RU2396924C2 - Devices for reduction of urinary incontinence in women - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to medicine and is used for improvement of medical state of women. Device contains support section, adapted for providing support for urethra; fastening section, connected with support section and adapted for prevention of said device displacement into vagina; insert, separate from support section, part of which is adapted for its placement within support section limits. Insert is configured in such way as to provide support for support section of said device.

EFFECT: ensuring introduction and removal of device without pain and difficulty.

23 cl, 28 dwg

Description

FIELD OF TECHNOLOGY

The invention relates generally to improving the medical condition of women, for example, by creating devices to prevent incontinence and / or prolapse in women.

BACKGROUND OF THE INVENTION

Incontinence is a common problem among women. It is estimated that up to 50% of women occasionally urinate unintentionally, and approximately 25% of women at some point seek medical advice to deal with this problem. Stress incontinence, which is the most common type of urinary incontinence, refers to the involuntary discharge of urine caused by increased pressure from the abdominal press that occurs during exercise, coughing, sneezing, laughing, etc. Despite the fact that many different factors can contribute to the development of incontinence in a stressful situation, it is most prevalent among women 35-65 years old and those who have gone through repeated vaginal births. Stress incontinence is both annoying and unpleasant for women, and it can also cause embarrassment. Many women wear sanitary napkins or diapers to deal with incontinence, although this does not represent a real solution to the problem, and they can be very uncomfortable and unreliable. Surgical treatment may include attaching perurethral tissue to the periosteum of the pubic bone or fascia of the rectus abdominis muscle in order to raise the bladder neck above the pelvic floor and thereby ensure uniform distribution of pressure on the bladder, bladder neck and middle part of the urethra. Recently, a procedure known as “TVT” (“Tension Free Vaginal Tape”) has been developed, in which a mesh tape is implanted under the middle part of the urethra, creating a “hammock” on which the urethra can bend during increased pressure inside the abdominal cavity. However, surgery is only suitable for severe cases, and most women with incontinence do not need surgical solutions and, naturally, would like to better avoid them.

One method of non-surgical treatment involves the use of devices that are inserted into the vagina by either a practitioner or the woman herself. Most devices are designed to provide pressure to the neck of the bladder in order to obstruct the flow or completely block the flow of urine through the urethra. Many different such devices are known in the art. For example, see US publication No. 2002/0183711 in the name of Moser, entitled “Urinary Incontinence Device” (“A device used for urinary incontinence”); U.S. Patent No. 6 739 340 in the name of Jensen et al., Entitled “Device for prevention of involuntary urination” (“Device for preventing involuntary urination”); U.S. Patent No. 6 679 831 in the name of Zunker et al., Entitled “Resilient incontinence insert and method of making the same” (“Resilient incontinence insert and method of manufacture”); U.S. Patent No. 6,460,542 in the name of James, entitled “Female incontinence control device”; U.S. Patent No. 6,413,206 in the name of Biswas, entitled “Intra-vaginal device” (“Intravaginal device”); U.S. Patent No. 5,785,640 in the name of Kresch, entitled “Method for Treating Female Incontinence”; U.S. Patent No. 5,771,899 in the name of Martelly et al. Entitled “Pessary”; US Patent No. 5,618,256 in the name of Reimer entitled “Device for Arrangement in the Vagina for the Prevention of Involuntary Urination with Females and an Applicator for use in Insertion of the Device ”(“ A device intended to be placed in the vagina to prevent involuntary urination in women, and an applicator intended to be used when the device is inserted ”); US Pat. No. 5,417,226 to Juma, entitled“ Female Anti-Incontinence Device ”(US Patent No. 5,386) 836 in the name of Biswas, entitled “Urinary Incontinence Device”; US Patent No. 5,007,894 to Enhorning, entitled “Female Incontinence Device” (Female Incontinence Device) ; and U.S. Pat. No. 4,920,986 to Biswas, entitled “Urinary Incontinence Device”, the descriptions of which are incorporated herein by reference.

One problem with many of the above devices is that they completely block the urethra, and thus they must be removed or compressed in order to allow the woman to urinate. To overcome this drawback, vaginal devices were created that have specialized forms that do not completely overlap the urethra, but these devices tend to be large, uncomfortable, and intrusive. In addition, they tend to cause irritation or pain in the vagina.

Another common disadvantage is that for most devices known in the art, there is also a tendency to cause difficulty or pain when inserted and / or removed. In order to ensure proper obstruction of the flow of urine, the device must be correctly placed in the vaginal canal. As a result, a doctor may be required to ensure proper placement of the device. In most cases, the device is adapted so that it remains in the vagina for a long period of time (due to the time and costs associated with the fact that a trained medical professional is needed to insert the device). However, when the device is in the vagina for a long period of time, it can cause vaginal infections, necrosis, or bleeding.

SUMMARY OF THE INVENTION

A feature of some exemplary embodiments of the invention relates to the creation of incontinence devices with inserts adapted to provide elastic reinforcement for at least a portion of the device. It is possible that the devices used for incontinence are made with support branches. In some exemplary embodiments, the insert is used in combination with support arms of an incontinence device to provide support for the patient urethra. In an exemplary embodiment of the invention, the insert compresses the support branches to radially expand them (radially outward from the center axis of the device) to provide support for the urethra. Perhaps the radial expansion is up to 20% of the previous device profile in the radial direction. Perhaps the radial expansion is up to 50% of the previous device profile in the radial direction. In some embodiments, the radial expansion is more than 50% of the previous device profile in the radial direction. In some exemplary embodiments of the invention, the insert is located where the support arms at the central nodal element of the incontinence device meet. In some exemplary embodiments of the invention, the insert penetrates the central nodal element of the incontinence device. In some exemplary embodiments of the invention, the insert is located on the surface of the device, on the inner surface, which is opposite the vaginal wall.

In an exemplary embodiment, the insert is conical in shape. Optionally, the insert is geometrically closed. Optionally, the insert has a variable geometry. Optionally, the insert has two stable states. Perhaps the insert is an o-ring. Optionally, the insert consists of a plurality of components assembled together with the possibility of separating them from each other. Perhaps at least part of the insert is elastic. In some exemplary embodiments of the invention, the insert is fixed in at least one predetermined position on the incontinence device. In some exemplary embodiments of the invention, the insert is fixed in a predetermined position on the incontinence device, with the possibility of its separation. In some exemplary embodiments of the invention, the insert is mounted relative to the incontinence device so that support and / or pressure is provided for the fixture branches.

In some exemplary embodiments of the invention, the incontinence device is placed at a predetermined position by using an applicator, such as the applicators described herein and in related applications. The incontinence device may be provided with an extraction device designed to remove the device from the vagina after use. In some exemplary embodiments of the invention, an incontinence device is provided with a closure member. Perhaps the support for the urethra is a support for the middle part of the urethra.

In some exemplary embodiments of the invention, the incontinence device is provided with an internal and / or external resilient support member. Preferably, the resilient support member biases the branches of the incontinence device. It is possible that the resilient support element biases the branches of the incontinence device radially outward from the central axis of the incontinence device. It is possible that the resilient support element biases the branches of the incontinence device in a radial direction inward to the central axis of the incontinence device. Preferably, the resilient support member is used at least for the support arms of the incontinence device. It is possible that the resilient support element is used at least for the fastening branches of the incontinence device. The insert may be positioned relative to the incontinence device so that support and / or pressure is provided for the support branches of the device. In some exemplary embodiments of the invention, the support provided by the insert for the device is a support that counteracts the forces acting on the branches from the side of the vaginal wall. In some exemplary embodiments of the invention, the pressure causes the branches to be pushed radially outward from the center axis of the fixture, which causes the fixture to radially expand.

In some exemplary embodiments of the invention, the incontinence device is configured with strain relief arms. Perhaps the stretching is reduced by performing branches with a folding part. In some exemplary embodiments of the invention, the tension reducing arms are folded during storage inside the applicator, however, when “deployed” (positioned), the arms expand to support and / or secure.

A feature of some exemplary embodiments of the invention relates to the implementation of an incontinence device with several stable configurations. In some exemplary embodiments of the invention, the incontinence device is configured with a component that has at least two stable positions. Optionally, a component having two stable positions is provided with a first stable position that does not cause radial expansion of the device, and with at least a second stable position that causes radial expansion of the device. Preferably, the component having two stable positions moves from the first stable position to the second stable position, essentially not moving relative to the incontinence device. It is possible that a component having two stable positions moves from the first stable position to the second stable position by moving relative to the incontinence device. In some exemplary embodiments of the invention, the fixture is configured with an extraction fixture that is capable of changing a second stable position to a first stable position. Perhaps the device is used with a closing element. Perhaps the device is “deployed” (installed in a predetermined position) into the vagina through the use of an applicator.

A feature of some exemplary embodiments of the invention relates to the implementation of an incontinence device that consists of different components with different material properties to provide a specific working profile. For example, in some exemplary embodiments of the invention, an insert for an incontinence device is provided, the insert being partially elastic and / or partially rigid. Perhaps a partially rigid insert is used to provide selective expansion and / or retraction of the support and / or fixing sections of the incontinence device. Preferably, different components with different material properties are used to distribute the forces acting on the incontinence device and / or on the side of the incontinence device. In some exemplary embodiments of the invention, the incontinence device consists of different materials with different material properties to provide an effective treatment for incontinence.

A feature of some exemplary embodiments of the invention relates to the implementation of at least a portion of the incontinence device with elastomechanical radial expansion. In some exemplary embodiments of the invention, the elastic central element provides a force for elastomechanical radial expansion. It is possible that the elastic central element is connected in working position with expanders (which in some embodiments are mechanical, hence the name "elastomechanical"), which cause radial expansion of the device. Perhaps the device is made with support branches that form part of the device, which expands in the radial direction. Perhaps the device is made with fixing branches, which form part of the device, which expands in the radial direction. In some exemplary embodiments of the invention, radial expansion of the incontinence device occurs when the device is expelled from the applicator. In some exemplary embodiments of the invention, the fixture is configured with an extraction fixture that holds the elastic central element from applying force to the expanders, resulting in radial compression of the fixture and / or allowing easier removal of the fixture.

A feature of some exemplary embodiments of the invention relates to the implementation of an incontinence device with an elastomeric ring designed to facilitate radial expansion and / or compression of the device. In some exemplary embodiments of the invention, the elastomeric ring is used in a variety of places relative to the fixture to provide radial expansion and / or compression of the fixture. It is possible that the elastomeric ring slides along the outside of the fixture to take on multiple positions. In some exemplary embodiments of the invention, the forms of the incontinence device and / or the pivot piece help the elastomeric ring to expand and / or contract the incontinence device. In some exemplary embodiments of the invention, the fixture is configured with an extraction fixture that biases the part to provide pivoting, which enables compression of the fixture and / or easier removal of the fixture. In some exemplary embodiments of the invention, the elastomeric ring is a component of an incontinence device having two stable positions. In some exemplary embodiments, the elastomeric ring is not flexible. The elastomeric ring may not be ring-shaped; perhaps it is, for example, square, rectangular, triangular, ovoid or u-shaped.

A feature of some exemplary embodiments of the invention is that at least one tensile member is provided for an incontinence device to create a radial expanding force but not compressive force acting on the device. In some exemplary embodiments of the invention, at least one tensile member extends between a branch of the fixing section and a corresponding branch of the supporting section of the incontinence device. At least one tensile member is optionally flexible. In some exemplary embodiments of the invention, at least one tensile member is stretched before being “deployed” (by placing the device in a predetermined position in the vagina) and during storage in the applicator. It is possible that at least one tensile element is substantially constricted during “deployment”, with the installation creating an expanding force acting on the device used in incontinence and depending on the natural length of the connector in an unstretched state. In some exemplary embodiments of the invention, the at least one tensile member helps counteract the movement of the support section and / or the fixing section after placement of the device in the vagina. Preferably, the flexibility of the support section and / or the fixing section is controlled depending on a predetermined response to at least one tensile element.

A feature of some exemplary embodiments of the invention relates to an incontinence device that coagulates to increase and / or decrease the size of its profile. In some exemplary embodiments of the invention, the incontinence device is folded around its central axis to reduce the diameter of the device. Preferably, the reduced diameter fixture is stored in the applicator prior to “deployment”. In an exemplary embodiment of the invention, when the folded incontinence device is pushed out of the applicator, it is at least partially deployed to increase its diameter to provide support for the patient's urethra. Preferably, the rolled-up device is configured with a plurality of projections to provide support and / or fastening. In some exemplary embodiments of the invention, the fixture is configured such that the branches and / or protrusions of the fixture are mounted on either side of the urethra themselves, either directly during “deployment” or after movement by the user causes a slight rotation of the fixture. Preferably, the folded fixture is cylindrical. Alternatively, the rolled up device has a larger diameter at one end than at the other end.

In an exemplary embodiment of the invention, the incontinence device is configured with a plurality of connected collapsed sections. Preferably, two collapsed sections are provided for the incontinence device. Preferably, the folded sections are connected by a flexible member. In some exemplary embodiments of the invention, a collapsed section is located at each end of the flexible member. Perhaps the folded sections are made with many protrusions to provide support and / or fixing. In some exemplary embodiments of the invention, the folded sections are folded around the central axis of the fixture to reduce their radial profile. Perhaps the device with a reduced radial profile is stored in the applicator. In some exemplary embodiments of the invention, when the incontinence device is “deployed”, the folded sections are deployed to increase their diameter to provide support for the patient urethra. Perhaps support is provided in the middle of the urethra.

A feature of some exemplary embodiments of the invention is related to providing lubrication of at least the outer surface of the applicator. An applicator for administering an incontinence device is preferably provided. It is possible that lubrication is provided through a reservoir ring located around the circumference of the applicator. Preferably, the reservoir ring is porous. The tank ring may be hollow. Preferably, lubrication is provided by means of a layer on the applicator, which is opened upon removal of the closure member. It is possible that the grease is provided by means of a movable sleeve, which is located on the applicator and in which the grease is located. In an exemplary embodiment, the applicator is lubricated prior to administration to the patient's vagina. Preferably, the ring is removed after lubrication, but before administration. It is possible that the sleeve is removed after lubrication, but before insertion. Optionally, an indicator, such as a ring, is used on the applicator to indicate the proper depth of insertion of the applicator to ensure effective deployment of the device. Preferably, the ring allows the applicator to stop physically at the proper depth of insertion of the applicator to ensure effective deployment of the device.

A feature of some exemplary embodiments of the invention relates to the implementation of applicators for increasing shelf life of devices used for incontinence. Perhaps any radially expanding device is used together with applicators, providing an increase in shelf life. In an exemplary embodiment of the invention, the applicator is provided with an expanded section for storing at least the support section of the incontinence device. The expanded section allows the support section to remain at least partially unstressed during storage. Perhaps the central nodal element of the incontinence device is also located in the extended section. It is possible that the expanded section is made with dimensions that enable it to accommodate at least partially expanded branches of the incontinence device. Perhaps the extended section is used to indicate the proper depth of insertion of the applicator to ensure efficient deployment of the device.

In some exemplary embodiments of the invention, the applicator is configured with a plurality of slots adapted and configured to accommodate branches of the incontinence device, such that when the incontinence device is placed inside the applicator, the branches protrude outward and / or not are compressed. Preferably, the movable sleeve is used to place the protruding outward branches in a predetermined position within the applicator in preparation for “deployment”. Preferably, an indicator, such as a ring, is used on the applicator to indicate the proper depth of insertion of the applicator to ensure effective deployment of the device.

A feature of some exemplary embodiments of the invention is to minimize the package size for deploying the incontinence device by reducing the size of the plunger used to deploy (push) the incontinence device from the applicator. In an exemplary embodiment of the invention, a telescopic plunger is provided. Perhaps the plunger is folded. Preferably, the telescopic plunger consists of at least two sections. Preferably, the plunger in the closed state has a size of approximately half its size in the expanded state. In an exemplary embodiment, the ring is located on the plunger to provide friction between the plunger and the applicator as they move relative to each other. Perhaps the ring counteracts the unintentional displacement of the plunger from the applicator.

In an exemplary embodiment of the invention, the applicator is in contact with a central part, such as a nodal element, of an incontinence device to “deploy” (push) it out of the applicator. Preferably, the applicator provides “deployment” (placement at a predetermined position) of the incontinence device by contacting at least one support arm. In one embodiment of the invention, at least a portion of the applicator, such as a plunger, is used to facilitate the installation of the support branch in the deployed position.

Thus, in accordance with an exemplary embodiment of the invention, there is provided an apparatus for treating urinary incontinence, comprising: a support section adapted to provide support for the urethra; a fixing section designed to obstruct the movement of the device; an insert, part of which is adapted to be placed near the support section; and wherein the insert selectively provides at least support for the support section of the device. Preferably, the insert is adapted to create pressure acting on the support section, which causes radial expansion of the support section. Perhaps the support section is flexible. In an exemplary embodiment of the invention, the support section is formed of at least one support branch. Perhaps the insert is an o-ring. Perhaps the insert is made expandable. Perhaps the support for the urethra is a support for the middle part of the urethra. In an exemplary embodiment of the invention, the device further comprises a closure element. Perhaps the insert is conical. Perhaps the insert consists of many elements geometrically linked to each other. Preferably, the insert is formed of at least a support protrusion and a locking protrusion. Perhaps the insert is a reversible membrane. Perhaps the insert is an insert with a ring. In an exemplary embodiment of the invention, the device further comprises an elastic support member. Optionally, the resilient support element biases the at least support section toward the center axis of the device. Optionally, the resilient support element biases the at least support section in a direction away from the center axis of the device. It is possible that the support section and the fixing section are respectively formed of at least two branches. Perhaps the branches are made with a folding part. Preferably, the closure element essentially encapsulates the device (surrounds the device like a shell). Possibly at least the support section and the fixing section are flexible. Perhaps the device is flexible. In an exemplary embodiment of the invention, the device further comprises an extraction device.

Thus, in accordance with an exemplary embodiment of the invention, there is provided an apparatus for treating urinary incontinence, comprising: a support section adapted to provide support for the urethra; a fixing section designed to obstruct the movement of the device; and an insert adapted to provide at least support for the support section, and at least a portion of the insert is elastic. Possibly, the insert is made up of many components assembled together with the possibility of separating them from each other. Perhaps the insert pushes the support section radially outward from the center axis of the device. Perhaps the insert is made with an expanded end that provides radial expansion of the fixing section. In an exemplary embodiment of the invention, the device further comprises a closure element. Perhaps the closure element essentially encapsulates the device. Possibly at least the support section and the fixing section are flexible. Perhaps the device is flexible. In an exemplary embodiment of the invention, the device further comprises an extraction device. Perhaps the support for the urethra is a support for the middle part of the urethra. Optionally, the support section is formed of at least one support branch.

Thus, in accordance with an exemplary embodiment of the invention, there is provided an apparatus for treating urinary incontinence, comprising: a support section adapted to provide support for the urethra; a fixing section designed to obstruct the movement of the device; at least one nodal element with an expander made with at least one expander attached to the device; an elastic element that passes through at least one nodal element with an expander; a removable safety catch provided for the expanded end of the elastic element, which prevents the extended end from passing through at least one nodal element with an expander, and while the elastic element is not substantially stretched, at least one expander provides radial expansion devices. In an exemplary embodiment of the invention, the device further comprises a closure element. It is possible that the closure element essentially encapsulates the nodal element, the support section and the fastening section (surrounds the nodal element, the support section and the fastening section like a shell). Possibly at least the support section and the fixing section are flexible. In an exemplary embodiment of the invention, the device further comprises an extraction device provided for a safety grip. Perhaps the support for the urethra is a support for the middle part of the urethra. Possibly, the support section consists of at least one support branch.

Thus, in accordance with an exemplary embodiment of the invention, there is provided an apparatus for treating urinary incontinence, comprising: a support section adapted to provide support for the urethra; a fixing section designed to obstruct the movement of the device; first groove; an elastomeric ring located on the outer surface of the device inside the first groove; and the elastomeric ring creates a compressive force acting on at least part of the device. Preferably, the elastomeric ring provides a compressive force to the support section to compress the support section in the radial direction. In an exemplary embodiment of the invention, the device further comprises a second groove located between the first groove and the support section. In an exemplary embodiment of the invention, the device further comprises a turning part located in the third groove. Preferably, when “deploying” (setting the device to a predetermined position), the elastomeric ring passes from the first groove into the second groove, causing a radial expansion of the support and fixing sections. In an exemplary embodiment of the invention, the device further comprises an extraction device attached to at least the part to provide rotation. In an exemplary embodiment of the invention, the device further comprises a closure element. Perhaps the support and fixing sections are flexible.

Thus, in accordance with an exemplary embodiment of the invention, there is provided an apparatus for treating urinary incontinence, comprising: a support section adapted to provide support for the urethra; a fixing section designed to obstruct the movement of the device; and a tensile member, wherein the tensile member is attached to the support section and the fixing section and is adapted to provide radial expansion of the device. Preferably, the tensile member is elastic.

Thus, in accordance with an exemplary embodiment of the invention, there is provided an apparatus for treating urinary incontinence, comprising: a support section adapted to provide support for the urethra; and wherein the device is provided with a first stable position and a second stable position, so that when the device is in the second stable position, the support section provides support for the urethra. Preferably, the support section is provided with a plurality of support branches. In an exemplary embodiment of the invention, the device further comprises a component having two stable positions, wherein the component having two stable positions is attached to the support section. Perhaps the component having two stable positions is a flexible membrane. Possibly, a component having two stable positions is a fixing element. Perhaps a component having two stable positions is a ring. In an exemplary embodiment of the invention, the device further comprises a first groove associated with the first stable position and a second groove associated with the second stable position. The ring may be slidable on the outside of the device from the first groove to the second groove. In an exemplary embodiment of the invention, the device further comprises an extraction device. Optionally, the extraction device is attached to a component having two stable positions to change the second stable position to the first stable position.

Thus, in accordance with an exemplary embodiment of the invention, there is provided an apparatus for treating urinary incontinence, comprising: a support section adapted to provide support for the urethra; an insert, wherein the insert comprises a first material that has first material properties, and at least a second material that has second material properties; and the insert provides selective expansion of the support section. Perhaps the first material is flexible. Perhaps the second material is more rigid than the support section.

Thus, in accordance with an exemplary embodiment of the invention, there is provided an apparatus for treating urinary incontinence, comprising: a central nodal element, wherein the central nodal element is a folded sheet; many supporting protrusions located on the nodal element; and many fixing protrusions located on the nodal element. Perhaps the central nodal element, when folded, has a larger diameter at one end than at the other end.

Thus, in accordance with an exemplary embodiment of the invention, an apparatus for treating urinary incontinence is provided, comprising a connector and a plurality of helically folded sections. The connector may be flexible. Preferably, the helically folded sections are formed with a plurality of protrusions to provide support for the urethra. Preferably, the helically folded sections are formed with a plurality of protrusions to provide fastening. Perhaps a plurality of helically folded sections mean two sections. Each of the two sections may be located on the opposite end of the connector.

Thus, in accordance with an exemplary embodiment of the invention, there is provided a device for introducing a vaginal device, comprising: a shell for containing a vaginal device in it; and a lubricating element located outside the shell. Perhaps the lubricating element is a ring located around the circumferential periphery of the shell. Preferably, the lubricating element is a lubricant layer deposited on the shell, which is opened by removing the closing element for the layer. Perhaps the lubricating element is a movable sleeve located around the circumferential periphery of the shell. Perhaps the lubricating element is a layer of lubricant on the shell. Preferably, the grease is highly viscous, so that after the grease is placed on the casing, it generally remains in place until use.

Thus, in accordance with an exemplary embodiment of the invention, a device has been developed for increasing the shelf life of a device inserted into the vagina, comprising: a shell adapted to receive at least the first part of the device and insert it into the vagina; a section adapted to receive at least the second part of the device so that the second part is at least partially expanded. Perhaps the section is an expanding shell. Preferably, the section is made with many slots. Perhaps the slots are made with dimensions and numbering, providing the ability to accommodate the second part of the device. In an exemplary embodiment of the invention, the device further comprises a sliding sleeve located outside the sheath for reinstalling the second part of the device before inserting the device into the vagina.

Thus, in accordance with an exemplary embodiment of the invention, there is provided a device for communicating movement of a device inserted into the vagina, comprising: an outer section adapted to be inserted into the vaginal applicator; and an inner section configured to introduce it into the outer section and move it inside the outer section. In an exemplary embodiment of the invention, the device further comprises a ring, wherein the ring is located on the outer section so that friction is created by the ring when the device is moved relative to the applicator.

Thus, in accordance with an exemplary embodiment of the invention, a telescopic device for introducing a vaginal device is provided, comprising: a sheath for containing a vaginal device in it; and a plunger (ejector), adapted for introducing it into the shell with ensuring alignment. Perhaps the plunger is essentially located inside the shell during storage. Perhaps the insert is provided for the vaginal device. The insert may be attached to the extraction / actuating device. The retrieval / actuation device may be attached to the plunger so that it can be separated. It is possible that moving the plunger outward from the sheath allows the insert to move at least partially through the vaginal device.

BRIEF DESCRIPTION OF THE DRAWINGS

Non-limiting embodiments of the invention will be described with reference to the following description of exemplary embodiments in conjunction with the drawings. The figures of the drawings are generally not shown to scale, and any dimensions should be understood only as exemplary, and not necessarily limiting. In the figures, identical structures, elements or parts that appear on more than one figure are preferably marked with the same or similar number in all the figures in which they appear, in which:

1A is a profile view of an incontinence device with a conical insert in accordance with an exemplary embodiment of the invention;

FIG. 1B is a profile view of an incontinence device with a conical insert during removal of the device in accordance with an exemplary embodiment of the invention;

FIG. 2A is a profile view of an incontinence device with a geometric locking insert in an applicator in accordance with an exemplary embodiment of the invention;

2B is a profile view of an incontinence device with a “deployable” (set to a predetermined position) insert with geometrical fixation in accordance with an exemplary embodiment of the invention;

FIG. 2C is a profile view of an incontinence device with an insert with geometric locking in the extended position in accordance with an exemplary embodiment of the invention;

FIG. 2D is a profile view of an incontinence device with a geometrical insert, showing removal of the device, in accordance with an exemplary embodiment of the invention;

Fig. 3A is a profile view of an incontinence device with a variable geometry insert located in an applicator in accordance with an exemplary embodiment of the invention;

FIG. 3B is a profile view of an incontinence device with a variable geometry insert in an expanded state in accordance with an exemplary embodiment of the invention;

3C is a profile view of an incontinence device with a variable geometry insert during removal in accordance with an exemplary embodiment of the invention;

FIG. 4A is a profile view of an incontinence device with a convertible (“reversible”) insert located in an applicator in accordance with an exemplary embodiment of the invention;

4B is a profile view of an incontinence device with a reversible insert in the expanded state in accordance with an exemplary embodiment of the invention;

4C is a profile view of an incontinence device with a reversible insert during removal in an exemplary embodiment of the invention;

5 is a profile view of an incontinence device with an integrated resilient support member in accordance with an exemplary embodiment of the invention;

6 is a profile view of an incontinence device configured with strain relief arms in accordance with an exemplary embodiment of the invention;

7A is a profile view of a rolled incontinence device in accordance with an exemplary embodiment of the invention;

7B is a profile view of a rolled incontinence device with an expanding proximal end in accordance with an exemplary embodiment of the invention;

Fig. 7C is a top and / or bottom view of a rolled up incontinence device in accordance with an exemplary embodiment of the invention;

Fig.7D is a top view of a rolled up incontinence device in an applicator in accordance with an exemplary embodiment of the invention;

Fig. 8 is a profile view of a connected, double-sided, rolled up incontinence device in accordance with an exemplary embodiment of the invention;

figa is a section of the applicator with a lubricating ring in accordance with an exemplary embodiment of the invention;

figv is a cross section of the applicator with a removable closing element in accordance with an exemplary embodiment of the invention;

figa is a side view of the applicator with a lubricating sleeve in accordance with an exemplary embodiment of the invention;

figv is a cross section of the applicator with a lubricating sleeve in accordance with an exemplary embodiment of the invention;

11A is a cross-sectional view of an applicator and a lightly loaded incontinence device in accordance with an exemplary embodiment of the invention;

11B is a sectional view of an applicator with an expanding proximal end into which an incontinence device is inserted in accordance with an exemplary embodiment of the invention;

figa is a side view of the applicator with slots and with a sliding sleeve in a distal position in accordance with an exemplary embodiment of the invention;

12B is a side view of an applicator with slots and with a sliding sleeve into which an incontinence device is inserted with branches protruding outward from the slots of the applicator in accordance with an exemplary embodiment of the invention;

figs is a section of the applicator with slots and with a sliding sleeve, which is inserted into the device used for incontinence, in accordance with an exemplary embodiment of the invention;

12D is a side view of an applicator with slots and with a sliding sleeve, wherein the sliding sleeve is in a proximal position, in accordance with an exemplary embodiment of the invention;

Fig.13 is a cross section of a telescopic plunger in accordance with an exemplary embodiment of the invention;

figa is a view with a local section of the applicator containing having two stable positions device used for incontinence, in accordance with an exemplary embodiment of the invention;

FIG. 14B is a two-position incontinence device in an expanded configuration in accordance with an exemplary embodiment of the invention;

Fig. 15A is a sectional view of an incontinence device with an o-ring insert in accordance with an exemplary embodiment of the invention;

15B is a sectional view of an incontinence device with a removable o-ring insert in accordance with an exemplary embodiment of the invention;

figs and 15D are top views of an exemplary configuration of the insert in the form of a sealing ring in accordance with an exemplary embodiment of the invention;

Fig. 16A is a sectional view of an incontinence device with a plurality of components assembled together with the possibility of separating them from each other, in storage configuration in accordance with an exemplary embodiment of the invention;

Fig. 16B is a sectional view of an incontinence device with a plurality of components assembled together with the possibility of separating them from each other, in an expanded configuration in accordance with an exemplary embodiment of the invention;

Fig. 16C is a sectional view of an incontinence device with a plurality of components assembled together with the possibility of separating them from each other, in a configuration when removed in accordance with an exemplary embodiment of the invention;

Fig.16D is a cross-section of an alternative incontinence device with a plurality of components assembled together with the possibility of separating them from each other, in an expanded configuration in accordance with an exemplary embodiment of the invention;

17A is a sectional view of an incontinence device with a plurality of components assembled together with the possibility of separating them from each other, including the elastic component, in storage configuration in accordance with an exemplary embodiment of the invention;

FIG. 17B is a sectional view of an incontinence device with a plurality of components assembled together with the possibility of separating them from each other, including the elastic component, in an expanded configuration in accordance with an exemplary embodiment of the invention;

17C is a sectional view of an incontinence device with a plurality of components assembled together with the possibility of separating them from each other, including the elastic component, in a configuration when removed in accordance with an exemplary embodiment of the invention;

Fig. 17D is a cross-section of an alternative incontinence device with a plurality of components assembled together with the possibility of separating them from each other, including an elastic component, in an expanded configuration in accordance with an exemplary embodiment of the invention;

Fig. 18A is a sectional view of an deployed incontinence device using a trapezoidal locking insert in accordance with an exemplary embodiment of the invention;

Fig. 18B is a sectional view of an incontinence device using a trapezoidal locking insert shown in the process of its removal in accordance with an exemplary embodiment of the invention;

FIG. 19A is a sectional view of an expandable elastomechanically incontinence device in storage configuration in accordance with an exemplary embodiment of the invention;

FIG. 19B is a sectional view of an expandable elastomechanically incontinence device in an expanded configuration in accordance with an exemplary embodiment of the invention; FIG.

FIG. 19C is a sectional view of an expandable elastomechanically incontinence device in a configuration when removed in accordance with an exemplary embodiment of the invention;

Fig. 20A is a sectional view of an incontinence device and configured with an elastomeric ring in storage configuration in accordance with an exemplary embodiment of the invention;

FIG. 20B is a sectional view of an incontinence device and configured with an elastomeric ring in an expanded configuration in accordance with an exemplary embodiment of the invention;

Fig. 20C is a sectional view of an incontinence device and made with an elastomeric ring in a configuration when removed in accordance with an exemplary embodiment of the invention;

Fig. 20D is a sectional view of an alternative incontinence device with an elastomeric ring in an expanded configuration in accordance with an exemplary embodiment of the invention;

Fig. 20E is a cross-section of an alternative incontinence device and configured with an elastomeric ring in a configuration when removed in accordance with an exemplary embodiment of the invention;

20F-I are cross-sectional views of alternative inserts that may be used with the incontinence devices described herein in accordance with an exemplary embodiment of the invention;

21A is a sectional view of an incontinence device and configured with dimensionally adjustable connectors in storage configuration in accordance with an exemplary embodiment of the invention;

21B is a cross-sectional view of an incontinence device and configured with dimensionally adjustable connectors in an expanded configuration in accordance with an exemplary embodiment of the invention;

figa is a cross section of an exemplary branch configuration in accordance with an exemplary embodiment of the invention;

FIG. 22B is an exemplary sectional view of an incontinence device in accordance with an exemplary embodiment of the invention; FIG.

figs is a cross section of an exemplary branch configuration in accordance with an exemplary embodiment of the invention;

figa is a cross-section of the device used in incontinence and made with the support section in the form of a leaf spring, in accordance with an exemplary embodiment of the invention;

23B is a cross-sectional view of an deployed incontinence device and configured with a support section in the form of a leaf spring, in accordance with an exemplary embodiment of the invention;

Fig is a cross section of the applicator with a lubricating layer in accordance with an exemplary embodiment of the invention; and

figa is a section of the applicator with slots and with a sliding sleeve in a distal position in accordance with an exemplary embodiment of the invention;

figv is a cross-section of the applicator with slots and with a sliding sleeve in the filling position in accordance with an exemplary embodiment of the invention;

figs is a cross-section of the applicator with slots and with a sliding sleeve in a position close to the deployed position, in accordance with an exemplary embodiment of the invention;

figa is a cross section of a telescopic (folding) applicator in a folded configuration in accordance with an exemplary embodiment of the invention;

figv is a cross section of a telescopic applicator in an expanded configuration in accordance with an exemplary embodiment of the invention;

27A is a profile view of an incontinence device with an expandable insert in an expanded configuration in accordance with an exemplary embodiment of the invention;

27B is a profile view of an incontinence device with an expandable insert in configuration when removed in accordance with an exemplary embodiment of the invention;

Fig. 28A is a profile view of an incontinence device with an insert with a ring in storage configuration in accordance with an exemplary embodiment of the invention;

28B is a profile view of an incontinence device with an insert with a ring in an expanded configuration in accordance with an exemplary embodiment of the invention; and

figs is a perspective view of an insert with a ring in accordance with an exemplary embodiment of the invention.

DETAILED DESCRIPTION AS AN EXAMPLE

OPTIONS FOR IMPLEMENTATION

Introduction

On figa shows a profile view of an exemplary embodiment of the device 100 used for incontinence. In an exemplary embodiment of the invention, fixture 100 is arranged around a central axis 150 and is divided into three parts. Perhaps the device has more or less parts. An upper section 106 is provided, which serves as a “fastening” (anchor) element designed to ensure the stability of the device inside the vagina. There are two types of pinning, namely axial pinning, which acts in the direction along the central axis of the vagina, and radial pinning, which acts in the lateral direction or essentially perpendicular to the central axis of the vagina. A lower section 110 is provided which serves as a “support” member and is intended to provide support for the urethra. In some embodiments of the invention, the support is created in place in the middle of the urethra. In some embodiments of the invention, the lower support section 110 provides at least one type of fastening in order to help secure the fixture 100 in a predetermined position. In some embodiments, the full length of the fixture 100 is from 30 mm to 50 mm, possibly the fixture 100 is larger or smaller depending on the individual needs of the patient. In some exemplary embodiments of the invention, the various sections, parts, and / or elements described are possible. In some exemplary embodiments of the invention, functions that perform various sections, parts and / or elements are possible.

In some exemplary embodiments, a central section 108, or nodal element, is provided, which (s) optionally connects the fastening 106 and the supporting 110 elements. The nodal element 108 of this and many other devices described herein has a length that is only a small part of the total length of the device in some embodiments of the invention. In some embodiments, the length of the nodal element is less than 15% of the total length of the fixture. In some embodiments, the length of the nodal element is less than 20% of the total length of the fixture. In other embodiments of the invention, the length of the nodal element is less than 30% of the entire length of the device. In an exemplary embodiment, the entire device is up to 75 mm long. Perhaps the length of the entire device is up to 60 mm. Perhaps the length of the entire fixture is 50 mm. In some exemplary embodiments of the invention, the entire device is at least 30 mm long. In some embodiments of the invention, the nodal element, which is short relative to the full length of the fixture, provides greater flexibility by varying the stiffness, comfort and size of the fixture 100. Perhaps the nodal element is made with one axis, the length of which does not exceed the length of the other axis, while the axes have equal length (for example, like a sphere or cube). In an exemplary embodiment of the invention, the nodal element, small relative to the full length of the fixture, allows a greater degree of regulation of the properties of the fastening and supporting branches described below. This is due to the fact that the full length of the device is to some extent determined by the “topography” (geometric shape of the surface) of the vagina. If, for example, the central nodal element constituted a significant part of the total length of the device, the branches would be short in length and would be located at an angle to the central nodal element close to 90 °. This configuration does not have the advantage of making it possible to take advantage of the flexibility that is possible with longer branches located at a smaller “installation” angle relative to the central node.

In some exemplary embodiments of the invention, a closure 120 is provided for the fixture 100, described in more detail below. Elements of tool 100 may function as an internal support structure for cover member 120. Perhaps the tension of cover member 120 is increased by branches of tool 100.

In an exemplary embodiment, the securing element 106 and the supporting element 110 each have four (4) branches or groups of branches, respectively 112 and 114. In the exemplary embodiment, four branches are provided for each section, of which two essentially protrude towards the bladder and two essentially protrude towards the bottom of the vagina near the intestines. Two support branches that extend toward the bladder enter natural grooves on both sides of the urethra in some embodiments of the invention. It is possible that the fastening and supporting elements are provided with a larger or smaller number of branches. For example, the fastening element may have more branches if there is concern about the undesired movement of the device 100. In other embodiments, the branches are provided at different angles with respect to the node element 108 and / or one another. Possibly branches 112 and 114 are flexible or rigid and are formed from a biocompatible material. Perhaps each of the branches is characterized by an individual reaction to the forces acting on them from the side of the vaginal wall, like an independent suspension in a car. It is possible that each of the supporting branches functions separately to provide support for the urethra. It is possible that cushioning elements adapted for contact are provided for branches where they are most likely to come into contact with the wall of the vagina of the user, in order to increase the contact surface area and, therefore, increase the comfort for the wearer. Gasket elements also reduce the likelihood of necrosis due to the reduced pressure arising between the device and the vaginal wall, as a result of an increase in the contact surface area between the device and the vaginal wall. In an exemplary embodiment of the invention, the fastening element does not cause significant pressure to be applied to the vagina and / or urethra of the wearer, thereby increasing comfort.

In some embodiments, another design is provided in place of the branches, which is capable of supporting the urethra in the case of the supporting section or preventing the device from being unintentionally displaced in the case of the fixing section. For example, at least one cone, a protrusion and / or a protruding part attached to the nodal element can be used to secure and provide support.

The fixture fixing branches prevent the device from being unintentionally displaced from a predetermined position. In an exemplary embodiment of the invention, the branches 112 of the fastening element counteract the movement of the device towards the uterus, since the angle at which the branches are located relative to the node element 108 increases. This actual increase in radius serves to counteract the movement of the device further into the vagina. In some embodiments of the invention, the branches 112 of the fastening element are designed so that they are located at a large angle relative to the nodal element to enhance this effect of fastening. It should be noted that this effect of reinforced fixing is observed only until the maximum angle is reached. The narrowed nodal element 108 provides increased flexibility and increased possible ranges of movement of the entire device 100 in some embodiments of the invention. It is possible that devices such as wires and / or springs are embedded in a tapered portion to increase the flexibility of the device 100. This additional flexibility can provide increased comfort for a woman to wear the device 100. Perhaps the additional flexibility of the device 100 allows for more convenient bowel movements than devices of the prior art. Any of the embodiments described herein, if required, is used in conjunction with a narrowed nodal element 108.

Although the branches are flexible, it should be noted that they are stiff enough to prevent unwanted movement of the device towards the entrance of the vagina. Perhaps the branches are rigid, but the nodal element is flexible, therefore, the nodal element provides flexible fastening and support. The movement towards the vaginal opening is prevented by branches which themselves are inserted into the vagina towards the cervix and which, in some exemplary embodiments of the invention, are held in place by pressure acting on them from the side of the vaginal wall, see, for example, description "Pulling" below. These elements (signs) “work” regardless of the “pulling” property or together with the “pulling” property of the vaginal walls, described below, which also helps to keep the device in place.

An additional feature of the fixing branches of the fixture 100 is that they operate at a distance from the support branches. This allows you to reduce the amount of pressure applied to the urethra from the side of the device, since in some exemplary embodiments of the invention, the support branches do not have to perform fixing functions in addition to providing support. Perhaps the support for the urethra is a support for the middle part of the urethra. Such a configuration increases the comfort for the wearer, prevents unnecessary tissue damage near the device, strengthens the function of securing the device, and in some possible embodiments of the invention allows the wearer to empty the bladder in a natural way without having to remove the device for urination.

The branches 112 of the fastening element 106 cause the device 100 to remain in place inside the vagina, essentially making it impossible to move in or out or rotate. One reason this happens is due to the particular tendency of the vaginal wall to contract and form a closed lumen. The branches of the device cause the walls to “stretch” above them, as a result of which the walls sag around the node element 108, thereby ensuring the stability of the device 100. The branches 114 of the support element 110 cause a relative rise of the tissues around the middle part of the urethra, acting as a “hammock”. This hammock serves as a support for the middle part of the urethra without creating tensile stress, much like the work of TVT (free of tensile stress, vaginal tape). In a woman who secretes urine during a state of tension (when pressure in the abdominal cavity rises during coughing, sneezing, etc.), the urethra sags down, but encounters a “hammock” in its middle part. "Collision" of the urethra and hammock causes an increase in pressure inside the urethra, resulting in retention of urine. In some embodiments of the invention, the diverging support branches 114 of the fixture 100 create a situation in which the "diameter" of the entire fixture in the radial direction inside the vaginal cavity will be from 25 mm to 50 mm. Perhaps the diameter will be larger or smaller depending on the individual needs of the patient.

It should also be noted that for some women, the devices described herein may also be used as agents for treating prolapse. For example, branches that are expanded to a specific radius for the treatment of incontinence, if required, can be expanded to a larger radius for the treatment of prolapse. For example, configurations for treating prolapse may have a diameter of up to 100 mm.

Various embodiments of an incontinence device are described herein, many of which use inserts that facilitate radial expansion of the incontinence device. It should be noted that many of these inserts may have many break positions that correspond to many configurations of incontinence devices. Certain positions may be selected depending on the needs of the patient. In addition, despite the fact that certain terminology is used (for example, “fastening” and “support”), it should be understood that these terms are intended only to provide ease of reference, and in some embodiments of the invention, the “fastening” section can be used to providing support for the urethra and / or vice versa.

Exemplary fixtures with an insert

for the treatment of incontinence

In some exemplary embodiments of the invention, the branches are made so that they are deflected toward the central axis of the fixture 100. It is expected that in such an embodiment, storage (for example, storage in an applicator, such as described below) in a compressed configuration creates less stress in fixture 100 than if it were made with branches rejected to form an extended configuration. Branches may be placed in an expanded configuration during or after the “deployment”, for example, by using the inserts described herein. It is contemplated that in an exemplary embodiment of the invention, removing (removing) the insert causes the branches to return to a compressed state to allow easy removal from the user's vagina. Many of the exemplary incontinence devices described and described herein are possibly made with fastening and / or supporting elements (e.g. branches) deflected (displaced) to form a compressed, non-deployed configuration.

1A-B, 2A-D, 3A-C, 15A-D, 16A-D, 17A-D, 18A-B, 23A-B, 27A-B and 28A-C show various exemplary embodiments inserts that may be used with the incontinence device. The inserts are typically used to provide additional support for the support branches, counteracting the pressure acting on the support branches from the side of the vaginal wall and / or during radial expansion. In addition, removable inserts, such as those described herein, enable incontinence devices to provide effective treatment for incontinence while avoiding some of the storage stresses that would normally occur in devices that provide such effective treatment. In an exemplary embodiment of the invention, storage stresses are avoided since the insert is stored in a non-deployed position, and this non-deployed position does not create pressure on the support arms corresponding to the level of pressure in the treatment. It should be understood that the inserts and configurations of devices described with reference to FIGS. 1A-B, 2A-D, 3A-C, 15A-D, 16A-D, 17A-D, 18A-B, 23A-B, 27A-B and 28A-C are provided by way of example only and that various configurations may be used depending on the needs of the patient. For example, the insert may be configured in such a way as to allow the support branches to be clamped to different diameters with radial expansion, measured from the center axis of the fixture. It is possible that the insert is provided with a plurality of fixation positions so that it can be locked onto the fixture, with each fixation position corresponding to a slightly different configuration of the fixture, such as diameter during radial expansion.

In the exemplary embodiment of the invention shown in FIG. 1A, the incontinence device 100 is provided with a conical insert 118. The conical insert 118 is designed so that when inserted into the conical recess 122 located in close proximity to to the nodal element 108, the conical insert 118 provides the application of radial pressure acting outward to the support branches 114, thereby causing them to diverge and provide support for the urethra. Perhaps the conical insert 118 is inserted into the conical recess 122 when "deployed" from the applicator, by means of pressure from the plunger. Optionally, the conical insert 118 is pre-installed in the conical recess 122 before being “deployed”. Possibly, the varying dimensions of the conical insert 118 are used depending on the “span” desired for the support branches 114.

In an exemplary embodiment of the invention, the conical insert 118 inserted into the conical recess 122 is fixed therein so that it can be removed by friction and / or pressure. Friction is created between the outer surface of the conical insert 118 and the surface of the conical recess 122 facing the conical insert 118. This friction counteracts the movement of the conical insert 118 from the conical recess 122, especially when pressure is applied to the conical insert 118 from the side of the support branches 114. B an exemplary embodiment of the invention, the pressure acting on the conical insert 118 from the side of the support branches 114, ultimately due to the pressure acting on fixture 100 from the side of the vaginal wall.

In some exemplary embodiments of the invention, the tapered insert 118 is made of any material capable of providing outward support branches 114. Perhaps the device 100 is located under the middle part of the urethra to provide support for it. Perhaps any of the devices described here provides support for the middle part of the urethra. The conical insert 118 may be made of the same material as the fixture 100. The conical insert 118 may be made of a harder and / or stiffer and / or denser material than the fixture 100 to provide increased back pressure resistance side of the vaginal wall. In some exemplary embodiments, retrieval device 116, such as a cord, is attached to conical insert 118.

FIG. 1B shows a profile view of an incontinence device 100 with a tapered insert 118 during removal of the device 100 in accordance with an exemplary embodiment of the invention. In some embodiments, the application of a force acting in the downward direction, that is, a force acting in the direction from the cervix, biases the conical insert 118 from the conical indentation 122. As soon as the support provided for the support branches 114 is removed by removing the conical insert 118, there is the possibility of easier displacement of the support branches 114 towards each other and to the Central axis 150, which contributes to an easier and / or more convenient removal of the device 100 than that taking into account that the branches 114 would be fully deployed when reinforced by the conical insert 118. Perhaps the conical insert 118 remains inside the closure element 120 when separated from the conical notch 122. Perhaps, additionally or alternatively, the extraction device is attached to the closure element 120, with this application of downward force to the extraction device causes the closing element 120 to flatten on the support branches 114, which causes them to shift towards the center cial axis 150 and, therefore, causes a decrease in the radial profile of device 100 for easier removal.

2A shows a profile view of an incontinence device 200 with an insert 202 with geometric locking in accordance with an exemplary embodiment of the invention. Tool 200 is slightly different from tool 100 in that it may consist of more than one part. The addition of at least one additional part enables the part of the insert to be fixed relative to the device 200 and to remove the part of the insert in order to facilitate the removal of the device 200. In addition, in some exemplary embodiments, the outer ring 206 of the device 200 is configured to introducing it between the supporting branches with mechanical fixation. The fixture 200 is shown in the applicator 204, which, if required, can be used to "deploy" the fixture 200 (placing the fixture 200 in a predetermined position) in the vagina. In some exemplary embodiments of the invention, fixture 200 is comprised of multiple components. Possibly, an outer ring 206 is provided, which is adapted to fix it in a groove 208 located on the inner surfaces of the support branches 210. Possibly, many grooves are located on the inner surfaces of the support branches 210, while the outer ring 206 is pushed from the groove into the groove until until the desired radial expansion of the support branches 210 is achieved. Perhaps an inner insert 212 is provided that is geometrically mateable with the inner surface of the outer ring 206 that That the inner insert 212 may be inserted through the outer ring 206. Perhaps more than the outer ring 206 and inner shell 212 comprise an insert 202 with a geometric locking. Possibly, a connecting device 214 is provided that provides for holding the inner insert 212 in close proximity to the outer ring 206 with an orientation suitable for introducing the inner insert 212 through the outer ring 206.

In an exemplary embodiment, the device 200 is stored in the applicator 204 in a partially assembled state, such as that shown in FIG. 2A. In some exemplary embodiments of the invention, holding the fixture 200 in a partially assembled state, especially when the outer ring 206 is not locked in the groove 208, provides a fixture adapted to better withstand storage stresses when not in use , which creates the possibility of longer storage and / or increased efficiency of the device 200. "Deployment" of the device 200 is illustrated in figv, while the internal Application 212 is urged through the outer ring 206 by a plunger 216 (shown in Figure 2A) in the exemplary embodiment. When the inner insert 212 is brought into contact with the outer ring 206, the outer ring 206 is displaced toward the groove 208 due to pressure on the plunger 216, which continues to act towards the cervix. The fixture 200 is finally fixed in the groove 208, which in turn causes the support arms 210 to radially outwardly move to the deployed position, resulting in a predetermined support tensile force, in an exemplary embodiment of the invention.

2C illustrates a fixture 200 when deployed in accordance with an exemplary embodiment of the invention. You can see that the outer ring 206 is fixed in the groove 208, which is given such a shape that corresponds to a predetermined profile of the outer ring. Possibly, a plurality of grooves are made in which the outer ring 206 can be inserted, each groove defining a different configuration of the device 200. Perhaps the outer ring 206 is made in such a way as to avoid improper use, for example, with grooves for accommodating support branches 210. The inner insert 212 is located inside the outer ring 206 with the possibility of its extraction. Possibly, the inner insert 212 is held in place by frictional forces between the outer ring 206 and the inner insert 212. Possibly, the inner insert 212 is held in place by compressive forces acting from the side of the support branches 210.

2D is a profile view of the fixture 200 showing the removal of the fixture 200, in accordance with an exemplary embodiment of the invention. Removing the fixture 200 is possibly accomplished by pulling the fixture 218 to retrieve away from the cervix. The retrieval device 218 may be attached to the inner insert 212. Additionally, or the retrieval device 218 may be attached to the device 200. Sufficient force acting on the retrieval device 218 away from the cervix causes the inner insert 212 to move from the outer ring 206 to in accordance with an exemplary embodiment of the invention. In an exemplary embodiment of the invention, sufficient force is such that it is sufficient to bias the inner insert 212 from a position where it is set to frictionally fit in the outer ring 206, taking into account at least the pressure exerted on the inner insert 212 from the side the walls of the vagina through the device 200 and the outer ring 206. Once, at least partially, the flexible outer ring 206 is no longer reinforced by the inner insert 212, it will be possible to displace about pore branches 210 towards each other and to the central axis of the tool 200, which makes it easier and / or more convenient to remove the tool 200. Perhaps the closure element is used with the attachment 200. In an exemplary embodiment, the closure element also contribute to the displacement of the support branches 210 towards each other and towards the central axis during extraction. The retrieval device may be attached to the closure element.

FIG. 3A shows an incontinence device 300 with a variable geometry insert 302 in accordance with an exemplary embodiment of the invention. In some exemplary embodiments of the invention, the fixture 300 differs from the fixture 100 and fixture 200 in that the variable geometry insert 302 extends along the entire length of the central nodal member of fixture 300 rather than being substantially within the boundaries of the support section. A variable geometry is attached to the insert 302 to provide at least three basic functions with respect to the fixture 300. First, a distal protrusion is used to prevent the insert 302 from being pulled out of the fixture 300 from the proximal side of the fixture 300 in an exemplary embodiment of the invention. Secondly, the locking protrusion 316 is used to fix the insert 302 relative to the fixture 300 when they are in the expanded state, in accordance with an exemplary embodiment of the invention. Thirdly, a support protrusion is used to provide support for the support branches of the fixture 300 in accordance with an exemplary embodiment of the invention.

In an exemplary embodiment, the device 300 is shown in an applicator 304 adapted to “deploy” the device 300 into the vagina to support the urethra. Perhaps the support for the urethra includes support for the middle part of the urethra. Perhaps the fixture 300 is used with the closure 306. In an exemplary embodiment, a plunger 308 is provided for the proximal end of the applicator 304 to facilitate deployment of the fixture 300, with the proximal end pointing toward the vaginal opening and the distal end pointing toward the cervix . Perhaps there are only two separate protrusions. In an exemplary embodiment, at the distal end of the insert 302, the distal protrusion 310 is located in a recess located at the convergence of the fixing branches 312. Perhaps the distal protrusion 310 is adapted and configured to counteract the passage, possibly preventing the passage of the entire insert 302 to the direction from the cervix through the channel 314, which passes through the device 300 and in which the insert 302 is placed. The locking protrusion 316 may be located between the distal and proximal ends in the flange 302 and, in accordance with some exemplary embodiments of the invention, is configured to fit with a locking recess 318 located in the channel 314. The support protrusion 320 is located at the proximal end of the insert 302 in the exemplary embodiment inventions. In some exemplary embodiments of the invention, fixture 300 is a fixture with several stable configurations, such as those described below.

FIG. 3B illustrates an incontinence device 300 in an exemplary deployed configuration in which the insert 302 is moved forward along the channel 314 so that the locking protrusion 316 is locked into the locking recess 318 so that it can be removed. In some exemplary embodiments of the invention, the locking protrusion 316 and / or the locking recess 318 are located at a sufficient distance from the support protrusion 320, so that when they are in the locked position with the possibility of release, the support protrusion 320 is in the position in which it provides reinforcement of the support branches 322. In an exemplary embodiment of the invention, the support protrusion 320 provides a clamping of the support branches 322 radially outward to a predetermined position of possibly dependent on the shape of the support collar 320. It is possible, reference branch 322 provides a support for the middle portion of the urethra.

Removing the fixture 300 may be accomplished by unlocking the insert 302 and removing it from the locking recess 318 and displacing the support protrusion from its “deployed” position at the convergence of the support arms 322. It is possible to remove the fixture 300 used for incontinence by pulling to the extraction device 324 shown in FIG. 3C, in a direction 326 from the cervix. In an exemplary embodiment of the invention, sufficient force applied to the extraction device 324 causes the locking protrusion 316 to be displaced from the locking recess 318, thereby locking the protrusion 316 and allowing the insert 302 to be moved toward the vaginal opening. In an exemplary embodiment of the invention, the distal protrusion 310 stops the downward movement of the insert 302 when it reaches a recess corresponding to the convergence of the fixing branches 312, since it is larger than the channel 314. A force that continues to act downwardly on the fixture 324 for removal, allows the extraction device 300 to be removed from the vagina, since the extraction device 324 is attached to an insert 302 that cannot be removed from the device 300. Optionally or additionally, the retrieval device 324 is attached to the closure member 306. Optionally, the retrieval is facilitated by the closure member 306, which allows the support arms 322 to be pulled toward the center axis of the implement 300, which allows easier and / or more comfortable retrieval.

15A, the incontinence device 1500 is shown in an unfolded position, with the device 1500 provided with an o-ring-shaped insert 1502, examples of which are shown in more detail in FIGS. 15C and D, in accordance with an exemplary embodiment the implementation of the invention. In some exemplary embodiments of the invention, the insert 1502 in the form of an o-ring is disposed so that it can be removed in at least one groove 1504 located on the surface of the support branches 1506, shown more clearly in FIG. 15, opposite the vaginal wall and adapted to receive the insert 1502 in the form of an o-ring and hold the insert 1502 there with the possibility of removal during use of the incontinence device 1500. In use, the support branches 1506 of the incontinence device 1500 are pressed radially outward by means of an insert 1502 in the form of an o-ring to provide support for the urethra. Perhaps supporting branches 1506 provide support for the middle part of the urethra. In some exemplary embodiments of the invention, an incontinence device 1500 is provided with a closure 1508 that functions similarly to the other closures described herein. In some exemplary embodiments of the invention, the o-ring insert 1502 is not located in the groove 1504 prior to deployment of the incontinence device 1500 into the vagina and is placed therein during deployment by using, for example, a plunger, such as described in connection with other embodiments.

15B shows a cross section of an incontinence device 1500 during removal in accordance with an exemplary embodiment of the invention. In some exemplary embodiments of the invention, to facilitate removal of the incontinence device 1500, the extraction device 1510 is used to bias the insert 1502 in the form of a sealing ring from the groove 1504. The extraction tool 1510 is attached to the insert 1502 in the form of a sealing ring and, furthermore, possibly attached to the incontinence device 1500 to enable the extraction device 1510 to facilitate removal iju device 1500, an incontinence, vaginal discharge, in which it is used, and / or to prevent the situation in which loose objects are freely movable within the body of the user. In some exemplary embodiments, the retrieval device 1510 is attached to the incontinence device 1500 by “threading” a portion of the retention device 1510 through the central assembly of the incontinence device. In some exemplary embodiments of the invention, the enlarged portion 1512 is used to prevent the extension device 1510 from being pulled out through the central assembly during removal. The force exerted on the retrieval device 1510 away from the user's cervix will lead to the displacement of the insert 1502 in the form of an o-ring from the fixture 1500 and ultimately to the displacement of the entire incontinence device 1500 from the vagina in some exemplary embodiments the implementation of the invention.

In some exemplary embodiments of the invention, an insert 1602, which is at least partially elastic, is provided for the incontinence device 1600, as shown in FIG. 16A. Fig. 16A shows an incontinence device 1600 in storage configuration, for example, in such a position if the device 1600 were in the applicator. In the storage configuration, the elastic component of the insert 1604 is stretched so that it has a longer length than the fixture 1600, as shown in FIG. 16A. With this configuration, the conically expanded configuration of the insert 1602 does not cause a significant radial expansion of the support 1608 and / or the fixing branches 1610 of the tool 1600 as shown in FIG. 16B. This is mainly due to the extensibility of the elastic component 1604 of the insert, which allows the insert 1602 to remain outside the "area" of the supporting 1608 and / or the fixing branches 1610 of the device 1600.

In some exemplary embodiments of the invention, the insert 1602 consists of a plurality of components, for example, an elastic insert component 1604 and an additional internal insert component 1606. In some exemplary embodiments, the inner insert component 1606 is configured to mate with the elastic insert component 1604 so that they can be separated from one another. The inner insert component 1606 may have material properties different from the material properties of the elastic insert component 1604, for reasons disclosed below. In an exemplary embodiment, the elastic insert component 1604 and the internal insert component 1606 are used in combination to provide radial expansion of the support arms 1608 and the support arms 1610 of the incontinence device 1600 during “deployment”. In some exemplary embodiments, the inner insert component 1606 is attached to the elastic insert component 1604 by a cord that extends the entire length of the elastic insert component 1604 within it and which is attached to the elastic insert component 1604 with the expanded end 1612 on the fastening side of the fixture 1600. Possibly, the expanded end 1612 is a knot formed by forming a knot on the cord and / or melting the cord. It should be noted that in some exemplary embodiments of the invention, the cord should be long enough to allow stretching of the elastic component of the insert 1604, which cup-like covers the inner component 1606 of the insert, so that it becomes longer than the device 1600.

16B, an incontinence device 1600 is shown in an expanded configuration in accordance with an exemplary embodiment of the invention. When the fixture 1600 is deployed from the applicator, the support 1608 and branch fixing 1610 can expand freely in the radial direction. In an exemplary embodiment of the invention, this freedom of movement is sufficient to allow the stretched insert 1602 to return to its nominal (initial) state. The insert 1602 is pulled together, causing the conically extending fastening end 1614 of the elastic insert component 1604 to force the fixing branches 1610 radially outwardly and force the expanding inner insert component 1606 located within the elastic insert component 1604 to force the supporting branches 1608 to radially outwardly shift when they are compressed towards the center of the fixture 1600. In some exemplary embodiments of the invention, the morning insert component 1606 is held within the elastic insert component 1604 due to friction between the two components. In some exemplary embodiments, the elastic insert component 1604 is formed with a small protrusion around its opening, which helps to hold the internal insert component 1606 within the elastic insert component 1604. In such an embodiment, the protrusion is not sufficient to withstand the forces exerted upon extraction acting on the inner insert component 1606, as described below, as a result of which the inner insert component 1606 is released and the fixture 1600 can be removed.

Fig. 16C shows an exemplary configuration of an incontinence device 1600 when removed in accordance with an exemplary embodiment of the invention. The offset of the inner insert component 1606 may be achieved by applying a pulling force to the extraction fixture 1616 to facilitate removal of the fixture 1600, in some exemplary embodiments of the invention. The offset of the inner component 1606 of the insert leads to a decrease in the outward radial force acting on the support branches 1608, which allows the return of the support branches 1608 to a nominal, less expanded state for easier extraction. In some exemplary embodiments of the invention, the support branches 1608 compress the elastic component 1604 of the insert, causing it to deform when the support branches 1608 return to their nominal state. As with the other incontinence devices described here, the force exerted on the extraction device 1616 away from the user's cervix causes the internal insert component 1606 to move, and the force that continues to act ultimately allows the device 1600 to be removed from the vagina. In some exemplary embodiments of the invention, fixture 1600 is provided with a closure 1618.

In the alternative embodiment shown in FIG. 16D, the incontinence device 1600 is provided with a composite central nodal element. Perhaps the contact surface in the joint is similar to the contact surface in the ball joint. In some exemplary embodiments of the invention, the composite nature of the central nodal element causes the fixing section 1620 and the supporting section 1622 of the tool 1600 to move to some extent independently due to the loads applied to them due to the movement of the carrier. In some exemplary embodiments of the invention, the support section 1622 and the fixing section 1620 are held to provide their friction causing relative position by the elastic insert component 1604.

It should be noted that in some exemplary embodiments of the invention, such as those shown in FIGS. 16 and 17, at least a portion of the incontinence device consists of more than one material. The insert may be made up of more than one material. In some exemplary embodiments of the invention, the insert is made of a first material that is at least partially flexible and / or a second material that is rigid enough to allow the support section of the incontinence device to expand when it is in the proper position to accomplish this. In some exemplary embodiments of the invention, the insert is at least stiffer than the support section of the incontinence device. In an exemplary embodiment, the first material is used for the elastic insert component 1604 and / or the second material is used for the internal insert component 1606. The selection of various materials may be based on the goals of the functioning of the incontinence device. For example, stiffer material may be used for the elastic insert component 1604 if, when removing the internal component 1606 of the insert, it is desirable that the support section still remain at least partially expanded. Perhaps a less rigid material is used for the inner component 1606 of the insert if it is desired to increase comfort for the wearer and / or reduce the degree of radial expansion of the device.

On figa-C shows the device 1700 used for incontinence, which also has an insert 1702, which is essentially a plurality of components assembled together with the possibility of separation from each other. The difference between the incontinence device 1700 shown in FIG. 17 and the incontinence device 1600 and shown in FIG. 16 is that the fastening end 1704 of the insert 1702 is not widened by the cone to cause radial expansion of the fastening branches 1706. Since, in an exemplary embodiment, the fastening end 1704 of the insert 1702 is not expanded to a cone, it should not be outside the fastening branches 1706 during storage, which is reflected in the embodiment ticipate, shown in Figure 17. It can be seen that during storage, the fastening end 1704 of the insert 1702 does not cause a radial expanding force to be applied to the fastening branches 1706. FIG. 17B shows the incontinence device 1700 during deployment, and FIG. 17C shows the device 1700 during removal. A fixture 1700 may be provided with a closure member 1714. In addition to performing an embodiment in which the fixing branches 1706 are not radially expanded, the load acting on the storage insert 1702 is reduced with respect to the embodiment shown in FIGS. 16A-D since it is not necessary to stretch the insert 1702 as much to accommodate the same dimensions during storage. In addition, when deploying, it is necessary that only one side of the insert 1702 is pulled together to cause radial expansion, in contrast to the two sides of the insert 1602 (fastening and supporting), similar to that shown in figa-D, which avoids two-stage deployment (first fixing branches when they are "released" from the applicator, then the supporting branches) of the fixture 1700.

An alternative embodiment of an incontinence device 1700 in which the support arms 1708 are configured to accommodate an elastic insert component 1710 that cups cover the inner insert component 1712 without having to place them outside the support arms 1708 during storage, shown in FIG. 17D. In some exemplary embodiments, this makes it possible to use a shorter cord connecting the inner insert component 1712 to the elastic insert component 1710, and also makes it possible to use the shorter elastic insert component 1710.

FIG. 18A shows an incontinence device 1800 that is provided with an insert receptacle 1802 adapted to receive the insert 1804 so that it can be removed in accordance with an exemplary embodiment of the invention. Optionally, the insertion slot 1802 connects together the fixing section 1806 and the supporting section 1808 of the incontinence device 1800. In an exemplary embodiment of the invention, the insert 1804 is expanded to a cone to allow radial expansion of the insert slot 1802 and / or the support section 1808 when the insert 1804 is inserted in the insert slot 1802. The integrated resilient support member 1820, described in more detail below in connection with FIG. 5, is shown when used in conjunction with the incontinence device 1800. 18B, it can be seen that in some exemplary embodiments of the invention, the integrated resilient support member 1820 is adapted to radially expand the support section 1808 when the insert 1804 is inserted into the insertion slot 1802. The tapered sides of the insert 1804 provide pressure to the open ends of the integrated resilient support member 1820, causing them to extend radially outward and thereby cause the support section 1808 and / or support branch 1816 to expand radially outward. In an exemplary embodiment of the invention, the slope of the conical ends and possibly their length determine the magnitude of this effect.

Although FIG. 18A shows an incontinence device 1800 in an expanded configuration, it should be understood that, possibly, the insert 1804 may not be inserted into the insert slot 1802 during storage. For example, the insert 1804 is forced to shift to its position in which it is inserted into the insert receptacle 1804 by means of a plunger, such as described elsewhere here, during “deployment” from the applicator.

FIG. 18B shows an incontinence device 1800 in a retrieval configuration in accordance with an exemplary embodiment of the invention. In some exemplary embodiments of the invention, incontinence device 1800 is provided with retrieval device 1812. Sufficient force exerted on the retrieval device 1812 to draw it away from the user's cervix causes the insert 1804 to move out of the insertion slot 1802, thereby eliminating the source of increased radial expansion of the support section 1808 and facilitating the removal of the tool 1800. efforts to retrieve 1812 causes flattening of at least support section 1808 and / or fixture sockets 1802. Possibly, the socket 1802 is preliminarily positioned so that it tapers inwardly towards the central axis of the fixture 1800. The force exerted in the direction away from the cervix of the user continues to be applied to pull the fixture 1800 out of the user's vagina. The expanded end 1814 of the extraction tool 1812 is used to prevent pulling of the removal tool 1812 from the incontinence device 1800 during removal, and also to prevent the insert 1804 from separating from the rest of the tool 1800. In some exemplary embodiments of the invention, the tool 1800 is provided with a cover member 1810, 1822.

On figa shows the device 2300 used for incontinence, which is made with an elastic, biased support section in accordance with an exemplary embodiment of the invention. The fixture 2300 consists of at least a fixing section 2302, a support section 2304, and an insert 2306 in one embodiment of the invention. Optionally, fixture 2300 includes a central nodal member constituting a structural member for intersecting and / or connecting between the fixing section 2302 and the supporting section 2304. In some exemplary embodiments, the supporting section 2304 consists of a plurality of branches 2310, two of which shown in figa-b. In an exemplary embodiment, the anchoring section 2302 is made of a biocompatible material and functions similarly to the other anchoring sections described herein. The fixing section 2302 is attached to the supporting section 2304, for example, by using a bent element 2308, as shown in figa.

In an exemplary embodiment of the invention, the support section 2304 is designed such that it retains the nominal (original) compressed configuration (which is characterized by an offset to the center axis of fixture 2300), but is flexible enough to fit in the extended configuration by insert 2306 (as shown on figv). In some exemplary embodiments of the invention, the support section 2304 provides very little support when it is in a compressed configuration. Possibly, the support section 2304 is a leaf spring, which is biased towards the central axis of the device 2300. Perhaps, the support section 2304 is made with an integrated elastic support element, such as shown in FIG. Perhaps the support section 2304 is composed of metal. Alternatively or additionally, the support section 2304 consists of plastic. In an exemplary embodiment, protective caps of biocompatible material are provided at the ends of branches 2310 to provide enhanced comfort for the user. Perhaps the material from which the protective caps for the branches 2310 are formed is flexible and is a material such as rubber or plastic. In some embodiments, insert 2306 may be used with fixture 2300 having only two branches 2310 of support section 2304.

In use, insert 2306 is forcibly biased upward toward bent member 2308 by means of a plunger (not shown). Continued application of pressure in this direction through the use of the plunger ultimately causes the deployment of the device 2300 from the applicator (not shown) with its transition to the deployed position shown in figv. On figv shows the insert 2306 inside the support section 2304, which bends at the points 2312 inflection during installation of the insert 2306 in it. The reconfiguration of the support section 2304 to provide support is the result of installing the insert 2306 at a predetermined position within it in an exemplary embodiment of the invention. In an exemplary embodiment, the insert 2306 is held within the support section 2304 by a compressive force exerted on it by the offset support section 2304. In one embodiment, the tool 2300 is removed by applying a force to the directional extractor 2314 down to the side of the cervix and towards the vaginal opening. The insert 2306 is displaced from the support section 2304 under a given force acting on the extraction device 2314, which makes it possible to compress the branches 2310 to a compressed configuration and allows convenient removal of the device 2300. In one embodiment of the invention, device 2300 is provided with a closure 2316, which similar to the closure elements described here elsewhere.

27A shows an incontinence device 2700 with an expandable insert 2702 in accordance with an exemplary embodiment of the invention. The fixture 2700 is shown in the unfolded state, for example, in the form in which it will be in the vagina of the user. The insertion head 2706 is expanded by the insert expander 2704 in an expanded configuration, and when removed, the insertion head 2706 is compressed or compressed when removing the insert expander 2704 in accordance with an exemplary embodiment of the invention. In an exemplary deployed configuration, an insert expander 2704 is located within a groove in the insert head 2706. In some embodiments, the insertion head 2706 expands by the insert expander 2704, which causes pressure from the insertion head 2706 to apply to the support branches 2708 of the fixture 2700. In one embodiment, the pressure exerted by the insertion head 2706 as a result of the insert expander 2704, causes radial expansion of supporting branches 2708 and subsequently incontinence treatment. In an exemplary embodiment, the insert expander 2704 is not located in the insert head 2706 during storage. Perhaps the insertion head 2706 is flexible. In an exemplary embodiment, the expandable insert 2702 has an expanded portion that prevents the expandable insert 2702 from being pulled through the fixture 2700 during removal, as shown in FIG. 27B.

27B shows an incontinence device 2700 in a retrieval configuration in accordance with an exemplary embodiment of the invention. The extraction is initiated by applying a pulling force to the extraction tool 2710, which causes the extension of the insert expander 2704 from the insert head 2706, in some exemplary embodiments of the invention. When the expander 2704 of the insert is displaced from the insert head 2706, the insert head 2706 substantially relieves the force exerted on the support branches 2708, which makes it possible to compress them, or at least makes them less resistant to compression towards the center axis of the fixture 2700 for more easier and more convenient removal of the device 2700. In one embodiment of the invention, the device 2700 is used in conjunction with a closing element 2712, which is made with a hole having such a size s that may pass therethrough device 2710 for retrieval, but not insert expander 2704, due to the larger size of the insert expander 2704. Continuous application of force acting on the extraction device 2710 in the downward direction from the cervix and towards the vaginal opening will eventually cause the insert expander 2704 to be “caught” on the closure member 2712 near the opening (since it cannot go through the hole), and to pull the fixture 2700 out of the vagina. As described here elsewhere, the force exerted on the closure member 2712 by using the extraction tool 2710 also contributes to the compression of the support branches 2708, which facilitates the removal of the tool 2700.

28A, an incontinence device 2800 with an insert 2802 with a ring is shown in a storage configuration in accordance with an exemplary embodiment of the invention. An exemplary insert 2802 with a ring can be seen in a perspective view of FIG. 28C. The fixture support branches 2806 extend through openings 2850 between the ring and the central portion of the ring insert 2802 in accordance with an exemplary embodiment of the invention. In some embodiments of the invention, the insert 2802 with the ring is not located inside the device 2800 during storage of the device 2800, which allows to increase the shelf life and improve performance when used. In an exemplary embodiment, the retrieval / actuation device 2812 is attached to the retrieval / actuation plate 2814 located distally from the center of the device 2800.

In an exemplary embodiment, deployment of fixture 2800 is initiated by applying a pulling force acting downwardly to retrieve / actuate fixture 2812, which causes fixture 2800 to move toward the proximal end of applicator 2808 and retract ring insert 2802 into fixture 2800 used for incontinence. In an exemplary embodiment of the invention, actuation protrusions 2816 are provided on the applicator 2808 to create a force that counteracts the "pulling" of the fixture 2800 onto the insert 2802. Possibly, the plunger 2804 is used to force the insert 2802 into the fixture 2800 to apply force to the abutment branches 2806, causing their radial expansion, while the supporting branches 2806 acquire an expanded configuration by pushing the device 2800 from the applicator 2808. Deployment from the applicator 2808 and into the vagina is carried out as described here in connection with other options for implementation.

An exemplary deployed configuration of fixture 2800 is shown in FIG. 28B. In one embodiment of the invention, the insert 2802 with the ring is installed so that it passes through the fixture 2800 and the insert head 2810 is located on the distal side of the fixture 2800. Perhaps the insert head 2810 is made with a shape, for example, similar to the tip of the arrow, to allow its passage through fixture 2800 during deployment, but to prevent insert 2802 from passing thereafter back through fixture 2800, returning to the original configuration. In an exemplary embodiment of the invention, in an expanded configuration, the ring insert 2802 provides a force to the support branches 2806, causing them to expand radially outward. Optionally, fixture 2800 is provided with retrieval / actuation device 2812, which, in addition to actuating incontinence fixture 2800, can be used like the other retrieval devices described herein. Optionally, fixture 2800 is provided with a closure member.

Exemplary devices with multiple resistant configurations for the treatment of incontinence

In some exemplary embodiments of the invention, incontinence devices are provided with many stable configurations for treating incontinence. Possibly, a component having two stable positions is used to create incontinence devices with a first stable position for storing and / or retrieving and a second stable position for treating incontinence. As used herein, a component having two stable positions is sometimes referred to as an insert, a fixing member, and / or an elastomeric ring. 4A-C and 14A-B show exemplary embodiments of inserts having two stable positions and used with incontinence devices, wherein said inserts do not substantially move relative to the incontinence device for translation them from the first stable position to the second. 3A-C and FIGS. 20A-C described above, described in another section below, show an exemplary embodiment of a device having two stable positions, in which a component having two stable positions moves relative to the incontinence device , when moving it from the first stable position to the second stable position. In addition, it should be noted that in the exemplary embodiment of the invention, the deployment of devices having two stable positions occurs after the devices are properly installed inside the vagina, while they are translated with a “click” in their second stable position, when an insert having two stable positions is moved to the second position. In an exemplary embodiment, the “click” deployment is more convenient than the other deployment types described herein since pressure will not be applied from the support arms to the vaginal wall until the incontinence device is in a position designed to provide treatment for incontinence.

FIG. 4A is a profile view of an incontinence device 400 with a reversible, two stable position insert 402 located in applicator 406 in accordance with an exemplary embodiment of the invention. Convertible insert 402 resembles a flexible cup-shaped membrane in an exemplary embodiment of the invention. The insert 402 is designed so that when the membrane is biased toward the proximal end of the fixture 400 in the first configuration, the membrane of the insert 402 is soft (unstressed). However, when the membrane is forcibly displaced through the center of the insert 402 toward the distal end of the fixture 400, the membrane of the insert 402 causes a radially expanding pressure to be applied to the support branches 404 of the fixture 400, and the branches 404 “jump” to a predetermined position. In an exemplary embodiment, the membrane of the insert 402 has a variable wall width and, therefore, a different tensile stress at each point. Possibly, insert 402 is located between support branches 404 of fixture 400. Possibly, the membrane of insert 402 is forcibly shifted to its own center, as a result of which fixture 400 is deployed into a second configuration by means of a plunger 408 located at the proximal end of applicator 406.

FIG. 4B is a profile view of an incontinence device 400 with a convertible insert 402 in the deployed position in accordance with an exemplary embodiment of the invention. In this exemplary embodiment, it can be seen that during deployment by means of the plunger 408, a force was applied to the center of the membrane of the insert 402, causing it to shift toward the distal end of the device 400. As described here, the membrane is made such that when it is biased towards the proximal end of the fixture 400, it is soft (unstressed), and when it is biased towards the distal end of the fixture 400, it is stiff enough to apply pressure in the radial direction to the supporting branches 404, causing an increase in their diameter to provide support for the urethra. Perhaps the support for the urethra is a support for the middle part of the urethra.

The removal of the fixture 400 is shown in FIG. 4C, which shows a profile view of the incontinence fixture 400, with a possible extraction fixture 410, such as a cord. The force exerted on the proximal retrieval device 410, away from the cervix, forces the membrane of insert 402 to transform the transforming membrane from at least a semi-rigid state to a soft state. The reduced radial pressure exerted by the membrane side of the insert 402 facilitates the movement of the support branches 404 towards the central axis of the fixture 400 to allow easier removal. In some exemplary embodiments of the invention, the force that continues to act on the extraction device 410 biases the support branches 404 toward the center axis of the device 400 and toward the vaginal opening. Additionally, alternatively or possibly, the extraction device 410 is attached to the closure member 412, which, when applied to the device 410 to extract a downward force, applies pressure to the support branches 404 towards the central axis of the device 400 to allow easier extraction . The embodiment shown in FIGS. 4A-C is possibly used with a built-in elastic support, as described below in connection with FIG.

On figa shows a view with a local section of the applicator 1402, showing located in the applicator 1402 and having two stable state device 1400 used for incontinence, in accordance with an exemplary embodiment of the invention. The insert having two stable positions in FIG. 14A-B differs from the insert in FIGS. 4A-C in that instead of using a membrane that has first and second stable positions depending on its displacement, mechanical branches are provided that have first and second stable provisions. As described in connection with other embodiments of incontinence devices, the two incontinence device 1400 used for incontinence is configured with a reduced diameter for storage inside the applicator 1402. The applicator 1402 is possibly similar to any of the applicators described herein and in related applications known to those skilled in the art or not yet invented. In an exemplary embodiment of the invention, the two incontinence device 1400 used for incontinence is provided with a two stable positions locking element 1408 that is attached to the element 1406 for reinforcing support branches. The locking element 1408 having two stable positions may be configured such that in the first stable position, when the fixing element 1408 having two stable positions is biased towards the support branches 1404 of the fixture 1400, the locking element 1408 having two stable positions does not cause significant pressure element 1406 for reinforcing support branches radially outward. However, in the second stable position, in which the locking element 1408 having two stable positions is biased towards the fixing branches 1420 of the fixture 1400 and which is shown in FIG. 14B, the two locking positions having the fixed element 1408 provide force to the element 1408 to strengthen the supporting branches, which causes a forced displacement of the support branches 1404 radially outward from the central axis of the incontinence device 1400. In some exemplary embodiments of the invention, a plurality of reinforcing arms are attached to the support arms 1404 of the incontinence device 1400 such that when the two retaining members 1408 are in the second stable position, the reinforcing arms cause the support arms 1404 to be biased. radially outward from the center axis of fixture 1400. It is possible that each supporting branch 1404 is provided with a reinforcing branch. Possibly, the selected support branches 1404 are provided with reinforcing branches, for example, if the forced deployment of the support branches 1404 is desired along only one axis.

In some exemplary embodiments of the invention, the support arm reinforcing member 1406 has a central portion with a male locking cylinder 1416. The locking member 1408 may have two stable positions and is provided with a central female receiver for the locking cylinder, which allows for mounting with two stable positions the locking element 1408 to the element 1406 to reinforce the support branches with the possibility of detachment. The fastening of the locking element having two stable positions with the possibility of detachment to the element to strengthen the supporting branches provides resistance to pressure from the side of the vaginal wall, which causes the device 1400 to shift to the first stable position. Perhaps the locking cylinder 1416 is made with a protrusion (edge), which has a slightly larger size compared to the inner circumferential periphery of the receiver for the locking cylinder, which, possibly, is an opening located on the fixing element having two stable positions, so that when locking the clamp cylinder 1416 to the receiver of the fixing cylinder 1416 with sufficient force, the receiver "passes" through the protrusion and is attached to the element 1406 to strengthen the reference branches with the possibility of detachment neniya. It is possible that the locking element 1408 having two stable positions is biased so that, being pressed against the supporting branch reinforcing element 1406, the locking element 1408 having two stable positions is locked in the reinforcement position and can be exited without pairing the locking cylinder 1416 with the receiver for the locking lockable cylinder. In some exemplary embodiments of the invention, the locking member 1408 having two stable positions is pushed against the member 1406 to reinforce the support branches by means of a plunger 1410. It is possible that the clamping force created by the clamping branches 1420 is greater than the force required to translate the member 1406 to strengthen the support branches from the first stable position to the second stable position, so that when the device 1400 is inserted into the vagina, when the securing branches 1420 when they are in a predetermined position, they prevent the fixture 1400 from moving towards the cervix when pressure to translate (“jump”) to a second stable position will be applied to element 1406 to reinforce the support arms through the plunger. Optionally, the incontinence device 1400 is provided with an extraction device 1412 that is attached to the two stable positions of the locking element 1408 so that it can change the position of the two stable positions of the locking element 1408 from the second stable position to the first stable position.

14B, the two incontinence device 1400 used for incontinence is shown deployed in a second stable position in accordance with an exemplary embodiment of the invention. It can be seen that the locking element 1408 having two stable positions is pressed against the element 1408 to reinforce the support branches, which causes the reinforcing branches to be pressed radially outward and, therefore, the support branches to be pressed radially outward from the center axis of the fixture 1400. In the example, In an embodiment of the invention, support arms 1404 provide support for the urethra. Perhaps the support is a support for the middle part of the urethra. Optionally, fixture 1400 is used in conjunction with a closure member 1418, such as closure members described herein. Possibly, the removal of the fixture 1400 is facilitated by applying force to the extraction fixture 1412, acting in a downward direction to the vaginal opening. This downwardly acting force forces the locking element 1408 having two stable positions to change the second stable position to the first stable position, while the reinforcement for the support branches 1404 is removed, and they can be shifted towards each other (“converging”) and toward the central the axis of the fixture 1400. The reduction in the radial diameter of the fixture 1400, due to this convergence, creates the possibility of easier and / or more convenient extraction than if the support from branch 1404 remained in the expanded state.

In an exemplary embodiment of the invention, the locking element 1408 having two stable positions is provided with reinforcing branches, and the central part of the element for reinforcing the supporting branches is omitted 1406.

Exemplary incontinence devices with an elastomeric ring

Some of the embodiments described in this section are provided with several stable configurations, such as those shown in FIGS. 20A-C. In certain exemplary embodiments of the invention, the elastomeric ring 2002 is used to radially expand and / or compress the incontinence device 2000, depending on whether the ring 2002 is in a first stable position or a second stable position. It is possible that radial expansion and / or contraction is caused by the properties of the materials and / or the configuration of the incontinence device, and the ring is selectively placed in a certain position to prevent transition to certain configurations. 20A, the incontinence device 2000 is shown in a first stable position, or in storage configuration, in accordance with an exemplary embodiment of the invention. The elastomeric ring 2002 is initially located in the first groove 2004 located between the fastening section 2006 of the incontinence device 2000 and the second groove 2008, in some exemplary embodiments of the invention, and is used to help keep the device 2000 in storage configuration . In an exemplary embodiment of the invention, the first groove 2004 is located on the body of the fixture 2000, while when the elastomeric ring 2002 provides pressure to the fixture 2000 from the first groove 2004, the supporting 2010 and fixing 2012 branches are not radially outwardly drawn.

In some exemplary embodiments of the invention, the elastomeric ring 2002 consists of latex, rubber, silicone, polyurethane or nylon. Optionally, the elastomeric ring 2002 is formed from any, at least to some extent, elastic material. In some exemplary embodiments of the invention, the elastomeric ring is not elastic and / or flexible. In some exemplary embodiments of the invention, elasticity and / or flexibility “helps” move the elastomeric ring 2002 from the first groove 2004 to the second groove 2008 and / or “helps” it stay in the grooves 2004, 2008. For example, in some given as In exemplary embodiments, the elasticity property of the ring 2002 is used to apply pressure, like a rubber band, to the tool 2000 while the ring 2002 is in the groove, which helps to keep the ring 2002 in the groove, and t kzhe when the first groove 2004 provides a retention device in the storage configuration and in the case of the second groove 2008 facilitates the radial expansion of support 2010 and 2012 fixing the branches. The elastomeric ring may not be ring-shaped, it may be square, rectangular, triangular, ovoid or, for example, u-shaped.

The deployment of the incontinence device 2000 translates the elastomeric ring 2002 from a first stable position in which the ring 2002 is located in the first groove 2004 into a second stable position in which the ring 2002 is located in the second groove 2008, in accordance with some of as an example, embodiments of the invention. As the fixture 2000 moves in the applicator 2014 toward the exit of the applicator 2016, the elastomeric ring 2002 collides with the translation element 2018 located on the inner surface of the applicator 2014. The fixture 2000 is exposed to a long-acting deployment pressure, causing the fixture 2000 to be pushed out applicator 2014, with the translating element 2018 pushing the elastomeric ring 2002 down the outer surface of the fixture 2000 until the elastomeric ring 2002 is installed in the second groove 2008. In some exemplary embodiments of the invention, the second groove 2008 is configured to prevent further movement of the elastomeric ring 2002 under the action of the translation member 2018, and further application of pressure to the tool 2000 causes the tool 2000 to deploy in a predetermined position, possibly in the user's vagina. Perhaps the first groove 2004 and / or the second groove 2008 is adapted to allow the movement of the ring 2002 from the first groove 2004 as a result of its collision with the 2018 translation element, but to prevent the movement of the ring 2002 from the second groove 2008. For example, the second groove 2008 has a larger depth than the first groove 2004 in some exemplary embodiments of the invention.

FIG. 20B shows an incontinence device 2000 used in a second stable position, or in a deployment configuration, with an elastomeric ring 2002 located in a second groove 2008 in accordance with an exemplary embodiment of the invention. When the elastomeric ring 2002 is located in the second groove 2008, the fastening branches 2012 are pressed radially outward partially due to the compressive force acting from the side of the elastomeric ring 2002, which is in its position in the second groove 2008, towards the center axis of the tool 2000, and due to the point 2020 of the pivot created due to the curvature of fixture 2000 at the location of the first groove 2004. In some exemplary embodiments of the invention, the pivot point is created by a “junction "Two points on at least two of the fastening branches that are the lowest on the curved portion of the first groove 2004. In the exemplary embodiment of the invention, the supporting branches 2010" do not benefit "from having a curved groove similar to that achieved by of the first groove 2004, therefore, a pivot point is provided by mounting part 2022 to provide rotation between the elastomeric ring 2002 and support branches 2010. Possibly, part 2022 to provide Gate is a ball. In some exemplary embodiments of the invention, the pivoting part 2022 is located in a third groove 2024 adapted to receive the pivoting part 2022 and to prevent it from falling out before being removed. As described above, the pressure acting from the side of the elastomeric ring 2002 and the part 2022 to ensure rotation, causes the support branches 2010 to expand in the radial direction. In some exemplary embodiments of the invention, the pressure applied to the fixture 2000 from the side of the elastomeric ring 2002 varies depending on the length of the lever arm between the ring 2002 and the pivot point (pivot point 2020 and / or part 2022 for pivoting) and / or from the effect that it is desired to provide for fixture 2000. Additionally or alternatively, the flexibility of the material from which fixture 2000 is made is also taken into account.

20C, an incontinence device 2000 is shown in a retrieval configuration in accordance with an exemplary embodiment of the invention. The radial profile of at least a portion of the incontinence device 2000 is reduced to facilitate removal of the device 2000 in some exemplary embodiments of the invention. Possibly, the reduction of the radial profile is carried out by displacing the part 2022 to provide rotation by using the extraction tool 2026 attached to the part 2022 to provide rotation. In an exemplary embodiment, the force exerted on the retractor 2026 to move away from the cervix and toward the vaginal opening of the user causes the part 2022 to bias from the third groove 2024. This bias of the bias 2022 to remove part of the mechanism causing the radial expansion of the support branches 2010, which allows the support branches 2010 to return to the configuration with a reduced radial profile. The force exerted continuously on the extraction device 2026 away from the cervix will eventually remove the device 2000 from the user's vagina. The retrieval device 2026 may be attached to the incontinence device 2000 by passing it through the central node of the device 2000 and made with an enlarged end 2028 to prevent the retrieval device 2026 from being pulled out of the device 2000 during removal. In some exemplary embodiments of the invention, fixture 2000 is provided with a closure member 2030.

The fixture in some exemplary embodiments of the invention is not necessarily a fixture having two stable positions, the fixture shown in FIG. 20D shows another exemplary embodiment of an incontinence fixture 2050 using an elastomeric ring 2052 for selectively applying pressure to the fixture 2050. The incontinence fixture 2050 shown in FIG. 20D is similar to many of the other embodiments described herein that use an insert 2054 to radially expand the support arms 2056 and / or to provide support for the support arms 2056 that counteracts the back pressure acting from the side of the vaginal wall and, in this embodiment, from the side of the elastomeric ring 2052 when the fixture 2050 is deployed. Possible insert configurations that can be used in conjunction with any of the embodiments described herein are shown in FIG. 20F-I. In some exemplary embodiments of the invention, the hollow channel passing through the center of the inserts is designed to allow passage of the extraction device. In some exemplary embodiments of the invention, the inserts are configured to provide different effects of radial expansion on the support arms of the incontinence device. Possibly, the inserts are configured to allow them to be detached to the incontinence device.

In an exemplary embodiment, the elastomeric ring 2052 operates in conjunction with [force] to remove the insert 2054 to radially compress the support arms 2056 to facilitate removal of the tool 2050. In the exemplary embodiment, the force applied to the tool 2058 for retrieval, similar to that shown in FIG. 20E, causes the insert 2054 to offset. This allows support branches 2056 to converge freely toward the center the axis of the fixture 2050, and the elastomeric ring 2042 provides pressure to the support branches 2056 to reinforce this compression displacement. In an exemplary embodiment of the invention, by applying a long acting force away from the user's cervix, the device 2050 is removed from the user's vagina.

An exemplary embodiment with an integrated resilient support element

5 is a profile view of an incontinence device 500 with an integrated resilient support member 502 in accordance with an exemplary embodiment of the invention. Optionally, fixture 500 is any of the fixtures described herein. In an exemplary embodiment, the resilient support member 502 is used to bias the support arms 504 of the fixture 500. It is possible that the support arms 504 are displaced to form a radially extended configuration. Possibly, the support members 504 are displaced to form a compact radial configuration. Preferably, the integrated support member 502 is embedded within the fixture 500. Optionally, the integrated support member 502 is located outside the fixture 500, similar to an exoskeleton. In some exemplary embodiments of the invention, the integrated support member 502 is used in conjunction with the support branches 504 of the fixture 500. The integrated support member 502 may be formed from a material with stable shape memory (such as stainless steel or polymers such as nylon-based materials) or silicone). In an exemplary embodiment of the invention, the integrated support element 502 with shape memory provides an increase in the shelf life of the device 502 during storage, since compression in the applicator for a long time will not significantly reduce the coefficient of elasticity of the integrated support element 502. The integrated support element 502 is made that when the fixture 500 is deployed from the applicator, the built-in support element 502 causes the support branches 504 to be deployed for flax outwardly from the central axis of device 500 for providing urethral support. Perhaps the integrated support element is used in conjunction with the fixing branches 508.

The removal of the fixture 500 is facilitated by the attachment of the extraction fixture 506 to the support branches 504. The force exerted on the fixture 506 to remove downward from the cervix causes the support elements 504 to “converge” to the central axis of the fixture 500, which makes it easier and / or more convenient extraction. Optionally, the extraction tool 506 and the integrated support member 502 are made of the same material. Optionally, the extraction tool 506 and the integrated support member 502 are made at the same time. Other exemplary embodiments of the invention utilize built-in support elements that bias the support and / or anchor arms toward the center axis of fixture 500 instead of moving them away from the center axis. A similar configuration may be used to provide better branch convergence for easier removal of the incontinence device.

An exemplary embodiment with branches that reduce tensile stress

FIG. 6 shows a profile view of an incontinence device 600 made with tensile stress reducing support and / or anchor arms 602, in accordance with an exemplary embodiment of the invention. Reducing the tensile stress in the support and / or fixing branches 602 provides an increase in the shelf life of the device 600 during storage. In an exemplary embodiment of the invention, the configuration of the incontinence device that is exposed to the highest stress and / or tensile stress, namely the connection between the support and / or anchor branches and the node, is modified to distribute this stress and / or tension . It is possible that stress and / or tension are reduced by distributing it over a larger adaptation zone. In an exemplary embodiment of the invention, a reduction in tensile stress at the support and / or anchor branches 602 is possibly achieved by performing them with an accordion-like section 604 that folds when compressed inside the applicator. Perhaps folding (bending) is carried out without the use of hinges and / or other mechanical means. Possibly, other devices, such as those described here, are made with tension-reducing branches, such as those shown in FIG. 6. However, when deployed from the applicator in an exemplary embodiment of the invention, the support and / or anchor arms 602 expand radially from the center axis of the fixture. In an exemplary embodiment of the invention, the branches 602 are deployed to provide support for the middle part of the urethra. Optionally, fixture 600 is used in conjunction with a closure member, such as closure members described herein. In some exemplary embodiments of the invention, the removal of the device is facilitated by the application of a force, acting downward, away from the cervix, to the extraction device attached to the closure member surrounding the device 600 like a sheath. As described here in other embodiments, this force causes the convergence of the branches of the fixture 600 towards the central axis of the fixture 600, which allows easier and / or more convenient extraction than without the convergence of the branches.

In an exemplary embodiment of the invention, an additional advantage of some embodiments of devices that reduce tensile stress is a higher flexibility of the dimensions of the device and / or dimensions of the applicator. It is possible that the configuration with decreasing tensile stress described here makes it possible to use an incontinence device that has a larger diameter than that which would normally be suitable for use with an applicator, for example, using prolapse devices that usually require a larger diameter. Alternatively, a narrower applicator can be used for a device with a reduction in tensile stress, which when deployed has a radius similar to that in the embodiment without reducing tensile stress. In an exemplary embodiment of the invention, this is due to the ability of the branches 602 to fold (bend), which take up less space in the folded state than in the state when the branches 602 are fully expanded. In another exemplary embodiment of the invention, the folding branches allow the use of a longer central nodal element than is usually installed in the applicator by increasing the length of the folding section 604 like an accordion.

Exemplary rolled incontinence devices

In accordance with some exemplary embodiments of the invention, incontinence devices are provided comprising at least one collapsed section. The exemplary embodiments shown in FIGS. 7A-D and 8. These fixtures 700, 800 can be distinguished from the other incontinence fixtures described herein by at least one feature in that instead of supporting and / or fixing branches converging towards the central axis to reduce the radial profile of the device, coagulation sections are provided with the ability to coagulate to reduce the radial profile of the device.

FIG. 7A is a profile view of a rolled incontinence device 700 in accordance with an exemplary embodiment of the invention. The tool 700 consists of a central element 702, which, when deployed, may have a substantially cylindrical shape. It is possible that at the proximal and distal ends or near the proximal and distal ends of the central element 702, support branches 704 (proximal end) and fastening branches 706 (at the distal end) are located. In some exemplary embodiments of the invention, the central element 702 consists of a folded sheet formed with branches 704, 706, as described in more detail in connection with figs. In some exemplary embodiments of the invention, the extraction tool 708 is attached to the tool 700 to facilitate removal. The extraction device 708 may be attached to the device 700 so that when a force is applied to the extraction device 708, acting downward from the cervix, the device 700 is deformed towards the vaginal opening, as a result of which its profile is reduced to provide more easy to extract. For example, the force exerted by the retractor to the retrieval device 708 may cause the proximal end of the device 700 to deform into a conical shape with its apex directed toward the vaginal opening.

Fig. 7B is a profile view of another embodiment of a rolled incontinence device 720, wherein the device 720 has an expanded proximal end in accordance with an exemplary embodiment of the invention. An enlarged proximal end may be desirable in the treatment of incontinence to provide additional support along with support branches 722 compared to fixture 700 that does not have an expanded proximal end. In an exemplary embodiment of the invention, the expanded proximal end allows the length of the support arms 722 to be reduced, which “reduces” the source of potential discomfort when deploying and / or using the tool 720. The support arms 704, 722 may have a variable length depending on the needs of the patient. Possibly, the securing branches 706 located at the distal end of the fixtures 700, 720 have a variable length depending on the needs of the patient. It is possible that the support and / or fixation branches are of sufficient length to prevent the vaginal tissue from being caught in the fold between the two ends of the central element 702. In some exemplary embodiments, the support and / or fixation branches are up to 10 mm long. Perhaps the length of the branches is more than 10 mm. Perhaps the length of the branches is less than 5 mm. Perhaps support is provided for the middle part of the urethra.

A top or bottom view of a rolled up incontinence device 700 in accordance with an exemplary embodiment of the invention is shown in FIG. 7C. You can see that, when viewed in conjunction with figa, the Central element 702 may have a substantially cylindrical shape. In some exemplary embodiments of the invention, the central element 702 consists of a sheet that is folded to form a substantially cylindrical shape. Perhaps the sheet consists of a material that is “biased” so as to allow the sheet to open out from a cylindrical shape, but this prevents the sheet from opening when it is, for example, in the applicator or in the vagina.

Therefore, in the exemplary application, the fixture 700 is folded like a scroll and placed in the applicator 730 shown in Fig.7D. The tool 700 is folded in such a way that its natural tendency to open will cause the tool 700 to expand to its substantially cylindrical shape, as well as applying at least some outward radial reference pressure when deployed from the applicator 730. The reference pressure may be directed to the middle part of the urethra. Optionally, fixture 720 is used as described herein in connection with fixture 700.

FIG. 8 illustrates a double-sided rolled incontinence device 800 in accordance with an exemplary embodiment of the invention. The device 800 may consist of a connecting node element 802, which is provided with folded spring-like sections with branches located at the proximal and distal ends of the connecting node element 802. Section 804 with supporting branches and section 806 with fixing branches may form sections with branches provided for the connecting node element 802. In an exemplary embodiment of the invention, the section with branches consists of helically with a return strip 808, which forms a substantially circular profile around the connecting node 802, as shown in FIG. Optionally, the spirally folded strip 808 has protrusions 810 located on it to provide support and / or fastening. In some exemplary embodiments of the invention, at least the spirally folded strip of branch sections 808 is flexible. The flexibility of the spirally folded strip 808 allows the strip to be compressed to insert the fixture 800 into the applicator. In addition, the flexibility of the spirally folded strip 808 may provide increased comfort for the patient using the fixture 800, since it tends to “fit” to the patient [fit to the patient’s body] better during movement than a rigid fixture. Perhaps the connecting node 802 is flexible. Perhaps the protrusions 810 are flexible. Possibly, protrusions 810 are provided with different lengths as described in connection with FIGS. 7A-D. Optionally, helically folded strips forming circles of a larger and / or smaller radius are used in conjunction with an incontinence device 800, depending on the needs of the patient.

An example of an elastomechanical incontinence device

On figa-C shows the device 1900 used for incontinence, which is provided with an elastomechanical principle of operation to achieve radial expansion and / or compression, in accordance with an exemplary embodiment of the invention. In some exemplary embodiments of the invention, at least one extender 1904 is provided for fixture 1900 attached to a fixture branch 1908 or to a support arm 1910 of fixture 1900. For fixture 1900 used for incontinence, an elastic member 1902 is provided which Some exemplary embodiments of the invention selectively cause radial expansion and / or contraction of fixture 1900 via expanders 1904.

Fig. 19A shows an incontinence device 1900 in storage configuration (for example, when it is in the applicator) in accordance with an exemplary embodiment of the invention. One end of the extenders 1904 is connected to a node element 1906 for expanders, and the other end is connected either to the fixing branch 1908 or to the support branch 1910 so that both ends of the extenders 1904 can rotate relative to the element to which they are attached. In storage configuration, the elastic member 1902 is stretched, which allows the expanders 1904 to rotate, allowing the support branches and the fixing branches to take a position that provides a reduced radial profile.

FIG. 19B shows an incontinence device 1900 when deployed in accordance with an exemplary embodiment of the invention. The elastic element 1902, previously stretched during storage, is contracted to its nominal (unstressed) state, capturing the nodal elements for expanders by means of the enlarged ends 1912 of the elastic element 1902 and forcibly displacing the expanders 1904 with the formation of an expanded configuration. In an exemplary embodiment of the invention, expanders 1904 push out their respective branches, causing the extension of the radial profile of fixture 1900. The branches are connected to the central node 1914 so that they can rotate to "receive" various operating configurations (for example, during storage, when expanded, when removed). In an exemplary embodiment of the invention, the enlarged end 1916 for the support section is dimensioned so that it extends through the assembly for expanders, but is designed to provide a safety catch 1918, which is removable, as seen in FIG. 19C.

19C, an incontinence device 1900 is shown in a retrieval configuration in accordance with an exemplary embodiment of the invention. The removal of the fixture 1900 is possibly facilitated by the reduction of the radial profile of the fixture 1900. In the exemplary embodiment, the reduction of the radial profile of the fixture 1900 is achieved by removing the safety grip 1918, which initially prevents the enlarged end 1916 for the support section from passing through the expander assembly. As soon as the enlarged end 1916 for the support section passes through the knot element for expanders, expanders provided for this knot element can freely compress the support branches towards the central axis of the fixture 1900, at least under the pressure acting on them from the side of the wall the vagina. Possibly, expanders 1904 are at least partially elastic. Possibly, the safety grip 1918 is removed by applying force to the extraction device 1920 in the opposite direction to the cervix of the user and towards the vaginal opening. Possibly, the safety catch 1918 is connected by a knot that can be loosened, which is untied when sufficient force is applied in the direction from the cervix. Possibly, the safety grip 1918 consists of a tear-off part that makes the grip 1918 not fixed relative to the enlarged end 1916 for the support section when sufficient force is applied to the grip 1918 by the extraction tool 1920. In some exemplary embodiments, a closure member 1924 is provided for an incontinence device 1900. The retrieval device 1920 may be attached to the closure member 1924, which facilitates the retrieval of the device 1900. In such an embodiment, the force exerted on the retrieval device 1920 for a long time and applied away from the user's cervix will subsequently pull the device 1900 with a reduced profile out of the vagina. the user together with the closing element 1924.

An exemplary embodiment of an incontinence device made with a tensile member

FIG. 21A shows an incontinence device 2100 that is configured with at least one tensile member 2102 in accordance with an exemplary embodiment of the invention. In some exemplary embodiments of the invention, at least one tensile member 2102 extends between the branches of the fixing section 2104 and the corresponding branches of the supporting section 2106 of the incontinence device 2100. At least one tensile member 2102 is optionally elastic. In some exemplary embodiments of the invention, at least one tensile member 2102 is stretched prior to deployment and / or during storage in the applicator 2108 to reduce the radial profile of the fixture 2100 and possibly create an effort to expand the branches of the support section 2106 during deployment.

21B, an incontinence device 2100 is shown in an expanded configuration in accordance with an exemplary embodiment of the invention. In some exemplary embodiments of the invention, at least one tensile member 2102 is substantially constricted during deployment, creating a deployment force acting on the support section 2106 and possibly on the fixing section 2104 of the fixture 2100 used in incontinence. The flexibility of the fixing section 2104 and / or the supporting section 2106 may vary to control the response to at least one tensile member 2102. For example, in an embodiment in which there is no significant radial expansion of the anchoring section 2104, it is advisable to reduce the flexibility of the anchoring section 2104 so that it does not "react" to the effect of at least one tensile member 2102, also how would she do this if she were more flexible. It should be understood that at least one tensile member 2102 can be used in conjunction with any of the incontinence devices described herein in order to facilitate deployment of the incontinence device.

Illustrative embodiments of lubricating applicators

In some exemplary embodiments of the invention, a lubricant is provided for the applicator used to insert the device into the vagina. Lubricating the applicator facilitates insertion and / or removal from the vagina and / or enhances user comfort. 9A-B, 10A-B, and 24 show exemplary embodiments of lubricating applicators.

9A is a cross-section of an applicator 900 with a lubricating ring 902 in accordance with an exemplary embodiment of the invention. Applicator 900 is used to insert an incontinence device into the patient's vagina. The introduction is carried out by using this applicator similar to the introduction of a regular tampon for menstruation. In an exemplary embodiment, the incontinence device is held within the distal end 904 of applicator 900 that is inserted into the vagina. When a pressing force is applied to the plunger 906 located at the proximal end of the applicator 900, the incontinence device is pushed out through the outlet 908, which makes it possible to use the incontinence device as soon as the applicator 900 is removed from the vagina. It should be noted that in the exemplary embodiment, the outlet 908 remains closed until a pushing force is applied to the plunger 908 and the incontinence device is pushed out of the applicator 900. Possibly, the outlet 908 consists of a plurality of sections.

During insertion of the incontinence device into the vagina together with the applicator 900, the insertion is possibly facilitated by lubricating the applicator 900. In an exemplary embodiment, a lubricating ring 902 is provided to lubricate the outer surface of the applicator 900. Perhaps, the ring 902 is made with the possibility of sliding along the length of the applicator to provide lubrication, at least in the area that is to be introduced into the vagina. The lubricant may be directed at least toward the distal end of the applicator near the outlet. Perhaps ring 902 is hollow. The materials inside ring 902 may be squeezed out of ring 902 through a plurality of small holes (not shown) located in ring 902. In an exemplary embodiment, ring 902 is filled with lubricant. Perhaps ring 902 is filled with drug. Perhaps the small holes face the applicator 900 so that when the materials exit the ring 902, they are mainly applied to the applicator 900. Perhaps the ring 902 is made of a flexible material, such as silicone. In an exemplary embodiment, ring 902 is pulled along applicator 900 with at least a slight pressure applied to ring 902 to extrude materials within it through multiple openings. When the ring 902 moves along the applicator 900, the material is deposited on the applicator 900 in accordance with the speed of the ring 902, the pressure on the ring 902, the amount of material inside the ring 902, and / or other variables. Ring 902 may be removed from applicator 900 before using applicator 900 to deploy the device. The ring 902 may remain on the applicator 900 during deployment of the device, and then disposed of with the applicator 900.

FIG. 9B is a cross-sectional view of an applicator 950 with a removable closure member 952 in accordance with an exemplary embodiment of the invention. The applicator 950 may be circumferentially closed with a removable closure 952. In an exemplary embodiment, the removable closure 952 closes a layer 954 of material, such as a lubricant and / or medicine, between it and the applicator 950. Possibly, the removable closure element 952 is made of a substance such as polymers, nylon or aluminum foil, which ensures that the lubricant and / or drug layer 954 is preserved for a long period of time. Before insertion of the applicator 950 into the patient's vagina, the removable closure member 952 is removed from the applicator 950 to open the material layer 954. Optionally, a removable closure element 952 and / or a material layer 954 only covers part of the applicator 950.

FIG. 10A illustrates a side view of an applicator 1000 with a lubricating sleeve 1002 in accordance with an exemplary embodiment of the invention. Similar to the embodiment with a lubricating ring described in connection with FIG. 9A, a lubricating sleeve 1002 is used to facilitate insertion of the applicator 1000 into the patient’s vagina to deploy the incontinence device by distributing lubricant over the outer surface of the applicator 1000. Optionally, a lubricating sleeve 1002 used to distribute the drug to the applicator 1000. A cross section of the applicator 1000 is shown in FIG. 10B. In an exemplary embodiment, the lubricating sleeve 1002 is provided with a reservoir 1004 that is used to store the lubricant and / or drug. A lubricating sleeve 1002 may be configured with a plurality of discharge channels, with at least a portion of the applicator 1000 “receiving” the coating when releasing lubricant through the exhaust channels. In an exemplary embodiment of the invention, the lubricating sleeve 1002 is moved along the surface of the applicator 1000 for applying the lubricant. Optionally, the lubricating sleeve 1002 is removed from the applicator 1000 by sliding it along the distal end of the applicator before introducing the applicator 1000 into the patient's vagina.

24 shows a lubricating applicator 2400 in accordance with an exemplary embodiment of the invention. Applicator 2400 functions to deploy incontinence device 2408, similarly to other applicators described herein, by applying pressure to plunger 2404 to expel device 2408 from sheath (closure member) 2402 and into the vagina in one embodiment of the invention. A lubricant layer 2406 is applied to the applicator 2400, possibly towards the proximal end 2410 of the applicator to facilitate insertion of the applicator 2400 into the vagina of the user. In some exemplary embodiments of the invention, the lubricant layer 2406 consists of a lubricant that is highly viscous. High viscosity grease is applied at the proximal end of the applicator 2400 during manufacture and remains in place during storage. During use, the viscous lubricant layer 2406 facilitates insertion of the applicator 2400 into the wearer's vagina. The 2406 grease may be silicone oil. Possibly, grease layer 2406 is composed of glycerol. Possibly, grease layer 2406 consists of petroleum jelly. Possibly, the lubricant layer 2406 consists of a viscous water-based material. Optionally, a viscous lubricant layer 2406 is applied to any of the applicators described herein.

Exemplary applicator embodiments for improving storage conditions of incontinence devices

In certain exemplary embodiments of the invention, methods and devices for storing and using incontinence devices are provided. FIGS. 11A-B, 12A-D, and 25A-C show exemplary embodiments that enable at least a portion of the device to remain in a substantially uncompressed state during storage. It is believed that the reduction of stresses during storage in at least part of the device provides improved characteristics of the device during use and / or shelf life of the device during storage.

11A shows a cross section of an applicator 1100 and a lightly loaded incontinence device 1102 in accordance with an exemplary embodiment of the invention. Optionally, the incontinence device 1102 is any of the devices described herein, or from devices expanding in the radial direction and known in the art. Typically, storing at least a partially elastic device in a compressed state results in some reduction in device efficiency. In an exemplary embodiment of the invention, an incontinence device, such as some of the devices described herein, is only freely “loaded” into the applicator 1100 to avoid deterioration of the incontinence device 1102 due to compression during storage inside the applicator 1100. Perhaps the term “freely loaded” means “loading” only the securing section 1104 of the incontinence device 1102 into the applicator 1100, while the supporting section 1106 and possibly the central node 1108 remain outside the applicator 1100. In an exemplary embodiment, a loading device 1110 is provided that is connected to the incontinence device 1102 and which passes through the applicator 1100 and exits through exit 1112 located at the distal end of the applicator 1100. Possibly, the loading device 1110 is connected to the incontinence device 1102, with the possibility of disconnecting, so that after loading Shortcuts to fixture 1102 to applicator 1100 remove fixture 1110 from applicator 1100. Possibly fixture 1110 is similar to a cord and looped around incontinence fixture 1102 so that two ends of the cord are accessible at exit 1112, as shown on figa.

The incontinence device 1102 is loaded into the applicator by applying a pulling force to the loading device 1110 towards the distal end of the applicator, the loading device 1110, in turn, allowing the incontinence device 1102 to be drawn into the applicator 1100 . Pulling force may be applied with clean hands to maintain applicator sterility. Possibly, a removable layer is provided on the applicator, which is removed after loading the device 1102 into the applicator 1100. In the embodiment shown in FIG. 11A, both ends of the loading device 1110 are pulled at the same time for loading. Removing the loading device 1110 from the applicator 1100 may possibly be accomplished by applying a pulling force to one end of the loading device 1110, accessible at the end 1112, until the entire loading device 1110 is pulled out of the applicator 1100. In the above, An example embodiment of the invention, a plunger (not shown) is supplied to the proximal end of the applicator 1100 (into which the incontinence device 1102 has been loaded) to allow deployment of the device 1102, used for incontinence, in the patient's vagina. Possibly, the plunger shown in FIG. 11B is provided separately from the applicator 1150 and is used only when deployment of the incontinence device 1102 is desired.

11B shows a cross section of an applicator 1150 with an expanding proximal end into which an incontinence device 1102 is loaded in accordance with an exemplary embodiment of the invention. The applicator 1150 is made with a section 1152, expanding towards its proximal end. As in the embodiment described in connection with FIG. 11A, the incontinence device 1102 is only partially loaded into the narrow portion of the applicator 1150, while the rest of the incontinence device 1102 is located inside the expandable section 1152. Perhaps , the expanding section 1152 is dimensioned to allow full expansion of the support section 1106 of the incontinence device 1102. In one embodiment of the invention, the expandable section 1152 is made with expandable segments, the number and dimensions of which enable each branch of the support section 1106. It is possible that the expandable section is at least partially conical in shape and not provided with separate expandable segments, but is made with a substantially expanding conical shape to accommodate fixture 1102 regardless of rotation orientation. Deployment of incontinence device 1102 is accomplished by using a plunger 1154 to pry incontinence device 1102 toward an outlet 1156 located at the distal end of applicator 1150. It is possible that plunger 1154 is configured with a shaped head 1158 in order to facilitate " convergence "(tightening) of the support section 1106 towards the Central axis of the device 1102. Perhaps the plunger 1154 is provided separately from the applicator 1150 and is used only when desired deployment of incontinence device 1102. Perhaps the expanding section 1152 begins to expand at an appropriate location on the applicator to indicate the correct insertion depth. In one embodiment, the applicator 1150 is basically open at the proximal end (unlike the applicator 1150 shown in FIG. 11B, which is basically closed). In some embodiments, the open proximal end is provided with a protrusion that corresponds to a protrusion on the plunger 1154, designed to prevent displacement of the plunger 1154 from the applicator 1150.

On figa shows a side view of the applicator 1200 with slots and with a sliding sleeve 1202 in accordance with an exemplary embodiment of the invention. The sliding sleeve 1202 is optionally located on the outer surface of the applicator 1200 and is configured to move up and / or down along the length of the applicator 1200. It can be seen that the applicator 1200 is configured with a plurality of slots 1204 in an exemplary embodiment of the invention. Perhaps the shape and / or number of slots 1204 correspond to the shape and / or number of support arms of the incontinence device. In an exemplary embodiment, the shelf life of the incontinence device is increased due to the fact that the device is stored in a compressed configuration inside the applicator. Instead, the support arms of the incontinence device 1206 may protrude out of the slots 1204 before deploying the device into the patient's vagina, as shown in FIG. 12B.

Fig. 12C is a section through a slotted applicator 1200 with a sliding sleeve 1202 into which an incontinence device 1206 is loaded in accordance with an exemplary embodiment of the invention. From this perspective, it can be seen that while the incontinence device 1206 is located inside the applicator 1200, it is partially located outside the applicator 1200, and the compressive force acting on the support branches 1208 during storage is avoided. In some exemplary embodiments of the invention, the sliding sleeve 1202 is provided with a reservoir 1210 from which substances can be applied to the surface of the applicator 1200. It is possible that the reservoir 1210 is provided with a plurality of openings between itself and the applicator 1200 to allow for the deposition of substances, stored therein to the surface of the applicator 1200. The substance that is stored in the reservoir 1210 may be a lubricant. Perhaps the substance that is stored in reservoir 1210 is a drug. The application of substances in the reservoir 1210 to the applicator 1200 is possible by moving the sliding sleeve 1202 up and / or down along the surface of the applicator 1200. In some exemplary embodiments of the invention, a lubricant is applied to the applicator 1200 from the reservoir 1210 before insertion of the applicator 1200 into the vagina to facilitate insertion of the applicator 1200 into the vagina and deployment of the incontinence device 1206 used within the applicator 1200.

12D is a side view of the slotted applicator 1200 with the sliding sleeve 1202, with the sliding sleeve 1202 in the deployment position, in accordance with an exemplary embodiment of the invention. Before deploying the incontinence device 1206, the sliding sleeve 1202 is moved along the applicator 1200 to its proximal end (closest to the vaginal opening when the applicator is inserted into the vagina), where the sliding sleeve 1202 is locked in position when deployed. The movement of the sliding sleeve 1202 leads to the pushing of the branches 1204 in the slot 1204, which ensures their preparation for deployment. After the sliding sleeve 1202 reaches its deployment position, it is held in place by a prong 1212 designed to prevent it from sliding backward toward the distal end 1214 of the applicator 1200. When the sliding sleeve 1202 is in the deployed position, branches 1208 are forced to the central axis of the incontinence device 1206, so that the device can be deployed from the applicator 1200. In some exemplary embodiments, Nia invention, the movement of the sleeve is not carried through its sliding (slip) but instead the sleeve moves up and down on the applicator 1200 by screwing and unscrewing it along the threads disposed on the outer surface of the applicator 1200.

On figa shows the applicator 2500, which is a three-part applicator with slots, designed to reduce the load on the device 2508 used for incontinence and placed therein during storage, in accordance with an exemplary embodiment of the invention. Applicator 2500 includes a sheath 2502, a slotted section 2504, and a plunger 2506 in one embodiment of the invention. Section 2504 with slots is essentially cylindrical and made with slots (similar to slots of applicator 1200) that correspond to the number and approximate size of support branches 2512 of tool 2508. During storage of tool 2508, support branches 2512 protrude from slots made in section 2504 with slots, as a result, the compressive forces acting on the device 2508 and causing stresses in it are reduced, and the service life during storage is increased, and the characteristics of the device 2508 are improved when its application. Perhaps supporting branches 2512 are protected by a bag or closing element while they are open.

In an exemplary embodiment of the invention, the slit section 2504 is coaxially mounted on the inner circumferential periphery of the sheath 2502 so that the slots remain open, thereby allowing the support branches 2512 of the fixture 2508 therein to protrude outward. The plunger 2506 is mounted coaxially on the inner circumferential periphery of the slotted section 2504, possibly provided with a protrusion 2518 in contact with the insert 2510, the insert 2510 being used to allow expansion of the support branches 2512 for deployment to provide treatment. In one embodiment, the plunger 2506 is slidable within the slit section 2504, and the slit section 2504 is slidable within the shell 2502.

In one embodiment, the slotted section 2504 is mounted in a friction fit in the jacket 2502 so that more force is required on the plunger 2506 to smoothly move the slotted section 2504 inside the jacket 2502 than to attach the insert 2510 to the tool 2508. In the process 25B, the plunger is moved by the user towards the distal end 2514 of the sheath 2502, which leads to the placement of the insert 2510 in the device 2508, but without significant displacement of the section 2504 with the prop ezami. The force that continues to act on the plunger 2506 toward the distal end 2514 after the insert 2510 is placed causes the slit section 2504 to shift toward the distal end 2514 of the sheath 2502. It should be noted that although the insert 2510 provides a radial expanding force to support branches 2512, while the fixture 2508 is still inside the applicator 2500, the flexibility of the fixture 2508 and possibly the inserts 2510 allow temporary compression of the fixture 2508 before stretching lkivaniem him out of the applicator 2500 and the deployment of user vagina. In an exemplary embodiment, deployment of tool 2508 occurs shortly after placement of insert 2510 in tool 2508.

As shown in FIG. 25C, the slotted section 2504 continues to move within the shell 2502 until the circumferential peripheral ring 2516 located around the distal end of the slotted section 2504 abuts the shell 2502. At least one protrusion is optionally used instead of the peripheral peripheral ring 2516. Continued application of force to the plunger 2506 will push the device 2508 out of the applicator 2500, and the force exerted by the insert 2510 on the support branches 2512 will ensure their radial expansion in the given floor zhenii in user the vagina, resulting in support for the user's urethra is created. Perhaps the support is a support for the middle part of the urethra.

An exemplary embodiment of a telescopic applicator

26A shows an applicator 2600, which in some embodiments is capable of receiving an axially compressed configuration before use. In addition, applicator 2600 prepares incontinence device 2604 for use during deployment in some embodiments of the invention. A telescopic applicator may be desirable, for example, for more convenient storage (takes up less space). For the applicator 2600, a sheath 2602 is provided in which the incontinence device 2604 is contained (the shown device 2604 is the device of FIGS. 27A-B) and most of the plunger 2606 while the applicator is in a compressed configuration. In an exemplary embodiment of the invention, an insert 2612 used to facilitate deployment of the fixture 2604 is attached to the actuation / retrieval fixture 2608 for the reasons given below. Optionally, the actuation / retrieval device 2608 is attached to the applicator 2600 and can be detached by a latch 2610.

In an exemplary embodiment, prior to using the applicator 2600 to deploy the incontinence device 2604, the plunger 2606 is pulled down to the configuration shown in FIG. 26B. Mating protrusions 2614 are provided on the plunger 2606 and the sheath 2602 to prevent the displacement of the plunger 2606 as it exits the applicator 2600 in some embodiments of the invention. A pulling force applied to the plunger 2606 causes the insert 2612 to partially pass through the fixture 2604, since the insert 2612 is attached to the actuator 2608 for actuation / extraction and the device 2608 for actuation / extraction is attached to the plunger 2606 through the latch 2610. Enlarged distal end the insert 2612 prevents the situation in which the insert 2604 completely passes through the device 2604. The proximal end of the insert 2612 is adapted to provide radial expansion of the support branching device 2604, particularly the deployment of device 2604 out of applicator 2600 and as described with reference to Figures 27A-B. In an exemplary embodiment, the latch 2610 is detached from the actuation / retrieval fixture 2608 to enable deployment of the fixture 2604 from the applicator 2600. Deployment is possible by moving the plunger 2606 forward toward the distal end of the applicator 2600 and pushing the fixture 2604 from the applicator.

Exemplary Plunger

13 is a sectional view of a telescopic plunger 1300 in accordance with an exemplary embodiment of the invention. In some situations, it is desirable to minimize the size of the entire package with an incontinence device, which typically includes an applicator, an incontinence device, and / or a plunger in some exemplary embodiments of the invention. The plunger, for example, is long enough to push the incontinence device out of the applicator, but is also long enough for the patient to manually actuate it. In an exemplary embodiment of the invention, the size of the plunger during storage is reduced by performing a telescopic plunger 1300. To reduce the length of the package with the device without changing the dimensions of the applicator, the plunger may be delivered in a “closed” or folded state that “expands” to deploy the device used for incontinence. In an exemplary embodiment of the invention, the telescopic plunger 1300 is made with two parts, one of which is inside the other. The outer part 1302 of the plunger 1300 is partially held inside the applicator body, as in the case of a non-telescopic plunger, while the inner part 1304 of the plunger 1300 is located at least partially inside the outer part 1302.

The deployment of the plunger 1300 in an exemplary embodiment of the invention provides for holding the inner portion 1304 and pulling it from the outer portion 1302 to the “open” position. Continued pulling of the inner portion 1304 from the outer portion 1302 causes the inner portion 1304 to be locked in the outer portion 1302 by an insert 1306 that is located on the inner portion 1304 and which enters a recess 1308 adapted to receive the insert 1306 and / or fix the insert 1306 relative to the outer portion 1302.

The plunger 1300 may be provided with a ring 1310, which, when inserted into the applicator, provides at least slight friction between the plunger 1300 and the applicator while these two elements are moving relative to each other, and is also intended to prevent the plunger from freely falling out of the applicator. Perhaps the ring 1310 consists of rubber. Perhaps the ring consists of a polymer-based substance. Perhaps ring 1310 is flexible. In some exemplary embodiments of the invention, the applicator is provided with a protrusion at its proximal opening where the plunger is to be inserted. This protrusion is adapted to counteract the possibility of the passage of the plunger 1300 and the ring 1310 without at least some slight force being applied by the person inserting the plunger 1300 into the applicator. In an exemplary embodiment of the invention, after the plunger 1300 is inside the applicator, this protrusion will prevent the plunger 1300 from moving back from the applicator, preventing the plunger from inadvertently moving out of the applicator.

Additional exemplary embodiments of the invention

It should be noted that a round ring (not shown in any figures), but previously described in document PCT / IL2005 / 000304, which is incorporated herein by reference, can be located on any applicator to indicate the proper depth of insertion of the applicator into the vagina. Perhaps the ring may be provided with selectable positions appropriate for women with different sizes to ensure personalization.

In addition, any of the incontinence devices described herein can be used with a closure element. In an exemplary embodiment of the invention, the closure member is made of a flexible, smooth mesh material. Perhaps the closure element is porous. The closure element may be in the form of a small bag that covers the incontinence device like a casing, while the incontinence device serves as an internal support structure for the closure element. Using a closure element can potentially provide one or more advantages when using the fixture. For example, the closure element may provide a reduction in friction between the applicator and the device during insertion. In addition, the closure element may provide a reduction in friction between the vagina and the device during insertion and / or extraction. In some embodiments of the invention, the mesh of the closure element, being stretched between the branches of the device, serves as a hanging support for the urethra. In a woman who excretes urine during an event related to stress (when the pressure in the abdominal cavity rises during coughing, sneezing, etc.), the urethra sags down, but encounters a blocking element in its middle part. This causes an increase in pressure inside the urethra, resulting in retention of urine. Perhaps the closure element provides support for the urethra. In an exemplary embodiment of the invention, the device does not press on the urethra or neck of the bladder, but only provides support when there is an increase in pressure in the abdominal cavity, as described above. Perhaps the device provides direct application of pressure to the urethra and / or neck of the bladder. In some embodiments, the closure element is disposable. Perhaps the closure element is sterilized between use cases, and it can be used repeatedly. Perhaps the cover element is decorated.

In some embodiments, the closure member facilitates removal of the device from the vagina. Firstly, the closure element may provide a reduction in friction between the incontinence device and the vaginal wall. Secondly, the closure element is optionally provided with an extraction device, such as a cord. It is possible that the closure element and the extraction device are formed from the same, integral piece of material. The extraction tool may contribute to the removal of the device for a number of reasons. Pulling the extraction device causes the closing element to be pulled. Tightening the closing element causes the walls of the vagina to straighten. Straightening the walls of the vagina leads to a decrease in the effect similar to the “pull” effect described above, and to the removal of the tensile force exerted on the device, which makes it possible to easily and smoothly remove the device from the vagina. In addition, the application of a pulling force to the extraction device may cause slight bending of the support and fixing branches toward the central axis of the incontinence device, thereby reducing the radial size of the incontinence device, and allowing easy and smooth extraction devices from the vagina. In an exemplary embodiment of the invention, the device can be stepped out of the vagina by applying a pulling force to the extraction device, causing the support branches to move to the vaginal opening (and thereby pull the fixing section along), suddenly releasing the cord and then repeating the process.

In some exemplary embodiments of the invention, the incontinence device provides lubricant in response to a configuration change and / or during removal of the device. The lubricant may be contained inside the incontinence device.

On figa-C shows a section of devices used for incontinence, which are given only as an example. In some exemplary embodiments of the invention, various cross-sectional configurations are used to vary tensile and compressive stresses occurring in incontinence devices during storage, deployment, use and / or recovery. Possibly, various cross-sectional configurations are used to reduce resistance to some movements of the incontinence device and / or to increase resistance to other movements. Various configurations may be used to prevent necrosis and / or discomfort in the wearer. These figures are used to show some of the many possibilities that can be applied to vary the shape and configuration of the fixtures described here. For example, the quadrilateral and ovoid branch shapes are not shown, but they can also be used in these inventions.

The present invention has been described by using detailed descriptions of embodiments thereof, which are given by way of example and are not intended to limit the scope of the invention. The described embodiments contain various features (elements), not all of which are required in all embodiments of the invention. In some embodiments of the present invention, only some of the features or possible combinations of features are used. Changes to the embodiments of the present invention that are described and the embodiments of the present invention containing various combinations of features noted in the described embodiments are possible for those skilled in the art. When used in the following claims, the terms “comprises”, “includes”, “has” and the words having the same root mean “including, but not limited to”. The scope of the invention is limited only by the following claims.

Claims (23)

1. Device for the treatment of urinary incontinence, containing
a support section adapted to provide support for the urethra;
a fixing section connected to the support section and adapted to prevent the movement of the specified device into the vagina;
an insert separate from the support section, part of which is adapted to be placed within the boundaries of the support section, the insert being configured to provide support for the support section of the device. 2. The device according to claim 1, in which the insert is adapted to create pressure acting on the support section, which causes radial expansion of the support section. 3. The device according to claim 1, in which the support section is flexible. 4. The device according to claim 1, in which the support section is formed of at least one support arm. 5. The device according to any one of the preceding paragraphs, in which the insert contains an o-ring. 6. The device according to any one of claims 1 to 4, in which the insert is expandable. 7. The device according to any one of claims 1 to 4, in which the insert is conical. 8. The device according to any one of claims 1 to 4, in which the insert is formed of many geometrically linked to each other elements. 9. The device according to any one of claims 1 to 4, in which the insert is formed of at least a support protrusion and a locking protrusion. 10. The device according to any one of claims 1 to 4, in which the insert is a reversible insert. 11. The device according to any one of claims 1 to 4, in which the insert is an insert with a ring. 12. The device according to any one of claims 1 to 4, further comprising an elastic supporting element. 13. The device according to item 12, in which the support section is configured to bias towards the Central axis of the specified device by means of an elastic support element. 14. The device according to item 12, in which the support section is configured to bias from the Central axis of the specified device by means of an elastic support element. 15. The device according to any one of claims 1 to 4, in which the support section and the fixing section are formed by at least two shoulders, respectively. 16. The device according to clause 15, in which these shoulders are made with a folding part. 17. The device according to any one of claims 1 to 4, in which at least the support section and the fixing section are flexible. 18. The device according to 17, and the specified device is flexible. 19. The device according to any one of claims 1 to 4, further comprising a retrieval device. 20. The device according to any one of claims 1 to 4, in which the support for the urethra is a support for the middle part of the urethra. 21. The device according to any one of claims 1 to 4, further comprising a closure element. 22. The device according to item 21, in which the closing element essentially encapsulates the specified device. 23. The device according to any one of claims 1 to 4, in which the specified part of the insert is adapted to be inserted inside the support section while providing the specified support.

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