FR2717675A1 - Shock-absorbing spacer block for location between adjacent vertebrae implanted during spinal surgery - Google Patents

Shock-absorbing spacer block for location between adjacent vertebrae implanted during spinal surgery Download PDF

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Publication number
FR2717675A1
FR2717675A1 FR9403716A FR9403716A FR2717675A1 FR 2717675 A1 FR2717675 A1 FR 2717675A1 FR 9403716 A FR9403716 A FR 9403716A FR 9403716 A FR9403716 A FR 9403716A FR 2717675 A1 FR2717675 A1 FR 2717675A1
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apophyses
core
block
spinal
inserts
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FR9403716A
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French (fr)
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FR2717675B1 (en )
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Taylor Jean
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Taylor Jean
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    • 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
    • A61B17/7062Devices acting on, attached to, or simulating the effect of, vertebral processes, vertebral facets or ribs ; Tools for such devices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12009Implements for ligaturing other than by clamps or clips, e.g. using a loop with a slip knot
    • 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
    • A61B17/82Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin for bone cerclage
    • 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
    • A61B17/84Fasteners therefor or fasteners being internal fixation devices
    • A61B17/842Flexible wires, bands or straps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B46/00Surgical drapes
    • A61B46/10Surgical drapes specially adapted for instruments, e.g. microscopes
    • 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
    • A61F2/30721Accessories
    • A61F2/30724Spacers for centering an implant in a bone cavity, e.g. in a cement-receiving cavity
    • 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
    • A61F2/44Joints for the spine, e.g. vertebrae, spinal discs
    • 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
    • A61F2002/30316The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30535Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30563Special structural features of bone or joint prostheses not otherwise provided for having elastic means or damping means, different from springs, e.g. including an elastomeric core or shock absorbers
    • 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
    • A61F2310/00Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00389The prosthesis being coated or covered with a particular material
    • A61F2310/00395Coating or prosthesis-covering structure made of metals or of alloys
    • A61F2310/00407Coating made of titanium or of Ti-based alloys

Abstract

The block (1) comprises a core (4) made of flexible and elastic material which is dimensioned and has elastic properties selected such that it is slightly compressed when the block is positioned between the spinal apophyses (2a,3a) of a pair of adjacent vertebrae (2,3). These properties allow further compression, return to a neutral position, and slight extension, as the spine flexes naturally. Two rigid inserts (5) of wear-resistant material are inset into the upper and lower faces of the core. The inserts have a V-shaped configuration to engage against the surfaces of the vertebral apophyses, and may be secured to the apophyses by associated straps (6). The core is made from silicone and is enclosed in an envelope of e.g. polyester.

Description

La présente invention concerne une cale interépineuse, destinée à amortir les mouvements relatifs de deux vertèbres adjacentes lors des mouvements de flexion ou d'extension du rachis. The present invention relates to an interspinous spacer, for damping the relative movements of two adjacent vertebrae during flexion or extension of the spine.

En cas de dégradation d'un disque inter-vertébral, les vertèbres attenantes à ce disque peuvent jouer l'une par rapport à l'autre selon une amplitude de mouvement supérieure à celle du mouvement anatomique. In case of degradation of an intervertebral disc, the adjacent vertebrae to the disc can play with respect to the other according to a magnitude of movement greater than the anatomical movement. L'involution capsulo-ligamentaire et discale est à l'origine d'un relâchement des éléments de contention vertébrale, notamment des ligaments inter et sur-épineux, et donc de phénomènes d'instabilité élastique, avec réduction de l'écart inter-épineux. The capsular ligament and disk involution is causing a loosening of the vertebral retention elements, in particular ligaments and inter-spinous and therefore phenomena of elastic instability, with reduction of the interspinous gap .

Il en résulte que les épineuses peuvent entrer en contact les unes avec les autres. As a result, the spiny may come into contact with each other. Ces néo-contacts produisent, par phénomène d'hyper-pression, d'importantes contraintes mécaniques, qui sont douloureuses. These New contacts occur, for ultra-high pressure phenomenon, significant mechanical stresses that are painful.

Dans le plan antéro-latéral, c'est-à-dire en zone inter-articulaire postérieure, ces mêmes phénomènes conduisent à un désalignement des vertèbres. In the antero-lateral plane, that is to say subsequent inter-articular area, these phenomena lead to a misalignment of the vertebrae. La pointe de l'articulaire inférieure de la vertèbre sus-jacente va venir au contact de la zone isthmique, produisant une densification osseuse réactionnelle aux phénomènes pathologiques d'hyper-pression mécanique. The tip of the joint bottom of the overlying vertebra will come into contact with the isthmic region, producing a reaction bone densification pathological phenomena mechanical hyper-pressure.

Il existe des dispositifs d'étayage du rachis comprenant des éléments rigides pourvus d'évidements aux dimensions des apophyses épineuses des vertèbres. There are shoring spine devices comprising rigid elements provided with recesses to the dimensions of the spinous processes of the vertebrae. Ces évidements permettent l'engagement de ces éléments rigides sur les apophyses épineuses de plusieurs vertèbres consécutives, et, donc, l'immobilisation relative de ces vertèbres. These recesses allow the engagement of these rigid elements on the spinous processes several consecutive vertebrae, and therefore, the relative immobilization of these vertebrae.

Ces dispositifs présentent l'inconvénient important de rigidifier le rachis, sur une portion relativement étendue de celui-ci, ce qui réduit notablement la mobilité du patient et peut être source de pathologies de part et d'autre de la zone rigidifiée. These devices have the significant drawback to stiffen the spine over a relatively large portion thereof, which considerably reduces the mobility of the patient and can cause pathologies from both sides of the stiffened area. De plus, ces implants sont relativement complexes et impliquent un acte chirurgical lourd. Moreover, these implants are relatively complex and involve a heavy surgery.

Il existe également des cales inter-épineuses destinées à être engagées entre les apophyses épineuses de deux vertèbres consécutives. There are also interspinous spacers for engagement between the spinous processes of two consecutive vertebrae.

Ces cales permettent de limiter les mouvements relatifs de deux vertèbres mais présentent l'inconvénient de ne pas agir de manière parfaitement anatomique, en raison de leur forme ou de leur matériau constitutif. These wedges can limit the relative movements of two vertebrae but have the disadvantage of not acting perfectly anatomically, because of their shape or their constituent material.

En effet, les cales en matériau rigide n'apportent que le maintien d'un écart défini entre les épineuses. Indeed, the shims in rigid material provide only maintaining a gap defined between the spinous.

Elles sont agressives pour les zones d'appui, qui peuvent être lésées. They are aggressive for the support areas that may be affected. De plus, ces cales sont placées juste en arrière du sac dural et risquent, en cas de mouvement accidentel, de venir créer des lésions graves et définitives aux structures nerveuses. In addition, these shims are placed just behind the dural sac and may, in case of accidental movement, to come create serious and permanent damage to the nervous structures.

Les cales en matériau tressé permettent un amortissement relatif, qui est toutefois très difficilement quantifiable et évaluable en termes mécaniques. The wedges woven material allow relative amortization, which is however very difficult to quantify and assessable in mechanical terms. Les matériaux constituant cette cale se dégradent, et finissent par perdre leurs caractéristiques d'amortissement. The materials for this wedge degrade and eventually lose their damping characteristics.

Les cales existantes à éléments amortisseurs mécaniques comprennent des pièces mobiles, susceptibles d'usure et même de rupture sous l'effet des contraintes répétées qu'elles sont amenées à subir. Existing blocks to mechanical damping elements include moving parts subject to wear and break even under the effect of repeated stress they are made to undergo. Elles sont donc extrêmement dangereuses compte-tenu de la région anatomique dans laquelle elles sont implantées. They are extremely dangerous in view of the anatomical region in which they operate.

La présente invention vise à remédier à cet inconvénient, tout en fournissant une cale ayant une résistance importante dans le temps. The present invention aims to overcome this disadvantage, while providing a shim having a high resistance over time. Notamment, cette cale vise à assurer un amortissement progressif des mouvements de deux vertèbres consécutives, à remettre en tension les éléments capsulo-ligamentaires inter-articulaires et à se substituer aux ligaments inter et sur-épineux lors des mouvements de flexion. In particular, this spacer is to ensure a progressive damping of the movements of two consecutive vertebrae, to restore tension inter-articular capsuloligamentous elements and to substitute for ligaments and inter-spinous during flexion.

Elle doit de plus avoir des caractéristiques d'amortissement sensiblement constantes d'une cale à l'autre, en cas de production en série de telles cales. It must also be substantially constant damping characteristics of a wedge to another, in case of mass production of such blocks.

A cette fin, la cale selon l'invention comprend To this end, the wedge according to the invention comprises
- un noyau en matière multidirectionnellement souple et élastique, dont les dimensions et le module d'élasticité sont déterminés, d'une part, de manière telle que ce noyau soit légèrement mis en compression lorsque la cale est placée entre les apophyses épineuses des deux vertèbres concernées et que le rachis est en lordose et, d'autre part, de manière telle qu'il puisse subir une compression supplémentaire en cas d'extension du rachis et retrouver sa forme neutre en cas de flexion du rachis, voire même subir un léger étirement en cas de flexion importante du rachis ; - a core multidirectionally flexible and resilient material, the dimensions and modulus of elasticity are determined, on the one hand, so that this core is slightly placed in compression when the wedge is placed between the spinous processes of two vertebrae concerned and the spine is in lordosis and the other, such that it can undergo further compression in case of extension of the spine and recover its neutral shape when bending the spine, or even suffer a slight stretching in cases of significant bending of the spine; et and
- deux inserts rigides, en matériau résistant aux frottements, rapportés sur les faces supérieures et inférieures du noyau, ces inserts ayant un profil sensiblement en forme de V, prévu pour recevoir les apophyses des deux vertèbres, et comprenant des moyens pour la fixation de la cale aux apophyses. - two rigid inserts, in friction-proof material, based on the upper and lower faces of the core, these inserts having a shape that is substantially V-shaped, for receiving the processes of the two vertebrae, and including means for securing the wedge to the apophyses.

Cette cale, grâce à son noyau élastique, permet d'assurer l'amortissement souple et progressif des mouvements relatifs de deux vertèbres lors de la flexion ou de l'extension du rachis, sans s'opposer aux autres mouvements relatifs des deux vertèbres, par exemple en pivotement de l'une par rapport à l'autre autour d'un axe vertical. This wedge, thanks to its elastic ring ensures flexible and progressive damping relative movements of two vertebrae during flexion or extension of the spine, without opposing the other relative movements of two vertebrae, by example by pivoting relative to each other about a vertical axis.

Elle fournit ainsi un amortissement parfaitement anatomique et confortable pour le patient, à l'inverse de cales existantes rigides ou insuffisamment souples, ou constituées en des matériaux inappropriés. It thus provides a perfect anatomical cushioning and comfortable for the patient, unlike existing rigid spacers or insufficiently flexible or constituted inappropriate materials.

Elle est prévue pour remplir l'espace interépineux alors que les vertèbres concernées sont en légère distraction, de façon à obtenir une distraction de l'articulaire postérieure, pour contrôler les mouvements des vertèbres et éviter les néo-contacts arthrosiques douloureux. It is intended to fill the interspinous space when the vertebrae concerned were slightly distracted, so as to obtain a distraction of the facet joint, to control the movements of the vertebrae and prevent osteoarthritic New contacts painful. Le relâchement de cette distraction, lorsque le patient est remis en lordose, aboutit à une mise en compression de la cale. The release of this distraction, when the patient is put into lordosis, resulting in a compression of the hold. Cette dernière permet ainsi d'assurer un amortissement progressif des mouvements, tout en remettant en tension les éléments capsulo-ligamentaires inter-articulaires et en se substituant aux ligaments inter et sur-épineux lors des mouvements de flexion. The latter allows to ensure a progressive damping of the movements, while switching the voltage capsuloligamentous inter-joint elements and replacing the ligaments and inter-spinous during flexion.

De plus, elle n'est pas insérée dans une chambre articulaire anatomique ni en zone intra-osseuse, et n'est donc pas en contact avec une pièce osseuse synovialisée. In addition, it is not inserted into an anatomic joint chamber or intra-bone area, and is thus not in contact with a bone part synovialized.

Un éventuel déplacement accidentel de la cale n'aurait, dès lors, pas de conséquenses graves pour le patient. A possible accidental movement of the wedge would therefore not serious consequenses for the patient.

Les inserts assurent la transmission au noyau des déplacements des apophyses, tout en protégeant le noyau de l'usure due aux frottements. The inserts ensure the transmission to the core processes of displacement, while protecting core wear due to friction. Ils permettent de plus un montage solide des moyens de fixation de la cale aux apophyses. They enable more secure mounting means for fixing the wedge to processes. En outre, ils constituent des repères permettant de mesurer les distances inter-épineuses et la compression du noyau produite par les différents mouvements du rachis. In addition, they are pins for measuring the interspinous distance and the compression of the core produced by the different movements of the spine.

Il n'y a pas de contacts blessants entre les apophyses et les inserts, grâce à la forme en V des inserts. No hurtful contacts between processes and inserts, thanks to the V-shape inserts.

De préférence, le noyau est en silicone et est placé, pour éviter tout risque de siliconite, dans une enveloppe en matériau approprié, notamment en polyester. Preferably, the core is made of silicone and is placed, to avoid siliconite, in a casing of suitable material, in particular polyester.

Avantageusement, pour l'obtention d'une forme parfaitement anatomique, la cale présente des faces latérales qui convergent l'une vers l'autre en direction de sa face antérieure et de sa face supérieure. Advantageously, for obtaining a perfectly anatomical shape, the wedge has side faces which converge towards each other in the direction of its front face and its upper face. La face antérieure peut avoir une forme concave, pour la même raison. The anterior surface may have a concave shape, for the same reason.

Suivant une forme de réalisation préférée de l'invention, les moyens de fixation de la cale aux apophyses sont constitués par des cavaliers venant s'engager sur les apophyses et se fixer sur les bords libres saillants des inserts. According to a preferred embodiment of the invention, the fastening means of the wedge to the apophyses comprise jumpers which engages on the processes and fixed on the protruding free edges of the inserts. Un montage simple et très résistant est ainsi obtenu. A simple and highly resistant assembly is thus obtained.

De préférence, les inserts et les cavaliers sont réalisés en titane et comprennent des trous pour leur fixation réciproque à l'aide de ligatures en fil chirurgical approprié. Preferably, the inserts and the riders are made of titanium and comprise holes for their reciprocal fastening using ligatures suitable suture.

Pour sa bonne compréhension, l'invention est à nouveau décrite ci-dessous en référence au dessin schématique annexé représentant, à titre d'exemple non limitatif, une forme de réalisation de la cale interépineuse qu'elle concerne. For a good understanding, the invention is again described below with reference to the appended diagrammatic drawing representing, by way of non-limiting example, one embodiment of the interspinous wedge which it relates.

La figure 1 en est une vue en perspective éclatée Figure 1 is an exploded perspective view
la figure 2 est une vue arrière de deux vertèbres consécutives, entre lesquelles cette cale a été mise en place, et Figure 2 is a rear view of two consecutive vertebrae, between which the hold has been established, and
la figure 3 est une vue latérale de ces deux vertèbres, avec coupe longitudinale de la cale. Figure 3 is a side view of two vertebrae, with longitudinal section of the wedge.

Les figures représentent une cale inter-épineuse 1, destinée à amortir les mouvements relatifs de deux vertèbres consécutives 2,3 lors des mouvements de flexion ou d'extension du rachis. The figures show an interspinous wedge 1 for damping the relative movements of two consecutive vertebrae 2.3 during flexion or extension of the spine.

La cale 1 comprend un noyau 4 en silicone, deux inserts 5 en titane et deux cavaliers 6 de fixation, également en titane. The wedge 1 comprises a core 4 made of silicone, two inserts 5 titanium and two riders 6 attachment, also made of titanium.

Le noyau 4 présente des faces latérales 4a qui convergent l'une vers l'autre en direction de sa face antérieure et de sa face supérieure, ainsi qu'une face antérieure 4b de forme légèrement concave. The core 4 has side faces 4a which converge towards one another in the direction of its front face and its upper face and a front face 4b of slightly concave shape.

Les dimensions et le module d'élasticité du noyau 4 sont déterminés de manière telle que ce noyau soit légèrement mis en compression lorsque la cale 1 est placée entre les apophyses épineuses 2a,3a des deux vertèbres 2,3 concernées et que le rachis est en lordose. Dimensions and core modulus of elasticity of 4 are determined such that this ring is slightly placed in compression when the shim 1 is placed between the spinous processes 2a, 3a of the two vertebrae concerned and 2,3 as the spine is lordosis. Ces dimensions et module d'élasticité sont également déterminés de manière telle que le noyau 4 puisse subir une compression supplémentaire en cas d'extension du rachis et retrouver sa forme neutre en cas de flexion du rachis, en subissant même un léger étirement en cas de flexion importante du rachis. These dimensions and modulus of elasticity are also determined so that the core 4 can undergo further compression in the event of extension of the spine and return to its neutral shape in the case of bending of the spine, at the same undergoing a slight stretch in the event of significant bending of the spine.

Les deux inserts 5 ont un profil sensiblement en forme de V leur permettant de recevoir les apophyses 2a,3a des deux vertèbres 2,3. The two inserts 5 have a profile that is substantially V-shaped to enable them to receive the apophyses 2a, 3a of the two vertebrae 2,3. Ils sont rapportés sur les faces supérieures et inférieures du noyau 4, grâce à des tétons 7 en forme de T qu'ils comprennent sur leurs faces opposées aux épineuses 2a,3a, ces tétons 7 étant noyés dans le silicone constituant le noyau 4. They are attached to the upper and lower faces of the core 4, through pins 7 T-shaped that they comprise on their faces opposite to the spinous 2a, 3a, these pins 7 being embedded in the silicone forming the core 4.

Les ailes latérales 5a des inserts 5 font saillie des faces supérieure et inférieure du noyau 4 et comprennent des trous 8, tandis que les extrémités des branches des cavaliers 6 comprennent des trous 9. The side wings 5a inserts 5 protrude from the upper and lower faces of the core 4 and comprises holes 8, while the ends of the legs of jumpers 6 comprise holes 9.

En outre, le noyau 4 est placé dans une enveloppe en matériau approprié, notamment en polyester, pour éviter tout risque de siliconite, cette enveloppe n'ayant pas été représentée au dessin par souci de clarté. Furthermore, the core 4 is placed in an envelope made of suitable material, including polyester, to avoid any risk of siliconite, this casing has not been represented in the drawing for clarity.

Comme le montrent les figures, la cale 1 est destinée à être insérée entre les apophyses épineuses 2a,3a des vertèbres 2,3. As shown in the figures, the spacer 1 is to be inserted between the spinous processes 2a, 3a of the vertebrae 2,3.

Cette cale 1, grâce à son noyau élastique 4, permet d'assurer l'amortissement souple et progressif des mouvements relatifs de deux vertèbres 2,3 lors de la flexion ou de l'extension du rachis, sans s'opposer aux autres mouvements relatifs de ces vertèbres, par exemple en pivotement de l'une par rapport à l'autre autour d'un axe vertical. This wedge 1, thanks to its elastic core 4, ensures the flexible and progressive damping relative movements of two vertebrae 2.3 during flexion or extension of the spine, without opposing the other relative movements of these vertebrae, for example by pivoting relative to each other about a vertical axis.

Elle fournit ainsi un amortissement parfaitement anatomique et confortable pour le patient, à l'inverse de cales existantes rigides ou insuffisamment souples, ou constituées en des matériaux inappropriés. It thus provides a perfect anatomical cushioning and comfortable for the patient, unlike existing rigid spacers or insufficiently flexible or constituted inappropriate materials.

Elle est prévue pour remplir l'espace interépineux alors que les vertèbres concernées sont en légère distraction, de façon à obtenir une distraction de l'articulaire postérieure, permettant de contrôler les mouvements des vertèbres et d'éviter les néo-contacts arthrosiques douloureux. It is intended to fill the interspinous space when the vertebrae concerned were slightly distracted, so as to obtain a distraction of the facet joint, to control the movements of the vertebrae and prevent osteoarthritic New contacts painful. Le relâchement de cette distraction, lorsque le patient est remis en lordose, aboutit à une mise en compression du noyau 4. La cale 1 permet ainsi d'assurer un amortissement progressif des mouvements, tout en remettant en tension les éléments capsulo-ligamentaires inter-articulaires et en se substituant aux ligaments inter et sur-épineux lors des mouvements de flexion. Releasing this distraction when the patient is returned to lordosis, results in a core compressing 4. The wedge 1 thus ensures a progressive damping of the movements, while switching the voltage capsuloligamentous elements inter- joint and replacing the ligaments and inter-spinous during flexion.

Elle est parfaitement anatomique grâce à la forme précitée du noyau 4. De plus, elle n'est pas insérée dans une chambre articulaire anatomique ni en zone intraosseuse, et n'est donc pas en contact avec une pièce osseuse synovialisée. It is perfectly anatomical thanks to the aforementioned shape of the core 4. In addition, it is not inserted into an anatomic joint chamber nor intraosseous region, and is thus not in contact with a bone part synovialized.

Les inserts 5 assurent la transmission au noyau 4 des déplacements des apophyses 2a,3a, tout en protégeant le noyau 4 de l'usure due aux frottements. The inserts 5 ensure the transmission to the core 4 of the displacements of processes 2a, 3a, while protecting the core 4 from wear due to friction. Ils permettent de plus un montage solide des cavaliers 6, les trous 8 et 9 permettant, après mise en place de la cale 1, de fixer les cavaliers 6 aux inserts 5 au moyen de ligatures en fil chirurgical approprié. They allow more secure mounting riders 6, the holes 8 and 9 allowing, after introduction of the wedge 1, setting the jumpers 6 to the inserts 5 by means of ligatures suitable suture.

En outre, les inserts 5 constituent des repères permettant de mesurer les distances inter-épineuses et la compression du noyau 4 produite par les différents mouvements du rachis. In addition, the inserts 5 are pins for measuring the interspinous distance and the compression core 4 produced by the different movements of the spine.

Grâce à l'adaptation de la forme de la cale 1 auxdits mouvements et à la forme en V des inserts 5, il n'y a pas de contacts blessants entre les apophyses 2a,3a et les inserts 5. By adapting the shape of the spacer 1 to said movements and the V-shape of the inserts 5, there is no contact between offensive processes 2a, 3a and the inserts 5.

Claims (6)

    REVENDICATIONS
  1. 1 - Cale inter-épineuse, caractérisée en ce qu'elle comprend 1 - Cale interspinous, characterized in that it comprises
    - un noyau (4) en matière multidirectionnellement souple et élastique, dont les dimensions et le module d'élasticité sont déterminés, d'une part, de manière telle que ce noyau (4) soit légèrement mis en compression lorsque la cale (1) est placée entre les apophyses épineuses (2a,3a) des deux vertèbres (2,3) concernées et que le rachis est en lordose et, d'autre part, de manière telle qu'il puisse subir une compression supplémentaire en cas d'extension du rachis et retrouver sa forme neutre en cas de flexion du rachis, voire même subir un léger étirement en cas de flexion importante du rachis ; - a core (4) multidirectionally flexible and resilient material, the dimensions and modulus of elasticity are determined, on the one hand, so that this core (4) is slightly placed in compression when the shim (1) is placed between the spinous processes (2a, 3a) of the two vertebrae (2,3) concerned and that the spine is in lordosis and, on the other hand, in such a way that it can undergo further compression when extending spine and recover its neutral shape when bending the spine, or even suffer a slight stretch under heavy bending of the spine; et and
    - deux inserts rigides (5), en matériau résistant aux frottements, rapportés sur les faces supérieures et inférieures du noyau (4), ces inserts (5) ayant un profil sensiblement en forme de V, prévu pour recevoir les apophyses (2a,3a) des deux vertèbres (2,3), et comprenant des moyens (6) pour la fixation de la cale (1) aux apophyses. - two rigid inserts (5), friction resistant material, based on the upper and lower faces of the core (4), these inserts (5) having a profile substantially V-shaped, adapted to receive the apophyses (2a, 3a ) of the two vertebrae (2,3), and comprising means (6) for fixing the spacer (1) to the apophyses.
  2. 2 - Cale inter-épineuse selon la revendication 1, caractérisée en ce que le noyau (4) est en silicone et est placé dans une enveloppe en matériau approprié, notamment en polyester. 2 - interspinous spacer according to claim 1, characterized in that the core (4) is made of silicone and is placed in a casing of suitable material, in particular polyester.
  3. 3 - Cale inter-épineuse selon la revendication 1 ou la revendication 2, caractérisée en ce qu'elle présente des faces latérales (4a) qui convergent l'une vers l'autre en direction de sa face antérieure (4b) et de sa face supérieure. 3 - Toe interspinous according to claim 1 or claim 2, characterized in that it has lateral faces (4a) which converge towards each other in the direction of its front side (4b) and its face higher.
  4. 4 - Cale inter-épineuse selon l'une des revendications 1 à 3, caractérisée en ce que sa face antérieure (4b) a une forme concave. 4 - Cale interspinous according to one of claims 1 to 3, characterized in that its anterior face (4b) has a concave shape.
    S - Cale inter-épineuse selon l'une des revendications 1 à 4, caractérisée en ce que ses moyens de fixation aux apophyses (2a,3a) sont constitués par des cavaliers (6) venant s'engager sur les apophyses (2a,3a) et se fixer sur les bords libres saillants des inserts (5). S - Cale interspinous according to one of claims 1 to 4, characterized in that its fixing means to the apophyses (2a, 3a) are formed by clips (6) which engages on the apophyses (2a, 3a ) and set on the protruding free edges of the inserts (5).
  5. 6 - Cale inter-épineuse selon l'une des revendications 1 à 5, caractérisée en ce que les inserts (5) et en ce que ses moyens de fixation aux apophyses (2a,3a) sont réalisés en titane. 6 - Cale interspinous according to one of claims 1 to 5, characterized in that the inserts (5) and in that its fixing means to the apophyses (2a, 3a) are made of titanium.
  6. 7 - Cale inter-épineuse selon la revendication 5 ou la revendication 6, caractérisée en ce que les inserts (5) et les moyens de fixation de la cale aux apophyses comprennent des trous (8,9) pour leur fixation réciproque à l'aide de ligatures en fil chirurgical approprié. 7 - interspinous spacer according to claim 5 or claim 6, characterized in that the inserts (5) and the fixing means of the wedge to the apophyses comprise holes (8,9) for their mutual fixing using ligatures in appropriate surgical thread.
FR9403716A 1994-03-24 1994-03-24 Cale interspinous. Expired - Fee Related FR2717675B1 (en)

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