FR2722975A1 - Surgical implant for fastening ligament against bone surface - Google Patents

Surgical implant for fastening ligament against bone surface Download PDF

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Publication number
FR2722975A1
FR2722975A1 FR9409372A FR9409372A FR2722975A1 FR 2722975 A1 FR2722975 A1 FR 2722975A1 FR 9409372 A FR9409372 A FR 9409372A FR 9409372 A FR9409372 A FR 9409372A FR 2722975 A1 FR2722975 A1 FR 2722975A1
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France
Prior art keywords
implant
shape memory
temperature
characterized
ms
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FR9409372A
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French (fr)
Inventor
Bertrand Cuisset
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DYNAMIQUE SANTE SARL
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DYNAMIQUE SANTE SARL
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Priority to FR9409372A priority Critical patent/FR2722975A1/en
Publication of FR2722975A1 publication Critical patent/FR2722975A1/en
Application status is Withdrawn legal-status Critical

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/08Muscles; Tendons; Ligaments
    • A61F2/0811Fixation devices for tendons or ligaments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064Surgical staples, i.e. penetrating the tissue
    • A61B17/0642Surgical staples, i.e. penetrating the tissue for bones, e.g. for osteosynthesis or connecting tendon to bone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/02Inorganic materials
    • A61L31/022Metals or alloys
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064Surgical staples, i.e. penetrating the tissue
    • A61B2017/0641Surgical staples, i.e. penetrating the tissue having at least three legs as part of one single body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/08Muscles; Tendons; Ligaments
    • A61F2/0811Fixation devices for tendons or ligaments
    • A61F2002/0847Mode of fixation of anchor to tendon or ligament
    • A61F2002/0858Fixation of tendon or ligament between anchor and bone, e.g. interference screws, wedges
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/08Muscles; Tendons; Ligaments
    • A61F2/0811Fixation devices for tendons or ligaments
    • A61F2002/0876Position of anchor in respect to the bone
    • A61F2002/0888Anchor in or on a blind hole or on the bone surface without formation of a tunnel
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006Properties of materials and coating materials
    • A61F2002/30092Properties of materials and coating materials using shape memory or superelastic materials, e.g. nitinol
    • A61F2002/30093Properties of materials and coating materials using shape memory or superelastic materials, e.g. nitinol operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30108Shapes
    • A61F2002/3011Cross-sections or two-dimensional shapes
    • A61F2002/30159Concave polygonal shapes
    • A61F2002/30177W-shaped, M-shaped or sigma shaped
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0014Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
    • A61F2210/0019Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028Shapes in the form of latin or greek characters
    • A61F2230/0056W-shaped, e.g. M-shaped, sigma-shaped

Abstract

The fastener has a W-shaped body defining a series of five-arm sections. A central vertical arm (1) is linked to a pair of upwardly-inclined outer arms (2,3) by intermediate arms (4,5), the outer and intermediate arm portions meeting at acute-angled bends (7,8). The central arm has a longitudinal through passage whose upper opening (11) is higher than the ends (9,10) of the two outer arm portions. The lower opening (12) of the through passage is flush with the lower surface of the junction between the two intermediate arm portions. The fastener is formed of a biocompatible shape-memory material, which has a martensitic transformation temperature below the temperature of the human body.

Description

Sysine impbstable de fixation d'endoprothèse notamment d'un implant ligamentaire impbstable Sysine fixing stent including a ligament implant
La présente invention se rapporte à des systèmes implantables de fixation d'endoprothèse notamment d'implant ligament aire. The present invention relates to implantable systems for attaching stent particular area ligament implant.

La présente invention peut par ailleurs être employée de manière unique, notamment pour la réalisation de matériel prothétique type agrafe. The present invention may also be used in a unique way, especially for the production of prosthetic hook type material.

Enfin la présente invention peut être fixée par soudure sur une autre pièce rigide tels les prothèses articulaires de reconstruction employées dans les différentes pathologies orthopédiques, notamment prothèses du fémur, du genou, cheville, pieds et mains (arthroplastie inter-phalangiennes et métatarso et métacarpo-phalangiennes), coude, épaule, rachis. Finally, the present invention can be fixed by welding to another rigid member such as reconstruction of joint prostheses employed in various orthopedic conditions, including prosthetic femur, knee, ankle, hand and foot (inter-phalangeal joint replacement and metacarpophalangeal and metatarsophalangeal phalangeal), elbow, shoulder, spine.

Tous les types de prothèse rigides chirurgicales et d'implants ligamentaire possédant une partie rigide se heurtent au problème essentiel de leur fixation. All types of surgical rigid prosthesis and ligament implants with a rigid part face the critical problem of fixing them.

L'invention concerne une technique de fixation auto bloquante pour un implant ligamenire, elle se rapporte également à une technique pour la réalisation d'une telle technique de fixation. The invention relates to a self-blocking fastening technology for ligamenire implant, it also relates to a technique for achieving such attachment technique. La technique de cette fixation peut être employée de manière unique lorsqu'elle est couplée à un implant ligamentaire raccordé à un système à mémoire de forme, ou faire partie intégrante d'une prothèse articulaire en permettant The technique of this attachment may be used uniquely when coupled to a ligament implant connected to a shape memory system, or be part of a joint prosthesis allowing
une fixation optimale. optimal fixation.

Dans la suite de la description et dans les revendications, on se référera plus particulièrement à ce système à mémoire de forme employé de manière unique de façon à permettre la fixation optimale d'un implant ligamentaire, étant entendu que cet exemple de réalisation n'est nullement limitatif, I'invention pouvant être employée dans d'autres applications qu'elles soient articulaires ou dans le cadre de la consolidation d'unis quelconque. In the following description and in the claims, we particularly refer to this system uniquely shape memory employee so as to allow the optimal attachment of a ligament implant, it being understood that this embodiment is no way limiting, the invention may be used in other applications, whether joint or as part of the consolidation of any united.

Comme on le sait, la fixation d'un implant ligamentaire peut se faire par différentes techniques: l'implant ligamentaire peut être fixé à la structure osseuse par une vis, une agrafe. As is known, fixing a ligament implant can be done by different techniques: the ligament implant can be attached to the bone structure of a screw, a staple. Elle peut se faire de manière courante par une structure rigide venant s'encastrer dans l'os spongieux après création d'un trou adapté. It can be done in conventional manner by a rigid structure from fitting into the spongy bone after creating a hole suitable. Cette technique est couramment employée dans le cas des prothèses ligamentaires genou. This technique is commonly used in the case of ligament knee prostheses. Une structure rigide de forme variable cylindrique, conique ou en V, permet la fixation d'une extrémité de la prothèse ligamentaire et son ancrage, on a également proposé dans le cas de prothèses articulaires orthopédiques, telles les prothèse de hanche, des genoux ou inter A rigid structure of variable cylindrical, conical or V-shaped, permits attachment of one end of the ligament prosthesis and its anchoring, have also been proposed in the case of orthopedic joint prostheses, such as hip replacements, knee or inter
phalangiennes des moyens d'ancrage avec du ciment, notamment à base de polymère acrylique tel que des polymethacrylate de méthyle. phalangeal anchoring means with cement, in particular based on acrylic polymer such as polymethyl methacrylate. Les problèmes de ce moyen de fixation sont bien connus. Problems of this attachment means are well known. Le ciment vieillit mal dans le temps. Cement badly aging over time. L'interface ciment os et rinterface prothèse ciment entraînent des contraintes favorisant la mobilité et donc le descellement de l'implant avec son cortège de symptomatologie douloureuse et de reprise chirurgicale. The bone cement interface and cement prosthesis rinterface cause stress promoting mobility and thus loosening of the implant with its attendant pain relief and surgical recovery. En outre lors de la réalisation de polymérisation du ciment à des températures atteignant 60 et plus, peuvent survenir des phénomènes de nécrose osseuse. Furthermore when performing polymerization cement at temperatures up to 60 and more may occur bone necrosis phenomena.

D'autres systèmes d'ancrage font appel a du matériel auto bloquant adjoignant l'emploi d'une surface madréporique favorisant une rehabitation osseuse. Other anchoring systems use hardware has the self-blocking adding the use of a surface madreporic promoting bone ingrowth.

Dans ces deux derniers cas implants avec ciment ou sans ciment, s'il est nécessaire d'envisager un changement de la prothèse, l'opération devient difficile voire impossible. In the latter two cases implants with cement or without cement, it is necessary to consider a change of the prosthesis, the operation becomes difficult or impossible.

Dans le cas notamment des implants employés dans les ligamentosplasties de reconstruction du genou, ces implants nécessitent pour leur fixation l'utilisation de vis ou agrafes qui peuvent fragiliser l'implant et qui nécessitent par ailleurs souvent leur ablation compte tenu de leur volume important. Particularly in the case of implants used in knee reconstruction ligamentosplasties these implants require for their attachment using screws or staples that can weaken the implant and require their removal also often given their volume. Dans le cas de plus petits implants utilisés notamment dans la chirurgie du pied sont apparus des ligaments de reconstruction nécessitant l'ancrage de la partie rigide de l'implant ligamentaire dans le spongieux, cette artifice est rendue indispensable parla petite dimension des os considérés qui ne permettraient pas l'emploi de matériels plus volumineux tels que les vis, en postopératoire peuvent survenir des phénomènes de migration de la pièce ancrée. In the case of smaller implants used especially in foot surgery appeared reconstruction ligaments requiring anchoring the rigid part of the ligament implant in the spongy, this artifice is made indispensable spoke small bones that considered not allow the use of larger devices such as screws, may occur in the postoperative migration phenomena anchored room.

Dans les Brevets FR k2 483 218; In Patent FR 483 218 k2; EPs0050533 ont été proposé de réaliser une fente longitudinale dans la tige d'un implant articulaire afin de lui conférer une élasticité et de EPs0050533 have been proposed to produce a longitudinal slot in the shank of a joint implant in order to impart elasticity thereto and
favoriser sa mise en place, mais cette dernière doit toujours se faire en force avec les risques de délabrement osseux notamment chez les sujets âgées. foster its implementation, but it must always be strong with the risk of bone decay especially in elderly subjects.

L'extraction est de même très difficile voire impossible en cas de problèmes et limite donc l'emploie de ce type d'implant notamment chez les enfants ou adolescents puisque en fonction de la croissance on ne peut retirer facilement la prothèse en question. The extraction is still very difficult if not impossible in case of problems and therefore limits the use of this type of implant, particularly among children and adolescents as a function of growth we can easily remove the prosthesis in question.

L'implant à système de mémoire de forme selon l'invention qui est réalisé dans un matériau biologique compatible est fendu de manière discontinue sur sa largueur en 4 parties et sur sa longueur de façon a former 5 parties distincts, 2 branches interne (4) et (5) et 2 branches externe (2) et (3) et une partie centrale (1), se caractérise en ce que le matériau présente une mémoire de forme et une température de transformation The implant shape memory system according to the invention which is carried out in a compatible biological material is slit discontinuously over its width into 4 parts and has a length so as to form five distinct parts, two inner arms (4) and (5) and two outer limbs (2) and (3) and a central part (1), is characterized in that the material has a shape memory and a processing temperature
martensitique inférieure à la température du corps humain. martensitic lower than the human body temperature.

L'invention consiste donc à réaliser un système d'ancrage dans un matériau à mémoire de forme et une température Ms inférieure à la température du corps humain, de sorte que par l'élévation à une température proche de celle du corps humain, les branches internes et externes 1 et 3 prennent une forme légèrement écartée par rapport à leur The invention therefore is to provide an anchor system of a shape memory material and an Ms temperature below the body temperature, so that by rising to a temperature close to that of the human body, the branches internal and external 1 and 3 take a form slightly spaced in relation to their
position initiale forme dont elles ont acquis la mémoire par un procédé connue de rbomrne de l'art. initial position as they acquired the memory by a known method rbomrne in the art.

Dans le cas de la chirurgie digestive se pose le même problème que dans la chirurgie orthopédique des petites articulations, il est nécessaire d'enfouir dans l'os la partie rigide de l'implant ligamentaire, ainsi notamment dans le cas du traitement chirurgical des hernies il est nécessaire de pratiquer un ancrage ligamentaire au niveau du pubis et la aussi le faible volume du matériel utilisé favorise sa migration ultérieure. In the case of gastrointestinal surgery poses the same problem as in orthopedic surgery of small joints, it is necessary to bury the bone in the rigid part of the ligament implant, and particularly in the case of surgical treatment of hernias it is necessary to practice a ligament anchor in the pubis and also the low volume of the material used favors its subsequent migration.

La présente invention à mémoire de forme et axe longitudinal indéformable permet la The present invention shape memory and non-deformable longitudinal axis allows the
mise en place précise d'un implant ligamentaire, puisque la partie indéformable sert d'axe de traction, et donc sert de guide lors de l'introduction de l'implant dans le tissu implanté. accurate implementation of a ligament implant, since the deformable portion serves as tensile axis, and thus serves as a guide during insertion of the implant in the implanted tissue.

La présente invention permet par son caractère à mémoire de forme et par son dessin d'assurer un meilleur appui sur la corticale osseuse dans le cas des prothèse articulaire et un meilleur ancrage dans la corticale et le spongieux dans le cas des implants ligamentaues. The present invention permits by its shape memory and character by its design to ensure better support on the cortical bone in the case of joint prosthesis and better anchoring in the cortical and cancellous in the case of ligamentaues implants.

Dans une autre forme de la présente invention, I'on notera que le matériau utilisé peut In another form of the present invention, I'On noted that the material used may
ne pas être à mémoire de forme. not be shape memory. La partie centrale (1) servant alors d'axe de traction lors de la rMse en place du systéme. The central part (1) while serving as a traction axis when the RMSE up of the system.

Le présent systéme à mémoire de forme se présente avec 5 branches qui peuvent être de coupe cylindrique, ronde ou rectangulaire, ces branches peuvent présenter sur leur This shape memory system is presented with five branches that can be cylindrical in section, round or rectangular, these branches may have on their
surface tous types de rainures qui assureraient un meilleur ancrage. all types of surface grooves that would ensure better anchoring.

Les 5 parties (2; 4; 5; 3; 1) peuvent être réalisées par toute technique connue telle 5 parts (2; 4; 5; 3; 1) can be made by any known technique such
que moulage, forgeage, frottage, usinage. as casting, forging, rubbing, machining. D'autres demandes de Brevet préconisent Other applications Patent advocate
l'emploi de 2 branches notamment dans le cas de prothèse avec appui cortical. Job 2 branches especially in the case of prosthesis with cortical support.

Ceci est vrai dans ce type d'indication car une augmentation du nombre de branches This is true in this type of indication for an increase in the number of branches
entrâîneraient une augmentation du coût et une fragilisation lors de leur utilisation dans le cas des petites articulations. would increase the cost and embrittlement when used in the case of small joints.

Mais cette demande de Brevet ne permet pas l'ancrage dans un tissu spongieux osseux But this patent application does not allow anchoring in a bone spongy tissue
en éliminant une mobilité de l'ancrage. eliminating a mobility anchor. La forme selon l'invention permet par ses portions (2; 8; 4; 5; 7; 3; 10; 9; 11) de prévenir ces déplacements. The form according to the invention by its portions (2; 8; 4; 5; 7; 3; 10; 9; 11) to prevent displacement.

La manière dont l'invention peut-être réalisée, ressortira des exemples de réalisation qui suivent, sont donnés à titre indicatif et non limitatifs à l'appui des figures annexées. How the invention may be carried out, from the examples of embodiments that follow, are indicative and not limiting to the accompanying drawings.

En se référant aux dessins schématiques annexés, on va décrire la présente invention. Referring to the accompanying schematic drawings, we will describe the present invention.

- La figure 1 est une vue de face conforme à l'invention disposée en position de - Figure 1 is a front view of the invention disposed in a position
présentation prête à l'emploi avant refroidissement. presentation ready for use before cooling.

- La figure 2 est une < ue de face conforme à l'invention disposée en position lors du - Figure 2 is a <ue face according to the invention disposed in position upon
refroidissement. cooling.

- La figure 3 est une vue de face conforme à l'invention disposée dans sa position finale après implantation et réchauffement à la température ambiante. - Figure 3 is a front view according to the invention arranged in its final position after implantation and warming to room temperature.

La présente invention ressemble: The invention looks like:
- Sensiblement à un W avec une branche centrale droite (1), comprenant deux extrémités (11) et (12) et deux branches latérales en V (10) et (4) et (5) et (3) coudées à leurs parties inférieures respectivement en (8) et (7). - substantially a W with a straight central branch (1) comprising two ends (11) and (12) and two lateral branches V (10) and (4) and (5) and (3) bent at their lower portions respectively in (8) and (7).

Par usinage on taille dans la partie centrale droite (1) un trou (6) d'un diamètre d'environ 0,5 mm. By machining are cut in the right central portion (1) a hole (6) of a diameter of about 0.5 mm. Ce trou est circulaire mais peut présenter une forme quelconque dans le sens transversal. This hole is circular, but can have any shape in the transverse direction. Cet orifice est présent suivant l'axe longitudinal de la partie (1). This orifice is present along the longitudinal axis of part (1).

Le matériau constituant la présente invention est un alliage Titane Nickel (49,3% atomique de Titane et 50,7% de Nickel) dont la transformation martensitique Ms est voisine de 15 C. The material constituting the present invention is a nickel titanium alloy (49.3 atomic% of titanium and 50.7% nickel), the martensitic transformation Ms is close to 15 C.

Mécaniquement, à température ambiante on écarte par un coin dans les espaces coudés (8), (7) ainsi que dans l'espace entre les portions (4) et (5) et (10) température ambiante T1 de manière à écarter les branches (2), (4), (5) et (3). Mechanically at room temperature, deviates by a wedge in the bent areas (8), (7) and in the space between the portions (4) and (5) and (10) ambient temperature T1 so as to move the legs (2), (4), (5) and (3). Cette opération est effectuée à une température supérieure à Ms (15 ). This operation is carried out at a temperature above Ms (15). L'invention (A) acquière une première mémoire de forme écartée, on retire les coins, L'implant est trempé dans l'eau glacée tout en resserrant les extrémités (2) et (3), L'implant acquière ainsi cette mémoire de forme repliée puisque la température T2 de 00C est inférieur à la température Ms, on répète dix fois l'opération aux températures Tl et T2. The invention (A) acquires a first shape memory discarded, the corners are removed, the implant is dipped in ice water while tightening the ends (2) and (3) The implant thus acquires the memory folded shape since the temperature T2 is 00C lower than the Ms temperature was repeated ten times the operation to the Tl and T2 temperatures.

Ainsi est obtenue un implant à mémoire de forme avec un orifice longitudinal ayant les formes écartés à la température T1 et repliée à la température T2, mais qui à température ambiante se présente sous forme de branches (2).(4).(5).(3) écartées. Thus is obtained a shape memory implant with a longitudinal bore having the shapes spaced at temperature T1 and folded at the temperature T2, but which at room temperature is in the form of legs (2). (4). (5) . (3) apart.

L'implant présente sur sa surface des alvéoles ou des micro porosités ou tous autres The implant has on its surface cavities or micro porosity or any other
reliefs permettant la prolifération des tissu osseux. reliefs permitting the proliferation of the bone tissue.

Au niveau de l'os spongieux, lorsque le chirurgien désire mettre en place un implant à mémoire de forme (A), il prépare de manière connue une ostéotomie. At the cancellous bone, when the surgeon wants to create a shape memory implant (A), it prepares manner known osteotomy. Pour replier les branches un composant tel un spray réfrigérant, ou de l'eau glacée peut être utilisée. To fold the branches a component such as a refrigerant spray, or cold water may be used.

Les extrémités des branches (2) et (3) sont repliées, la largeur de l'implant est alors de 7 mm. The ends of the limbs (2) and (3) are folded, the width of the implant is then 7 mm. Puis cet implant est introduit dans le tissu spongieux, avec la température Then the implant is introduced into the spongy tissue, with temperature
ambiante de l'os les branches s'écartent sans qu'il soit nécessaire de recourir à un réchauffement artificiel par exemple électrique de l'implant. Ambient bone branches diverge without the need to resort to artificial warming example electrical implant. Compte tenu de la forme sensiblement en W, L'implant est bloqué dans le tissu spongieux dans tous les sens. Given the shape substantially W, the implant is blocked in the spongy tissue in all directions. Si le chirurgien désire retirer l'implant, par traction inverse celui ci est enlevé. If the surgeon wishes to remove the implant, reverse pull this one is removed.

ll n'est pas nécessaire de refroidir l'implant pour extraire comme cela a été décrit dans It is not necessary to cool the implant to extract as described in
le cas de prothèse articulaire (N" dépôt Brevet 86420306.2) car en position écartée le tissu spongieux n'offre pas assez de résistance à une traction réalisée dans le sens contraire du sens de la mise en place de l'implant. the case of joint replacement (N "deposit Patent 86420306.2) in position away because the spongy tissue does not offer enough resistance to tensile performed in the opposite direction of the direction of the establishment of the implant.

Une nouvelle mise en place peut être pratiquée, car l'ostéotomie, permet de placer l'implant à un autre niveau. A new installation can be performed because the osteotomy, can place the implant to another level. Ainsi ce type d'implant à mémoire de forme sensiblement en Thus this type of implant shape memory substantially
W, peut être utilisé sur des enfants ou adolescents puisque en fonction de la croissance, on peut retirer facilement la prothèse en question. W can be used on children or teenagers as a function of growth, one can easily remove the prosthesis in question.

Cet implant à mémoire de forme à axe longitudinal indéformable peut être mis en place aussi de la même manière au niveau des tendons, muscles, ou ligament. This implant longitudinal axis to dimensionally stable shape memory may be implemented also in the same way in the tendons, muscles or ligaments.

La première portion (2) se prolonge en une branche de longueur inférieure (4), puis la The first portion (2) extends into a lower limb length (4) and the
zone fixe (1) se prolonge à la portion (5) de longueur inférieure à la portion suivante (3). fixed area (1) extends to the portion (5) of length less than the following portion (3).

La présente invention présente une forme sensiblement en W, mais peut présenter une autre forme faites de plusieurs W, possédant une partie centrale commune (1). The present invention has a substantially W-shaped but can have another shape made of several W, having a common central part (1).

Différents types de longueur peuvent être envisagés. Different types of length can be considered. Selon une caractéristique de l'invention la portion (1) fixe présente un trou traversant (6). According to one feature of the invention the portion (1) fixed has a through hole (6). Ce trou traversant (16) présente donc une extrémité (11) dépassant , les extrémités (9) et (10) et à une forme à angle aigu, permettant son introduction dans le tissu implanté, l'on notera que dans une forme avantageuse de l'invention, le trou traversant (6) présente une autre This through hole (16) thus has an end (11) projecting from, the ends (9) and (10) and a shape at an acute angle, allowing its introduction into the implanted tissue, it will be appreciated that in an advantageous the invention, the through hole (6) has a further
extrémité (12) épousant la courbure reliant les parties (8) et (7), mais dans une autre forme, cette extrémité peut être dessiné sur un prolongement de la partie fixe (11) et serait donc en relief par rapport aux parties (8) et (9). end (12) conforming to the curvature of connecting portions (8) and (7), but in another form, this end can be drawn on an extension of the fixed part (11) and is therefore raised with respect to the parts (8 ) and (9). L'ensemble du système de fixation est donc monobloc et en un matériau martensitique. The whole attachment system is therefore single piece and in a martensitic material.

Nous noterons que la partie 1 de l'implant à mémoire de forme présente une longueur plus importante que les parties 2 et 3 ceci permet la mise en place de l'implant, d'exercer une trration dans l'axe longitudinal et d'autoriser l'entrée première de l'extrentité (11) dans le tissu implanté. We note that Part 1 of the shape memory implant has a greater length than the parts 2 and 3 it allows the introduction of the implant, to exert trration in the longitudinal axis and to allow the first input of the extrentité (11) in the implanted tissue. Ainsi la partie 1 sert de guide à l'ensemble de runplant.Cette forme permet donc la mise en place de l'implant dans un tissu tendineux, tel le tendon d'achille. Thus Part 1 provides a guide to all runplant.Cette shape allows the introduction of the implant in a tendon tissue such as the Achilles tendon. Nous notons que la partie (1) peut présenter une We note that section (1) may apply
dimension autre dans la mesure ou elle permet de conserver un axe de traction. Another dimension to the extent it will keep a tensile axis. En l'absence de cette partie fixe longitudinale indéformable la traction ne s'exercerait pas de manière uniforme et l'implant serait mobile dans tous les plans. In the absence of this longitudinal fixed portion deformable traction does not exercise consistently and the implant would be moving in all planes. La forme de la partie centrale (1) peut présenter toute modification qui permettront la fixation particulière d'un implant ligamentaire, celui-ci pouvant en particulier être constitué de 2 parties âme et gaine de même, au niveau de la surface inteme du trou traversant toute modifications de forme sont envisageables. The shape of the central portion (1) may have any modification which will allow the particular fixing a ligament implant, which may each in particular be made of 2 parts core and sheath even at the inner surface of the through hole any amendments are considered.

Les développements de l'invention sont particulièrement adaptés aux petites articulations. The developments of the invention are particularly suitable for small joints.

Les portions (8) et (7) entre les portions (2) et (4) d'une part et (5) et (3) d'autre part ont une forme extemes arrondies, ce qui permet une extraction facile de l'implant. The portions (8) and (7) between the portions (2) and (4) on the one hand and (5) and (3) on the other hand have an extemal round form, which allows easy extraction of the implant.

Les extrémités (10) et (9) ont une forme appropriées mais de préférence elles sont à angles aigus dans une forme avantageuse de l'invention mais peuvent présenter une forme quelconque. The ends (10) and (9) have a suitable shape but preferably they are at acute angles in an advantageous embodiment of the invention but may have any shape.

Claims (5)

REVENDICATIONS
1. Système de fixation d'endoprothèse notamment d'implant ligamentaire caractérisé par une configuration sensiblement en W constitué de 5 branches:1 branche centrale (1), 2 branches latérales, composées de segments (2); 1. stent fixation system including ligament implant characterized by a configuration substantially W consists of 5 parts: one central branch (1), two lateral branches made up of segments (2); (4) et (5); (4) and (5); (3) coudées respectivement en (8) et (7). (3) bent in respectively (8) and (7). La branche (1) présentant un orifice longitudinal dont l'extrémité (11) dépasse des extrémités (9) et (10) des branches (3) et (2) et dont extrémité inférieure (12) est en continuité avec les portions coudées (4) et (5). The leg (1) having a longitudinal orifice, the end (11) beyond the ends (9) and (10) of the legs (3) and (2) and whose lower end (12) is continuous with the bent portions ( 4) and (5).
2. Système de fixation d'endoprothèse selon la revendication (1), réalisé en un matériau biologiquement compatible, caractérisé en ce que le matériau présente une mémoire de forme et une température de transformation martensitique Ms inférieure à la température du corps humain. 2. stent fixation system according to claim (1), made of a biologically compatible material, characterized in that the material has a shape memory and martensitic transformation temperature Ms less than the human body temperature.
3. Système de fixation selon la revendication 1 à 2 caractérisé en ce les branches latérales (2); 3. Fixing system according to claim 1 to 2, characterized in that the lateral branches (2); (4) et (3); (4) and (3); (5) sont symétriques par rapport à la branche centrale (1). (5) are symmetrical with respect to the central branch (1).
4. Système de fixation selon l'une des revendications 1 à 3 caractérisé en ce que l'implant est en un alliage comprenant les alliages, titane, nickel, de cuivre-manganeze, de cuivre de zinc, de platine fer, de cuivre aluminium zinc. 4. Fixing system according to one of claims 1 to 3 characterized in that the implant is an alloy comprising alloys, titanium, nickel, copper-manganeze, zinc copper, iron platinum, aluminum copper zinc.
5. Procédé pour la fabrication d'un système de fixation à mémoire de forme sensiblement en W bloquant selon la revendication (2) caractérisé en ce qu'il consiste: 5. A method for producing a shape memory securing system substantially W-blocking according to claim (2) characterized in that it consists:
- A réaliser tout d'abord un système de fixation à mémoire de forme serlsiblement en W et une température de transformation martensitique Ms inférieur à la température du corps humain, - To achieve firstly a shape memory fixation system serlsiblement W and a temperature of martensitic transformation Ms below the human body temperature,
- Puis à porter ce système de fixation à mémoire de forme sensiblement en W à une température T1 supérieure à Ms tout en écartant les branches (2) (4) (5) (3), - Then wear this shape memory fastening system substantially W at a temperature T1 higher than Ms while spreading the branches (2) (4) (5) (3),
- Puis à refroidir le système de fixation à mémoire de forme ainsi écarté à une température T2 inférieure à Ms tout en resserrant les extrémités de ces branches écartées, - then cooling the shape memory fixation system and spaced at a temperature T2 lower than Ms while tightening the ends of said branches apart,
- Et enfin à répéter plusieurs fois ces deux dernières opérations T1 et - And finally to repeat several times the last two operations and T1
T2 jusqu'à ce que les branches de l'implant aient acquis une mémoire de forme: écarté T1 et replié T2. T2 until the arms of the implant have acquired a form of memory: discarded T1 and T2 folded.
FR9409372A 1994-07-28 1994-07-28 Surgical implant for fastening ligament against bone surface Withdrawn FR2722975A1 (en)

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