123 may be absent from the distal region 162 of the fluid impermeable barrier 106.
- a distal terminating end of the fluid permeable membrane 123 may be secured to the first panel 108 and the fluid permeable support 122 may extend distally beyond this distal terminating end of the fluid permeable membrane 123.
- the fluid permeable support 122 may include a first surface interfacing the second panel 110, a second surface opposite to the first surface and interfacing the fluid permeable membrane 123, and two sides extending between the first surface and the second surface. 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 such that the fluid permeable support 122 is generally not exposed within the chamber 122 (e.g. , substantially all of the fluid permeable support 122 is covered in the chamber 112 by the first panel 108, the second panel 110, and/or the fluid permeable membrane 123).
- This configuration prevents air from escaping through the fluid permeable support 122, and instead directs substantially all suction to pull fluid through the fluid permeable membrane 123 into the fluid permeable support 122, and then to the inlet 130a for removal from the chamber.
- the port of a fluid collection assembly may be curved.
- FIG. 2E is a cross-sectional schematic of a fluid collection assembly 250, according to an embodiment.
- the fluid collection assembly 250 may include any aspect of the fluid collection assembly 200.
- the fluid collection assembly 250 may include a port 280 having an inlet 280a positioned adjacent to a terminating end of the fluid permeable support 122 in the distal region 172.
- the first part of the port 280 may extend distally from the inlet 280a before curving or angling proximally and extending through the fluid outlet 118.
- the first part of the port 280a extends through an opening in the fluid permeable membrane 123.
- the first part of the port 280 extends past a terminating end of the fluid permeable membrane 123.
- the first panel 108 and the second panel 110 may be sealed or attached such that the terminating end 172a of the fluid permeable support 123 in the distal region 172 interface only the fluid impermeable barrier 106 and the inlet 280a (e.g., the terminating end 172a is not exposed in the chamber 112).
- FIG. 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 may be fluidly coupled to each other via one or more conduits 342.
- fluid collection assembly 300 may be operably coupled to one or more of the fluid storage container 309 or the vacuum source 311 via the conduit 342.
- Bodily fluids (e.g., urine or other bodily fluids) collected in the fluid collection assembly 300 may be removed from the fluid collection assembly 300 via the conduit 342 which protrudes into the fluid collection assembly 300.
- Vacuum force may be introduced into the chamber of the fluid collection assembly 300 via the inlet of the conduit 342 responsive to vacuum e.g., vacuum) force applied at the outlet of the conduit 342.
- the vacuum force may be applied to the outlet of the conduit 342 by the vacuum source 311 either directly or indirectly.
- the vacuum force may be applied indirectly via the fluid storage container 309.
- the outlet of the conduit 342 may be disposed within the fluid storage container 309 and an additional conduit 342 may extend from the fluid storage container 309 to the vacuum source 311.
- the vacuum source 311 may apply vacuum to the fluid collection assembly 300 via the fluid storage container 309.
- the vacuum force may be applied directly via the vacuum source 311.
- the outlet of the conduit 342 may be disposed within the vacuum source 311.
- An additional conduit 342 may extend from the vacuum source 311 to a point outside of the fluid collection assembly 300, such as to the fluid storage container 309.
- the vacuum source 311 may be disposed between the fluid collection assembly 300 and the fluid storage container 309.
- the fluid storage container 309 is sized and shaped to retain a fluid therein.
- the fluid storage container 309 may include a bag (e.g., drainage bag), a bottle or cup (e.g., collection jar), or any other enclosed container for storing the bodily fluids.
- the conduit 342 may 342 extend from the fluid collection assembly 300 and attach to the fluid storage container 309 at a first point therein.
- An additional conduit 342 may attach to the fluid storage container 309 at a second point thereon and may extend and attach to the vacuum source 311. Accordingly, a vacuum (e.g., vacuum) may be drawn through fluid collection assembly 300 via the fluid storage container 309. Fluid, such as urine, may be drained from the fluid collection assembly 300 using the vacuum source 311.
- a vacuum e.g., vacuum
- the vacuum source 311 may include one or more of a manual vacuum pump, and electric vacuum pump, a diaphragm pump, a centrifugal pump, a displacement pump, a magnetically driven pump, a peristaltic pump, or any pump configured to produce a vacuum.
- the vacuum source 311 may provide a vacuum or vacuum to remove fluid from the fluid collection assembly 300.
- the vacuum source 311 may be powered by one or more of a power cord (e.g., connected to a power socket), one or more batteries, or even manual power e.g., a hand operated vacuum pump).
- the vacuum source 311 may be sized and shaped to fit outside of, on, or within the fluid collection assembly 300.
- the vacuum source 311 may include one or more miniaturized pumps or one or more micro pumps.
- the vacuum sources 311 disclosed herein may include one or more of a switch, a button, a plug, a remote, or any other device suitable to activate the vacuum source 311.
- FIG. 4 is a flow diagram of a method 400 of manufacturing a fluid collection assembly, according to an embodiment.
- the method 400 may form any of the fluid collection assemblies discloses herein.
- the method 400 may include an act 405, which recites “providing a fluid impermeable barrier including a first panel defining an opening and a second panel, the opening being sized to receive at least a portion of a penis therethrough.
- the method 400 may include an act 410, which recites “attaching an outer periphery of the first panel to an 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 at the distal region, the fluid impermeable barrier at least defining a chamber.
- the method 400 may include an act 415, which recites “positioning a fluid permeable body having a fluid permeable support and a fluid permeable membrane including a wicking a material in the chamber such that the fluid permeable membrane is positioned to contact the penis in the chamber when the penis extends through the opening, and a port extends through the fluid outlet with a first part of the port defining an inlet that is positioned adjacent to the fluid permeable support such that the fluid permeable membrane is absent between the inlet and the fluid permeable support, a second part of the port defining an outlet positioned outside the chamber and configured to attach to a conduit.”
- the act 415 includes positioning (e.g., securing) the fluid permeable support such that the fluid permeable support is disposed between the fluid permeable membrane and the second panel with the fluid permeable membrane positioned to contact the penis in the chamber with the penis between the fluid permeable membrane and the first panel when the penis extends through the opening.
- the method 400 may include an act of positioning (e.g., securing) a port including the fluid outlet to the distal region, the port including a first part defining an inlet positioned at least adjacent to the fluid permeable support and a second part defining an outlet positioned outside the chamber, the second part configured to be attached to a conduit.
- the at least the second part of the port may angle and/or curve relative to a longitudinal axis of the fluid collection assembly from the first part towards the proximal region.
- the act 415 includes positioning e.g., securing) 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, the fluid permeable membrane being positioned to contact the penis in the chamber with the penis between the fluid permeable membrane and the second panel when the penis extends through the opening.
- the method 400 may include an act of securing a port including the fluid outlet to the distal region, the port including a first part defining an inlet positioned at least adjacent to the fluid permeable support and a second part defining an outlet positioned outside the chamber, the first part extending through the fluid permeable membrane and the second part configured to be attached to a conduit.
- the at least the second part of the port may angle and/or curve relative to a longitudinal axis of the fluid collection assembly from the first part towards the proximal region.
- the method 400 further comprises an act of positioning the inlet on a surface of the fluid permeable support that interfaces the fluid permeable membrane.
- the method 400 further comprises an act of positioning the inlet adjacent to a terminating end of the fluid permeable support in the distal region.
- the method 400 further comprises an act of covering an interfacing surface of the fluid permeable support and two sides of the fluid permeable support with the fluid permeable membrane.
- Acts of the method 400 are for illustrative purposes and may be performed in different orders, split into multiple acts, modified, supplemented, or combined. In an example, one or more of the acts of the method 400 may be omitted from the method 400.
- the embodiments disclosed above relate to fluid collection assemblies configured to collection bodily fluids from a male. However, it is noted that such fluid collection assemblies may also be used to collection bodily fluids from a female since the urethral opening of the female is, functionally, similar to a buried penis.
- Terms of degree indicate structurally or functionally insignificant variations.
- the term of degree when the term of degree is included with a term indicating quantity, the term of degree is interpreted to mean ⁇ 10%, ⁇ 5%, or +2% of the term indicating quantity.
- the term of degree when the term of degree is used to modify a shape, the term of degree indicates that the shape being modified by the term of degree has the appearance of the disclosed shape.
- the term of degree may be used to indicate that the shape may have rounded corners instead of sharp corners, curved edges instead of straight edges, one or more protrusions extending therefrom, is oblong, is the same as the disclosed shape, etc.
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- Heart & Thoracic Surgery (AREA)
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Abstract
Un exemple d'ensemble de collecte de fluide de l'invention comprend une gaine comprenant une chambre et un corps perméable aux fluides disposé dans la chambre. La gaine comprend une barrière imperméable aux fluides comprenant une région proximale, une région distale, un premier panneau, un second panneau fixé au premier panneau et définissant une ouverture dans la région proximale de la barrière imperméable aux fluides, et une sortie de fluide dans la région distale. Le corps perméable aux fluides comprend un support perméable aux fluides et une membrane perméable aux fluides. La membrane perméable aux fluides comprend un matériau à effet de mèche et est positionnée de manière à entrer en contact avec le pénis dans la chambre lorsque le pénis se déploie à travers l'ouverture.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/US2023/030373 WO2025038088A1 (fr) | 2023-08-16 | 2023-08-16 | Ensembles et systèmes de collecte de fluide mâle, procédés d'utilisation, et procédés pour les fabriquer |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/US2023/030373 WO2025038088A1 (fr) | 2023-08-16 | 2023-08-16 | Ensembles et systèmes de collecte de fluide mâle, procédés d'utilisation, et procédés pour les fabriquer |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2025038088A1 true WO2025038088A1 (fr) | 2025-02-20 |
Family
ID=87974512
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/US2023/030373 Pending WO2025038088A1 (fr) | 2023-08-16 | 2023-08-16 | Ensembles et systèmes de collecte de fluide mâle, procédés d'utilisation, et procédés pour les fabriquer |
Country Status (1)
| Country | Link |
|---|---|
| WO (1) | WO2025038088A1 (fr) |
Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US12419778B2 (en) | 2019-06-21 | 2025-09-23 | Purewick Corporation | Fluid collection devices including a base securement area, and related systems and methods |
| US12440370B2 (en) | 2020-10-21 | 2025-10-14 | Purewick Corporation | Apparatus with compressible casing for receiving discharged urine |
| US12447042B2 (en) | 2020-04-17 | 2025-10-21 | Purewick Corporation | Fluid collection assemblies including a fluid impermeable barrier having a sump and a base |
| US12465515B2 (en) | 2019-10-28 | 2025-11-11 | Purewick Corporation | Fluid collection assemblies including a sample port |
| US12465514B2 (en) | 2020-04-17 | 2025-11-11 | Purewick Corporation | Fluid collection devices, systems, and methods securing a protruding portion in position for use |
| US12472090B2 (en) | 2020-04-17 | 2025-11-18 | Purewick Corporation | Female external catheter devices having a urethral cup, and related systems and methods |
| US12478499B2 (en) | 2021-01-07 | 2025-11-25 | Purewick Corporation | Wheelchair securable urine collection systems and related methods |
| US12491104B2 (en) | 2020-04-20 | 2025-12-09 | Purewick Corporation | Fluid collection devices adjustable between a vacuum-based orientation and a gravity-based orientation, and related systems and methods |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US12419778B2 (en) | 2019-06-21 | 2025-09-23 | Purewick Corporation | Fluid collection devices including a base securement area, and related systems and methods |
| US12465515B2 (en) | 2019-10-28 | 2025-11-11 | Purewick Corporation | Fluid collection assemblies including a sample port |
| US12447042B2 (en) | 2020-04-17 | 2025-10-21 | Purewick Corporation | Fluid collection assemblies including a fluid impermeable barrier having a sump and a base |
| US12465514B2 (en) | 2020-04-17 | 2025-11-11 | Purewick Corporation | Fluid collection devices, systems, and methods securing a protruding portion in position for use |
| US12472090B2 (en) | 2020-04-17 | 2025-11-18 | Purewick Corporation | Female external catheter devices having a urethral cup, and related systems and methods |
| US12491104B2 (en) | 2020-04-20 | 2025-12-09 | Purewick Corporation | Fluid collection devices adjustable between a vacuum-based orientation and a gravity-based orientation, and related systems and methods |
| US12440370B2 (en) | 2020-10-21 | 2025-10-14 | Purewick Corporation | Apparatus with compressible casing for receiving discharged urine |
| US12478499B2 (en) | 2021-01-07 | 2025-11-25 | Purewick Corporation | Wheelchair securable urine collection systems and related methods |
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