CN-122028882-A - Male fluid collection assemblies and systems, methods of use and methods of manufacture

Abstract

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

Inventors

• Claire Glockner
• CAMILLE ROSE NEWTON

Assignees

• 普利维克公司

Dates

Publication Date

20260512

Application Date

20230816

Claims (20)

1. 1. A fluid collection assembly comprising: A sheath comprising a fluid-impermeable barrier including a proximal end region, a distal end region extending from the proximal end region, a first panel, a second panel attached to the first panel and defining an opening in the proximal end region of the fluid-impermeable barrier sized to receive at least a portion of a penis therethrough, and a fluid outlet at the distal end region, the fluid-impermeable barrier defining at least a chamber; A fluid permeable body disposed in the chamber and comprising: a fluid permeable support, and A fluid permeable membrane comprising a wicking material and arranged such that the fluid permeable support is disposed between the fluid permeable membrane and one of the first or second panels, the fluid permeable membrane being arranged to contact the penis in the chamber when the penis extends through the opening, and A port extending through the fluid outlet and comprising (1) a first portion defining an inlet disposed adjacent the fluid permeable support such that there is no fluid permeable membrane between the inlet and the fluid permeable support, and (2) a second portion defining an outlet located outside the chamber and configured for attachment to a conduit.
2. 2. The fluid collection assembly of claim 1, wherein the fluid permeable support is located between the fluid permeable membrane and the first panel, wherein the fluid permeable membrane is disposed to contact the penis in the chamber when the penis extends through the opening, wherein the penis is located between the fluid permeable membrane and the second panel.
3. 3. The fluid collection assembly of claim 2, wherein at least the second portion of the port is sloped and/or curved from the first portion toward the proximal end region relative to a longitudinal axis of the fluid collection assembly.
4. 4. A fluid collection assembly according to any one of claims 2 or 3, wherein the inlet is provided on a side wall of the first portion of the port and the covered end of the first portion is provided adjacent the fluid permeable membrane.
5. 5. The fluid collection assembly of claim 2, wherein: The inlet being provided at an end of the first portion and adjacent to the end of the fluid permeable support in the distal region, and The port extends distally from the inlet and then bends and/or tilts to extend proximally.
6. 6. The fluid collection assembly of claim 1, wherein the fluid permeable support is located between the fluid permeable membrane and the second panel, wherein the fluid permeable membrane is disposed to contact the penis in the chamber when the penis extends through the opening, wherein the penis is located between the fluid permeable membrane and the first panel.
7. 7. The fluid collection assembly of claim 6, wherein the first portion of the port extends through an aperture in the fluid permeable membrane such that the inlet is disposed adjacent the fluid permeable support and the fluid permeable membrane is absent between the inlet and the fluid permeable support.
8. 8. The fluid collection assembly of claim 7, wherein at least the second portion of the port is sloped and/or curved from the first portion toward the proximal end region relative to a longitudinal axis of the fluid collection assembly, and the inlet is disposed on a surface of the fluid permeable support that interfaces with the fluid permeable membrane.
9. 9. The fluid collection assembly of claim 6, wherein: the inlet being disposed adjacent to the end of the fluid permeable support in the distal region, and The port extends distally from the inlet and then bends and/or tilts to extend proximally.
10. 10. The fluid collection assembly according to any one of claims 5 to 9, wherein the fluid permeable membrane and the fluid permeable support each comprise an opening aligned with the opening in the second panel and sized to receive at least a portion of a penis therethrough.
11. 11. The fluid collection assembly according to any one of claims 1 to 10, wherein the fluid permeable membrane comprises a gauze material or a wicking fabric material.
12. 12. The fluid collection assembly according to any one of claims 1 to 11, wherein the fluid permeable support comprises a porous spun fiber structure.
13. 13. The fluid collection assembly of claim 12, wherein the fluid permeable support comprises a porous spun nylon fiber structure.
14. 14. The fluid collection assembly according to any one of claims 1 to 13, wherein: The fluid permeable support includes a first surface interfacing with one of the first or second panels, a second surface opposite the first surface and interfacing with the fluid permeable membrane, and two sides extending between the first and second surfaces, and At least one of the fluid-permeable membrane, the second panel, and/or the second covers the two sides of the fluid-permeable support such that substantially all of the fluid-permeable support is covered by the first panel, the second panel, and/or the fluid-permeable membrane in the chamber and the fluid-permeable support is not exposed to the chamber.
15. 15. A system, comprising: The fluid collection assembly according to any one of claims 1 to 14; a vacuum source configured to apply a vacuum force; Fluid storage container At least one conduit connected to the outlet and in fluid communication with the vacuum source and the fluid storage vessel.
16. 16. A method of manufacturing a fluid collection assembly, the method comprising: providing a fluid-impermeable barrier comprising a first panel and a second panel, the second panel defining an opening sized to receive at least a portion of a penis therethrough; Attaching the outer perimeter of the first panel to the outer perimeter 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 defining at least a chamber, and A fluid permeable body having a fluid permeable support and a fluid permeable membrane comprising a wicking material is disposed in the chamber such that the fluid permeable membrane is disposed in contact with the penis in the chamber when the penis extends through the opening, and a port extends through the fluid outlet, wherein a first portion of the port defines an inlet disposed adjacent the fluid permeable support such that there is no fluid permeable membrane between the inlet and the fluid permeable support, and a second portion of the port defines an outlet located outside the chamber and configured for attachment to a catheter.
17. 17. The method of claim 16, wherein disposing a fluid permeable body in the chamber comprises: The fluid permeable support is arranged such that the fluid permeable support is located between the fluid permeable membrane and the first panel, wherein the fluid permeable membrane is arranged to contact the penis in the chamber when the penis extends through the opening, wherein the penis is located between the fluid permeable membrane and the second panel.
18. 18. The method of claim 17, wherein at least the second portion of the port is inclined and/or curved from the first portion toward the proximal end region relative to a longitudinal axis of the fluid collection assembly.
19. 19. The method of claim 17 or claim 18, wherein the inlet is provided on a side wall of the first portion of the port and the covered end of the first portion is provided adjacent the fluid permeable membrane.
20. 20. The method according to claim 17, wherein: The inlet being provided at an end of the first portion and adjacent to the end of the fluid permeable support in the distal region, and The port extends distally from the inlet and then bends and/or tilts to extend proximally.

Description

Male fluid collection assemblies and systems, methods of use and methods of manufacture Background In many cases, the mobility of a human or animal may be limited or impaired, making the conventional urination process difficult or impossible. For example, a person may experience or have disabilities that affect mobility. A person may be in an environment where movement is limited, such as experienced by a flight crew, a driver, and personnel working in a hazardous area. In addition, urine collection is sometimes required for monitoring purposes or for clinical testing. Urinary catheters (e.g., foley catheters) can be used to address some of these conditions, such as urinary incontinence. Unfortunately, however, urinary catheters can be uncomfortable, painful, and can lead to complications such as infection. In addition, a bedpan, i.e., a receptacle for a bedridden patient (e.g., a patient in a medical facility) to go to the toilet, is sometimes used. However, bedpans are prone to discomfort, spillage and other hygiene issues. Men suffering from the most serious consequences of urinary incontinence (e.g., discomfort, rashes, and ulcers) are often elderly and often bedridden for extended periods of time. They also require constant assistance to maintain hygiene. These patients are often characterized by a penis that generally decreases in size with age, folds in the skin containing adipose tissue cause the penis to shrink inwardly, pointing generally upward in a supine position, making it difficult for the patient to reach the penis and operate the device. The urine collection device should be designed with reference to these features. Existing solutions are commonly used in standing or sitting postures (e.g. cups and funnels) with the urination orifice opposite the distal end of the penis. Other designs, such as condom catheters, are difficult to handle by the patient, often do not match in size, and cannot be reliably secured in place. Thus, there is a need for a device that is capable of collecting urine from a person or animal (particularly a male) comfortably and with minimal contamination to the user and/or surrounding area. Disclosure of Invention Embodiments disclosed herein relate to male fluid collection assemblies, systems including the same, methods of making the same, and methods of using the same. In one embodiment, a fluid collection assembly is disclosed. The fluid collection assembly includes a sheath. The sheath includes a fluid-impermeable barrier including a proximal end region, a distal end region extending from the proximal end region, a first panel, a second panel attached to the first panel and defining an opening in the proximal end region of the fluid-impermeable barrier, the opening sized to receive at least a portion of a penis therethrough, and a fluid outlet at the distal end 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 located between the fluid permeable membrane and one of the first panel or the second panel. In some embodiments, the fluid-permeable support, the fluid-permeable membrane, and the fluid-impermeable barrier are not fixed to one another (e.g., the fluid-permeable support and the fluid-permeable membrane are movable within the chamber). The fluid permeable membrane is configured to contact the penis within the chamber when the penis extends through the opening. The fluid collection assembly further includes a port extending through the fluid outlet. The port includes a first portion defining an inlet disposed adjacent the fluid permeable support such that there is no fluid permeable membrane between the inlet and the fluid permeable support. The port includes a second portion defining an outlet located outside the chamber and configured to be attached to a conduit. In one embodiment, a method of manufacturing a fluid collection assembly includes providing a fluid impermeable barrier including a first panel and a second panel, the second panel defining an opening. The opening is sized to receive at least a portion of a penis therethrough. The method further includes attaching the outer perimeter of the first panel to the outer perimeter 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 defining at least a chamber. The method further includes disposing a fluid permeable body having a fluid permeable support and a fluid permeable membrane comprising a wicking material within the chamber such that the fluid permeable membrane is disposed in contact with the penis within the chamber when the penis ext