Systems and methods for incontinence control

• US 10,143,772 B2
• Filed: 09/15/2017
• Issued: 12/04/2018
• 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.
• Primary Examiner(s): LACYK, JOHN P
• Application Number:
  US15/706,596
• Publication Number:
  US 20180000981A1
• Time in Patent Office: 445 Days
• Field of Search: 600 29- 32, 128DIG 25, 604358, 604359, 60438501, 60438517
• 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 a substance carried by at least one of the body and the adhesive and configured for controlling the odor of the general vaginal-urethral area of a female.

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 comprising an anterior end, a posterior end, an outer periphery, a first side, a second side opposite the first side, a first planar surface substantially covering the first side and configured to occlude the urethral meatus, and a second planar surface substantially covering the second side and including a central region extending substantially between the anterior end and the posterior end of the body, wherein the first planar surface is configured to provide a sealing engagement between the body and the urethral meatus; and

an elongate tether having a first tether end incorporated into the body and a second, free tether end, the elongate tether extending from a location at or adjacent the outer periphery of the body, the elongate tether further having an exterior portion configured for grasping, such that a moment can be placed on the body via a tensile force applied on the tether, to aid the body to be peeled from the vestibule floor.

2. The system of claim 1, wherein the first planar surface and the second planar surface are parallel to each other.

3. The system of claim 1, wherein the elongate tether extends from an anterior portion of the body.

4. The system of claim 1, wherein a portion of the body bounded by the first planar surface and the second planar surface has a substantially uniform thickness.

5. The system of claim 1, wherein the first planar surface of the body is provided with an adhesive layer.

6. The system of claim 1, wherein the body comprises a silicone hydrogel.

7. The system of claim 6, wherein the body comprises a water gradient silicone hydrogel.

8. The system of claim 7, wherein the water gradient silicone hydrogel of the body has a plurality of regions having different water holding capacities, and wherein the water gradient silicone hydrogel of the body has a range between the lowest water holding capacity and the highest water holding capacity of between about 30% and about 80%.

9. The system of claim 8, wherein the water gradient silicone hydrogel of the body has a range between the lowest water holding capacity and the highest water holding capacity of between about 40% and about 70%.

10. The system of claim 8, wherein the water gradient silicone hydrogel of the body has a range between the lowest water holding capacity and the highest water holding capacity of between about 50% and about 60%.

11. The system of claim 7, wherein the water gradient silicone hydrogel of the body has a plurality of regions having different water holding capacities including a first region immediately adjacent the first planar surface and a second region immediately adjacent the second planar surface.

12. The system of claim 11, wherein the first region has a lower water holding capacity than the second region.

13. The system of claim 12, wherein the difference between the water holding capacity of the first region and the second region is greater than about 10%.

14. The system of claim 12, wherein the difference between the water holding capacity of the first region and the second region is greater than about 50%.

15. The system of claim 7, wherein the water gradient silicone hydrogel comprises a photocrosslinked polymer.

16. The system of claim 7, wherein the first planar surface comprises a treated surface.

17. The system of claim 16, wherein the first planar surface comprises at least one treated surface selected from the list consisting of:

a corona discharge treated surface, a plasma discharge treated surface, a cleaned surface, a degreased surface, a chemically etched surface, and acid etched surface, a mechanically etched surface, a photoetched surface, a surface having applied surface additives, a primer applied surface, a solvent applied surface, a mechanically abraded surface, and a particle blasted surface.

18. The system of claim 1, wherein the body comprises a molded structure.