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EP1128781A1 - Suspension device for treating prolapsus and urinary incontinence - Google Patents

Suspension device for treating prolapsus and urinary incontinence

Info

Publication number
EP1128781A1
EP1128781A1 EP99971689A EP99971689A EP1128781A1 EP 1128781 A1 EP1128781 A1 EP 1128781A1 EP 99971689 A EP99971689 A EP 99971689A EP 99971689 A EP99971689 A EP 99971689A EP 1128781 A1 EP1128781 A1 EP 1128781A1
Authority
EP
European Patent Office
Prior art keywords
cord
anchoring
suspension device
fixed
parts
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP99971689A
Other languages
German (de)
French (fr)
Inventor
François Régis ORY
Michel Therin
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sofradim Production SAS
Original Assignee
Sofradim Production SAS
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Sofradim Production SAS filed Critical Sofradim Production SAS
Publication of EP1128781A1 publication Critical patent/EP1128781A1/en
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0004—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
    • A61F2/0031—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra
    • A61F2/0036—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra implantable
    • A61F2/0045—Support slings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00805—Treatment of female stress urinary incontinence
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0063—Implantable repair or support meshes, e.g. hernia meshes

Definitions

  • the present invention relates to a suspension device for the surgical treatment of prolapse, in particular genital, urinary and rectal, and urinary incontinence in elderly women.
  • Genital, urinary and rectal prolapse arise from a relaxation of the tissues supporting the organs, as well as of the perineum.
  • Their surgical treatment involves connecting one or more of these organs (bladder, vagina, uterus, rectum) to anatomically stable areas, in particular, anterior side, at the level of the ligament of Cooper, on the postero-superior edge of the pubis or, posterior side, at the level of the promontory, that is to say the antero-superior angle of the sacrum, by "suspending" these organs from these anatomically stable areas.
  • Surgical treatment of prolapse is currently carried out using non-absorbable sutures or parietal reinforcement strips.
  • the sutures have the advantage of being simple to put in place during the treatment of an open prolapse, of having a reduced cost and wide possibilities of use.
  • they have the drawback of ensuring a punctual and inelastic fixing of the suspension wire, which is capable of causing shearing of the fabrics on which they are placed, leading to a break in the anchoring.
  • their effectiveness is moderate over time.
  • they are complex to set up during the treatment of laparoscopic prolapse, given the need to make many knots.
  • the advantage of the strips is that they are simple to put in place whatever the route used (open or laparoscopic route), that they are effective and that the stresses that are exerted are distributed over several anchoring points. ⁇ es are also capable of rapid integration into the anchor wall, by tissue rehabitation.
  • a strip of relatively rigid material such as polypropylene monofilament, has edges which can be traumatic for the surrounding tissues, over the entire length of the strip.
  • the device which it relates comprises at least one " filiform suspension cord, made of non-absorbable material and of limited elasticity, and at least two anchoring parts connected to the ends of this cord; these anchoring parts are of material in the form of a sheet, with a flexible and perforated structure, suitable for adapting to the configuration of the respective implantation walls, and said parts are intended to be fixed to these same walls using appropriate means, such as suturing or stapling, and to then be integrated, by tissue rehabitation through them, to these walls.
  • the device according to the invention has, unlike the means used according to the prior art, a dual structure, each part (cord or anchoring parts) being optimized for the function which it must fulfill: the cord, the fact that it is threadlike, is not traumatic for the surrounding tissues, and its possible twisting is without consequence on its work in traction and therefore on its resistance over time, as well as on the maneuverability of the device; thanks to the elasticity of this cord, the surgeon can adapt the tension of the suspension without disturbing the anchoring zones; the anchor pieces can be adapted to the shape of their anchor site and can be fixed to it at several mutually distant points and then be integrated into the walls on which they are anchored by tissue rehabitation through them.
  • the device comprises a cord and two anchoring parts, one of which is fixed to one of the ends of the cord and the other to the other of these ends.
  • the device comprises a cord, two anchor pieces fixed on each end of the cord and an anchor piece fixed at a determined location of the length of the cord, in particular at the level of the middle area of it.
  • the anchoring pieces fixed to the ends of the cord are connected to the anatomically stable zone while the anchoring piece fixed at a determined location of the length of the cord surrounds part of the organ to be supported, in the manner of a slingshot.
  • the device thus shaped can in particular be used for cystopexy by sub-cervical sling.
  • the device comprises two cords each provided with an anchor piece connected to one of their ends, the other two ends of the cords being connected to a single anchor piece.
  • the anchors connected to one end of the cords are intended to be fixed to the anatomically stable area while said single anchor is intended to be fixed to the member to be suspended.
  • This device can in particular be used to allow vaginal suspension at the headland, in case of conservation of the uterus.
  • the cords can be parallel or form an angle between them.
  • the device comprises two cords each provided with an anchoring piece connected to one of their ends, the two other ends of the cords being connected to two anchoring pieces, they- same connected to each other at one of their edges.
  • These two assembled anchoring parts thus have a form of sheet allowing the assembly to be engaged on either side of a part of an organ, in particular on the end of this organ, which it can "oversee”.
  • the device thus shaped can in particular be used for suspending the vagina at the headland after hysterectomy.
  • the cord is preferably constituted by a braid of polypropylene or polyethylene terephthalate (polyester) threads.
  • the elasticity curve of this cord is as linear as possible so that the practitioner can make tension adjustments.
  • a tensile strength of ten kilos is largely sufficient, and an elongation at break of the order of 40%, obtained linearly from a load of one or two kilos, is preferable.
  • the cord is constituted by a knitted braid in thrown stitches, constituted by four threads of two ends of polyester of 167 decitex texture.
  • This cord advantageously has a section greater than about one square millimeter to avoid any cutting effect with respect to the surrounding tissues during its tensioning.
  • the anchors can be formed by a knitted or non-woven mesh, preferably made of polypropylene or polyethylene terephthalate (polyester), of the type used for reinforcing walls following the treatment of inguinal hernias. They have shapes and dimensions adapted to the anchoring to be produced and are preferably largely perforated to allow the aforementioned tissue rehabitation through them.
  • the material of the cord and of the anchoring parts is identical.
  • cord and the anchoring parts can be joined by sewing or by welding, in particular by ultrasound.
  • the invention is again described below with reference to the appended diagrammatic drawing representing, by way of nonlimiting examples, several embodiments of the suspension device that it relates to.
  • Figures 1 to 3 are flat views according to three embodiments;
  • Figure 4 is a perspective view according to a fourth embodiment;
  • Figure 5 is a very simplified sectional view of the bottom of the trunk of a person, with embodiment, by means of a device of the type shown in Figure 1, a posterior suspension of the vagina, with anchoring to headland level;
  • Figure 6 is a view similar to Figure 5, with realization, by means of two devices of the type shown in Figure 1, of a cystopexy with suspension of the anterior and lateral walls of the vagina to the ligament of Cooper;
  • Figure 7 is a view similar to Figure 5, with embodiment, by means of two devices of the type shown in Figure 1, a posterior suspension of the rectum with anchoring at the headland;
  • Figure 8 is a view similar to Figure 5, with embodiment, by means of a device shown in Figure 2, of a cystopexy by sling under cervical;
  • FIG. 9 is a view similar to FIG. 5, with embodiment, by means of a device of the type shown in FIG. 3, of a suspension of the vagina with anchoring at the level of the promontory, the uterus being preserved
  • Figure 10 is a view similar to Figure 5, with embodiment, by means of a device of the type shown in Figure 4, a vaginal suspension with anchoring at the headland, after hysterectomy.
  • FIG. 1 represents a suspension device 1 for the surgical treatment of prolapse, in particular genital, urinary or rectal in elderly women.
  • This device comprises a cord 2 and two anchoring parts 3 fixed to the ends of the cord 1.
  • the cord 2 is threadlike and is constituted by a knitted braid in thrown stitches, formed by four threads of two ends of polyester of textured 167 decitex.
  • the anchoring pieces 3 are constituted by a mesh knitted with polyester threads identical to those forming the cord 2. They have a flexible and perforated structure, suitable for adapting to the configuration of the walls of the anchoring zones or of the members to hang, and have shapes and dimensions adapted to the anchoring to be achieved.
  • These anchoring parts 3 are fixed to the cord 2 by sewing or welding, in particular by ultrasound.
  • FIG. 5 shows a posterior suspension of the vagina 13 at the headland 1 1, produced with a device 1 of this type, the anchoring parts 3 being fixed to the respective implantation walls by suturing or stapling, and then being integrated into these walls , by tissue rehabitation through them.
  • FIG. 6 shows a cystopexy, that is to say a support of the bladder 12, carried out by suspension of the anterior and lateral walls of the vagina 13 from the ligament of Cooper 14, according to the so-called Burch technique, using two devices 1 as shown in Figure 1.
  • Figure 7 shows a posterior suspension of the rectum 15, with anchoring at the promontory 1 1, made by means of two devices of the type shown in Figure 1, the parts d anchor 3 fixed to the promontory 1 1 being superimposed while the other two anchor pieces 3 are fixed on either side of the rectum 15.
  • FIG. 2 shows a device 1 comprising a cord 2 and two anchoring parts 3 as mentioned above, fixed on each of the ends of the cord 2.
  • This device 1 also comprises an anchoring part 4, similar to the anchoring parts 3, fixed at the center of the cord 2.
  • FIG. 3 shows another device 1, comprising two parallel cords 2, each provided with an anchoring part 3 connected to a of their ends, the other two ends of the cords 2 being connected to a single anchoring part 3, of larger dimensions than those of the other two parts 3.
  • FIG. 4 shows yet another device 1, comprising two cords 2 provided with anchoring parts 3 connected at their ends. Two anchoring pieces 3 are connected to each other at one of their edges.
  • These two anchoring pieces 3 thus have a form of sheet allowing them, as shown in FIG. 10 in the case of a suspension of the vagina 13 at the headland 11 after hysterectomy, to cap the end of the vagina 13.
  • the invention thus provides a suspension device for the surgical treatment of prolapse, especially genital, urinary and rectal, and urinary incontinence in elderly women, which overcomes the drawbacks of devices homologous to the prior art.
  • this device has a dual structure, each part (cord or anchoring parts) being optimized for the function which it must fulfill: the cord, because it is threadlike, is not traumatic for the surrounding tissues, and its possible twisting is without consequence on its work in traction and therefore on its resistance over time, as well as on the maneuverability of the device; thanks to the elasticity of this cord, the surgeon can adapt the tension of the suspension without disturbing the anchoring zones; the anchor pieces can be adapted to the shape of their anchor site and can be fixed to it at several mutually distant points and then be integrated into the walls on which they are anchored by tissue rehabitation through them.
  • the invention is not limited to the embodiment described above by way of example but that it embraces, on the contrary, all the variant embodiments.
  • the dimensions and shapes of the anchoring pieces 3 may be slightly different from one application to another, so as to have a shape adapted to the configuration of the corresponding implantation wall.

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  • Health & Medical Sciences (AREA)
  • Urology & Nephrology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

The invention concerns a device (1) comprising at least one filiform suspension cord (2), made of non-absorbable material and with limited elasticity, and at least two anchoring parts (3) linked to the ends of said cord (2); said anchoring parts (3) are made of sheet material, having a flexible and open-worked structure, capable of adapting to the configuration of the respective implanting walls, and said parts (3) are designed to be fixed to those same walls by appropriate means, such as suturing or stapling means, and to be then incorporated, by tissue rehabitation through them, in said surfaces.

Description

DISPOSITIF DE SUSPENSION POUR LE TRAITEMENT DE PROLAPSUS ET D'INCONTINENCES URINAIRES SUSPENSION DEVICE FOR THE TREATMENT OF PROLAPSUS AND URINARY INCONTINENCES
La présente invention concerne un dispositif de suspension pour le traitement par voie chirurgicale de prolapsus, notamment génitaux, urinaires et rectaux, et d'incontinences urinaires chez la femme âgée.The present invention relates to a suspension device for the surgical treatment of prolapse, in particular genital, urinary and rectal, and urinary incontinence in elderly women.
Les prolapsus génitaux, urinaires et rectaux proviennent d'un relâchement des tissus soutenant les organes, ainsi que du périné. Leur traitement chirurgical implique de relier un ou plusieurs de ces organes (vessie, vagin, utérus, rectum) à des zones anatomiquement stables, notamment, côté antérieur, au niveau du ligament de Cooper, sur le bord postéro-supérieur du pubis ou, du côté postérieur, au niveau du promontoire, c'est-à-dire de l'angle antéro-supérieur du sacrum, en "suspendant" ces organes à ces zones anatomiquement stables.Genital, urinary and rectal prolapse arise from a relaxation of the tissues supporting the organs, as well as of the perineum. Their surgical treatment involves connecting one or more of these organs (bladder, vagina, uterus, rectum) to anatomically stable areas, in particular, anterior side, at the level of the ligament of Cooper, on the postero-superior edge of the pubis or, posterior side, at the level of the promontory, that is to say the antero-superior angle of the sacrum, by "suspending" these organs from these anatomically stable areas.
Le traitement chirurgical des prolapsus est actuellement réalisé au moyen de sutures non resorbables ou de bandelettes de renfort pariétal.Surgical treatment of prolapse is currently carried out using non-absorbable sutures or parietal reinforcement strips.
Les sutures ont pour avantage d'être simples à mettre en place lors du traitement d'un prolapsus par voie ouverte, d'avoir un coût réduit et des possibilités d'utilisation étendues. Elles ont toutefois pour inconvénient d'assurer une fixation ponctuelle et peu élastique du fil de suspension, qui est susceptible de provoquer un cisaillement des tissus sur lesquels elles sont mises en place, conduisant à une rupture de l'ancrage. Il en résulte que leur efficacité est modérée dans le temps. De plus, elles sont complexes à mettre en place lors du traitement des prolapsus par voie laparoscopique, compte tenu de la nécessité de faire de nombreux noeuds.The sutures have the advantage of being simple to put in place during the treatment of an open prolapse, of having a reduced cost and wide possibilities of use. However, they have the drawback of ensuring a punctual and inelastic fixing of the suspension wire, which is capable of causing shearing of the fabrics on which they are placed, leading to a break in the anchoring. As a result, their effectiveness is moderate over time. In addition, they are complex to set up during the treatment of laparoscopic prolapse, given the need to make many knots.
Les bandelettes ont pour avantages d'être simples à mettre en place quelle que soit la voie employée (voie ouverte ou laparoscopique), d'être efficaces et de permettre une répartition sur plusieurs points d'ancrage des contraintes qui sont exercées. ϋes sont en outre susceptibles d'une intégration rapide à la paroi d'ancrage, par réhabitation tissulaire.The advantage of the strips is that they are simple to put in place whatever the route used (open or laparoscopic route), that they are effective and that the stresses that are exerted are distributed over several anchoring points. ϋes are also capable of rapid integration into the anchor wall, by tissue rehabitation.
Ces bandelettes ont toutefois pour inconvénient de devoir être vrillées lorsque les parois d'implantation res l «-o ne sont pas parallèles. La zone vrillée travaille dans des conditions guère favorables, en se déplaçant le long de la bande lors d'une tension, avec amincissement de cette dernière en son centre, rendant sa mise en place malaisée et accentuant l'effet de cisaillement. Une bande en matériau relativement rigide, tel qu'en polypropylène monofilament, présente des bords pouvant être traumatisants pour les tissus environnants, sur l'ensemble de la longueur de la bande.These strips have the drawback, however, of having to be twisted when the implantation walls res l "-o are not parallel. The twisted zone works in hardly favorable conditions, moving along the strip during a tension, with thinning of the latter in its center, making its installation difficult and accentuating the shearing effect. A strip of relatively rigid material, such as polypropylene monofilament, has edges which can be traumatic for the surrounding tissues, over the entire length of the strip.
Il n'existe pas à ce jour d'implant donnant toute satisfaction pour le traitement spécifique des prolapsus et des incontinences urinaires, et la présente invention vise à remédier à cette lacune.To date, there is no implant giving any satisfaction for the specific treatment of prolapse and urinary incontinence, and the present invention aims to remedy this shortcoming.
A cet effet, le dispositif qu'elle concerne comprend au moins un cordon de suspension" filiforme, en matériau non résorbable et à élasticité limitée, et au moins deux pièces d'ancrage reliées aux extrémités de ce cordon ; ces pièces d'ancrage sont en matériau sous forme de feuille, à structure souple et ajourée, propre à s'adapter à la configuration des parois respectives d'implantation, et lesdites pièces sont destinées à être fixées à ces mêmes parois à l'aide de moyens appropriés, tels que suture ou agrafage, et à être ensuite intégrées, par réhabitation tissulaire à travers elles, à ces parois.To this end, the device which it relates comprises at least one " filiform suspension cord, made of non-absorbable material and of limited elasticity, and at least two anchoring parts connected to the ends of this cord; these anchoring parts are of material in the form of a sheet, with a flexible and perforated structure, suitable for adapting to the configuration of the respective implantation walls, and said parts are intended to be fixed to these same walls using appropriate means, such as suturing or stapling, and to then be integrated, by tissue rehabitation through them, to these walls.
Ainsi, le dispositif selon l'invention présente, à la différence des moyens employés selon la technique antérieure, une structure duale, chaque partie (cordon ou pièces d'ancrage) étant optimisée pour la fonction qu'elle doit remplir : le cordon, du fait qu'il est filiforme, n'est pas traumatisant pour les tissus environnants, et son vrillage éventuel est sans conséquence sur son travail en traction et donc sur sa résistance dans le temps, ainsi que sur la maniabilité du dispositif ; grâce à l'élasticité de ce cordon, le chirurgien peut adapter la tension de la suspension sans perturber les zones d'ancrage ; les pièces d'ancrage peuvent être adaptées à la forme de leur site d'ancrage et peuvent être fixées à celui-ci selon plusieurs points mutuellement distants puis être intégrées aux parois sur lesquelles elles sont ancrées par réhabitation tissulaire à travers elles. Les ruptures par cisaillement des sutures au niveau des points d'ancrage sont supprimées et la structure ajourée des pièces d'ancrage permet une intégration tissulaire intime et précoce, sans formation de coque fibreuse périphérique, pour une récupération fonctionnelle et une convalescence rapide du patient. Selon une forme de réalisation de l'invention, le dispositif comprend un cordon et deux pièces d'ancrage, dont une est fixée sur une des extrémités du cordon et l'autre sur l'autre de ces extrémités.Thus, the device according to the invention has, unlike the means used according to the prior art, a dual structure, each part (cord or anchoring parts) being optimized for the function which it must fulfill: the cord, the fact that it is threadlike, is not traumatic for the surrounding tissues, and its possible twisting is without consequence on its work in traction and therefore on its resistance over time, as well as on the maneuverability of the device; thanks to the elasticity of this cord, the surgeon can adapt the tension of the suspension without disturbing the anchoring zones; the anchor pieces can be adapted to the shape of their anchor site and can be fixed to it at several mutually distant points and then be integrated into the walls on which they are anchored by tissue rehabitation through them. The shear ruptures of the sutures at the anchor points are eliminated and the openwork structure of the anchor pieces allows intimate and early tissue integration, without the formation of a peripheral fibrous shell, for functional recovery and rapid convalescence of the patient. According to one embodiment of the invention, the device comprises a cord and two anchoring parts, one of which is fixed to one of the ends of the cord and the other to the other of these ends.
L'une des pièces d'ancrage est destinée à être fixée à l'organe à suspendre et l'autre à la zone anatomiquement stable. Ce dispositif peut notamment être utilisé, individuellement ou en double, pour permettre une suspension utérine ou rectale postérieure avec ancrage au niveau du promontoire ou une cystopexie par suspension des parois antérieure et latérales du vagin au ligament de Cooper (technique dite de Burch). Selon une autre forme de réalisation de l'invention, le dispositif comprend un cordon, deux pièces d'ancrage fixées sur chacune des extrémités du cordon et une pièce d'ancrage fixée en un emplacement déterminé de la longueur du cordon, en particulier au niveau de la zone médiane de celui-ci. Les pièces d'ancrage fixées aux extrémités du cordon sont reliées à la zone anatomiquement stable tandis que la pièce d'ancrage fixée en un emplacement déterminé de la longueur du cordon vient entourer une partie de l'organe à soutenir, à la manière d'une fronde. Le dispositif ainsi conformé peut notamment être utilisé pour une cystopexie par fronde sous cervicale.One of the anchoring pieces is intended to be fixed to the organ to be suspended and the other to the anatomically stable area. This device can in particular be used, individually or in duplicate, to allow a posterior uterine or rectal suspension with anchoring at the level of the promontory or a cystopexy by suspension of the anterior and lateral walls of the vagina to the Cooper ligament (so-called Burch technique). According to another embodiment of the invention, the device comprises a cord, two anchor pieces fixed on each end of the cord and an anchor piece fixed at a determined location of the length of the cord, in particular at the level of the middle area of it. The anchoring pieces fixed to the ends of the cord are connected to the anatomically stable zone while the anchoring piece fixed at a determined location of the length of the cord surrounds part of the organ to be supported, in the manner of a slingshot. The device thus shaped can in particular be used for cystopexy by sub-cervical sling.
Selon encore une autre forme de réalisation de l'invention, le dispositif comprend deux cordons munis chacun d'une pièce d'ancrage reliée à une de leurs extrémités, les deux autres extrémités des cordons étant reliées à une pièce d'ancrage unique. Les pièces d'ancrage reliées à l'une des extrémités des cordons sont destinées à être fixées à la zone anatomiquement stable tandis que ladite pièce d'ancrage unique est destinée à être fixée à l'organe à suspendre. Ce dispositif peut notamment être utilisé pour permettre une suspension vaginale au promontoire, en cas de conservation de l'utérus. Les cordons peuvent être parallèles ou former un angle entre eux.According to yet another embodiment of the invention, the device comprises two cords each provided with an anchor piece connected to one of their ends, the other two ends of the cords being connected to a single anchor piece. The anchors connected to one end of the cords are intended to be fixed to the anatomically stable area while said single anchor is intended to be fixed to the member to be suspended. This device can in particular be used to allow vaginal suspension at the headland, in case of conservation of the uterus. The cords can be parallel or form an angle between them.
Selon encore une autre forme de réalisation de l'invention, le dispositif comprend deux cordons munis chacun d'une pièce d'ancrage reliée à une de leurs extrémités, les deux εutres extrémités des cordons étant reliées à deux pièces d'ancrage, elles-mêmes reliées l'une à l'autre au niveau d'un de leurs bords. Ces deux pièces d'ancrage assemblées présentent ainsi une forme de feuillet permettant à l'ensemble d'être engagé de part et d'autre d'une partie d'un organe, notamment sur l'extrémité de cet organe, qu'il peut "chapeauter". Le dispositif ainsi conformé peut notamment être utilisé pour une suspension du vagin au promontoire après hystérectomie.According to yet another embodiment of the invention, the device comprises two cords each provided with an anchoring piece connected to one of their ends, the two other ends of the cords being connected to two anchoring pieces, they- same connected to each other at one of their edges. These two assembled anchoring parts thus have a form of sheet allowing the assembly to be engaged on either side of a part of an organ, in particular on the end of this organ, which it can "oversee". The device thus shaped can in particular be used for suspending the vagina at the headland after hysterectomy.
Le cordon est de préférence constitué par une tresse de fils de polypropylene ou de polyethylene téréphtalate (polyester).The cord is preferably constituted by a braid of polypropylene or polyethylene terephthalate (polyester) threads.
La courbe d'élasticité de ce cordon est la plus linéaire possible de façon à permettre au praticien de procéder à des réglages de tension. Une résistance à la rupture de dix kilos est largement suffisante, et un allongement à la rupture de l'ordre de 40 %, obtenu linéairement depuis une charge de un ou deux kilos, est préférable.The elasticity curve of this cord is as linear as possible so that the practitioner can make tension adjustments. A tensile strength of ten kilos is largely sufficient, and an elongation at break of the order of 40%, obtained linearly from a load of one or two kilos, is preferable.
De préférence, le cordon est constitué par une tresse tricotée en mailles jetées, constituée par quatre fils de deux bouts de polyester de 167 décitex texture.Preferably, the cord is constituted by a knitted braid in thrown stitches, constituted by four threads of two ends of polyester of 167 decitex texture.
Ce cordon a avantageusement une section supérieure à un millimètre carré environ pour éviter tout effet coupant par rapport aux tissus environnants lors de sa mise en tension.This cord advantageously has a section greater than about one square millimeter to avoid any cutting effect with respect to the surrounding tissues during its tensioning.
Les pièces d'ancrage peuvent être constituées par un treillis tricoté ou non tissé, de préférence en polypropylene ou polyethylene téréphtalate (polyester), du type de ceux utilisés pour le renfort de parois suite au traitement de hernies inguinales. Elles présentent des formes et des dimensions adaptées à l'ancrage à réaliser et sont de préférence largement ajourées pour permettre la réhabitation tissulaire précitée à travers elles.The anchors can be formed by a knitted or non-woven mesh, preferably made of polypropylene or polyethylene terephthalate (polyester), of the type used for reinforcing walls following the treatment of inguinal hernias. They have shapes and dimensions adapted to the anchoring to be produced and are preferably largely perforated to allow the aforementioned tissue rehabitation through them.
De préférence, le matériau du cordon et des pièces d'ancrage est identique.Preferably, the material of the cord and of the anchoring parts is identical.
Le cordon et les pièces d'ancrage peuvent être solidarisés par couture ou par soudure, notamment par ultrasons. Pour sa bonne . compréhension, l'invention est à nouveau décrite ci-dessous en référence au dessin schématique annexé représentant, à titre d'exemples non limitatifs, plusieurs formes de réalisation du dispositif de suspension qu'elle concerne.The cord and the anchoring parts can be joined by sewing or by welding, in particular by ultrasound. For her good. understanding, the invention is again described below with reference to the appended diagrammatic drawing representing, by way of nonlimiting examples, several embodiments of the suspension device that it relates to.
Les figures 1 à 3 en sont des vues à plat selon trois formes de réalisation ; la figure 4 en est une vue en perspective selon une quatrième forme de réalisation ; la figure 5 est une vue en coupe très simplifiée du bas du tronc d'une personne, avec réalisation, au moyen d'un dispositif du type de celui représenté à la figure 1 , d'une suspension postérieure du vagin, avec un ancrage au niveau du promontoire ; la figure 6 est une vue similaire à la figure 5, avec réalisation, au moyen de deux dispositifs du type de celui représenté à la figure 1 , d'une cystopexie avec suspension des parois antérieure et latérales du vagin au ligament de Cooper ; la figure 7 est une vue similaire à la figure 5, avec réalisation, au moyen de deux dispositifs du type de celui représenté à la figure 1 , d'une suspension postérieure du rectum avec ancrage au niveau du promontoire ; la figure 8 est une vue similaire à la figure 5, avec réalisation, au moyen d'un dispositif représenté à la figure 2, d'une cystopexie par fronde sous cervicale ; la figure 9 est une vue similaire à la figure 5, avec réalisation, au moyen d'un dispositif du type de celui montré à la figure 3, d'une suspension du vagin avec ancrage au niveau du promontoire, l'utérus étant conservé, et la figure 10 est une vue similaire à la figure 5, avec réalisation, au moyen d'un dispositif du type de celui montré à la figure 4, d'une suspension vaginale avec ancrage au niveau du promontoire, après hystérectomie.Figures 1 to 3 are flat views according to three embodiments; Figure 4 is a perspective view according to a fourth embodiment; Figure 5 is a very simplified sectional view of the bottom of the trunk of a person, with embodiment, by means of a device of the type shown in Figure 1, a posterior suspension of the vagina, with anchoring to headland level; Figure 6 is a view similar to Figure 5, with realization, by means of two devices of the type shown in Figure 1, of a cystopexy with suspension of the anterior and lateral walls of the vagina to the ligament of Cooper; Figure 7 is a view similar to Figure 5, with embodiment, by means of two devices of the type shown in Figure 1, a posterior suspension of the rectum with anchoring at the headland; Figure 8 is a view similar to Figure 5, with embodiment, by means of a device shown in Figure 2, of a cystopexy by sling under cervical; FIG. 9 is a view similar to FIG. 5, with embodiment, by means of a device of the type shown in FIG. 3, of a suspension of the vagina with anchoring at the level of the promontory, the uterus being preserved, and Figure 10 is a view similar to Figure 5, with embodiment, by means of a device of the type shown in Figure 4, a vaginal suspension with anchoring at the headland, after hysterectomy.
Par simplification, les éléments qui se retrouvent dans ces différentes formes de réalisation, ou qui sont similaires d'une forme de réalisation à une autre, sont désignés par les mêmes références numériques. La figure 1 représente un dispositif 1 de suspension pour le traitement par voie chirurgicale de prolapsus, notamment génitaux, urinaires ou rectaux chez la femme âgée.For simplicity, the elements which are found in these different embodiments, or which are similar from one embodiment to another, are designated by the same reference numerals. FIG. 1 represents a suspension device 1 for the surgical treatment of prolapse, in particular genital, urinary or rectal in elderly women.
Ce dispositif comprend un cordon 2 et deux pièces d'ancrage 3 fixées aux extrémités du cordon 1. Le cordon 2 est filiforme et est constitué par une tresse tricotée en mailles jetées, formée par quatre fils de deux bouts de polyester de 167 décitex texturée.This device comprises a cord 2 and two anchoring parts 3 fixed to the ends of the cord 1. The cord 2 is threadlike and is constituted by a knitted braid in thrown stitches, formed by four threads of two ends of polyester of textured 167 decitex.
Les pièces d'ancrage 3 sont constituées par un treillis tricoté de fils de polyester identiques à ceux formant le cordon 2. Elles ont une structure souple et ajourée, propre à s'adapter à la configuration des parois des zones d'ancrage ou des organes à suspendre, et présentent des formes et des dimensions adaptées à l'ancrage à réaliser.The anchoring pieces 3 are constituted by a mesh knitted with polyester threads identical to those forming the cord 2. They have a flexible and perforated structure, suitable for adapting to the configuration of the walls of the anchoring zones or of the members to hang, and have shapes and dimensions adapted to the anchoring to be achieved.
Ces pièces d'ancrage 3 sont fixées au cordon 2 par couture ou soudure, notamment par ultrasons.These anchoring parts 3 are fixed to the cord 2 by sewing or welding, in particular by ultrasound.
La figure 5 montre une suspension postérieure du vagin 13 au promontoire 1 1 , réalisée avec un dispositif 1 de ce type, les pièces d'ancrage 3 étant fixées aux parois d'implantation respectives par suture ou agrafage, et étant ensuite intégrées à ces parois, par réhabitation tissulaire à travers elles.FIG. 5 shows a posterior suspension of the vagina 13 at the headland 1 1, produced with a device 1 of this type, the anchoring parts 3 being fixed to the respective implantation walls by suturing or stapling, and then being integrated into these walls , by tissue rehabitation through them.
La figure 6 montre une cystopexie, c'est-à-dire un soutien de la vessie 12, réalisée par suspension des parois antérieure et latérales du vagin 13 au ligament de Cooper 14, selon la technique dite de Burch, en utilisant deux dispositifs 1 tels que montrés à la figure 1. La figure 7 montre quant à elle une suspension postérieure du rectum 15, avec ancrage au niveau du promontoire 1 1 , réalisée au moyen de deux dispositifs du type de celui montré à la figure 1 , les pièces d'ancrage 3 fixées au promontoire 1 1 étant superposées tandis que les deux autres pièces d'ancrage 3 sont fixées de part et d'autre du rectum 15.FIG. 6 shows a cystopexy, that is to say a support of the bladder 12, carried out by suspension of the anterior and lateral walls of the vagina 13 from the ligament of Cooper 14, according to the so-called Burch technique, using two devices 1 as shown in Figure 1. Figure 7 shows a posterior suspension of the rectum 15, with anchoring at the promontory 1 1, made by means of two devices of the type shown in Figure 1, the parts d anchor 3 fixed to the promontory 1 1 being superimposed while the other two anchor pieces 3 are fixed on either side of the rectum 15.
La figure 2 montre un dispositif 1 comprenant un cordon 2 et deux pièces d'ancrage 3 telles que précitées, fixées sur chacune des extrémités du cordon 2. Ce dispositif 1 comprend en outre une pièce d'ancrage 4, similaire aux pièces d'ancrage 3, fixée au niveau de la zone médiane du cordon 2.FIG. 2 shows a device 1 comprising a cord 2 and two anchoring parts 3 as mentioned above, fixed on each of the ends of the cord 2. This device 1 also comprises an anchoring part 4, similar to the anchoring parts 3, fixed at the center of the cord 2.
Ainsi que cela apparaît à la figure 8, dans le cas d'une cystopexie par fronde sous cervicale, les pièces d'ancrage 3 sont fixées au ligament de Cooper 14, tandis que la pièce d'ancrage 4 vient entourer le col urinaire, à la manière d'une fronde. La figure 3 montre un autre dispositif 1 , comprenant deux cordons 2 parallèles, munis chacun d'une pièce d'ancrage 3 reliée à une de leurs extrémités, les deux autres extrémités des cordons 2 étant reliées à une pièce d'ancrage 3 unique, de dimensions plus importantes que celles des deux autres pièces 3.As shown in FIG. 8, in the case of a cystopexy by sub-cervical sling, the anchoring pieces 3 are fixed to the Cooper ligament 14, while the anchoring piece 4 surrounds the urinary neck, the way of a sling. FIG. 3 shows another device 1, comprising two parallel cords 2, each provided with an anchoring part 3 connected to a of their ends, the other two ends of the cords 2 being connected to a single anchoring part 3, of larger dimensions than those of the other two parts 3.
Comme le montre la figure 9, dans le cas d'une suspension du vagin 13 au promontoire 1 1 , en cas de conservation de l'utérus 10, les pièces d'ancrage 3 reliées aux deux extrémités des cordons 2 sont fixées au promontoire 1 1 tandis que la pièce d'ancrage 3 unique est fixée au niveau de la face antérieure du vagin 13, les deux cordons 2 passant de part et d'autre de l'utérus 10. La figure 4 montre encore un autre dispositif 1 , comprenant deux cordons 2 munis de pièces d'ancrage 3 reliées à leurs extrémités. Deux pièces d'ancrage 3 sont reliées l'une à l'autre au niveau d'un de leurs bords.As shown in Figure 9, in the case of a suspension of the vagina 13 to the promontory 1 1, in case of conservation of the uterus 10, the anchor pieces 3 connected to the two ends of the cords 2 are fixed to the promontory 1 1 while the single anchoring piece 3 is fixed at the level of the anterior face of the vagina 13, the two cords 2 passing on either side of the uterus 10. FIG. 4 shows yet another device 1, comprising two cords 2 provided with anchoring parts 3 connected at their ends. Two anchoring pieces 3 are connected to each other at one of their edges.
Ces deux pièces d'ancrage 3 présentent ainsi une forme de feuillet leur permettant, comme le montre la figure 10 dans le cas d'une suspension du vagin 13 au promontoire 1 1 après hystérectomie, de chapeauter l'extrémité du vagin 13.These two anchoring pieces 3 thus have a form of sheet allowing them, as shown in FIG. 10 in the case of a suspension of the vagina 13 at the headland 11 after hysterectomy, to cap the end of the vagina 13.
L'invention fournit ainsi un dispositif de suspension pour le traitement par voie chirurgicale de prolapsus, notamment génitaux, urinaires et rectaux, et d'incontinences urinaires chez la femme âgée, qui permet de remédier aux inconvénients des dispositifs homologues de la technique antérieure. En effet, ce dispositif présente, à la différence des moyens employés selon la technique antérieure, une structure duale, chaque partie (cordon ou pièces d'ancrage) étant optimisée pour la fonction qu'elle doit remplir : le cordon, du fait qu'il est filiforme, n'est pas traumatisant pour les tissus environnants, et son vrillage éventuel est sans conséquence sur son travail en traction et donc sur sa résistance dans le temps, ainsi que sur la maniabilité du dispositif ; grâce à l'élasticité de ce cordon, le chirurgien peut adapter la tension de la suspension sans perturber les zones d'ancrage ; les pièces d'ancrage peuvent être adaptées à la forme de leur site d'ancrage et peuvent être fixées à celui-ci selon plusieurs points mutuellement distants puis être intégrées aux parois sur lesquelles elles sont ancrées par réhabitation tissulaire à travers elles.The invention thus provides a suspension device for the surgical treatment of prolapse, especially genital, urinary and rectal, and urinary incontinence in elderly women, which overcomes the drawbacks of devices homologous to the prior art. In fact, unlike the means used according to the prior art, this device has a dual structure, each part (cord or anchoring parts) being optimized for the function which it must fulfill: the cord, because it is threadlike, is not traumatic for the surrounding tissues, and its possible twisting is without consequence on its work in traction and therefore on its resistance over time, as well as on the maneuverability of the device; thanks to the elasticity of this cord, the surgeon can adapt the tension of the suspension without disturbing the anchoring zones; the anchor pieces can be adapted to the shape of their anchor site and can be fixed to it at several mutually distant points and then be integrated into the walls on which they are anchored by tissue rehabitation through them.
Il va de soi que l invention n'est pas limitée à la forme de réalisation décrite ci-dessus à titre d'exemple mais qu'elle en embrasse, au contraire, toutes les variantes de réalisation. Ainsi, il apparaît que les dimensions et formes des pièces d'ancrage 3 peuvent être légèrement différentes d'une application à l'autre, de manière à présenter une forme adaptée à la configuration de la paroi d'implantation correspondante.It goes without saying that the invention is not limited to the embodiment described above by way of example but that it embraces, on the contrary, all the variant embodiments. Thus, it appears that the dimensions and shapes of the anchoring pieces 3 may be slightly different from one application to another, so as to have a shape adapted to the configuration of the corresponding implantation wall.
De la même manière, il est entendu que le dessin est purement schématique et exemplatif. Notamment, les zones anatomiques d'implantation des pièces d'ancrage 3 peuvent varier en fonction de l'évolution des techniques chirurgicales. Celles montrées aux figures 5 à 10 ne constituent qu'une aide à la compréhension du dispositif de suspension selon l'invention et ne sont pas sensées être représentatives de l'anatomie réelle de la région. Likewise, it is understood that the drawing is purely schematic and exemplary. In particular, the anatomical areas of implantation of the anchoring pieces 3 may vary according to the development of surgical techniques. Those shown in Figures 5 to 10 are only an aid to understanding the suspension device according to the invention and are not intended to be representative of the real anatomy of the region.

Claims

REVENDICATIONS
1 - Dispositif de suspension pour le traitement par voie chirurgicale de prolapsus, notamment génitaux, urinaires et rectaux, et d'incontinences urinaires chez la femme âgée, caractérisé en ce qu'il comprend au moins un cordon de suspension (2) filiforme, en matériau non résorbable et à élasticité limitée, et au moins deux pièces d'ancrage (3) reliées aux extrémités de ce cordon (2) ; ces pièces d'ancrage (3) sont en matériau sous forme de feuille, à structure souple et ajourée, propre à s'adapter à la configuration des parois respectives d'implantation, et lesdites pièces (3) sont destinées à être fixées à ces mêmes parois à l'aide de moyens appropriés, tels que suture ou agrafage, et à être ensuite intégrées, par réhabitation tissulaire à travers elles, à ces parois.1 - Suspension device for the surgical treatment of prolapse, particularly genital, urinary and rectal, and urinary incontinence in elderly women, characterized in that it comprises at least one threadlike suspension cord (2), non-absorbable material with limited elasticity, and at least two anchoring parts (3) connected to the ends of this cord (2); these anchoring parts (3) are made of material in the form of a sheet, with a flexible and perforated structure, capable of adapting to the configuration of the respective implantation walls, and said parts (3) are intended to be fixed to these same walls using appropriate means, such as suturing or stapling, and to be then integrated, by tissue rehabitation through them, to these walls.
2 - Dispositif de suspension selon la revendication 1 , caractérisé en ce qu'il comprend un cordon (2) et deux pièces d'ancrage (3), dont une est fixée sur une des extrémités du cordon (2) et l'autre sur l'autre de ces extrémités.2 - Suspension device according to claim 1, characterized in that it comprises a cord (2) and two anchoring parts (3), one of which is fixed to one end of the cord (2) and the other to the other of these ends.
3 - Dispositif de suspension selon la revendication 1 , caractérisé en ce qu'il comprend un cordon (2), deux pièces d'ancrage (3) fixées sur chacune des extrémités du cordon (2) et une pièce d'ancrage (4) fixée en un emplacement déterminé de la longueur du cordon (2), en particulier au niveau de la zone médiane de celui-ci.3 - Suspension device according to claim 1, characterized in that it comprises a cord (2), two anchoring parts (3) fixed on each end of the cord (2) and an anchoring part (4) fixed at a determined location along the length of the cord (2), in particular at the center of the latter.
4 - Dispositif de suspension selon la revendication 1 , caractérisé en ce qu'il comprend deux cordons (2) munis chacun d'une pièce d'ancrage (3) reliée à une de leurs extrémités, les deux autres extrémités des cordons (2) étant reliées à une pièce d'ancrage (3) unique.4 - Suspension device according to claim 1, characterized in that it comprises two cords (2) each provided with an anchoring piece (3) connected to one of their ends, the other two ends of the cords (2) being connected to a single anchor piece (3).
5 - Dispositif de suspension selon la revendication 1 , caractérisé en ce qu'il comprend deux cordons (2) munis chacun d'une pièce d'ancrage (3) reliée à une de leurs extrémités, les deux autres extrémités des cordons (2) étant reliées à deux pièces d'ancrage (3), elles- mêmes reliées l'une à l'autre a niveau d'un de leurs bords.5 - Suspension device according to claim 1, characterized in that it comprises two cords (2) each provided with an anchoring piece (3) connected to one of their ends, the other two ends of the cords (2) being connected to two anchoring parts (3), themselves connected to each other at one of their edges.
6 - Dispositif de suspension selon l'une des revendications 1 à 5, caractérisé en ce que le cordon (2) est constitué par une tresse tricotée de fils de polypropylene ou de polyethylene téréphtalate (polyester).6 - Suspension device according to one of claims 1 to 5, characterized in that the cord (2) consists of a braid knitted with polypropylene or polyethylene terephthalate (polyester) threads.
7 - Dispositif de uspension selon la revendication 6, caractérisé en ce que le cordon (2) est constitué par une tresse tricotée en mailles jetées, constituée par quatre fils de deux bouts de polyester de 167 décitex texture.7 - Uspension device according to claim 6, characterized in that the cord (2) consists of a braid knitted in discarded mesh, consisting of four threads of two ends of polyester of 167 decitex texture.
8 - Dispositif de suspension selon l'une des revendications 1 à8 - Suspension device according to one of claims 1 to
7, caractérisé en ce que le cordon (2) a une section supérieure à un millimètre carré.7, characterized in that the cord (2) has a section greater than one square millimeter.
9 - Dispositif de suspension selon l'une des revendications 1 à9 - Suspension device according to one of claims 1 to
8, caractérisé en ce que les pièces d'ancrage (3) sont constituées par un treillis tricoté ou non tissé, de préférence en polypropylene ou polyethylene téréphtalate (polyester), du type de ceux utilisés pour le renfort de parois suite au traitement de hernies inguinales.8, characterized in that the anchoring pieces (3) consist of a knitted or nonwoven mesh, preferably made of polypropylene or polyethylene terephthalate (polyester), of the type used for reinforcing walls following the treatment of hernias inguinal.
10 - Dispositif de suspension selon l'une des revendications 1 à10 - Suspension device according to one of claims 1 to
9, caractérisé en ce que le cordon (2) et les pièces d'ancrage (3) sont solidarisés par couture ou par soudure, notamment par ultrasons. 9, characterized in that the cord (2) and the anchoring parts (3) are joined by sewing or by welding, in particular by ultrasound.
EP99971689A 1998-11-10 1999-11-09 Suspension device for treating prolapsus and urinary incontinence Withdrawn EP1128781A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
FR9814306A FR2785521B1 (en) 1998-11-10 1998-11-10 SUSPENSION DEVICE FOR THE TREATMENT OF PROLAPSUS AND URINARY INCONTINENCES
FR9814306 1998-11-10
PCT/FR1999/002751 WO2000027304A1 (en) 1998-11-10 1999-11-09 Suspension device for treating prolapsus and urinary incontinence

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EP1128781A1 true EP1128781A1 (en) 2001-09-05

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EP (1) EP1128781A1 (en)
FR (1) FR2785521B1 (en)
WO (1) WO2000027304A1 (en)

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US6575897B1 (en) 2003-06-10
WO2000027304A1 (en) 2000-05-18

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