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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France
Prior art keywords
hook
characterized
shape memory
memory material
vertebral
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Pending
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FR9412843A
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French (fr)
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Felman Daniel
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Priority to FR9412843A priority Critical patent/FR2725892A1/en
Publication of FR2725892A1 publication Critical patent/FR2725892A1/en
Application status is Pending legal-status Critical

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7056Hooks with specially-designed bone-contacting part
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7002Longitudinal elements, e.g. rods
    • A61B17/7004Longitudinal elements, e.g. rods with a cross-section which varies along its length
    • A61B17/7007Parts of the longitudinal elements, e.g. their ends, being specially adapted to fit around the screw or hook heads
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties
    • A61B2017/00867Material properties shape memory effect
    • 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
    • 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

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 SPINAL HOOK EFFECT SHAPE MEMORY
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. The device, object of this patent, is designed to securely attach reversibly and 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 for straightening and fixing the spine or whether the seat of a pathological deviation, whether it has a break in continuity, devices making use of 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 firstly to be embedded in the portions of the vertebrae own for this purpose, such as vertebral lamina, the transverse processes, the pedicles, the facet joints, and the spinous processes, on the other hand receiving in a suitably shaped orifice connecting elements with one or more 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 of a metal block of roughly parallelepipedal or cylindrical form in which have been machined two main cavities, one for a tenon and mortise with the vertebral reliefs wherein the hook forms a mortise and relief vertebral the tenon, the other accepting the one or more connecting elements between 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. In the prior art, the fixing hooks on the spine is effected by impaction after preparation more or less summary of the tenon by 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. although the fit is understood between the hooks and the vertebra, given the irregular geometry of the vertebral relief, is not very reliable. 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. Under the effect of various stresses generated by the movements of the vertebral column, it can produce débricolages causing the bankruptcy of any assembly.

Pour remédier à ce problème on a proposé de multiplier les formes et les dimensions des crochets. To remedy this problem was proposed to multiply the forms and dimensions of the hooks. On a recours également à des artifices complémentaires tels que des vis introduites dans l'épaisseur des crochets. We also appeal to additional devices such as screws inserted in the thick 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 fixing dowel bars with hooks appealed either to threads blocked by nuts, or toothed bars or to screw complémentaires.Ces systems are moderately reliable and attends postoperative material movements resulting in reducing 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. We must not lose sight of the spine interventions take place at the bottom of a deep and narrow operative field, the bottom of which it is difficult to perform 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. The object of the present invention is to provide a new type of hooks remedying the drawbacks cited above and allowing easy implementation and atraumatic, easy attachment to the bony portions and full reversibility of said attachment. Ainsi pourra-t-on procéder à des essais de mise en place aussi nombreux que nécessaire sans léser le support osseux. So will do we proceed to implementation of testing as many as needed 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 to supplement or replace a mechanical fastener by a fastener through 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 the shape memory materials exhibit two forms with different physical properties, on either side of the transition temperatures and austenitic called martensique.

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. Because of this variability in shape and physical properties using the single shape-memory material for making hooks may not 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 the hook-like manufactured without memory material (eg titanium, stainless steel ...) one or more pieces of shape memory alloy which have a role of fixing or locking of the implant by turning 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. According to one example of the invention, the titanium hook comprises a recessed portion for receiving the connecting element, rod or plate. 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. is fixed within this hollow portion a suitable shape memory alloy member in order 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 non-activated position, said martensitic, the alloy part with shape memory is in, for example, in the case of a hollow cylinder-shaped orifice in the form of a ring, perfectly completing a circular groove, so not to spill inside the cylindrical hole.

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

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. This activation is carried out after the connecting rod has been introduced into the cavity for receiving and mounting carried by the rod and one or more hooks is satisfactory. Dès que la transformation est obtenue, par exemple par application du sérum chaud la tige de liaison est solidement maintenue. Once the transformation is achieved, for example by application of hot serum the connecting rod is securely maintained.

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 20 "C, so that the mere use of chilled saline (40C) and warm saline (40" C) is sufficient to pass from one to another safe state 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. Similarly, parts of the hooks designed to embed the bone parts of the vertebra are lined in their concave parts of a piece of metal of suitable shape memory, semi-elliptical, semi-cylindrical, semi-rectangular, or simply formed by two shape memory rods sealed to the bottom of the mortise. Cette ou ces pièces, sont disposées dans une rainure de forme appropriée à l'intérieur de la mortaise. This or these pieces are arranged in a suitably shaped groove within 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 shape memory metal piece is fully embedded in the groove so that one can introduce snugly bone portion in 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 arms of the memory metal piece are tightened in the manner of a claw, i.e. the two ends of the arms are closer to 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. Thus will be avoided an expulsion effect bone part when the memory metal is activated and the bone part is held by the ends of the clamp. Ce dispositif est applicable à une grande varité de forme de crochets vertébraux ou de barres ou de plaques d'union. This device is applicable to a wide varité 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. As a possible embodiment of the invention, the hooks are made of titanium and the memory material in the titanium-nickel alloy. Du fait de la stabilité électrochimique de cet alliage les crochets peuvent être réalisés avec d'autres matériaux. Due to the electrochemical stability of this alloy brackets can be achieved 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 to edit on the double articulated mortise intended to firmly secure 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) An apparatus formed of a connecting piece called vertebral hook for surgery of the spine, characterized in that it comprises a non-activated portion and an activatable part under the effect of temperature, the portion being made transformable shaped 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 part and a main or accessory parts applied in the cavities and made of shape memory material, so that activation of the memory material by the heat used to lock the hook on the vertebra and the rods or connecting 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 at least one memory metal pieces applied inside the hook holes make no projecting inside holes in their martensitic form and contrary taper this orifice in their austenitic shape.
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 shape memory material is disposed within the cavity for receiving the connecting elements between vertebral hooks so that the introduction of connecting elements in the recesses for receiving operates to snugly and that the locking of the connecting elements in the brackets is achieved 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 tenon is inserted into the mortise of the snug connecting hook 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) Apparatus according to any preceding claim characterized in that they may be combined or not the two locking systems 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 of the preceding claims characterized in that the locking of any bone implant is achieved by activating one or more memory materials of parts associated with a support material 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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FR9412843A FR2725892A1 (en) 1994-10-21 1994-10-21 Vertebral implant insertion process using shape memory material

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FR9412843A FR2725892A1 (en) 1994-10-21 1994-10-21 Vertebral implant insertion process using shape memory material

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