READJUSTABLE MIDURETHRAL SLING

Abstract

An adjustable midurethral sling is provided. The adjustable midurethral sling includes a midurethral sling, a frame, an adjustment suture, a housing, two end parts, tunnel opening hooks, outlets, and tunnel opening hook insertion holes. The adjustable midurethral sling is used in a surgical treatment of an involuntary leakage, wherein the involuntary leakage is defined as a urinary incontinence in cases of an abdominal pressure increase as a result of coughing, sneezing etc.

Claims

1. A re-adjustable midurethral sling, comprising; a midurethral sling, wherein the midurethral sling is implanted from a transobturator or retropubic route with a carrier arm to a midurethral region, a frame, wherein the frame partially covers one side of the midurethral sling, an adjustment suture enabling loosening and tightening, a housing, wherein the housing hides the adjustment suture, two end parts gripping both tail ends of the midurethral sling, tunnel opening hooks, wherein the tunnel opening hooks are is to be adapted to a surgery by being attached to the two end parts at an application direction, outlets, wherein the outlets are thinner from each end part enabling to attach the each end part tightly to each tunnel opening hook, and tunnel opening hook insertion holes, wherein the tunnel opening hook insertion holes enable an insertion of the tunnel opening hooks at the two end parts.

2. The re-adjustable midurethral sling according to claim 1, comprising two end part guides.

3. The re-adjustable midurethral sling according to claim 1, wherein the midurethral sling is macroporous.

4. The re-adjustable midurethral sling according to claim 1, wherein material of the midurethral sling is selected from the group consisting of polyester, polypropylene, polyurethane, polyamide, silicon, polytetrafluoroethylene, polyethylene terephthalate, a latex and a thermally shaped plastic.

5. The re-adjustable midurethral sling according to claim 1, wherein the frame is selected from the group consisting of polyester, polypropylene, polyurethane, polyamide, silicon, polytetrafluoroethylene, polyethylene-terephthalate, a biopolymer, a latex and a thermally hardened plastic.

6. The re-adjustable midurethral sling according to claim 1, wherein the each end part is selected from the group consisting of polyethylene, silicon rubber, natural rubber, soft polyvinyl, a thermally shaped biocompatible plastic and an elastic biopolymer.

7. The re-adjustable midurethral sling according to claim 1, wherein each tunnel opening hook is biocompatible.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0009] FIG. 1, Adjustable midurethral sling and its attachments

[0010] FIG. 2, End parts and midurethral sling articulation of the end part

[0011] FIG. 3, Hook attachment to the end part enabling tunnel opening from different directions

[0012] FIG. 3A, Transobturator route in-out and retropubic route down-up implantation feature

[0013] FIG. 3B, Transobturator route out-in and retropubic route up-down implantation feature

[0014] FIG. 4, The views of the coated and uncoated sides of the midurethral sling

[0015] FIG. 4A, View of the coated side of the midurethral sling

[0016] FIG. 4B, View of the uncoated side of the midurethral sling

[0017] FIG. 5, View of the tunnel opening hook attached to the end part, when the end part is available in the kit in a detached way

[0018] FIG. 6, View of the midurethral sling and the end part guides hinged to said sling which aid in the implantation of the midurethral sling when the end part is available in the kit in a detached way

[0019] FIG. 7, View of the attachment of the midurethral sling to the end part by means of the end part guides from the transobturator route from outside-inside or from the retropubic route in the down-up direction when the end part is available in the kit in a detached way

[0020] FIG. 8, View of the attachment of the midurethral sling to the end part by means of the end part guides from the transobturator route from inside-outside or from the retropubic route in the up-down direction when the end part is available in the kit in a detached way

REFERENCE NUMBERS

[0021] 1 Midurethral Sling [0022] 2 Single side coating [0023] 3 Adjustment suture [0024] 4 Adjustment suture housing [0025] 5 Midurethral Sling end part [0026] 6 Midurethral Sling end part tail section [0027] 7 Tunnel opening hook [0028] 8 End part outlet holes [0029] 9 Tunnel opening hook insertion holes [0030] 10 End part guide

DETAILED DESCRIPTION OF THE EMBODIMENTS

[0031] A midurethral sling (1) with macro-pores that has been produced from a biocompatible material that has been implanted from the transobturator or retropubic route with a carrier arm to the midurethral region, wherein the mid and side sections thereof comprises sutures which allow the mesh to be readjusted and wherein one side has been covered with a biocompatible frame (2) made of silicon, polyurethane, or polytetrafluoroethylene derivatives such that said coating prevents damaging of the mesh. The material of the midurethral sling (1) can be polyester, polypropylene (PP), polyurethane (PU), polyamide (PA), silicon, polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET), latex or a thermally shaped plastic structure. Having the coating only on one side, ensures that the mesh is not damaged during displacement when the expected technical force is applied, which also allows successive application of the procedure, and besides this the attachment effect of the surface without coating to the desired tissue in order to provide a treatment effect is allowed, therefore a synergy is created where the combination effect is enhanced. In the case that only a mesh is available instead of the coated section, a structure which is not as slippery is obtained; therefore the mesh may be damaged during the re-adjustment procedures in such cases. In the case that the whole mesh is coated the attachment effect to the tissue is weakened. The trauma subjected to the mesh during adjustment is minimized by means of the coating and adjustment is allowed (as many adjustments as necessary) without necessitating the patient to go through a surgical operation even if it is a minor operation. Additionally the usage of an additional material having higher volume or density that is to be attached to the mesh is eliminated by means of the coating process. Biocompatible adhesives can be used in the coating process. These adhesives can be natural or synthetic, collagen based. A coated area (2) can be provided in the same way at both sides from the exact mid section of the macro-porous midurethral sling that is made of biocompatible material. For tightening, after the mesh is implanted, the suture (3) is passed from the closest coating region remaining under the skin, and is taken out of the side of the incision and is fixed. Therefore a system is provided which allows increasing tightness when both sides are pulled at the same time and which prevents the rupturing of the mesh whilst doing this. In the same way, for the loosening function the two sutures (3) close to the mid section of the mesh are taken out of the side of the vagina case by passing them through the area where coating can be provided, and said sutures are then fixed. Therefore loosening function can be provided if necessary. The needles that are provided at the end sections of the sutures designed for providing the adjustment function are cut after being taken outside, and are knotted to each other or if they are not knotted they can be placed inside a housing (4). When the function related to adjustment is completed the sutures are cut and removed easily. The midurethral sling (1) has been attached from the tail section (6) at both sides to the end part (5), that is made of a biocompatible high density polyethylene, silicon, natural rubber, soft PVC and other similar material. The end part (5) is such that it is biocompatible and it can tightly grip the metal tunnel opening hook (7). The end part (5) must allow the usage of the tunnel opening hook (7) according to the implantation route of the midurethral sling, namely from the transobturator route, in-out, out-in, or retropubic route as down-up, up-down. When the end part (5) is attached to the tunnel opening hook (7), it is attached such that it tightly winds around the hook in order to ensure that the midurethral sling (1) does not detach itself from the hook against the resilience it shall encounter when travelling through the tissue. The end parts (5) can not only be fixed to the midurethral sling (1) but they can also be provided as detached parts inside the set. In such a case the end part (5) shall be placed according to the desired direction, independent from the tunnel opening hook and the midurethral sling (1). Following this, when the tunnel opening hook (7) is taken out, an end part (5) which is ready to implant the midurethral sling (1) can be obtained inside the tunnel. At this stage, the midurethral sling (1) shall be able to be implanted into the body by being driven, using the tunnel opening hook attachment holes (9) from inside the end part (5) via the end part guides (10) located at the ends thereof. When the midurethral sling (1) is implanted into the body, the end part (5) and the end part guides (10) are removed and the procedure is completed. In the case that the end part (5) is fixedly attached to the midurethral sling (1), the transobturator application shall be as in-out or out-in. This situation is suitable only for the usage of the dominant hand of the expert carrying out the application in one direction. In the case that the end part (5) is provided as an independent part inside the kit, and the midurethral sling (1) is implanted into the body by being passed through the end part (5) via the end part guides (10), the person carrying out the application can use his/her dominant hand in both directions. When the end part (5) is provided as an independent part inside the kit, this allows the synchronous moving of the midurethral sling (1) via the end part guides (10) in both directions.

[0032] There may be three types of hooks inside the set; one each for two types, two for another type that is left and right; the total of the hooks can be 5 at most. The novelty is that the desired hook can be used for all application types, without needing to make any changes on the mesh. In order for the end part (5) to be able to be attached via the hook at the desired frequency to all routes mentioned above, the outlets (8) on both ends of the end part are smaller in dimension when compared to the body; and at the top and the bottom proximal to the outlets (8) entrance holes (9) into which the tunnel opening hook (7) is inserted to the end part (5), are provided. After the midurethral sling (1) is implanted, first the tunnel opening hooks (7) and then the end parts (6) are removed from the area of implantation. Following this a suture (3) is stitched to the midurethral sling (1) under the skin at a section that is closest to said sling and afterwards the suture is taken out of the incision area and is kept inside a housing (4) outside the skin. The same procedure shall be carried out from the mid section of the vagina wall and this loosening function is provided. When the end parts (5) are provided independently inside the kit and the end part guides (10) are used for midurethral sling implantation (1), the independent end parts (5) are placed via the tunnel opening hooks (7) inside the body at the desired direction and the guides (10) are removed from the tunnel opening hooks (7) leaving the midurethral sling inside the tunnel that has been prepared. The midurethral sling (1) is moved by means of the hook attachment holes (9) from inside the end parts (5) via the end part guides (10). When the end part guide (10) is visible outside the tissue after being moved inside the end part (5), first of all the end part (5) is removed and then the end part guide (10) is separated outside of the skin, from the midurethral sling (1). The implantation and adjustment applications following this, is the same with the applications where the end part (5) is fixed to the midurethral sling (1).