WO2010023418A1

WO2010023418A1 - Prosthetic implant for suburethral support with rounded gusset

Info

Publication number: WO2010023418A1
Application number: PCT/FR2009/051654
Authority: WO
Inventors: Laure-Cécile MARTIN; Jean-Paul Gilbert Ricol
Original assignee: Compagnie De Recherche En Composants, Implants Et Materiels Pour L'application Clinique
Priority date: 2008-09-01
Filing date: 2009-09-01
Publication date: 2010-03-04

Abstract

The invention relates to a prosthetic implant (1) for suburethral support comprising an elongate suburethral support element (3) provided with at least a first gusset (11) designed to fasten said support element (3) within biological tissues of the patient, said first gusset (11) defining an opening (11A) delimited by a first edge (15), which extends along a first length (L₁) between a first end (15A) and a second end (15B), and a second edge (16), which extends along a second length (L₂) between a third end (16A) and a fourth end (16B), said implant (1) being characterized in that the second length (L₂) is longer than the first length (L₁), and in that the second edge (16) is joined to the first edge (15) so as to confer a substantially rounded shape on said first gusset (11). Prosthetic implants.

Description

PROTHETIC IMPLANT OF SUB-URETRAL SUPPORT

A BOMB FIT

TECHNICAL AREA

The present invention relates to the general technical field of surgically implantable devices for supporting the urethra, for the purpose of treating urinary incontinence, and in particular for treating female urinary stress incontinence.

The present invention more particularly relates to a suburethral prosthetic prosthetic implant comprising an elongate suburethral support element provided with at least a first gusset adapted to hang said support element within the biological tissues of the patient.

The invention also relates to a method for manufacturing a prosthetic implant for suburethral support comprising:

a step of supplying and / or manufacturing an elongated suburethral support element; a step of producing a first gusset in which said support element is equipped with at least one first gusset designed to hang said support element within the biological tissues of the patient.

PRIOR ART

Urinary incontinence is an involuntary loss of urine through the urethra. This involuntary loss usually stems from the fact that the tissues responsible for holding back the urine are no longer able to exert sufficient forces to oppose the urinary expulsion forces. Stress urinary incontinence in particular corresponds to a loss of urine not preceded by a feeling of need, and which does not occur at rest but during the effort.

Among the surgical treatments proposed for correcting urinary incontinence, the use of urethral support treatment with a strip is particularly known. The strip in question is surgically placed without tension, under the middle part of the urethra, and is intended to support it during the effort to prevent any leakage of urine. There are several types of strips associated with different surgical routes. The TVT (Tension-free Vaginal Tape) strip, associated with the surgical treatment by the retro-pubic route and the TOT (Trans-Obturator Tape) strip associated with the trans-obturator surgical treatment, to name only some of the most widespread.

The method using the TVT strip proves, however, relatively difficult to implement and presents significant operational risks, insofar as there is in particular a risk of perforation of the bladder when handling the needles used for fitting the tube. strip. This is the reason why it is essential, with this surgical method, to perform a cystoscopy. More serious consequences have sometimes been noted, such as perforation of the iliac artery or the small intestine, resulting in visceral complications sometimes fatal.

The surgical treatment using the TOT strip has a priori less risk of perforation of noble organs, but does not completely eliminate the risk of vascular complications because of the length of the path occupied by the strip within the body.

In order to overcome the drawbacks of the TVT and TOT methods set out above, it has recently been proposed by the applicant a minimally invasive method using a suburethral strip comprising at each of its ends a gusset.

This suburethral strip is relatively short and is intended to be placed vaginally without tension, maintaining the position of the strip within the body of the patient being obtained by simply pressing and friction of the gussets on the biological tissue. This strip gives overall satisfaction, especially since it is particularly simple and cheap construction, while being effective and minimally invasive.

It does, however, have a number of disadvantages. Thus, it has been observed in some cases and under certain conditions a non-optimal maintenance of the strip within the biological tissues, likely to cause recurrences and / or vaginal erosions, the strip not properly held tending to rub against the vagina which causes erosions.

SUMMARY OF THE INVENTION

The objects assigned to the invention therefore aim at proposing a new prosthetic implant for suburethral support which does not have the drawbacks mentioned above and which makes it possible to effectively correct urinary incontinence of effort by reducing the risk of operative complications. and recidivism, while being of particularly simple construction, reliable and cheap.

Another object of the invention is to propose a new prosthetic prosthetic suburethral support implant whose design allows an excellent positional retention of said implant within the body of the patient.

Another object of the invention is to propose a new prosthetic implant for suburethral support of particularly simple construction.

Another object of the invention is to propose a new prosthetic implant for suburethral support which is particularly easy to implement, while being extremely stable in position within the body of the patient once laid.

Another object of the invention is to propose a new prosthetic implant suburethral support particularly simple and inexpensive to manufacture.

Another object of the invention is to propose a new prosthetic prosthetic suburethral support implant capable of being put in place exclusively vaginally. Another object of the invention is to propose a novel method of manufacturing a prosthetic prosthetic suburethral support implant which makes it possible to obtain a prosthetic implant for suburethral support that is particularly effective and of simple and inexpensive construction.

Another object of the invention is to propose a novel method of manufacturing a prosthetic prosthetic implant sub-urethral whose implementation, particularly in an industrial context, is particularly easy, fast and cheap.

The objects assigned to the invention are achieved by means of a suburethral prosthetic retaining implant comprising an elongated suburethral support element provided with at least a first gusset adapted to hook said support element within the biological tissues of the patient, said first gusset defining an opening delimited by a first edge which extends on a first length between a first and a second end and a second edge extending along a second length between a third and a fourth end, said implant being characterized in that the second length is greater than the first length and in that the second edge is joined to the first edge so as to confer by construction a substantially convex shape to said first gusset.

The objects assigned to the invention are also achieved by means of a method for manufacturing a prosthetic implant for suburethral support comprising: a step of supplying and / or manufacturing a sub-urethral support element; elongated urethral

a step of producing a first gusset in which said support element is equipped with at least one first gusset designed to hang said support element within the biological tissues of the patient, said first gusset defining an opening delimited by a first edge extending on a first length between a first and a second end and a second edge extending in a second length between a third and a fourth end characterized in that a substantially domed shape is imparted to said first gusset by joining to the first edge the second edge whose second length is greater than the first length of said first edge.

SUMMARY DESCRIPTION OF THE DRAWINGS

Other advantages and objects of the invention will appear in more detail on reading the description which follows, and with the aid of the accompanying drawings provided for purely illustrative and non-limiting purposes, in which:

- Figure 1 illustrates, in a view from above, a prosthetic implant according to a first embodiment of the invention in a state before its final formatting.

- Figure 2 illustrates, in a schematic view, a prosthetic implant according to the invention, which corresponds to the implant of Figure 1 in its terminal shaping.

FIG. 3 is a diagrammatic longitudinal sectional view of the prosthetic implant of FIG.

- Figure 4 illustrates, in a view from above, a prosthetic implant according to a second embodiment of the invention in a state before its final formatting.

- Figure 5 illustrates, in a view from above, a prosthetic implant according to a third embodiment of the invention in a state before its final formatting.

FIGS. 6 to 12 illustrate various stages of surgical placement of the prosthetic implant of FIGS. 1 to 3.

FIG. 13 illustrates the prosthetic implant of FIGS. 1 to 3 accompanied by a surgical instrument designed to facilitate its placement. FIGS. 2 to 5 and 13 show a prosthetic implant 1 of suburethral support according to the invention intended to be implanted in the body of a patient in order to carry out a retaining of the urethra making it possible to correct the incontinence urinary tract, including urinary stress incontinence in women.

BEST MODE OF REALIZING THE INVENTION

The term "prosthetic implant" here designates a prefabricated prosthesis intended to be introduced into the body of the patient, preferably surgically. Figure 12 illustrates the prosthetic implant 1 in its operative position, that is to say the position in which it will allow to support the urethra 2 and thus prevent involuntary leakage of urine. According to the invention, the suburethral prosthetic retaining implant 1 comprises a suburethral support element 3 of elongate shape extending longitudinally between a right end 3A and a left end 3B. Preferably, the suburethral support element 3 is formed by a textile strip, such as that illustrated in FIG. 13. This strip is preferably made of knitted polypropylene and advantageously has an open structure, that is to say ie provided with openings defined by different sets of son. According to the invention, the suburethral support element 3 is substantially flexible, and more specifically is sufficiently flexible and flexible to firstly avoid a phenomenon of shearing biological tissues after its introduction within the body, and on the other hand allow him to follow the possible movements of surrounding biological tissues after implantation.

Advantageously, the right end 3A at least has a first and a second face 4, 5 opposite. Advantageously, the left end 3B also has a first and a second face 6, 7 opposite.

The textile strip advantageously forming the suburethral support element 3 is thus preferably composed of a substantially rectangular main band 8 and itself having first and second opposite faces 9, 10. The first faces 4, 6 respectively right and left ends 3A, 3B advantageously extend in the extension of the first face 9 of the main strip 8, in the same plane as the latter, while the respective second faces 5, 7 right and left ends 3A, 3B extend in the extension of the second face 10 of the main band 8, in the same plane as said second face 10.

According to the invention, the suburethral support element 3 is provided with at least one first gusset 11, for example located at the right end 3A, said first gusset 11 being designed to hook said support element 3 to within the biological tissues of the patient. For this purpose, the gusset 11 advantageously projects from the first face 4 of the right end 3A.

In other words, the first gusset 11 preferably rises substantially to the right of the face 4, so as to form a protrusion on the surface of the right end 3A on the side of its first face 4.

By "gusset" is meant here a small pocket, which, in this case, opens preferentially on the side of the central portion 8A of the main band 8.

The first gusset 11 thus forms a flexible pouch that deploys on the surface of said right end 3A to provide a means for anchoring, by support and friction, said right end 3A within the biological tissues of the patient, so as to maintain the support element 3 in a determined position.

Advantageously, and as illustrated in the figures, the right end 3A is provided not only with a first gusset 11 which rises to the right of the first face 4 of the right end 3A, but also of a second gusset 12 which rises to the right of the second face 5, said gussets 11, 12 being located on either side of the right end 3A. Similarly, the left end 3B also advantageously comprises two gussets 13, 14 which rise respectively from the first and second faces 6, 7 of the left end 3B.

According to the invention, the first gusset 11 has by construction a substantially curved shape, that is to say that said gusset 11 naturally forms a protuberance. Preferably and as illustrated in FIGS. 1 to 3, the first gusset 11 defines an opening 11 A allowing access to the interior of said gusset 11, which forms a substantially closed pocket. Said opening 11A is delimited by a first edge 15 extending on a first length 11_ between a first and a second end 15A, 15B and a second edge 16 extending along a second length L ₂ between a third and a fourth end 16A , 16B.

Preferably, said first and second ends 15A, 15B are respectively joined audites third and fourth ends 16A, 16B, so that the first and second edges 15, 16 together form a closed contour.

However, other configurations of joining the first edge to the second edge can be envisaged, as will be described below.

Advantageously, the second length L ₂ is greater than the first length Li to confer by construction a substantially convex shape to said first gusset 11, as can be seen in FIGS. 2 and 3. For example, the distance separating the first and second ends 15A , 15B, which corresponds to the length Li, is substantially between 15 and 25 mm, and is for example equal to 19 mm, while the distance separating the third and fourth ends 16A, 16B, which corresponds to the length L ₂ , is substantially between 18 and 40 mm, and is for example equal to 28 mm. Thus, by joining together two edges 15, 16 of different lengths, and more particularly by fixing them at their respective ends, the longest edge 16 is bent, while the other edge 15 remains substantially flat. . The longer edge 16 thus flexed thereby forms, by construction, a bulging outgrowth.

The latter advantageously has a shape memory, that is to say that the curved protrusion in question can be flattened under the effect of a mechanical stress (for example during the surgical introduction) to return (or less tend to return) then naturally and automatically in its curved configuration by springback. This technical measure makes it possible to guarantee an excellent effect of attachment of the retaining element 3 within the body of the patient.

Preferably, said first gusset 11 has a pointed front face 110 to facilitate the introduction of said right end 3A into the biological tissues of the patient. Preferably, said first gusset 11 further has an enlarged rear face 111 to form a non-return abutment for attachment of said right end 3A within said biological tissues. Said rear face 111 is formed, in the example illustrated in the figures, by the first and second edges 15, 16 delimiting the opening 11 A of the gusset 11.

In other words, the first gusset 11 is advantageously shaped in the form of a point towards the outside of the retaining element 3, so as to facilitate the penetration and displacement of said retaining element 3 in the dissection space. At the rear of the tip, the first gusset 11 has an enlarged base, formed by the first and second edges 15, 16, intended to bear against the biological tissues and thus prevent slippage of the textile strip forming the element. 3. The right end 3A equipped with its first gusset 11 thus operates in the manner of an umbrella since it has an increased capacity of penetration into the tissues in one direction (direction of implantation) while having a some resistance to going back, in the direction of explantation, thanks to the presence of the bulge formed by the second edge 16, which ensures excellent retention of the suburethral support element 3 in the body of the patient.

As illustrated in the figures, the second, third and fourth gussets 12, 13, 14 are constructed symmetrically to the first gusset 11. This means that the suburethral support element 3 advantageously has not only a symmetry with respect to the plane of extension P but also a symmetry with respect to the median plane P 'which is perpendicular to the plane P which passes through the center 8A of the suburethral support element 3. Advantageously, the right end 3A, as well as preferably the 3B, is (are), at least in part, wider than the rest of the suburethral support element 3. For example, as shown in the figures, the suburethral support element 3 can be in the form of a rectangular central strip 8 of substantially constant width, the right end 3A presenting for its part at least a portion of width greater than the width of the central strip 8, as illustrated in FIGS. For example, the right end 3A is advantageously in the form of a flat piece in the form of a triangle whose base, of length Li, corresponds to the first edge 15 and extends perpendicularly to the axis of longitudinal extension XX of the retaining element 3, a vertex of the triangle being disposed on said longitudinal axis XX 'to form a tip. In this case, the right end 3A has a tapered shape which facilitates the introduction of the retaining element 3 into the dissection space while providing, in the mean extension plane P of said element 3, an anti -Ret obtained thanks to the lateral recess that forms the end 3A with respect to the central strip 8.

Thus, in this preferred embodiment illustrated in Figures 1 to 3, the right end 3A is provided with non-return means both in the mean extension plane P (said non-return means being in this case formed by widening of the right end 3A relative to the remainder of the support element 3) and in the plane P 'perpendicular to the plane P (said non-return means being formed in this plane by the first and second gussets 11) .

Preferably, the first gusset 11 extends over the entire face 4 of the right end 3A from which it is derived. This means in particular, in the case of the variant illustrated in Figures 1 to 3, that the gusset 11 also extends to the right of the widened areas of the right end 3A, so that said gusset 11, 12 thus reinforces the anti-return effect provided by said widening in the plane P, adding an additional hooking component in the plane P '.

Advantageously, the first gusset 11 comes from material with said right end 3B.

One of the main advantages of using gussets as a means of attachment is precisely the possibility of easily making gussets on each side of the retaining element from a single piece. In the variants illustrated in the figures, the first gusset 11 is thus advantageously made from the textile strip forming the suburethral support element 3.

Advantageously, as illustrated in FIG. 1, said textile strip comprises a first wing 17 disposed at said right end 3A, the first edge 15 being formed by said right end 3A, as explained in the foregoing, while the second edge 16 is formed by said first flange 17, the latter being advantageously folded over the first face 4 of the right end 3A to form the first gusset 11. For example, the first flange 17 is folded along a fold line 17A (shown in dashed line on 1) so as to be folded over the first face 4, said first flange 17 then being advantageously sewn to the first face 4 to form the first gusset 11. The flipping operation of the first flange 17 makes it possible to compare the first and second edges 15, 16, while the fixing by seam (or welding or bonding) of the wing 17 to the face 4 to form the first gusset 11 perme t securing the second and fourth ends 15B, 16B, which causes the bulging of the second edge 16 taking into account the difference in length of said first and second edge 15, 16.

It is thus possible, from a single piece of textile in one piece (illustrated in Figure 1), to achieve in a particularly simple manner, using simple folding and sewing operations, a support element 3 according to the invention which has excellent retention within the body of the patient.

Advantageously, the other gussets 12, 13, 14 are formed identically, by folding on the respective respective face 5, 6, 7 a corresponding wing, then sewing the latter.

According to a substantially similar principle of formation of a curved gusset, corresponding to the variant of FIG. 4, the textile strip is in the form of a single piece consisting of a rectangular central strip 8 extended to each its ends 3A, 3B by a substantially circular plate, center C with respect to the first end 3A. A cutout of said circular plate of center C is made along the line corresponding to the radius R 1. We thus obtaining a circular plate of center C provided with a notch over the entire length of its radius Ri. The circular plate thus split then advantageously forms a wing 17 which can then be shaped cone summit C, said cone encompassing the triangle delimited by the dotted lines Ri, R2 and B and being attached to the strip by the side R2.

Thus, the wing 17 is folded on itself so as to envelop at a distance both the face 4 and the face 5, the circular perimeter of said wing 17 forming the base of the cone and corresponding to the second edge 16, the third of which and the fourth end 16A, 16B are both joined with the first end 15A of the first edge 15.

The gussets 11, 12 are in this case formed by a single cone which surrounds the faces 4, 5 of the end 3A and forms on the side of the face 4 the first gusset 11 and the side of the face 5 the second gusset 12 .

Of course, it would in particular be conceivable, without departing from the scope of the invention, to operate the junction between the fourth end 16B of the second edge 16 and the first edge 15 at any point of the latter, or at the second face 5, or even to wind said second edge 16 on itself in an overlapping manner, the fourth end 16B coming into contact with the outer surface of the wing 17 beyond the third end 16A and the first end 15A of the first edge 15.

In the variant of Figure 5, the textile strip is in the form of a single piece consisting of a rectangular central strip 8 extended at each of its ends 3A, 3B by a partially circular plate, center C with respect to the first end 3A. The partially circular plate corresponds in other words to a circular plate which one would cut an angular sector extending between two rays R 3, R _4. This partially circular plate, amputated by an angular sector, advantageously constitutes the wing 17 which is shaped as a crown cone C by folding the radius R ₃ on the radius R ₄ and fixing together, for example by sewing, said rays R3, _R4. The "cone" thus obtained forms the first gusset 11. Advantageously, it will be noted that if one reports according to the same principle the radius R ₃ no longer on the radius R ₄ but on the radius R ₅ (shown in dotted lines in FIG. 5) which joins the center C with the first end 15A a configuration substantially analogous to that of the variant of FIG. 4 is found, the second edge 16 encircling the first edge 15 to which it is attached by said radius R5 narrower than on the variant of FIG. 4.

Of course, the invention is in no way limited to a particular embodiment variant, and may in particular include any assembly configuration for forming a gusset 11 in relief, and in particular in dome, on the first and the second face 4 5, by forcing one of the edges 16 of the opening 11A of said gusset to flex under stress to fit the first length 11 of a retaining member, preferably constituted by the first edge 15, said first length l_i being less than the own length L _{2 of} said edge when the latter is at rest, and especially flat.

Advantageously, the overall length of the suburethral support element 3 is substantially between 90 and 140 mm, and preferably of the order of 110 mm.

Advantageously, the average width of the suburethral support element 3 is substantially between 9 and 20 mm, and preferably is of the order of 12 mm.

The introduction of the prosthetic implant 1 according to the invention is advantageously carried out in the following manner.

First of all, the patient is installed in gynecological position, legs with 90 degrees of flexion. The description of the operative procedures performed in the following relates to this position. A median vertical deep incision of about 2.5 cm is made on the inner vaginal wall about 1.5 cm from the urinary meatus, as shown in Figure 6. From this incision, scissors are inserted laterally between the vaginal wall and urethra, perpendicular to the ischio-pubic branch, by seeking contact with this bony branch. This step is illustrated in Figure 7. This path is then continued behind this bone branch keeping the same axis perpendicular and open the pelvic aponeurosis. On the spot, the scissors are then open gently and then closed before being removed. The same gestures are made on each side. As illustrated in FIG. 8, the tip of the curved scissors is then threaded into one of the gussets of the end of the polypropylene strip forming the prosthetic subthethral retaining implant 1 according to the invention.

Thus sheathed, said strip is slid into the path made in the previous steps, taking the end 3A of the strip to the level of the obturator muscles, through the fascia and without crossing the obturator membrane. The passage of the tip of the scissors with a slight protrusion through the fascia must be felt. It guarantees the correct positioning of each end 3A, 3B of the strip. Alternatively, as illustrated in Figure 9, it is possible to use an ancillary 18 to find the dissection path, the ancillary 18 serving as a guide to the scissor to take the tape to the level of the obturator muscles, through of the fascia and without crossing the obturator membrane. At the end of this step, the ancillary 18 is then removed.

As shown in Figure 10, the scissors are finally removed, leaving the strip in the path. The same gesture is performed identically on the other side. The strip is thus simply placed without tension against the urethra, as shown in Figures 11 and 12. If the tension is not sufficient, the reintroduction of the scissors at the bottom of the path, in one of the gussets of the end concerned , is easy and will allow the proper repositioning.

The gussets 11, 12, 13, 14 provide an optimal anti-return effect, thanks in particular to their naturally curved shape, which allows the stent to be held in a stable position within the body of the patient.

This surgical method is minimally invasive, and therefore reduces the operating time and the risks of associated complications. These risks of complications are all the more reduced as the implant once placed is at a distance from the vasculo-nervous bundle and the obturator membrane is not perforated. The postoperative neuralgic pains are thus substantially reduced. In addition, the amount of implanted material is minimized, given the small dimensions of the strip next to the strips used in previously known techniques.

The strip according to the invention is thus particularly suited to the surgical technique described in the foregoing, which is an exclusive vaginal introduction technique.

Finally, the invention also relates to a method of manufacturing a prosthetic implant 1 suburethral support, and in particular a prosthetic implant 1 according to the invention.

The manufacturing method according to the invention comprises:

a step of supplying and / or manufacturing an elongated suburethral support element 3,

a step of producing a first gusset 11, in which said support element 3 is equipped with at least one first gusset 11 designed to hang said support element 3 within the biological tissues of the patient, the first gusset 11 having by construction a substantially domed shape.

Advantageously, said first gusset 11 defines an opening 11A delimited by a first edge 15 extending on a first length Li between a first and a second end 15A, 15B and a second edge 16 extending along a second length L ₂ between a third and fourth ends 16A, 16B. Preferably, said first and second ends 15A, 15B are respectively joined to said third and fourth ends 16A, 16B.

According to the invention and as explained in the foregoing, the second length L ₂ is preferably greater than the first length Li to impart by construction a substantially convex shape to said first gusset 11.

Advantageously, said step of manufacturing or supplying the suburethral support element 3 comprises the manufacture or supply of a textile strip intended to form said suburethral support element 3, said strip extending longitudinally between a left end 3B and a right end 3A, said right end (3A) having a first face (4), said strip comprising a first flange 17 disposed at said right end 3A, the first edge 15 being formed by said right end 3A while the second edge 16 is formed by said first flange 17, said step of producing the first gusset January 1 comprising a forming operation of said gusset 11 in which the first flange 17 is folded on the first face 4 of the 3A to form the first gusset 11. The method according to the invention thus makes it possible to manufacture extremely easily, quickly and easily industhalable a prosthesis having excellent resistance within the body of the patient, from a single textile piece cut to adopt a shape conforming to that of FIG.

POSSIBILITY OF INDUSTRIAL APPLICATION

The invention finds its industrial application in the design, manufacture and use of surgical implants.

Claims

1 - suburethral prosthetic prosthetic implant (1) comprising an elongate suburethral support element (3) provided with at least one first gusset (11) designed to hang said support element (3) within the biological tissues of the patient, said first gusset (11) defining an opening (11A) delimited by a first edge (15) extending on a first length (Li) between a first and a second end (15A, 15B) and a second edge (16) extending along a second length (L ₂ ) between a third and a fourth end (16A, 16B), said implant (1) being characterized in that the second length (L ₂ ) is greater than the first length (Li) and in that the second edge (16) is joined to the first edge (15) so as to confer by construction a substantially convex shape to said first gusset (11).

2 - Implant (1) according to claim 1 characterized in that the first and second ends (15A, 15B) of the first edge (15) are respectively joined to the third and fourth ends (16A, 16B) of the second edge (16) .

3 - Implant (1) according to claim 1 or 2 characterized in that the suburethral support element (3) extends longitudinally between a right end (3A) and a left end (3B), said first gusset ( 11) being located at the right end (3A).

4 - Implant (1) according to claim 3 characterized in that said right end (3A) has a first and a second opposite face (4, 5), said first gusset (11) projecting from said first face (4).

5 - Implant (1) according to one of claims 1 to 4 characterized in that said first gusset (11) has a front face (110) pointed to facilitate the introduction of said right end (3A) in the biological tissue of the patient and an enlarged rear face (111) to form a non-return abutment for attachment of said right end (3A) within said biological tissues. 6 - Implant (1) according to one of the preceding claims characterized in that said first gusset (11) comes from material with said right end (3A).

7 - Implant (1) according to claim 6 characterized in that the suburethral support element (3) is formed by a textile strip and in that said first gusset (11) is made from said textile strip.

8 - Implant (1) according to claim 7 characterized in that the textile strip comprises a first flange (17) disposed at said right end (3A), the first edge (15) being formed by said right end (3A) while the second edge (16) is formed by said first flange (17), said first flange (17) being folded over the first face (4) of the right end (3A) to form the first gusset (11).

9 - Implant (1) according to claim 8 characterized in that the first flange (17) is formed by a slotted circular plate or amputated an angular sector and in that said circular plate is shaped cone to obtain the first gusset (11).

10 - Process for manufacturing a suburethral prosthetic prosthetic implant (1) comprising:

a step of supplying and / or manufacturing an elongate suburethral support element (3),

a step of producing a first gusset (11) in which said support element (3) is equipped with at least one first gusset (11) designed to hook said support element (3) within the biological tissues of the patient, said first gusset (11) defining an opening defined by a first edge (15) extending on a first length (Li) between a first and a second end (15A, 15B) and a second edge (16); extending along a second length (L ₂ ) between a third and a fourth end (16A,

16B), characterized in that a substantially curved shape is provided by construction to said first gusset (11) by joining to the first edge (15) the second edge (16) whose second length (L ₂ ) is greater than the first length (Li) of said first edge (15).

- Method according to claim 10 characterized in that, during the step of producing a first gusset, the first and second ends (15A, 15B) are joined to the third and fourth ends (16A, 16B) respectively.

- Manufacturing method according to claim 10 or 11 characterized in that said step of manufacturing or supplying the suburethral support element (3) comprises the manufacture or supply of a textile strip intended to form said element of suburethral support (3), said strip extending longitudinally between a left end (3B) and a right end (3A) and comprising a first wing disposed at said right end (3A), said right end (3A) having a first face (4), the first edge (16) being formed by said right end (3A) while the second edge (16) is formed by said first wing (17), said step of producing the first gusset (11) comprising a forming operation of said gusset (11) in which the first flange (17) is folded over the first face (4) of the right end to form the first gusset (11).