# Patent

## Title
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.

## Background
CROSS-REFERENCE TO RELATED APPLICATIONS
This application claims the benefit under 35 U.S.C. §120 as a continuation of U.S. patent application Ser. No. 12/999,114 having a 371(c) date of Mar. 23, 2011, which is a national stage application of PCT App. No. PCT/US10/33349 filed on May 3, 2010, which in turn claims the benefit of U.S. Provisional Patent App. No. 61/181,556 filed May 27, 2009. All of the foregoing priority applications are hereby incorporated by reference in their entireties.


FIELD OF THE INVENTION
The invention relates to a method and device for relieving or mitigating the problems associated with female urinary incontinence.
BACKGROUND OF THE INVENTION
Female urinary incontinence is a troublesome problem for many individuals and can be classified into four major categories. From least to severe:

    
    
        stress incontinence, in which a slight urine loss occur due to the momentary pressure caused by sneezing, coughing, laughing, or simply lifting a heavy object;
        urge incontinence, in which a strong frequent desire to void is accompanied by involuntary urination within a minute or two of the urge;
        overflow incontinence, which occurs when the bladder fills beyond capacity, creating pressure which exceeds urethral resistance—no urge to urinate is present, so the bladder just overflows; and
        continuous incontinence, which is a conscious or unconscious urination, which is usually the result of an abnormal passage caused by surgery, trauma, or neural damage.
    
    


A number of devises have been proposed to deal with female urinary incontinence, represented by, for example, U.S. Pat. No. 5,074,855 to Rosenbluth et al., U.S. Pat. No. 6,131,575 to Lenker et al., U.S. Pat. No. 6,461,340, to Lenker et al., U.S. Pat. No. 3,789,828 to Schulte, U.S. Pat. No. 5,509,427 to Simon et al. U.S. Pat. No. 4,892,535 to Bjornberg et al., U.S. Pat. No. 6,179,775 to Thompson, U.S. Pat. No. 6,836,684 to Rijkhoff, and Statutory Invention Registration (SIR) No. H1602 to Brock, the disclosures of each of which are hereby incorporated herein by reference.
Rosenbluth et al. and both Lenker et al. patents disclose a resilient pad configured to seal against and occlude the urethral meatus, i.e., the urethral opening. These devices are described as shaped and sized to fit each individual user's anatomy, implying that the application of this device requires careful attention for a comfortable fit. Moreover, the devices are designed for individual custom fitting, calling for predetermined sizes to be trimmed individually for optimal fit, including the use in some cases of a mold of the relevant portions of the vulva taken prior to sizing the pad. A mirror or light is suggested to facilitate insertion, indicating that the devices are difficult to apply and suggests that the device may be designed for clinical use, attended by a physician or health care professional. Moreover, these devices do not appear to be designed for highly active women, e.g. running, jogging, high and low impact aerobics or any exercise where the movement of the lower torso is essential. The devices are rigid around the perimeter contributing to discomfort as used in its intended position. In addition, the complex construction and individual custom fitting indicates a probable high overall cost to the consumer.
Lenker et al. U.S. Pat. No. 6,131,575 discloses in addition to the rigid female incontinence device, a more flexible device but only for male incontinence, shown in their FIGS. 26 to 30, and which is retained on the glans of a patient's penis by an adhesive layer formed of a pressure-sensitive hydrophilic hydrogel.
The device described in Shulte's patent is a mechanical device surgically implanted for prolonged use and features a fluid flow valve which can be operated manually, in contrast to the present invention's simplicity, ease of use and temporary nature as needed at the discretion of the user. In structure, the Shulte device appears to be a rigid mechanical device with a valve. Simon et al.'s device is designed to be inserted directly inside of the urethra with an “expandable balloon at its proximal end,” again, which is in total contrast to our present invention. Bjornberg et al. and Brock describe absorbent pads of the type that can be used as incontinence pads. Brock further describes a continuous layer of adhesive for securing the pad to a wearer's skin. The pads of both Bjornberg et al. and Brock are intended to cover large general areas.
Thompson describes a device to enhance clitoral stimulation during intravaginal intercourse, using a hydrophilic, non-allergenic adhesive to seat a foraminous, elongated, generally triangular shaped pad in the female vestibule to lie beneath the labia minora to support and engage the ventral aspect of the clitoris when it is engorged with blood during the arousal phase of female sexual stimulation.
Rijkhoff et al. describes a device that uses an implanted sensor and means for generating electrical pulses to stimulate nerves to inhibit contraction of the detrusor, the muscle that expels urine from the bladder. It recognizes what has been shown by investigators, that activation of afferent nerve fibres, innervating mechanoreceptors located in the clitoris, has a strong inhibitory effect on the bladder.
BRIEF SUMMARY OF THE INVENTION
The present invention provides a method and device for use in stress female urinary incontinence. Somewhat as in the electrical stimulation of mechanoreceptors located in the clitoris, the present method physically stimulates the clitoris to provide a strong inhibitory effect on the bladder, relieving stress urinary incontinence. Notwithstanding the ability to completely relieve, stress incontinence, the device is remarkably simple. Unlike prior devices, it is not an absorbent pad to catch urine, it is not a clinical device that requires help in insertion, it does not have a rigid or semi-rigid component, nor does it have projections, and is not a complicated electronic impulse generator; moreover, the device can be used in the absence of intravaginal intercourse. It is a small, flexible adhesive patch of a size that can be comfortably applied directly to the clitoris. The patch is formed of a backing sheet of an impervious film material containing adhesive on one side. A release liner prevents the adhesive from drying out.
More particularly, a method is provided for treating stress female urinary incontinence, comprising applying an adhesive 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, preferably a hydrophilic, non-allergenic adhesive. The adhesive is provided by the application of the adhesive layer of the above-described patch directly to the clitoris. In a more particularized embodiment, the method involves identifying persons in need of a device or a method for treating stress female urinary incontinence.
The present invention provides a simple, low cost solution to a vexing problem, making it affordable and available. It is designed to comfortably fit any human female who suffers from urinary incontinence and includes all the necessary elements that compliment comfort, ease of use and confidence. The device is produced with soft, pliable materials that allow the user to continue daily routines with no discomforts or embarrassing interruptions. The present invention is also designed to permit the user to apply the device with no assistance, whatsoever, from anyone.
This device can be produced in various sizes, e.g. small, medium and large, to accommodate the over the-counter market. It is well suited for highly active women, e.g. engaging in running, jogging, high or low impact aerobics or any exercise where movement of the lower torso is essential. The product is very portable and can be available in individually sealed and sterilized packages of multiple units, which can easily fit into the average sized purse or pouch. The cost, comfort, simplicity, portability and ease of use attributed to this device, surpasses all other products presently available in the consumer's over-the-counter market.



BRIEF DESCRIPTION OF THE DRAWINGS
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:
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;
FIG. 2 is a top plan view of the device of FIG. 1;
FIG. 3 is a top plan view of a device similar to the device of FIG. 1, but having a rectangular shape;
FIG. 4 is a top plan view of a device similar to the device of FIG. 1, but having a triangular shape;
FIG. 5 is a sketch of a vagina illustrating components relevant to the invention; and
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
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 11⁄2 inches long and 1 1/16 inches wide.
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).
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.
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.
Regardless of the adhesive composition used, the final adhesive layer should preferably be pressure sensitive, hydrophilic and non-allergenic.
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.
FIG. 3 shows a patch constructed in the same manner as the patch of FIG. 1, but having a generally rectangular shape) 11⁄2 inches long and 1 and 1/16 inches wide.
FIG. 4 shows a patch constructed in the same manner as the patch of FIG. 1, but having a generally triangular shape 1 and 1⁄2 inches high and 1 and 3⁄4 inches at its base.
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.
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.

## 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 physically 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, having a length of approximately 1.5 inches.

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

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

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

14. The patch of claim 1, wherein the patch comprises a triangular shape.

15. The patch of claim 1, wherein the patch comprises a rectangular shape.

16. 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 mechanically 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.

17. The method of claim 16, for treating stress female urinary incontinence.

18. The method of claim 16, for treating urge female urinary incontinence.

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

20. The method of claim 16, for treating continuous female urinary incontinence.

21. The method of claim 16, wherein the patch comprises an adhesive layer on a side of the patch.

22. The method of claim 16, wherein the patch when applied contacts a clitoral hood of the person.

23. The method of claim 16, further comprising removing the patch from a release sheet prior to applying the patch directly to the clitoris.