SYSTEMS AND METHODS FOR INCONTINENCE CONTROL

• US 20160095759A1
• Filed: 09/30/2015
• Published: 04/07/2016
• Est. Priority Date: 10/03/2014
• Status: Active Grant

• Current Assignee: Soft Health Technologies LLC
• Original Assignee: Soft Health Technologies LLC
• Inventors: Berryman, Thomas J., Taylor, John M.
• Granted Patent: US 9,555,151 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 13/00063 comprising medicaments or additives, e.g. odor control, PH control, debriding, antimicrobic drug delivery dressings A61K9/70; chemical aspect of the additives A61L15/00
• 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 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 2/005 with pressure applied to urethra by an element placed in the vagina
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• CPC Class Codes: A61F 2013/15121 for mild incontinence
• CPC Class Codes: A61F 2210/00 Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2230/0063 Three-dimensional shapes
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0078 Gender-specific, e.g. different for male and female patients
• CPC Class Codes: A61F 2310/00389 The prosthesis being coated or covered with a particular material
• CPC Class Codes: A61L 15/18 containing inorganic materials
• CPC Class Codes: A61L 15/20 containing organic materials
• CPC Class Codes: A61L 15/26 Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds; Derivatives thereof A61L15/225 takes precedence
• CPC Class Codes: A61L 15/28 Polysaccharides or their derivatives A61L15/225 takes precedence
• CPC Class Codes: A61L 15/34 Oils, fats, waxes or natural resins A61L15/225 takes precedence
• CPC Class Codes: A61L 15/40 containing ingredients of undetermined constitution or reaction products thereof , e.g. plant or animal extracts
• CPC Class Codes: A61L 15/425 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 15/46 : Deodorants or malodour counteractants, e.g. to inhibit the formation of ammonia or bacteria
• CPC Class Codes: A61L 15/58 : Adhesives
• CPC Class Codes: A61L 2300/102 : Metals or metal compounds, e.g. salts such as bicarbonates, carbonates, oxides, zeolites, silicates
• CPC Class Codes: A61L 2300/108 : Elemental carbon, e.g. charcoal
• CPC Class Codes: A61L 2300/216 : with other specific functional groups, e.g. aldehydes, ketones, phenols, quaternary phosphonium groups
• CPC Class Codes: A61L 2300/30 : Compounds of undetermined constitution extracted from natural sources, e.g. Aloe Vera
• CPC Class Codes: A61L 2300/406 : Antibiotics
• CPC Class Codes: A61L 2300/606 : Coatings

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, an adhesive carried on at least a first portion of the surface and configured to provide a sealing engagement between the body and the urethral meatus, and wherein at least the adhesive includes a water gradient silicone hydrogel.

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, the body having a surface configured to occlude the urethral meatus;

an adhesive carried on at least a first portion of the surface and configured to provide a sealing engagement between the body and the urethral meatus; and

wherein at least the adhesive comprises a water gradient silicone hydrogel.

2. The system of claim 1, wherein the water gradient silicone hydrogel has a plurality of regions having different water holding capacities, and wherein the water gradient silicone hydrogel has a range between the lowest water holding capacity and highest water holding capacity of between about 30% and about 80%.

3. The system of claim 2, wherein the water gradient silicone hydrogel has a range between the lowest water holding capacity and highest water holding capacity of between about 40% and about 70%.

4. The system of claim 2, wherein the water gradient silicone hydrogel has a range between the lowest water holding capacity and highest water holding capacity of between about 50% and about 60%.

5. The system of claim 1, wherein the water gradient silicone hydrogel has a plurality of regions having different water holding capacities, and wherein a difference between the lowest water holding capacity and highest water holding capacity is greater than about 10%.

6. The system of claim 5, wherein the difference between the lowest water holding capacity and highest water holding capacity is greater than about 20%.

7. The system of claim 5, wherein the difference between the lowest water holding capacity and highest water holding capacity is greater than about 30%.

8. The system of claim 5, wherein the difference between the lowest water holding capacity and highest water holding capacity is greater than about 40%.

9. The system of claim 5, wherein the difference between the lowest water holding capacity and highest water holding capacity is greater than about 50%.

10. The system of claim 1, wherein the adhesive and the body each comprise a water gradient silicone hydrogel.

11. The system of claim 10, wherein the adhesive has a first water holding capacity and the body has a second water holding capacity, and wherein the first water holding capacity is less than the second water holding capacity.

12. The system of claim 11, wherein a difference between the lowest water holding capacity and highest water holding capacity is greater than about 10%.

13. The system of claim 11, wherein the difference between the lowest water holding capacity and highest water holding capacity is greater than about 20%.

14. The system of claim 11, wherein the difference between the lowest water holding capacity and highest water holding capacity is greater than about 30%.

15. The system of claim 11, wherein the difference between the lowest water holding capacity and highest water holding capacity is greater than about 40%.

16. The system of claim 11, wherein the difference between the lowest water holding capacity and highest water holding capacity is greater than about 50%.

17. The system of claim 10, further comprising an internal substrate between the adhesive and the body.

18. The system of claim 17, wherein the water gradient silicone hydrogel is cross-linked with UV light.

19. The system of claim 10, wherein the adhesive and body each consist of a water gradient silicone hydrogel.

20. The system of claim 10, wherein the water gradient silicone hydrogel is cross-linked with UV light.

21. The system of claim 20, wherein the water gradient silicone hydrogel is at least partially masked during a UV cross-linking process.

22. The system of claim 20, wherein a UV beam is attenuated during a UV cross-linking process.

23. The system of claim 1, further comprising a wetting agent.

24. The system of claim 23, wherein the wetting agent is an internal wetting agent.

25. The system of claim 24, wherein the internal wetting agent comprises hyaluronic acid.

26. The system of claim 25, wherein the internal wetting agent comprises methacrylated hyaluronic acid.

27. The system of claim 23, wherein the wetting agent comprises poly(oxyethylene)-poly(oxybutylene).

28. The system of claim 23, wherein the wetting agent is photocrosslinkable.

29. The system of claim 1, wherein the body and the adhesive are formed with a process using one or more reusable molds.

30. The system of claim 29, wherein the one or more reusable molds comprise a material consisting of one of a quartz, a silica glass or a water-soluble polymer.