Systems and methods for incontinence control

• US 10,010,393 B1
• Filed: 11/03/2017
• Issued: 07/03/2018
• Est. Priority Date: 03/17/2017
• Status: Active Grant

• Current Assignee: Soft Health Technologies LLC
• Original Assignee: Soft Health Technologies LLC
• Inventors: Nguyen, John, Taylor, John M., Berryman, Thomas J.
• Primary Examiner(s): Cox, Thaddeus
• Application Number:
  US15/802,759
• Time in Patent Office: 242 Days
• CPC Class Codes: A61F 13/45 characterised by the shape cup-shaped type tampons A61F13/2045
• CPC Class Codes: A61F 13/47209 having only interlabial part, i.e. with no extralabial parts
• CPC Class Codes: A61F 13/47227 for interlabial use
• CPC Class Codes: A61F 13/47236 characterised by an unusual contour
• CPC Class Codes: A61F 13/82 with means for attaching to the body
• CPC Class Codes: 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
• CPC Class Codes: A61F 2013/15121 for mild incontinence
• CPC Class Codes: A61F 2210/0061 swellable
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2250/0078 Gender-specific, e.g. different for male and female patients

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

1. A system for managing female incontinence comprising:

a body of biocompatible material configured to fit between the labia minora and the vestibule floor of a female human subject, the body including a ventral side having a surface configured for placement over the vestibule floor around the urethral meatus of the subject;

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

an engagement feature extending from a dorsal side of the body, opposite the ventral side of the body and configured to be grasped by the subject in order to apply a removal force on the body to separate the body from at least one of the urethral meatus and the vestibule floor, wherein the body is a non-molded structure of sheet material.

2. The system of claim 1, wherein the body comprises a foam.

3. The system of claim 2, wherein the body comprises polyvinyl chloride foam.

4. The system of claim 2, wherein the body comprises polyolefin foam.

5. The system of claim 1, wherein the body comprises cellulose.

6. The system of claim 1, wherein the body comprises a woven layer.

7. The system of claim 1, wherein the body comprises foam tape.

8. The system of claim 1, wherein the engagement feature comprises sheet material.

9. The system of claim 1, wherein the engagement feature is carried by a second sheet.

10. The system of claim 9, wherein the second sheet includes a first portion coupled to the body and a second portion including the engagement feature.

11. The system of claim 10, wherein the second sheet further comprises a third portion coupled to the body, 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.

12. The system of claim 11, wherein the first portion of the second sheet is coupled to a first lateral end of the body and the third portion of the second sheet is coupled to a second lateral end of the body.

13. The system of claim 10, wherein the first portion of the second sheet is coupled to a first lateral end of the body, and further comprising a third sheet including a first portion coupled to a second lateral end of the body and a second portion coupled to the second portion of the second sheet.

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

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

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

17. The system of claim 16, wherein the silicone hydrogel comprises a water gradient silicone hydrogel.

18. The system of claim 1, further comprising 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.

19. The system of claim 18, wherein the second adhesive layer is removable from the first adhesive layer without detaching the first adhesive layer from the body.

20. The system of claim 18, wherein the second adhesive layer comprises a hydrogel.

21. The system of claim 18, wherein the second adhesive layer comprises pHEMA.

22. The system of claim 18, wherein the second adhesive layer comprises a silicone hydrogel.

23. The system of claim 22, wherein the silicone hydrogel comprises a water gradient silicone hydrogel.

24. The system of claim 1, wherein the body is formed of a die-cut sheet.

25. The system of claim 1, wherein the body has a substantially uniform thickness.