WO2010049368A1

WO2010049368A1 - Kit for supporting an organ including an elongate implantable member with a reinforcement means

Info

Publication number: WO2010049368A1
Application number: PCT/EP2009/064028
Authority: WO
Inventors: Stephan Christian Bretones
Original assignee: Compagnie De Recherche En Composants, Implants Et Materiels Pour L'application Clinique
Priority date: 2008-10-30
Filing date: 2009-10-24
Publication date: 2010-05-06

Abstract

The invention relates to a kit for supporting an organ, said kit including a first elongate implantable member (10) for supporting said organ and extending between first a (1A) and a second (1B) end, said first end (1A) defining a first lower surface (1C) and a first upper surface (1D) opposed to each other, wherein said first elongate implantable member (10) is to be secured to said organ by the first end (1A) thereof and retained in biological tissue by the second end (1B) thereof, said kit being characterised in that the first end (1A) includes a first reinforcing means (6) for improving the support of said organ, said first reinforcement means (6) being combined with the first end (1A) so that the first lower (1C) and upper (1D) surfaces each have a substantially continuous surface. The invention can be used for implantable devices for supporting an organ.

Description

KIT FOR MAINTAINING AN ORGAN COMPRISING AN IMPLANTABLE ELEMENT EXTENDING WITH A MEANS OF REINFORCING

The present invention relates to the general field of implantable medical devices intended to maintain an organ within the human or animal body, in particular for the treatment of a subsidence or weakening of an organ, for example in the case of genital prolapse of the woman.

The present invention more particularly relates to a kit for maintaining, in a functional position, a human or animal organ, said kit comprising at least one elongated first implantable element intended to maintain said organ, said first elongate implantable element extending between a first and a second end, said first end having a substantially flat shape defining a first lower face and a first opposite upper face, said first elongate implantable element being intended to be firstly fixed by its first end to said member, and secondly retained by its second end in biological tissues.

The prolapse of an organ of the urogenital tract is known, especially in the female population, and its frequency of appearance increases with certain risk factors, such as in particular overweight, obesity, menopause, deliveries difficult or numerous deliveries. In general, prolapse is manifested by a collapse of an organ, often the bladder, vagina, rectum or uterus, in the pelvic floor. Such sagging is mainly due to a weakening of one or more means of suspension or support, that is to say, the muscles and / or ligaments, responsible for the functional maintenance of organs in the pelvic floor. In the case of a descent of the bladder into the pelvic floor, which represents a fairly common prolapse among the various collapses of organs, we speak of cystocele. The cystocele is called "lateral" when the pelvic floor collapses substantially lateral following a collapse of the bladder, whereas it is question of "central" cystocele when the floor collapses more centrally due to prolapse of the bladder. The cystocele frequently causes a colpocele which results in a descent of the bladder in the vagina.

There are different types of cystocele treatments, which vary in particular according to the severity of the cystocele. In the case of a severe cystocele (degree of severity 2 or 3), its treatment involves the use of more or less heavy surgery, using various techniques well known to those skilled in the art. A first technique consists in repairing the means of retaining and suspending the pelvic floor, in particular by reinforcing the latter. The surgeon practices in this case a repair of autologous tissue without using prosthetic material, so as to restore, if possible as naturally as possible, the positioning and functioning of the organs of the pelvic floor. This technique does not require direct intervention on the organs, especially on the bladder, which limits the possible risks of piercing or damaging an organ.

Although this technique provides some satisfactory results in terms of atraumatic repair of the cystocele, however, it generally remains insufficient, especially if the prolapse is important. The use of this technique is therefore limited and leads to significant risks of recurrence and therefore of new surgery.

To remedy the aforementioned problems, it is also known to use a second type of surgical technique for the treatment of cystocele in women. This second technique proposes a direct intervention on the organ of the pelvic floor concerned by the slump or on one of the neighboring organs. This second technique uses suture son or prosthesis for the support or the maintenance of the organ. In case of cystocele, because of the fragility of the bladder and its specific positioning in the pelvic floor, it is conventional to intervene on the vagina, including a suspension of the latter, called "colposuspension". Given the positioning of the vagina in the pelvis, the colposuspension retaining the vagina in its functional position, provides effective support of the bladder and thus helps treat the cystocele.

The son or the prosthesis are conventionally introduced by the abdominal route, by the cozlioscopic route or vaginally. For the realization of colposuspension vaginally, the surgeon usually practices a colpotomy.

During colposuspension with suture threads, the surgeon first over-lays the vagina, then stretches the threads towards Cooper's ligaments or solid structures such as the pubic spine, where he sutures the threads. . This technique allows a strong fixation of the vagina and considerably limits the risk of subsequent sagging of the vagina. Despite the effectiveness of the suspension of the vagina and the strength of the fixation, this method does have some disadvantages that make it a particularly traumatic method for tissues and painful for the patient.

Indeed, suture son, especially because of their shape, tend to be aggressive vis-à-vis the vagina and biological tissues with which they are in contact, especially after suspension of the vagina. In addition, when the surgeon exerts a pulling force on the In order to adjust the colposuspension, the tension exerted on the suture threads has a tendency to collapse the wall of the vagina, which may, in some cases, lead to a phenomenon of retraction of the vagina. In addition, sutures can sometimes become embedded in the lining of the vagina or in the tissues of the Cooper ligament or solid structures such as the pubic spine. They can even, under certain conditions and because of their finesse, be particularly sharp and seriously damage the tissues, or even pass trans-vesical. In addition, because of the solid attachment of the vagina, all natural movements of the vagina are considerably limited or totally annihilated, which affects the normal functioning of the vagina.

Such drawbacks generally result in pain for the patient and the need, in many cases, to remove the threads completely.

In order to overcome some of the disadvantages mentioned above when using sutures, the surgeon may use a prosthesis, designed based on a prosthetic tissue plate of substantially rectangular shape adapted to the shape of the vagina. The surgeon places the prosthesis under the vagina so that it conforms to the shape of the vagina and effectively supports the vagina. The prosthesis is held in position by suture son integrally with each end of the prosthesis, the son being fixed by the surgeon in the obturator holes.

Although this suspension system is satisfactory, particularly in terms of atraumatic vagina, it nonetheless has some disadvantages frequently encountered when using the prosthesis.

Because of its size, the prosthesis constitutes a particularly invasive colposuspension system that has a large contact surface with the biological tissues and the wall of the vagina. This contact obviously favors the risk of infection or rejection by the body. In addition, the prosthesis can retract and thus cause retraction of the vagina, the prosthesis can sometimes even, under certain conditions, become embedded in the vaginal wall and then cause a high risk of exposure, by erosion.

In most cases, the presence of one or more of the aforementioned disadvantages causes discomfort for the patient, even pain, and the need to proceed with the removal of the prosthesis, during a new surgical procedure. This new operation adds to and complicates the treatment of the cystocele, presents certain risks for the patient, and mobilizes time, equipment and medical personnel.

The objects assigned to the present invention therefore aim at overcoming the aforementioned drawbacks and at proposing a kit for maintaining, in a functional position, a human or animal organ, of particularly simple and inexpensive design, allowing an effective, solid and little maintenance. traumatic of the organ. Another object assigned to the invention is to propose a new kit allowing a reliable, stable and low-traumatic maintenance of the organ, throughout the duration of the treatment, while limiting the risk of frowning of the wall of the organ.

Another object assigned to the invention is to propose a new kit of simple and quick design to implement.

Another object assigned to the invention is to propose a new kit that allows a simple fixation, solid and stable in biological tissues.

Another object assigned to the invention is to propose a new kit that allows safe and effective restraint, particularly atraumatic and without tension of the organ. Another object assigned to the invention is to propose a new kit whose shape and dimensions are adapted to the anatomy and particularly atraumatic.

Another object assigned to the invention is to provide a new kit made of a conventional material, cheap and which limits the risk of rejection or infection.

Another object assigned to the invention is to propose a new kit adapted to the treatment of a prolapse of an organ of the uro-genital system of women.

Another object of the invention is to propose a new kit whose implementation is simple, fast and easy for the surgeon, while being substantially atraumatic and not painful for the patient.

Another object of the invention is to propose a novel method of maintaining a human or animal organ, in a functional position, which is particularly simple to implement, and which allows an effective, solid and low-traumatic maintenance of the organ.

Another object of the invention is to propose a new method of maintaining a human or animal organ fast to achieve and not requiring special skills of the surgeon. The objects assigned to the invention are achieved by means of a kit for maintaining, in a functional position, a human or animal organ, said kit comprising at least a first elongated implantable element intended to maintain said organ, said first element implantable elongate extending between first and second ends, said first end having a substantially flat shape defining a first lower face and an opposite upper face, said first elongate implantable element being intended to be firstly fixed by its first end of said organ, and secondly retained by its second end in biological tissue, said kit being characterized in that the first end of the first elongated implantable element comprises a first reinforcement means adapted to improve the maintenance of said organ, said first reinforcing means being associated with the first end so that said first lower and upper faces of the first end of said first elongated implantable element each have a substantially continuous surface.

The objects assigned to the invention are also achieved by means of a surgical method for maintaining a human or animal organ, in a functional position, said method comprising a first fixation step during which a first implantable element the first end having a substantially flat shape defining a first lower face and a first opposite upper face, said method also comprising a first step of wherein said first elongated implantable element is retained at its second end in biological tissue, the first end of said first elongated implantable element comprising a first reinforcing means adapted to enhance the retention of said member, said first reinforcing means being associated at the first e xtremity so that said first lower and upper faces of the first end of said first elongate member each have a substantially continuous surface. 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 an elongated implantable element according to the invention. FIG. 2 illustrates, in a front view, a detail of the elongated implantable element of FIG.

- Figure 3 illustrates, in a schematic top view, a second embodiment of an elongated implantable element according to the invention.

FIG. 4 illustrates, in a sectional side view, the elongate implantable element according to FIG. 3.

- Figure 5 illustrates, in a partial schematic front view, the introduction into the vagina and the suture on the vagina of an elongated implantable element according to Figures 1 and 2.

- Figure 6 illustrates, in a schematic side view, an embodiment of a helical ancillary according to the invention. - Figure 7 illustrates, in a partial schematic front view, the establishment of an elongate implantable element according to the invention and previously sewn by a first end to the wall of the vagina.

- Figure 8 illustrates, in a view a partial schematic front view, two elongated implantable elements according to the invention in the operative position. The present invention relates to a kit for maintaining, in a functional position, an organ human or animal. The term "kit" means a set composed of several elements that can cooperate or be used in combination so as to lead to a global result. Preferably, the kit of the invention is intended for the treatment of female genital prolapse, by maintaining an organ, said organ being an organ of the urogenital tract, preferably the bladder or the vagina. kit is thus designed to remedy a sagging or inadvertent descent of the bladder or vagina 21.

In the description which follows, it will be attempted to describe a preferred embodiment of the invention in which the kit is intended for the treatment of a cystocele, preferably by colposuspension, said cystocele may cause an anterior colpocele. Preferably, the colposuspension using the kit of the invention is part of a global method of treating the cystocele, during which the surgeon also performs a repair of the muscles and pelvic floor tissues, at the same time. especially helps autologous tissues. However, it is quite possible that said kit allows colposuspension sufficient alone to treat the cystocele. The present invention is however not limited to the treatment of the cystocele and can effectively correct other genital prolapse, for example a hysterocele (prolapse of the uterus), a rectocele (prolapse of the rectum in the vagina 21), other prolapse may also be considered.

The suspended organ is either the one that has undergone a subsidence or another organ located near the collapsed organ. Preferably, the suspended member is an elongated, tubular member having a main axis of extension X-X '. It is thus possible to suspend different organs of the pelvis, including the vagina 21, rectum or uterus. In the case of the treatment of the hysterocele, the uterus is advantageously suspended. In the case of treatment of the cystocele, because of the fragility of the bladder and the significant risks of piercing or damaging it with surgical instruments, it intervenes directly on the vagina 21, by suspension or support of the vagina 21 in the pelvis, so as to restore the normal and functional positioning of the bladder.

The kit of the present invention comprises at least a first elongated implantable element 10 for maintaining a human or animal organ in a functional position. In the sense of "elongated implantable element", it is necessary to understand a slender element, substantially elongate and extending mainly along a substantially longitudinal extension axis YY '. The first elongate implantable element 10 is intended on the one hand to be inserted into the body in the biological tissues not accessible directly from the outside of the body, so as not to be in contact with the outside of the body, and secondly to exert support, restraint or support of an organ of the body. The first elongate implantable element 10 extends between first and second ends IA, 1 B, preferably substantially longitudinally along its main extension axis Y-Y ', as illustrated in FIG. 1.

The first elongate implantable element 10 is adapted to be attached on the one hand by its first end IA to the organ, for example to the vagina 21. In other words, it is intended that the first end IA of the first elongated implantable element 10 is attached or connected to the organ, for example by suturing to the side wall of the vagina 21, at a suture zone 3. In this case, the first elongate implantable element 10 is attached only to the vagina 21, preferably laterally, and extends from the latter without exercising true support of said vagina 21, but rather a restraint. It is also possible that the first elongated implantable element 10 is sutured at the level of the lower wall of the vagina 21 or of another more central organ of the pelvis, so as to ensure only the maintenance in the operative position of the organ by forming a stable hammock in which said body rests.

Preferably, said first end IA has a substantially flat shape defining a first lower face IC and a first opposite upper face ID. The first end IA therefore extends, preferably, substantially two-dimensionally, not three-dimensional, that is to say that it advantageously has a length and a width substantially greater than its thickness. In other words, said first end IA takes the form of a strip which comprises two faces substantially opposite to the main extension axis YY 'of the first elongated element 10, which is of interest to ensure an atraumatic contact with the organ.

Advantageously, the first elongate implantable element 10, in its entirety, is substantially flat, preferably in the form of a first band 1, as illustrated in the figures. Alternatively, it is of course quite conceivable that the first elongated implantable element 10 take another form compatible with the present invention, for example the shape of a cable or a tube. In the remainder of the description, it will be attempted to describe a preferred embodiment of the invention, in which the first elongate implantable element 10 is a first band 1.

Preferably, the suture, for example by overlocking, of the first end IA of the band 1 is made on the organ with a conventional biocompatible suture, resorbable or not, intended to ensure the stable fixation of the band 1 as long as necessary. Alternatively, it is also possible to consider any other fixation of the band 1 on the body, for example using a biological glue or non-return hooks.

In a preferred embodiment of said invention, the first end IA comprises at least one suture 4 for suturing the band 1 on the organ. As is 1, the suture 4 is fixed, by construction, at at least an angle of the first end 1A before insertion of the band 1 into the body, which facilitates the suture operation for the surgeon who no longer needs to use another wire. Preferably, the first end IA has a sufficient width, substantially greater than 0.5 cm, and a small thickness to ensure atraumatic fixation directly on the body, to ensure proper maintenance of the latter and avoid the risks of frowning of the organ wall. Such a conformation of the first end AI also makes it possible to avoid the problems of exposure or deterioration of the wall of the organ.

The first end IA of the band 1 comprises a first reinforcement 6 designed to improve the maintenance of the organ. The first reinforcing means 6 is associated with the first end IA so that said first lower faces IC and upper ID of the first end IA of said strip 1 each have a substantially continuous surface. Preferably, the first reinforcing means 6 is connected, plain or hooked to the lower face and / or upper IC, ID of the first end IA, or integral with said lower face and / or upper IC, ID. The first lower and upper faces IC, ID of the first end IA advantageously have a substantially uninterrupted surface, that is to say that the first reinforcing means 6 is attached, fixed or glued to the first end IA, such that so that the latter advantageously has a substantially flat profile without space between the reinforcement means 6 and the first end IA. Advantageously, the first reinforcing means 6 is at least partially, preferably entirely, pressed against said first end IA.

In a preferred embodiment, the first reinforcing means 6 comprises a fold 6A made from the first end IA, said fold 6 comprising a transverse edge 6B, as illustrated in FIGS. 1, 3 and 4, fixed to said first end IA, said transverse edge 6B extending in a direction substantially perpendicular to the main extension axis YY 'of the first elongate implantable element 1. The first reinforcing means 6 is preferably intended to provide strength and rigidity to the first end IA, so that the band 1 allows a reliable and stable maintenance of the organ without frowning the wall of the organ.

The first reinforcing means 6 is advantageously positioned, substantially transversely to the Y-Y 'axis, over at least a portion of the width of the first end IA of the first elongated implantable element 10. Advantageously, the first means reinforcement 6 comprises an extra thickness forming a piece integral, monobloc, with the first end IA, said extra thickness being advantageously fully plated on the first end IA. Said overthickness preferably forms a solid rail which stiffens the strip 1 and very clearly improves the maintenance of the member, in particular by ensuring regular suspension, without risk of frowning of the organ wall. In addition, the presence of the reinforcing means 6 facilitates, for the surgeon, the manipulation of the band 1, its orientation in the body and on the vagina 21, as well as its suture at the wall of the vagina 21.

The first reinforcing means 6 is preferably made of a biocompatible material identical to that of the strip 1, or preferably from the strip 1 when the first reinforcing means 6 takes for example the shape of the fold 6A. In this case, the fold 6A takes for example the shape of a hem, a fold of prosthetic fabric constituting the band 1 and previously sewn, or a thickened thermoformed during the manufacturing process of the band 1. Alternatively, the first reinforcing means 6 comprises a solid rod fixed to the first end IA, produced integrally with the strip 1 or introduced into a hem or fold 6 A, at the first end IA, said rod being then preferentially positioned in a direction substantially perpendicular to the Y-Y 'axis. Advantageously, such a rod, and more generally the first reinforcement means 6, is made of a biocompatible material, in particular biocompatible polymer, for example polypropylene, silicone or polyester, or biocompatible metal, for example titanium or stainless steel, said material allowing an effective compromise between a sufficient rigidity to ensure a solid retention of the member and a flexibility promoting atramautisme said first reinforcement means 6.

The elongated implantable element 10, preferably the band 1, is further designed to be retained by its second end IB in biological tissues. In the sense of "biological tissues" means any type of muscle, viscera, ligaments, walls, bones or other element internal to the body, capable of accommodating a stable attachment of the second end IB.

In a first embodiment, the second end 1B of the band 1 is adapted to be fixed, maintained or attached, preferably by suture, to biological tissues located substantially in proximity to the supported organ. It is thus conceivable, for example, that the band 1 is sewn by its first end IA to a central organ of the pelvis and sutured by its second end IB to the ligament of Cooper or to solid structures such as the pubic spine, so as to guarantee the effective maintenance of said organ. In this case, the second end IB also advantageously comprises a reinforcement means (not shown) designed to improve the maintenance of the organ and the attachment of said second end IB to said biological tissues. The second end IB of the band 1 is then also solidified with a reinforcing means substantially identical to the first reinforcing element 6 previously described. Thus, the band 1 preferably comprises a reinforcement means at each of its ends IA, IB, so that the attachment of said band 1 to the organ and to the tissues, for example to the Cooper ligament, is solid, reliable and not very traumatic. In a second particularly preferred embodiment, the second end 1 B is designed to pass through a natural orifice of the body and be maintained there without positive fixation device or anchoring means in the tissues. In this embodiment, the second end IB is advantageously designed to pass through and be retained at a plug hole 23, left 23 A or right 23B, by simple friction on the biological tissues, that is to say that the simple friction of the second end IB on the biological tissues is advantageously sufficient to ensure its maintenance, without any fastening element, fastener or anchor, the body being thus suspended in "voltage free".

For the purposes of the present invention, the term "obturator hole" means an ischio-pubic or foramen hole closed substantially entirely by an obturator membrane 27, each of the two ischiopubic holes being surrounded by the pubic bone 24 and the 25, 23B are separated from each other by the pubic symphysis 26. Preferably, the second end 1B is thus naturally maintained by the obturator membrane 27 as well as FIG. only by the ligaments and muscles nearby that exert a natural pressure on the second end IB.

Therefore, and as illustrated in FIG. 8, the band 1 of the invention has a length sufficient to at least cover the distance separating the organ to be suspended, here the vagina 21, from the obturator holes 23. Advantageously, the strip 1 has a length substantially between 5 and 30 cm, preferably substantially between 8 and 12 cm, preferably substantially equal to 10 cm. In general, the length of the band 1 is adjusted by the surgeon after its functional placement, in order to be adapted to the anatomy of each patient.

Preferably, the strip 1 is substantially rectangular in shape, with a substantially identical width at all points (see Figure 1). The band 1 thus has a width substantially between 0.5 and 5 cm, preferably substantially between 0.5 and 2 cm, preferably substantially equal to 1 cm, such a width allowing an effective and substantially atraumatic maintenance of the band. organ.

Alternatively, it is conceivable that the first end IA of the band 1 has a width substantially greater than the width of the second end IB. In this preferred embodiment of the invention, the band 1 may be in the form of a substantially trapezoidal band (see FIG. In this case, the width of the first end IA is substantially between 0.5 and 5 cm, preferably substantially between 2 and 4 cm. The widening of the band 1 at its first end IA, in combination with the first reinforcement 6, has the advantage of ensuring a stable and stable maintenance of the vagina 21 and to avoid the risk of frowning or injury to the wall of the vagina 21, without being invasive. In this case, the width of the second end IB is preferably between

0.5 and 2 cm, preferably substantially less than 1 cm to further limit tissue trauma. Such a tapered shape of the second end IB is substantially atraumatic and minimizes the lesions and risks of tissue trauma when passing said second end IB through the corresponding obturator hole 23.

In this embodiment, the second end IB of the first band 1 is advantageously substantially one-dimensional, ie in the form of, for example, a wire, and comprises a holding device 13 designed to retain said second end IB in the biological tissues. Said holding device 13 is preferably added to the second end IB, after the functional placement of the band 1 in the body of the patient, so as to ensure, by simply pressing and friction on biological tissue, a suspension in The holding device 13, made of a biocompatible material and of substantially rounded shape, which is particularly atraumatic, is independent of the second end IB and inserted into force on the latter end after the insertion of the second end. band 1 in the patient's body.

Preferably, the band 1 thus preferably has a thickness substantially between 0.1 and 3 mm, preferably substantially between 0.1 and 1 mm. Such a thickness limits the trauma of the tissues, in particular by ensuring a slightly aggressive passage through the obturator hole 23 and an effective natural restraint of the band 1 at the latter. Preferably, the thickness of the strip 1 is substantially greater, that is to say substantially between 0.5 and 3 mm, at its first end IA which comprises the first reinforcing means 6.

Advantageously, the first reinforcing means 6 represents a length of the elongate implantable element 1 substantially between 0.1 and 5 cm, preferably substantially between 0.3 and 0.7 cm, preferably substantially equal to 0. , 5 cm. The first reinforcing means 6 advantageously occupies the entire width of the band 1 and a limited length of the latter, this length varying mainly according to the type of suspension sought (trans-obturator, "tension free", to the ligament of Cooper, .. .) and the organ to suspend. In the first embodiment, in case of fixation of the second end IB to the tissues, the reinforcing means present on said second end IB preferably has a length sufficient for the surgeon to be able to adjust the length of the the band 1 to the anatomy of the patient, for example by cutting it at the second end IB, and secondly keep a sufficient length of the reinforcement means of the second end IB to ensure a reliable and strong maintenance of band 1. Advantageously, regardless of its shape, the band 1 has flexibility and flexibility compatible with its implementation, and in particular with its passage through the obturator hole 23. The band 1 is also designed to be little or not extensible in order to substantially support without deforming the organ. The band 1 is made of biocompatible material, preferably a prosthetic textile, such as polypropylene which has the advantage of forming a well tolerated prosthetic tissue and conventionally used for organ maintenance applications. Alternatively, said strip 1 may be made of any biocompatible polymer material, for example polyester or polytetrafluoroethylene.

The band 1 is also perforated, preferably in the form of a mesh 7, that is to say a knitted mesh prosthetic fabric comprising a multitude of openings 8 to limit the contact of the band 1 with the wall of the vagina 21 as well as with the biological tissues in general. Advantageously, the band 1 is made of a monobrin polypropylene or multi-strand polyester mesh, said mesh allowing, at the level of the openings 8, a cellular colonization which contributes to a substantially definitive fixation of the band 1 at the level of the obturator holes 23 and the risks of tissue necrosis.

Therefore, the functional establishment of the band 1 for the suspension of an organ of the urogenital tract is particularly well tolerated, little traumatic and limits postoperative pain. Moreover, the use of such a band 1 does not require special surgical skills for the surgeon. The kit of the present invention also comprises at least one second elongate implantable element 20 also for maintaining said organ. The second elongated implantable element 20 extends between a first 2A and a second 2B ends. Its first end 2A has a substantially flat shape defining a second bottom face 2C and a second opposite upper face 2D. The second elongated implantable element 20 is designed to be on the one hand fixed by its first end 2A to said organ, and on the other hand retained by its second end 2B in biological tissues.

The first end 2A of the second elongate implantable element 20 comprises a second reinforcement means 6 'designed to improve the retention of said member, said second reinforcement means 6' being associated with the first end 2A so that said second lower faces 2C and upper 2D of the first end 2A of said second implantable element 20 each have a substantially continuous surface. Preferably, the second element 20 is identical to the first element 10 previously described. Advantageously, each elongated implantable element 10, 20 has a shape substantially identical to that of a band. The second element 20 is preferably a second band 2, identical to the first band 1 above. Preferably, it is provided that the first end 1A, 2A of each band 1, 2 is attached or connected to the vagina 21, preferably sutured to the side wall of the vagina 21, so as to provide a substantially symmetrical support of the vagina 21. The strips 1, 2 are thus advantageously intended to extend substantially symmetrically with respect to each other, with respect to a main extension axis XX 'of the organ, preferably of the vagina 21, said organ being substantially elongated and tubular.

In a particularly advantageous embodiment of the invention, the strips 1, 2 are designed to be in contact with the organ for less than 20% of their length, or even preferably only about 1 cm of their length, at from the first end IA, 2A. In this case, the strips 1, 2 are simply attached to the vagina 21, preferably laterally, and extend from the latter without exercising true support of said vagina 21, but rather a restraint, Alternatively, it is possible that the first ends IA, 2A of the strips 1, 2 are attached substantially to the lower wall of the vagina 21, so as to form a stable hammock in which said vagina 21 rests. Advantageously, each band 1, 2 comprises a first reinforcing means 6, 6 'at its first end IA, 2 A identical to that described in the previous description and designed to improve the maintenance of the organ. However, it is perfectly conceivable that only one of the bands 1, 2 comprises a first reinforcement means at its first end IA, 2A. This first reinforcing means 6, 6 'is thus designed to stiffen, that is to say solidify or strengthen, said first end IA, 2A so that the band 1, 2 allows a safe, reliable support and atraumatic of the organ.

In a first embodiment, the second end IB, 2B of each elongated implantable element 10, 20 is advantageously designed to be attached to biological tissues, for example Cooper's ligaments, preferably by suture. In this case, the second end IB, 2B of at least one of the strips 1, 2 comprises, preferably, another reinforcing means (not shown), substantially identical to the first or second reinforcement means 6, 6 ' cited above, designed to improve organ retention and fixation of said second end IB, 2B to biological tissues, so as to provide strong and efficient fixation of the band 1 to biological tissues. In another particularly preferred embodiment, the second end IB, 2B of each elongate implantable element 10, 20 is designed to pass through and be retained at a shutter hole 23, 23A and 23B, respectively, by simple friction. on biological tissues. In this case, the strips 1, 2 preferably each have a length sufficient for at least 1 cm of the length of each strip 1, 2, at the second end IB, 2B, to exceed 23 corresponding shutter holes. Advantageously, each band 1, 2 preferably has dimensions, in particular a length, a thickness and a width, in accordance with those of the band 1 previously described and perfectly adapted to the colposuspension. In addition, the first reinforcing means 6 represents a band length 1, 2 substantially between 0.1 and 5 cm, preferably substantially between 0.3 and 0.7 cm, preferably substantially equal to 0.5 cm. . Advantageously, the strips 1, 2 are made of prosthetic textile, preferably single-strand polypropylene or multi-strand polyester.

In an advantageous embodiment, the first end 1A, 2A of each elongate implantable element 10, has a width substantially greater than that of the second end IB, 2B of each elongate implantable element 10, 20. Preferably, the band 1 , 2 then has a substantially trapezoidal shape, as illustrated in FIG. 3, which, combined with the presence of the first reinforcing means 6, makes it possible to avoid the risk of frying the wall of the body and guaranteeing a maintenance solid, reliable and particularly atraumatic said organ. In order to facilitate placement in the patient's body, the kit of the present invention also advantageously includes an ancillary surgical instrument. This instrument 30 comprises a gripping element 31 intended to be held by a surgeon and an insertion member 32 extending from the latter in a substantially curved profile adapted to its introduction through a shutter hole 23, such as illustrated in Figure 7. Advantageously, it is a helical needle (Figure 6) whose shape is particularly suited to the patient's anatomy. In addition, the needle advantageously comprises a tapered end 32A intended to effectively cross, by limiting the trauma of the tissues, the obturator membrane 27.

In a particularly advantageous embodiment, the insertion member 32 of the surgical instrument 30 comprises an opening 33 in which the second end IB, 2B of the band 1, 2 is intended to be introduced and then to be maintained thereafter. the passage of the second end IB, 2B through the shutter hole 23 A, 23B corresponding. The diameter of the opening 33 is smaller than the width of the second end IB, 2B of the band 1, 2, the surgeon being then forced to force said second end IB, 2B through the eye 33 to guarantee the holding said second end IB, 2B on the ancillary during the entire operation of introduction and introduction of the strips 1, 2.

This surgical instrument 30, in particular because of its shape and size adapted to the morphology of the patient, has the advantage of facilitating the introduction of the band 1, 2 through the obturator holes 23, while limiting the tissue trauma during the operation. Alternatively, it is also possible to use another type of curved needle for the placing strips 1, 2, for example an Emmet needle.

Finally, the present invention also relates to a surgical method for maintaining a human or animal organ in a functional position. Preferably, this method is used for the treatment of female genital prolapse, by maintaining an organ of the urogenital tract.

A first embodiment describes a surgical method for suspending a central organ of the pelvis, using a first and only elongated implantable element 10, in accordance with the above. Said surgical method comprises a first fixation step in the course of which a first elongate holding implantable element 10, extending between first and second ends IA, IB, is fixed by its first end IA to said organ. Said first end IA has a substantially flat shape defining a first lower face IC and an opposite upper face ID opposite.

This method also includes a first holding step in which said first elongated implantable element 10 is retained by its second end IB in biological tissues. The first end IA of said first elongated implantable element 10 comprises a first reinforcing means 6 designed to improve the maintenance of said member. Said first reinforcing means 6 is associated with the first end IA so that said first lower and upper faces of the first end IA of said first implantable element 10 each have a substantially continuous surface. In this first embodiment, the surgeon performs a conventional laparoscopic surgical method to support an organ, for example a laparoscopic fixation method, during which the two ends of the first elongated element 10 forming the first band 1 are sutured respectively to the organ and the tissues, for example to the ligament of Cooper or to the spine of the pubis. The reinforcing means 6 present on at least one of the ends IA, IB of the band 1 promotes the strength of the support.

In a second advantageous embodiment, the present method constitutes a transobturator vaginal colposuspension method. Said method is preferably carried out under locoregional anesthesia of the patient and lasts on average 30 minutes. This method will now be briefly described, with reference to the implementation of a kit according to the invention.

According to the invention, the surgical method comprises a first incision step in which the surgeon makes a first incision at the level of the root of the left thigh and a second incision at the level of the root of the patient's right thigh. . The surgeon then performs, preferably, a third incision in the wall of the vagina 21, that is to say that he practices a colpotomy, during which the wall of the vagina 21 is retained by pins 28 to keep the incision open (see Figure 5). Preferably, the surgeon then takes off the bladder from the vagina 21 and opens the para-vesical pits (not shown).

During the surgical method, the surgeon first introduces into the patient, through the third incision, first and second elongate implantable elements 10, 20, advantageously forming the strips 1, 2 according to the description above .

Said method then comprises a first fixation step during which the first elongated implantable element 10, extending between a first IA and a second 1 B ends, is fixed by its first end IA to the vagina 21, said first end IA having a substantially flat shape defining a first lower face IC and a first upper face 1 D opposite.

During the fixation step, the surgeon therefore practices a colpotomy to introduce said band 1, the first end IA of the band 1 being sutured by the surgeon to the left lateral wall of the organ (see FIG. ). To achieve this suture, the surgeon preferably uses suture son 4, previously connected to the band 1. It is also conceivable that the band 1 does not include suture son 4; the surgeon then uses other sutures to achieve fixation of the first end IA vagina 21.

In addition, the first end 1A of the first band 1 comprises a first substantially rigid reinforcement means 6, designed to facilitate the suture of said first end AI on the vagina 21 and improve the retention of the vagina 21. The first reinforcement means 6 is associated with the first end IA so that said first lower faces IC and upper ID of the first end IA each have a substantially continuous surface. Said method also comprises a first holding step during which the band 1 is introduced into the tissues and retained in the latter by its second end IB, in particular at the left obturator hole 23A, through which it passes. Preferably, the retaining step is performed substantially subsequent to the fixing step.

Said method then comprises, for the introduction of the second elongated implantable element 20 forming a second band 2, a second fixation step during which at least the second elongated implantable holding element 20, extending between a first 2A and a second 2B ends, is fixed by its first end 2A to said organ. Said first end 2A having a substantially flat shape defining a second bottom face 2C and a second opposite upper face 2D.

The method also includes a second holding step in which said second elongate implantable element 20 is retained by its second end 2B in biological tissue, precisely at the right obturator hole 23B, through which it passes. The first end 2A of said second elongated implantable element 20 comprising a second reinforcement means adapted to improve the retention of said member, said second reinforcing means being associated with the first end 2A so that said second lower face 2C and upper 2D of the first end 2A of said second elongated implantable element 20 each have a substantially continuous surface. Thus, advantageously, the surgeon sets up the first band 1 during a first fixing step and a first holding step, then the second band 2 during a second fixing step and a second holding step, so that on the one hand the first end IA, 2A of each band 1, 2 is attached to the side wall, left and right, respectively, of the vagina 21, and secondly the second end IB, 2B of each band 1, 2 is retained at the obturator hole, respectively left 23 A and right 23B, by simple friction on the biological tissue.

Preferably, after the fixation step and to perform the retaining step, the surgeon introduces through a thigh root incision a substantially helical curved surgical instrument comprising a helical needle insertion member 32 and wherein a tapered end 32A is for piercing the obturator membrane 27 so that the ancillary passes through the corresponding obturator hole 23 and joins the colpotomy area. The surgeon may alternatively use another type of curved needle, for example an Emmet needle.

After the step of introducing the instrument 30, the surgeon preferably introduces the second end IB, 2B of the band 1, 2, through an opening 33 of the ancillary 30, so as to maintain the band 1, 2 on said ancillary 30. Said ancillary 30 is then extracted from the body of the patient through the obturator hole 23, by the same path as that for the introduction of the ancillary 30, so as to leave free the second end IB, 2B in the biological tissues at the obturator hole 23, said band 1, 2 being retained by simple friction of its second end IB, 2B on said biological tissues. The surgeon then removes the ancillary 30 from the patient's body, removes the second end IB, 2B and thus leaves the second end IB, 2B free in the biological tissues at the obturator hole 23.

Finally, this method includes a step in which the surgeon adjusts the length of the band 1, 2 to effectively maintain the vagina 21 without tension. The surgeon advantageously draws on the second end IB, 2B of each band 1, 2, previously put in place. He can then cut the second end IB, 2B to the length he deems sufficient to ensure optimal maintenance of the vagina 21 and prevent the band 1, 2 from exceeding too far beyond the obturator hole 23. In practice, the surgeon draws on each of the second ends IB, 2B and adjusts the length of the strips 1, 2 for effective treatment of the cystocele. This practice reduces the trauma associated with the insertion of the bands 1, 2 in the body, while using a standard size of bands 1, 2 adjustable to any type of patient. The surgeon then sutures the incision of the root of the thigh and finally closes the colpotomy by suture, for example overlocked. This surgical method does not require any particular skill of the surgeon, does not require additional time compared to the placement of a colposuspension prosthesis and causes only a very limited number of incisions in the patient. In addition, this method allows colposuspension safer, less traumatic and especially less invasive for the patient than previous prostheses. The risks of erosion and retraction of the vagina 21, common with prolonged use of the anterior prostheses, are also greatly reduced, particularly because of the low contact area of the bands 1, 2 of the present invention with the vagina 21. This method also uses a simple design kit, easy to use and adaptable to any type of anatomy.

Finally, the kit of the present invention makes it possible, in addition to the treatment of the cystocele, to limit the cases of postoperative "masked" incontinence that may occur due to the presence of prolapse. The introduction of the strips 1, 2 as described above thus also reduces the cases of incontinence of the woman following a surgical treatment of genital prolapse.

Claims

1 - Kit for maintaining, in a functional position, a human or animal organ, said kit comprising at least a first elongate implantable element (10) for maintaining said organ, said first elongated implantable element (10) extending between a first (IA) and a second (IB) end, said first end (IA) having a substantially flat shape defining a first lower face (1 C) and an opposite first face (ID), said first elongate implantable member (10) being intended to be on the one hand fixed by its first end (IA) to said organ, and on the other hand retained by its second end (IB) in biological tissues, said kit being characterized in that the first end (IA) of first elongate implantable element (10) comprises a first reinforcing means (6) adapted to enhance the retention of said member, said first reinforcing means (6) being associated with the first ext rim (IA) so that said first lower (IC) and upper (ID) faces of the first end (IA) of the first elongated implantable element (10) each have a substantially continuous surface.

2 - Kit according to claim 1 characterized in that the first reinforcing means (6) is at least partially pressed against said first end (IA).

3 - Kit according to claim 1 or 2 characterized in that the first reinforcing means (6) comprises a fold (6A) made from the first end (IA), said fold (6A) comprising a transverse edge (6B) attached to said first end (IA), said transverse edge (6B) extending in a direction substantially perpendicular to the main extension axis (Y-Y ') of the first elongated implantable element (10).

4 - Kit according to one of claims 1 to 3 characterized in that the first elongated implantable element (10) is substantially flat, preferably in the form of a band.

5 - Kit according to one of claims 1 to 4 characterized in that the second end (IB) of the first elongated implantable element (10) is designed to be fixed to the biological tissue and comprises another reinforcing means designed to improve the maintenance of the organ and attachment of said second end (IB) to said biological tissues. 6 - Kit according to one of claims 1 to 4 characterized in that the second end

(IB) of the first elongate implantable member (10) is adapted to pass through and be retained at a plug hole (23) by simply friction on the biological tissue.

7 - Kit according to one of the preceding claims characterized in that the first elongate implantable element (10) has a length substantially between 5 and 30 cm, preferably substantially between 8 and 12 cm, preferably substantially equal to 10 cm. . 8 - Kit according to one of the preceding claims characterized in that the first reinforcing means (6) is a length substantially between 0.1 and 5 cm, preferably substantially between 0.3 and 0.7 cm, preferably substantially equal to 0.5 cm.

9 - Kit according to one of the preceding claims characterized in that the first elongated implantable element (10) has a width substantially between 0.5 and 5 cm, preferably substantially between 0.5 and 2 cm, preferably substantially equal to 1 cm.

10 - Kit according to one of the preceding claims characterized in that the first end (IA) of the first elongated implantable element (10) has a width substantially greater than that of the second end (IB) of said first elongated implantable element (10) . 11 - Kit according to one of the preceding claims characterized in that the first elongate implantable element (10) is made of prosthetic textile, preferably polypropylene monofilament or polyester multi-strand.

12 - Kit according to one of the preceding claims characterized in that it comprises at least one second elongated implantable element (20) for holding said member, said second elongate implantable element (20) extending between a first (2A ) and a second (2B) end, said first end (2A) having a substantially flat shape defining a second lower face (2C) and a second opposite top face (2D), said second elongate implantable member (20) being adapted to be on the one hand fixed by its first end (2A) to said organ, and secondly retained by its second end (2B) in biological tissues, the first end (2A) of the second elongate implantable element (20) comprising a second reinforcement means (6 ') adapted to improve the retention of said member, said second reinforcing means (6') being associated with the first end (2A) so that the said the second lower (2C) and upper (2D) faces of the first end (2A) of the second elongated implantable element (20) each have a substantially continuous surface.

13 - Kit according to claim 12 characterized in that the second end (IB, 2B) of each elongate implantable element (10, 20) is designed to pass through and be retained at a shutter hole (23), respectively left ( 23A) and right (23B), by simple friction on the biological tissues. 14 - Kit according to one of claims 12 or 13 characterized in that the elongated holding elements (10, 20) are intended to extend substantially symmetrically relative to each other with respect to an axis of main extension (XX ') of the organ.

15 - Kit according to one of the preceding claims characterized that it is intended for the treatment of female genital prolapse, by maintaining an organ of the urogenital tract, preferably the bladder or vagina (21) . 16 - Kit according to one of the preceding claims characterized in that it is intended for the treatment of a cystocele, preferably by colposuspension.

17 - Kit according to one of the preceding claims characterized in that it comprises a surgical instrument (30) comprising a gripping member (31) to be held by a surgeon and an insertion member (32) extending from the latter in a substantially curved profile adapted to its introduction through a shutter hole (23).

18 - Kit according to claim 17 characterized in that the introduction member (31) of the surgical instrument (30) comprises an opening (33) in which the second end (IB, 2B) of the elongated implantable element (1, 2) is intended to be introduced to be maintained thereafter during the passage of the second end (IB, 2B) through the shutter hole (23) corresponding.