RU2380064C2 - Device for urinary incontinence prevention in women - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: device for urinary incontinence correction located around the central axis comprises: a nodal element located on the central axis, a support component used to support urethra attached to said nodal element; and a stabilising component used to counteract to motion of said device attached to said nodal element; where said nodal element makes 30% and less of the whole length of the device comprising said nodal element, the support component and stabilising component combined. The method of using the device for urinary incontinence correction involves insertion of said device for urinary incontinence correction and extension of said device for urinary incontinence correction in the position to support the middle of urethra. An apparatus for insertion of the device for urinary incontinence correction of the appropriate extension depth contains: a cover to enclose specified vaginal devices for urinary incontinence correction and a restraint where said restraint prevents too deep insertion and where said terminator is adjustable on said cover.

EFFECT: inventions provide prevention of vaginal infections, necrosis or bleeding.

36 cl, 13 dwg

Description

Related Applications

This application is a partial continuation of the PCT application No. PCT / IL2004 / 000433, filed May 20, 2004, claiming priority of Israeli patent application No. 156070, filed May 22, 2003, and Israeli patent application No. 157117, filed July 27, 2003, the disclosures of which are incorporated herein by reference . This application also, in accordance with 35 USC 119 (3), claims the priority of provisional: US application No. 60/553964, filed March 18, 2004; US Provisional Application No. 60/555977, filed March 25, 2004; preliminary; US application No. 60/570469, filed May 13, 2004; US Provisional Application No. 60/570535, filed May 13, 2004; US provisional application No. 60/598835, filed August 5, 2004, and US provisional application No. 60/602636, filed August 19, 2004, the disclosures of which are incorporated herein by reference.

The technical field of the invention

The present invention relates mainly to female urinary incontinence, for example, provides a device for preventing female urinary incontinence.

BACKGROUND OF THE INVENTION

Urinary incontinence is a common problem among women. It is estimated that up to 50% of women sometimes inadvertently lose their urine, and that approximately 25% of women seek medical help at some point in order to cope with this problem. Stress urinary incontinence is the most common type of urinary incontinence related to involuntary loss of urine resulting from an increase in intra-abdominal pressure that occurs during exercise, during coughing, sneezing, laughing, etc. When stress incontinence occurs, it is usually the result of abnormal prolapse of the urethra and bladder neck below the level of the pelvic floor. And at the same time, many different factors can contribute to the development of stress urinary incontinence, this is widespread among women 35-65 years old and women who have repeatedly given birth through the birth canal. Stress urinary incontinence is both annoying and unpleasant for a woman, and it can also cause embarrassment. Many women wear sanitary napkins or feminine hygiene bags in order to combat urinary incontinence, although this is not a valid solution to the problem and, moreover, it can be very uncomfortable and unreliable. Surgical treatment may include attaching paraurethral tissues to the periosteum of the pubic bone joint or fascia of the rectus muscle in order to raise the neck of the bladder up from the pelvic floor, in addition, this distributes pressure equally to the bladder, neck of the bladder, and also the middle of the urethra . Recently, an operation known as “TVT” (“TVT method or free synthetic loop plastic surgery”) has been developed in which a mesh tape is implanted under the middle of the urethra, creating an overhanging hammock on which the urethra can bend over while increasing abdominal pressure. However, surgery is only suitable for serious cases, in addition, most women experiencing urinary incontinence do not need surgical approaches.

One of the methods of non-surgical treatment involves the use of devices that are placed in the vagina, either by the doctor or directly by the woman herself. Most devices are designed to put pressure on the neck of the bladder in such a way as to prevent or completely block the flow of urine through the urethra. Many such devices are known in the art. For example, see descriptions of inventions, which are hereby incorporated by reference: US Patent Application No. 2002/0183711, Moser, entitled "Urinary Incontinence Device"; US patent No. 6739340, Jensen and others, named "Device for prevention of involuntary urination"; US patent No. 6679831, Zunker et al., entitled "Resilient incontinence insert and a method of making the same"; US patent No. 6460542, James, entitled "Female incontinence control device"; U.S. Patent No. 6,413,206 to Biswas named "Intra-vaginal device"; US patent No. 5785640, Kresch, entitled "Method for Treating Female Incontinence"; US patent No. 5771899, Martelly et al., called "Pessary"; US patent No. 5618256, 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"; US patent No. 5417226, Juma, named "Female Anti-Incontinence Device"; US patent No. 5386836, Biswas ;, named "Urinary Incontinence Device"; US patent No. 5007894, Enhorning, named "Female Incontinence Device"; and U.S. Patent No. 4,920,986 to Biswas, entitled "Urinary Incontinence Device".

One of the problems with many of the above devices is that they completely block the urethra and, therefore, they must be removed or compressed in order to enable the woman to urinate. To overcome this drawback, vaginal devices of a specialized form have been developed that do not completely block the neck of the bladder, but these devices tend to be large, uncomfortable and intrusive. They also tend to cause irritation or pain in the vagina.

Another common drawback is that most devices known in the art also tend to be difficult or painful to install and / or remove. In order to correctly prevent the flow of urine, the device must be properly located in the vaginal canal. As a result, a doctor may be required to properly install such a device. In most cases, the device is adapted to remain in the vagina for a long period of time (due to the time and cost of trained professional medical personnel required for medical purposes to insert the device). At the same time, being in the vagina for a long period of time, the device can cause the appearance of vaginal infections, necrosis or bleeding.

SUMMARY OF THE INVENTION

An aspect of some embodiments of the present invention relates to devices for treating female urinary incontinence, consisting of at least a nodal element located on a central axis. If desired, the length of the nodal element is only 30% or less than the length of the entire device. In some embodiments of the invention, the device further includes a stabilizing element and support. In some embodiments of the invention, the design of the nodal element provides greater control of the flexibility of the device for advanced functionality. Additionally, part of the flexible neck is located in the nodal element of the device. Operational flexibility, especially in the central core, improves user comfort. In some embodiments of the invention, a device for treating female urinary incontinence provides for its single use. Additionally, the device has a one-piece housing design. Additionally, the device is made from one material. Additionally, the device is made in various sizes. For example, in some embodiments of the invention, devices are provided having a total length of 30 mm to 50 mm. Additionally, 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 stabilizing and supporting parts provided with grippers. Additionally, the shape and number of grips are different. Additionally, there are four supporting and / or stabilizing grips. Additionally there are fewer or more than four captures. Additionally, the grips do not have the same shape. Additionally, the grips have various degrees of compliance, rigidity and elasticity. Additionally, the grips have soft ends or soft inserts. In some embodiments of the invention, the angle of the grippers with respect to the central axis of the device and / or relative to each other can be changed. Additionally, the supporting grips are curved. Additionally, the stabilizing grips diverge radially, essentially perpendicular to the nodal element. In some embodiments of the invention, the size and shape of the supporting grips are not related to the size and shape of the stabilizing grips. Additionally, the grips are cantilever.

In an exemplary embodiment of the invention, the device includes an additional structure that exerts direct pressure on the urethra to improve the correction of urinary incontinence. Additionally, a device with an additional structure is used during intense physical activity. In some embodiments of the invention, direct pressure on the urethra is applied through an annular spacer that connects the grips of the support portion. Additionally, the spacer consists of smooth segments. Additionally, the spacer consists of internal arc segments.

An aspect of some embodiments of the invention relates to devices for treating female urinary incontinence, which have an adjustable size of support that affects the urethra. Additionally, the size of the support is mechanically adjustable, for example, by using an expanding liner. Additionally, parts of the device are console. Additionally, the expanding liner is interchangeable with other expanding liners in order to resize the support. Different shapes and sizes provide better fit for the user and, in some cases, provide more effective therapy.

An aspect of some embodiments of the invention relates to a device for treating female urinary incontinence, which includes a device retrieval device, such as traction. In an exemplary embodiment of the invention, when a pulling force is applied to the rod, the grips of the device are compressed in the direction of the nodal element, reducing the profile of the device, and provide easier and less painful removal of the device. Additionally, the rod is attached directly to the supporting grips, as a result of which the application of force to the rod at least compresses the supporting grips for easier removal of the device. Additionally, the rod is attached to a device made like a stretched cover or sheath, and when a force is applied to the rod, a device made like a stretched cover has an effect on the grips and causes them to contract for easier removal of the device. Additionally, the device is removed without the need for the patient to touch himself.

Thus provided is a device for the correction of urinary incontinence, comprising a nodal element supporting a part designed to provide support for the urethra attached to the specified nodal element, and a stabilizing part designed to counteract the movement of the specified device attached to the specified nodal element; where the specified nodal element is not more than 30% of the total length of the specified device, including the specified nodal element, the supporting part and the specified stabilizing part, taken together. Additionally, the nodal element is not more than 20% of the entire length of the specified device for the correction of urinary incontinence. Additionally, the nodal element is not more than 15% of the total length of the specified device for the correction of urinary incontinence. In some embodiments of the invention, the support portion has at least 2 support arms. In some embodiments, the stabilizing portion has at least 2 stabilizing grips. Additionally, the device further includes a shell. Additionally, the shell essentially encapsulates the specified nodal element, the supporting part and the specified stabilizing part. In some embodiments of the invention, the supporting part and said stabilizing part are flexible. Additionally, the nodal element is flexible. In some embodiments of the invention, the apparatus further includes a device for removing the device. Additionally, the device retrieval device is attached to said supporting part. In some embodiments of the invention, the apparatus further includes supporting struts connecting said supporting grips. In some embodiments of the invention, the device further includes an applicator for introducing said device into the vagina.

In this way, a device for correcting urinary incontinence is provided, comprising a support portion for providing support to the urethra; and an expanding insert for adjusting the diameter of said support portion. In some embodiments of the invention, the device further includes a nodal element and a stabilizing part, designed to counter the movement of the specified device. In some embodiments of the invention, the device further includes a shell. Additionally, the specified shell essentially encapsulates the specified nodal element, the supporting part, the specified stabilizing part and the expanding liner. In some embodiments of the invention, the device further includes a device for removing the device. Additionally, the device retrieval device is attached to said supporting part. In some embodiments of the invention, the device further includes an applicator for introducing said device into the vagina.

Thus, a device for correcting urinary incontinence is provided, comprising a body for correcting urinary incontinence if it is inserted into the vagina; and a device extraction device for moving said device. Additionally, the specified device extraction device is a draft. In an exemplary embodiment of the invention, said device is flexible and deformable by said traction.

Thus, a method is provided for using a device for correcting urinary incontinence, including introducing said device for correcting urinary incontinence and deploying said device for correcting urinary incontinence in a position that maintains the middle part of the urethra. Additionally, administration is facilitated by an applicator. In some embodiments of the invention, the method further includes removing said device. Further, the extraction is facilitated by the device extraction device.

Thus, a device for introducing a vaginal device is provided, comprising a sheath for containing said vaginal device and a stopper, wherein said stopper prevents too deep insertion. Additionally, the specified limiter is located on the specified shell in such a position that, when the specified device is inserted into the vagina to the specified limiter, the specified vaginal device will take the corresponding position within the specified vagina for deployment. In an exemplary embodiment of the invention, said limiter is controllably located on said shell.

In one embodiment of the device, the supporting part comprises a body provided with a plurality of grips designed to provide support for the urethra to correct urinary incontinence when inserted into the vagina, and the device further comprises a device for compressing the grippers and a device extraction device attached to the gripper compression device, which when pulled, it causes: a) compression of the grips and b) removal of the device.

Brief Description of the Figures

Non-limiting embodiments of the invention will be described with reference to the following description of exemplary embodiments in conjunction with the figures. The figures are mainly shown not to scale, and any sizes are given only as an example and without any limitation. In the figures, identical structures, elements or parts that are shown in more than one figure are preferably indicated by the same or similar position number in all the figures in which they are shown.

On figa shows a side view of the internal supporting structure of an exemplary embodiment of the invention;

on figv shows a top view of the internal supporting structure of an exemplary embodiment of the invention;

FIG. 1C is a perspective view of an internal supporting structure of an exemplary embodiment of the invention;

FIG. 1D is a side view of an internal supporting structure with an additional tapered flexible neck of an exemplary embodiment of the invention;

on figa shows a side view of an additional internal supporting structure of an exemplary embodiment of the invention;

on figv shows a top view of an additional internal support; designs of an exemplary embodiment of the invention;

on figs shows a bottom view of an additional supporting structure of an exemplary embodiment of the invention;

FIG. 2D is a side view of an additional internal support structure with outwardly projecting ends of the grippers of an exemplary embodiment of the invention;

FIG. 3A is a side view of an additional internal support structure with a urethral support ring of an exemplary embodiment of the invention;

on figv shows a view with a local section of an additional internal supporting structure with a urethral supporting ring is given as an example of an embodiment of the invention;

on figs shows a top view of an additional internal supporting structure with a urethral supporting ring is given as an example of an embodiment of the invention;

3D is a perspective view of an additional internal support structure with a support ring of an exemplary embodiment of the invention;

on figa shows a side view of an expandable internal support; designs of an exemplary embodiment of the invention;

FIG. 4B shows a top view of an expandable internal support structure of an exemplary embodiment of the invention;

on figs shows a perspective view of an expandable internal supporting structure of an exemplary embodiment of the invention;

on figa shows a view with a local section of an expandable internal structure in the initial position of an exemplary embodiment of the invention;

on figv shows a view with a local section of an expandable internal structure in the expanded position of an exemplary embodiment of the invention;

on figa shows a side view of an additional expandable internal supporting structure of an exemplary embodiment of the invention;

on figv shows a top view of an additional expandable internal supporting structure of an exemplary embodiment of the invention;

on figs shows a bottom view of an additional expandable internal supporting structure of an exemplary embodiment of the invention;

on figa shows a view with a local section of an additional expandable internal structure in the initial position of an exemplary embodiment of the invention;

on figv shows a view with a local section of an additional expandable internal structure in the expanded position of an exemplary embodiment of the invention;

on figa shows a side view of the expanding liner shown as an example of an embodiment of the invention;

on figv shows a perspective view of the expanding liner shown as an example of a variant embodiment of the invention;

on figs shows a top view of the expanding liner shown as an example of an embodiment of the invention;

Fig. 9A is an illustration of an additional shell of an exemplary embodiment of the invention;

Fig. 9B is a sectional view showing an additional internal supporting structure inside the shell of an exemplary embodiment of the invention;

10A is a perspective view of an applicator of an exemplary embodiment of the invention;

10B is a perspective view of an alternative applicator of an exemplary embodiment of the invention;

11 is a view in local section, showing a device for preventing urinary incontinence in the applicator of an exemplary embodiment of the invention;

on figa shows a view of the female pelvic region with a device that prevents involuntary urination, placed in accordance with an exemplary embodiment of the invention;

on figv shows an illustration of the female pelvic region with a device that prevents involuntary urination, located directly in the place of use for an exemplary embodiment of the invention;

on figs shows an illustration of a device that prevents involuntary urination, placed directly at the place of use in accordance with an exemplary embodiment of the invention;

12D is a flowchart showing an introduction process in accordance with an exemplary embodiment of the invention;

on figa shows a view of the female pelvic region with a removable device that prevents involuntary urination, in accordance with an exemplary embodiment of the invention;

13B is a flowchart showing a removal process in accordance with an exemplary embodiment of the invention;

on figs shows a spatial view of an additional internal structure with a pull rod attached to the supporting grips of an exemplary embodiment of the invention; and

on fig.13D shows a spatial view of an additional internal structure at the moment when a pulling force is applied to the pulling rod of an exemplary embodiment of the invention.

Detailed description of exemplary embodiments

Introduction

The present invention provides a device and device variants for the correction of urinary incontinence in women. A device related to the present invention is adapted for single use, wearing only a short period of time, and then discarded and replaced with a new device (if necessary). Alternatively, the device is reusable provided that it is sterilized between uses. The device related to the present invention is simple and easy to use, and is also easily inserted in exactly the same user-friendly and familiar manner as a tampon inserted in the vagina during menstrual bleeding. Unlike the large and intrusive devices known from the prior art, the device related to the present invention is comfortable, and after it is installed, the woman does not have to worry until it is removed. At the moment when involuntary urination takes place, this often happens due to increased pressure in the bladder, for which there is no compensation for back pressure from the neck of the bladder or urethra. This is usually the result of abnormal dropping of the neck of the bladder and urethra to a low position due to an intra-abdominal pressure system. Known as "hypermobility," this is the result of some damage to the support apparatus, which usually holds the urethra and neck of the bladder in an elevated position, along the underside of the pubic bone joint. Lowering the neck of the bladder and urethra, which occurs, for example, at the moment when a woman coughs, sneezes or laughs, causes an involuntary leakage of urine.

An incontinence treatment device

On figa shows a side view of an exemplary embodiment of a device 100 that prevents urinary incontinence. For ease of description, the device 100 is located around a central axis 150 and is divided into three parts. An upper portion 106 is provided that serves as a “stabilizing” element to stabilize the device inside the vagina. There are two types of stabilization: axial stabilization, which acts in a direction along the central axis of the vagina, and radial stabilization, which acts transversely or substantially perpendicular to the central axis of the vagina. A lower portion 110 is provided that serves as a “supportive” member for creating support for the urethra. In some embodiments of the invention, support is located in the middle of the urethra. In some embodiments, the lower support portion 110 provides at least one form of stabilization to help stabilize the device 100 in a proper position. In some embodiments of the invention, the entire length of the device 100 is from 30 mm to 50 mm. Additionally, the device 100 is larger or smaller depending on the individual needs of the patient.

In addition, an intermediate part 108 is provided that acts as a “nodal element” and which connects the stabilizing elements 106 and the supporting elements 110. The nodal element 108 of this device and many of the other devices described herein has a length that is only a small part of the entire length of said devices in some embodiments of the invention. In some embodiments of the invention, the length of the nodal element is less than 15% of the total length of the device. In some embodiments of the invention, the length of the nodal element is less than 20% of the total length of the device. In other embodiments of the invention, the length of the nodal element is less than 30% of the total length of the device. In some embodiments of the invention, the nodal element, which is short relative to the entire length of the device, provides greater flexibility when changing the stiffness, comfort and size of the device 100. Optionally, the additional nodal element is not performed with one axis longer than the other, the axes are equal in length ( e.g. sphere or cube). For an exemplary embodiment of the invention, the nodal element is small relative to the entire length of the device, which makes it possible for greater control over the action of the stabilizing and supporting arms described below.

These elements of the device 100 function as an internal supporting structure for the casing shown in FIG. 9A and FIG. 9B, in some embodiments of the invention. It should also be noted that for some women, the devices described here can also be used as corrections for prolapse.

In an exemplary embodiment, the stabilizing member 106 and the supporting member 110 each have four (4) grips 112 and 114, respectively. For an exemplary embodiment of the invention, four grips are placed on each part, of which two mainly exert pressure in the direction of the bladder, and two mainly exert pressure in the direction of the posterior wall of the vagina adjacent to the intestine. Two supportive grips that exert pressure in the direction of the bladder are placed inside the natural folds on both sides of the urethra in some embodiments of the invention. Additionally, the stabilizing and supporting elements may have more or fewer grips. For example, the stabilizing element may have a larger number of grips, if there is concern about the unwanted movement of the device 100. In other embodiments of the invention, the grips are located at different angles with respect to the node element 108 and / or relative to each other. Additionally, the grippers 112 and 114 are flexible or rigid and are made of biocompatible material. For an exemplary embodiment of the invention, the stabilizing element does not exert significant pressure on the woman's vagina and / or urethra, thereby improving comfort. In some embodiments of the invention, a different construction is provided instead of grips, which is capable of supporting the urethra in the case of the supporting 1 part or preventing inadvertent movement of the device in the case of the stabilizing part. For example, at least one corner element, protrusions and / or protruding parts attached to the nodal element can be used for stabilization or support.

The stabilizing grips of the device prevent the device from being inadvertently moved to the wrong position. In an exemplary embodiment of the invention, the grips are flexible. This flexibility improves the ability of stabilizing grips to prevent the device from moving further into the vagina. When a force is applied to the device to move it into the vagina, flexible stabilizing grips tend to expand in different directions. This expanding action of stabilizing grips increases the friction between the device and the walls of the vagina, preventing movement. The grips are flexible, but it should be noted that they are hard enough to prevent the device from moving in the direction of entry into the vagina. Additionally, the grips are solid, but the nodal element is flexible, the nodal element thus provides for flexible stabilization and support. Movement in the direction of the vaginal opening is resisted by grips that move only in the back side relative to the opening of the vagina, a tubercle located in the vagina. These properties work independently and in combination with the stretched and overhanging behavior of the vaginal walls described earlier, which also helps to hold the device in place.

An additional design feature of the stabilizing grips of the device 100 is that they act remotely from the supporting grips. This limits the amount of pressure applied to the urethra by the device. Alternatively or additionally, the distant position of the stabilizing grips relative to the supporting element is designed so that the stabilizing grips can be installed only in the rear side relative to the opening of the vagina, the tubercle located in the vagina, and at the same time, the supporting grips provide support for the middle part of the urethra. This position increases the comfort for the woman, prevents excessive damage to tissues adjacent to the device, increases the stabilizing fixation of the device and, in some embodiments of the invention, allows the wearer to urinate as he wishes without having to remove the device to urinate.

FIGS. 1B and 1C help show the position of the device 100 and show in more detail the grips 112 and grips 114 of an example embodiment of the invention. The grips 112 of the stabilizing element 106 force the device 100 to remain in place inside the vagina without the possibility of significant movement in or out or rotation. One of the reasons for this is the result of the special desire of the vaginal walls to compress and form an occluded lumen. Grips of the device cause "stretching and overhanging" of the vaginal walls over them, as a result of sagging of the walls of the vagina around the node element 108, stabilization of the device 100 is achieved. Grips 114 of the supporting element 110 cause tissue to rise around the middle of the urethra, acting as an overhanging hammock. This overhanging hammock supports the middle of the urethra in a stress-free manner, similar to a TVT operation. In a woman who loses urine in the process of accidentally arising tension (in cases when intra-abdominal pressure rises, during coughing, sneezing, etc.), the urethra bends down, but meets an overhanging hammock in its middle part. The meeting of the urethra and the “overhanging hammock” causes a rise (an urethral bend is formed) of intraurethral pressure, as a result of which urine retention occurs. In some embodiments of the invention, the diverging radially supporting grips 114 of the device 100 create an external diameter of the device from 25 mm to 50 mm inside the vaginal cavity. Additionally, the diameter is larger or smaller depending on the individual needs of the woman.

For an exemplary embodiment of the invention, the grips 112 of the stabilizing elements resist the movement of the device in the direction of the uterus, because the grips increase their angle with respect to the nodal element 108. This effective increase in radius works by counteracting the movement of the device further into the vagina. In some embodiments of the invention, the grips 112 of the stabilizing elements have a large angle with respect to the nodal element in order to improve this stabilization effect. It should be noted that this increased stabilization effect is observed only up to the maximum angle.

FIG. 1D illustrates an embodiment of the invention in which the nodal member 118 is constricted. The tapered nodal element 118 increases flexibility and possible ranges of motion for the entire device 100 in some embodiments of the invention. Additionally, devices, such as wires and / or springs, are mounted in the neck in order to improve the flexibility of the device 100. This additional flexibility can improve the comfort of a woman while she is wearing the device 100. Any of the embodiments further described herein may be used in combination with a narrowed nodal element 118.

An additional substantially perpendicular stabilizer grip embodiment

On figa shows an additional embodiment of a device 200 to combat female urinary incontinence. This embodiment consists of a stabilizing element 206, a supporting element 210, and a knot element 208. In this embodiment, the stabilizing element is provided with grippers 212 that radially diverge substantially perpendicular to the knot element 208. This grip position of the stabilizing element is particularly effective for preventing spontaneous the movement of the device, preventing urinary incontinence, in the direction of the opening of the vagina, as the movement in each direction is resistance. As can be seen in FIG. 1A, the grippers 214 of the support member are formed such that they bend in the direction of the central axis of the device 200, and the ends 218 of the grippers do not protrude far outward from the central axis of the device, unlike the embodiment 220 shown in FIG. .2D, where the ends 222 of the grippers 214 extend significantly from the central axis of the device 200. In addition, the inwardly directed ends of the grippers improve the comfort of the woman and, in some embodiments, facilitate removal of the device 200 because of their shape but provides ends that do not protrude into the vaginal wall. This embodiment operates similarly to the device 100 in FIG. 1A.

The device 220 shown in FIG. 2D is an alternative, exemplary embodiment of an anti-urinary incontinence device. As described above, the ends of the grips 222 extend radially away from the central axis of the device 220. This embodiment provides an elongated portion where the urethra is supported. It should be noted that any shapes and sizes of grips described in this application are interchangeable depending on the needs of each particular woman.

Urinary incontinence device adapted to provide additional support

Not all women and not under any load can be fully corrected by the above devices in cases where urinary incontinence occurs. For example, FIGS. 3A-D illustrate a device 300 that is adapted to directly compress the urethra during intense exercise. Additionally, this embodiment is used to correct women with relatively severe urinary incontinence, where the other embodiments described here are ineffective. For an exemplary embodiment, this device 300 has a stabilizing element, a supporting element and a nodal element. Additionally, the device 300 is provided with grippers 312 of the stabilizing element and grippers 314 of the supporting element.

In addition to the above, an additional support structure 320 is provided which is attached to the grippers 314 of the support member. Depending on the level of external suburethral pressure exerted by the additional supporting structure 320, there is additionally created full or partial occlusion of the urethra for a limited period of time. Attaching an additional supporting structure 320 to the device 300 can be achieved by using a recess 322 or by any other means of connection known in the art.

Despite the fact that the figures show mainly annular additional supporting structure 320, it should be noted that any shape that can provide an additional supporting structure in the urethra can be used if desired. For example, the curvature of the segments of the additional supporting structure 320 may deviate inward in the direction of the central axis (forming support in the form of a “+” sign), or the additional supporting structure 320 may consist of substantially smooth segments (forming the shape of a box). Various forms, if desired, are used depending on the needs of a particular woman. Additionally or alternatively, the additional supporting structure 320 has a constant diameter over its entire length or has various diameters and widths.

Variable geometry urinary incontinence device

As already indicated, not all women can be corrected by the above device. Despite the fact that the above basic anatomical features are usually present in every woman, the size of these anatomical features and their relationship to each other may vary slightly. Because of this, it can be difficult to provide one size suitable for everyone, for all types of devices. The device shown in FIG. 1 solves this problem by providing a flexible device that is capable of self-adapting to multiple sizes. In addition, it is possible that some women will not be able to use the device of FIG. 1, its geometric and functional properties are limited by the number of sizes that should be provided. One possible solution to this problem is illustrated in FIGS. 4A-C. The device 400 shown optionally consists of the above basic elements, like some other embodiments (that is, it has a stabilizing element 406, a supporting element 410 and a node element 408), but there are some changes that make it possible to change the geometry of the specified device 400. How can be seen in figa, the device 400 is equipped with a supporting element 414, in which the geometry of the grips can be adjusted depending on the specific needs of women.

The expanding insert 800 shown in FIGS. 8A-C is mounted within the divergence region of the grippers 414 of the support members. The rod portion 806 of the expansion liner 800 extends internally through a previously formed special channel within the device 400 along the central axis. The expanding insert has the ability to move along the central axis of the device 400 in the direction of the stabilizing element 406. Moreover, for the exemplary embodiment of the invention, the expanding insert 800 is only capable of moving in the direction of the stabilizing element 406, not far from the stabilizing element 406. An additional device is provided, which includes two expanding liners on each side of the central axis of the nodal element. Such an embodiment would make it possible to control the variable geometry of the grippers 412 of the stabilizing elements and the grippers 414 of the supporting elements.

On figa shows a device 400 for the correction of urinary incontinence of variable geometry. The design of FIG. 5A illustrates the device 400 in its basic state without changing geometry by the expanding insert 800. FIG. 5B again demonstrates how the expanding insert 800 interacts with the device 400 to change the angle of the grippers 414 of the support member with respect to the center axis of the device 400. You can see that when you move the expanding liner 800 along the Central axis of the device 400 in the direction of the stabilizing element 406, the grips 414 of the supporting element take a wider angle with respect to central axis.

For an exemplary embodiment of the invention, the expanding insert also provides additional convenience to the device 400. This also serves as an additional supporting element for the grippers 414 mainly in cases where a larger diameter is required to counter forces from the side of the vaginal walls acting in the opposite direction.

An embodiment of an anti-urinary incontinence device of variable geometry with perpendicular stabilizing grips.

FIGS. 6A-C also show an exemplary embodiment of the device 600, in which the geometry is different in view of the position of the expanding insert 800. The action for different movements is essentially the same as in the embodiment shown in FIG. 4A -C, however, it should be noted that the grips of the stabilizing element 612 have a slightly different configuration. This type of grip configuration (i.e., extending substantially perpendicular to the central axis of the device 600) functions similar to the grip 212 of the stabilizing elements shown in FIGS. 2A-D. It should be understood that the embodiments shown in the figures are given only as an example, and that any of the variable geometry incontinence devices described or proposed here can be used with an expanding insert without considering the size of the device, number of grips, configuration captures and / or forms of captures.

FIGS. 7A and 7B show the multi-stage geometric property of the device 600. The position of FIG. 7A illustrates the device 600 in its basic state without changing the geometry by means of the expanding insert 800. FIG. 7B illustrates how the expanding insert 800 interacts with the device 600, changing the angle of the grippers 614 of the supporting element located on the supporting element 610, relative to the Central axis and the node element 608 of the device 600. It can be seen that when moving the expanding insert 800 along the central axis of the device 600 in the direction of the stabilizing element 606, the grips 614 of the supporting element take a wider angle with respect to the central axis.

On figa-C shows in detail the expanding insert 800 of an exemplary embodiment. In this exemplary embodiment of the invention, there are three main parts of the design of the expanding insert 800: the head 804, the stem 806 and the tip 808. In operating condition, the rod 806 of the expanding insert 800 is extended into the channel located along the central axis of any of the variable geometry devices, described in the present description. For the weaving example of an embodiment of the invention, the tip 808 is sized to be slightly larger than the diameter of the channel along the central axis. Moreover, the tip 808 is formed to facilitate insertion into the channel, but to resist removal from the channel. Additionally, the expanding liner is supported in the central channel by arranging a series of protrusions along the inner circumference of the channel, which allows the arrowhead 808 to be held when moving in the direction of the stabilizing element, but which prevent the wider portion of the tip 808 of the liner 800 from being carried back towards the supporting element. Additionally provided are various sizes of expanding liners, which are interchangeable and which are selected depending on the need for an angle relative to the central axis. For an exemplary embodiment, an expanding liner is provided that sets different grips at different angles with respect to the central axis of the device preventing urinary incontinence. Additionally, the expanding insert has the ability to rotate. Additionally, the head 804 of the expanding insert 800 is made of a flexible material that allows the head to be inserted more easily inside the applicator 1100, the applicator is shown in FIG. 11.

Shell

On figa shows a device that prevents urinary incontinence, used in combination with a shell 900. For an exemplary embodiment of the invention, the shell 900 is made of a flexible, smooth, mesh material. Additionally, the sheath 900 is designed as a small bag that encapsulates a device 904, which acts as an internal supporting structure, shown in figv. Using a shell 900 may potentially provide one or more advantages in using the device. For example, the sheath limits friction between the applicator and the device during administration. In addition, the sheath limits the friction between the vagina and the device during administration. In some embodiments of the invention, the mesh of the sheath 900, being stretched between the grips of the device, serves as a stretched cover support for the urethra. In a woman who loses urine during an accidentally arising tension (with an increase in intra-abdominal pressure, during coughing, sneezing, etc.), the urethra bends down, but meets the membrane 900 in its middle part. This causes an increase in intraurethral pressure, resulting in retention of urine. For an exemplary embodiment of the invention, the device does not exert pressure on the urethra or neck of the bladder, only provides support if there is an increase in intra-abdominal pressure, as described above. Additionally, the device applies direct pressure to the urethra and / or neck of the bladder. In some embodiments of the invention, the shell 900 is disposable. Additionally, the membrane is sterilized between uses and reused. Additionally, the shell is decorated.

In some embodiments of the invention, the sheath 900 helps to remove the device from the vagina. First, sheath 900 limits friction between the urinary incontinence device and the walls of the vagina. Secondly, the sheath 900 is further provided with an extraction device, such as a rod 902, for removing the device. For an exemplary embodiment of the invention, the rod 902 is attached to the shell 900. Additionally, the shell 900 and the rod 902 are made of a single piece of the same material. Link 902 facilitates removal of the device in several ways. Removing the traction 902 compresses the sheath 900. Compressing the sheath 900 causes the walls of the vagina to align. Alignment of the walls of the vagina limits the overhanging effect described previously and reduces the voltage applied to the device, making it possible to easily and easily remove the device from the vagina. In addition, pulling the traction 902 causes the grips to bend slightly in the direction of the central axis, thereby limiting their size and allowing easy and unhindered removal of the device from the vagina. For an exemplary embodiment of the invention, the device can "go" out of the vagina by pulling it over the traction 902, causing the supporting grips to move in the direction of the vaginal opening (and thereby removing the stabilizing part), suddenly releasing the traction and then repeating the process.

Applicator and introduction

On figa shows the applicator, which serves to introduce the device into the vagina. The introduction is achieved through the use of this applicator is completely similar to the introduction of conventional swabs used during menstruation. An urinary incontinence device is placed inside the distal end 1002, which is inserted inside the vagina. When extending the proximal end 1004, the device extends through the outlet 1006, providing immediate action as soon as the applicator is removed from the vagina. It should be noted that for the exemplary embodiment of the invention, the exit 1006 remains closed until the proximal end 1004 is pulled out and the device for preventing urinary incontinence is pulled out of the applicator. Additionally, output 1006 is similar to a flower. The rod 902 is visible, protruding from the opening 1008 of the proximal end 1004. FIG. 11B is a cross-sectional view of the applicator 1000. While the device is located inside the applicator 1000, its flexible grips 1112 and 1114 converge in the direction of the central axis, providing a much smaller profile than in its deployed position, and allowing it to be inserted through the small diameter applicator. An exemplary applicator 1050 is shown in FIG. 10B. The applicator 1050 is not only equipped with a proximal end 1054, a distal end 1052 and an outlet 1056, as well as an applicator 1000, but this embodiment further includes a limiter 1058 that is mounted on the applicator 1050 so that while the limiter 1058 is held by the user upon insertion and the applicator 1050 is advanced inside the vagina to the distal protrusion 1060 of the limiter 1058, the opening of the device located inside the applicator 1050 occurs at the corresponding depth inside the vagina, providing an effective correction. Disclosure of the device using this embodiment of the applicator is similar to that described previously with the addition of the use of a limiter 1058 for the convenience of measuring depth. Additionally, the limiter may have a plurality of selectable positions corresponding to various sizes of women for personalization located on said device such that, when the said limiter (1058) is adjusted in one of the indicated positions, inserting the said device inside the vagina to the specified limiter (1058) will lead to that the device will be in the appropriate position inside the vagina for deployment.

In some embodiments, an applicator is used that conveniently has a urinary incontinence correction device for insertion into the vagina. For example, any of the devices described herein can be mounted on or in the applicator in a straightened and / or folded configuration, prepared to be inserted inside the vagina. For an exemplary embodiment of the invention, the device is inserted into the vagina using the applicator, and then it is expanded into an expanded form when the mechanism that holds the device in a compressed position is released. For an exemplary embodiment of the invention, the dispensed assembly is tied around the device using the device extraction device, the assembly is released after the device is inserted inside the vagina, and the device recovery device is located in an accessible place so that the device extraction device can be used to remove the device.

For an exemplary embodiment of the invention, a pull rod is used to hold stabilizing grips in a low profile state until disclosed by bringing them together. Additionally, the traction for removal brings the stabilizing grips together in an easily released assembly, which, if the traction is tensioned after the introduction of the device, releases the assembly and allows the stabilizing legs to spontaneously straighten into the working position. For an exemplary embodiment of the invention, the traction for removal is then protruded from or remains near the opening of the vagina, allowing the device to be removed at a later time. Additionally, the grips of the device have grooves to accommodate traction to bring the grips together. In some embodiments of the invention, the slots are reinforced to prevent traction from damaging the device when it is stored before use.

On figa applicator 1000 is shown inserted inside the vagina to open the device, preventing urinary incontinence located inside. The proximal end 1004 of the part of the applicator 1000 is partially extended towards the distal end 1002, and the stabilizing part of the device for preventing urinary incontinence is placed inside the vagina. Continued extension of the proximal end 1004 towards the distal end 1002 will completely release the device 1200 from the applicator 1000. Upon completion of the opening of the device 1200, the applicator 1000 is removed from the vagina, leaving the device in place. The device 1200 naturally tends towards an appropriate therapeutic position due to the shape of the device and its compatibility with the internal structure of the vagina. For example, in some exemplary embodiments of the invention, the supporting grips are adapted to be placed inside folds that can be formed on both sides of the urethra. The natural tendency for supporting grips is to fit in folds. It is no accident that in some embodiments of the invention, the device is designed to support the urethra as a result of this position. As a result, as soon as the device is placed in the working position, it becomes resistant to unwanted movement due to its correspondence to the structure of the vagina. For an exemplary embodiment of the invention, the extraction device 902 for removing the device is held permanently attached to the device 1200. Additionally, the applicator is not used to place the 1200 device in the vagina.

For the exemplary embodiment of the invention, after the introduction, the flexible grips of the device 1200 acquire their predetermined voltage and increase the diameter of the device inside the vagina 1202 shown in FIG. 12B. The device stabilizes itself under the bladder 1204 between the cervix 1206 and the pubic bone joint 1208, supporting the middle of the urethra 1210. The thrust 902 is additionally protruded from the vestibule 1212, like the usual tampon used for menstruation, allowing removal. In addition, device 1200 is shown in the shell of FIG. 12B, but it should be understood that the shell is only optional depending on the needs of the individual patient.

An exemplary embodiment of the invention is shown in a proper position for correcting urinary incontinence in FIG. 12C. Fig. 12C is a view of a device located in place with a shell cut showing an internal supporting structure inside. The device 1200 is installed under the middle of the urethra 1210 and between the cervix 1206 and the pubic bone 1208, as described above. It should be noted that for an exemplary embodiment of the invention, the device does not exert significant pressure on the urethra. Rather, it acts as support in cases where the urethra moves down in the event of stress, such as a cough. In addition to the natural tendency to close the walls of the vagina to provide support, the sheath is additionally used as support similar to an overhanging hammock, hanging between the grips of the device 1200.

12D is a flowchart 1218 that describes the insertion process of an anti-urinary incontinence device in accordance with an exemplary embodiment of the invention. At 1220, the distal end 1002 of the applicator 1000 is inserted into the vaginal opening. It should be noted that for an exemplary embodiment of the invention, the applicator can be inserted at any variable angle relative to the opening of the vagina. Applicator 1000 is pushed out by the user inside the vagina at 1222 by an amount sufficient to appropriately accommodate a device that prevents urinary incontinence. The proximal end 1004 then extends, at 1224, toward the distal end 1002 while keeping the distal end 1002 substantially stable. The proximal end 1004 thus acts as a “pusher” that pushes the device from the applicator to the exit 1006, as shown in FIG. 10. Once the device is completely free of the applicator 1000 and thus deployed into the vagina, the applicator 1000, including the distal 1002 and proximal 1004 ends, is removed from the vagina by the user during step 1226. The extraction device 902 remains attached to the device during the process and during completion protrudes from the opening of the vagina. Additionally, applicator 1000 is removed at 1228.

Delete

The removal of an anti-urinary incontinence device is further aided by the device retrieval device 1302 in accordance with an exemplary embodiment of the invention. On figa shows a device 1300, removed from the vagina. The main process for removing the device has been explained previously, it should be noted that the downward force on the thrust 1302 causes the sheath to reduce the profile of the device inside the vagina, as described in the present description, making it possible for easier removal. Removing an additional device without a shell, but having the advantages of the same action, is described below with reference to figs and fig.13D.

13B is a flowchart 1310 that describes a process for removing a device from a vagina. During action 1312, the user discovers a device extraction device and begins to exert a force on the device removal device at a distance from the vaginal opening. This force on the device extraction device causes the device shell to exert pressure on the device grips. When the grippers are compressed in the direction of the central axis of the device, this essentially reduces its diameter. At act 1314, the extraction force is continuously applied to the device extraction device when the device begins to move from the vagina. The user maintains this effort at act 1316 until the device is released from the vagina and removed by the user. Additionally, the device is thrown in action 1318.

An additional embodiment of the invention for its easy removal

In an exemplary embodiment of the invention, a device 1380 for correction of urinary incontinence is created, which is configured to be easily removed from the vagina. FIG. 13C shows an anti-urinary incontinence device, typically consisting of a stabilizing part 1386, a supporting part 1390, and a knot member 1388. A device retrieval device, such as a rod 1398, is directly attached to the grips of the device supporting member 1394. As can be seen in FIG. 13D, if a downward force is applied (that is, a force in the direction of the vaginal opening), the grips of the support member 1394 are compressed in the direction of the central axis of the device 1380. Additionally, the connection between the grippers 1394 and the traction is strengthened to prevent damage to the grips as a result acting downward extracting force. As the diameter of the device becomes smaller due to the additional exerted force and the compression of the grippers 1394, it becomes easier to pull the device 1380 from the vagina. In addition, the use of a device extraction device enables a woman to move the device 1380 in a non-invasive and hygienic manner without touching herself. It should be noted that this method will work with hard or flexible grips of the supporting element 1394. For example, in the case of rigid grips, since the nodal element 1388 is made of flexible material, the force on the grippers 1394 will absorb the voltage applied to the rigid grips in the nodal element 1388 allowing compression of the grips in the direction of the central axis. In some embodiments of the invention, the ends of the grips are not pointed outward from the central axis of the device, making it possible to more easily remove, because there is less friction between the device and the walls of the vagina.

The present invention has been described using detailed descriptions of embodiments thereof, which are presented as an example and are not intended to limit the scope of the invention. The described embodiments include various geometric and functional properties, not all of which are required in all embodiments of the invention. Some embodiments of the present invention use only some of the geometric and functional properties or possible combinations of geometric and functional properties. The embodiments of the present invention that are described and the embodiments of the present invention containing various combinations of geometric and functional properties noted in the described embodiments will be apparent to those skilled in the art. While the terms “contain,” “include,” “have,” and their derivatives mean “including, but not limited to,” as used in the formula. The scope of the claims of the invention is limited only by the following claims.

Claims (36)

1. A device (100) for the correction of urinary incontinence located around a central axis (150), comprising:
a nodal element (108) located on the central axis (150), a supporting part (110), designed to provide support for the urethra, attached to the specified nodal element;
and a stabilizing part (106), designed to counter the movement of the specified device, attached to the specified nodal element;
where the specified nodal element is not more than 30% of the total length of the specified device, including the specified nodal element (108), the supporting part (110) and the specified stabilizing part (106) combined. 2. The device according to claim 1, where the specified nodal element (108) is not more than 20% of the entire length of the specified device for the correction of urinary incontinence. 3. The device according to claim 2, where the specified nodal element (108) is not more than 15% of the entire length of the specified device for the correction of urinary incontinence. 4. The device according to claim 1, where the specified supporting part (110) is equipped with at least two supporting grips (114). 5. The device according to claim 1, where the specified stabilizing part (106) is equipped with at least two stabilizing grips (112). 6. The device according to claim 1, additionally containing a shell (900). 7. The device according to claim 6, where the specified shell (900) essentially encapsulates the specified nodal element (108), the supporting part (110) and the specified stabilizing part (106). 8. The device according to any one of claims 1 to 7, where at least said supporting part (110) and said stabilizing part (106) are flexible. 9. The device according to any one of claims 1 to 7, where at least the specified nodal element (108) is flexible. 10. The device according to claim 1, additionally containing a device for removing the device (902). 11. The device according to claim 10, where the specified device for removing the device (902) is attached to the specified supporting part (110). 12. The device according to claim 4, further comprising supporting struts (320) connecting said supporting grips (114). 13. The device according to claim 1, additionally containing an applicator (1000), designed to introduce the specified device into the vagina. 14. The device according to claim 1, where the device (100) is symmetrically located around the Central axis (150). 15. The device according to claim 1, where the length of the device (100) is 50 mm or less. 16. The device for the correction of urinary incontinence according to claim 1, where the supporting part (410) is designed to provide support for the urethra, using many external protruding outwards grips (414); and the device further comprises an expanding liner (800), designed to increase the diameter of the specified supporting part (410), moving the grippers (414) outward. 17. The device according to clause 16, further comprising a shell (900). 18. The device according to 17, where the specified shell (900) essentially encapsulates the specified nodal element (408), the supporting part (410), the specified stabilizing part (406) and the expanding liner (800). 19. The device according to clause 16, further comprising a device (902) for removing the device. 20. The device according to claim 19, where the specified device (902) for removing the device is attached to the specified supporting part (410). 21. The device according to any one of paragraphs.16 or 20, further comprising at least one sheath (900) or an applicator (1000), designed to introduce the specified device into the vagina. 22. The device for the correction of urinary incontinence according to claim 1, where the supporting part contains
a casing (400) provided with a plurality of grips (414) designed to support the urethra for correcting urinary incontinence when inserted into the vagina; and the device further comprises:
tool (900) for compressing the grips and
a device extraction tool (902) connected to a gripper compression tool (900) which, when pulled, causes: a) gripper compression (414); and b) removing the device. 23. The device according to item 22, where the specified device (902) for removing the device is a draft. 24. The device according to item 23, where the specified device is flexible and deformable through the specified traction. 25. The device according to claim 1, in which at least one of the supporting part (110) and the stabilizing part (106) diverge radially from the central axis (150). 26. The device according A.25, where the supporting part (110) and the stabilizing part (106) are equipped with grippers (112, 114) located around the central axis (150), so that the grippers (112, 114) provide support and stabilization any orientation. 27. The device according to claim 1, where the supporting part (110) and the stabilizing part (106) are made the same. 28. The device according to claim 1, in which the support of the urethra is urethral support. 29. The device according to claim 1, in which the support of the urethra is the support of the middle part of the urethra. 30. The device according to claim 1, in which the supporting part (110) provides support for the neck of the bladder. 31. A method of using a device for the correction of urinary incontinence, comprising:
the introduction of the specified device (100) for the correction of urinary incontinence according to claims 1-30 and
the deployment of the specified device (100) for the correction of urinary incontinence in a position that ensures the maintenance of the middle part of the urethra. 32. The method according to p, where the introduction is facilitated by the applicator (1000). 33. The method according to p or 32, further comprising removing the specified device. 34. The method according to p, where the removal is facilitated by means of a device (902) for removing the device. 35. An apparatus (1050) for introducing an urinary incontinence correction device having an appropriate deployment depth, comprising:
a sheath for containing said vaginal urinary incontinence correction device and a stop (1058), where said stop (1058) prevents too deep insertion and where said stop (1058) is adjustable mounted on said sheath. 36. The device according to clause 35, further comprising a plurality of selectable positions located on the specified device so that when the specified limiter (1058) is installed in one of the specified positions, introducing the specified device into the vagina to the specified limiter (1058) will lead to that the device will be in the appropriate position inside the vagina for deployment.

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