Apparatus for the prevention of urinary incontinence in females

An apparatus for treating urinary incontinence, comprising a node; a support section adapted for providing urethral support attached to the node; and, an anchoring section adapted for resisting movement of the apparatus attached to the node; wherein the node is no longer than 30% of the entire length of the apparatus comprising the node, support section and the anchoring section together.

FIELD OF INVENTION

The present invention relates generally to urinary incontinence in females, for example by providing devices for the prevention of female incontinence.

BACKGROUND OF THE INVENTION

Urinary incontinence is a widespread problem among females. It is estimated that up to 50% of women occasionally leak urine involuntarily, and that approximately 25% of women will seek medical advice at some point in order to deal with the problem. Stress incontinence, the most common type of urinary incontinence, refers to the involuntary loss of urine resulting from abdominal pressure rise, occurring during exercise, coughing, sneezing, laughing, etc. When stress incontinence occurs, it is usually the result of the abnormal descent of the urethra and bladder neck below the level of the pelvic floor. While many different factors may contribute to the development of stress incontinence, it is most prevalent among women ages 35-65 and those who have had multiple vaginal deliveries. Stress incontinence is both aggravating and unpleasant for women, and it can also be embarrassing. Many women wear sanitary pads or diapers in order to deal with incontinence, though this is not a real solution to the problem and it can be very inconvenient and unreliable. Surgical treatment may involve securing the paraurethal tissues to the periosteum of the pubic bone or the rectus facia in order to elevate the bladder neck above the pelvic floor and thereby distribute pressure equally to the bladder, the bladder neck, and the mid-urethra. Recently, a procedure known as “TVT” (“Tension Free Vaginal Tape”) was developed, in which a mesh tape is implanted underneath the mid-urethra, creating a hammock on which the urethra may kink during a rise in intra-abdominal pressure. However, surgery is only suitable for severe cases, and the majority of women experiencing incontinence do not need surgical solutions.

One modality of non-surgical treatment involves the use of devices that are inserted into the vagina, either by a medical practitioner or by the woman herself. Most devices are designed to apply pressure against the bladder neck so as to inhibit or completely block the flow of urine through the urethra. A variety of such devices are known in the art. For example, refer to U.S. Patent Application No. 2002/0183711 to Moser, entitled, “Urinary Incontinence Device”; U.S. Pat. No. 6,739,340 to Jensen, et al., entitled, “Device for prevention of involuntary urination”; U.S. Pat. No. 6,679,831 to Zunker, et al., entitled, “Resilient incontinence insert and a method of making the same”; U.S. Pat. No. 6,460,542 to James, entitled, “Female incontinence control device”; U.S. Pat. No. 6,413,206 to Biswas, entitled, “Intra-vaginal device”; U.S. Pat. No. 5,785,640 to Kresch, entitled “Method for Treating Female Incontinence”; U.S. Pat. No. 5,771,899 to Martelly, et al., entitled, “Pessary”; U.S. Pat. No. 5,618,256 to Reimer, entitled, “Device for Arrangement in the Vagina for Prevention of Involuntary Urination with Females and an Applicator for use in Insertion of the Device”; U.S. Pat. No. 5,417,226 to Juma, entitled, “Female Anti-Incontinence Device”; U.S. Pat. No. 5,386,836 to Biswas, entitled, “Urinary Incontinence Device”; U.S. Pat. No. 5,007,894 to Enhorning, entitled, “Female Incontinence Device”; and U.S. Pat. No. 4,920,986 to Biswas, entitled, “Urinary Incontinence Device”, the disclosures of which are herein incorporated by reference.

One problem with many of the above listed devices is that they completely block the urethra and thus they need to be removed or collapsed in order to allow the woman to urinate. To overcome this drawback, vaginal devices have been developed having specialized shapes that do not completely block the bladder neck but these devices tend to be large, uncomfortable, and intrusive. They also tend to cause irritation or soreness to the vagina.

Another common shortcoming is that most devices known in the art also tend to be difficult or painful to insert and/or remove. In order to correctly inhibit urine flow, the device needs to be properly positioned in the vaginal canal. As a result, a doctor may be required to properly position the device. In most cases, the device is adapted for remaining in the vagina for a prolonged period of time (due to the time and expense of requiring a trained medical professional to insert the device). However, when positioned in the vagina for an extended period of the time, the device may cause vaginal infections, necrosis, or bleeding.

SUMMARY OF THE INVENTION

An aspect of some embodiments of the invention relates to a device for treating feminine incontinence which is comprised of at least a node. Optionally, the length of the node is only 30% or less of the length of the entire device. In some embodiments of the invention, the device further comprises an anchor and a support. In some embodiments of the invention, the node construction allows for greater flexibility control of the device for improved function. Optionally, a flexible neck portion is located at the node of the device. Flexibility, especially at the central core body, enhances comfort to the wearer. In some embodiments of the invention, a device for treating feminine incontinence is provided which is disposable. Optionally, the device is of unitary body construction. Optionally, the device is constructed of a single material. Optionally, the device is manufactured in varying sizes. For example, in some embodiments of the invention devices are provided which are between 30 mm and 50 mm in total length. Optionally, the devices are larger or smaller depending on the needs of the individual user. In some embodiments of the invention, the device is inserted using an applicator.

In an exemplary embodiment of the invention, the device has anchor and support portions provided with arms. Optionally, the shape and number of arms are variable. Optionally, there are four support and/or anchor arms. Optionally, there are more or less than four arms. Optionally, the arms are not the same shape. Optionally, the arms are provided with varying degrees of compliance, rigidity and resiliency. Optionally, the arms are provided with soft tips or pads. In some embodiments of the invention, the angle of the arms with respect to the central axis of the device and/or each other can be changed. Optionally, the support arms are curved. Optionally, the anchor arms radiate substantially perpendicular from the node. In some embodiments of the invention, the size and shape of the support arms are not related to the size and shape of the anchor arms. Optionally, the arms are cantilevered.

In an exemplary embodiment of the invention, the device includes an additional structure which exerts direct pressure to the urethra for enhanced incontinence treatment. Optionally, the device with additional structure is used during strenuous physical activity. In some embodiments of the invention, direct pressure to the urethra is applied by a ring strut which connect the arms of the support section. Optionally, the strut is comprised of straight segments. Optionally, the strut is comprised of inwardly arcing segments.

An aspect of some embodiments of the invention relates to a device for treating feminine incontinence which is provided with an adjustable size of urethral support. Optionally, the support size is adjustable mechanically, for example by using an extending insert. Optionally, portions of the device are cantilevered. Optionally, the extending insert is interchangeable with other extending inserts in order to modify the support dimensions. Variable shape and size allow for a better fit to the wearer and in some cases deliver more effective therapy.

An aspect of some embodiments of the invention relates to a device for treating feminine incontinence which includes a device displacer, such as a string. In an exemplary embodiment of the invention, upon application of removal force on the string, the arms of the device collapse towards the node, reducing the device's profile and allowing for easier and less pain inducing removal. Optionally, the string is attached directly to the support arms, whereupon application of force on the string, at least the support arms collapse for easier removal. Optionally, the string is attached to the sling-like device or cover, whereupon application of force on the string, the sling-like device exerts force on the arms and causes them to collapse for easier removal. Optionally, the device is removed without the patient having to touch herself.

There is thus provided an apparatus for treating urinary incontinence, comprising: a node; a support section adapted for providing urethral support attached to said node; and, an anchoring section adapted for resisting movement of said apparatus attached to said node; wherein said node is no longer than 30% of the entire length of said apparatus comprising said node, support section and said anchoring section together. Optionally, the node is no longer than 20% of the entire length of said apparatus for treating urinary incontinence. Optionally, the node is no longer than 15% of the entire length of said apparatus for treating urinary incontinence. In some embodiments of the invention, the support section is provided with at least 2 supporting arms. In some embodiments of the invention, the anchoring section is provided with at least 2 anchoring arms. Optionally, the apparatus further comprises a cover. Optionally, the cover substantially encapsulates said node, support section and said anchoring section. In some embodiments of the invention, the support section and said anchoring section are flexible. Optionally, the node is flexible. In some embodiments of the invention, the apparatus further comprises a device displacer. Optionally, the device displacer is attached to said support section. In some embodiments of the invention, the apparatus further comprises support struts interlinking said supporting arms. In some embodiments of the invention, the apparatus further comprises an applicator adapted to insert said apparatus into a vagina.

There is thus provided an apparatus for treating urinary incontinence, comprising: a support section adapted for providing urethral support; and an extending insert adapted to adjust the diameter of said support section. In some embodiments of the invention, the apparatus further comprises a node and an anchoring section adapted for resisting movement of said apparatus. In some embodiments of the invention, the apparatus further comprises a cover. Optionally, said cover substantially encapsulates said node, support section, said anchoring section and extending insert. In some embodiments of the invention, the apparatus further comprises a device displacer. Optionally, a device displacer is attached to said support section. In some embodiments of the invention, the apparatus further comprises an applicator adapted to insert said apparatus into a vagina.

There is thus provided an apparatus for treating urinary incontinence, comprising: a body adapted for treating incontinence when inserted in a vagina; and, a device displacer for providing movement to said apparatus. Optionally, said device displacer is a string. In an exemplary embodiment of the invention, said apparatus is flexible and distorted by said string.

There is thus provided a method of using an apparatus for the treatment of urinary incontinence, comprising: inserting said incontinence treating apparatus; and, deploying said incontinence treating apparatus in a position to render mid-urethral support. Optionally, inserting is facilitated by an applicator. In some embodiments of the invention, the method further comprises removing said apparatus. Optionally, removing is facilitated by a device displacer.

There is thus provided an apparatus for inserting a vaginal device, comprising: an enclosure for containing said vaginal device; and a stopper, wherein said stopper prevents over insertion. Optionally, said stopper is located on said enclosure in a position such that upon insertion of said apparatus into said vagina up to said stopper, said vaginal device will be in appropriate position within said vagina for deployment. In an exemplary embodiment of the invention, said stopper is adjustably located on said enclosure.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

Introduction

The present invention provides a device, and variations of the device, for the treatment of urinary incontinence females. The device of the present invention is adapted to be disposable, worn only for a short period of time and then discarded and replaced with a new device (if needed). Alternatively, the device is recycled for use by sterilizing it in between uses. The device of the present invention is simple and easy to use, and is optionally inserted effortlessly in the same user-friendly and familiar manner that a tampon is inserted into the vagina during menstruation. As opposed to large and intrusive devices of the prior art, the device of the present invention is comfortable, and, once inserted, the woman need not think about it again until it is removed. When involuntary urination occurs, it often happens because of a rise in pressure in the bladder for which there is no compensating counter-pressure from the bladder neck or urethra. This is usually the result of the abnormal descent of the bladder neck and the urethra into a low position, away from the intra-abdominal pressure system. Known as “hypermobility”, this is the result of some injury to the support mechanism which normally keeps the urethra and the bladder neck in a raised position, along the backside of the pubic bone. The lowering of the bladder neck and the urethra that occur, for example, when a woman coughs, sneezes, or laughs, causing involuntary leakage of urine.

A Device for Treating Incontinence

Referring toFIG. 1A, a profile view of an exemplary embodiment of the incontinence device100is shown. For ease of description, the device100is arranged around a central axis150and divided into three parts. A top section106is provided which serves as the “anchoring” element, for stabilizing the device within the vagina. There are two types of anchoring, axial anchoring which acts in the direction along the central axis of the vagina, and radial anchoring which acts side-to-side or substantially perpendicular to the central axis of the vagina. A bottom section110is provided which serves as the “supporting” element, for generating urethral support. In some embodiments of the invention, support is generated at a mid-urethral location. In some embodiments of the invention, the bottom supporting section110provides at least one form of anchoring to help anchor device100in position. In some embodiments of the invention, the entire length of device100is between 30 mm and 50 mm. optionally, device100is larger or smaller depending on the individual needs of the patient.

Also, an intermediate section108is provided which acts as a “node” and which connects anchoring106and supporting110elements. The node108of this and many other devices described herein has a length which is only a small portion of the overall length of the device, in some embodiments of the invention. In some embodiments of the invention, the length of the node is less than 15% of the entire length of the device. In some embodiments of the invention, the length of the node is less than 20% of the entire length of the device. In other embodiments of the invention, the length of the node is less than 30% the entire length of the device. In some embodiments of the invention, a node which is short relative to the entire length of the device allows for more flexibility in varying the stiffness, the comfort, and the size of device100. Optionally, the node is not provided with one axis longer than the other, the axes are equal in length (e.g. a sphere or a cube). In arm exemplary embodiment of the invention, a small node in relation to the overall length of the device allows for greater control over the behavior of the anchoring and support arms, described below.

The elements of the device100function as an internal support structure for a cover, depicted inFIGS. 9Aand B, in some embodiments of the invention. It should also be noted that for certain women, the described devices herein can also be used as a treatment for prolapse.

In an exemplary embodiment, the anchoring element106and the supporting element110have four (4) arms112and114, respectively. In an exemplary embodiment of the invention, four arms are provided to each section in which two generally exert pressure towards the bladder, and two generally exert pressure towards the vaginal floor adjacent the bowels. The two support arms which exert pressure towards the bladder fit within natural slots on either side of the urethra in some embodiments of the intention. Optionally, the anchoring and supporting elements are provided with more or less arms. For example, the anchoring element could have more arms if there is concern about unwanted movement of device100. In other embodiments of the invention, the arms are provided at varied angles with respect to the node108and/or each other. Optionally the arms112and114are flexible or rigid and are constructed of a biocompatible material. In an exemplary embodiment of the invention, the anchoring element does not apply significant pressure to the wearer's vagina and/or urethra, thereby enhancing comfort. In some embodiments of the invention, other structure is provided instead of arms which is capable of supporting the urethra, in the case of the support section, or preventing the device from unintentionally moving, in the case of the anchor section. For example, at least one cone, protrusions, and/or extensions attached to the node could be used for anchoring and support.

The anchoring arms of the device prevent the device from moving unintentionally out of position. In an exemplary embodiment of the invention, the arms are flexible. This flexibility enhances the anchoring arms' ability to prevent motion of the device further into the vagina. As force strives to exert itself on the device, and move it into the vagina, the flexible anchoring arms tend to spread apart. This spreading action of the anchoring arms increases the friction between the device and the vaginal wall, prevent movement. While the arms are flexible, it should be noted that they are rigid enough to prevent unwanted motion of the device towards the entrance of the vagina. Optionally, the arms are rigid but the node is flexible, the node thus providing flexible anchoring and support. Movement towards the vaginal opening is resisted by the arms which position themselves just on the posterior side, in relation to the vaginal opening, of a hump located in the vagina. These features work independently from and in conjunction with the tenting behavior of the vaginal walls described above, which also helps to maintain the device in place.

An additional feature of the anchoring arms of the device100is that they operate remotely from the support arms. This reduces the amount of pressure applied to the urethra by the device. Alternatively or additionally, the remote position of the anchoring arms in relation to the support element is calculated so that the anchoring arms can position themselves just on the posterior side, in relation to the vaginal opening, of a hump located in the vagina while the supporting arms provide mid-urethral support. Such a configuration increases comfort to the wearer, prevents unnecessary damage to the tissues adjacent to the device, increases the anchoring function of the device, and in some embodiments of the invention allows the wearer to void voluntarily without having to remove the device to urinate.

FIGS. 1B and 1Cassist with illustrating the configuration of the device100, and more specifically the arms112and114, in an exemplary embodiment of the invention. The arms112of the anchoring element106force the device100to remain in situ within the vagina, unable to substantially move inwards or outwards, or to rotate. One reason this occurs is as a result of the special tendency of vaginal walls to collapse and form an occluded lumen. The arms of the device cause “tenting” of the walls on top of them with resultant sagging of the walls around the node108, thereby stabilizing the device100. The arms114of the supporting element110cause elevation of the tissues around mid-urethra, acting as a hammock. This hammock supports mid-urethra in a tension free manner, much like the TVT operation. In a woman who leaks urine during a stressful event (when abdominal pressure rises during coughing, sneezing, etc.), the urethra sags down but meets the hammock in its mid part. The meeting of the urethra and the hammock causes an elevation (sort of like a kinking of the urethra) of the intra-urethral pressure with resultant urinary continence. In some embodiments of the invention the radiating support arms114of device100create an overall device diameter of 25 mm to 50 mm within the vaginal cavity. Optionally, the diameter is larger or smaller depending on the individual needs of the patient.

In an exemplary embodiment of the invention, the anchor element arms112resist motion of the device towards the uterus because the arms increase their angle to the node108. This effective increase in radius operates to counteract the motion of the device further into the vagina. In some embodiments of the invention, anchor element arms112are provided with a large angle to the node to enhance this anchoring effect. It should be noted that this enhanced anchoring effect is observed only up until a maximum angle.

FIG. 1Dillustrates an embodiment of the invention in which the node118is narrowed. A narrowed node118increases the flexibility and the possible ranges of movement for the overall device100in some embodiments of the invention. Optionally, devices such as wires and/or springs are embedded in the neck in order to enhance flexibility for device100. This additional flexibility can enhance the comfort of the woman while wearing the device100. Any of the embodiments described herein are optionally utilized in conjunction with a narrowed node118.

An Optional Substantially Perpendicular Anchor Arm Embodiment

Referring now toFIG. 2A, an additional embodiment of a device200is shown for battling feminine urinary incontinence. This embodiment is comprised of an anchor element206, a support element210and a node208. In this embodiment of the invention, the anchor element is provided with arms212which radiate substantially perpendicular to the node208. This anchor element arm configuration is particularly useful for preventing inadvertent movement of the incontinence device towards the vaginal opening, although motion in either direction is resisted. As can be seen fromFIG. 1A, the support element arms214are shaped such that they bend towards the central axis of the device200, and the tips218of the arms do not substantially extend outwards away from the central axis of the device. This is in contrast to the embodiment220shown inFIG. 2D, wherein the tips222of the arms214extend away from the central axis of the device200significantly. In addition, the inward directed arm tips enhance the comfort of the wearer and in some embodiments of the invention facilitate device200removal, as their shape provides tips which do not jut into the vaginal wall. This embodiment functions in a similar manner to the device100ofFIG. 1A.

The device220illustrated inFIG. 2Dconstitutes an alternate exemplary embodiment of the urinary incontinence device. As described above, the arm tips222extend radically away from the central axis of the device220. This embodiment provides an elongated section wherein the urethra is supported. It should be noted that any of the shapes and sizes of the arms described in this application are interchangeable depending on the needs of the individual woman.

An Incontinence Device Adapted to Provide Supplemental Support

Not all women, and not all activity, can be treated with exactly the same devices when it comes to incontinence. For example,FIGS. 3A-Dillustrate a device300which is adapted to directly compress the urethra during strenuous physical activity. Optionally, this embodiment is used for treatment of women who have relatively severe incontinence where the other embodiments described herein are ineffective. In an exemplary embodiment of the invention, this device300is provided with an anchor element, a support element and a node. Optionally, the device300is provided with anchor element arms312and support element arms314.

In addition to the above, an additional support320is provided which is attached to the support element arms314. Dependent on the level of external under-urethral pressure exerted by the additional support320, there is optionally a full or partial occlusion of the urethra for a limited period of time. Attachment of the additional support320to the device300may be accomplished by using a notch322or by any other means of connection known in the art.

While the Figs. depict a generally circular additional support320, it should be noted that any shape which can provide additional support to the urethra is optionally utilized. For example, the curvature of the additional support320segments can be biased inward towards the central axis (creating a plus sign shaped support) or the additional support320can consist of substantially straight segments (creating a box shape). Different shapes are optionally utilized depending on the needs of the individual wearer. Additionally or alternatively, the additional support320is of constant diameter at its entire length, or different diameters and widths.

Variable Geometry Incontinence Device

As mentioned previously, not all women can be treated with the same device. While the same basic anatomical features are generally present in every woman, the size of these features and their relationship to each other can vary slightly. Because of this, it can be difficult to provide a “one size fits all” type of device. The device depicted inFIG. 1addresses this problem by providing a flexible device which is capable of adapting itself to multiple geometries. While it is possible that some women cannot use the device ofFIG. 1, its features certainly reduce the number of sizes that need to be supplied. One optional way to solve this problem is illustrated inFIGS. 4A-C. The device400illustrated optionally consists of the same basic elements as some of the other embodiments (i.e. an anchoring element406, a support element410and a node408), however there are some modifications which allow for a variable geometry of the device400. It can be seen fromFIG. 4Athat a device400is provided in which the geometry of the support element arms414can be adjusted, depending on the particular needs of the patient.

An extending insert800, depicted inFIGS. 8A-C, is positioned within the area proscribed by the support element arms414. A shaft portion806of the extending insert800penetrates into a preformed tunnel within the device400along the central axis. The extending insert is provided with the ability to transit along the central axis of the device400towards the anchoring element406. However, in an exemplary embodiment of the invention, the extending insert800is only capable of transit towards the anchoring element406, not away from the anchoring element406. Optionally, a device is provided which comprises two extending inserts on each side of the central axis of the node. Such an embodiment would allow for variable geometry control of the anchor element arms412and the support element arms414.

Referring now toFIG. 5A, a device400for treating incontinence with variable geometry is shown. The configuration ofFIG. 5Aillustrates the device400in its base state, without geometry modification by the extending insert800.FIG. 5B, however, demonstrates how the extending insert800interacts with the device400to change the angle of the support element arms414with respect to the central axis of the device400. It can be seen that as the extending insert800moves through the central axis of the device400towards the anchoring element406, the support element arms414assume a wider angle to the central axis.

In an exemplary embodiment of the invention, the extending insert also provides an additional utility to the device400. It also serves as a supplemental support element for the arms414, mainly when a larger diameter is needed, to negate the counteracting forces from the vaginal walls.

An Embodiment of a Variable Geometry Incontinence Device With Perpendicular Anchor Arms

FIGS. 6A-Calso illustrate an exemplary embodiment of the invention600in which the geometry is variable based on the position of an extending insert800. The operation for variable motion is essentially the same as the embodiment depicted inFIGS. 4A-C, however, it is noted that the anchoring element arms612are of slightly different configuration. This type of arm configuration (i.e. extending substantially perpendicular to the central axis of the device600) function similarly to the anchor element arms212depicted inFIGS. 2A-D. It should be understood that the embodiments depicted in the Figures are by way of example only, and that any of the variable geometry incontinence devices described or suggested herein can be used with an extending insert without regard to the size of the device, the number of the arms, the configuration of the arms, and/or the shape of the arms.

Turning now toFIGS. 7Aand B, the multiple geometry nature of the device600is shown. The configuration ofFIG. 7Aillustrates the device600in its base state, without geometry modification by the extending insert800.FIG. 7B, however, demonstrates how the extending insert800interacts with the device600to change the angle of the support element arms614, located on support element610, with respect to the central axis and node608of the device600. It can be seen that as the extending insert800moves through the central axis of the device600towards the anchoring element606, the support element arms614assume a wider angle to the central axis.

FIGS. 8A-Cshow the extending insert800of an exemplary embodiment in greater detail. In this exemplary embodiment of the invention, the three basic components of the extending insert800are the head804, the shaft806and the tip808. In operation, the shaft806of the extending insert800is pushed into a tunnel located along the central axis of any of the variable geometry devices described herein. In an exemplary embodiment of the invention, the tip808is sized to be slightly larger than the diameter of the central axis tunnel. Furthermore, the tip808is shaped to facilitate insertion into the tunnel but to counter removal from the tunnel. Optionally, the extendible insert is maintained in the central tunnel by placing a series of protrusions along the inner circumference of the tunnel, which allow passage of the arrow shaped tip808when moving towards the anchor element, but which prevent passage of the wider tip808portion of the insert800back towards the support element. Optionally, various sized extendible inserts are provided which are interchangeable and which are chosen depending on the requirements for degree of angle in relation to the central axis. In an exemplary embodiment of the invention, an extendible insert is provided which positions different arms at different angles with respect to the central axis of an incontinence device. Optionally, some arms are not affected by the extendible insert. Optionally, the extendable insert is rotatable. Optionally, the head804of the extending insert800is constructed of a flexible material which allows it to be more easily inserted into an applicator1100, the applicator depicted inFIG. 11.

Cover

FIG. 9Ashows an incontinence device being used in conjunction with a cover900. In an exemplary embodiment of the invention, the cover900is made of a flexible, smooth mesh material. Optionally, the cover900is designed as small sack which encapsulates the device904, which acts as an internal support structure, shown inFIG. 9B. Use of the cover900can potentially provide one or more benefits in using the device. For example, the cover reduces friction between the applicator and the device upon insertion. In addition, the cover reduces friction between the vagina and the device during insertion. In some embodiments of the invention, the mesh of the cover900, being stretched between the arms of the device, serves as a sling-like support for the urethra. In a woman who leaks urine during a stressful event (when abdominal pressure rises during coughing, sneezing, etc.), the urethra sags down but meets the cover900in its mid part. This causes an elevation of the intra urethral pressure with resultant urinary continence. In an exemplary embodiment of the invention, the device does not put pressure against the urethra or the bladder neck, but only provides support when there is a rise in abdominal pressure, as described above. Optionally, the device applies direct pressure to the urethra and/or bladder neck. In some embodiments of the invention, the cover900is disposable. Optionally, the cover is sterilized between uses and is reusable. Optionally, the cover is decorated.

In some embodiments of the invention, the cover900assists with removal of the device from the vagina. First, the cover900reduces friction between the incontinence device and the vaginal wall. Second, the cover900is optionally provided with a device displacer, such as a string902. In an exemplary embodiment of the invention, the string902is attached to the cover900. Optionally, the cover900and the string902are constructed of the same unitary piece of material. The string902assists with the removal of the device in a number of ways. Pulling the string902causes tightening of the cover900. Tightening of the cover900causes the straightening of the vaginal walls. The straightening of the vaginal walls reduces the tent-like effect described above and relieves tension applied to the device, allowing for an easy and smooth removal of the device from the vagina. In addition, pulling on the string902causes the arms to fold slightly towards the central axis, thereby reducing its size and allowing for an easy and smooth removal of the device from the vagina. In an exemplary embodiment of the invention, the device can be “walked” out of the vagina by pulling on string902causing the support arms to move towards the vaginal opening (and thereby pulling the anchor section along), releasing the string suddenly, and then repeating the process.

Applicator and Insertion

Referring now toFIG. 10A, an applicator is shown which serves for insertion of the device into the vagina. Insertion is accomplished using this applicator in a similar fashion to inserting a regular menstrual tampon. The incontinence device is kept within the distal end1002that is inserted into the vagina. When pushing the proximal end1004, the device is pushed through the exit1006, allowing for its immediate action once the applicator is removed from the vagina. It should be noted that in an exemplary embodiment of the invention, the exit1006remains closed until the proximal end1004is pushed and the incontinence device is forced out of the applicator. Optionally, the exit1006is flower-like. The string902is visible, protruding out of the opening1008of the proximal end1004. A cutaway view of the applicator1000is shown inFIG. 11. When the device is still within the applicator1000, its flexible arms1112and1114converge towards the central axis, providing for a much smaller profile than in its deployed configuration and allowing for its insertion via a small diameter applicator.

An exemplary embodiment of the invention, an applicator1050is depicted inFIG. 10B. While applicator1050is equipped with a proximal end1054, a distal end1052and an exit1056, as with applicator1000, this embodiment additionally includes a stopper1058which is positioned along applicator1050such that when stopper1058is grasped by a user upon insertion and applicator1050is advanced into the vagina up to the distal lip1060of stopper1058, deployment of a device located within applicator1050is at an appropriate depth within the vagina to render effective treatment. Deployment of a device using this embodiment of an applicator is carried out in a manner similar to that described above, with the addition of using stopper1058for convenient depth measurement. Optionally, the stopper can be provided with selectable positions corresponding to different sized women, for personalization

In some embodiments of the invention, an applicator is used which conveniently positions an incontinence treatment device for insertion into a vagina. For example, any of the devices described herein can be positioned on or in an applicator in a collapsed and/or folded configuration ready to be inserted into a vagina. In an exemplary embodiment of the invention, the device would be inserted into the vagina using the applicator, and then would be allowed to spring into an expanded shape by releasing the mechanism holding the device in a collapsed configuration. In an exemplary embodiment of the invention, a releasable knot is tied around the device using the device displacer, the knot bring released once the device is inserted into the vagina and the device displacer being located in an accessible place so that the device displacer can be used for removal of the device.

In an exemplary embodiment of the invention, the removal string is used to hold the anchor arms in a low profile condition until deployment by tying them together. Optionally, the removal string ties the anchor arms together in an easy-to-release knot which when the string is pulled on after device insertion, the knot releases and allows the anchor legs to spring into position. In an exemplary embodiment of the invention, the removal string then protrudes from or remains in the vicinity of the vaginal opening to allow for device removal at a later time. Optionally, the arms of the device are provided with slots for accommodating a string for tying the arms together. In some embodiments of the invention, the slots are reinforced to prevent the string from damaging the device while it is in storage, prior to use.

Referring now toFIG. 12A, the applicator1000is seen being inserted into the vagina for deployment of the incontinence device located within. The proximal end1004portion of the applicator1000is partially pushed towards the distal end1002and the anchor portion of the incontinence device1200has deployed into the vagina. Continued pushing of the proximal end1004towards the distal end1002will result in the device1200being completely free of the applicator1000. Upon complete deployment of the device1200, the applicator1000is removed from the vagina, leaving the device is in situ. The device1200naturally gravitates towards the proper therapeutic position due to the shape of the device and its compatibility with the internal structures present within the vagina. For example, in some exemplary embodiments of the invention, the support arms are adapted to fit within the creases which can be found on either side of the urethra. The naturally tendency for the support arms is to settle in the creases. Not coincidentally, in some embodiments of the invention the device is designed to render urethral support from such a position. As a corollary to the above, once the device has settled into position, it becomes resistant to unwanted motion, due to its fit into the geography of the vagina. In an exemplary embodiment of the invention, the device displacer902stays connected to the device1200throughout. Optionally, an applicator is not used to deploy the device1200in the vagina.

In an exemplary embodiment of the invention, after insertion, the flexible arms of the device1200gain their pre-intended tension and enlarge the diameter of the device within the vagina1202, depicted inFIG. 12B. The device anchors itself under the bladder1204between the uterine cervix1206and the pubic bone1208, supporting the mid-urethra1210. The string902optionally protrudes out of the vaginal introitus1212, as with the regular menstrual tampon, allowing for removal. While the device1200is shown with a cover inFIG. 12B, it should be understood that a cover is only optional depending on the needs of the individual patient.

An exemplary embodiment of the invention is shown in the proper position for rendering incontinence treatment inFIG. 12C.FIG. 12Cis a closer view of the device in situ, along with a cutaway of the cover, which shows the internal support structure within. The device1200is positioned underneath the mid-urethra1210and between the uterine cervix1206and the pubic bone1208as described above. It should be noted that in an exemplary embodiment of the invention, the device does not exert substantial affirmative pressure on the urethra. Rather, it acts as a support when the urethra moves downward due to a stressful event, such as coughing. In addition to the natural tenting tendency of the vaginal wall to provide support, the cover is optionally utilized as a “hainmock” like support, being suspended between the arms of the device1200.

Referring now toFIG. 12D, a flowchart1218is depicted which describes the process of inserting an incontinence device in accordance with an exemplary embodiment of the invention. At action1220, the distal end1002of the applicator1000is inserted into the vaginal opening. It should be noted that in an exemplary embodiment of the invention, the applicator can be inserted at any rotational angle relative to the vaginal opening. The applicator1000is pushed into the vagina at action1222by the user in an amount sufficient to adequately deploy the incontinence device. The proximal end1004is then pushed at action1224towards the distal end1002while substantially holding the distal end1002steady. The proximal end1004thus acts as a “plunger” which forces the device out of the applicator through an exit1006, as described inFIG. 10. Once the device is completely free of the applicator1000, and has therefore deployed in the vagina, the applicator1000including the distal1002and proximal1004ends is removed from the vagina by the user at action1226. The device displacer902remains attached to the device throughout the process and upon its conclusion protrudes from the vaginal opening. Optionally, the applicator1000is disposed of at action1228.

Removal

Removal of the incontinence device is optionally assisted by the device displacer1302, in accordance with an exemplary embodiment of the invention.FIG. 13Adepicts a device1300being removed from the vagina. The basic process for device removal is explained above, however, it is important to note that downward force on the string1302causes the cover to reduce the device's profile within the vagina as described herein, allowing for easier removal. Removal of an optional device without a cover, but taking advantage of the same effect, is described below in conjunction withFIGS. 13Cand D.

Referring now toFIG. 13B, a flowchart1310is depicted which describes the process of removing the device from the vagina. At action1312, the user locates the device displacer and begins to exert force on the device displacer away from the vaginal opening. This tension on the device displacer causes the cover of the device to apply pressure to the arms of the device. As the arms collapse towards the central axis of the device, it inherently reduces its diameter. At action1314, removing force is continually exerted on the device displacer as the device begins to dislodge from the vagina. The user maintains this force at action1316until the device is free of the vagina and removed from the user. Optionally, the device is disposed of at action1318.

Optional Embodiment for Easy Removal

In an exemplary embodiment of the invention, a device1380for treating incontinence is provided which is adapted to be easily removed from the vagina. Depicted inFIG. 13Cis an incontinence device generally comprised of an anchoring section1386, a support section1390and a node1388. A device displacer, such as a string1398is directly attached to the support element arms1394of the device. It can be seen inFIG. 13Dthat when downward force (i.e. force towards the vaginal opening) is applied, the support element arms1394collapse towards the central axis of the device1380. Optionally, the juncture between the arms1394and the string is reinforced to prevent damage to the arms from the downward, removing force. As the diameter of the device gets smaller through additional exerted force and arm1394collapse, it gets easier to pull the device1380out of the vagina. In addition, use of the device displacer allows the woman to remove the device1380in a non-invasive and sanitary manner, without touching herself. It should be noted that this technique will work with rigid or flexible support element arms1394. For example in the case of rigid arms, as long as the node1388is constructed of a flexible material, force on the arms1394will result in the node1388absorbing the stress applied to the rigid arms, allowing for the arms to collapse towards the central axis. In some embodiments of the invention, the tips of the arms are not pointed outwards from the central axis of the device allowing for easier removal because there is less friction between the device and the vaginal walls.

The present invention has been described using detailed descriptions of embodiments thereof that are provided by way of example and are not intended to limit the scope of the invention. The described embodiments comprise different features, not all of which are required in all embodiments of the invention. Some embodiments of the present invention utilize only some of the features or possible combinations of the features. Variations of embodiments of the present invention that are described and embodiments of the present invention comprising different combinations of features noted in the described embodiments will occur to persons of the art. When used in the following claims, the terms “comprises”, “includes”, “have” and their conjugates mean “including but not limited to”. The scope of the invention is limited only by the following claims.