ES2833406T3 - Incontinence treatment device including a non-porous suburethral sling - Google Patents

Abstract

Incontinence treatment device (20), comprising: a non-porous sling (22); a first fixture (40); a first line (50) attached to the first end (24) of the non-porous sling (22) and connected to the first fixture (40); a first extension member (30) attached to the first end (24) of the non-porous sling (22) with the first attachment (40) attached to the first extension member (30); a second fixture (42) provided with a channel (90) formed through the second fixture and including a limiter segment (96) disposed in the channel (90); and a second line (52) attached to a second end (26) of the non-porous sling (22) and introduced through the channel (90) of the second fixture (42), the second line (52) including a device (62 ) adjustment attached to the second line (52); a second extension member (32) attached to the second end (26) of the non-porous sling (22) with the second attachment (42) attached to the second extension member (32); wherein the limiter segment (96) is configured to resist movement of the adjustment device (62) through the channel (90); characterized in that the adjustment device (62) can be moved through the channel (90) from a first position, which places the adjustment device (62) between the second fixation (42) and the non-porous sling (22), to a second position, which positions the second fixture (42) between the adjustment device (62) and the non-porous sling (22), thereby to tighten the non-porous sling (22) by shortening an effective distance of the device (20), between the first and second fixation (40, 42), and because the first fixation (40) is provided with a hole formed through the first fixation (40), and the first line (50) is inserted through the hole of the first fixture (40), and wherein furthermore the first line (50) includes a stop device (60) attached to the first line (50), with the first fixture (40) located between the stop device (60) and the non-porous sling (22).

Description

DESCRIPTION

Incontinence treatment device including a non-porous suburethral sling

Background

Devices for treating urinary incontinence include slings, supports, artificial urinary sphincters, and other devices that are implanted in a user to support and / or close the urethra.

A sling is a device that is surgically implanted to support the urethra and inhibit undesirable leakage of urine from the urethra. Slings are typically made from mesh and are implanted through one or more incisions. The sling is attached to a supporting tissue or tissues and the tissue eventually grows through the mesh to support the urethra. The surgeon will determine and apply perioperatively the appropriate level of tension in the sling with respect to the urethra that will allow the user to achieve a condition of continence after the intervention.

US 2010/312052 describes a magnifying device comprising an inflatable bag, a support and a pump. The support includes a first connection line and a second connection line that can each be attached to soft tissue to dispose the inflatable bag with respect to a tubular member of a human body. A first clamp is connected to the first connection line and a second adjustable clamp is connected to the second connection line. The adjustable fixture includes a body with a through channel and a collar defining openings that allow a frictional sliding joint and passage of the first connecting line between the body and the collar.

An improvement in incontinence treatment devices would be welcomed by the patient and the surgical staff.

Resume

One aspect discloses an incontinence treatment device according to the appended claims. Brief description of the drawings

The accompanying drawings are included to facilitate understanding of the embodiments and are incorporated into and constitute a part of this specification. The drawings show the embodiments and, in conjunction with the description, serve to explain the principles of the embodiments. Other embodiments and many of the anticipated advantages of the embodiments will become apparent upon a better understanding by referring to the following detailed description. Items in the drawings are not necessarily represented to scale with each other. Like reference numbers indicate corresponding like parts.

Figure 1 is a perspective view of one embodiment of an incontinence treatment device provided with a fixture and an adjustment device.

Figure 2 is a perspective view of the fixture and adjustment device shown in Figure 1.

Figure 3 is a sectional view of the fixture and adjustment device shown in Figure 1.

Figure 4A is a schematic view of an incontinence treatment device implanted in the user and configured to allow passage of urine.

Figure 4B is a schematic view of the incontinence treatment device shown in Figure 4A adjusted to close the user's urethra.

Figure 5A and Figure 5B show various adjustment states of the incontinence treatment device shown in Figure 4B.

Figure 6 is a schematic view of one embodiment of an incontinence treatment device implanted in a user.

Figure 7 is a schematic view of one embodiment of an incontinence treatment device implanted in a user.

Detailed description

In the following detailed description, reference is made to the accompanying drawings, which form a part thereof, and in which specific embodiments according to which the invention may be implemented are shown by way of example. In this regard, the direction terminology, such as "top", "bottom", "front", "rear", "front", "rear", etc., is used with reference to the orientation of the figure or figures. described. Because the components of the embodiments may be arranged in several different orientations, the directional terminology is used for illustrative purposes and is not in any way limiting. It will be understood that it is possible to use other embodiments and that structural or logical changes are possible without departing from the scope of the present invention. Therefore, the following detailed description shall not be construed in a limiting sense, and the scope of the present invention is defined by the appended claims.

It will be understood that it is possible to combine the features of the various illustrative embodiments described herein, unless otherwise specified.

Tissue includes soft tissue, which includes dermal tissue, subdermal tissue, ligaments, tendons, or membranes. In the present specification the term "tissue" does not include bone.

In this specification, the word "close" means to close or close substantially. To close an opening is to join two surfaces by bringing them closer together, so that the free space between the two surfaces is reduced or eliminated. Closing the urethra means closing the urethra substantially, albeit reversibly, to prevent the passage of urine and allow a person to achieve a condition of continence.

In this specification, a "user" is a person who has been implanted with an incontinence treatment device.

In this specification, "non-porous" means a material without through holes. For example, although the non-porous material may include depressions and / or cavities in the surface of the material, the material does not have holes that extend through the material from one surface to the other surface. Therefore, in this specification, non-porous means a material that is configured to prevent tissue growth through the implanted material.

The embodiments disclose an incontinence treatment device provided with a non-porous support and an adjustment mechanism attached to the support. The non-porous support does not promote or allow tissue growth through the support, so the support will be able to move relative to the tissue long after it has been implanted. The adjustment mechanism has the function of adjusting and moving the non-porous support. The adjustment mechanism moves the support between a first position that allows the passage of urine and a second position that closes the urethra. The adjustment mechanism is arranged as an adjustment device that is frictionally attached to a limiting segment arranged within a channel of a fixture. The adjustment device is adapted to be forced as the limiter segment passes into the second position, which is configured to tighten the bracket and close the urethra.

Figure 1 is a perspective view of one embodiment of an incontinence treatment device 20. The incontinence treatment device 20 (device 20) includes a sling 22 or a support 22 provided with tissue attachments 40, 42 and an adjustment mechanism 70. The tissue attachments 40, 42 secure the sling 22 in position in the pelvis and the adjustment mechanism 70 is accessible by the user / patient to adjust the position of the sling 22. The sling 22 is arranged as a non-porous material that prevents growth of body tissue in or through sling 22 after implantation. The adjustment mechanism 70 may have the function of moving the sling 22 with respect to the tissue in order to move the sling 22 between a first position, which allows the passage of urine through the urethra, and a second position, which closes the urethra. Sling 22 includes a first end 24 and a second end 26. Device 20 includes a first extension member 30 attached to first end 24 and a second extension member 32 attached to second end 26 of bracket 22, a first attachment 40 attached to the first extension element 30 and a second clamp 42 attached to the second extension element 32, with a first line 50 inserted through the first clamp 40 and with a second line 52 inserted through the second clamp 42. The first line 50 is attached to the first end 24 of the sling 22 and is provided with a stop device 60. The first fixation 40 is arranged between the stop device 60 and the sling 22. The second line 52 is connected to the second end 26 of the sling 22 and is provided with an adjustment device 62. Adjuster 62 is movable through a channel formed in second fixture 42, so that adjuster 62 and second fixture 40 combine to form adjusting mechanism 70.

Sling 22 is configured to be implanted in a user to support the urethra and treat incontinence. In one embodiment of the sling 22, it consists of a suburethral sling 22 that is implanted under or below the urethra. In one embodiment, each of the first and second attachments 40, 42 is secured in position relative to sling 22, for example, by attaching a length of the first and second extension members 30, 32 and the posterior connection. of the fixings 40, 42 to one of the respective elements 30, 32. The adjustment of the device 20 is carried out by the adjustment mechanism 70.

The adjustment mechanism 70 has the function of moving the sling 22 between a first configuration that allows the passage of the user's urine and a second configuration that supports and closes the urethra to allow the user to achieve a condition of continence. In one embodiment, the adjustment mechanism 70 may be actuated by the user long after the sling 22 has been implanted and the surgical incision has healed. With this in mind, in one embodiment, the suburethral sling 22 is arranged as a non-porous film that is adapted to reduce or prevent tissue growth through the sling 22, allowing the sling 22 to move or slide with respect to the sling. to tissue after implantation.

Suitably, sling 22 is made from polymer materials. For example, in one embodiment, sling 22 is a synthetic material made from rubber, silicone, thermoplastic polymers, thermoset polymers, or suitable polymer blends or copolymers. A suitable sling 22 is molded from silicone polymer.

Extension elements 30, 32 are attached to fixtures 40, 42, respectively. Extension elements 30, 32 and fasteners 40, 42 are made from material suitable for implantation in the human body. Preferably, extension elements 30, 32 and fasteners 40, 42 are not bioabsorbable after implantation. By way of example, extension elements 30, 32 and fasteners 40, 42 are suitably made from polypropylene.

Each of the fasteners 40, 42 is configured to be inserted into and attached to tissue. In one embodiment, each fixture is provided with at least one projection 80 that extends away from a central axis of the fixture and is also configured for attachment to tissue. In the embodiment shown, each of the fasteners 40, 42 includes multiple projections 80 - or fins - that configure each fastener 40, 42 for attachment to tissue upon implantation.

Figure 2 is a perspective view and Figure 3 is a sectional view of one embodiment of the adjustment mechanism 70. One of the fixtures 40, 42, the second fixture 42, is provided with a channel 90 extending between a first end 92 and a second end 94 of the fixture 42. The channel 90 is shaped to include a limiter segment 96 between the first and second ends 92, 94.

In one embodiment, the second extension member 32 is attached to an outer surface of the second fixture 42. In one embodiment, the second extension member 32 is integrally molded with respect to a polymer wall of the second fixture 42.

The second line 52 is introduced through the channel 90 of the second fixture 42. The adjusting device 62 is dimensioned to have a lateral dimension that is larger than a lateral dimension of the limiting segment 96. In this manner, the adjusting device 62 The adjustment is retained in the first end 92 of the bracket 42 when the adjustment mechanism 70 is in a first position that allows the user to urinate. The adjuster 62 is adapted to pull through the limiter segment 96 when a force is applied on the second line 52, pulling the adjuster 62 from the first end 92 to the second end 94 of the fixture 42. The limiter segment 96 is arranged to hold adjuster 62 adjacent to second end 94 of fixture 42 until the user applies a return force on second line 52, at which point adjuster 62 returns through channel 90 to the first end 92 of fixture 42. Selective arrangement of adjuster 62 adjacent to second end 94 of fixture 42 reduces the effective length of sling 22, which has the function of closing the urethra and allowing the user to achieve a condition of continence .

The first and second extension elements 30, 32 are attached to each of the respective anchors 40, 42, and these elements combine to provide the device 20 with a locking mechanism configured to secure the sling 22 to tissue upon implantation. . Upon implantation, sling 22 is suspended in a path having a path length extending between fixtures 40, 42. The first and second lines 50, 52 are movable relative to fixtures 40, 42, respectively. At least one second line 52 is movable through second fixation 42 to shorten the path length of sling 22, allowing the compression to be applied to the urethra to achieve a condition of continence, as shown and described in the Figures 4A and 4B shown below.

Lines 50, 52 are made from material suitable for implantation in the human body. Preferably, lines 50, 52 are not bioabsorbable after implantation. By way of example, the lines are suitably made from polypropylene.

Figure 4A is a schematic view of the implanted device 20. When implanted, the non-porous structure of sling 22 will provide strength and prevent tissue growth through or attachment to sling 22. Eventually, a protective pocket of epithelial tissue will grow around device 20. The non-porous nature of sling 22 allows parts of device 20 to move within the tissue pocket surrounding sling 22.

During implantation, the first and second anchors 40, 42 are fixed in tissue and the sling 22 is suspended along a path length PL1 that extends between the anchors 40, 42 below the urethra U. 40, 42 are attached to the tissue, the non-porous sling 22 can move freely relative to the tissue. The adjustment mechanism 70 occupies a first position in which the adjustment device 62 is located between the sling 22 and the second attachment 42. In the first position shown, the sling 22 is located below urethra U and urethra U is not closed, allowing the passage of the user's urine. The adjustment mechanism 70 has the function of moving the sling 22, shortening the trajectory length PL1, which tightens the sling 22 to close the urethra U, as shown in Figure 4B.

Figure 4B is a schematic view of device 20 with a force F applied on second line 52 that is sufficient to pull adjustment device 62 through fixture 42. Referring further to Figure 3, force F applied on the second line 52 pulls the adjuster 62 through the limiter segment 96 until the adjuster 62 is disposed at the second end 94 of the fixture 42. The selective arrangement of the adjuster 62 through the fixture 42 to arranging the clamp 42 between the adjusting device 62 and the sling 22 moves the adjusting mechanism 70 to a second position that shortens the path length PL1 to a shorter path length PL2. The shorter path length PL2 allows the sling 22 to be compressed and the urethra U closed. In the second position shown, the sling 22 effectively tightens and shortens the distance of the device 20 between the first and second fixings 40, 42, which closes the urethra U to allow the user to achieve a containment condition.

Figures 5A and 5B are schematic views of device 20 with a force F applied in the first line 50 (Figure 5A) to move the adjustment mechanism 70 from the second position to return to the first position (Figure 5B) in order to allow the passage of the user's urine. For example, the force F applied on the first line 50 pulls the stopper 60 away from the first fixture 40 and pulls the adjusting fixture 62 to again pass through the channel 90 (Figure 3) formed in fixture 42. In this way, the adjuster 62 is repositioned between the sling 22 and the fixture 42, which releases the sling 22. Arrangement of the adjuster 62 between the sling 22 and the fixture 42 effectively increases the distance of the sling. device 20 between fixings 40, 42. Increasing the effective distance of device 20 relieves tension on sling 22, which releases pressure from sling 22 against urethra U to allow opening of urethra U and passage of the urine.

The incontinence treatment device 20 can be implanted in the user's pelvis. The adjustment mechanism 70 has the function of allowing the user to select a first configuration of the device 20 that allows urination or a second configuration that allows the user to achieve a condition of continence.

In one example, the first line 50 and the second line 52 are directed to a location outside of the patient's body (eg, through the abdominal wall or through the groin) to allow the user to selectively access and move the adjustment mechanism 70.

In one example, the first line 50 and the second line 52 are directed to a location within the patient's body (for example, within the scrotum or lips) and also have the function of allowing the user to access the device. adjustment mechanism 70.

Figure 6 is a schematic view of device 20 implanted in the pelvis P of a user. In one example, each of the attachments 40, 42 is suitably implanted into a membrane of the obturator foramen OF in order to dispose the sling 22 under the urethra U. Each of the first and second lines 50, 52 are directed through the patient's skin to a location outside the body that allows the user to adjust the adjustment mechanism 70 and move the urethra U between open and closed positions. A suitable antibiotic or barrier is used on the skin to prevent migration of bacteria along lines 50, 52 into the patient's body.

Device 20 is configured for implantation into the patient through a single incision. In an illustrative approach, a single incision is made adjacent to the urethra and tissue is dissected to expose urethra U. A suitable introducer tool is used to direct the first fixation 40 to the membrane covering the first obturator foramen OF and to allowing the first line 50 to pass through the skin to a location outside the body. A similar introducer tool is used on the contralateral side of the body to dispose the second fixation 42 in the membrane covering the second obturator foramen OF and to pass the second line 52 through the skin to a location outside the body. In a suitable implantation procedure, the incision is made to expose the urethra (a vaginal incision in the case of a female or a perineal incision in the case of a male) and the introducer tool is moved in a " out inward ”from the groin, through the membrane located over the obturator foramen OF, around the descending pubic branch PR, and out of the incision for attachment to the first line 50 and the first fixation 40. It is pulled towards behind the introducer tool already attached to the first line 50 and to the first fixture 40 along its path around the descending pubic branch PR, through the obturator foramen OF, and exiting the skin. A similar "out-in" path is used on the contralateral side of the body to provide the second line 52 and the second fixation 42.

Figure 7 is a perspective view of the device 20 implanted in the pelvis P of the user, with the first and second lines 50, 52 implanted under the skin and in the body of the user. In one example, the attachments 40, 42 are attached to the tissue covering the obturator foramen OF to suspend the sling 22 below the urethra U. In one example, each of the first and second lines 50, 52 passes suitably to an indoor location of the body, such as into the skin of the scrotum or into the lips of a female user. It is desirable that the user be able to apply a force using the first line 50 and the second line 52. With this in mind, a clamping device 98 is attached to one end of each of the lines 50, 52 to allow the user to apply a pulling force along lines 50, 52 to move adjustment mechanism 70 and open / close urethra U.

Although specific embodiments have been illustrated and described herein, one of ordinary skill in the art will understand that it is possible to substitute a variant of alternative and / or equivalent implementations for the specific embodiments shown and described without departing from the scope of the present invention. . This application is intended to cover any adaptation or variation of the medical devices described herein. Therefore, this invention is intended to be limited only by the claims.

Claims (8)

1. Incontinence treatment device (20), comprising: a non-porous sling (22); a first fixture (40); a first line (50) attached to the first end (24) of the non-porous sling (22) and connected to the first fixture (40); a first extension member (30) attached to the first end (24) of the non-porous sling (22) with the first attachment (40) attached to the first extension member (30); a second fixture (42) provided with a channel (90) formed through the second fixture and including a limiter segment (96) disposed in the channel (90); Y a second line (52) attached to a second end (26) of the non-porous sling (22) and introduced through the channel (90) of the second fixation (42), the second line (52) including a device (62) adjuster attached to the second line (52); a second extension member (32) attached to the second end (26) of the non-porous sling (22) with the second attachment (42) attached to the second extension member (32); wherein the limiter segment (96) is configured to resist movement of the adjustment device (62) through the channel (90); characterized in that the adjustment device (62) can be moved through the channel (90) from a first position, which places the adjustment device (62) between the second fixation (42) and the non-porous sling (22), to a second position, which positions the second fixture (42) between the adjustment device (62) and the non-porous sling (22), thereby to tighten the non-porous sling (22) by shortening an effective distance of the device (20), between the first and second fixings (40, 42), and because the first fixation (40) is provided with a hole formed through the first fixation (40), and the first line (50) is inserted through the hole of the first fixation (40), and in which further The first line (50) includes a stop device (60) attached to the first line (50), with the first fixation (40) positioned between the stop device (60) and the non-porous sling (22). 2. An incontinence treatment device according to claim 1, wherein the non-porous sling (22) is a suburethral sling (22). An incontinence treatment device according to claim 1, wherein each of the first fixture (40) and the second fixture (42) includes at least one projection projecting outward relative to a central axis of the fixture. configured for attachment to tissue. Incontinence treatment device according to claim 1, wherein the channel is formed through the second fixture (42) between opposite ends (92, 94) of the second fixture (42) and the limiting segment (96 ) is disposed in the channel approximately midway between the opposite ends (92, 94) of the second fixture (42). An incontinence treatment device according to claim 1, wherein the second fixture (42) has a first end (92) and a second end (94), the first end (92) being disposed closer to the sling ( 22) non-porous than the second end (94), and the adjusting device (62) is movable through the channel from the first end (92) to the second end (94), and the limiter segment (96) is configured to offer resistance to movement of the adjusting device (62) from the second end (94) to the first end (92) of the second fixture (42). An incontinence treatment device according to claim 1, wherein the adjusting device (62) is movable through the channel from the second position to the first position to thereby loosen the sling (22) by increasing the distance. effective device (20) between the first and second fixings (40, 42). An incontinence treatment device according to claim 1, wherein each of the first and second attachments (40, 42) includes at least two tissue attachment wings (80) that configure each attachment for insertion into a membrane that covers an obturator foramen of a user. Incontinence treatment device according to claim 1, wherein the first line (50) is coaxial with respect to the first fixation (40) and the second line (52) is coaxial with respect to the second fixation (42 ).