FR2694882A1 - Intervertebral disk prosthesis. - Google Patents

Intervertebral disk prosthesis. Download PDF

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Publication number
FR2694882A1
FR2694882A1 FR9210232A FR9210232A FR2694882A1 FR 2694882 A1 FR2694882 A1 FR 2694882A1 FR 9210232 A FR9210232 A FR 9210232A FR 9210232 A FR9210232 A FR 9210232A FR 2694882 A1 FR2694882 A1 FR 2694882A1
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FR
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Application
Patent type
Prior art keywords
plates
characterized
prosthesis
prosthesis according
l5
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
FR9210232A
Other languages
French (fr)
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FR2694882B1 (en )
Inventor
Mazda Keyvan
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
FABRICATION MAT ORTHOPEDIQUE
Ste de Fabrication de Material Orthopedique en Abrege Sofamor SNC
Original Assignee
FABRICATION MAT ORTHOPEDIQUE
Ste de Fabrication de Material Orthopedique en Abrege Sofamor SNC
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Filing date
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    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES
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    • A61L27/10Ceramics or glasses
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    • 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
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    • 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
    • A61F2310/00005The prosthesis being constructed from a particular material
    • A61F2310/00011Metals or alloys
    • A61F2310/00023Titanium or titanium-based alloys, e.g. Ti-Ni alloys
    • 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
    • A61F2310/00005The prosthesis being constructed from a particular material
    • A61F2310/00179Ceramics or ceramic-like structures
    • A61F2310/00185Ceramics or ceramic-like structures based on metal oxides
    • A61F2310/00203Ceramics or ceramic-like structures based on metal oxides containing alumina or aluminium oxide
    • 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
    • A61F2310/00005The prosthesis being constructed from a particular material
    • A61F2310/00179Ceramics or ceramic-like structures
    • A61F2310/00185Ceramics or ceramic-like structures based on metal oxides
    • A61F2310/00239Ceramics or ceramic-like structures based on metal oxides containing zirconia or zirconium oxide ZrO2
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES
    • A61L2430/00Materials or treatment for tissue regeneration
    • A61L2430/38Materials or treatment for tissue regeneration for reconstruction of the spine, vertebrae or intervertebral discs

Abstract

Prosthesis comprising two plates (1, 2) secured to the corresponding vertebrae (L4, L5), and a ball joint linking the plates to one another, its centre of rotation (C), in an anterior-posterior plane (OX, OY) being offset rearwards in the posterior part of the plates. The ball joint with reference to a transversal plane (OX, OZ) is located substantially in the middle of the plates, and with reference to a vertical plane (OY, OZ) is located under the plate (1) of the lower vertebra (L5). The prosthesis also includes an elastic intercalary cushioning ring (10) having an opening (10a) for the passage of the joint (3) and being lodged in the space delimited between the plates and around the joint. This positioning of the centre of curvature (C) prevents straining of the articular apophyses during movements of the vertebrae, while the elastic ring (1) matches the prosthesis to the physiological lordosis of the vertebral column, cushioning the multiple stresses occurring during these movements.

Description

La présente invention a pour objet une prothèse The present invention relates to a prosthesis
discale intervertébrale. intervertebral disc.

Comme on le sait, un disque intervertébral se As is known, an intervertebral disc
présente sous la forme d'une lentille biconvexe attachée in the form of a biconvex lens attached
par ses faces aux surfaces articulaires des corps verté by its sides to the articular surfaces of the body Verté
braux. braux. Il est constitué d'une partie périphérique dure It consists of a hard peripheral part
(annulus), formée de lamelles fibreuses concentriques, (Annulus) formed of fibrous concentric lamellae,
et d'une partie centrale (nucleus pulposus), gélatineuse and a core (nucleus pulposus), gelatinous
et molle, constitué de minces faisceaux fibreux séparés par des espaces remplis d'un tissu muqueux. and soft, composed of thin fibrous bundles separated by spaces filled with a mucosal tissue. Un disque A disk
intervertébral est un élément déformable permettant tous Intervertebral is a deformable element enabling all
les mouvements relatifs possibles (6 degrés de liberté) mais qui limite les amplitudes de ces derniers, notamment en torsion, en association avec les ligaments ilz- the possible relative movement (6 degrees of freedom) but which limits the amplitudes of these, especially in torsion, in association with the ligaments ilz-
tervertébraux et les butoirs osseux. tervertébraux and bone bumpers. Le disque intervertébral est une structure viscoélastique d'amortissement, qui participe à la résistance et à la stabilité du rachis verticalisé en état de pesanteur. The intervertebral disc is a viscoelastic damping structure, which contributes to the strength and stability of the spine verticalized in weight status.

Un disque intervertébral peut subir des altérations pour diverses raisons, notamment vieillissement et dégénérescence, pouvant provoquer des hernies discales. A disc can undergo alterations for various reasons, including aging and degeneration, can cause herniated discs.

La dégénérescence discale correspond à une destruction fonctionnelle puis anatomique du disque, qui semble résulter de l'effet des contraintes mécaniques sur un disque aux structures en voie de désorganisation. Disc degeneration is a functional and anatomical destruction of the disc, which seems to result from the effect of mechanical stress on a drive to the disorganization of road structures.

La dégénérescence discale modifie le comportement mécanique du disque et aboutit à une diminution de hauteur de l'espace intersomatique, laquelle entraîne une perturbation de l'ensemble fonctionnel disque--articulaires. Disc degeneration alters the mechanical behavior of the disc and results in a decrease in height of the intersomatic space, which results in a disturbance of the pod drive - joint.

Il en résulte une instabilité susceptible de provoquer des conséquences cliniques gênantes, notamment des lombalgies. This results in instability may cause harmful clinical consequences, including low back pain. Ainsi l'instabilité segmentaire entraîne un fonctionnement anormal des articulaires, induisant une réaction arthrosique, source de douleurs et de processus ostéophytiques. And the segmental instability causes abnormal operation joint, inducing osteoarthritis reaction, a source of pain and osteophytic process.

On a donc proposé de remplacer le disque déficient par un disque artificiel, dont de nombreux types de réalisations ont été envisagés. It is therefore proposed to replace the defective disk with an artificial disk, including many types of projects were considered. Ainsi certaines prothèses comportent des articulations ne supprimant aucun degré de liberté, alors que d'autres au contraire négligent totalement certains mouvements et n'autorisent au maximum qu'un degré de liberté. Thus some prosthetic joints have not removing any degree of freedom, while others overlook the contrary totally certain movements and only allow a maximum degree of freedom. Les auteurs des pre mières prothèses considèrent que le disque artificiel ne doit en aucune manière imposer un mouvement, que la stabilité de l'unité fonctionnelle est assurée par la rétention des freins ligamentaires restants et qu'une articulation non contrainte garantit une liaison os/prothèse durable. The authors of pre Mieres prostheses consider that the artificial disc should not in any way impose a movement, that the stability of the functional unit is provided by the retention of the remaining ligament brakes and an unconstrained articulation ensures bone bonding / prosthesis sustainable.

Les auteurs du second type de prothèse estiment physiologiquement inutiles certains degrés de liberté, et rétablissent un degré de liberté considéré comme essentiel. The authors of the second type of prosthesis feel physiologically useless certain degrees of freedom, and restore a considered essential degree of freedom. Ainsi on connaît une prothèse formant charnière n'autorisant la rotation qu'autour d'un axe transversal. Thus there is known a hinge prosthesis not allowing rotation only around a transverse axis.

Les prothèses articulées peuvent être extrêmement variées et comporter notamment des matériaux présentant une certaine souplesse, ou bien mettre en oeuvre des moyens mécaniques tels que des ressorts The prostheses can be articulated in particular extremely varied and include materials having flexibility, or implement mechanical means such as springs
Toutefois ces réalisations connues ne donnent pas entière satisfaction, par exemple parce que les frottements au niveau de l'articulation restent trop élevés (prothèse décrite dans le brevet FR 2 659 226), ou parce que l'on observe une instabilité de la prothèse en rotation. However these known designs do not entirely satisfactory, for example because the friction at the joint still too high (prosthesis described in FR 2659226), or because the instability of the prosthesis was observed in rotation. De plus, la prothèse décrite dans le brevet précité ne permet qu'une inclinaison et une flexion extension limitée à 10 degrés dans tous les plans, va leur faible en regard de la mobilité naturelle d'une vertèbre. Moreover, the prosthesis described in the aforementioned patent allows only limited tilting and bending extension at 10 degrees in all planes, is low compared to the natural mobility of a vertebra.

Il est encore actuellement relativement difficile de cerner les indications de l'arthroplastie discale, qui est proposée notamment pour le traitement des lombalgies et sciatalgies par instabilité, des lombosciatiques post-dissectomie, et des spondylolisthésis de grade I. It is currently still relatively difficult to identify the signs of disc arthroplasty, proposed especially for the treatment of low back pain and sciatica by instability, post-discectomy sciatica, and spondylolisthesis grade I.

En fait, le but de l'implant constitué par la prothèse discale visée par l'invention est triple a) Etre dimensionné pour pouvoir restaurer une hauteur normale de l'espace intersomatique. In fact, the purpose of the implant consisting of the disc prosthesis intended by the invention is triple a) be dimensioned to be able to restore normal height of the disc space. En effet, la dégénérescence discale, modifiant le comportement mécanique du disque et aboutissant à une diminution de hauteur de l'espace intersomatique, entraîne une perturbation de l'ensemble fonctionnel disque-articulaires. In fact, disc degeneration altering the mechanical behavior of the disc and terminating in a decrease in height of the intersomatic space, causes disruption of functional articular disc together. Cette diminution ide hauteur provoque une surcharge mécanique sur les facettes articulaires, arthrogène et source possible de lombalgie. This height IDE decrease causes mechanical load on the facet joints, and arthrogenic possible source of low back pain. Elle peut entraîner un déplacement vers le haut et en avant de l'articulaire supérieur de la vertèbre inférieure, aboutissant à un rétrécissement du trou de conjugaison, cause possible de sciatalgie. It can displace upwardly and forwardly of the upper joint of the lower vertebra, resulting in a narrowing of the intervertebral foramen, possible cause of sciatica.

b) Autoriser une mobilité physiologique entre les deux vertèbres instrumentées. b) Allow physiological mobility between the two instrumented vertebrae.

L'instabilité peut être consécutive à la dégénérescence discale ou induite par la chirurgie. The instability may be due to disc degeneration or induced by surgery. Les limites entre mobilité normale et anormale ne sont pas encore définies avec précision. The boundaries between normal and abnormal mobility are not yet precisely defined. L'instabilité segmentaire entraîne un fonctionnement anormal des articulaires, induisant comme déjà indiqué une réaction arthrosique. The segmental instability causes abnormal functioning of joints, as already indicated inducing an osteoarthritic reaction.

c) Posséder une stabilité intrinsèque et autoriser un mouvement intersomatique. c) possess an intrinsic stability and allow an intersomatic movement.

L'arthroplastie s'adresse à des cas où jusqu'à présent une arthrodèse est indiquée. Arthroplasty is for cases where far arthrodesis is indicated. Elle peut être une alternative intéressante à cette intervention, non dénuée de conséquences sur les étages adjacents. It can be an interesting alternative to this intervention, not without consequences on adjacent floors. En effet, toutes les arthrodèses lombaires entraînent dans les segments adjacents une augmentation des contraintes et un déplacement des centres de rotation, pouvant conduire à une hypermobilité. Indeed, all lumbar arthrodesis result in adjacent segments increased stress and a displacement of the centers of rotation, which may lead to hypermobility.

Le suivi à long terme des zones adjacentes aux arthrodèses montre un pincement discal constant à partir de la quinzième année, et surtout un glissement ou un déplacement angulaire dont la fréquence augmente avec le recul. The long term monitoring of areas adjacent to arthrodesis shows a constant disc space narrowing from the fifteenth year, especially slipping or angular displacement whose frequency increases with the decrease. On peut aussi observer une arthrose importante, une hernie discale ou une spondylolyse acquise de cette néocharnière. significant osteoarthritis can also be observed, a herniated disc or spondylolysis acquired this néocharnière.

La prothèse discale visée par l'invention comprend deux plaques équipées de moyens de fixation aux vertèbres correspondantes, ainsi qu'un dispositif d'articulation des plaques l'une sur l'autre. The disc prosthesis covered by the invention comprises two plates equipped with fastening means to corresponding vertebrae, and a plate of the articulation device on each other.

Conformément à l'invention, le dispositif d'articulation est une rotule dont le centre de rotation, dans un plan antéro-postérieur est décalé vers l'arrière dans la partie postérieure des plaques et du corps vertébral, dans un plan transversal est situé sensiblement au milieu des plaques et du corps vertébral, et dans un plan vertical est situé juste sous la plaque de la vertèbre inférieure ; According to the invention, the articulation device is a ball whose center of rotation, in an anteroposterior plane is shifted rearward in the posterior part of the plates and of the vertebral body in a transverse plane is situated substantially the middle plates and the vertebral body, and in a vertical plane is located just under the plate of the lower vertebra; cette prothèse comporte de plus un anneau intercalaire d'amortissement, réalisé en une matière souple, percé d'une ouverture de passage de la rotule et dimensionné pour se loger dans l'espace délimité entre les plaques et autour de la rotule en épou sant sensiblement le contour des plaques. the prosthesis further comprises an intermediate ring damper, made of a flexible material, pierced with a passage opening for the patella and dimensioned to fit within the space defined between the plates and around the kneecap in sant substantially SPOUSE the contour of the plates.

Le positionnement du centre de courbure de la rotule tel que défini selon l'invention présente l'avantage d'éviter de contraindre les apophyses articulaires, comme dans les vertèbres naturelles, ce qui n'avait pas été jusqu'à présent obtenu avec les prothèses connues. The positioning of the center of curvature of the ball joint as defined in the invention has the advantage of avoiding forcing articular processes, as in the natural vertebrae, which had not been so far obtained with the prostheses known.

De plus la prothèse selon l'invention possède tout à la fois la résistance mécanique nécessaire et des frottements réduits au niveau de l'articulation, grâce au dimensionnement approprié du système à rotule. In addition the prosthesis of the invention has at the same time the necessary mechanical strength and friction reduced at the joint by suitable dimensioning of the spherical system. En effet le centre de rotation n'est ni trop éloigné de l'articulation, ni trop proche de celle-ci, et permet ainsi de reproduire une mobilité proche de la mobilité naturelle. Indeed the center of rotation is not too far away from the joint, or too close to it, and so can reproduce a mobility close to the natural mobility.

D'autres particularités et avantages de l'invention apparaîtront au cours de la description qui va suivre, faite en référence aux dessins annexés qui en illustrent une forme de réalisation à titre d'exemple non limitatif. Other features and advantages of the invention appear from the following description with reference to the accompanying drawings which illustrate an embodiment by way of example.

La figure I est une vue en perspective éclatée d'une paire de vertèbres équipées des éléments constitutifs d'une prothèse discale selon une forme de réalisation de l'invention. Figure I is an exploded perspective view of a pair of vertebrae equipped with the constituent elements of a disc prosthesis according to an embodiment of the invention.

La figure 2 est une vue de dessus de la plaque inférieure de la prothèse discale de la Fig.l Figure 2 is a top view of the bottom plate of the disc prosthesis of the fig.l
La figure 3 est une vue en coupe longitudinale suivant 3/3 de la Figea de la prothèse selon l'invention dans une position où les deux plaques sont parallèles. Figure 3 is a longitudinal sectional view of the 3/3 froze of the prosthesis according to the invention in a position where the two plates are parallel.

La figure 4 est une vue en élévation de la prothèse des Fig.l à 3 dans une position où les deux plaques sont inclinées l'une par rapport à l'autre. Figure 4 is an elevational view of the prosthesis of fig.l 3 viewed in a position where the two plates are inclined relative to each other.

On voit à la Fiv.1 deux vertèbres adjacentes, par exemple les vertèbres lombaires L5 et L4, pouvant être reliées par une prothèse discale. There is shown in Fiv.1 two adjacent vertebrae, for example the lumbar vertebrae L5 and L4, which may be connected by a disc prosthesis. Cette prothèse comprend deux plaques 1 et 2, fixées respectivement à la vertèbre inférieure L5 et à la vertèbre supérieure L4, une articulation à rotule 3 des deux plaques 1 et 3 l'une sur l'autre, et un anneau souple 10 d'amortissement intercalé entre les deux plaques 1 et 2 et traversé par la rotule 3. This prosthesis comprises two plates 1 and 2 respectively secured to the lower vertebra L5 and to the upper vertebra L4, a ball joint 3 of the two plates 1 and 3 one over the other, and a flexible ring 10 of damping interposed between the two plates 1 and 2 and traversed by the ball joint 3.

Les plaques 1, 2 sont similaires, ont des dimensions sensiblement égales à celles des vertèbres L5, L4 The plates 1, 2 are similar, have substantially equal dimensions to those of the vertebrae L5, L4
(ces vertèbres pouvant être situées à d'autres étages que L5-L4, y compris des étages non lombaires) et épousent approximativement le contour des surfaces articulaires associées. (These vertebrae can be located at other floors that L5-L4, including non lumbar levels) and approximately espouse the contour of the articular surfaces associated. Chaque plaque 1, 2 présente ainsi un bord curviligne 4, sensiblement elliptique, et un bord rectiligne 5 reliant les deux extrémités tronquées de l'ellipse 4. D'autre part chaque plaque 1, 2 est percée, dans sa partie centrale, d'un trou traversant 6 dans lequel est insérée une pastille 7, 8 respective, ayant un corps dimensionné pour pouvoir s'engager dans le trou 6 correspondant.Ce dernier peut être avantageusement conique, de même que les bases complémentaires des pastilles 7, 8, qui peuvent ainsi être solidarisées de manière amovible avec les plaques ou plateaux correspondant 1, 2 Each plate 1, 2 thus has a curvilinear edge 4, substantially elliptical, and a straight edge 5 which connects the two truncated ends of the ellipse 4. Furthermore each plate 1, 2 is pierced in its central part, of a through hole 6 into which is inserted a pellet 7, respective 8 having a body sized to be able to engage in the hole 6 correspondant.Ce latter may advantageously be conical, as well as the complementary bases of the pellets 7, 8, which can thus be fastened detachably to the corresponding sheets or plates 1, 2
Les pastilles 7, 8 constituent ensemble l'articulation 3 à rotule. The pellets 7, 8 constitute together the joint ball 3. La première pastille 7, insérer dans la plaque inférieure 1, présente une surface sphérique convexe 9, située en saillie par rapport à la face correspondante de la plaque 1, tandis que sa surface opposée 11, plane, affleure la face opposée, tournée vers l'extérieur de la plaque 1. La pastille 8 de la plaque supérieure 2 fait également saillie de sa face tournée vers la plaque 1, et présente une surface sphé rique concave 12. Le rayon de courbure de cette dernière est égal à celui (r) de la surface sphérique 9, afin de pouvoir glisser sur celle-ci en formant une articulation à rotule.La face opposée 13 de la pastille 8 est plane et affleure la face extérieure de la plaque 2. The first wafer 7 inserted in the bottom plate 1 has a convex spherical surface 9 situated projecting with respect to the corresponding face of the plate 1, while its opposite surface 11, flat, flush with the opposite side facing the outside the plate 1. the chip 8 of the upper plate 2 also protrudes from its side facing the plate 1, and has a concave America SPHE surface 12. the radius of curvature thereof is equal to that (r) of the spherical surface 9, to slide thereon, forming a joint rotule.La opposite face 13 of the chip 8 is planar and flush with the outer face of the plate 2.

Le centre de courbure ou de rotation C de la rotule 3, distant des surfaces 9 et 12 du rayon de courbure r, est localisé de la manière suivante The center of curvature or rotation C of the ball 3, 9 and remote surfaces 12 of radius of curvature r, and is located as follows
- ce centre C est, dans un plan antéro-postérieur (OX, OY), décalé vers l'arrière dans la partie postérieure des plaques 1, 2 et des corps vertébraux; - C is the center in an anteroposterior plane (OX, OY), offset towards the rear in the rear part of the plates 1, 2 and of the vertebral bodies;
- dans un plan transversal (OX, OZ), le centre de rotation C est situé sensiblement au milieu des plaques 1, 2 et des corps vertébraux; - in a transverse plane (OX, OZ), the center of rotation C is substantially located in the middle of the plates 1, 2 and of the vertebral bodies;
- et dans un plan vertical (OY, OZ), le centre C est situé juste sous la plaque 1 recouvrant la face supérieure de la vertèbre inférieure, par exemple L5 dans l'exemple illustré à la Fig.1. - and in a vertical plane (OY, OZ), the center C is located just under the plate 1 covering the upper face of the lower vertebra, for example L5 in the example illustrated in Fig.1.

Ce positionnement du centre C correspond à un rayon de courbure r compris approximativement entre la hauteur de la prothèse quand les plaques 1, 2 sont parallèles, et la moitié de cette hauteur. This positioning of the center C corresponds to a radius of curvature r between approximately the height of the prosthesis when the plates 1, 2 are parallel, and half of this height.

La prothèse comporte de plus un anneau intercalaire d'amortissement 10, réalisé en une matière souple appropriée, percé d'une ouverture 10a de passage de la rotule 3. L'anneau souple 10 est dimensionné pour pouvoir être logé dans l'espace intercalaire délimité entre les plaques 1, 2 et autour de la rotule 3, en épousant sensiblement le contour des plaques. The prosthesis further comprises an intermediate damping ring 10, made of a suitable flexible material, pierced with a passage 10a of the ball opening 3. The flexible ring 10 is dimensioned to be accommodated in the enclosed interspace between the plates 1, 2 and around the ball joint 3, substantially matching the contour of the plates.

A l'état libre non comprimé (fiv.1), l'anneau souple 10 a une épaisseur variable de sa partie antérieure à sa partie postérieure. A uncompressed free state (fiv.1), the elastic ring 10 has a variable thickness in its front part to its rear part. Sa partie antérieure a une épaisseur maximum H, qui décroît régulièrement, de part et d'autre du centre du bord de cette partie antérieure, jusqu'à la partie postérieure de l'anneau 10, dont l'épaisseur h est ainsi nettement inférieure à H. Its anterior part has a maximum thickness H, which decreases gradually, on either side of the center of the edge of the anterior portion to the posterior portion of the ring 10, whose thickness h is thus significantly lower H.

L'anneau 10 se présente donc sous la forme d'une- pièce asymétrique dont les faces opposées sont inclinées l'une par rapport à l'autre, en se rapprochant vers la partie antérieure The ring 10 is thus in the form of asymmetric UNE piece whose opposite faces are inclined with respect to each other, by moving towards the anterior portion
Chaque plaque 1, 2 comporte, sur sa face de laquelle fait saillie la pastille correspondante 7, 8, une surépaisseur annulaire centrale 14, 15. Cette dernière est contiguë à la pastille associée 7, 8 qu'elle entoure en formant un renfort, venu de matière avec le reste de la plaque De préférence, comme représenté, les renforts 14 et 15 ont une surface conique, dont l'épaisseur décroît à partir de la pastille 7, 8. Each plate 1, 2 has, on its face from which protrudes the corresponding pad 7, 8, a central annular extra thickness 14, 15. This latter is contiguous with the associated pad 7, 8 it surrounds to form a reinforcement come integral with the rest of the plate preferably, as shown, the reinforcements 14 and 15 have a conical surface, the thickness of which decreases from the wafer 7, 8.

Dans chaque plaque 1, 2 sont ménagés un ensemble de trous 16, convenablement répartis le long des bords de la plaque. In each plate 1, 2 are formed a plurality of holes 16 suitably distributed along the edges of the plate. Ces trous 16 sont agencés pour recevoir des picots 17, fixés dans la plaque 1, 2 par tout moyen convenable, tel que vissage de leur base cylindrique 17a. These holes 16 are arranged to receive pins 17 fixed in the plate 1, 2 by any suitable means such as screwing their cylindrical base 17a. Leurs pointes 17b, impactées dans l'os sous-cho- dral des plateaux vertébraux, assurent la fixation des plaques 1, 2 aux vertèbres telles que L5 L4, L5. Their tips 17b, impacted into the bone sub-cho- DraI endplates, assure the fixing of the plates 1, 2 to the vertebrae such as L5 L4, L5.

Les pastilles 7, 8 formant l'articulation en rotule 3 sont de faibles dimensions par rapport à celles des plaques 1, 2, et sont de manière générale choisies en un matériau présentant les meilleures caractéristiques tribologiques possibles (caractéristiques mécaniques : statiques, dynamiques et résistance à I'usure), et bien entendu biostable. The pellets 7, 8 forming the ball joint articulation 3 are of small dimensions compared to those of the plates 1, 2, and are generally selected of a material having the best possible tribological characteristics (mechanical properties: static, dynamic and resistance to the wear), and of course biostable. Leur coefficient de frottement doit être faible et leur durée de vie, ainsi que celle des plaques 1, 2, très élevée (par exemple 40 ans). Their coefficient of friction should be low and their life and that of the plates 1, 2, very high (eg 40 years).

Ces pastilles 7, 8 peuvent être réalisées en un matériau approprié tel qu'une céramique notamment un oxyde fritté tel qu'alumine ou zircone, une pierre de synthèse, un alliage métallique avec traitement de surface (dépôt de diamant etc) These pellets 7, 8 may be made of a suitable material such as in particular a sintered ceramic oxide such as alumina or zirconia, a synthetic stone, metal alloy with surface treatment (diamond deposition etc.)
L'anneau souple 10 d'amortissement est avantageusement constitué en un élastomère, notamment un silicone de dureté shore A. The flexible ring 10 of damping is advantageously made of an elastomer, in particular a hardness of silicone shore A.

Les plateaux 1, 2 sont prévus en nombre standard, adaptés à tous les morphotypes possibles des corps vertébraux. The plates 1, 2 are provided in standard number, suitable for all possible morphotypes of vertebral bodies. Les rotules 3 sont par contre en nombre supérieur, adaptées à la morphologie de chaque individu et de chaque étage vertébral. The bearings 3 are against greater in number, adapted to the morphology of each individual and each vertebral level. On peut ainsi réaliser une gamme de pièces (plaques 1, 2, rotules 3, anneaux souples 10) adaptées à toutes les hauteurs discales des patients et permettant des combinaisons en nombre infini, adaptées à chaque cas particulier. It is thus possible a range of parts (plates 1, 2, ball 3, the elastic rings 10) suitable for all patients and disc heights allowing combinations infinite in number, adapted to each particular case.

Outre les avantages techniques déjà mentionnés, la prothèse discale selon l'invention présente les avantages suivants Besides the technical advantages already mentioned, the disc prosthesis according to the invention has the following advantages
Grâce au dimensionnement approprié de la rotule 3 et à la position de son centre d'articulation C, définis ci-dessus, les surfaces en frottement sont réduites et le frottement provoqué par le basculement des plaques 1, 2 l'une par rapport à l'autre (Fig.4) reste faible. By appropriate dimensioning of the ball 3 and the position of its center of rotation C, defined above, the rubbing surfaces are reduced and the friction caused by the tilting of the plates 1, 2 with respect to the other (Fig.4) remains low.

Il en résulte une usure réduite des pastilles 7, 8. Par ailleurs les surfaces 9, 12 de l'articulation ont cependant un rayon de courbure suffisant pour ne pas centrale ner une instabilité excessive de la prothèse, tout en lui assurant une mobilité tridimensionnelle convenable, pratiquement identique à celle des vertèbres naturelles This results in reduced wear of the pads 7, 8. Furthermore, the surfaces 9, 12 of the articulation, however, have a sufficient radius of curvature not central ner excessive instability of the prosthesis, while providing a suitable three-dimensional mobility virtually identical to that of natural vertebrae
Durant les mouvements tridimensionnels des plaques 1, 2 et des vertèbre correspondantes, l'anneau souple 10 assure une fonction d'amortissement des contraintes multiples qui limite les mouvements, les faces opposées de l'anneau 10 restant toujours en contact avec les faces correspondantes des plaques 1.La variation de la hauteur, ou de l'épaisseur de l'anneau 10 de l'avant vers l'arrière présente l'avantage de l'adapter à la lordose physiologique du rachis lombaire Le rapport Hfh s adapte ainsi à la statique rachidienne de profil, en fonction de l'étage discal concerné. During the three-dimensional movements of the plates 1, 2 and the corresponding vertebra, the elastic ring 10 provides a damping function of the multiple constraints that limit the movements, the opposite faces of the ring 10 remains always in contact with the corresponding faces of plates 1.La variation of the height, or thickness of the ring 10 of the front to back has the advantage of adapting to the physiological lordosis of the lumbar spine the report HFH s well suits the static spinal profile, depending on the disc floor concerned. L'inclinaison des faces de l'anneau 10 l'une sur l'autre peut varier en fonction de l'étage et de la morphologie du patient. The inclination of the ring 10 faces to each other may vary depending on the floor and of the morphology of the patient. A titre d'exemple elle peut atteindre 150 en L5/S1. For example it can reach 150 L5 / S1.

Il convient par ailleurs d'observer que le fait que l'épaisseur de la partie antérieure de l'anneau 10 soit supérieure à celle de sa partie postérieure permet une mise en jeu plus précoce du matériau souple constitutif de cet anneau. It should also be noted that the fact that the thickness of the anterior portion of the ring 10 is greater than that of its rear part enables earlier game layout of the constituent flexible material of this ring. Ceci entraîne donc la production d'un effet amortisseur dès l'apparition d'un mouvement des corps vertébraux associés à la prothèse. This therefore results in the production of a damping effect upon the occurrence of a movement of the vertebral bodies associated with the prosthesis. D'autre part, le choix convenable d'un matériau souple pour l'anneau 10, permet l'obtention d'une raideur optimale pour reproduire les pentes des rotations d'un disque sain dans les diverses sollicitations. Moreover, the appropriate choice of a flexible material for the ring 10, allows obtaining an optimum stiffness to reproduce the slopes of rotations of a healthy disk in the various stresses. Finalement, la prothèse selon l'invention permet d'obtenir une raideur et un amortissement très proches ou même identiques à ceux d'un disque naturel. Finally, the prosthesis according to the invention provides stiffness and a very close or even identical to those sinking of a natural disc.

La mise en place par le chirurgien de la prothèse qui vient d'être décrite se fait que la manière suivante. The establishment by the surgeon for the prosthesis which has just been described is as follows.

Tout d'abord le chirurgien place sur la vertèbre inférieure, par exemple L5, la plaque correspondante I, la centre convenablement par rapport au corps vertébral, et la fixe par enfoncement des picots 17 dans la vertè bre. Firstly the surgeon places on the lower vertebra L5 for example, the corresponding plate I, suitably the center relative to the vertebral body, and fixed by pressing the pins 17 in the green fiber.

Ensuite le chirurgien met en place sur la vertèbre supérieure, par exemple L4, la plaque supérieure 2, en la positionnant convenablement par rapport à la plaque inférieure 1. Then the surgeon places on the upper vertebra, for example L4, the upper plate 2, by appropriately positioning the relative to the bottom plate 1.

Le chirurgien dispose ensuite entre les plaques 1, 2 un "sandwich" composite constitué par l'assemblage de l'anneau souple 10 et de la rotule 3, formée par les pastilles 7, 8. Il place cet assemblage dans la zone centrale entre les plaques 1, 2, avec les pastilles 7, 8 en regard des trous coniques 6, puis relâche la distraction imposée jusque là aux corps vertébraux recevant les plaques 1, 2. Il en résulte une impaction qui provoque l'entrée des bases coniques des pastilles 7, 8 dans les trous 6, et leur solidarisation à force avec les plaques 1, 2. The surgeon then placed between the plates 1, 2 a "sandwich" composite formed by the assembly of the elastic ring 10 and the ball joint 3, formed by the pads 7, 8. It places this assembly into the central zone between the plates 1, 2, with the pellets 7, 8 opposite conical holes 6, and then releases the previously imposed distraction to the vertebral bodies receiving the plates 1, 2. This results in impaction which causes entry conical bases pellets 7, 8 in the holes 6, and securing force with the plates 1, 2.

Les valeurs des amplitudes angulaires des mouvements possibles avec la prothèse selon l'invention sont proches des amplitudes ci-dessous d'un disque sain The values ​​of the angular amplitudes of movements possible with the prosthesis according to the invention are close to the amplitudes below a healthy disc
L4/L5 L5/S1 - Flexion/extension 240 180 - Inclinaison 140 < 140 - Rotation axiale 40 40 L4 / L5 L5 / S1 - Flexion / extension 240 180 - Tilt 140 <140 - 40 40 Axis of rotation
La prothèse selon l'invention garantit par sa solidité la restauration de l'espace intersomatique de hauteur H, tout en présentant une stabilité intrinsèque, c est-à-dire n'autorisant pas une mobilité non physiologique, surtout en translation. The prosthesis according to the invention guarantees sturdiness by the restoration of disc space height H, while exhibiting intrinsic stability, that is to say not allowing non-physiological mobility, especially in translation.

Les matériaux susceptibles d'être utilisés pour la constitution de la prothèse sont bien entendu biocompatibles et doivent être biologiquement neutres, c'est à-dire non toxiques, insensibles à la corrosion. The materials that may be used for the incorporation of the prosthesis are biocompatible and must of course be biologically neutral, that is to say non-toxic, insensitive to corrosion. De plus ils ne doivent pas être pro-inflammatoires > leurs qualités mécaniques et biologiques ne devant pas être altérées par le mode de stérilisation choisi. In addition they must not be pro-inflammatory> mechanical and biological qualities that should not be altered by the sterilization method chosen. A titre d'exemple les plaques 1, 2 peuvent être en acier inoxydable, stelliteftitane ou alliage de titane. For example the plates 1, 2 can be stainless steel, or titanium alloy stelliteftitane.

L'alliage de titane présente l'avantage de posséder des caractéristiques radiologiques et magnétiques avantageuses pour le suivi iconographique de la pathologie rachidienne, ainsi qu'une excellente biotolérance et des caractéristiques mécaniques élevées. The present titanium alloy the advantage of possessing advantage radiological and magnetic characteristics for Pictures monitoring spinal pathology, as well as excellent bio-tolerance and high mechanical characteristics.

Bien entendu l'invention est susceptible de diverses variantes d'exécution. Naturally, the invention is susceptible of various alternative embodiments. Ainsi les picots 17 de fixation aux vertèbres peuvent être remplacés par tous autres éléments équivalents, tels que vis, plots... En revanche la fixation par ciment (méthylméthacrylate) n est pas envisageable, compte tenu de la proximité des éléments nerveux et du dégagement de chaleur lors de la polymérisation. Thus the pins 17 for attachment to the vertebrae can be replaced by any other equivalent elements, such as screws, pins ... But fixing by cement (methyl methacrylate) is not feasible, given the proximity of neural elements and clearance heat during polymerization. Le nombre et l'emplacement des trous filetés 16 recevant les picots coniques 17 peut varier. The number and location of the threaded holes 16 receiving the tapered pins 17 can vary.

Pour des étages non lombaires, l'anneau souple 10 peut ne pas présenter l'asymétrie décrite et donc avoir une épaisseur uniforme For non lumbar levels, the flexible ring 10 may not exhibit the asymmetry described and thus have a uniform thickness
Il convient d'observer que la prothèse discale selon l'invention ne comporte pas de pièce libre, contrairement à certaines prothèses discales connues. It should be noted that the disc prosthesis according to the invention does not include a free room, unlike some known disc prostheses. Ceci présente l'avantage d'éliminer tout risque d'éjection d'une telle pièce libre contre l'aorte ou vers le canal rachidien This has the advantage of eliminating any risk of ejection of such a free play against the aorta or to the spinal canal

Claims (10)

    REVENDICATIONS
  1. 1. Prothèse discale intervertébrale, comprenant deux plaques (1, 2) équipées de moyens de fixation aux vertèbres correspondantes (L4, L5), et un dispositif (7, 8) d'articulation des plaques l'une sur l'autre, caractérisée en ce que le dispositif d'articulation est une rotule (3) dont le centre de rotation (C), dans un plan antéro-postérieur (OX, OY) est décalé vers l'arrière dans la partie postérieure des plaques et du corps vertébral, dans un plan transversal (OX, OZ) est situé sensiblement au milieu des plaques et du corps vertébral, et dans un plan vertical (OY,OZ) est situé juste sous la plaque (1) de la vertèbre inférieure (L5), et en ce que cette prothèse comporte de plus un anneau intercalaire d'amortissement (10), réalisé en une matière souple, percé d'une ouverture (10a) de passage de la rotule (3) et dimensionné pour se loger dans l'espace délimité entre les plaques et autour de la rotule en épousant sensiblement le contour des plaques. 1. intervertebral disk prosthesis comprising two plates (1, 2) equipped with fixing means to the corresponding vertebrae (L4, L5), and a device (7, 8) of articulation of the plates on each other, characterized in that the articulation device is a ball (3) whose center of rotation (C), in an anteroposterior plane (OX, OY) is offset rearward in the posterior part of the plates of the vertebral body and in a transverse plane (OX, OZ) is located substantially in the middle of the plates and the vertebral body, and in a vertical plane (OY, OZ) is located just under the plate (1) of the lower vertebra (L5), and in that said prosthesis further comprises an intermediate damping ring (10) made of flexible material, having an opening (10a) for passage of the ball (3) and dimensioned to fit within the delimited space between the plates and around the kneecap substantially matching the contour of the plates.
  2. 2. Prothèse selon la revendication 1, caractérisée en ce que l'articulation à rotule (3) est constituée par une première pastille (7) à surface sphérique convexe (9) et une seconde pastille (8) à surface sphérique concave (12) recevant la surface sphérique convexe, ces deux surfaces sphériques ayant le même rayon de courbure (r) et les pastilles étant solidaires des parties centrales des plaques respectives (1, 2), sur les faces en vis-à-vis desquelles elles font saillie. 2. A prosthesis according to claim 1, characterized in that the ball joint (3) is constituted by a first pad (7) with a convex spherical surface (9) and a second wafer (8) with a concave spherical surface (12) receiving the convex spherical surface, two spherical surfaces having the same radius of curvature (r) and the pads being secured to the central portions of the respective plates (1, 2) on the faces vis-à-vis which they protrude.
  3. 3. Prothèse selon la revendication 2, caractérisée en ce que chaque plaque (1, 2) comporte, sur la face de laquelle fait saillie la pastille (7, 8), une surépaisseur annulaire centrale (14, 15), contiguë à la pastille qu'elle entoure en formant renfort 3. A prosthesis according to claim 2, characterized in that each plate (1, 2) comprises, on the face from which protrudes the pad (7, 8), a central annular thickened portion (14, 15) adjoining the wafer it surrounds by forming reinforcement
  4. 4. Prothèse selon la revendication 3, caractérisée en ce que le renfort (14, 15) a une surface conique, dont l'épaisseur décroît à partir de la pastille (7, 8). 4. Prosthesis according to claim 3, characterized in that the reinforcement (14, 15) has a conical surface, the thickness of which decreases from the wafer (7, 8).
  5. 5. Prothèse selon l'une des revendications 2 à 4, caractérisée en ce que les pastilles (7, 8) ont une base conique adaptée à des trous coniques conjugués ménagés dans les plaques (1, 2). 5. A prosthesis according to one of Claims 2 to 4, characterized in that the wafers (7, 8) have a conical base adapted to conjugates conical holes in the plates (1, 2).
  6. 6. Prothèse selon l'une des revendications 1 à 5, caractérisée en ce que les moyens de fixation des plaques (1, 2) aux vertèbres (L5, L4) comprennent des picots coniques (17) vissés dans des trous (16) formés dans les plaques et convenablement répartis sur cellesci. 6. A prosthesis according to one of claims 1 to 5, characterized in that the plate fastening means (1, 2) to the vertebrae (L5, L4) comprise conical pins (17) screwed in holes (16) formed in the plates and suitably distributed on cellesci.
  7. 7. Prothèse selon l'une des revendications 1 à 6, caractérisée en ce que les plaques ont des dimensions identiques et sensiblement égales à celles d'une vertèbre, notamment lombaire 7. A prosthesis according to one of claims 1 to 6, characterized in that the plates have identical dimensions and substantially equal to those of a vertebra, in particular lumbar
  8. 8. Prothèse selon l'une des revendications 1 à 7, caractérisée en ce que l'anneau souple (10) d'amortissement a une partie antérieure d'épaisseur maximum (H), supérieure à celle (h) de sa partie postérieure, ladite épaisseur (H) décroissant régulièrement du centre du bord de la partie antérieure à la partie postérieure, et les faces opposées de l'anneau (10), à l'état non comprimé, sont corrélativement inclinées l'une par rapport à l'autre. 8. A prosthesis according to one of claims 1 to 7, characterized in that the elastic ring (10) damping has an anterior portion of maximum thickness (H) greater than that (h) of its rear part, said thickness (H) decreases regularly from the center to the edge of the anterior portion to the posterior portion, and the ring of opposed faces (10) in an uncompressed state, are correspondingly inclined relative to the other.
  9. 9 Prothèse selon l'une des revendications 1 à 8, caractérisée en ce que les pastilles (7, 8) de la rotule (3) sont réalisées en l'un des matériaux suivants: céramique notamment oxyde fritté tel qu'alumine ou zircone, pierre de synthèse, alliage métallique avec traitement de surface. 9 A prosthesis according to one of claims 1 to 8, characterized in that the wafers (7, 8) of the ball (3) are made in one of the following materials: sintered ceramics including oxide such as alumina or zirconia, synthetic stone, metal alloy with surface treatment.
  10. 10 Prothèse selon l'une des revendications 1 à 9, caractérisée en ce que l'anneau souple (10) est en élastomère, notamment un silicone de dureté shore A. 10 A prosthesis according to one of claims 1 to 9, characterized in that the elastic ring (10) is made of elastomer, in particular a hardness of silicone shore A.
FR9210232A 1992-08-24 1992-08-24 Intervertebral disk prosthesis. Expired - Fee Related FR2694882B1 (en)

Priority Applications (1)

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FR9210232A FR2694882B1 (en) 1992-08-24 1992-08-24 Intervertebral disk prosthesis.

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FR9210232A FR2694882B1 (en) 1992-08-24 1992-08-24 Intervertebral disk prosthesis.
CN 93118231 CN1090485A (en) 1992-08-24 1993-08-24 Intervertebral disc prosthesis
PCT/FR1993/000825 WO1994004100A1 (en) 1992-08-24 1993-08-24 Intervertebral disk prosthesis

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FR2694882B1 FR2694882B1 (en) 1994-10-21

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FR (1) FR2694882B1 (en)
WO (1) WO1994004100A1 (en)

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FR2694882B1 (en) 1994-10-21 grant
WO1994004100A1 (en) 1994-03-03 application

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