Method and device for female urinary incontinence

Abstract

A method and device for use in stress female urinary incontinence. A small, flexible adhesive patch is applied directly to the clitoris of a person suffering from stress female urinary incontinence. The adhesive is of a type sufficient to stimulate the mechanoreceptors located in the clitoris whereby to inhibit discharge from the bladder. The patch is formed of a backing sheet of an impervious material containing adhesive on one side. A release liner prevents the adhesive from drying out.

Claims

1. A patch for treating female urinary incontinence, the patch sized and configured to fit directly on and cover a clitoris without covering a urethra, the patch configured when applied to stimulate the clitoris to inhibit discharge from a bladder.

2. The patch of claim 1, comprising an adhesive layer on a side of the patch.

3. The patch of claim 2, wherein the adhesive layer is removably attached to a release sheet.

4. The patch of claim 2, wherein the adhesive layer comprises a pressure-sensitive adhesive.

5. The patch of claim 2, wherein the adhesive layer comprises a silicone adhesive.

6. The patch of claim 2, wherein the adhesive layer comprises a bioadhesive.

7. The patch of claim 2, wherein the adhesive layer comprises a combination of a pressure-sensitive adhesive and a bioadhesive.

8. The patch of claim 1, wherein the adhesive layer comprises a viscous gel.

9. The patch of claim 1, wherein the adhesive layer comprises a substantially solid composition.

10. The patch of claim 1, wherein the patch is impervious to body fluids.

11. The patch of claim 1, wherein the patch comprises an arcuate shape.

12. The patch of claim 1, wherein the patch comprises an oval shape.

13. A method for treating female urinary incontinence, comprising applying a flexible patch having a substantially flat skin-contacting surface directly onto a clitoris of a person suffering from female urinary incontinence, wherein applying the patch is sufficient to stimulate the clitoris, thereby inhibiting discharge from a bladder of the person, wherein applying the patch does not comprise covering a urethra of the person with the patch.

14. The method of claim 13, for treating stress female urinary incontinence.

15. The method of claim 13, for treating urge female urinary incontinence.

16. The method of claim 13, for treating overflow female urinary incontinence.

17. The method of claim 13, for treating continuous female urinary incontinence.

18. The method of claim 13, wherein the patch comprises an adhesive layer on a side of the patch.

19. The method of claim 13, wherein the patch when applied contacts a clitoral hood of the person.

20. The method of claim 13, further comprising removing the patch from a release sheet prior to applying the patch directly to the clitoris.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) For a more complete understanding of the present invention, reference is now made to the following descriptions taken in conjunction with the accompanying drawing, in which:

(2) FIG. 1 is a perspective view of the device, in this embodiment having an oval shape, shown with a portion peeled up to better illustrate its construction;

(3) FIG. 2 is a top plan view of the device of FIG. 1;

(4) FIG. 3 is a top plan view of a device similar to the device of FIG. 1, but having a rectangular shape;

(5) FIG. 4 is a top plan view of a device similar to the device of FIG. 1, but having a triangular shape;

(6) FIG. 5 is a sketch of a vagina illustrating components relevant to the invention; and

(7) FIG. 6 is a cross-section of the clitoral region of the vagina, showing application of the patch of FIG. 1.

DETAILED DESCRIPTION OF THE INVENTION

(8) Referring to FIGS. 1 and 2, a generally oval patch 10 of this invention is shown formed of a backing sheet 16 coated with a layer of adhesive 14 and covered with a release sheet/layer 12. The adhesive layer 14 is preferably pressure sensitive, hydrophilic and non-allergenic, as known to the art. The patch is approximately 1 inches long and 1 1/16 inches wide.

(9) The backing sheet 16 is preferably impervious to body fluids (e.g., urine and/or menses) and is preferably manufactures from a thin, flexible plastic film, although other flexible liquid impervious materials may also be used, all as known to the art. As used herein, the term flexible refers to materials which are compliant and will readily conform to the general shape and contours of clitoris region. The backing sheet 16 material may as described for the backsheet material of Brock SIR No. H1602, incorporated herein by reference, and can comprise a woven or nonwoven material, polymeric films such as thermoplastic films of polyethylene or polypropylene, or composite materials such as a film-coated nonwoven material, illustrated by a polyethylene film having a thickness of from about 0.012 mm (0.5 mil) to about 0.051 mm (2.0 mils).

(10) The release layer/sheet 12 keeps the adhesive from drying out and can be formed of an adhesive releasing material, as known by the art, and as also illustrated in Brock SIR No. H1602. Other non-limiting examples of the adhesive releasing material/sheet includes paper, resin film, nonwoven fabric, and nonwoven fabric laminated with resin film, each having been treated with silicon. The release layer is removed before applying the patch 10.

(11) The adhesive layer can comprise of a hydrophilic adhesive composition which may be sticky, viscous gel, or a substantially solid composition. The adhesive layer can also comprise of pressure sensitive adhesives (PSA) made from polymer such as acrylic and methacrylic ester homo- or copolymers, butyl rubber-based systems, silicones, urethanes, vinyl esters and amides, olefin copolymers, butyl rubber-based or synthetic rubbers, and the like. In another embodiment, the adhesive layer can comprise of bioadhesives (BAs), as known to the art. In contrast to PSAs that adhere mainly to dry substrates, BAs exhibit good tack when adhered to hydrated biological substrates/tissues. Non-limiting examples includes slightly cross-linked polyacrylic and polymethacrylic acids as well as blends of hydrophilic cellulose derivatives (40-95%) with polyethylene glycol. In other embodiments, the adhesive layer can comprise different combinations of PSA and BA polymeric materials of different hydrophilicity and thus different solubilities in water or in the liquids secreted by the tissue area in contact with the adhesive layer.

(12) Regardless of the adhesive composition used, the final adhesive layer should preferably be pressure sensitive, hydrophilic and non-allergenic.

(13) While a single patch 10 is shown in FIG. 1, in actual production and/or sale, a plurality of such patches may be formed on a single release sheet and sold as a kit whereby individual patches can be removed and applied as needed.

(14) FIG. 3 shows a patch constructed in the same manner as the patch of FIG. 1, but having a generally rectangular shape) 1 inches long and 1 and 1/16 inches wide.

(15) FIG. 4 shows a patch constructed in the same manner as the patch of FIG. 1, but having a generally triangular shape 1 and inches high and 1 and inches at its base.

(16) The patch 10 is applied with the adhesive layer directly on the clitoris. FIG. 5 is a sketch of a vagina illustrating relevant components of a vagina, including the vaginal opening 18, the urethral opening 20, the labia minora 22, the labia majora 24, the clitoral hood 26 and the clitoris at 28. Referring to FIG. 6, the patch 10 is applied between opposing folds of the labia majora 24 with the adhesive layer 14 directly contacting the clitoris 28 and covering the clitoral shaft 30. The adhesive layer 14 is protected from body fluids and, in its position, physically stimulates the clitoris 28 to provide a strong inhibitory effect on the bladder, relieving stress urinary incontinence.

(17) Although the present invention has been described in connection with the preferred embodiments, it is to be understood that modifications and variations may be utilized without departing from the principles and scope of the invention, as those skilled in the art will readily understand. Accordingly, such modifications may be practiced within the scope of the following claims.