FR2878734A1 - Urethral support device to treat incontinence, comprises an implantable element and a removable sheath, where element having monofilament knitted polypropylene fabric with a principal axis to make the fabric inextensible in axis direction - Google Patents

Abstract

The element (1) is surrounded by a removable sheath. The inextensible fabric comprises: two synthetic suture threads (4), which is parallel to the principal axis (3); and a strip of non-woven polypropylene fibers (6) with two lateral parts are fixed on the median part of the monofilament knitted polypropylene fabric in the direction of the principal axis, where the thread and non-woven fibers pass-repass across the knitted polypropylene fabric. The element (1) having a transversal dimension, which is higher than the rest of the element. The sheath (2) having a zone with two sections, where the zone is placed at the level of the element, which faces the urethra (7). An independent claim is also included for a surgical instrument using the above device.

Description

URETRAL SUPPORT DEVICE AND INSTRUMENT

SURGICAL

  The present invention relates to a urethral surgical support device and its ancillary device for the treatment of female urinary incontinence during exercise.

  Urinary stress incontinence is defined as an involuntary loss of urine through the urethra, triggered by a greater or lesser effort, outside any contraction of the bladder. This situation is very frequent and its consequences are of course medical but also psychological and economic.

  The main factors retained in its mechanism are the loss of the anatomic support of the urethra and the alteration of the intrinsic sphincter mechanism.

  Rehabilitation can be offered in young women. The most often the treatment of stress incontinence is surgical. More than 150 interventions have been described.

  Since 1994, the role of urethral support in continence with effort has been highlighted, resulting in a new surgical technique: the TVT (Tension free Vaginal Tape, vaginal tape with free tension). It is a monofilament knitted polypropylene strip surrounded by a plastic sheath placed under the urethra by vaginal approach and ascending retro-pubic approach. The strip positioned, thanks to a specific ancillary, is released from its sheath by a section of its ends protruding from the skin.

  This plastic sheath which covers the prosthesis allows during the installation not to traumatize and cut through the tissues crossed. The irregular edges of the prosthesis allow self-fixation of the prosthesis in the musculo-aponeurotic tissues of the patient.

  Numerous urethral support devices are known. These are still urethral strips, polypropylene, used to create a hammock under urethral.

  Ideally, the prosthesis should be a solid, flexible band with little shape memory and withstand the longitudinal traction exerted during placement, without shortening in width. Some extensible strips are also responsible for the release of microparticles during installation.

  The strip must also be biocompatible, biostable in time, resistant to infections through a wide mesh, its weight must be as low as possible.

  Polypropylene knitted monofilament is the material of choice for strips because the pores of the prosthesis allow the free circulation of macrophages, polynuclear and fibroblasts to fight against infection and promote tissue colonization. Their irregular edges allow these flexible strips to self-fix. However, these strips are extensible in both longitudinal and transverse directions of their plane and deform during installation (tiling phenomenon). This effect is formidable for the functional result of the intervention.

  Some devices attempt to minimize the deformation of the strip by the use of a tensioning wire passing and ironing longitudinally through the strip. This single wire is only attached to the ends of the strip / sheath assembly and the strip elongates to remove the ends of the sheath necessary for its removal.

  The strips using the thermo-bonded polypropylene project are not elastic, but offer a risk of displacement after the pose which compromises the functional result of the intervention.

  Five separate approaches have been described for disposing the strip under the urethra; the ascending, descending or mixed retro-pubic pathway and the trans-obturator pathway from outside to inside or from inside to outside. Since the trivialization of the TVT technique many complications have been described including some serious ones.

  The trans-obturator approach removes these risks since the surgical procedure avoids the Retzius space and the abdominal cavity. The transobturator approach from inside to outside has the advantage of limiting para-urethral vaginal dissection but it does not allow precise control of the exit point of the needle. This can cause vasculo nerves wound at the obturator hole.

  The mini-invasive placement of the strips requires specific ancillaries.

  All monofilament polypropylene knit strips use flat plastic sheaths for implantation, since the strip can not slip into the tissues.

  They all use needles of comparable shape, depending on the chosen approach.

  The diameter of the needle is never that of the strip and this is responsible for a deformation of the prosthesis at removal of the sheaths.

  Some devices can not be reused without artifice, in case of incorrect installation (vesical wound for example). In other cases, it is difficult to disconnect, once snapped, the needle of the strip.

  Finally, some ancillaries are reusable and require cleaning and sterilization manipulations.

  The object of the present invention is therefore to provide a simple urethral support device in its design and in its operating mode, economic and easily implantable, and to support the urethra to treat incontinence without strangulation possible.

  Another object of the present invention is a surgical instrument for the implantation of this urethral support device.

  To this end, the invention relates to a urethral support device for treating incontinence comprising an implantable element and a removable sheath surrounding this implantable element.

  According to the invention, this implantable element comprises a monofilament knitted fabric having a main axis and means for rendering this fabric inextensible in the direction of the main axis.

  The chosen approach for the implementation of this device will be transobturator from outside to inside to limit the per and postoperative complications.

  In various particular embodiments of the urethral support device, each having its particular advantages and capable of many possible technical combinations: the means for rendering the fabric inextensible comprise at least two wires parallel to the main axis, which are fixed in points to the fabric along this main axis.

  These wires are live between the attachment points.

  the means for rendering the fabric inextensible comprise at least one nonwoven fiber strip, the implantable element comprises a portion intended to come opposite the urethra, said portion intended to come opposite the urethra having a dimension transverse superior to the rest of the implantable element.

  The invention also relates to a surgical instrument comprising a handle having a first main axis and a needle connected to one end thereof. According to the invention, this needle comprises a planar curved part and a rectilinear part with a point, the rectilinear part being perpendicular to the first main axis. In addition, at least the planar curved portion has a variable section, from the rectilinear portion to the handle to increase the diameter of an orifice generated by the tip.

  Here, the term "flat curved portion", a curved portion of the needle such that a plane containing the two ends of said curved portion also contains a continuous set of points connecting these two ends. In other words, these points are coplanar and the curved part does not have, for example, a spiral shape.

  The invention will be described in more detail with reference to the accompanying drawings, in which: FIG. 1 is a diagrammatic representation of the support device according to a first embodiment of the invention showing the implantable element (FIG. its removable sheath (Figure 1b); FIG. 2 is a schematic representation of the retaining device according to a second embodiment of the invention showing the implantable element (FIG. 2a) and this element surrounded by its removable sheath (FIG. 2b); - Figure 3 is a schematic representation of the support device according to a third embodiment of the invention showing the implantable element (Figure 3a) and this element surrounded by its removable sheath (Figure 3b); - Figure 4 is a schematic representation of the device according to a fourth embodiment of the invention showing the implantable element surrounded by its removable sheath and a dressing (Figure 4a), Figure 4b) shows the folded dressing; FIG. 5 is a schematic representation of the surgical instrument according to one embodiment of the invention; The urethral support device comprises an implantable element 1 and a removable sheath 2 surrounding said implantable element. This removable sheath 2 serves to slide and protect the implantable element 1 during the insertion and passage of this element through the tissues in the cavity created by a needle. After positioning the implantable element 1, this sheath 2 is removed and discarded.

  The implantable element 1 comprises a monofilament knitted fabric having a main axis 3, for example longitudinal, and means for making this fabric inextensible in the direction of this main axis.

  These means for rendering the fabric inextensible comprise in a first embodiment at least two yarns 4 parallel to the main axis 3, which are fixed at several points 5 to said fabric along this main axis 3 (FIG. 1). These son 4 being previously tensioned can be tied by for example at regular intervals intervals or not.

  Preferably, these son 4 pass and iron under tension through the monofilament knitted fabric.

  These threads 4 are synthetic sutures resorbable son or not. When these son 4 are non-absorbable, they are advantageously polypropylene.

  These means for rendering the fabric inextensible comprise, in a second embodiment, at least one nonwoven fiber strip 6, for example a strip of thermobonded fibers. This non-woven fiber strip 6 may either be sewn or heat-bonded to the middle portion of one face of the monofilament knitted fabric in the direction of the main axis 3, or be connected through its side portions to monofilament knitted fabrics (Figure 2). In the latter case, the monofilament knitted fabrics can be knotted together with a nonabsorbable suture to the nonwoven fiber web.

  For an implantable element of width equal to 11 mm for example, the nonwoven fiber strip 6 has a width of between 3 and 4 mm, and preferably equal to 3 mm.

  Alternatively, the nonwoven fiber web 6 can pass and iron through the monofilament knitted fabric at regular intervals or not and be tied (FIG. 3).

  Advantageously, the sheath 2 is made of a material making it possible to visualize the implantable element 1 to check its quality of support. The cylindrical sheath 2, oval or cylindrical flattened can be made of a plastic material such as polyethylene, silicone or polyester, for example.

  The length of the implantable element 1 is typically greater than cm and preferably equal to 40 cm 10%.

  The width of the implantable element 1 is uniform and between 10 and 15 mm (Figure la).

  In this case, the implantable element 1 comprises along said main axis 3 and on either side of the portion intended to be placed facing the urethra 7 a median portion surrounded by two lateral parts, which are advantageously brought towards the median portion along said main axis 3 so as to limit the diameter of the sheath 2. The parts placed on either side of the portion intended to come opposite the urethra 7 and have a section in the form of "S" or "U" inside the sheath 2. The portion intended to come opposite the urethra 7 is for its part substantially flat. The sheath 2 then typically has a diameter of 6 to 8 mm corresponding to the diameter of the orifice created by the needle of the ancillary.

  Alternatively, the width of the implantable element 1 may not be uniform, the portion intended to come opposite the urethra 7 having a dimension transverse to said axis 3 (or width) greater than the rest of the implantable element 1. an example given by way of illustration, the portion intended to come opposite the urethra 7 has a transverse dimension of between 10 and 15 mm and a longitudinal dimension of between 15 and 35 mm and more preferably equal to 20 mm.

  The sheath 2 may comprise two removable sections which overlap and are separable by simple application of a voltage at their end.

  These two sections can also come on both sides of the portion of the implantable element intended to come opposite the urethra 7 (Figures lb, 2b, 3b).

  Advantageously, however, the sheath 2 forms a continuous and resistant element. It then comprises a rapid separation zone in two sections which is placed at the level of the portion of the implantable element intended to be placed opposite the urethra 7. This rapid separation zone may be a breakable zone under the application an appropriate voltage by the operator. The sheath 2 may then have, for example, a small thickness of material compared to the thickness of the remainder of the sheath 2. This rapid separation zone may also be a dressing 8, one face of which is covered with an adhesive layer 9 on around its periphery (FIG. 4a), the dressing 8 covering its edges blocking in position the two tubular sections forming the sheath 2 positioned on either side of the flat portion of the implantable element 1 intended to face the the urethra 7 (Figure 4b). This dressing 8 is easily detachable by the surgeon to allow the release of these tubular sections and their removal.

  The device further comprises, at its ends, cylindrical or oval silicon studs 11, for example, which are somewhat resilient for receiving the end of a needle and providing a needle / friction fitting.

  The implantable element may be coated or coated with a product for example to facilitate colonization or laying. This product may be collagen (equine, bovine, porcine or human), alginate or silicone.

  The invention also relates to a surgical instrument 10 comprising a handle 12 having a first main axis 13, which is longitudinal in this embodiment. It also comprises a needle 14, which is connected at one end to said handle 12 permanently or not. The needle 14 is indeed disposable or reusable after sterilization. It is preferably made of a solid and biocompatible material such as for example stainless steel or titanium.

  This needle 14 has a planar curved portion 15 to match the shape of the body and a rectilinear portion 16 connected to this curved portion 15. The rectilinear portion 16 is perpendicular to the longitudinal axis 13 of the handle 12 to help the surgeon to incise the tissue without excessive trauma, the rectilinear portion 16 being in a direction perpendicular to the force applied by the surgeon. It further comprises a tip 17 forming the end of the needle. Advantageously, the tip 17 is slightly sharpened to help the incision.

  The flat curved portion 15 has a variable section, from the rectilinear portion 16 to the handle 12 to allow the expansion of the orifices and corresponding cavities created by the tip during incisions / passes of the tip through the different tissues. This dilation of the orifices and cavities allows a better penetration of the prosthesis without trauma to the tissues.

  Furthermore, the flat curved portion 15 has a center of curvature 18 such that the parallel 19 to the first axis 13 passing through this center 18 is offset with respect to said first axis of the handle. In this embodiment, the planar curved portion 16 forms a portion of a semicircle which connects the rectilinear portion carrying the tip to the other end of the needle. This other end 20 has the shape of a rod inserted in the handle 12.

  The rectilinear portion 16 includes a frictional attachment surface of an end pad of the urethral support device as described above for quick connection and disconnection.

  In an embodiment of the present invention given purely by way of illustration, FIG. 5 shows such a surgical instrument. The length of the rectilinear part is equal to 10 mm 10%. The section of the needle varies between 4 and 6 mm from the rectilinear part towards the handle.

  Preferably, the half-diameter or radius of the semicircle connecting the rectilinear part 16 carrying the tip towards the other end of the needle 14 is equal to 30 mm 10% and the angle formed by this half-circle part is preferably greater than 140.

Claims (17)

  A urethral retaining device for treating incontinence comprising an implantable element (1) and a removable sheath (2) surrounding said implantable element, characterized in that said implantable element (1) comprises a monofilament knitted fabric having a main axis ( 3) and means for rendering said fabric inextensible in the direction of said main axis (3).   2. Device according to claim 1, characterized in that said means for rendering said fabric inextensible comprise at least two son (4) parallel to said main axis (3), which are fixed at points (5) to said fabric along said axis principal (3).   3. Device according to claim 2, characterized in that said son (4) pass and iron through said monofilament knitted fabric.   4. Device according to claim 3, characterized in that said son (4) are synthetic suture son.   5. Device according to claim 1, characterized in that said means for rendering said fabric inextensible comprise at least one nonwoven fiber web (6).   6. Device according to claim 5, characterized in that said nonwoven fiber web (6) comprises two side portions along said main axis (3) and in that each of said side portions is attached to a monofilament knitted fabric.   7. Device according to claim 5, characterized in that said non-woven fiber strip (6) is fixed on the middle part of a face of said monofilament knitted fabric in the direction of said main axis (3) 8. Device according to claim 5, characterized in that said non-woven fiber web (6) passes and passes through said monofilament knitted fabric along said main axis (3).   9. Device according to any one of claims 1 to 8, characterized in that said fibers and said monofilament knitted fabric are polypropylene.   10. Device according to any one of claims 1 to 9, characterized in that the implantable element (1) comprises a portion intended to come opposite the urethra (7), said portion intended to come opposite the urethra (7) having a transverse dimension greater than the rest of the implantable element (1).   11. Device according to any one of claims 1 to 10 characterized in that the implantable element (1) comprises a portion intended to come opposite the urethra (7), the implantable element (1) comprising of and other of said substantially planar portion (7), a medial portion surrounded by two lateral portions brought towards said median portion along said main axis (3) so as to limit the diameter of said sheath (2).   12. Device according to any one of claims 1 to 11, characterized in that said sheath (2) comprises a rapid separation zone in two sections, said zone being placed at the portion of the implantable element (1). intended to be placed opposite the urethra (7).   13. Surgical instrument comprising a handle (12) having a first main axis (13) and a needle (14) connected at one end to said handle (12), characterized in that said needle (14) comprises a planar curved portion (15). ) and a straight portion (16) with a tip (17), said rectilinear portion (16) being perpendicular to said first major axis (13), and in that at least said planar curved portion (15) has a variable section, from the rectilinear portion (16) to the handle (12) to increase the diameter of an orifice generated by said tip (17).   Surgical instrument according to claim 13, characterized in that the planar curved portion (15) has a center of curvature (18) and that the parallel to the first axis passing through the center of curvature (18) is offset relative to said first axis (13) of the handle.   15. Surgical instrument according to claim 13 or 14, characterized in that said flat curved portion (15) forms part of a semicircle.   16. Surgical instrument according to claim 15, characterized in that the diameter of the semicircle is 30 mm +/- 10% and the section of the needle (14) varies between 4 and 6 mm.   Surgical instrument according to any one of claims 13 to 16, characterized in that the rectilinear part (16) comprises a frictional fixation surface of one end of the urethral support device according to any one of claims 1 to 12.