FR2787990A1 - Prosthesis for correcting female urinary incontinence made in two halves connecting vaginal wall on either side of bladder to abdominal muscles - Google Patents

Abstract

The invention relates to a prosthesis for correcting urinary incontinence in women. It consists of two right and left hemi-prostheses, each comprising:. first means intended to be fixed to the vaginal wall and rising respectively to the right and to the left of the bladder neck ,. second means intended to ensure the connection and then the fixing of said first means at the base of the rectus abdominis muscles.

Description

1 PROSTHESIS FOR CORRECTING URINARY INCONTINENCE

IN WOMEN

  The invention relates to a prosthesis for correcting urinary incontinence in women. The prosthesis is more particularly capable of correcting urinary incontinence of mechanical origin which is durable or even permanent, by

  association with possibly other pelvic static disorders.

  In this case, the phenomenon of urinary incontinence is caused by a

  lowering of the bladder neck, resulting in a change in the uretero-bladder angle, leading to uncontrollable urinary flow.

  Consequently, prostheses intended to correct female urinary incontinence must simultaneously fulfill two conditions, respectively: e bring the bladder neck back into the pelvic enclosure;

  * correct the urethro-vesical angle.

  EP-A-498 912, FR-A-2 698 781 and more particularly in document FR-A-2 724 313 have proposed a prosthesis intended to be implanted for a short period in the vagina, the prosthesis consisting of an element with extensible membranes, intended to exert constant pressure on the one hand, behind on the posterior vaginal pouch, and on the other hand, forward on the

symphysis.

  Even if this type of prosthesis temporarily corrects the incontinence phenomenon, it remains uncomfortable and often leads to

  irritation of the vaginal mucosa. In other words, it cannot be stored durably in the vagina.

  Female urinary incontinence can also be treated surgically.

  A first technique consists in ensuring the suspension of the bladder neck by means of a sub urethral sling produced in the form of an autograft between the wall of the urethra and the vaginal wall.35 A first drawback is linked to the very principle of autograft, which can sometimes be rejected. Furthermore and above all, there is a possible shearing between the two walls. Finally, there is the appearance of a phenomenon of dysuria and incomplete urination. 5 A second technique consists in punctually fixing the vaginal dome on either side of the bladder neck by suturing. The fixing is ensured by wires

  secured at their ends to the vaginal dome and a pelvic fixation point. However, there is a risk of embrittlement and loosening of the fixing points.

  In other words, a first objective of the present invention is to provide a prosthesis intended to correct urinary incontinence in women,

  which can be put in place definitively, by fulfilling the conditions for maintaining bladder in the pelvic enclosure, and for maintaining the urethro-vesical angle.

  A second objective of the invention consists in proposing a prosthesis which, once put in place, has no brittleness.

  To do this, the invention provides a prosthesis intended to correct urinary incontinence in women, characterized in that it consists of two right and left hemi-prostheses, each comprising: * first means intended to be fixed to the vaginal wall and rising respectively to the right and to the left of the bladder neck; * second means, intended to ensure the connection then the fixing of said

  first means at the base of the rectus muscles.

  In other words, each of the two hemi-prostheses forming the prosthesis of the invention has first means which are fixed directly in the vaginal wall, on either side of the bladder neck, each of the first means being connected by a second means only at the base of the rectus muscles. In this way, the prosthesis of the invention allows the stable and solid suspension of both the vaginal wall and the bladder neck by forming a kind of hammock in which the said bladder neck rests, leading to a distribution of the traction forces perfectly 3 uniform. In addition, the implantation of the prosthesis directly in the vaginal wall

  allows the sub urethral tissues to maintain their integrity.

  In an advantageous embodiment, the first means of the invention consist of a mesh of which one of the edges is intended to be made integral with the vaginal wall after incision thereof.

  In practice, the mesh is woven using yarns of materials of choice, absorbable or not.

  As absorbable material, it is possible to use, without being limiting, fibers of the polyaraglycolic acid type, the diameter of which is between 10 and 30 micrometers. As non-absorbable material, multi-strand yarns chosen from the family of biocompatible polyesters are used, advantageously

  polyethylene terephthalate, the diameter of which is between 10 and 30 micrometers.

  In a first embodiment, the incision is made in the vaginal wall on either side of the bladder neck. The edge of the mesh is then fixed by separate points in the internal face of the bank of each of the two vaginal wounds formed. In another embodiment, a single wall incision is made

  vaginal opposite the bladder neck. In this case, the edge of each of the two nets is fixed to each of the edges of the wound.

  After fixing the mesh, the wound (s) heal, causing fibrosis of the mesh so as to ensure excellent support. We then obtain a fascia which consolidates the prosthesis and gradually forms a consolidation stent

and maintaining the bladder neck.

  According to another characteristic of the invention, the second means consist of a wire, one end of which is fixed to the first means while

  the other end is attached to the base of the rectus muscles.

  Advantageously, the thread used is a non-absorbable thread.

  In a first embodiment, the wire is a multi-strand metal wire whose diameter is between 50 and 80 micrometers.

  In a second embodiment, the yarn consists of fibers chosen from the family of biocompatible polyesters, in particular multi-strand yarns of

  polyethylene terephthalate, the diameter of which is between 10 and 30 micrometers.

  In a preferred embodiment of the prosthesis of the invention, the mesh is in the form of a part of generally triangular shape.

  Advantageously, the triangular mesh piece has: * a first acute angle opposite the side intended to be made integral with the vaginal wall; * a second acute angle formed between the side intended to be made integral with the vaginal wall and one of the sides connecting said first acute angle;

* a third obtuse angle.

  According to this embodiment, the wire allowing the connection of the triangular piece of fishnet at the base of the rectus muscles is fixed at the top of the

first acute angle.

  Furthermore, to correct the urethro-vesical angle, the obtuse angle is included

  between 90 and 140, advantageously 110.

  For a value lower than 90 C, the uretero-vesical angle is too small to ensure urinary flow under normal physiological conditions.

  For a value greater than 140 C, the uretero-vesical angle is too large, so that urinary incontinence is not corrected.

  The invention and the advantages which result therefrom will emerge more clearly from the example.

  of the following embodiment in support of the appended figures.

  Figure 1 is a representation of one of the two hemiprotheses constituting the prosthesis of the invention.

  Figure 2 is a schematic representation of the prosthesis of the invention once put in place.

  Figure 3 is a schematic representation of the incision made in the vaginal wall according to a first embodiment after removal of the uterus.

  Figure 4 is a cross section of the incision according to Figure 3.

  Figure 5 is a schematic representation of the incision made in the vaginal wall according to a second embodiment after removal of the uterus.

  FIG. 6 is a schematic cross section according to FIG. 5.

  The prosthesis described and detailed below consists of two hemiprostheses intended to be fixed between the base of the rectus muscles and the vaginal wall.

  The two hemiprotheses are strictly identical and shown in Figure 1. They consist of a mesh (1) of triangular shape on which is fixed a wire (2), in particular by sewing. The perimeter of the triangular-shaped mesh is defined by: * a first side (3) situated in the extension of the wire (2), the size of which is between 25 and 75 mm, advantageously 50 mm; * a second side (4) intended to be fixed in the vaginal wall, the size of which is between 10 and 60 mm, advantageously 25 mm;

  + a third side (5) connecting the first side (3) and the second side (4).

  In addition, the triangular-shaped mesh consists of three angles a, [3, y, respectively: * a first acute angle (a) between the first side (3) and the third side (5); * a second acute angle ([) between the second side (4) and the third side (5);

  * an obtuse angle (y) between the first side (3) and the second side (4).

  As already said before, the angle (y) is between 90 and 140. In

  the embodiment described, the angle (y) is equal to 110.

  The fishnet triangle is made of non-absorbable medical prosthetic material of the polyethylene terephthalate multistrand type, whose diameter is 6 between 10 and 12 micrometers, marketed under the brand DIOLENE

by AKZO.

  As already said, the wire (2) is fixed at the end of the side (3) at the top of the first angle (a). This wire, the size of which is between 150 and 300 mm, advantageously 250 mm, is a multi-strand wire identical to that used for the

creation of the fishnet.

  In Figure 2, there is shown the establishment of the prosthesis of the invention.

  We distinguish in this figure the bladder (6), the bladder neck (7), the urethra (8); the vagina (9), the pubic symphysis (10), the base of the rectus muscles (11) and the uterus (12). As this diagram shows, each of the two hemiprotheses is positioned on either side of the bladder neck (7) between the vaginal wall (13) and the base of the rectus muscles (11). The side (4) of the mesh of each of

  hemiprostheses is attached to the vaginal wall by surgical incision.

  This can be done in two different places on the vaginal wall.

  According to a first embodiment shown in Figure 3, a single incision (14) of the vaginal wall (13) is made directly opposite the cervix

  bladder (7). According to this embodiment, each of the two edges (4) of the mesh (1) is fixed by stitching on each of the two banks (15, 16) of the vaginal wound (14). In this way and as shown in FIG. 4, the mesh (1) forms a kind of hammock on which the bladder neck (7) rests.

  In a second embodiment, not a single incision is made but two incisions (17,18) on either side of the bladder neck (7). As before, each of the edges (4) of the two nets (1) are fixed by stitching point by point in each of the edges (19, 20) of the wounds (17,18). As

  previously, the nets thus placed constitute a hammock on which the bladder neck rests (7).

  In practice, each of the two hemiprotheses is positioned identically according to the following process: * first of all, using forceps or a tractor, the cervix is pulled in order to bring the vaginal wall forward; * then a single vaginal incision is made opposite the bladder neck or two incisions on either side of said neck; e each of the two nets is then positioned in the incisions thus formed; * using the finger, we then take off the retzius space, laterally and behind the branches of the pubic symphysis; * then make a transverse suprapubic incision over about a centimeter; * then, a metallic guide is introduced through said incision, which is then led through the lower ligament of the rectus muscles, all guided by the index inserted into the detachment of the retzius; * after bringing the guide and finger into contact, the wire is grasped using the metal guide, then it is withdrawn up to the suprapubic breach; * the lower element of the hemiprothesis is then fixed by separate points at the

  bank of the vaginal wound at the level of its internal face.

  As already said, we proceed to an identical lateral operation for the

second hemiprothesis.

  Once the prostheses are positioned, each of the vaginal incisions is closed.

  Then apply adequate tension to the thread and knot in front of the aponeurosis of the rectus muscles to allow the final positioning

  of the prosthesis. Once all of these operations have been completed, the suprapubic breach is closed.

  This method has the advantage of being non-destructive, insofar as

  does not use an opening in the abdominal wall.

  As already said, scarring leads to fibrosis of the fishnet triangle which ensures excellent support. The fascia obtained by colonization of the mesh consolidates the prosthesis to form a stent for consolidation and

maintenance of the bladder neck.

  The advantages of the invention appear clearly from the preceding description.

  Note in particular the simplicity of the prosthesis, which consists of two main elements. We also observe the easy installation, allowing the maintenance of the bladder neck without any surgery performed on it,

nor on the abdominal wall.

Claims (7)

  1 / Prosthesis intended to correct urinary incontinence in women, characterized in that it consists of two right and left half-prostheses, each comprising: * first means (1) intended to be fixed to the vaginal wall (9) and going back respectively to the right and left of the bladder neck (7); * second means (2) intended to ensure the connection then the fixing of said   first means (1) at the base of the rectus muscles (11).   2 / Prosthesis according to claim 1, characterized in that the first means (1) consist of a mesh (1) one of the edges (4) of which is intended to   be secured to the vaginal wall (9).   3 / Prosthesis according to one of the preceding claims, characterized in that the second means (2) consist of a wire (2) one of the ends of which is   fixed to the first means (1) while the other end is fixed to the base of the rectus muscles (11).   4 / Prosthesis according to claim 2, characterized in that the mesh (1) is in the form of a generally triangular piece having: * a first acute angle (a) opposite the side (4) intended to be made integral the vaginal wall (9); * a second acute angle (3) formed between the side (4) intended to be made integral with the vaginal wall (9) and one of the sides (5) connecting said first acute angle; * a third obtuse angle (y).   / Prosthesis according to claims 3 and 4, characterized in that the wire (2) is   fixed at the top of the first acute angle (a).   6 / Prosthesis according to claim 5, characterized in that the obtuse angle (y) is between 90 and 140, advantageously 110.   7 / Prosthesis according to claim 2, characterized in that the mesh (1) consists of polyaraglycolic acid fibers with a diameter between 10 and 30 micrometers.   8 / Prosthesis according to one of claims 2 to 6, characterized in that the mesh (1) consists of multi-strand son chosen from the family of polyesters   biocompatible. 9 / Prosthesis according to claim 3, characterized in that the wire (2) is a wire   multi-strand metal with a diameter between 50 and 80 micrometers.