WO1996041588A1 - Internal prosthesis consisting of a fabric or other substrate, and apparatus for celioscopically inserting same - Google Patents

Internal prosthesis consisting of a fabric or other substrate, and apparatus for celioscopically inserting same Download PDF

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Publication number
WO1996041588A1
WO1996041588A1 PCT/FR1996/000850 FR9600850W WO9641588A1 WO 1996041588 A1 WO1996041588 A1 WO 1996041588A1 FR 9600850 W FR9600850 W FR 9600850W WO 9641588 A1 WO9641588 A1 WO 9641588A1
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WO
WIPO (PCT)
Prior art keywords
support
tube
mandrel
prosthesis
shape
Prior art date
Application number
PCT/FR1996/000850
Other languages
French (fr)
Inventor
Jean Louis Dulucq
Jean Cuilleron
Original Assignee
Microval S.A.R.L.
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 Microval S.A.R.L. filed Critical Microval S.A.R.L.
Publication of WO1996041588A1 publication Critical patent/WO1996041588A1/en

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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
    • A61F2/0063—Implantable repair or support meshes, e.g. hernia meshes
    • 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
    • A61F2002/0068—Implantable repair or support meshes, e.g. hernia meshes having a special mesh pattern
    • 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
    • A61F2002/0072—Delivery tools therefor

Definitions

  • the invention relates to the technical sector of prosthetic implants in particular for the treatment of inguinal or crural hernias by conventional laparotomy or under laparoscopy.
  • prostheses are generally used in the form of a textile or other support, woven or nonwoven.
  • it is essential to distinguish two main types of prostheses namely:
  • the invention relates to a prosthesis of the type whose support is intended to act as reinforcement to the anatomical area to be treated.
  • these supports are put in place as indicated, either by laparotomy, or by laparoscopy, on the anatomical area to be treated by being fixed to the fibrous and osteotendinous reliefs of the area considered, by means of stitches or staples.
  • a prosthetic element which teaches the production of a predetermined shape by thermoforming.
  • This patent indicates that the edges of the prosthesis are stiffened in particular by fusion, so that there is a difference in rigidity between these edges and the center of the prosthesis.
  • the disclosed form is a simple convex shape, mathematically definable by being decomposable into a cone and a sphere. All external borders go through a map.
  • the shape disclosed by the teaching of this patent is not congruent and cannot perfectly respect all the anatomical elements existing at the level of the anatomical area to be treated as such.
  • the object of the invention is to remedy these drawbacks in a simple, safe, effective and rational manner.
  • the problem which the invention proposes to solve is to produce an internal prosthesis in the form of a flexible support, the geometry of which corresponds perfectly and not entirely to the anatomical area to be treated, in order to exempt the operator from any fixing by staples. or others with the objective of respecting all the anatomical elements, such as the relief zone of the iliac and spermatic networks.
  • an internal prosthesis in the form of a textile or other support, woven or non-woven, inert and biocompatible, the support being subjected, in whole or in part, to a treatment capable of giving it a predetermined geometric shape that is perfectly congruent, said shape being obtained by imprinting the anatomical area to be treated.
  • the prosthesis has a truly anatomical shape in its entirety, which imposes a right shape different from the left shape.
  • the shape obtained is a left shape, the borders of which cannot pass through a plane but are also of left shape, perfectly respecting all the anatomical elements.
  • Another problem which the invention proposes to solve is to improve the operability during surgery in laparoscopic surgery with a view to its installation by means of a trocar in particular.
  • the support is treated to present a shape memory resulting from the nature of the material or by a controlled rigidity of said material in order to be able to be rolled up and inserted in a laparoscopic trocar in particular, and to self-deploy in a cavity, returning to its original shape.
  • the prosthesis is coated with a biological substance to improve its biocompatibility and its adhesion to adjacent tissues.
  • the geometric shape corresponds, as indicated above, either to the right inguino-pelvic zone for the treatment of right hernias, or to the left inguino-pelvic zone for the treatment of left hernias .
  • Another problem which the invention proposes to solve is to facilitate the introduction of the prosthesis into a trocar. More particularly, the problem which the invention proposes to solve is being able to wind the prosthesis with a view to its introduction into the trocar in opposition to the techniques currently used or generally, the prosthesis must be wound manually.
  • an apparatus which consists of a winding mandrel having means for temporarily coupling the support, said mandrel being housed inside a tube with capacity d drive in rotation, said tube having arrangements for the passage of the support for its winding on the mandrel which is removable relative to said tube, to leave only the support inside the tube after separation from the coupling means temporary.
  • the temporary coupling means consist of one or more wires making it possible to connect the support to the mandrel and projecting laterally through orifices, the tube being split entirely or partly for the engagement of said support.
  • one of the ends of the mandrel has a centered knurled endpiece which is guided in rotation at one end of the tube, the other end of which has a fixed endpiece.
  • Figures 1 and 2 are views of an embodiment of the internal three-dimensional prosthesis, in the case of an application to a parietal prosthesis, Figure 1 showing the prosthesis for the treatment of straight hernias, while the Figure 2 shows the prosthesis for the treatment of left hernias.
  • Figure 3 is a perspective view before assembly of the device for placing the prosthesis.
  • Figure 4 is a view corresponding to Figure 3 after mounting of the components of the device.
  • Figure 5 is a longitudinal sectional view of the device before winding the prosthesis.
  • Figure 6 is a view corresponding to Figure 5, after winding the prosthesis around the mandrel.
  • Figure 7 is a view corresponding to Figure 6, after removal of the suture and the winding mandrel.
  • Figure 8 is a cross-sectional view taken along line 8.8 of Figure 7.
  • the three-dimensional prosthesis is performed from any textile or other support (1), woven or non-woven, by being performed in any type of inert and biocompatible material.
  • the support (1) generally has a mesh structure, more or less ventilated, depending on the pathological case to be treated.
  • the material constituting the support can be an inert implantable polymer which is completely biocompatible, sterile, pyrogen-free, non-absorbable and with bi-directional elasticity.
  • the structure can be constituted by a fabric or a mesh with locked meshes, shaped so as not to fray or break.
  • This shape (1a) which in the geometric sense, is a left shape, comes from anatomical moldings, so that the support (1) has a right shape different from the left shape.
  • (1) can be obtained using different techniques, for example, heat treatment, thermoforming, etc.
  • the support (1) is treated to present a shape memory 25 resulting from the nature of the material or by a controlled rigidity of said material, in order to be able to be rolled up and inserted in a laparoscopic trocar in particular and to self-deploy in a cavity by returning to its initial shape.
  • the shape memory must be sufficient to prevent the support from folding in on itself during its installation, but on the contrary being able to deploy spontaneously and naturally to perfectly fit the anatomical region considered.
  • the entire support can be coated with a biological substance making it possible to improve the biocompatibility of the prosthesis, its recolonnization by the adjacent connective tissues. Such a coating also makes it possible, by the adhesive properties of the biological substance, to improve the natural fixation of the prosthesis.
  • Another problem which the invention proposes to solve is to facilitate the winding of the prosthesis and its insertion into a trocar.
  • an apparatus has been designed and developed which allows the surgeon to wind the support (1) and to insert the prosthesis into the trocar, without having to touch it.
  • the device consists essentially of a winding mandrel (2) shaped to be engaged inside a tube (3) with rotational drive capacity.
  • the mandrel (2) is removable relative to the tube (3).
  • the tube (3) has, over all or part of its length, a slot (3a) for the engagement of the support (1) inside said tube.
  • the tube (3) is closed on one side by a fixed end piece (4).
  • the other end of the tube (3) receives the mandrel (2), one of the ends of which has a knurled end piece (2a) centered and guided in rotation relative to the tube.
  • the support (1) is connected to the mandrel (2) by one or more wires (5).
  • the mandrel (2) is pierced coaxially at (2b) for the engagement of a suture thread (5) which alternately overflows through orifices (2c) distributed and aligned along the generatrices of the mandrel (2) to be connected to the support (1) ( Figures 3, 4 and 5).
  • the prosthesis in particular the support (1) is wound inside the tube (3), is carried out by simple rotation of the end piece (2a) of the mandrel (2), the tube being held by the end piece fixed (4).
  • the support (1) is already engaged in the tube through the slot (3a), by its longitudinal edge.
  • the support is completely wound inside the tube (figure 6)
  • the mandrel (2) can then be removed from the tube (3), the support (1) remaining wound inside said tube ( Figures 7 and 8).
  • the surgeon then introduces the tube (3) with the prosthesis wound in the trocar.
  • the anatomical prosthesis wound at the time of its introduction into the trocar, can self-deploy, facilitating its implementation

Abstract

An internal prosthesis consisting of an inert, biocompatible, woven or non-woven fabric or other substrate (1) at least partially treated in such a way that it has a predetermined perfectly congruent geometrical shape (1a) determined by making an impression of the anatomical region to be treated.

Description

Prothèse interne sous forme d'un support textile ou autre et son appareil d'insertion par voie coelioscopiαue. Internal prosthesis in the form of a textile or other support and its insertion device by laparoscopic route.
L'invention se rattache au secteur technique des implants prothétiques notamment pour le traitement des hernies inguinales ou crurales par laparotomie classique ou sous coelioscopie.The invention relates to the technical sector of prosthetic implants in particular for the treatment of inguinal or crural hernias by conventional laparotomy or under laparoscopy.
Pour ce genre d'intervention, on utilise généralement des prothèses sous forme d'un support textile ou autre, tissé ou non tissé. Il convient à cet égard, de distinguer essentiellement deux grands types de prothèses, à savoir :For this kind of intervention, prostheses are generally used in the form of a textile or other support, woven or nonwoven. In this regard, it is essential to distinguish two main types of prostheses, namely:
- celles dont le support est conformé pour être inserré dans un trou herniaire par exemple, pour le boucher (Cf : Brevets WO-A-9213500,- those whose support is shaped to be inserted in a hernial hole for example, for the butcher (Cf: Patents WO-A-9213500,
EP-A-0614650)EP-A-0614650)
- celles dont le support est conformé pour servir de renfort aux tissus au niveau desquels ils sont implantés.- those whose support is shaped to serve as reinforcement to the tissues at which they are implanted.
L'invention concerne une prothèse du type de celle dont le support est destiné à faire office de renfort à la zone anatomique à traiter.The invention relates to a prosthesis of the type whose support is intended to act as reinforcement to the anatomical area to be treated.
Généralement, ces supports sont mis en place comme indiqué, soit par laparotomie, soit par coelioscopie, sur la zone anatomique à traiter en étant fixés aux reliefs fibreux et ostéotendineux de la zone considérée, au moyen de points de suture ou d'agrafes.Generally, these supports are put in place as indicated, either by laparotomy, or by laparoscopy, on the anatomical area to be treated by being fixed to the fibrous and osteotendinous reliefs of the area considered, by means of stitches or staples.
Quels que soient les modes de réalisation de ces supports, (tissage, tricotage, extrusion...) ou leurs matériaux constitutifs (polyester, polypropylène, PTFE...) et quelles ques soient leurs formes géométriques (carrée, rectangulaire, en Y...), ces derniers se présentent toujours sous une forme plane, qui ne peut, en conséquent, épouser aucun des reliefs de la région anatomique considérée. Le chirurgien est donc obligé de placer de nombreuses agrafes pour sécuriser l'emplacement de la prothèse, sans être certain de maîtriser leur position exacte, ce qui peut représenter un risque dans le cas notamment d'une mise en place par laparoscopie. Ces nombreuses agrafes nécessaires à la mise en forme de la prothèse restent à demeure, ce qui peut nécessiter une réintervention si l'une ou plusieurs d'entre elles sont mal positionnées.Whatever the embodiments of these supports, (weaving, knitting, extrusion ...) or their constituent materials (polyester, polypropylene, PTFE ...) and whatever their geometric shapes (square, rectangular, Y. ..), the latter are always in a flat form, which cannot, therefore, match any of the reliefs of the anatomical region considered. The surgeon is therefore obliged to place numerous staples to secure the location of the prosthesis, without being certain of controlling their exact position, which can represent a risk in the case in particular of a laparoscopic placement. These numerous staples necessary for shaping the prosthesis remain permanently, which may require reoperation if one or more of them are incorrectly positioned.
Par le brevet WO-A-9507666, on connaît un élément prothetique qui enseigne la réalisation d'une forme prédéterminée par thermoformage. Ce brevet indique que les bords de la prothèse sont rigidifiés notamment par fusion, de sorte qu'il existe une différence de rigidité entre ces bords et le centre de la prothèse. La forme divulguée est une forme simple convexe, mathématiquement définissable en étant décomposable en un cône et une sphère. Toutes les frontières extérieures passent par un plan. Autrement dit, la forme divulguée par l'enseignement de ce brevet n'est pas congruente et ne peut pas respecter parfaitement tous les éléments anatomiques existants au niveau de la zone anatomique à traiter en tant que telle.From patent WO-A-9507666, a prosthetic element is known which teaches the production of a predetermined shape by thermoforming. This patent indicates that the edges of the prosthesis are stiffened in particular by fusion, so that there is a difference in rigidity between these edges and the center of the prosthesis. The disclosed form is a simple convex shape, mathematically definable by being decomposable into a cone and a sphere. All external borders go through a map. In other words, the shape disclosed by the teaching of this patent is not congruent and cannot perfectly respect all the anatomical elements existing at the level of the anatomical area to be treated as such.
L'invention s'est fixée pour but de remédier à ces inconvénients, de manière simple, sûre, efficace et rationnelle.The object of the invention is to remedy these drawbacks in a simple, safe, effective and rational manner.
Le problème que se propose de résoudre l'invention est de réaliser une prothèse interne sous forme d'un support souple, dont la géométrie correspond parfaitement et ne totalité à la zone anatomique à traiter, afin de dispenser l'opérateur de toute fixation par agrafes ou autres en ayant pour objectif de respecter tous les éléments anatomiques, tels que la zone à relief des réseaux iliaques et spermatiques. Pour résoudre un tel problème, il a été conçu et mis au point une prothèse interne sous forme d'un support textile ou autre, tissé ou non tissé, inerte et biocompatible, le support étant soumis, en totalité ou en partie, à un traitement apte à lui donner une forme géométrique prédéterminée parfaitement congruente, ladite forme étant obtenue par empreinte de la zone anatomique à traiter.The problem which the invention proposes to solve is to produce an internal prosthesis in the form of a flexible support, the geometry of which corresponds perfectly and not entirely to the anatomical area to be treated, in order to exempt the operator from any fixing by staples. or others with the objective of respecting all the anatomical elements, such as the relief zone of the iliac and spermatic networks. To solve such a problem, it was designed and developed an internal prosthesis in the form of a textile or other support, woven or non-woven, inert and biocompatible, the support being subjected, in whole or in part, to a treatment capable of giving it a predetermined geometric shape that is perfectly congruent, said shape being obtained by imprinting the anatomical area to be treated.
Il en résulte que la prothèse présente une forme réellement anatomique dans sa totalité, ce qui impose une forme droite différente de la forme gauche. Au sens géométrique, la forme obtenue est une forme gauche, dont les frontières ne peuvent pas passer par un plan mais sont également de forme gauche, en respectant parfaitement tous les éléments anatomiques.As a result, the prosthesis has a truly anatomical shape in its entirety, which imposes a right shape different from the left shape. In the geometric sense, the shape obtained is a left shape, the borders of which cannot pass through a plane but are also of left shape, perfectly respecting all the anatomical elements.
Un autre problème que se propose de résoudre l'invention, est d'améliorer la maniabilité per-opératoire en chirurgie coelioscopique en vue de sa mise en place au moyen d'un trocart notamment.Another problem which the invention proposes to solve is to improve the operability during surgery in laparoscopic surgery with a view to its installation by means of a trocar in particular.
Pour résoudre un tel problème, le support est traité pour présenter une mémoire de forme résultant de la nature du matériau ou par une rigidité contrôlée dudit matériau afin de pouvoir être enroulé et inserré dans un trocart de coelioscopie notamment, et de s'autodéployer dans une cavité, retrouvant sa forme initiale.To solve such a problem, the support is treated to present a shape memory resulting from the nature of the material or by a controlled rigidity of said material in order to be able to be rolled up and inserted in a laparoscopic trocar in particular, and to self-deploy in a cavity, returning to its original shape.
Selon une autre caractéristique, la prothèse est enduite d'une substance biologique pour améliorer sa biocompatibilité et son adhésion aux tissus adjacents.According to another characteristic, the prosthesis is coated with a biological substance to improve its biocompatibility and its adhesion to adjacent tissues.
Dans le cas d'une application à une prothèse pariétale, la forme géométrique correspond, comme indiqué précédemment, soit à la zone inguino-pelvienne droite pour le traitement des hernies droites, soit à la zone inguino-pelvienne gauche pour le traitement des hernies gauches. Un autre problème que se propose de résoudre l'invention est de faciliter l'introduction de la prothèse dans un trocart. Plus particulièrement, le problème que se propose de résoudre l'invention est de pouvoir enrouler la prothèse en vue de son introduction dans le trocart en opposition aux techniques actuellement utilisées ou généralement, la prothèse doit être enroulée manuellement.In the case of an application to a parietal prosthesis, the geometric shape corresponds, as indicated above, either to the right inguino-pelvic zone for the treatment of right hernias, or to the left inguino-pelvic zone for the treatment of left hernias . Another problem which the invention proposes to solve is to facilitate the introduction of the prosthesis into a trocar. More particularly, the problem which the invention proposes to solve is being able to wind the prosthesis with a view to its introduction into the trocar in opposition to the techniques currently used or generally, the prosthesis must be wound manually.
Pour résoudre un tel problème, il a été conçu et mis au point un appareil qui est constitué par un mandrin d'enroulement présentant des moyens d'accouplement temporaire du support, ledit mandrin étant logé à l'intérieur d'un tube avec capacité d'entrainement en rotation, ledit tube présentant des agencements pour le pasage du support en vue de son enroulement sur le mandrin qui est démontable par rapport audit tube, pour ne laisser que le support à l'intérieur du tube après séparation du moyen d'accouplement temporaire.To solve such a problem, an apparatus has been designed and developed which consists of a winding mandrel having means for temporarily coupling the support, said mandrel being housed inside a tube with capacity d drive in rotation, said tube having arrangements for the passage of the support for its winding on the mandrel which is removable relative to said tube, to leave only the support inside the tube after separation from the coupling means temporary.
Pour résoudre le problème posé de laisser le support à l'intérieur du tube, les moyens d'accouplement temporaire sont constitués par un ou plusieurs fils permettant de relier le support au mandrin et débordant latéralement par des orifices, le tube étant fendu en totalité ou en partie pour l'engagement dudit support.To solve the problem posed of leaving the support inside the tube, the temporary coupling means consist of one or more wires making it possible to connect the support to the mandrel and projecting laterally through orifices, the tube being split entirely or partly for the engagement of said support.
Pour résoudre le problème posé de procéder à l'enroulement de la prothèse, l'une des extrémités du mandrin présente un embout molleté centré et guidé en rotation à l'une des extrémités du tube dont l'autre extrémité présente un embout fixe.To solve the problem posed of winding the prosthesis, one of the ends of the mandrel has a centered knurled endpiece which is guided in rotation at one end of the tube, the other end of which has a fixed endpiece.
L'invention est exposée, ci-après plus en détail à l'aide des dessins annexés, dans lesquels : Les figures 1 et 2 sont des vues d'une forme de réalisation de la prothèse interne tri-dimentionnelle, dans le cas d'une application à une prothèse pariétale, la figure 1 montrant la prothèse pour le traitement des hernies droites, tandis que la figure 2 montre la prothèse pour le traitement des hernies gauches.The invention is set out below in more detail using the appended drawings, in which: Figures 1 and 2 are views of an embodiment of the internal three-dimensional prosthesis, in the case of an application to a parietal prosthesis, Figure 1 showing the prosthesis for the treatment of straight hernias, while the Figure 2 shows the prosthesis for the treatment of left hernias.
La figure 3 est une vue en perspective avant montage de l'appareil de mise en place de la prothèse.Figure 3 is a perspective view before assembly of the device for placing the prosthesis.
La figure 4 est une vue correspondant à la figure 3 après montage des éléments constitutifs de l'appareil. La figure 5 est une vue en coupe longitudinale de l'appareil avant enroulement de la prothèse.Figure 4 is a view corresponding to Figure 3 after mounting of the components of the device. Figure 5 is a longitudinal sectional view of the device before winding the prosthesis.
La figure 6 est une vue correspondant à la figure 5, après enroulement de la prothèse autour du mandrin.Figure 6 is a view corresponding to Figure 5, after winding the prosthesis around the mandrel.
La figure 7 est une vue correspondant à la figure 6, après retrait du fil de suture et du mandrin d'enroulement.Figure 7 is a view corresponding to Figure 6, after removal of the suture and the winding mandrel.
La figure 8 est une vue en coupe transversale considérée selon la ligne 8.8 de la figure 7.Figure 8 is a cross-sectional view taken along line 8.8 of Figure 7.
La prothèse tri-dimentionnelle, selon l'invention, est exécutée à partir de tout support (1) textile ou autre, tissé ou non tissé, en étant exécuté en tout type de matériau inerte et bio-compatible. Le support (1) présente généralement une structure maillée, plus ou moins aérée, en fonction du cas pathologique à traiter. A titre d'exemple, le matériau constitutif du support peut être un polymère implantable inerte totalement biocompatible, stérile, apyrogène, non résorbable et à élasticité bi¬ directionnelle. La structure peut être constituée par un tissu ou un treillis à mailles bloquées, conformé pour ne pas s'effilocher ou se rompre.The three-dimensional prosthesis, according to the invention, is performed from any textile or other support (1), woven or non-woven, by being performed in any type of inert and biocompatible material. The support (1) generally has a mesh structure, more or less ventilated, depending on the pathological case to be treated. For example, the material constituting the support can be an inert implantable polymer which is completely biocompatible, sterile, pyrogen-free, non-absorbable and with bi-directional elasticity. The structure can be constituted by a fabric or a mesh with locked meshes, shaped so as not to fray or break.
La structure de base du support, au niveau de sa composition, n'est pas décrite en détail car, comme indiqué, différentes formes de réalisation peuvent être prévues. Cette structure et le matériau constitutif ne font pas partie de l'objet spécifique de l'invention.The basic structure of the support, in terms of its composition, is not described in detail because, as indicated, different embodiments can be provided. This structure and the constituent material are not part of the specific object of the invention.
Selon une caractéristique à la base de l'invention, le supportAccording to a characteristic underlying the invention, the support
(1) est soumis en totalité ou en partie à un traitement apte à lui donner une forme géométrique prédéterminée (1a) correspondant à l'anatomie considérée de la zone à traiter. Cette forme (1a), qui au sens géométrique, est une forme gauche, est issue de moulages anatomiques, de sorte que le o support (1) présente une forme droite différente de la forme gauche.(1) is subjected in whole or in part to a treatment capable of giving it a predetermined geometric shape (1a) corresponding to the anatomy considered of the area to be treated. This shape (1a), which in the geometric sense, is a left shape, comes from anatomical moldings, so that the support (1) has a right shape different from the left shape.
Dans ces conditions, et dans le cas d'une prothèse pariétale, deux formes tridimentionnelles sont prévues pour le traitement respectivement des hernies droites (figure 1) ou des hernies gauches (figures 2). Compte-tenu de ces dispositions et comme le montrent les 5 figurent des dessins, les régions frontières de la forme géométrique (1a) ne passent pas par un plan, mais sont également de forme gauche, pour respecter parfaitement tous les éléments anatomiques, en particulier la zone à relief des vaisseux iliaques et spermatiques.Under these conditions, and in the case of a parietal prosthesis, two three-dimensional forms are provided for the treatment respectively of right hernias (Figure 1) or left hernias (Figures 2). In view of these provisions and as shown in the 5 figures appear, the border regions of the geometric shape (1a) do not pass through a plane, but are also of left shape, to perfectly respect all the anatomical elements, in particular the raised area of the iliac and spermatic vessels.
20 A noter que la forme géométrique tridimentionnelle du support20 Note that the three-dimensional geometric shape of the support
(1) peut être obtenue selon différentes techniques, à savoir par exemple, traitement thermique, thermoformage...(1) can be obtained using different techniques, for example, heat treatment, thermoforming, etc.
En outre, le support (1) est traité pour présenter une mémoire 25 de forme résultant de la nature du matériau ou par une rigidité contrôlée dudit matériau, afin de pouvoir être enroulé et inserré dans un trocart de coelioscopie notamment et de s'autodéployer dans une cavité en retrouvant sa forme initiale. La mémoire de forme doit être suffisante pour éviter au support de se replier sur lui même lors de sa mise en place, mais 30 au contraire pouvoir se déployer spontanément et naturellement pour épouser parfaitement la région anatomique considérée. L'ensemble du support peut être enduit d'une substance biologique permettant d'améliorer la biocompatibilité de la prothèse, sa recolonnisation par les tissus conjonctifs adjacents. Une telle enduction permet également, par les propriétés adhésives de la substance biologique, d'améliorer la fixation naturelle de la prothèse.In addition, the support (1) is treated to present a shape memory 25 resulting from the nature of the material or by a controlled rigidity of said material, in order to be able to be rolled up and inserted in a laparoscopic trocar in particular and to self-deploy in a cavity by returning to its initial shape. The shape memory must be sufficient to prevent the support from folding in on itself during its installation, but on the contrary being able to deploy spontaneously and naturally to perfectly fit the anatomical region considered. The entire support can be coated with a biological substance making it possible to improve the biocompatibility of the prosthesis, its recolonnization by the adjacent connective tissues. Such a coating also makes it possible, by the adhesive properties of the biological substance, to improve the natural fixation of the prosthesis.
Comme indiqué, un autre problème que se propose de résoudre l'invention est de faciliter l'enroulement de la prothèse et son insertion dans un trocart. A cet égard, il a été conçu et mis au point un appareil qui permet au chirurgien d'enrouler le support (1) et d'inserrer la prothèse dans le trocart, sans être obligé de la toucher.As indicated, another problem which the invention proposes to solve is to facilitate the winding of the prosthesis and its insertion into a trocar. In this regard, an apparatus has been designed and developed which allows the surgeon to wind the support (1) and to insert the prosthesis into the trocar, without having to touch it.
Comme le montrent les figures 3 à 8, l'appareil est constitué essentiellement par un mandrin d'enroulement (2) conformé pour être engagé à l'intérieur d'un tube (3) avec capacité d'entrainement en rotation. Le mandrin (2) est démontable par rapport au tube (3). Le tube (3) présente, sur la totalité ou une partie de sa longueur, une fente (3a) pour l'engagement du support (1) à l'intérieur dudit tube. Le tube (3) est fermé d'un côté par un embout fixe (4). L'autre extrémité du tube (3) reçoit le mandrin (2) dont l'une des extrémités présente un embout molleté (2a) centré et guidé en rotation par rapport au tube. Le support (1) est relié au mandrin (2) par un ou plusieurs fils (5). Par exemple, le mandrin (2) est percé coaxialement en (2b) pour l'engagement d'un fil de suture (5) qui déborde alternativement par des orifices (2c) répartis et alignés selon les génératrices du mandrin (2) pour être relié au support (1) (figures 3, 4 et 5).As shown in Figures 3 to 8, the device consists essentially of a winding mandrel (2) shaped to be engaged inside a tube (3) with rotational drive capacity. The mandrel (2) is removable relative to the tube (3). The tube (3) has, over all or part of its length, a slot (3a) for the engagement of the support (1) inside said tube. The tube (3) is closed on one side by a fixed end piece (4). The other end of the tube (3) receives the mandrel (2), one of the ends of which has a knurled end piece (2a) centered and guided in rotation relative to the tube. The support (1) is connected to the mandrel (2) by one or more wires (5). For example, the mandrel (2) is pierced coaxially at (2b) for the engagement of a suture thread (5) which alternately overflows through orifices (2c) distributed and aligned along the generatrices of the mandrel (2) to be connected to the support (1) (Figures 3, 4 and 5).
L'enroulement de la prothèse, notamment du support (1) à l'intérieur du tube (3), s'effectue par simple rotation de l'embout (2a) du mandrin (2), le tube étant maintenu par l'embout fixe (4). Lorsque le chirurgien commence l'enroulement, le support (1) est déjà engagé dans le tube au travers de la fente (3a), par son bord longitudinal. Lorsque le support est totalement enroulé à l'intérieur du tube (figure 6), il suffit d'exercer une traction sur les brins débordants (5a) et (5b) du fil de suture (5), pour désolidariser d'une manière concomitante, le support (1) du mandrin (2). Le mandrin (2) peut alors être retiré du tube (3), le support (1) restant enroulé à l'intérieur dudit tube (figures 7 et 8). Le chirurgien introduit alors le tube (3) avec la prothèse enroulée dans le trocart.The prosthesis, in particular the support (1) is wound inside the tube (3), is carried out by simple rotation of the end piece (2a) of the mandrel (2), the tube being held by the end piece fixed (4). When the surgeon begins winding, the support (1) is already engaged in the tube through the slot (3a), by its longitudinal edge. When the support is completely wound inside the tube (figure 6), it suffices to exert a traction on the overhanging strands (5a) and (5b) of the suture (5), to dissociate in a concomitant manner , the support (1) of the mandrel (2). The mandrel (2) can then be removed from the tube (3), the support (1) remaining wound inside said tube (Figures 7 and 8). The surgeon then introduces the tube (3) with the prosthesis wound in the trocar.
Les avantages ressortent bien de la description, en particulier on souligne et on rappelle :The advantages clearly emerge from the description, in particular it is emphasized and recalled:
- La forme tridimentionnelle de la prothèse prédéterminée pour correspondre en totalité à l'anatomie de la zone à traiter, évitant l'emploi d'agrafes de positionnement,- The three-dimensional shape of the predetermined prosthesis to fully correspond to the anatomy of the area to be treated, avoiding the use of positioning clips,
- Par sa forme tridimentionnelle et sa rigidité contrôlée, la prothèse anatomique, enroulée au moment de son introduction dans le trocart, peut s'autodéployer, facilitant sa mise en place,- By its three-dimensional shape and controlled rigidity, the anatomical prosthesis, wound at the time of its introduction into the trocar, can self-deploy, facilitating its implementation,
- La facilité d'enroulement de la prothèse et son insertion dans un trocart par l'utilisation de l'appareil spécifique. - The ease of winding the prosthesis and inserting it into a trocar by using the specific device.

Claims

R E V E N D I C A T I O N SR E V E N D I C A T I O N S
-1- Prothèse interne sous forme d'un support textile ou autre, tissé ou non tissé, inerte et biocompatible, caractérisée en ce que le support (1) est soumis en totalité ou en partie à un traitement apte à lui donner une forme géométrique prédéterminée (1a) parfaitement congruente, ladite forme étant obtenue par empreinte de la zone anatomique à traiter.-1- Internal prosthesis in the form of a textile or other support, woven or non-woven, inert and biocompatible, characterized in that the support (1) is subjected in whole or in part to a treatment capable of giving it a geometric shape predetermined (1a) perfectly congruent, said shape being obtained by imprinting the anatomical area to be treated.
-2- Prothèse selon la revendication 1, caractérisée en ce que le support (1) est traité pour présenter une mémoire de forme résultant de la nature du matériau ou par une rigidité contrôlée dudit matériau afin de pouvoir être enroulé et inserré dans un trocart de coelioscopie notamment et de s'autodéployer dans une cavité, retrouvant sa forme initiale.-2- Prosthesis according to claim 1, characterized in that the support (1) is treated to present a shape memory resulting from the nature of the material or by a controlled rigidity of said material so as to be able to be wound and inserted in a trocar of in particular laparoscopy and to self-deploy in a cavity, regaining its initial form.
-3- Prothèse selon la revendication 1 , caractérisée en ce qu'elle est enduite d'une substance biologique pour améliorer sa biocompatibilité et son adhésion aux tissus adjacents.-3- Prosthesis according to claim 1, characterized in that it is coated with a biological substance to improve its biocompatibility and its adhesion to adjacent tissues.
-4- Prothèse selon la revendication 1 , caractérisée en ce que la forme géométrique (1a) correspond à la zone inguino-pelvienne droite pour le traitement des hernies droites.-4- Prosthesis according to claim 1, characterized in that the geometric shape (1a) corresponds to the right inguino-pelvic area for the treatment of straight hernias.
-5- Prothèse selon la revendication 1 , caractérisée en ce que la forme géométrique (1a) correspond à la zone inguino-pelvienne gauche pour le traitement des hernies gauches.-5- Prosthesis according to claim 1, characterized in that the geometric shape (1a) corresponds to the left inguino-pelvic area for the treatment of left hernias.
-6- Appareil pour la mise en place d'une prothèse selon l'une quelconque des revendications 1 à 5, caractérisé en ce qu'il est constitué par un mandrin d'enroulement (2) présentant des moyens d'accouplement temporaire (5) du support (1), ledit mandrin (2) étant logé à l'intérieur d'un 41588 PCT/FR96/00850-6- Apparatus for the establishment of a prosthesis according to any one of claims 1 to 5, characterized in that it is constituted by a winding mandrel (2) having temporary coupling means (5 ) of the support (1), said mandrel (2) being housed inside a 41588 PCT / FR96 / 00850
1010
tube (3) avec capacité d'entrainement en rotation, ledit tube (3) présentant des agencements pour le pasage du support (1) en vue de son enroulement sur le mandrin (2) qui est démontable par rapport audit tube (3), pour ne laisser que le support à l'intérieur du tube (3) après séparation des moyens d'accouplement temporaire (5).tube (3) with rotational drive capacity, said tube (3) having arrangements for the passage of the support (1) for its winding on the mandrel (2) which is removable relative to said tube (3), to leave only the support inside the tube (3) after separation of the temporary coupling means (5).
-7- Appareil selon la revendication 6, caractérisé en ce que les moyens d'accouplement temporaire sont constitués par un ou plusieurs fils (5) permettant de relier le support (1) au mandrin (2), le tube (3) étant fendu en totalité ou en partie pour l'engagement dudit support (1).-7- Apparatus according to claim 6, characterized in that the temporary coupling means consist of one or more son (5) for connecting the support (1) to the mandrel (2), the tube (3) being split in whole or in part for engaging said support (1).
-8- Appareil selon la revendication 6, caractérisé en ce que l'une des extrémités du mandrin (2) présente un embout molleté (2a) centré et guidé en rotation à l'une des extrémités du tube (3) dont l'autre extrémité présente un embout fixe (4). -8- Apparatus according to claim 6, characterized in that one end of the mandrel (2) has a knurled tip (2a) centered and guided in rotation at one end of the tube (3), the other end has a fixed tip (4).
PCT/FR1996/000850 1995-06-12 1996-06-06 Internal prosthesis consisting of a fabric or other substrate, and apparatus for celioscopically inserting same WO1996041588A1 (en)

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FR95/07262 1995-06-12
FR9507262A FR2735015B1 (en) 1995-06-12 1995-06-12 INTERNAL PROSTHESIS IN THE FORM OF A TEXTILE OR OTHER MEDIUM AND ITS COELIOSCOPIC INSERTION APPARATUS

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FR2735015A1 (en) 1996-12-13

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