FR2725892A1 - Vertebral implant insertion process using shape memory material - Google Patents

Vertebral implant insertion process using shape memory material Download PDF

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Publication number
FR2725892A1
FR2725892A1 FR9412843A FR9412843A FR2725892A1 FR 2725892 A1 FR2725892 A1 FR 2725892A1 FR 9412843 A FR9412843 A FR 9412843A FR 9412843 A FR9412843 A FR 9412843A FR 2725892 A1 FR2725892 A1 FR 2725892A1
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Prior art keywords
hook
shape memory
vertebral
memory material
hooks
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FR9412843A
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French (fr)
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Priority to FR9412843A priority Critical patent/FR2725892A1/en
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7056—Hooks with specially-designed bone-contacting part
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7002—Longitudinal elements, e.g. rods
    • A61B17/7004—Longitudinal elements, e.g. rods with a cross-section which varies along its length
    • A61B17/7007—Parts of the longitudinal elements, e.g. their ends, being specially adapted to fit around the screw or hook heads
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • 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
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006—Properties of materials and coating materials
    • A61F2002/30092—Properties of materials and coating materials using shape memory or superelastic materials, e.g. nitinol
    • 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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0014—Particular 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
    • A61F2210/0019—Particular 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

Abstract

The vertebral implant is formed with two portions, one of which is transformable in shape as a result of formation from a shape memory material. A main body portion of the implant is mechanically and dimensionally stable, and has one or more cooperating accessories of the shape memory material. The accessories are activated by the presence of heat to change their shape to engage within one or more bone cavities by friction with the bone surfaces, thus locking the main body in position relative to a vertebra. The transformation in the material may be between martensitic and austenitic crystalline states.

Description

CROCHET VERTEBRAL A EFFET MEMOIRE DE FORME
Le dispositif, objet du présent brevet, vise à fixer solidement et de manière réversible deux ou plusieurs vertèbres entre elles par une voie d'abord chirurgicale.VERTEBRAL HOOK WITH SHAPE MEMORY EFFECT
The device, object of this patent, aims to securely and reversibly fix two or more vertebrae together by a surgical approach.

On a proposé depuis longtemps, pour redresser et fixer la colonne vertébrale soit qu'elle soit le siège d'une déviation pathologique, soit qu'elle présente une solution de continuité, des dispositifs faisant appel à des crochets reliés par des tiges.It has long been proposed, to straighten and fix the spine either that it is the seat of a pathological deviation, or that it presents a solution of continuity, devices calling on hooks connected by rods.

Rappelons que les crochets sont destinés d'une part à s'encastrer dans les parties des vertèbres propres à cet usage, tels que les lames vertébrales, les apophyses transverses, les pédicules, les articulaires postérieures, les apophyses épineuses et, d'autres part à recevoir dans un orifice de forme appropriée les éléments de liaison avec un ou plusieurs autres crochets.Recall that the hooks are intended on the one hand to be embedded in the parts of the vertebrae suitable for this use, such as the vertebral laminae, the transverse processes, the pedicles, the posterior articulations, the spinous processes and, on the other hand receiving in an appropriately shaped orifice the connecting elements with one or more other hooks.

Un crochet vertébral est généralement formé d'un bloc métallique de forme grossièrement parallépipèdique ou cylindrique dans lequel ont été usiné deux cavités principales, l'une destinée à un assemblage à tenon et mortaise avec les reliefs vertébraux dans lequel le crochet forme une mortaise et le relief vertébral le tenon, l'autre acceptant le ou les éléments de liaison entre les crochets successifs.A vertebral hook is generally formed by a metal block of roughly parallelepipedal or cylindrical shape in which two main cavities have been machined, one intended for a tenon and mortise assembly with the vertebral reliefs in which the hook forms a mortise and the vertebral relief the tenon, the other accepting the connecting element or elements between the successive hooks.

Dans l'état de l'art, la fixation des crochets sur la colonne vertébrale se fait par impaction après préparation plus ou moins sommaire du tenon par rugination. On comprend bien que l'ajustage entre les crochets et la vertèbre, compte tenu de la géométrie irrégulière des reliefs vertébraux, n'est pas très fiable. Sous l'effet de diverses contraintes engendrées par les mouvements de la colonne vertébrales, il peut se produire des débricolages entraînant la faillite de tout le montage.In the state of the art, the fixing of the hooks on the vertebral column is done by impaction after more or less summary preparation of the post by rugination. It is understood that the adjustment between the hooks and the vertebra, taking into account the irregular geometry of the vertebral reliefs, is not very reliable. Under the effect of various constraints generated by the movements of the spine, there may be disjointing resulting in the bankruptcy of the entire assembly.

Pour remédier à ce problème on a proposé de multiplier les formes et les dimensions des crochets. On a recours également à des artifices complémentaires tels que des vis introduites dans l'épaisseur des crochets.To remedy this problem, it has been proposed to multiply the shapes and dimensions of the hooks. Additional devices are also used, such as screws inserted into the thickness of the hooks.

De même la fixation des barres de jonction aux crochets fait appel soit à des filetages bloqués par des écrous, soit à des barres crantées, soit à des vis complémentaires.Ces systèmes sont modéremment fiables et on assiste à des déplacements post opératoires du matériel entraînant des pertes de réduction. Similarly, the attachment of the junction bars to the hooks uses either threads blocked by nuts, or notched bars, or complementary screws. These systems are moderately reliable and there is post-operative movement of the material causing reduction losses.

Il ne faut pas perdre de vue que les interventions du rachis se déroulent au fond d'un champ opératoire étroit et profond, au fond duquel il est délicat de pratiquer des manipulations complexes.It should not be forgotten that spinal procedures take place at the bottom of a narrow and deep operating field, at the bottom of which it is difficult to practice complex manipulations.

L'objet de la présente invention est de proposer un nouveau type de crochets remédiant aux inconvénients cités ci-dessus et permettant une mise en place facile et atraumatique, une fixation aisée aux reliefs osseux et une réversibilité complète de la dite fixation. Ainsi pourra-t-on procéder à des essais de mise en place aussi nombreux que nécessaire sans léser le support osseux.The object of the present invention is to provide a new type of hooks overcoming the drawbacks mentioned above and allowing easy and atraumatic installation, easy attachment to bone reliefs and complete reversibility of said attachment. This will allow us to carry out as many placement tests as necessary without damaging the bone support.

L'invention consiste à compléter ou à remplacer une fixation mécanique par une fixation grâce à l'effet de mémoire de forme.The invention consists in supplementing or replacing a mechanical fixation with a fixation thanks to the shape memory effect.

Rappelons que les matériaux à mémoire de forme présentent deux formes aux propriétés physiques différentes, de part et d'autre des températures de transition appelées martensique et austénitique.Recall that shape memory materials have two forms with different physical properties, on either side of the transition temperatures called martensic and austenitic.

Du fait de cette variabilité de forme et de propriétés physiques l'utilisation du seul matériau à mémoire de forme pour fabriquer des crochets ne peut pas convenir.Due to this variability in shape and physical properties, the use of the only shape memory material for making hooks cannot be suitable.

Nous associons donc au crochet fabriqué en matériau sans mémoire de forme ( exemple: titane, acier...) une ou plusieurs pièces en alliage à mémoire de forme qui ont un rôle de fixation ou de verrouillage de l'implant en activant l'effet de mémoire par la température.We therefore associate with the hook made of material without shape memory (example: titanium, steel ...) one or more pieces of shape memory alloy which have the role of fixing or locking the implant by activating the effect memory by temperature.

Selon un exemple de l'invention, le crochet en titane comporte une partie évidée destinée à recevoir l'élément de liaison, tige ou plaque. On fixe à l'intérieur de cette partie creuse une pièce en alliage à mémoire de forme appropriée pour pouvoir par la suite serrer les tiges ou plaques.According to an example of the invention, the titanium hook comprises a recessed part intended to receive the connecting element, rod or plate. Is fixed inside this hollow part a piece of memory alloy suitable shape to be able to subsequently tighten the rods or plates.

En position non activée, dite martensitique, la pièce en alliage à mémoire de forme se présente, par exemple, dans le cas d'un orifice en forme de cylindre creux, sous forme d'un anneau, remplissant parfaitement une rainure circulaire, de manière à ne pas déborder à l'intérieur de l'orifice cylindrique.In the non-activated, so-called martensitic, position, the shape memory alloy part is, for example, in the case of a hollow cylinder-shaped orifice, in the form of a ring, perfectly filling a circular groove, so not to overflow inside the cylindrical orifice.

En position activée , austénitique, la pièce de métal à mémoire se déforme et adopte une forme géométrique ovalaire ou en 8 de chiffre.In the activated, austenitic position, the memory metal piece deforms and adopts an oval or 8-digit geometric shape.

Cette activation est réalisée, après que la tige de liaison ait été introduite dans l'espace creux destiné à le recevoir et que le montage réalisé par la tige et un ou plusieurs crochets soit satisfaisant. Dès que la transformation est obtenue, par exemple par application du sérum chaud la tige de liaison est solidement maintenue.This activation is carried out after the connecting rod has been introduced into the hollow space intended to receive it and the assembly produced by the rod and one or more hooks is satisfactory. As soon as the transformation is obtained, for example by application of hot serum, the connecting rod is firmly held.

Selon une forme préférentielle de réalisation de l'invention, la transformation se réalise à une température de 20"C environ, si bien que la simple utilisation de sérum refroidi (40C) et de sérum chaud (40"C) suffit à passer d'un état à l'autre sans danger pour les tissus humain.According to a preferred embodiment of the invention, the transformation is carried out at a temperature of about 20 "C, so that the simple use of cooled serum (40C) and hot serum (40" C) is enough to pass from state to state safe for human tissue.

De la même manière, les parties des crochets destinées à encastrer les parties osseuses de la vertèbre sont garnies dans leurs parties concaves d'une pièce de métal à mémoire de forme appropriée, semi-elliptique, semi-cylindrique, semi-rectangulaire ou encore simplement formée par deux tiges à mémoire de forme scellées au fond de la mortaise. Cette ou ces pièces, sont disposées dans une rainure de forme appropriée à l'intérieur de la mortaise.In the same way, the parts of the hooks intended to embed the bony parts of the vertebra are lined in their concave parts with a piece of metal with appropriate shape memory, semi-elliptical, semi-cylindrical, semi-rectangular or even simply formed by two memory sticks sealed at the bottom of the mortise. This or these pieces are arranged in a groove of suitable shape inside the mortise.

Sous la forme martensitique la pièce de métal à mémoire est entièrement encastrée dans la rainure de manière à ce que l'on puisse introduire à frottement doux la partie osseuse dans le crochet métallique.In the martensitic form the piece of memory metal is completely embedded in the groove so that the bone part can be introduced with gentle friction into the metal hook.

Sous sa forme austénitique les deux branches de la pièce à métal à mémoire se resserrent à la manière d'une pince de crabe, c'est à dire que les deux extrémités des branches se rapprochent plus que leur base.In its austenitic form the two branches of the memory metal part tighten in the manner of a crab clamp, that is to say that the two ends of the branches come closer than their base.

Ainsi sera évité un effet d'expulsion de la pièce osseuse lorsque le métal à mémoire est activé et la pièce osseuse sera maintenue par les extrêmités de la pince. Ce dispositif est applicable à une grande varité de forme de crochets vertébraux ou de barres ou de plaques d'union.This will prevent the effect of expelling the bone piece when the memory metal is activated and the bone piece will be held by the ends of the forceps. This device is applicable to a wide variety of shape of vertebral hooks or bars or union plates.

Comme une réalisation possible de l'invention, les crochets seront en titane et le matériau à mémoire en alliage titane-nickel. Du fait de la stabilité électrochimique de cet alliage les crochets peuvent être réalisés avec d'autres matériaux.As a possible embodiment of the invention, the hooks will be made of titanium and the memory material of titanium-nickel alloy. Due to the electrochemical stability of this alloy, the hooks can be made with other materials.

L'invention peut être utilisée pour des montages en double mortaise articulée, destinés à fixer solidement deux apophyses épineuses successives. The invention can be used for articulated double mortise assemblies, intended to securely fix two successive spinous processes.

Claims (7)

REVENDICATIONS 1) Dispositif formé d'une pièce de liaison appelé crochet vertébral destinée à la chirurgie de la colonne vertébrale, caractérisé en ce qu'il comporte une partie non activable et une partie activable sous l'effet de la température, la partie transformable étant réalisée en matériau à mémoire de forme.1) Device formed by a connecting piece called a vertebral hook intended for spinal surgery, characterized in that it comprises a non-activatable part and a part which can be activated under the effect of temperature, the transformable part being produced made of shape memory material. 2) Dispositif selon la revendication 1 formé d'un crochet caractérisé en ce qu'il comporte une partie principale mécaniquement stable et une ou des parties accessoires appliquées au niveau des cavités et fabriquées en matériau à mémoire de forme, de manière à ce que l'activation de ce matériel à mémoire par la chaleur permet de verrouiller le crochet sur le vertèbre et les barres ou plaques de liaison sur le crochet.2) Device according to claim 1 formed of a hook characterized in that it comprises a mechanically stable main part and one or more accessory parts applied at the level of the cavities and made of shape memory material, so that the activation of this memory material by heat makes it possible to lock the hook on the vertebra and the connecting bars or plates on the hook. 3) Dispositif selon les revendications 1 et 2 caractérisé en ce que la ou les pièces en métal à mémoire appliquées à l'intérieur des orifices du crochet ne font pas de saillie à l'intérieur des orifices dans leur forme martensitique et au contraire rétrécissent cet orifice dans leur forme austénitique.3) Device according to claims 1 and 2 characterized in that the memory metal part (s) applied inside the holes of the hook do not protrude inside the holes in their martensitic form and on the contrary shrink this orifice in their austenitic form. 4) Dispositif selon la revendication 3 caractérisé en ce que le matériel en mémoire de forme est disposé à l'intérieur de la cavité destinée à recevoir les éléments de liaison entre crochets vertébraux de manière à ce que l'introduction des éléments de liaison dans les cavités destinées à les recevoir s'opère à frottement doux et que le verrouillage des éléments de liaison dans les crochets soit réalisé par activation du métal à mémoire de forme.4) Device according to claim 3 characterized in that the material in shape memory is arranged inside the cavity intended to receive the connecting elements between vertebral hooks so that the introduction of the connecting elements in the cavities intended to receive them operates with gentle friction and the locking of the connecting elements in the hooks is carried out by activation of the shape memory metal. 5) Dispositif selon les revendications 3 et 4 caractérisé en ce que le tenon vertébral est introduit dans la mortaise du crochet de liaison à frottement doux sous la forme martensitique et est verrouillé sous la forme austénitique.5) Device according to claims 3 and 4 characterized in that the vertebral post is introduced into the mortise of the connecting hook with gentle friction in the martensitic form and is locked in the austenitic form. 6) Dispositif selon l'une quelconque des revendications précédentes caractérisé en ce qu'on peut associer ou non les deux systèmes de verrouillage sur un même crochet vertébral.6) Device according to any one of the preceding claims, characterized in that the two locking systems may or may not be combined on the same vertebral hook. 7) Dispositif selon l'ensemble des revendications précédentes caractérisé en ce que le verrouillage d'un implant osseux quelconque est obtenu par l'activation d'une ou plusieurs pièces de matériaux à mémoire associées à un support en matériau sans effet de mémoire de forme. 7) Device according to all of the preceding claims characterized in that the locking of any bone implant is obtained by the activation of one or more pieces of memory material associated with a material support without shape memory effect .
FR9412843A 1994-10-21 1994-10-21 Vertebral implant insertion process using shape memory material Pending FR2725892A1 (en)

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