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 wedge, intended to absorb the relative movements of two adjacent vertebrae during flexion or extension movements 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. 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. In the event of degradation of an inter-vertebral disc, the vertebrae adjoining this disc can act relative to each other according to a range of motion greater than that of the anatomical movement. The capsulo-ligament and disc involution is at the origin of a loosening of the elements of vertebral compression, in particular of the inter- and super-spinous ligaments, and therefore of 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. Ces néo-contacts produisent, par phénomène d'hyper-pression, d'importantes contraintes mécaniques, qui sont douloureuses. As a result, the thorns can come into contact with each other. These neo-contacts produce, by hyper-pressure phenomenon, significant mechanical stresses, which 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. 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. In the anterolateral plane, that is to say in the posterior interarticular zone, these same phenomena lead to a misalignment of the vertebrae. The tip of the lower articular of the overlying vertebra will come into contact with the isthmic area, producing a bone densification reaction to the pathological phenomena of 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. 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. There are devices for shoring up the spine comprising rigid elements provided with recesses the dimensions of the spinous processes of the vertebrae. These recesses allow the engagement of these rigid elements on the spinous processes of 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. De plus, ces implants sont relativement complexes et impliquent un acte chirurgical lourd. These devices have the significant drawback of stiffening the spine, over a relatively large portion of it, which significantly reduces the patient's mobility and can be a source of pathologies on either side of the stiffened area. In addition, these implants are relatively complex and involve a heavy surgical procedure.
Il existe également des cales inter-épineuses destinées à être engagées entre les apophyses épineuses de deux vertèbres consécutives. There are also interspinous wedges intended to be engaged 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 make it possible to limit the relative movements of two vertebrae but have the disadvantage of not acting in a perfectly anatomical manner, because of their shape or of their constituent material.
En effet, les cales en matériau rigide n'apportent que le maintien d'un écart défini entre les épineuses. In fact, the shims made of rigid material only provide the maintenance of a defined gap between the thorns.
Elles sont agressives pour les zones d'appui, qui peuvent être lésées. 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.They are aggressive for the support areas, which can be injured. In addition, these wedges are placed just behind the dural sac and risk, in the event of accidental movement, coming to create serious and permanent lesions to the nerve structures.
Les cales en matériau tressé permettent un amortissement relatif, qui est toutefois très difficilement quantifiable et évaluable en termes mécaniques. Les matériaux constituant cette cale se dégradent, et finissent par perdre leurs caractéristiques d'amortissement. The braided material shims allow relative damping, which is however very difficult to quantify and assess in mechanical terms. The materials constituting this wedge degrade, and end up losing 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. Elles sont donc extrêmement dangereuses compte-tenu de la région anatomique dans laquelle elles sont implantées. Existing holds with mechanical damping elements include moving parts, susceptible to wear and even break under the effect of the repeated stresses which they are brought to undergo. They are therefore extremely dangerous considering the anatomical region in which they are implanted.
La présente invention vise à remédier à cet inconvénient, tout en fournissant une cale ayant une résistance importante dans le temps. 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. The present invention aims to remedy this drawback, while providing a shim having a high resistance over time. In particular, this wedge aims to ensure a progressive damping of the movements of two consecutive vertebrae, to restore tension to the inter-articular capsulo-ligament elements and to replace the inter and super spinous ligaments during flexion movements.
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 have substantially constant damping characteristics from one block to another, in the case of mass production of such blocks.
A cette fin, la cale selon l'invention comprend
- 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 ; et
- 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.To this end, the wedge according to the invention comprises
- a core of multidirectionally flexible and elastic material, the dimensions and modulus of elasticity of which are determined, on the one hand, in such a way that this core is slightly compressed when the wedge is placed between the spinous processes of the two vertebrae concerned and that the spine is in lordosis and, on the other hand, in such a way that it can undergo additional compression in the event of extension of the spine and recover its neutral form in the event of flexion of the spine, or even undergo a slight stretching in case of significant flexion of the spine; and
- two rigid inserts, made of friction-resistant material, attached to the upper and lower faces of the core, these inserts having a substantially V-shaped profile, intended to receive the processes of the two vertebrae, and comprising means for fixing the wedge at 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 core, ensures flexible and progressive damping of the relative movements of two vertebrae during flexion or extension of the spine, without opposing the other relative movements of the two vertebrae, by example in pivoting of one relative to the other around 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 perfectly anatomical and comfortable cushioning for the patient, unlike existing rigid or insufficiently flexible wedges, or made of 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. Le relâchement de cette distraction, lorsque le patient est remis en lordose, aboutit à une mise en compression de la cale. 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. It is intended to fill the interspinous space while the vertebrae concerned are in slight distraction, so as to obtain a distraction of the posterior articular, to control the movements of the vertebrae and avoid painful arthritis neo-contacts. The relaxation of this distraction, when the patient is returned to lordosis, results in compression of the wedge. The latter thus makes it possible to ensure progressive damping of the movements, while restoring tension to the inter-articular capsulo-ligament elements and replacing the inter and super-spinous ligaments during flexion movements.
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 in an anatomical articular chamber or in the intraosseous zone, and is therefore not in contact with a synovialized bony part.
Un éventuel déplacement accidentel de la cale n'aurait, dès lors, pas de conséquenses graves pour le patient.Any accidental displacement of the wedge would therefore not have serious consequences 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. Ils permettent de plus un montage solide des moyens de fixation de la cale aux apophyses. 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. The inserts ensure the transmission to the nucleus of the movements of the processes, while protecting the nucleus from wear due to friction. They also allow a solid mounting of the means of fixing the wedge to the processes. In addition, they constitute benchmarks for measuring the interspinous distances and the compression of the nucleus 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. There is no hurtful contact between the processes and the inserts, thanks to the V-shape of the 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, in order to avoid any risk of siliconite, in an envelope made of an appropriate 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. La face antérieure peut avoir une forme concave, pour la même raison. Advantageously, in order to obtain a perfectly anatomical shape, the wedge has lateral faces which converge towards one another in the direction of its anterior face and its upper face. The front side 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. Un montage simple et très résistant est ainsi obtenu. According to a preferred embodiment of the invention, the means for fixing the wedge to the processes are formed by jumpers coming to engage on the processes and to be fixed on the projecting free edges of the inserts. A simple and very 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 jumpers are made of titanium and include holes for their reciprocal fixing using ligatures made of suitable surgical thread.
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 nonlimiting example, an embodiment of the interspinous wedge which it concerns.
La figure 1 en est une vue en perspective éclatée
la figure 2 est une vue arrière de deux vertèbres consécutives, entre lesquelles cette cale a été mise en place, et
la figure 3 est une vue latérale de ces deux vertèbres, avec coupe longitudinale de la cale.Figure 1 is an exploded perspective view
FIG. 2 is a rear view of two consecutive vertebrae, between which this wedge has been placed, and
Figure 3 is a side view of these 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 represent an interspinous wedge 1, intended to absorb the relative movements of two consecutive vertebrae 2,3 during flexion or extension movements 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 made of titanium and two jumpers 6 for fixing, 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 lateral faces 4a which converge towards one another in the direction of its anterior face and its upper face, as well as an anterior 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. 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. The dimensions and the modulus of elasticity of the core 4 are determined in such a way that this core is slightly put in compression when the wedge 1 is placed between the spinous processes 2a, 3a of the two vertebrae 2.3 concerned and the spine is in lordosis. These dimensions and modulus of elasticity are also determined in such a way that the core 4 can undergo additional compression in the event of extension of the spine and regain its neutral shape in the event of flexion of the spine, even undergoing a slight stretching in the event of significant flexion 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. 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. The two inserts 5 have a substantially V-shaped profile allowing them to receive the processes 2a, 3a of the two vertebrae 2,3. They are attached to the upper and lower faces of the core 4, by means of T-shaped nipples 7 which they comprise on their faces opposite to the thorns 2a, 3a, these nipples 7 being embedded in the silicone constituting 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 lateral wings 5a of the inserts 5 project from the upper and lower faces of the core 4 and include holes 8, while the ends of the branches of the jumpers 6 include 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. In addition, the core 4 is placed in an envelope made of an appropriate material, in particular polyester, to avoid any risk of siliconite, this envelope not having been shown in the drawing for the sake of 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 wedge 1 is intended 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 flexible and progressive damping of the relative movements of two vertebrae 2,3 during flexion or extension of the spine, without opposing other relative movements of these vertebrae, for example in pivoting of one relative to the 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 perfectly anatomical and comfortable cushioning for the patient, unlike existing rigid or insufficiently flexible wedges, or made of 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. 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. It is intended to fill the interspinous space while the vertebrae concerned are in slight distraction, so as to obtain a distraction of the posterior articular, making it possible to control the movements of the vertebrae and to avoid painful arthritis neo-contacts. The relaxation of this distraction, when the patient is put back into lordosis, results in a compression of the nucleus 4. The wedge 1 thus makes it possible to ensure a progressive damping of the movements, while putting back in tension the capsulo-ligament elements inter- articular and by replacing the inter and super-spiny ligaments during flexion movements.
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 nucleus 4. In addition, it is not inserted in an anatomical articular chamber or in the intraosseous zone, and is therefore not in contact with a synovialized bony part.
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. 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. The inserts 5 ensure the transmission to the core 4 of the movements of the processes 2a, 3a, while protecting the core 4 from wear due to friction. They also allow a solid mounting of the jumpers 6, the holes 8 and 9 allowing, after positioning of the wedge 1, to fix the jumpers 6 to the inserts 5 by means of ligatures in suitable surgical wire.
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 constitute benchmarks for measuring the interspinous distances and the compression of the 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. Thanks to the adaptation of the shape of the shim 1 to said movements and to the V shape of the inserts 5, there are no injurious contacts between the processes 2a, 3a and the inserts 5.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| FR9403716AFR2717675B1 (en) | 1994-03-24 | 1994-03-24 | Interspinous wedge. |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| FR9403716AFR2717675B1 (en) | 1994-03-24 | 1994-03-24 | Interspinous wedge. |
| Publication Number | Publication Date |
|---|---|
| FR2717675A1true FR2717675A1 (en) | 1995-09-29 |
| FR2717675B1 FR2717675B1 (en) | 1996-05-03 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| FR9403716AExpired - Fee RelatedFR2717675B1 (en) | 1994-03-24 | 1994-03-24 | Interspinous wedge. |
| Country | Link |
|---|---|
| FR (1) | FR2717675B1 (en) |
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| Date | Code | Title | Description |
|---|---|---|---|
| CL | Concession to grant licences | ||
| CL | Concession to grant licences | ||
| ST | Notification of lapse | Effective date:20081125 |