WO2016112107A1

WO2016112107A1 - Intravaginal device for alleviating incontinence

Info

Publication number: WO2016112107A1
Application number: PCT/US2016/012342
Authority: WO
Inventors: Jacky Lee
Original assignee: Jacky Lee
Priority date: 2015-01-06
Filing date: 2016-01-06
Publication date: 2016-07-14

Abstract

Devices and methods for alleviating female urinary incontinence are presented. A preferred device includes an elongated body, which has two ends, and an opening at least partially extending between the two ends. The device is inserted intravaginally and the opening is placed around the vaginal wall facing the urethra. The opening is configured to apply pressure on a portion of a vaginal wall, sufficient to compress at least a portion of the urethra. Another preferred device includes a curved body having an inner potion and an outer portion, and a lever coupled with the inner portion. The device is inserted intravaginally and the lever is moved toward the vaginal wall to apply pressure on the vaginal wall to compress a portion of the urethra.

Description

INTRA VAGINAL DEVICE FOR ALLEVIATING INCONTINENCE

[0001] This application claims priority to our U.S. provisional patent application with the serial number 62/100199 filed January 6, 2015 which is incorporated by reference herein in its entirety. Field of the Invention

[0002] The field of the invention is female urollogy, and more specifically female urinary incontinence.

Background

[0003] Urinary incontinence affects the quality of life of millions of women worldwide. It generally occurs in women over 40 years of age. Symptoms begin with a few drops of urine escaping on exertion or laughing, coughing or sneezing, progressively become more frequently and in increasing quantities, until a later stage when there is a gradual dribbling all the time, even when tying in bed. In many women a slight cold or intestinal derangement is enough to make them lose control temporarily. [0004] As used herein, the term "urinary incontinence" means the involuntary loss of urine when a person increase their intra-abdominal pressure by activities such as lifting weights, coughing, exercising, jogging, etc. There are four types of urinary incontinence in women: stress incontinence, urge incontinence, overflow incontinence, and total incontinence. The etiology of stress incontinence in women can be due to incompetence of urinary sphincters, mobility of the urethra when women perform activities that increase internal abdominal pressure such as coughing, sneezing, lifting weights or other exercise, and lack of urethral support by pelvic fascia and ligaments secondary to pregnancy or other medical reasons. The psychological impact of this clinical condition can be isolation, embarrassment, unable to perform activities such as lifting weights (including, for example, lifting infants and children), and clinical complications such as VEiginal voiding and poor hygiene, and perivaginal skin changes, and dermatitis secondary to infection.

[0005] The most common cause for female urinary incontinence is that sustained in child- birth, where stretching or bruising has damaged the musculature of the sphincter of the bladder. Studies have showed that there is a statistically higher probability of the development of stress urinary incontinence in tbe case of surgical delivery, or natural childbirth of a baby with a birth weight of 4000 g or more.

[0006] Many efforts have been put forth to treat female urinary incontinence. Currently available treatment methods include injection of bulking agent into the female urethra, insertion of a Foley catheter, and surgical procedures (e.g., open bladder suspension, laparoscopic bladder suspension, or sling procedure which is using slings, insertion of mesh, etc). However, some of those surgical procedures can be accompanied with side effects due to malfunction of devices. Indeed, in 60 percent of cases, various side effects have been reported including recurring symptoms, complications, infections, and open ended laparoscopic abdominal sacro-colpoplexy. And. even aside from side effects, these surgeries can have high failure rates.

[0007] Several devices have been designed to treat female urinary incontinence by occluding the urethral lumen. One problem is that since the female urethra is located within the anterior vaginal wall, only about half of the lumen is accessible for occluding. For example, US Patent No. 6,530,879 to Adamkiewicz discloses an intravaginal device, basically a bulky ball, which when inserted into the vagina is intended to both compress the ureter and prevent prolapse. However, Adamkiewicz's device can affect normal functioning of the organ, such as secretion of body fluid through the vagina.

[0008] U.S. Patent No. 6,770,025 to Zunker discloses a molar-shaped device, which is inserted intra-vaginally, and engages anterior and posterior vaginal walls in the bladder neck region to alleviate female urinary incontinence.. Similar to the '025 patent, U.S Patent No. 6,808,485 to Zunker also discloses a device that is inserted intra-vaginally to engage at least two opposing vaginal walls. In both cases, the devices do not specifically or exclusively occlude the lumen of urethra, and instead can dbform the shape of the vaginal cavity. [0009] U.S. Patent No. 8,449,446 to Ziv discloses an umbrella like device which expands intra-vaginally to place pressure through the vaginal wall against the urethra.

[0010] U.S. Patent No. 8,047,980 to Bartning discloses several other devices (basked handle shaped, dog bone shaped, and rabbit ear shaped devices) mat can be inserted intra-vaginally to put pressure on the urethra. [0011] All of these prior art devices have drawbacks. Among other things, the urethral lumen may have to be occluded completely to ] prevent leakage of urine, and devices that rely upon limited flexibility of the vaginal walls. Given the flexible nature of the vaginal wall, and large differences in sizes of vaginal cavities, such devices are inherently problematic. Thus, there is still a need for improved device that is user friendly to provide a non-surgical means to treat stress urinary incontinence.

Summar^y of The Invention

[0012] The inventive subject matter provides systems and methods for alleviating female urinary incontinence. [0013] One aspect of the inventive subject matter is a device for treating urinary incontinence of a female. The device includes an elongated Irody, which has two ends, and an opening at least partially extending between the two ends. The opening, in a closed configuration, is sized and dimensioned to apply pressure on a portion of a vaginal wall, sufficient to compress at least a portion of the urethra. [0014] Another aspect of the inventive subject matter is a method for treating urinary incontinence in a female. The method includes a step of inserting a device in an open configuration into a user's vagina. The device lias an elongated body, which has two ends, and an opening at least partially extending between the two ends. The opening, in a closed configuration, is sized and dimensioned to apply pressure on a portion of a vaginal wall, sufficient to compress at least a portion of the urethra. Once the device is inserted, the method continues with a step of placing the opening around the vaginal wall facing the urethra. Then, a pressure is applied on the urethra by changing the device from the open configuration to a closed configuration.

[0015] Another aspect of the inventive subject matter is a device for treating urinary incontinence of a female. The device includes a curved body having an inner potion and an outer portion, and a lever coupled with the inner portion. The lever is configured to apply pressure on a vaginal wall to compress a portion of the urethra.

[0016] Still another aspect of the inventive subject matter is a method for treating urinary incontinence in a female. The method includes a step of inserting a device in an open configuration into a user's vagina. The device lias a curved body having an inner potion and an outer portion, and a lever coupled with the inner portion. Once the device is inserted, the method continues with a step of compressing a portion of the urethra by moving the lever toward the vaginal wall around the urethra.

[0017] Various objects, features, aspects and advantages of the inventive subject matter will become more apparent from the following detailed description of preferred embodiments, along with the accompanying drawing figures in which like numerals represent like components.

Brief Description of The Drawings

[0018] Figure 1A is a perspective view of one embodiment of the incontinence device in a substantially open configuration.

[0019] Figure IB is a perspective view of one embodiment of the incontinence device of Figure 1 A in a substantially closed configuration.

[0020] Figure 2 is a perspective view of one embodiment of the incontinence device of Figures 1 A-B in a twisted configuration. [0021] Figure 3 is a perspective view of anoth er embodiment of an incontinence device.

[0022] Figure 4A is a perspective view of still another embodiment of an incontinence device with side support railings.

[0023] Figure 4B is a front view of the incontinence device of Figure 4A.

[0024] Figure 4C is a back view of the incontinence device of Figures 4A-B. [0025] Figure 5 is a perspective view of still another embodiment of an incontinence device with side support railings and a releasing grip.

[0026] Figure 6 is a perspective view of still another embodiment of an incontinence device with a lever.

Detailed description

[0027] The following discussion provides many example embodiments of the inventive subject matter. Although each embodiment represents a single combination of inventive elements, the inventive subject matter is considbred to include all possible combinations of the disclosed elements. Thus if one embodiment comprises elements A, B, and C, and a second embodiment comprises elements B and D, then the inventive subject matter is also considered to include other remaining combinations of A, B, C, or D, even if not explicitly disclosed. [0028] The inventive subject matter relates generally to solve a problem of female urinary incontinence by providing a device, a method, and a system for pressing a portion of female urethra accessible from the anterior wall of vagina. In preferred embodiments, the device can be effective in preventing leakage of urine when the user coughs or laughs, or otherwise experiences increased intra-abdominal pressure. [0029] One aspect of the inventive subject matter includes a device to alleviate or treat female urinary incontinence. Figures 1A-B illustrate a clip 100 for alleviating female urinary incontinence in an open configuration (Figure 1A) and a substantially closed configuration (Figure IB). The clip 100 comprises a left wall 105 and a right wall 110 coupled with each other at a hinge 107. Preferably, the left wall 105 and the right wall are symmetrical along the hinge 107. In the open configuration (Figure 1 A), the left wall 105 and the right wall 110 are placed substantially in the same plane such thait inner portion of the left wall 105 and the right wall 110 can be exposed outside.

[0030] In the substantially closed configuration (Figure 2B), the left wall 105 and the right wall 110 are folded along the hinge 107 such that the left wall 105 and the right wall 110 can form an elongated body (e.g., tube) having a first end 115, a second end 120, and an opening 130. In some emabodiments, the clip 100 can ha ve other shapes, including for example, a substantially square shape, a curvilinear triangular shape, a quatrefoil shape, a trapezoid shape, an oval shape, or any other shape that may be appropriate to fit to the uremia and inner walls (anterior or posterior) of the vagina. [0031] The opening 130 of the device is sized and dimensioned to hold a portion of the vaginal wall around the urethra and apply sufficient pressure to compress the portion of the urethra. Thus it is desired that the opening 130 is sized large enough to encompass the diameter of the urethra and the thickness of the vaginal wall, but small enough to apply sufficient pressure when the tissues (urethra and vaginal wall) are held in the opening. The size of the opening is determined by a distance between a lip 125 of the left wall 105 and a lip 126 of the right wall 110 in the substantially closed configuration. It is contemplated that the opening is less than 2.S cm, preferably less than 2 cm, and more preferably less man 1.5 cm.

[0032] As shown in Figure 2, in some embodiments, the clip 100, in the substantially closed configuration, can be curved (e.g., twisted) in a first curvature from the first end 115 and the second end 120. It is contemplated that the curvature (degree of twist) of the clip 100 is at least S degrees, at least 10 degrees, at least 20 degrees, preferably at least 60 degrees, more preferably at least 90 degrees, most preferably about 180 degrees. Thus, in these

embodiments, a portion of the opening 130 of the clip 100 close to the first end 115 can face substantially opposite direction to another porti on of the opening 130 close to the second end 120. The twisted curvature of the clip 100 can twist the tissue (urethra and a portion of the vaginal wall) held by the opening 130 and provides additional pressure on the tissue. Thus, a user can adjust the pressure on the tissue by adjusting the degree of twisted curvature of the clip 100.

[0033] Additionally, the clip 100, in the substantially closed configuration, can be curved (e.g., bent) in a second curvature about the middle portion of the clip (between the first end 115 and the second end 120). It is contemplated mat the curvature (degree of bent) can be at least 60 degrees, more preferably at least 90 degrees, most preferably about 120 degrees.

[0034] It is contemplated that any suitable types of materials can be used to construct the clip 100. Preferably, the clip 100 comprises soft and/or elastic material (e.g., rubber, plastic, etc.). Also, the clip 100 may comprise heat resistant material and/or water repellant materials.

More preferably, the clip 100 can comprise medically inert or otherwise compatible materials (e.g., polycarbonate, methyl methacrylate, etc.)¹. It is also contemplated that in some embodiments, the clip 100 can comprise foam or memory foam materials (e.g., polyurethane, etc) so that the shape of the clip 100 can be changed when the clip 100 is inserted into the vagina. In other embodiments, the clip 100 can comprise metal materials (e.g., metal alloy, nickel titanium) which provide shape memory effect and elasticity to the clip 100.

[0035] In some embodiments, the clip 100 can comprise disposable material. In other embodiments, the clip 100 can be washed with soap and water and be reused. The device can easily be retrieved and removed for the user to pass urine, and it can be reapplied after the user completes urination. [0036] It is contemplated that the clip 100 can be additionally coated with anti-bacterial agent (e.g., copper coating, silver coating, etc.), and/or coated with anti-viral agent (e.g., hydrophobic long-chained porycation N,N dodecyl,methyl-polyethylenimine, copper alloy coating, etc.). In some embodiments, die clip 100 can be also coated with anti-fungal agent (e.g., chromogranin A-derived antifungal peptide, etc).

[003η Preferably, the clip 100 is applied to at least 60%, 70%, 80% or 90% of the length of the urethra. Thus, the length of the clip 100 may vary, but it is contemplated that the length of the clip 100 (distance between the first end 115 and the second end 120) is at a range of 0.1 inches to 3 inches, preferably between 0.5 inches to 3 inches, more preferably between 1 inch to 3 inches. In a preferred einbodiment, the clijp is sized and dimensioned to surround at least a portion of the anterior vaginal wall without contacting posterior or lateral vaginal walls. However, in other embodiments, the device is sized and dimensioned to contact at least a portion of the posterior or lateral vaginal wall.

[0038] In some embodiments, the color of the clip 100 may change (e.g., blue to yellow, green to red, etc.) over time to provide the user the adequate time to replace the clip 100. For example, the clip 100 can be in green color whan it is new and unused, and the color of the clip 100 can be changed to yellow in a day (or in a week, or in a month) to alarm the user that the clip needs to be replaced soon.

[0039] In other embodiments, the clip 100 includes an indicator (e.g., line mark, arrow, threaded portion, etc.) to indicate an orientation and/or location of the clip 100. For example, the left wall 105 has a threaded portion or a line mark to indicate that the line-marked left wall 105 should be placed on the left side when the clip 100 is inserted into the body.

[0040] Figure 3 shows another embodiment of a clip 300 with a plurality of protrusions 310 on the inner surface 305 of the clip 300. The protrusions can be in any suitable shape to facilitate grabbing, holding, or irnmobilizing tb e tissue (urethra and a portion of the vaginal wall). For example, the protrusions can be a teeth-like structure, a patterned padding. In a preferred embodiment, the protrusions are placed only on the inner surface 305 near the hps 325, 326 of the clip 300. In other embaiirnents, however, the protrusions are placed substantially throughout the entire inner surface 305 of the clip 300. [0041] Figures 4A-4C show a perspective view (Figure 4A), a front view (Figure 4B), and a back view (Figure 4C) of another embodiment of a clip 400 with side support railings 405a, 405b. In this embodiment, the clip 400 has a U-shaped surface 410 coupled with the side support railings 405a, 405b. The U-shaped surface 410 is also coupled with the body 41S of the clip 400. The U-shaped surface 410 is configured to couple with a portion of vaginal wall (e.g., upper wall of vagina). Thus, the U-shaped surface 410 of the clip 400 is configured to sit along the urethra, which lies above the upper wall of vagina.

[0042] The side support railings 405a, 405b provides additional support from the portion of the vagina wall so that the clip 400 can be stabilized at the place where the U-shaped surface contacts the vaginal wall around the urethra, even during movement of the user wearing the clip 400. [0043] The body 415 of the clip 400 surrounds the inner part 420. In a preferred embodiment, the inner part 420 is connected with the body 415 only at a connecting portion 430 (shown in Figure 4C). In this embodiment, the connecting portion 430 connects only a portion of the inner part with the body 415 along the length (e.g., distance from the first end 115 to the second end 120 in Figure 1 A). The connecting portion 430 provides internal torque in the body 415 with the rotation of inner part 420. However, it is also contemplated that in some embodiments, the inner part 420 is connected with the body 415 at more than two connecting portions. It is also contemplated that in other embodiments, the inner part 420 is connected with the body 415 throughout the entire length of the clip 400.

[0044] In a preferred embodiment, the U-shaped surface 410 can be deformed to adjust the pressure on the part of vaginal wall. In this emlxxiiment, the partially connected inner part 420 can be rotated or twisted relative to the body 415. The cross section of the inner part 420 can be defined by a term called 'Cam profile'. This cross sectional profile (shape) helps translate rotatory motion (turning of inner part 420) into a linear motion (upward

displacement caused in the center of U-shaped surface 410). For example, a clock-wise movement of the inner part 420 (arrow 440 in Figure 4B) moves the protruded portion of the inner part 420 toward the base of the U-shaped surface 410 so that the U-shaped surface 410 is deformed upwardly. Such deformation of the U-shaped surface 410 applies a slightly more pressure on the part of vaginal wall resting on the U-shaped surface 410, which, in turn, applies a pressure on the urethra to at least partially stop any urine to pass through the urethra. [0045] In a preferred embodiment, the inner part 420 includes a knob 425. The knob 425 is used to turn or twist the inner part 420 about a common axis of the body 415 and inner part 420 (e.g., an axis running along the length of the clip 400).

[0046] Preferably, the inner part 420 compriseii a solid rubber. However, it is contemplated mat any suitable types of materials can be used to construct the clip 400 and/or inner part 420 as described above for Figures 1 A-B.

[0047] Figure 5 shows another embodiment of the clip 500. In this embodiment, the clip 500 has a U-shaped surface 510 coupled with the side support railings 505a, 505b. The U-shaped surface 510 is also coupled with the body 515 of the cup 500. The U-shaped surface 510 is configured to couple with a portion of vaginal wall (e.g., upper wall of vagina). Similar to clip 400 in Figures 4A-C, the side support railings 505a, 505b provides additional support from the portion of the vagina wall so that the clip 500 can be stabilized at the place where the U-shaped surface contacts the vaginal wall around the urethra, even during movement of the user wearing the clip 500. Also, similar to the clip 400, the body 515 of the clip 500 surrounds the inner part 520, which can beturned or twisted by turning or twisting the knob 525.

[0048] In a preferred embodiment, the clip 500 also includes a cord 530 having a finger- holder 535 at the end of the cord 530. The cord 530 is connected to the portion of the body 515 facing down (closer to the vagina opening]: when the clip 500 is inserted into the vagina such that at least a portion of the cord 530 and the finger-holder 535 can be exposed outside of the user's body. In this einbodiment, the user can hold and pull the finger-holder 535 to remove the clip 500 from the vagina.

[0049] Figure 6 shows another device to allevi ate or treat female urinary incontinence. In Figure 6, the device is a U-shaped clip 600, which includes an outer portion 610 and an inner portion 605. The U-Shaped clip 600 has a curved body that is sized and dimensioned to sit on the lower vaginal opening, where the outer portion 610 extends outside of the vaginal area and around to the anus, and the inner portion 605 is configured to be placed inside the vagina and wrapped around the bottom portion of the vaginal wall.

[0050] The U-shaped clip 600 includes a lever 620, which is preferably coupled to the inner portion 605 of the U-shaped clip 600. The leve r 620 is configured to move upwardly and apply pressure and/or force on the portion of th e vaginal wall around the urethra. Thus, it is desirable that the lever 620 has a width of the inner vaginal opening.

[0051] In a preferred embodiment, the upward movement of the lever 620 is controlled by pulling a cord 650 that is coupled to the lever 620. The cord 650 has a distal end coupled to the lever 620 and a proximal end, which is exposed outside of the body. When the cord is pulled toward the outside of the body, the lever 620 is moved upwardly and touches a portion of the vaginal wall feeing the urethra. Thus, when the cord 650 is pulled with a sufficient force, the lever applies a pressure on the portion of the vaginal wall facing the urethra sufficient enough to occlude the lumen of the urethra to stop dripping of the urine. [0052] Preferably, die cord 650 is secured and/or immobilized in the cord lock 660. In some embodiments, the cord lock 660 comprises a groove with a plurality of downward teeth such that the user can locate the cord 650, guide the cord 650 into the groove of the cord lock 660 where the downward teeth would lock the cord 650 in place based on wherever the user decides to place it. To disengage the cord 650 from the cord lock 660, the user can pull the cord 650 outward (as the downward teeth only allow downwards force, not upwards), and to remove the cord 650 from the cord lock 660.

[0053] In some embodiments, the cord 650 includes indicators of the location of the cord 650. For example, the cord 650 can be color-coded (e.g., marked with different color in every 0.5 cm, etc.) so that the user can apply the approximately right amount of upwards pressure. [0054] In some embodiments, the U-shaped clip 600 includes stabilizers 630 at the inner portion 605. The stabilizers 630 can be a plurality of protrusions located at the end of the inner portion 605 to provide additional support of the inner portion 605 when the inner potion 605 contacts the portion of the vaginal wall. In other embodiment, the U-shaped clip 600 also includes stabilizers 625 on the lever 620. Similar to the stabilizers 630 at the inner potion 605, the stabilizers 625 can be a plurality of protrusions located on the surface of the lever 620 provide additional support of the lever 620 when the leva- 620 contacts the portion of the vaginal wall.

[0055] Additionally, in some embodiments, at least a portion of U-shaped clip 600 includes a padding 640. The padding 640 preferably comprises elastic materials and/or soft materials such that the padding 640 reduces friction between the U-shaped clip 600 and the portion of the vagina tissue. It is contemplated that any suitable types of soft and/or elastic materials can be used to construct the padding 640. For example, the padding may comprise a soft rubber, silicon, a plastic, etc.

[0056] Another inventive subject matter includes a method of treating urinary incontinence using a clip. One embodiment is a method of treating urinary incontinence using a clip described in Figures 1 A-5. A clip is inserted intra-vaginally in an open configuration, and placed in an orientation such that an opening of the clip faces the portion of the vaginal wall facing the urethra. Then the opening of the clip is placed on the vaginal wall and the clip is substantially closed and/or twisted to apply pressure on the urethra transvaginally.

[0057] Depending on the size of the clip, a portion of the clip can contact a portion of the posterior or lateral vaginal wall to provide further stability of the clip in the vagina. However, it is also contemplated that the clip only contacts the anterior wall of the vagina, which faces the urethra.

[0058] In a preferred embodiment, the clip opens and closes by the dexterity of the hands of patients or caretakers. In some other embodiments, the clip opens and closes by operation of a hand-held applicator. Application of the clip can be practiced by the patient, or taught by the physician, nurse practitioner, or physician assistant in a very short session of counseling. Once the clip is inserted it occludes the lumen of the urethra accessible from the anterior wall of the vagina in a "torted-bent" fashion to support the urethra and prevent leakage of urine.

[0059] One embodiment is a method of treating urinary incontinence using a clip described in Figure 6. In this embodiment, the U-shaped clip 600 is inserted into a user's vagina in an orientation such that the outer portion 610 extends outside of the vaginal area and around to the anus, and the inner portion 60S is configured to be placed inside the and wrapped around the bottom portion of the vaginal wall. Once the U-shaped clip 600 is oriented appropriately in the user's vagina, the method continues with, a step of compressing a portion of the urethra by moving the lever 620 (e.g., by pulling the cord 650) toward the vaginal wall around the urethra. When the appropriate amount of force is applied to the urethra, the cord can be immobilized in the cord lock 660.

[0060] Depending on the size of the clip, a portion of the clip can contact a portion of the posterior or lateral vaginal wall to provide further stability of the clip in the vagina. However, it is also contemplated that the clip only contacts the anterior wall of the vagina, which faces the urethra. [0061] In a preferred embodiment, the clip opens and closes by the dexterity of the hands of patients or caretakers. In some other embodiments, the clip opens and closes by operation of a hand-held applicator.

[0062] Another aspect of the present disclosure is a method of preventing female stress incontinence by applying the incontinence clip device. The method includes a step of instructing the patient to empty the bladder by performing triple voiding before applying the incontinence clip device. This can be accomplished by 1) passing the urine, 2) waiting for ten seconds and passing urine again, 3) waiting for another ten seconds and passing urine again. Generally, no urine drops should come after the patient completely empties the bladder three times. However, a patient can empty her bladder using any method that is appropriate and convenient for her depending on her physical, medical, or psychological conditions. The method also includes a step of instructing the patient to take the device out of the sterile package, to check for defects, and to check the working conditions of the device by opening and closing the wings of the device. Then the method includes a step of instructing the patient to gently insert the device into the vagina with two fingers on the wings, or by using a handheld applicator. The method further includes a step of instructing the patient to cough and make sure the device is in place and does not come off the urethra.

[0063] It is contemplated that before applying the device, the user patient receives supervision and consultation from a physician / healthcare providers about how to check for any defects on the device, how to open and close the device, how to open and insert the device, and how to open and remove the device. It is also contemplated that such supervision and consultation can be substituted by one or more written, audio, or audiovisual instructions accompanied with the incontinence clip device.

[0064] The incontinence clip device provides roany advantages over other methods preventing female urinary incontinence. First, l>ecause the incontinence clip device is an external device applied to the female urethra via the vaginal route, which is anatomically located superficially by the vaginal opening, it provides a non-surgical option to control stress incontinence as applying this device is not an invasive procedure. It is safer to insert and easy to remove by the female patient. Furthermore, the incontinence clip device can be provided at a much lower cost and less discomfort than other alternatives or invasive procedure. [0065] In some embodiments, the numbers expressing quantities of properties such as dimensions used to describe and claim certain (imbodiments of the invention are to be understood as being modified in some instances by the term "about." Accordingly, in some erribodiments, the numerical parameters set forth in the written description and attached claims are approximations that can vary depending upon the desired properties sought to be obtained by a particular embodiment. In some embodiments, the numerical parameters should be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of some embodiments of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as practicable. The numerical values presented in some embodiments of the invention may contain certain errors necessarily resulting from the standard deviation found in their respective testing measurements.

[0066] Unless the context dictates the contrary, all ranges set forth herein should be interpreted as being inclusive of their endpoints and open-ended ranges should be interpreted to include only commercially practical values. Similarly, all lists of values should be considered as inclusive of intermediate values unless the context indicates the contrary.

[0067] As used in the description herein and throughout the claims that follow, the meaning of "a," "an," and "the" includes plural referenc e unless the context clearly dictates otherwise. Also, as used in the description herein, the meaning of "in" includes "in" and "on" unless the context clearly dictates otherwise.

[0068] The recitation of ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each individual value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g. "such as") provided with respect to certain embodiments herein is intended merely to better iUuminate the invention and does not pose a limitation on the scope of the invention otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the invention. [0069] Groupings of alternative elements or embodiments of the invention disclosed herein are not to be construed as limitations. Each group member can be referred to and claimed individually or in any combination with other members of the group or other elements found herein. One or more members of a group can be included in, or deleted from, a group for reasons of convenience and/or patentability. When any such inclusion or deletion occurs, the specification is herein deemed to contain the group as modified thus fulfilling the written description of all Markush groups used in the appended claims.

[0070] The following discussion provides many example embbodiments of the inventive subject matter. Although each embodiment represents a single combination of inventive elements, the inventive subject matter is considlered to include all possible combinations of the disclosed elements. Thus if one embodiment comprises elements A, B, and C, and a second embocliment comprises elements B and D, then the inventive subject matter is also considered to include other iernaining combina tions of A, B, C, or D, even if not explicitly disclosed. [0071] As used herein, and unless the context dictates otherwise, the term "coupled to" is intended to include both direct coupling (in which two elements that are coupled to each other contact each other) and indirect coupling; (in which at least one additional element is located between the two elements). Therefore, the terms "coupled to" and "coupled with" are used synonymously. [0072] It should be apparent to those skilled in the art that many more modifications besides those already described are possible without departing from the inventive concepts herein. The inventive subject matter, therefore, is not to be restricted except in the spirit of the appended claims. Moreover, in interpreting both the specification and the claims, all terms should be interpreted in the broadest possible manner consistent with the context In particular, the terms "comprises" and "comprising" should be interpreted as referring to elements, components, or steps in a non-exclusive manner, mdicating that the referenced elements, components, or steps may be present, or utilized, or combined with other elements, components, or steps that are not expressly referenced. Where the specification claims refers to at least one of something selected from the group consisting of A, B, C .... and N, the text should be interpreted as requiring only one element from the group, not A plus N, or B plus N, etc.

Claims

CLAIMS What is claimed is:

1. A device for treating urinary incontinence of a female, comprising;

an elongated body having a first and second ends, and an opening at least partially

extending between the first end and the second end; and

wherein the opening is sized and dimensioned to apply pressure on a portion of a vaginal wall, sufficient to compress at least a portion of the urethra in a closed configuration.

2. The device of claim 1, wherein the elongated body has a first curvature from the first end to die second end in the closed configuration.

3. The device of claim 2, wherein the elongated body is in a helical shape in the closed configuration.

4. The device of claim 1, wherein the opening; is configured to twist at least a part of the portion of the urethra in the closed configuration.

5. The device of claim 1, wherein the device comprises a soft and elastic material.

6. The device of claim 1 , wherein the device comprises a heat resistant material.

7. The device of claim 1, wherein the device comprises a water repellant material.

8. The device of claim 1 , wherein the device comprises a medically inert or medically

compatible plastic.

9. The device of claim 8, wherein the medically inert or medically compatible plastics is selected at least one of the following: polycarbonate, methyl methacrylate, foam, and polyurethane.

10. The device of claim 1, wherein a length of the device is at a range of 0.5 inches to 3 inches.

11. The device of claim 1 , wherein the horizontal cross section of the device has a shape of at least one of the following: a U shape, an omega shape, a substantially square shape, a curvilinear triangular shape, a quatrefoil shape, a trapezoid shape, and an oval shape.

12. The device of claim 1, wherein the elongated body includes an indicator indicating an orientation of the device.

13. The device of claim 1, wherein the body has an inner surface and an outer surface, and the inner surface of the body has a protrusion.

14. The device of claim 1 , wherein the body further comprises a side support railing that is sized and dimensioned to fit around the portion of the vaginal wall.

15. A device for treating urinary incontinence of a female, comprising;

a curved body having an inner potion and an outer portion;

a lever coupled with the inner portion; and

wherein the lever is configured to apply pressure on a vaginal wall to compress a portion of the urethra.

16. The device of claim 15, wherein the inner portion is configured to contact a portion of lateral or posterior vaginal wall.

17. The device of claim IS, wherein the inner portion has a plurality of protrusions.

18. The device of claim 1 S, wherein the inner portion has a padded portion.

19. The device of claim IS, wherein the lever has a plurality of protrusions.

20. The device of claim IS, wherein the lever in coupled with a cord extending outside of the vagina, and the location of the lever is changeable by pulling the cord.

21. The device of claim 20, the curved body further comprises a cord lock, which at least temporarily immobilizes the cord.

22. The device of claim 21, wherein the cord lock is a plurality of protrusions.

23. The device of claim IS, wherein the curved, body further comprises a side support railing that is sized and dimensioned to fit around the portion of the vaginal wall.

24. A method for treating urinary incontinence in a female comprising steps of:

inserting a device in an open configuration into a user's vagina, wherein the device has an elongated body having a first and second ends and an opening at least partially extending between the first end and the second end; placing the opening around the vaginal wall facing the urethra; and

applying pressure on the urethra by changing the device from the open configuration to a closed configuration.

25. The method of claim 24, wherein the step o f inserting is performed by the dexterity of the hands.

26. The method of claim 24, wherein the step of inserting is performed using a hand-held applicator.

27. The method of claim 24, wherein the step o f applying pressure is performed by twisting the device.

28. The method of claim 24, further comprising a step of contacting a portion of the device to at least a portion of the posterior vagina J wall.

29. The method of claim 24, further comprising a step of contacting a portion of the device to at least a portion of the lateral vaginal wall.

30. A method for treating urinary incontinence in a female comprising steps of:

inserting a device into a user's vagina, wherein the device has a curved body having an inner potion and an outer portion, and a lever coupled with the inner portion; and compressing a portion of the urethra by moving the lever toward the vaginal wall around the urethra.

31. The method of claim 30, wherein the step o f inserting is performed by the dexterity of the hands.

32. The method of claim 30, wherein the step of inserting is performed using a hand-held applicator.

33. The method of claim 30, wherein the lever is coupled with a cord, and the step of

compressing a portion of the urethra is performed by pulling the cord.

34. The method of claim 30, further comprising a step of stabilizing the device by

immobilizing the cord in a cord lock.

35. The method of claim 30, further comprising a step of contacting the inner portion of the device to at least a portion of the posterior vaginal wall.

36. The method of claim 30, further comprising a step of contacting the inner portion of the device to at least a portion of the lateral vaginal wall.