WO2006032812A2 - Prosthetic assembly for tissue reinforcement in the treatment of inguinal hernias - Google Patents

Prosthetic assembly for tissue reinforcement in the treatment of inguinal hernias Download PDF

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Publication number
WO2006032812A2
WO2006032812A2 PCT/FR2005/050752 FR2005050752W WO2006032812A2 WO 2006032812 A2 WO2006032812 A2 WO 2006032812A2 FR 2005050752 W FR2005050752 W FR 2005050752W WO 2006032812 A2 WO2006032812 A2 WO 2006032812A2
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WO
WIPO (PCT)
Prior art keywords
prosthesis
anatomical
treatment
impression
assembly according
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PCT/FR2005/050752
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French (fr)
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WO2006032812A3 (en
Inventor
Jean-Louis Dulucq
Olivier Cuilleron
Original Assignee
Microval
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Publication of WO2006032812A2 publication Critical patent/WO2006032812A2/en
Publication of WO2006032812A3 publication Critical patent/WO2006032812A3/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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30667—Features concerning an interaction with the environment or a particular use of the prosthesis
    • A61F2002/30708—Means for distinguishing between left-sided and right-sided devices, Sets comprising both left-sided and right-sided prosthetic parts
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0084—Means for distinguishing between left-sided and right-sided devices; Sets comprising both left-sided and right-sided prosthetic parts
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0097—Visible markings, e.g. indicia

Abstract

The invention relates to a prosthetic assembly for tissue reinforcement in the treatment of inguinal hernias. The inventive assembly comprises a right prosthesis (1) and a left prosthesis (2) which are made from a mesh structure. Each of the prostheses is produced from an impression of the inguinal-pelvic anatomical region in order to be perfectly adapted to the right or left zone. Moreover, the lower outer edge (1b and 2b) of each prosthesis (1 and 2) is equipped with a visual indication means (3) which enables the prosthesis to be oriented for the implantation thereof. The anatomical form (1a and 2a) of each prosthesis (1 and 2) produced from the impression is determined in order to prevent the use of clips.

Description

ENSEMBLE PROTHETIQUE POUR LE RENFORCEMENT DES TISSUS DANS LE TRAITEMENT DES HERNIES INGUINALES PROSTHETIC ASSEMBLY FOR TISSUE REINFORCEMENT IN THE TREATMENT OF INGUINAL HERNIA
L'invention se rattache au secteur technique des implants prothétiques, notamment pour le renforcement des tissus pour le traitement des hernies inguinales.The invention relates to the technical field of prosthetic implants, especially for strengthening tissues for the treatment of inguinal hernias.
Il est notoirement connu d'utiliser les prothèses sous forme d'un support textile ou autre, tissé ou non tissé, apte à faire office de renfort aux tissus au niveau desquels elles sont implantées.It is well known to use prostheses in the form of a textile or other support, woven or non-woven, able to act as reinforcement tissue where they are implanted.
La mise en place de ces prothèses, qui s'effectue généralement au moyen d'agrafes, sutures ou autres, peut poser des problèmes de mise en place, des douleurs post-opératoires pouvant nécessiter parfois une ré- intervention par exemple.The placement of these prostheses, which is generally done by means of staples, sutures or other, may pose problems of implementation, postoperative pain may sometimes require a re-intervention for example.
Pour tenter de remédier à ces inconvénients, on peut traiter une hernie inguinale par exemple au moyen de prothèse dite anatomique. Une telle solution ressort, par exemple, de l'enseignement du document WO-A- 9507666.In an attempt to overcome these disadvantages, an inguinal hernia can be treated, for example by means of an anatomical prosthesis. Such a solution emerges, for example, from the teaching of document WO-A-9507666.
On peut citer également l'enseignement du document FR 2.735.015 dont le demandeur de la présente est également titulaire. Ce document décrit une prothèse interne sous forme d'un support textile qui est soumis, en totalité ou en partie, à un traitement apte à lui donner une forme géométrique prédéterminée correspondant à l'anatomie considérée de la zone à traiter. II ressort de renseignement du document FR 2.735.015 que la zone anatomique de la prothèse, au niveau de la structure maillée, peut être obtenue par différentes techniques parfaitement connues par un homme du métier, telles que, par exemple, traitement thermique, thermoformage, ... A partir de cet état de la technique, le problème que se propose de résoudre l'invention est de pouvoir proposer une prothèse qui corresponde très exactement à la zone anatomique (droite ou gauche dans le cas des hernies inguinales) et faciliter la mise en place et l'implantation de ce type de prothèse par le chirurgien afin de parfaitement la positionner, notamment lorsqu'elle est implantée par cœlioscopie, ce positionnement pouvant être rendu délicat suite à la forme anatomique de la prothèse. En effet, il n'est pas toujours aisé pour le chirurgien de repérer exactement où se situe la forme anatomique de la prothèse et si elle a été pliée à l'endroit ou à l'envers.We can also mention the teaching of the document FR 2.735.015 which the applicant of this also holds. This document describes an internal prosthesis in the form of a textile support which is subjected, in whole or in part, to a treatment capable of giving it a predetermined geometric shape corresponding to the considered anatomy of the area to be treated. It is apparent from document FR 2.735.015 that the anatomical zone of the prosthesis, at the level of the mesh structure, can be obtained by various techniques perfectly known to those skilled in the art, such as, for example, heat treatment, thermoforming, ... From this state of the art, the problem to be solved by the invention is to be able to propose a prosthesis that corresponds very exactly to the anatomical area (right or left in the case of inguinal hernias) and to facilitate implementation and implantation of this type of prosthesis by the surgeon to perfectly position it, especially when implanted by laparoscopy, this positioning can be made difficult following the anatomical shape of the prosthesis. Indeed, it is not always easy for the surgeon to pinpoint exactly where the anatomical shape of the prosthesis is and whether it has been folded up or down.
Pour résoudre ces différents problèmes techniques, il a été conçu et mis au point, selon l'invention, un ensemble prothétique pour le renforcement des tissus dans le traitement des hernies inguinales qui comprend : - une prothèse droite et une prothèse gauche réalisées à partir d'une structure maillée ;To solve these various technical problems, it has been designed and developed, according to the invention, a prosthetic assembly for tissue strengthening in the treatment of inguinal hernias which comprises: - a right prosthesis and a left prosthesis made from a mesh structure;
- chaque prothèse résulte d'une prise d'empreinte de la zone anatomique inguino-pelvienne pour être parfaitement adaptée à ladite zone droite ou gauche ; - chaque prothèse présente, au niveau du bord externe inférieur, un moyen d'indication visuel apte à permettre l'orientation de la prothèse pour son implantation ; - la forme anatomique de chaque prothèse résultant de la prise d'empreinte, est déterminée pour éviter l'utilisation d'agrafes.each prosthesis results from taking an impression of the anatomical zone inguino-pelvic to be perfectly adapted to said right or left zone; - Each prosthesis has, at the lower outer edge, a visual indication means adapted to allow the orientation of the prosthesis for implantation; - The anatomical shape of each prosthesis resulting from the impression, is determined to avoid the use of staples.
Pour résoudre le problème posé de permettre l'orientation de la prothèse et son implantation, compte tenu de sa forme anatomique, le moyen d'indication visuel est un marquage.To solve the problem posed to allow the orientation of the prosthesis and its implantation, given its anatomical shape, the visual indication means is a marking.
Avantageusement, le marquage est un repère orienté vers le haut à partir du bord inférieur externe. Le repère est un trait rectiligne dont l'extrémité située vers le haut présente une indication de direction. L'indication de direction est dirigée à l'extérieur de la prothèse.Advantageously, the marking is a mark pointing upwards from the outer lower edge. The mark is a straight line with the upward end showing a direction indication. The direction indication is directed to the outside of the prosthesis.
Pour résoudre le problème posé de parfaitement adapter la prothèse droite ou gauche, à la zone anatomique inguino-pel vienne, la structure maillée est constituée par un tricot indémaillable avec un fil d'environ 150 μm, 100 % polypropylène biocompatible soumis à un traitement lui conférant une forme anatomique correspondant à la prise d'empreinte de la zone anatomique inguino-pelvienne droite ou gauche.To solve the problem posed of perfectly adapting the right or left prosthesis to the anatomical zone inguino-pelvic, the mesh structure is constituted by a knitable knit with a thread of about 150 microns, 100% biocompatible polypropylene subjected to a treatment him conferring an anatomical shape corresponding to the impression of the right or left inguino-pelvic anatomical zone.
Selon une autre caractéristique, chaque prothèse présente, à partir de son bord externe inférieur, sensiblement au niveau de la forme anatomique, un évidement pour le passage des différents ligaments.According to another feature, each prosthesis has, from its lower outer edge, substantially at the anatomical shape, a recess for the passage of the various ligaments.
L'invention est exposée ci-après plus en détail à l'aide des figures des dessins annexés dans lesquels :The invention is described below in more detail with reference to the figures of the accompanying drawings, in which:
- la figure 1 est une vue en perspective d'une prothèse droite ;- Figure 1 is a perspective view of a right prosthesis;
- la figure 2 est une vue en perspective d'une prothèse gauche. L'ensemble prothétique pour le renforcement des tissus dans le traitement des hernies inguinales comprend une prothèse droite (1) et une prothèse gauche (2), réalisées à partir d'une structure maillée. Avantageusement, la structure maillée est constituée par un tricot indémaillable avec un fil d'environ 150 μm, 100 % polypropylène biocompatible. Cette structure est soumise à un traitement apte à lui conférer une forme anatomique.- Figure 2 is a perspective view of a left prosthesis. The prosthetic assembly for tissue strengthening in the treatment of inguinal hernias comprises a right prosthesis (1) and a left prosthesis (2) made from a mesh structure. Advantageously, the mesh structure is constituted by a knitable knit with a thread of about 150 microns, 100% biocompatible polypropylene. This structure is subjected to a treatment capable of giving it an anatomical shape.
Selon une caractéristique à la base de l'invention, la forme anatomique de la structure maillée résulte d'une prise d'empreinte de la zone anatomique inguino-pelvienne pour être parfaitement adaptée à ladite zone droite ou gauche. Le traitement de mise en forme, pour créer la zone anatomique (la, 2a) est réalisé par tout moyen connu et approprié. Par exemple, il peut s'agir d'un traitement thermique, comme il ressort de l'enseignement de la demande internationale précitée WO-A-9507666.According to a feature underlying the invention, the anatomical shape of the mesh structure results from an impression of the anatomical zone inguino-pelvic to be perfectly adapted to said right or left zone. The shaping treatment, to create the anatomical area (la, 2a) is achieved by any known and appropriate means. For example, it may be a heat treatment, as is apparent from the teaching of the aforementioned international application WO-A-9507666.
Chaque prothèse présente, à partir de son bord externe inférieur (Ib, 2b), sensiblement au niveau de la zone anatomique (la, 2a), un évidement (Ic, 2c) pour le passage des différents ligaments.Each prosthesis has, from its lower outer edge (Ib, 2b), substantially at the level of the anatomical zone (1a, 2a), a recess (Ic, 2c) for the passage of the various ligaments.
Selon une caractéristique importante de l'invention, chaque prothèse droite (1) et gauche (2) présente, au niveau de son bord externe inférieur (Ib, 2b), un moyen d'indication visuelle (3) apte à permettre l'orientation de la prothèse pour son implantation. Ce moyen d'indication visuelle (3) est un marquage constitué par un repère orienté vers le haut à partir du bord inférieur externe (Ib, 2b). Avantageusement ce repère est un trait rectiligne dont l'extrémité située vers le haut présente une indication de direction (3a) orientée à l'extérieur de la prothèse. Ce repère (3) permet par conséquent à l'opérateur, au moment de l'implantation de la prothèse droite ou gauche, de vérifier sa bonne orientation par rapport à la zone anatomique inguino-pelvienne à traiter afin d'être certain que la zone anatomique (la ou 2a) est située du bon côté et à l'endroit.According to an important characteristic of the invention, each right (1) and left (2) prosthesis has, at its lower external edge (Ib, 2b), a visual indication means (3) able to allow the orientation of the prosthesis for its implantation. This visual indication means (3) is a marking consisting of a marker pointing upwards from the outer lower edge (Ib, 2b). Advantageously, this mark is a rectilinear line whose end located upwardly has a direction indication (3a) oriented outside the prosthesis. This marker (3) therefore allows the operator, at the time of implantation of the right or left prosthesis, to verify its correct orientation with respect to the inguino-pelvic anatomical zone to be treated in order to be certain that the zone anatomical (la or 2a) is located on the right side and in the right place.
Selon l'invention et d'une manière importante, la forme anatomique de chaque prothèse, droite (1) et gauche (2), résultant de la prise d'empreinte de la zone anatomique inguino-pelvienne, est déterminée pour éviter l'utilisation d'agrafes ou de moyens d'ancrage. A noter également que chaque prothèse (1) et (2) présente, à partir de son bord externe inférieur, sensiblement au niveau de la forme anatomique, un évidement pour le passage des différents ligaments.According to the invention and to a large extent, the anatomical shape of each prosthesis, right (1) and left (2), resulting from the impression of the anatomical zone inguino-pelvic, is determined to avoid the use staples or anchoring means. Note also that each prosthesis (1) and (2) has, from its lower outer edge, substantially at the anatomical shape, a recess for the passage of the various ligaments.
On rappelle que chaque prothèse, droite ou gauche, est mise en place par tout moyen connu et approprié pour un homme du métier, notamment par laparotomie ou par cœlioscopie.It is recalled that each prosthesis, right or left, is put in place by any means known and appropriate for a skilled person, including laparotomy or laparoscopy.
Les avantages ressortent bien de la description. The advantages are apparent from the description.

Claims

R E V E N D I C A T I O N SR E V E N D I C A T IO N S
-1- Ensemble prothétique pour le renforcement des tissus dans le traitement des hernies inguinales, caractérisé en qu'il comprend :Prosthetic assembly for strengthening the tissues in the treatment of inguinal hernias, characterized in that it comprises:
- une prothèse droite (1) et une prothèse gauche (2) réalisées à partir d'une structure maillée ;- a right prosthesis (1) and a left prosthesis (2) made from a mesh structure;
- chaque prothèse résulte d'une prise d'empreinte de la zone anatomique inguino-pelvienne pour être parfaitement adaptée à ladite zone droite ou gauche ;each prosthesis results from taking an impression of the anatomical zone inguino-pelvic to be perfectly adapted to said right or left zone;
- chaque prothèse (1) et (2) présente, au niveau du bord externe inférieur (Ib) et (2b), un moyen d'indication visuel (3) apte à permettre l'orientation de la prothèse pour son implantation ;- Each prosthesis (1) and (2) has, at the lower outer edge (Ib) and (2b), a visual indication means (3) adapted to allow the orientation of the prosthesis for implantation;
- la forme anatomique (la) et (2a) de chaque prothèse (1) et (2) résultant de la prise d'empreinte, est déterminée pour éviter l'utilisation d'agrafes.- The anatomical shape (la) and (2a) of each prosthesis (1) and (2) resulting from the impression, is determined to avoid the use of staples.
-2- Ensemble selon la revendication 1, caractérisé en ce que le moyen d'indication visuel (3) est un marquage.-2- assembly according to claim 1, characterized in that the visual indication means (3) is a marking.
-3- Ensemble selon la revendication 2, caractérisé en ce que le marquage est un repère orienté vers le haut à partir du bord inférieur externe.An assembly according to claim 2, characterized in that the marking is a marker pointing upwards from the outer lower edge.
-4- Ensemble selon la revendication 3, caractérisé en ce que le repère (3) est un trait rectiligne dont l'extrémité (3a) située vers le haut présente une indication de direction.-4- The assembly of claim 3, characterized in that the mark (3) is a straight line whose end (3a) located upward has an indication of direction.
-5- Ensemble selon la revendication 4, caractérisé en ce que l'indication de direction est dirigée à l'extérieur de la prothèse. -6- Ensemble selon l'une quelconque des revendications 1 à 5, caractérisé en ce que la structure maillée est constituée par un tricot indémaillable avec un fil d'environ 150 μm, 100 % polypropylène biocompatible soumis à un traitement lui conférant une forme anatomique correspondant à la prise d'empreinte de la zone anatomique inguino-pelvienne droite ou gauche.An assembly according to claim 4, characterized in that the direction indication is directed to the outside of the prosthesis. -6- assembly according to any one of claims 1 to 5, characterized in that the mesh structure is constituted by a knitable knit with a thread of about 150 microns, 100% biocompatible polypropylene subjected to a treatment giving it an anatomical shape corresponding to the impression of the right or left inguino-pelvic anatomical zone.
-7- Ensemble selon l'une quelconque des revendications 1 à 6, caractérisé en ce que chaque prothèse présente, à partir de son bord externe inférieur (Ib) et (2b), sensiblement au niveau de la forme anatomique (la) et (2a), un évidement (Ic) et (2c) pour le passage des différents ligaments. An assembly according to any one of claims 1 to 6, characterized in that each prosthesis has, from its lower outer edge (Ib) and (2b), substantially at the anatomical shape (1a) and ( 2a), a recess (Ic) and (2c) for the passage of the various ligaments.
PCT/FR2005/050752 2004-09-20 2005-09-16 Prosthetic assembly for tissue reinforcement in the treatment of inguinal hernias WO2006032812A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR0452094 2004-09-20
FR0452094A FR2875396B1 (en) 2004-09-20 2004-09-20 PROSTHETIC ASSEMBLY FOR TISSUE REINFORCEMENT IN THE TREATMENT OF INGUINAL HERNIA

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WO2006032812A2 true WO2006032812A2 (en) 2006-03-30
WO2006032812A3 WO2006032812A3 (en) 2006-06-01

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US9713519B2 (en) 2012-01-06 2017-07-25 Atrium Medical Corporation Implantable prosthesis
US10646321B2 (en) 2016-01-25 2020-05-12 Sofradim Production Prosthesis for hernia repair
US10682215B2 (en) 2016-10-21 2020-06-16 Sofradim Production Method for forming a mesh having a barbed suture attached thereto and the mesh thus obtained
US10743976B2 (en) 2015-06-19 2020-08-18 Sofradim Production Synthetic prosthesis comprising a knit and a non porous film and method for forming same
US10772995B2 (en) 2004-09-28 2020-09-15 Atrium Medical Corporation Cross-linked fatty acid-based biomaterials
US10792312B2 (en) 2004-09-28 2020-10-06 Atrium Medical Corporation Barrier layer
US10814043B2 (en) 2004-09-28 2020-10-27 Atrium Medical Corporation Cross-linked fatty acid-based biomaterials
US10864304B2 (en) 2009-08-11 2020-12-15 Atrium Medical Corporation Anti-infective antimicrobial-containing biomaterials
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US11083823B2 (en) 2005-09-28 2021-08-10 Atrium Medical Corporation Tissue-separating fatty acid adhesion barrier
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FR3017532B1 (en) * 2014-02-18 2016-03-11 Cousin Biotech IMPLANTABLE PROSTHESIS FOR REPAIRING ABDOMINAL WALL IN THE INGUINAL REGION, AND METHOD FOR MANUFACTURING SUCH PROSTHESIS

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US10772995B2 (en) 2004-09-28 2020-09-15 Atrium Medical Corporation Cross-linked fatty acid-based biomaterials
US11793912B2 (en) 2004-09-28 2023-10-24 Atrium Medical Corporation Cross-linked fatty acid-based biomaterials
US10792312B2 (en) 2004-09-28 2020-10-06 Atrium Medical Corporation Barrier layer
US10814043B2 (en) 2004-09-28 2020-10-27 Atrium Medical Corporation Cross-linked fatty acid-based biomaterials
US10869902B2 (en) 2004-09-28 2020-12-22 Atrium Medical Corporation Cured gel and method of making
US11083823B2 (en) 2005-09-28 2021-08-10 Atrium Medical Corporation Tissue-separating fatty acid adhesion barrier
US11166929B2 (en) 2009-03-10 2021-11-09 Atrium Medical Corporation Fatty-acid based particles
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WO2006032812A3 (en) 2006-06-01
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