WO2010040856A1

WO2010040856A1 - Prosthetic system for supporting an organ

Info

Publication number: WO2010040856A1
Application number: PCT/EP2009/063273
Authority: WO
Inventors: Stephan Christian Bretones
Original assignee: Compagnie De Recherche En Composants, Implants Et Materiels Pour L'application Clinique
Priority date: 2008-10-10
Filing date: 2009-10-12
Publication date: 2010-04-15

Abstract

The invention relates to a prosthetic system (1) for supporting an organ of the human or animal urogenital apparatus, said system (1) comprising, on the one hand, a main body (2) designed to come into contact with said organ and, on the other hand, a retention member designed to ensure that said main body (2) is maintained in a functional position within the human or animal organism, said system (1) additionally comprising a supporting device (9) designed to contribute, at least in part, to said retention member being maintained in the functional position, by means of said supporting device (9) bearing and rubbing on biological tissues, said system (1) being characterized in that the supporting device (9) is independent of said retention member and is designed to be connected to said retention member.

Description

PROTHETIC SYSTEM FOR MAINTAINING AN ORGAN

The present invention relates to the general field of medical devices intended for the maintenance of an organ, in particular the technical field of prosthetic systems intended to correct urinary incontinence and / or prolapse.

The present invention relates more particularly to a prosthetic system for maintaining an organ of the human or animal uro-genital apparatus, said system comprising on the one hand a main body intended to come into contact with said organ and on the other hand a retaining member intended to maintain the functional position of said main body within the human or animal body, said system further comprising a holding device designed to contribute, at least in part, to maintaining said organ in a functional position retaining, by support and friction of said holding device on biological tissues.

The present invention also relates to a prosthetic implant for maintaining an organ of the human or animal uro-genital apparatus, said implant comprising a prosthetic system in accordance with the foregoing.

Urinary incontinence usually manifests as an involuntary and uncontrollable leakage of urine through the urethra, usually without a feeling of need to urinate. Urinary incontinence affects both women and men and its causes are varied. It can in particular be due to weakening or even deterioration of the tissues and / or muscles surrounding the bladder and responsible for the retention of urine. In women, incontinence can occur especially after one or more childbirth (s). There are different types of incontinence including stress incontinence manifested by uncontrolled loss of urine in case of significant effort.

One of the surgical means for treating urinary incontinence is to support the urethra using a strip implanted under the urethra. It is a suburethral strip, in particular of the TOT (Trans-Obturator Tape) type, the two ends of which are held without fixation in the tissues near the obturator holes.

In the case of surgical treatment of urinary incontinence using the TOT strip, two incisions are made in the skin on the inner thighs and an incision is made in the vagina. The TOT strip is placed below the urethra and then each of its ends is first passed in the direction of the incisions of the thigh, through one of the obturator holes, then freely held in the surrounding tissue the obturator hole. These are on the one hand the positioning of the strip in these tissues and secondly the colonization following the insertion of the strip which allow the maintenance of the strip without other fixation.

Thus, such a strip has the advantage of being retained without tension or fixation, which promotes its atraumatism for the patient.

Even though this type of strip is satisfactory in terms of suspension of the urethra, there is nevertheless a risk of inadvertent stall of the strip, especially in case of significant effort of the patient, especially in the days that follow the implantation of the strip. It is sometimes necessary to perform a new surgical procedure, which increases the treatment, especially in terms of cost, treatment time and mobilization of medical staff. The objects assigned to the present invention therefore seek to overcome the aforementioned drawbacks and to propose a new prosthetic system for maintaining an organ of the human or animal uro-genital apparatus whose design promotes a stable, efficient and reliable maintenance of the organ.

Another object assigned to the invention is to propose a new prosthetic holding system which comprises a holding device that is easy to implement and to adjust according to the patient and / or the desired maintenance.

Another object assigned to the invention is to propose a new prosthetic holding system whose design of the holding device is particularly simple and inexpensive.

Another object assigned to the invention is to propose a new prosthetic maintenance system whose design makes it possible to limit the risks of both trauma to biological tissue and pain for the patient.

Another object assigned to the invention is to propose a new prosthetic holding system in which the holding device has a conventional shape and particularly atraumatic.

Another object assigned to the invention is to propose a new prosthetic holding system whose embodiment of the holding device involves conventional materials, available and inexpensive.

Another object assigned to the invention is to propose a new prosthetic holding system in which the holding device is made of a material compatible with the human body and / or animal and limiting the risk of rejection and infection. Another object assigned to the invention is to propose a new prosthetic holding system whose design of the retaining member uses conventional materials, available and inexpensive.

Another object assigned to the invention is to propose a new prosthetic maintenance system whose design of the main body involves known materials, easily accessible and cheap.

Another object assigned to the invention is to propose a new prosthetic maintenance system for treating urinary incontinence.

Another object assigned to the invention is to propose a new prosthetic maintenance system for treatment of genital prolapse.

Another object assigned to the invention is also to provide a new prosthetic implant for maintaining an organ of the human or animal uro-genital apparatus whose design promotes a stable, effective and reliable maintenance of the organ.

Another object assigned to the invention is also to propose a new surgical method for fitting a prosthetic system for maintaining an organ of the human or animal uro-genital apparatus allowing a stable, efficient and reliable maintenance of the organ.

Another object assigned to the invention is also to propose a new surgical method very clearly limiting any risk of trauma and deterioration of biological tissue.

Another object assigned to the invention is also to propose a new surgical method allowing a particularly rapid implementation and easy holding device while ensuring an adjustability of the latter.

Another object assigned to the invention is also to provide a new surgical method that allows adjustment of the prosthetic system both simple and easy to implement.

The objects assigned to the invention are achieved with the aid of a prosthetic system for maintaining an organ of the human or animal uro-genital apparatus, said system comprising on the one hand a main body intended to come into contact with of said member and secondly a retaining member for maintaining in a functional position said main body within the human or animal body, said system further comprising a holding device designed to contribute, at least in part, maintaining the functional position of said retaining member, by pressing and friction of said holding device on biological tissues, said system being characterized in that the holding device is independent of said retaining member and is adapted to be connected to said retaining member .

The objects assigned to the invention are also attained by means of a surgical method for fitting a prosthetic system for maintaining an organ of the human or animal uro-genital apparatus, said system comprising, on the one hand, a main body intended to come into contact with said member and secondly a retaining member intended to maintain the functional position of said main body within the human or animal body, said system further comprising a holding device designed to contribute, at least in part, to maintaining the functional position of said retaining member by supporting and friction of said holding device on biological tissues, said method comprising a first step of introducing the main body so as to ensure its contact with said member as well as a second step of introducing the retention member of in such a way that said retaining member maintains the main body in the operative position, said method comprising, after the first and second steps, a third assembly step, during which said holding device is connected to the retaining member .

Other objects, features and advantages 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, among which:

- Figure 1 illustrates, in a schematic top view, a first embodiment of a prosthetic system according to the invention, wherein the prosthetic system comprises a suburethral strip.

FIG. 2 illustrates, in a schematic view from above, a second embodiment of a prosthetic system according to the invention, in which the prosthetic system comprises a colposuspension prosthesis,

- Figure 3 illustrates, in a schematic top view, a first embodiment of a holding device according to the invention.

FIG. 4 illustrates, in a schematic side view, the holding device of FIG. 3.

- Figure 5 illustrates, in a schematic top view, the strip of Figure 1 on which is inserted a holding device according to that shown in Figures 3 and 4.

- Figure 6 illustrates, in a schematic view from above, the strip of Figure 1 on which is inserted a holding device according to that shown in Figures 3 and 4. FIG. 7 illustrates, in a partial diagrammatic sectional view, the placement in the woman of a suburethral strip according to the first embodiment of the invention illustrated in FIG. 1, in the context of a treatment of urinary incontinence.

The present invention relates to a prosthetic system 1 for maintaining an organ of the human or animal uro-genital apparatus, that is to say a system for supporting or supporting an organ of the urinary or genital system . The prosthetic system 1 of the invention may advantageously constitute a prosthetic system 1 for supporting, retaining, holding in place, retaining or fixing the organ. By system is meant a set composed of several elements that may or may not be independent of each other.

The prosthetic system 1 of the invention is thus composed of several elements. It comprises on the one hand a main body 2 intended to come into contact with said member and on the other hand a retaining member 12 intended to maintain the functional position of said main body 2 within the human or animal body.

Preferably, the main body 2, and in particular a central zone 3 of said main body 2, is designed to come into contact with the member, in particular at the lower face of said member, so as to support it effectively. In other words, the main body is intended to hold the body, in particular by positioning said main body 2 under said body.

Advantageously, the retaining member 12 is intended to be connected by a first end 12A to said main body 2 and to rest on biological tissues by a second end 12B, said retaining member 12 being intended to guarantee a stable and effective retention of the main body 2 in an optimal position. The retaining member 12 may in particular be fixed permanently or removably on the main body 2, the retaining member 12 being for example assembled with said main body 2 after the introduction of said main body 2 into the body of the patient. Preferably, the prosthetic system of said invention comprises at least two retention members connected to said main body 2.

It is preferable that the retaining member 12 is freely held in the biological tissues, in particular on and between the latter, said biological tissues being mainly tissues, muscles and viscera located near the suspension zone of the organ.

In the present invention, the objective of the prosthetic system is to restore the initial position of an organ of the urogenital apparatus which has collapsed or which would be weakened for example, in particular of the bladder, the vagina or the vagina. urethra.

As shown in Figure 1, in a first embodiment, the retaining member 12 is intended to be merged with the main body 2. In this embodiment, the retaining member 12 comprises a strip under -urethral 4 to support the urethra (not shown) as part of the treatment of urinary incontinence. The strip 4 has a substantially elongated and flat shape, said strip extending between a first end 4A and a second end 4B, said ends forming the retaining member of the strip 4. Advantageously, the strip has a length between substantially 5 and 70 cm, preferably between substantially 40 and 60 cm, advantageously between substantially 50 and 55 cm. Preferably, the width of the strip is compatible with its suburethral use, namely it is between substantially 0.1 and 20 cm, advantageously between substantially 0.1 and 5 cm, preferably substantially equal to 1 cm. As shown in FIG. 7, the first end 4A is intended firstly to traverse the right obturator membrane 13A and the right obturator hole, at the level of the right ischiopubic branch 14A, and secondly to advantageously be maintained at the level of the surrounding tissue the right obturator hole, especially in the subcutaneous tissues 15A. The second end 4B is, for its part, intended firstly to pass through the left obturator membrane 13B and the left obturator hole, at the level of the left ischiopubic limb 14B, and secondly to be advantageously maintained at the level of the tissues surrounding the left obturator hole, especially in the subcutaneous tissues 15B. The strip 4 is thus freely retained by its ends 4A, 4B in the biological tissues, close to the obturator holes, preferably beyond them after the obturator membranes 13A, 13B of the right and left obturator holes have been crossed by said ends 4A ₁ 4B.

As illustrated in FIG. 7, the strip 4 is thus positioned under the urethra, in contact with it, under the bladder 16, and its first and second ends 4A, 4B pass through the right and left shutter holes, respectively, so as to be housed in the housings. subcutaneous tissues 15A, 15B and to be held there by simple friction and support, near the right and left internal shutter muscles 17A, 17B. The ends 4A, 4B are preferably maintained near the inner face of the thigh, near the initial incision area 18A, 18B respectively to the right and left of the patient.

Advantageously, the strip 4 is simply placed, that is to say it does not require any positive anchoring means penetrating into the tissues to ensure its establishment and its stable maintenance. The strip 4 thus advantageously constitutes a trans-closure prosthesis placed. Such a system for placing the sub-urethral strip 4 is commonly called "tension free" since it makes it possible to keep the sub-urethral strip 4 in the operative position without tension on the urethra and without traumatic fixation means of said strip 4 in the tissues.

In a second embodiment, the prosthetic system relates to coiposuspension prostheses intended to be used for the treatment of a prolapse in women, especially in the case of cystocele or colpocele. As such, such a prosthesis is preferably positioned under the vagina 19 so as to support it to prevent its collapse but also to reduce a possible collapse of the bladder 16 located above the vagina 19 in the pelvic floor.

In this case, the main body 2 comprises a prosthesis 5 for the maintenance of an organ in the context of the treatment of genital prolapse. These include, as shown in Figure 2, a coiposuspension prosthesis intended to support the vagina 19. In this embodiment, the prosthesis 5 also comprises at least a first and a second end 5A 5B forming at least two retaining members for said prosthesis 5, said ends 5A, 5B being intended to be freely retained in the tissues near the shutter holes respectively right and left. It further comprises a central plate 6 intended to be fixed on the lower wall of the vagina 19 so as to form a kind of hammock for the suspension of said vagina 19. Alternatively, such a prosthesis may also be used for example for the suspension of the vagina. uterus, bladder or rectum.

In the remainder of the description, preference will be given to describe a prosthetic system comprising a suburethral strip 4 in which the retaining member 12 is substantially coincidental with the main body 2 to form said strip 4. did it is conceivable, without departing from the scope of this invention, for the prosthetic system to include another type of prosthesis, band or implant intended for the maintenance or support of an organ of the urogenital apparatus.

Preferably, the strip 4 of the present invention, formed of the substantially coinciding retaining member and main body 2, is made of a deformable and non-extensible material. Preferably, it is made of polypropylene. In other words, the strip 4 comprises a mesh 8 made of polypropylene with openings 7, for example in the form of a monofilament knit. Such a mesh 8 considerably limits the risks of exposure or infection on the supported organ because it leaves free a part of the surface of the organ at the openings 7. Thus, the cell colonization can possibly be done between mesh of the strip 4, which also helps to reduce the risk of rejection by the body. The strip 4, like the prosthesis 5, is also particularly atraumatic. It has a flexibility that can deform and follow perfectly any movement of the organ and tissues that surround it.

The prosthetic system 1 further comprises a holding device 9 designed to contribute, at least in part, to maintaining the functional position of said retaining member 12, by pressing and friction of said holding device 2 on biological tissues. Within the meaning of the invention, the holding device 9 therefore participates in a stable holding of the retaining member 12 in the tissues, so that the retaining member 12 best serves its function on the main body 2.

In other words, the strip 4 comprises a holding device 9 designed to retain, thanks to its positioning between the muscles and tissues, in position said strip 4, especially in case of high tension exerted on the latter during a intense effort of the patient for example. Such a holding device 9 is used to ensure a stable retention of the strip 4, when said strip 4 supports the urethra.

The holding device 9 is independent of the retaining member 12, namely of said strip 4, said holding device 9 being designed to be connected to said retaining member 12 ie to said strip 4. The holding device 9 is thus intended to be separated from the strip 4 and not come into contact with the latter after implantation and functional placement of said strip 4 within the body.

Indeed, in a preferred embodiment of said invention, the holding device 9 is intended to be attached to the strip 4, after the introduction of the latter in the body of the patient. The holding device 9 is therefore advantageously connected, connected, attached or fixed on the strip 4, preferably at at least one of its ends 4A,

4B. Such a holding device 9 makes it possible to implement a surgical method for laying a suburethral strip 4 in the course of which the surgeon first places, in a conventional manner, said strip 4, then positions the holding device 9 on the strip 4.

This method is particularly simple and quick to perform for the surgeon. It also has the advantage of allowing safe and effective support of the strip 4.

Particularly preferably, the holding device 9 is removable and can therefore be attached to the strip 4 and possibly removed from said strip 4, said holding device 9 being fixed reversibly on the strip 4.

Preferably, the holding device 9 is designed to be connected to the strip 4 with a possibility of sliding relative to the latter. In other words, when the holding device 9 is associated with the strip 4, it can be moved on said strip 4 or removed from the latter, in particular by sliding along said strip 4, Indeed, the holding device 9 comprises an opening 10, through which the strip 4 of the prosthetic system 1 is intended to be introduced so as to connect the holding device 9 to said strip 4. The surgeon can therefore easily during the intervention modulate the positioning of the holding device 9 according to the desired effect.

Alternatively, it is also conceivable that the holding device 9 placed on the strip 4 can slide alone, without intervention of the surgeon, towards the end 4A, 4B of the strip 4 when a too abrupt movement of the patient requires it, so as to avoid tissue trauma.

FIG. 5 shows the holding device 9 connected to the second end 4B of the strip 4. Advantageously, the holding device 9 thus comprises an opening 10 into which one of the ends 4A, 4B of said strip 4 is introduced. The strip 4 is inserted through the aperture 10 forming eye of the holding device 9, which can then be moved along said strip 4. Alternatively, the holding device 9 may also comprise at least two complementary parts, previously separated and whose assembly allows positioning of said holding device 9 on the strip 4.

In a preferred embodiment, the holding device 9 is intended to be force-fitted onto the strip 4. The opening 10 then has, according to an essential characteristic, a width substantially smaller than that of the strip 4, so as to a surgeon must provide a tensile force on the strip 4 to make it pass through the opening 10 of the holding device 9. In other words, when the surgeon wants to insert the holding device 9 on the strip 4, he must providing a pulling force to introduce and slide said device 9 to the desired location.

Once introduced on the strip 4 by sliding from one of the ends 4A, 4B towards the central zone 3 of the strip, the holding device 9 is designed so that it can not be easily moved again in the opposite direction, know in the direction of the end by which it was introduced. It is therefore almost impossible for the holding device 9 to be detached from the strip 4 after it has been inserted on the latter, into the body of the patient. Thus, a natural movement of the body or even an intense effort of the patient would be substantially insufficient to separate the holding device 9 of the strip 4.

In this regard, it is also conceivable, without departing from the scope of this invention, that the holding device 9 is fixed irreversibly and non-movably, in particular by the surgeon, on the strip 4, at a specific location of this invention. last. It is then possible for the holding device to be, for example, melted on the strip or firmly attached thereto, after functional positioning of said strip 4 in the body.

Alternatively, it is also possible for the holding device 9 to slide naturally on the strip 4, towards the end 4A, 4B of said strip, when a significant effort is provided by the patient, so as to slightly modify the position of said holding device 9 in order to avoid in particular excessive friction on the tissues.

The advantage of such a device 9 lies in the fact that it allows to retain the strip 4 in its operative position within the body. Indeed, after the introduction of the strip 4, the surgeon introduces the device of holding 9 on at least one of the ends 4A, 4B, preferably the holding device 9 being inserted on each end 4A, 4B. The device 9 then rests on the surrounding tissues the obturator holes and effectively retains the strip, by friction and support on said tissues. Friction forces are established between the holding device 9 and the biological tissues, during the introduction of the device 9 into the tissues, and maintain the strip 4 in an optimal operating position, which helps to limit its inadvertent stall. . Such stall can occur especially in case of high tension on said strip 4, for example, a sudden and violent force of the patient.

Thus, the holding device 9 of the present invention advantageously serves as a stopping point of the strip 4, in case of risk of accidental unhitching of the latter.

The friction of the holding device 9 with the tissues, however, is not traumatic for said tissues because the holding device 9 has, preferably, an atraumatic shape. Therefore, the introduction and maintenance of said holding device 9 in the body is neither traumatic for the body nor painful for the patient.

In this regard, the holding device 9 advantageously has a substantially rounded shape, preferably substantially discoid. In Figure 4, showing a side view of the device 9, said device 9 advantageously takes the form of a slightly flattened bead on its upper faces 9A and lower 9B. Alternatively, the holding device 9 is in a substantially spherical shape, for example in the form of a round bead, or in a cylindrical shape such as a pellet or a washer. In a preferred embodiment of the holding device 9, said device 9 comprises a diameter d between substantially 1 and 20 mm, preferably between substantially 3 and 10 mm, preferably substantially equal to 7 mm. In addition, the holding device 9 comprises a height h between substantially 0.1 and 20 mm, preferably between substantially 0.5 and 3 mm, preferably substantially equal to 1 mm. Preferably, the opening 10 represents between approximately 10 and 90%, advantageously between approximately 20 and 40% of the diameter d of the device 9.

In a particularly advantageous embodiment of the present invention, said holding device 9 is made of a biocompatible and resorbable material. Thus, the holding device 9 is eliminated naturally in the body after a more or less long period of implantation, for example after the time required for efficient and sufficient cell colonization of the strip 4, said cell colonization allowing ensure the maintenance of said strip 4 in the long term.

Alternatively, particularly depending on the type of treatment, it may also be possible to set up within the patient a nonabsorbable holding device 9. In this case, said holding device 9 is preferably made of a biocompatible and non-resorbable material, that is to say that it is composed of one or more materials compatible with implantation within the human body. or animal. Preferably, the material of the device 9 is intended not to resorb in the body, ie it can not degrade once implanted in the body. The holding device 9 is therefore designed to have a life, within the body of the patient, as long as the treatment requires. The holding device 9 is preferably made of a material that is not very deformable, preferably substantially non-deformable, in order to guarantee an effective retaining function of the strip 4. In fact, unlike the prior devices having such flexibility that they are directly implanted with the strip 4 and that they then rest on the tissues, the holding device 9 of the present invention is deformed little in the presence of tensile force, so as not to pass into the hole of the incision having served at the introduction of the strip alone. The device 9, however, has a slight flexibility, which notably guarantees its atraumatism for the patient. Indeed, because of a subcutaneous location close to the skin 20 of said holding device 9, as shown in Figure 7, the holding device 9 preferably retains a deformability.

Advantageously, and to meet the constraints of flexibility, biocompatibility and strength, as well as the resorbable nature of the material, the holding device 9 is made of PGA (polyacid glycolique) and / or PLA (poly lactic acid).

Alternatively, it is also conceivable that the holding device 9 is made of a polymeric material, and preferably silicone, or any other non-absorbable material. For example, the holding device 9 may be made of biocompatible metal, such as titanium or stainless steel, polypropylene, or any biocompatible material capable of meeting the constraints required by the restraint function that is intended to ensure said holding device 9.

Preferably, the holding device 9 is manufactured using one or more of the aforementioned materials so that it is substantially solid, without any hollow, with the exception of the opening 10, that is, that is to say that the material fills the entire device 9. However, it is quite possible that the holding device 9 is substantially hollow. In other words, in this case, the material does not completely fill the device 9 and represents for example only an outer wall layer of said device 9, the interior of the device 9 being substantially empty of material.

The present invention also relates, as such, to a prosthetic implant for maintaining an organ of the human or animal uro-genital apparatus, said implant comprising a prosthetic system according to the above in which said holding device 9 is connected with the retaining member 12, namely the strip 4. In other words, the present invention also relates to a prosthetic implant comprising both the sub-urethral strip 4 and the holding device 9.

The present invention further relates, as a full-fledged invention, to a surgical method of fitting a prosthetic system for maintaining an organ of the human or animal uro-genital apparatus. Such a method according to the invention will now be described with reference to FIG. 7. In the present case, this is an example of a surgical method for treating urinary incontinence in women.

The prosthetic system 1 of the method is substantially in accordance with the foregoing and comprises firstly a main body 2 intended to come into contact with said body, here the urethra, and secondly a retaining member 12 for to maintain the functional position of said main body 2 within the human or animal body. The prosthetic system 1 of the method further comprises a holding device 9 designed to contribute, at least in part, to maintaining the functional position of said retaining member 12, by support and friction of said holding device 9 on biological tissues. Said method comprises a prior incision step, during which two incisions 18A, 18B on the inside of the right and left thigh of the patient, are performed as well as an incision in the wall of the vagina 19. Said surgical method then comprises a first step of introducing the main body 2 so as to ensure its contact with said member and a second step of introducing the retaining member 12 so that said retaining member 12 maintains in the functional position of said main body.

In the present case, the retaining member 12 is substantially merged with the main body 2 and forms with the latter a suburethral strip 4. Thus, in an advantageous embodiment of said method, the first and second stages are substantially concurrent.

For performing these introductory steps, the surgeon inserts a needle from an incision in the thigh towards the vagina 19, so as to create a path for the strip. At the level of the vagina 19, the surgeon fixes the strip 4 on the needle, through the eye of said needle, and the strip 4 is then conducted along the path made beforehand. The end 4A of the strip 4 is brought close to the internal obturating muscle 17A, passes through the obturator membrane 13A ₁ spring outside the right obturator hole, near the incision area 18A, in the surrounding tissue hole shutter. This setting operation is repeated, on the left, with the second end 4B of the strip 4.

Particularly advantageously, when the strip 4 is positioned correctly, it is simply left to rest on the tissue near the shutter holes, without fixing it. In its operative position, the strip 4 is positioned under the urethra, with a substantially in "V" under the urethra, said ends 4A, 4B of said strip 4 then being held freely in the tissues.

Said method comprises after said first and second steps a second assembly step, during which said holding device 9 is connected to the strip 4. After the introduction of the strip 4 by the needle into the tissues, said strip 4 is removed from the needle and the surgeon inserts, by the right incision 18A, on the end 4A of said strip 4 a holding device 9. This assembly step is repeated for the second end 4B of said strip 4 at the left incision 18B.

In a particularly advantageous embodiment of said surgical method, the assembly step comprises a phase of insertion of the strip 4 through an opening 10 of the holding device 9, with a possibility of sliding of said holding device 9 by relative to said strip 4. The surgeon inserts the holding device 9 at the first end 4A of the strip 4, said end 4A being close to the right initial incision 18A. The surgeon then repeats this insertion forcefully at the second end 4B of the strip 4.

Preferably, after the assembly step, the surgical method comprises a step of adjusting the length of the strip 4 during which the holding device 9 is intended to slide along the strip 4, so as to determine the optimal length of the latter. The surgeon introduces the holding device 9 on the strip 4, preferably in force, and moves, for example by sliding, said holding device 9 so that the latter is positioned at a precise location which allows effective restraint and without tension of the strip 4. The surgical method preferably comprises, after the step of adjusting the length of the strip, a cutting step of the strip 4 beyond the holding device 9, which is intended to form the end 4A, 4B of said 4. As shown in Figure 6, the surgeon cuts the strip 4 so as to overflow a portion of the strip 4 beyond the holding device 9. It is also possible that the surgeon cuts the strip 4 This cutting operation has the advantage that the strip 4 protrudes little or no beyond the holding device 9.

Advantageously, after the assembly step, the prosthetic system is allowed to rest on the biological tissues, without fixing it to the latter. Thus, the strip 4 on which is inserted the holding device 9 is held freely on the tissues and retained without fixation. The strip 4 is simply placed without being fixed to the biological tissue by any means of attachment. The holding device 9 also ensures sufficient immobilization of the strip 4 so that the cell colonization can be done naturally.

Such a method has the advantage of allowing a simple and rapid intervention, without particular difficulty for the surgeon. This method also allows to maintain efficiently and reliably a strip or a prosthetic implant. The use of the holding device 9 by the surgeon allows the implementation of an effective and simple surgical method of laying a suburethral strip 4, which is fixed stably, reliably and without tension in the body .

Claims

- Prosthetic system (1) for maintaining an organ of the human or animal uro-genital apparatus, said system (1) comprising firstly a main body (2) intended to come into contact with said organ and other a retaining member (12) intended to maintain the functional position of said main body (2) within the human or animal body, said system (1) further comprising a holding device (9) designed to contribute , at least in part, to maintain the functional position of said retaining member (12) by the support and friction of said holding device (9) on biological tissues, said system (1) being characterized in that the holding device ( 9) is independent of said retainer (12) and is adapted to be connected to said retainer (12).

- Prosthetic system (1) for holding according to claim 1 characterized in that the holding device (9) is adapted to be connected to the retaining member (12) with a possibility of sliding relative to the latter. - Prosthetic system (1) for holding according to claim 1 or 2 characterized in that the holding device (9) comprises an opening (10), through which the retaining member (12) of the system (1) is intended to be introduced so as to connect the holding device (9) to said retaining member (12).

- Prosthetic system (1) for holding according to one of claims 1 to 3 characterized in that the holding device (9) is intended to be forced into the retaining member (12). 5 - prosthetic system (1) for holding according to one of claims 1 to 4 characterized in that the holding device (9) has a form atraumatic.

6 - prosthetic system (1) for holding according to claim 5 characterized in that the holding device (9) has a substantially rounded shape, preferably substantially discoid.

7 - Prosthetic system (1) for holding according to one of claims 1 to 6 characterized in that the holding device (9) is made of a biocompatible material and resorbable.

8 - prosthetic system (1) for holding according to one of claims 1 to 6 characterized in that the holding device (9) is made of a biocompatible and non-resorbable material.

9 - Prosthetic system (1) for holding according to one of claims 1 to 8 characterized in that the holding device (9) is made of a low deformable material, preferably substantially non-deformable.

10-prosthetic system (1) for holding according to claim 8 or 9 characterized in that the holding device (9) is made of a polymeric material, and preferably silicone.

11 - prosthetic system (1) for holding according to one of the preceding claims characterized in that the holding device (9) comprises a diameter of between substantially 1 and 20 mm, preferably between substantially 3 and 10 mm, preferably substantially equal to 7 mm. 12-prosthetic system (1) for holding according to one of claims 1 to 11 characterized in that the retaining member (12) is made of a deformable material and not extensible.

13- prosthetic system (1) for holding according to claim 12 characterized in that the retaining member (12) is made of polypropylene.

14- prosthetic system (1) for holding according to one of the preceding claims characterized in that the main body (2) is made of a deformable material and not extensible, preferably polypropylene.

15 - prosthetic system (1) of maintenance according to one of claims 1 to 14 characterized in that the main body (2) comprises a prosthesis (5) for the maintenance of an organ in the context of the treatment of genital prolapse .

16- prosthetic system (1) for holding according to one of claims 1 to 15 characterized in that the retaining member (12) is intended to be merged with the main body (2).

17 - prosthetic system (1) for holding according to claim 16 characterized in that the retaining member (12) comprises a suburethral strip (4) to support the urethra as part of the treatment of urinary incontinence.

18 - prosthetic implant for maintaining an organ of the human or animal uro-genital apparatus, said implant comprising a prosthetic system (1) according to one of claims 1 to 17 wherein said holding device (9) is connected to said retainer (12).