# US 10,869,746 B2 · Systems and methods for incontinence control

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- Number: US 10,869,746 B2
- Document ID: US10869746B2
- Status: Granted
- Kind: B2
- Application number: 16/235,423
- Filed: 2018-12-28
- Published: 2019-12-19
- Granted: 2020-12-22
- Earliest claimed: 2017-03-17
- Assignees: Soft Health Technologies, LLC
- Applicants: Soft Health Technologies, LLC
- Inventors: John Nguyen; John M. Taylor; Thomas J. Berryman
- Web page: https://patentgrep.com/patent/US10869746B2

## CPC

- A61F 2/0009: {placed in or outside the body opening close to the surface of the body (plugging an opening in the wall of a hollow or tubular organ A61B17/0057)}
- A61F 13/45: characterised by the shape (cup-shaped type tampons A61F13/2045)
- A61F 13/47209: {having only interlabial part, i.e. with no extralabial parts}
- A61F 13/47227: {for interlabial use}
- A61F 13/47236: {characterised by an unusual contour}
- A61F 13/82: with means for attaching to the body
- A61F 2013/15121: {for mild incontinence}
- A61F 2210/0061: swellable
- A61F 2210/0076: multilayered, e.g. laminated structures
- A61F 2250/0078: Gender-specific, e.g. different for male and female patients
- 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 (dental prosthetics A61C)

## Abstract

A system for managing female incontinence includes a body of biocompatible material configured to fit between the labia minora and the vestibule floor, the body having a surface configured to occlude the urethral meatus, a first adhesive layer disposed on at least a first portion of the surface and configured to provide a sealing engagement between the body and the urethral meatus, and a second adhesive layer disposed over the first adhesive layer and configured to provide a sealing engagement between the body and the urethral meatus, wherein the second adhesive layer is removable from the first adhesive layer.

## Claims

### Claim 1

A system for managing female incontinence comprising:
a non-molded first sheet configured to fit between the labia minora and the vestibule floor of a female human subject, the first sheet comprising a substantially planar dorsal surface and a substantially planar ventral surface, the substantially planar ventral surface of the first sheet configured for placement over the vestibule floor around the urethral meatus of the subject;
an adhesive layer comprising a substantially planar dorsal surface and a substantially planar ventral surface, the substantially planar dorsal surface of the adhesive layer coupled to the substantially planar ventral surface of the first sheet, and the substantially planar ventral surface of the adhesive layer configured to provide a sealing engagement between the first sheet and the urethral meatus; and
a non-molded second sheet having a first portion and second portion, the first portion of the second sheet coupled to the substantially planar dorsal surface of the first sheet and the second portion of the second sheet forming a dorsally-extending fin configured to be grasped to apply a removal force to the first sheet and adhesive layer.

### Claim 2 (depends on 1)

The system of claim 1, wherein the first portion of the second sheet includes a first end of the second sheet and the second portion of the second sheet includes a second end of the second sheet, and wherein the first end of the second sheet is coupled to the substantially planar dorsal surface of the first sheet at a first lateral end of the first sheet.

### Claim 3 (depends on 2)

The system of claim 2, further comprising a third sheet having a first end and a second end, the first end of the third sheet coupled to the substantially planar dorsal surface of the first sheet at a second lateral end of the first sheet, opposite the first lateral end.

### Claim 4 (depends on 3)

The system of claim 3, wherein the second end of the third sheet is coupled to the second end of the second sheet.

### Claim 5 (depends on 1)

The system of claim 1, wherein the first sheet comprises a foam.

### Claim 6 (depends on 5)

The system of claim 5, wherein the first sheet comprises polyvinyl chloride foam.

### Claim 7 (depends on 5)

The system of claim 5, wherein the first sheet comprises polyolefin foam.

### Claim 8 (depends on 1)

The system of claim 1, wherein the first sheet comprises cellulose.

### Claim 9 (depends on 1)

The system of claim 1, wherein the first sheet comprises a woven layer.

### Claim 10 (depends on 1)

The system of claim 1, wherein the first sheet comprises a foam tape.

### Claim 11 (depends on 1)

The system of claim 1, wherein the second sheet further comprises a third portion coupled to the substantially planar dorsal surface of the first sheet, and wherein the second portion of the second sheet is located between the first portion of the second sheet and the third portion of the second sheet.

### Claim 12 (depends on 11)

The system of claim 11, wherein the first portion of the second sheet includes a first end of the second sheet and the third portion of the second sheet includes a second end of the second sheet, and wherein the first end of the second sheet is coupled to the substantially planar dorsal surface of the first sheet at a first lateral end of the first sheet, and the second end of the second sheet is coupled to the substantially planar dorsal surface of the first sheet at a second lateral end of the first sheet, opposite the first lateral end.

### Claim 13 (depends on 12)

The system of claim 12, wherein the dorsally-extending fin of the second portion of the second sheet comprises a left side, a right side, and an elongate central fold between the left side and the right side.

### Claim 14 (depends on 1)

The system of claim 1, wherein the adhesive layer comprises a hydrogel.

### Claim 15 (depends on 1)

The system of claim 1, wherein the adhesive layer comprises pHEMA.

### Claim 16 (depends on 1)

The system of claim 1, wherein the adhesive layer comprises a silicone hydrogel.

### Claim 17 (depends on 1)

The system of claim 1, wherein the first sheet is a die-cut sheet.

### Claim 18 (depends on 1)

The system of claim 1, wherein the adhesive layer is coupled to the first sheet by an intermediate “tie” layer.

### Claim 19 (depends on 1)

The system of claim 1, wherein the adhesive layer is removable from the first sheet.

### Claim 20 (depends on 1)

The system of claim 1, wherein the second sheet comprises a fabric.
