WO2001062190A1 - Intervertebral implant with rigid body and support surfaces - Google Patents

Intervertebral implant with rigid body and support surfaces Download PDF

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Publication number
WO2001062190A1
WO2001062190A1 PCT/FR2001/000515 FR0100515W WO0162190A1 WO 2001062190 A1 WO2001062190 A1 WO 2001062190A1 FR 0100515 W FR0100515 W FR 0100515W WO 0162190 A1 WO0162190 A1 WO 0162190A1
Authority
WO
WIPO (PCT)
Prior art keywords
implant according
block
implant
bearing faces
blade
Prior art date
Application number
PCT/FR2001/000515
Other languages
French (fr)
Inventor
Frédéric HANSEN
Original Assignee
Stryker Spine Sa
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Stryker Spine Sa filed Critical Stryker Spine Sa
Priority to AU2001235741A priority Critical patent/AU2001235741A1/en
Publication of WO2001062190A1 publication Critical patent/WO2001062190A1/en

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    • 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
    • A61F2/442Intervertebral or spinal discs, e.g. resilient
    • 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
    • A61F2/4455Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
    • A61F2/447Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages substantially parallelepipedal, e.g. having a rectangular or trapezoidal cross-section
    • AHUMAN NECESSITIES
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    • 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
    • A61B17/7059Cortical plates
    • AHUMAN NECESSITIES
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    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
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    • 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
    • A61B17/86Pins or screws or threaded wires; nuts therefor
    • A61B17/8625Shanks, i.e. parts contacting bone tissue
    • A61B17/8635Tips of screws
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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
    • A61F2/02Prostheses implantable into the body
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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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    • A61F2002/30317The prosthesis having different structural features at different locations within the same prosthesis
    • A61F2002/30324The prosthesis having different structural features at different locations within the same prosthesis differing in thickness
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    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
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    • 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
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Definitions

  • the present invention relates to vertebral link systems.
  • a therapy often used essentially consists in carrying out an osteosynthesis by the use of rigid cages comprising an open cavity towards the upper and lower vertebrae, capable of receiving bone graft or any other substance promoting bone regrowth.
  • rigid cages comprising an open cavity towards the upper and lower vertebrae, capable of receiving bone graft or any other substance promoting bone regrowth.
  • the bone regrowth allowing the desired fusion to be obtained is stimulated and accelerated in proportion to the stresses suffered by the graft.
  • the constraints become too great and therefore cause an opposite effect on the quality of bone regrowth, or even necrosis of bone tissue.
  • existing cages absorb almost all of the stresses without deformation due to their high rigidity.
  • the graft is hardly stimulated, which does not allow to have the best conditions for obtaining a fusion.
  • This is the case of the implant described in document WO97 / 37620.
  • This document describes a cage-plate having a rigid open body of generally parallelepipedal or ovoid shape intended to receive the graft thanks to open upper and lower faces. The materials used for the manufacture of such implants do not allow optimization of the fusion.
  • this type of implantable cage does not leave the surgeon the possibility of choosing the restoration of a certain mobility between the two instrumented vertebrae, in place of the fusion. Indeed, in certain cases, it is more judicious to restore a mobility to the pathological vertebral stage than to carry out the arthrodesis. This is the case for young patients and / or having vertebral bodies in excellent condition, where subsequent reintervention is certain on the stages adjacent to the instrumented stage, if a fusion is carried out.
  • An object of the present invention is to provide an implant ensuring optimized bone fusion and to allow the choice between this fusion and a restoration of mobility.
  • an intervertebral implant comprising a rigid body having two bearing faces on the plates of two adjacent vertebrae and elastically deformable before receiving the block, allowing the two faces to be brought together support each other, and a cavity for receiving a block of material.
  • the deformability of the body allows a better fusion because the stresses will be better distributed between the structure and the graft.
  • the deformability of the body allows the implant to ensure it.
  • the body is in one piece.
  • the body comprises a folded blade forming the bearing faces.
  • the blade has a non-uniform thickness along the blade.
  • the deformation of the body is optimized for the use of the implant and for the desired deformation.
  • the blade at least partially defines the cavity.
  • the body has a zone for joining the bearing faces.
  • the junction zone and the bearing faces give the body a “U” profile.
  • at least one of the bearing faces has a profile adapted and complementary to the profile of the vertebral plateau with which it is intended to come into contact.
  • the body comprises means for anchoring to one face of the vertebrae contiguous to the vertebral plateau.
  • the body comprises at least two anchoring lugs to the respective vertebrae, each lug extending in continuity of material with only one of the bearing faces.
  • each leg extends in continuity of material with the bearing face intended to be in abutment on the plate of the vertebra associated with this leg.
  • each leg extends in continuity of material with the bearing face intended to be in abutment on the vertebral plate associated with the other leg.
  • each fixing lug comprises at least one orifice intended to receive a bone screw.
  • the body comprises a block of non-rigid material.
  • the block includes bone graft and / or any substance promoting bone regrowth.
  • the implant can achieve a fusion.
  • the block comprises biocompatible polymer (s) and / or any other biocompatible viscoelastic material.
  • the implant acts as a disc prosthesis allowing the restoration of mobility.
  • a method of implantation implant comprising an approach to the spine in an anterior way, a discectomy, a sharpening of the upper and lower plates of the disc space, a verification of the dimensions of the disc space, the choice of the type of block depending on whether a fusion or a restoration of mobility is desired, insertion of the implant into the prepared disc space, anchoring of the implant to the vertebral bodies, closure of the way first.
  • FIG. la is a perspective view of the implant according to the invention according to a first embodiment
  • FIG. lb is a top view of the implant according to the first embodiment
  • FIG. 2 is a perspective view of one of the bone screws of Figure 1;
  • FIG. 3 is a perspective view of a block according to the first embodiment;
  • - Figure 4 is a perspective view of the body according to the first embodiment
  • - Figure 5 is a side view of the body according to the first embodiment
  • FIG. 6 is a perspective view of the body according to a second embodiment
  • FIG. 7 is a side view of the body according to the second embodiment.
  • FIG. 8 is a side view in a sagittal plane of a cervical vertebra.
  • the implant 1 comprises a body 2 resiliently deformable, a block 3 included within the body 2 and bone screws 4 for fixing.
  • the body 2 is formed by a blade describing a path resembling an " ⁇ ".
  • the loop of the " ⁇ " includes a lower bearing face 10, a rear wall 11 connecting the face 10 to an upper bearing face 12, the assembly describing a "U” shape.
  • the bearing faces 10,12 are opposite to each other and generally extend in two planes parallel to each other.
  • This loop is generally parallelipipedic to fill the disc space as much as possible.
  • This loop delimits a cavity 20 which is suitable for receiving block 3.
  • This block 3 may be made up either of bone graft or of any other substance which promotes bone regrowth such as bone substitutes, or of a biocompatible polymer or of any other biocompatible viscoelastic material.
  • the implant 1 will be used in order to obtain a fusion between the two instrumented vertebrae.
  • the elastic deformability of the blade in “ ⁇ ” makes it possible to obtain a distribution of the stresses between the body 2 and the block 3 consisting of bone graft. Thus the constraints supported by the graft allow the latter to produce a better quality bone for fusion.
  • the implant 1 will be used with the aim of restoring mobility between the two instrumented vertebrae.
  • the elastic deformability of the blade in “ ⁇ ” associated with the viscoelasticity of block 3 makes it possible to reproduce the mechanical reactions of the healthy natural vertebral disc replaced by the implant 1.
  • the branches of the profile in “ ⁇ ” of the body 2 include two legs 13 extending the lower support face 10 at right angles thereto and allowing the implant 1 to be fixed on the body of the upper vertebra, and a lug 14 extending the upper support face 12 at right angles to it ci and allowing the fixation of the implant on the body of the lower vertebra.
  • the legs 13,14 are inclined relative to each other to be oriented so as to follow the curvature of the anterior wall of the vertebral bodies to which they are fixed.
  • Each of the legs 13,14 comprises at least one orifice 15 which is capable of receiving a bone screw 4 with a head 5 for fixing in the vertebral body.
  • the orifice 15, preferably of generally circular section, has a surface 18 capable of receiving the head 5 of the bone screw 4.
  • the surface 18 is substantially complementary to the surface 7 of the head 5 of the bone screw 4 contiguous to the threaded rod.
  • each of the bone screws 4 comprises implementing means 8 in the form of a hollow imprint of hexagonal section, a bone thread 6 and a notch 9 located at the opposite end of the head. 5, along the axis of the screw which allows the self-tapping of the screw in the vertebral body.
  • the parts of the blade acting as lower 10 and upper 12 bearing faces are shaped to conform as much as possible to the shape of the vertebral plates with which they are in contact. Thus the implant is better stabilized in the disc space.
  • the upper plate 43 of the vertebra has a substantially rectilinear horizontal profile while the lower plate 42 has a profile concave in airplane wing complementary to that convex of the upper plate 12 of the body 2 as described below.
  • the lower bearing face 10 of the body 2 is able to come into contact with the plate 43 of the vertebra 40.
  • the lower bearing face 10 has a substantially rectilinear horizontal profile in the sagittal plane.
  • the upper bearing face 12 of the body 2 is able to come into contact with the plate 42 of the vertebra 40.
  • the upper bearing face 12 has a profile consisting of two generally rectilinear sections 16,17 inclined with respect to each other to give this profile a convex shape.
  • the rear section 16 is the longer of the two sections. It extends, in the sagittal plane, over approximately 80% of the length of the body 2.
  • the section 16 is slightly inclined towards the rear of the body 2. It is therefore slightly inclined relative to the lower bearing face 10
  • the section 17 is inclined towards the front of the body more strongly than the inclination of the rear section 16 towards the rear.
  • the bearing faces 10,12 comprise at least one orifice 30 passing through the thickness of the blade, of preferably circular section.
  • This orifice 30 connects the internal cavity 20 to the structure 2 with the bearing face 12 or the bearing face 10.
  • this orifice 30 allows the progression of the fusion towards the trays 42,43 of the adjacent vertebrae.
  • this orifice 30 allows a strengthening of the anchoring, because there is bone regrowth within the orifice 30 which will fill it up again over the thickness of the blade.
  • the bearing faces 10,12 comprise a multitude of orifices 30 of circular section and uniformly distributed on the bearing faces 10,12.
  • the deformation of the body 2 is controlled by the variations in the thickness of the blade along the profile described by the bearing face 12, the rear wall 11 and the bearing face 10.
  • the distribution of stresses between the body 2 and the block 3 is optimized.
  • the cavity 20 is suitable for receiving the block 3.
  • the choice of the composition of the block 3 depends on the will of the surgeon to obtain either a fusion between the two vertebrae within the framework of an arthrodesis, or to restore mobility between the two vertebrae.
  • block 3 will consist of bone graft and / or any other substance promoting bone regrowth.
  • the block 3 will consist of one or more biocompatible polymers or any other biocompatible viscoelastic material.
  • the block 3 has an external surface complementary to that of the cavity for a perfect match with the shape of the cavity 20 which is delimited by the profile of the blade of the body 2: the surface 10a is complementary to the lower bearing face 10 of the body 2.
  • the surface 12a is complementary to the upper bearing face 12 of the body 2 and consists of two sections 16a, 17a complementary to the sections 16, 17 of the bearing face 12.
  • the surface 11a is complementary to the internal face of the posterior wall 11 of the body 2.
  • the practitioner prepares the implant 1 for implantation: if the practitioner decides to perform a fusion, he introduces into the cavity 20 a block 3 of graft and / or any other substance promoting bone regrowth; if the practitioner decides to restore mobility, he introduces into the cavity 20 a block 3 consisting of biocompatible polymer (s) or any other biocompatible viscoelastic material.
  • the practitioner sets up the implant 1 which he fixes with the bone screws 4 to the vertebral bodies, through the orifices 15 in the fixing lugs 13, 14. He then closes the lane first.
  • the body 102 of the implant is always formed of a blade which describes a path resembling a "U". It always has a lower bearing face 110 similar to the previous bearing face 10, a rear wall 111 similar to the previous wall 11, an upper bearing face 112 similar to the upper upper bearing face 12.
  • the attachment to the overlying vertebra is effected by a fixing lug 113 extending the upper support face 112.
  • the attachment to the underlying vertebra is effected by two fixing lugs 114 extending the lower support face 110.
  • the anchoring means are identical to those of the previous embodiment.
  • the blade here has a "U” shape and no longer an " ⁇ " shape so that the two branches of "U" do not cross, as in the previous mode.
  • the U-shaped blade of the body 112 delimits an identical cavity 20 capable of receiving the block 3.
  • the installation of this second embodiment does not differ from the implementation of the first embodiment.
  • the blade can be replaced by a helical spring capable of receiving a block of biomaterials at its core.
  • the bone screws may include a blocking mechanism vis-à-vis the fixing lugs to prevent their recoil.
  • the bone screws can be polyaxial with respect to the fixing lugs.

Abstract

The invention concerns an intervertebral implant comprising a rigid body having two support surfaces on the end-plates of two adjacent and elastically deformable vertebrae, enabling to bring the two support surfaces closer together, and a cavity for receiving a block of material.

Description

IMPLANT INTERVERTEBRAL A CORPS RIGIDE ET FACES D'APPUI INTERVERTEBRAL IMPLANT WITH RIGID BODY AND SUPPORTS
La présente invention concerne les systèmes de liaisons vertébrales. Lors de pathologies discales, une thérapie souvent utilisée consiste essentiellement à effectuer une ostéosynthèse par l'utilisation de cages rigides comportant une cavité ouverte vers les vertèbres supérieure et inférieure, apte à recevoir du greffon osseux ou toute autre substance favorisant la repousse osseuse. D'autre part, il est reconnu que la repousse osseuse permettant d'obtenir la fusion recherchée est stimulée et accélérée proportionnellement aux contraintes subites par le greffon. Cependant au delà d'une certaine limite, les contraintes deviennent trop importantes et provoquent de ce fait un effet inverse sur la qualité de la repousse osseuse, voire la nécrose des tissus osseux. Les cages actuellement existantes absorbent la quasi totalité des contraintes sans déformation du fait de leur rigidité importante. Ainsi, le greffon n'est quasiment pas stimulé, ce qui ne permet pas d'avoir les meilleurs conditions pour l'obtention d'une fusion. Tel est le cas de l'implant décrit dans le document WO97/37620. Ce document décrit une cage-plaque présentant un corps ouvert rigide de forme globalement parallélipipédique ou ovoïde destinée à recevoir du greffon grâce à des faces supérieure et inférieure ouvertes. Les matériaux utilisés pour la fabrication de tels implants ne permettent pas l'optimisation de la fusion.The present invention relates to vertebral link systems. During disc pathologies, a therapy often used essentially consists in carrying out an osteosynthesis by the use of rigid cages comprising an open cavity towards the upper and lower vertebrae, capable of receiving bone graft or any other substance promoting bone regrowth. On the other hand, it is recognized that the bone regrowth allowing the desired fusion to be obtained is stimulated and accelerated in proportion to the stresses suffered by the graft. However, beyond a certain limit, the constraints become too great and therefore cause an opposite effect on the quality of bone regrowth, or even necrosis of bone tissue. Currently existing cages absorb almost all of the stresses without deformation due to their high rigidity. Thus, the graft is hardly stimulated, which does not allow to have the best conditions for obtaining a fusion. This is the case of the implant described in document WO97 / 37620. This document describes a cage-plate having a rigid open body of generally parallelepipedal or ovoid shape intended to receive the graft thanks to open upper and lower faces. The materials used for the manufacture of such implants do not allow optimization of the fusion.
D'autre part, ce type de cage implantable ne laisse pas au chirurgien la possibilité de choisir la restauration d'une certaine mobilité entre les deux vertèbres instrumentées, en lieu et place de la fusion. En effet, dans certains cas, il est plus judicieux de restaurer une mobilité à l'étage vertébral pathologique que d'en effectuer l' arthrodese . C'est le cas pour des patients jeunes et/ou aillant des corps vertébraux en excellent état, où la réintervention ultérieure est certaine sur les étages adjacents à l'étage instrumenté, si on effectue une fusion. Un but de la présente invention est de fournir un implant assurant une fusion osseuse optimisée et de permettre le choix entre cette fusion et une restauration de la mobilité.On the other hand, this type of implantable cage does not leave the surgeon the possibility of choosing the restoration of a certain mobility between the two instrumented vertebrae, in place of the fusion. Indeed, in certain cases, it is more judicious to restore a mobility to the pathological vertebral stage than to carry out the arthrodesis. This is the case for young patients and / or having vertebral bodies in excellent condition, where subsequent reintervention is certain on the stages adjacent to the instrumented stage, if a fusion is carried out. An object of the present invention is to provide an implant ensuring optimized bone fusion and to allow the choice between this fusion and a restoration of mobility.
En vue de la réalisation de ce but, on prévoit selon la présente invention un implant intervertébral comprenant un corps rigide présentant deux faces d'appui sur les plateaux de deux vertèbres adjacentes et deformable élastiquement avant réception du bloc, en permettant de rapprocher les deux faces d'appui l'une de l'autre, et une cavité de réception d'un bloc de matériau .With a view to achieving this goal, an intervertebral implant is provided according to the present invention comprising a rigid body having two bearing faces on the plates of two adjacent vertebrae and elastically deformable before receiving the block, allowing the two faces to be brought together support each other, and a cavity for receiving a block of material.
Ainsi, dans le cas d'une fusion, la déformabilité du corps permet une meilleure fusion car les contraintes seront mieux réparties entre la structure et le greffon. Dans le cas d'une restauration de mobilité, la déformabilité du corps permet à l'implant de l' assurer.Thus, in the case of a fusion, the deformability of the body allows a better fusion because the stresses will be better distributed between the structure and the graft. In the case of a restoration of mobility, the deformability of the body allows the implant to ensure it.
Avantageusement, le corps est d'une seule pièce. Avantageusement, le corps comporte une lame pliée formant les faces d'appui.Advantageously, the body is in one piece. Advantageously, the body comprises a folded blade forming the bearing faces.
Avantageusement, la lame présente une épaisseur non uniforme le long de la lame. Ainsi, la déformation du corps est optimisée pour l'emploi de l'implant et pour la déformation recherchée .Advantageously, the blade has a non-uniform thickness along the blade. Thus, the deformation of the body is optimized for the use of the implant and for the desired deformation.
Avantageusement, la lame définit au moins en partie la cavité.Advantageously, the blade at least partially defines the cavity.
Avantageusement, le corps présente une zone de jonction des faces d'appui.Advantageously, the body has a zone for joining the bearing faces.
Avantageusement, la zone de jonction et les faces d'appui donnent au corps un profil en « U ». Avantageusement, au moins une des faces d'appui comporte un profil adapté et complémentaire au profil du plateau vertébral avec lequel elle est destinée à entrer en contact.Advantageously, the junction zone and the bearing faces give the body a “U” profile. Advantageously, at least one of the bearing faces has a profile adapted and complementary to the profile of the vertebral plateau with which it is intended to come into contact.
Avantageusement, le corps comporte des moyens d'ancrage à une face des vertèbres contiguë au plateau vertébral .Advantageously, the body comprises means for anchoring to one face of the vertebrae contiguous to the vertebral plateau.
Avantageusement, le corps comporte au moins deux pattes d'ancrage aux vertèbres respectives, chaque patte s' étendant en continuité de matière avec une seule des faces d'appui.Advantageously, the body comprises at least two anchoring lugs to the respective vertebrae, each lug extending in continuity of material with only one of the bearing faces.
Avantageusement, chaque patte s'étend en continuité de matière avec la face d' appui destinée à être en appui sur le plateau de la vertèbre associé à cette patte. Avantageusement, chaque patte s'étend en continuité de matière avec la face d'appui destinée à être en appui sur le plateau vertébral associé à l'autre patte.Advantageously, each leg extends in continuity of material with the bearing face intended to be in abutment on the plate of the vertebra associated with this leg. Advantageously, each leg extends in continuity of material with the bearing face intended to be in abutment on the vertebral plate associated with the other leg.
Avantageusement, chaque patte de fixation comporte au moins un orifice destiné à recevoir une vis osseuse . Avantageusement, le corps comprend un bloc en matériau non rigide.Advantageously, each fixing lug comprises at least one orifice intended to receive a bone screw. Advantageously, the body comprises a block of non-rigid material.
Avantageusement, le bloc comporte du greffon osseux et/ou toute substance favorisant la repousse osseuse.Advantageously, the block includes bone graft and / or any substance promoting bone regrowth.
Ainsi l'implant peut réaliser une fusion. Avantageusement, le bloc comporte du ou des polymères biocompatibles et/ou tout autre matériau viscoélastique biocompatible. Ainsi, l'implant fait office de prothèse de disque permettant la restauration de la mobilité.Thus the implant can achieve a fusion. Advantageously, the block comprises biocompatible polymer (s) and / or any other biocompatible viscoelastic material. Thus, the implant acts as a disc prosthesis allowing the restoration of mobility.
On prévoit d'autre part une méthode d'implantation de l'implant comprenant un abord de la colonne vertébrale selon une voie antérieure, une discectomie, un avivement des plateaux inférieur et supérieur de l'espace discal, une vérification des dimensions de l'espace discal, le choix du type de bloc suivant que l'on désire une fusion ou une restauration de mobilité, une insertion de l'implant dans l'espace discal préparé, l'ancrage de l'implant sur les corps vertébraux, la fermeture de la voie d'abord.There is also provided a method of implantation implant comprising an approach to the spine in an anterior way, a discectomy, a sharpening of the upper and lower plates of the disc space, a verification of the dimensions of the disc space, the choice of the type of block depending on whether a fusion or a restoration of mobility is desired, insertion of the implant into the prepared disc space, anchoring of the implant to the vertebral bodies, closure of the way first.
D'autres caractéristiques et avantages de l'invention apparaîtront encore lors de la description qui suit d'un mode préféré de réalisation et d'une variante donnés à titre d'exemples non limitatifs. Aux dessins annexés :Other characteristics and advantages of the invention will become apparent from the following description of a preferred embodiment and of a variant given by way of nonlimiting examples. In the accompanying drawings:
- la figure la est une vue en perspective de l'implant selon l'invention selon un premier mode de réalisation;- Figure la is a perspective view of the implant according to the invention according to a first embodiment;
- la figure lb est une vue de dessus de l'implant selon le premier mode de réalisation ;- Figure lb is a top view of the implant according to the first embodiment;
- la figure 2 est une vue en perspective d'une des vis à os de la figure 1 ; - la figure 3 est une vue en perspective d' un bloc selon le premier mode de réalisation ;- Figure 2 is a perspective view of one of the bone screws of Figure 1; - Figure 3 is a perspective view of a block according to the first embodiment;
- la figure 4 est une vue en perspective du corps selon le premier mode de réalisation ; - la figure 5 est une vue de coté du corps selon le premier mode de réalisation ;- Figure 4 is a perspective view of the body according to the first embodiment; - Figure 5 is a side view of the body according to the first embodiment;
- la figure 6 est une vue en perspective du corps selon un second mode de réalisation ;- Figure 6 is a perspective view of the body according to a second embodiment;
- la figure 7 est une vue de coté du corps selon le second mode de réalisation ;- Figure 7 is a side view of the body according to the second embodiment;
- la figure 8 est une vue de coté dans un plan sagittal d'une vertèbre cervicale.- Figure 8 is a side view in a sagittal plane of a cervical vertebra.
En référence aux figures la à 5, l'implant 1 comprend un corps 2 deformable élastiquement , un bloc 3 inclus au sein du corps 2 et des vis à os 4 de fixation.Referring to Figures la to 5, the implant 1 comprises a body 2 resiliently deformable, a block 3 included within the body 2 and bone screws 4 for fixing.
Le corps 2 est formé d' une lame décrivant un chemin ressemblant à un « α ». La boucle du « α » comprend une face d'appui inférieure 10, un mur postérieur 11 reliant la face 10 à une face d'appui supérieure 12, l'ensemble décrivant une forme en « U ». Les faces d'appui 10,12 sont opposées l'une à l'autre et s'étendent généralement dans deux plan parallèles entre eux. Cette boucle est de forme généralement parallelipipedique pour remplir au maximum l'espace discal. Cette boucle délimite une cavité 20 qui est apte à recevoir le bloc 3. Ce bloc 3 pourra être constitué soit de greffon osseux ou de toute autre substance qui favorise la repousse osseuse comme les substituts osseux, soit d'un polymère biocompatible ou de tout autre matériau viscoélastique biocompatible. Dans le premier cas, l'implant 1 sera utilisé dans le but d'obtenir une fusion entre les deux vertèbres instrumentées. La déformabilité élastique de la lame en « α » permet d' obtenir une répartition des contraintes entre le corps 2 et le bloc 3 constitué de greffon osseux. Ainsi les contraintes supportées par le greffon permettent à ce dernier de produire un os de meilleure qualité pour la fusion. Dans le second cas, l'implant 1 sera utilisé dans le but de restaurer la mobilité entre les deux vertèbres instrumentées. La déformabilité élastique de la lame en « α » associée à la viscoélasticité du bloc 3 permet de reproduire les réactions mécaniques du disque vertébral naturel sain remplacé par l'implant 1. Les branches du profil en « α » du corps 2 comprennent deux pattes 13 prolongeant la face d'appui inférieure 10 à angle droit avec celui-ci et permettant la fixation de l'implant 1 sur le corps de la vertèbre supérieure, et une patte 14 prolongeant la face d'appui supérieure 12 à angle droit avec celui-ci et permettant la fixation de l'implant sur le corps de la vertèbre inférieure. En vue de dessus, comme représenté sur la figure lb, les pattes 13,14 sont inclinées l'une par rapport à l'autre pour être orientées de manière à suivre la courbure du mur antérieur des corps vertébraux auxquels elles sont fixées. Chacune des pattes 13,14 comportent au moins un orifice 15 qui est apte à recevoir une vis à os 4 avec une tête 5 pour la fixation dans le corps vertébral. L'orifice 15, de section généralement circulaire de préférence, comporte une surface 18 apte à recevoir la tête 5 de la vis à os 4. La surface 18 est sensiblement complémentaire de la surface 7 de la tête 5 de la vis à os 4 contiguë à la tige filetée. D'autre part, chacune des vis à os 4 comprend des moyens de mise en œuvre 8 sous la forme d'une empreinte en creux de section hexagonale, un filetage à os 6 et une entaille 9 située à l'extrémité opposée de la tête 5, selon l'axe de la vis qui permet l' autotaraudage de la vis dans le corps vertébral.The body 2 is formed by a blade describing a path resembling an "α". The loop of the "α" includes a lower bearing face 10, a rear wall 11 connecting the face 10 to an upper bearing face 12, the assembly describing a "U" shape. The bearing faces 10,12 are opposite to each other and generally extend in two planes parallel to each other. This loop is generally parallelipipedic to fill the disc space as much as possible. This loop delimits a cavity 20 which is suitable for receiving block 3. This block 3 may be made up either of bone graft or of any other substance which promotes bone regrowth such as bone substitutes, or of a biocompatible polymer or of any other biocompatible viscoelastic material. In the first case, the implant 1 will be used in order to obtain a fusion between the two instrumented vertebrae. The elastic deformability of the blade in “α” makes it possible to obtain a distribution of the stresses between the body 2 and the block 3 consisting of bone graft. Thus the constraints supported by the graft allow the latter to produce a better quality bone for fusion. In the second case, the implant 1 will be used with the aim of restoring mobility between the two instrumented vertebrae. The elastic deformability of the blade in “α” associated with the viscoelasticity of block 3 makes it possible to reproduce the mechanical reactions of the healthy natural vertebral disc replaced by the implant 1. The branches of the profile in “α” of the body 2 include two legs 13 extending the lower support face 10 at right angles thereto and allowing the implant 1 to be fixed on the body of the upper vertebra, and a lug 14 extending the upper support face 12 at right angles to it ci and allowing the fixation of the implant on the body of the lower vertebra. In top view, as shown in Figure lb, the legs 13,14 are inclined relative to each other to be oriented so as to follow the curvature of the anterior wall of the vertebral bodies to which they are fixed. Each of the legs 13,14 comprises at least one orifice 15 which is capable of receiving a bone screw 4 with a head 5 for fixing in the vertebral body. The orifice 15, preferably of generally circular section, has a surface 18 capable of receiving the head 5 of the bone screw 4. The surface 18 is substantially complementary to the surface 7 of the head 5 of the bone screw 4 contiguous to the threaded rod. On the other hand, each of the bone screws 4 comprises implementing means 8 in the form of a hollow imprint of hexagonal section, a bone thread 6 and a notch 9 located at the opposite end of the head. 5, along the axis of the screw which allows the self-tapping of the screw in the vertebral body.
Les parties de la lame faisant office de faces d'appui inférieure 10 et supérieure 12 sont conformées pour épouser au maximum la forme des plateaux vertébraux avec lesquels elles sont en contact. Ainsi l'implant est mieux stabilisé dans l'espace discal. Dans le mode de réalisation présenté dans les figures la à 5, les faces d'appui 10,12 sont conformées pour s'adapter aux plateaux vertébraux d'une vertèbre cervicale 40 présentée figure 8. La vertèbre cervicale 40 comporte un corps vertébral 41 présentant un plateau supérieur avec une face 43 et un plateau inférieur avec une face 42. En coupe suivant le plan sagittal médian à la figure 8, le plateau supérieur 43 de la vertèbre à un profil sensiblement rectiligne horizontal alors que le plateau inférieur 42 a un profil concave en aile d' avion complémentaire de celui convexe du plateau supérieur 12 du corps 2 comme il est décrit ci-après. La face d'appui inférieure 10 du corps 2 est apte à venir en contact avec le plateau 43 de la vertèbre 40. De ce fait, la face d'appui inférieure 10 a un profil sensiblement rectiligne horizontal dans le plan sagittal. La face d'appui supérieure 12 du corps 2 est apte à venir en contact avec la plateau 42 de la vertèbre 40. De ce fait, la face d'appui supérieure 12 présente un profil constitué de deux tronçons de forme générale rectiligne 16,17 inclinés l'un par rapport à l'autre pour donner à ce profil une forme convexe. Le tronçon arrière 16 est le plus long des deux tronçons. II s'étend, dans le plan sagittal, sur environ 80% de la longueur du corps 2. Le tronçon 16 est légèrement incliné vers l'arrière du corps 2. Il est donc légèrement incliné par rapport à la face d' appui inférieure 10. Le tronçon 17 est incliné vers l'avant du corps plus fortement que l'inclinaison du tronçon arrière 16 vers l'arrière. Sa longueur est environ égale au quart de celle du tronçon arrière 16. Les deux tronçons 16,17 donnent à la face d'appui supérieure 12 un profil proche de celui d'une aile d'avion. Les faces d'appui 10,12 comportent au moins un orifice 30 traversant l'épaisseur de la lame, de section préférentiellement circulaire. Cet orifice 30 met en communication la cavité interne 20 à la structure 2 avec la face d' appui 12 ou la face d' appui 10. Dans le cas du choix d'une fusion, cet orifice 30 permet la progression de la fusion vers les plateaux 42,43 des vertèbres adjacentes. Dans le cas du choix d'une restauration de mobilité, cet orifice 30 permet un renforcement de l'ancrage, car il y a repousse osseuse au sein de l'orifice 30 qui le recomblera sur l'épaisseur de la lame. Préférentiellement , les faces d'appui 10,12 comportent une multitude d'orifices 30 de section circulaire et uniformément répartis sur faces d' appui 10,12. La déformation du corps 2 est maîtrisée par les variations de l'épaisseur de la lame le long du profil que décrit la face d'appui 12, le mur postérieur 11 et la face d'appui 10. Ainsi, la répartition de contraintes entre le corps 2 et le bloc 3 est optimisée .The parts of the blade acting as lower 10 and upper 12 bearing faces are shaped to conform as much as possible to the shape of the vertebral plates with which they are in contact. Thus the implant is better stabilized in the disc space. In the embodiment presented in FIGS. an upper plate with a face 43 and a lower plate with a face 42. In section along the median sagittal plane in FIG. 8, the upper plate 43 of the vertebra has a substantially rectilinear horizontal profile while the lower plate 42 has a profile concave in airplane wing complementary to that convex of the upper plate 12 of the body 2 as described below. The lower bearing face 10 of the body 2 is able to come into contact with the plate 43 of the vertebra 40. As a result, the lower bearing face 10 has a substantially rectilinear horizontal profile in the sagittal plane. The upper bearing face 12 of the body 2 is able to come into contact with the plate 42 of the vertebra 40. As a result, the upper bearing face 12 has a profile consisting of two generally rectilinear sections 16,17 inclined with respect to each other to give this profile a convex shape. The rear section 16 is the longer of the two sections. It extends, in the sagittal plane, over approximately 80% of the length of the body 2. The section 16 is slightly inclined towards the rear of the body 2. It is therefore slightly inclined relative to the lower bearing face 10 The section 17 is inclined towards the front of the body more strongly than the inclination of the rear section 16 towards the rear. Its length is approximately equal to a quarter of that of the rear section 16. The two sections 16, 17 give the upper bearing face 12 a profile close to that of an airplane wing. The bearing faces 10,12 comprise at least one orifice 30 passing through the thickness of the blade, of preferably circular section. This orifice 30 connects the internal cavity 20 to the structure 2 with the bearing face 12 or the bearing face 10. In the case of the choice of a fusion, this orifice 30 allows the progression of the fusion towards the trays 42,43 of the adjacent vertebrae. In the case of the choice of a restoration of mobility, this orifice 30 allows a strengthening of the anchoring, because there is bone regrowth within the orifice 30 which will fill it up again over the thickness of the blade. Preferably, the bearing faces 10,12 comprise a multitude of orifices 30 of circular section and uniformly distributed on the bearing faces 10,12. The deformation of the body 2 is controlled by the variations in the thickness of the blade along the profile described by the bearing face 12, the rear wall 11 and the bearing face 10. Thus, the distribution of stresses between the body 2 and the block 3 is optimized.
La cavité 20 est apte à recevoir le bloc 3. Le choix de la composition du bloc 3 dépend de la volonté du chirurgien d' obtenir soit une fusion entre les deux vertèbres dans le cadre d'une arthrodese, soit de restaurer une mobilité entre les deux vertèbres. Dans le premier cas, le bloc 3 sera constitué de greffon osseux et/ou de toute autre substance favorisant la repousse osseuse. Dans le deuxième cas, le bloc 3 sera constitué d'un ou de plusieurs polymères biocompatibles ou de tout autre matériau viscoélastique biocompatible. Le bloc 3 présente une surface externe complémentaire de celle de la cavité pour une parfaite adéquation avec la forme de la cavité 20 qui est délimité par le profil de la lame du corps 2 : la surface 10a est complémentaire de la face d'appui inférieure 10 du corps 2. La surface 12a est complémentaire de la face d'appui supérieure 12 du corps 2 et est constitué de deux tronçons 16a, 17a complémentaires des tronçons 16,17 de la face d'appui 12. De même, la surface lia est complémentaire de la face interne du mur postérieur 11 du corps 2. La mise en place de l'implant 1 dans le corps du patient s'effectue au travers d'une voie d'abord antérieure qui permet d' accéder directement aux corps vertébraux, et ce, sur leur face antérieure. Le praticien y effectue une discectomie du disque intervertébral endommagé puis avive les plateaux inférieur de la vertèbre supérieure, et supérieur de la vertèbre inférieure délimitant l'espace discal. Après avoir vérifié la taille de cet espace discal ainsi dégagé, le praticien prépare l'implant 1 à l'implantation : si le praticien décide de réaliser une fusion, il introduit dans la cavité 20 un bloc 3 de greffon et/ou de toute autre substance favorisant la repousse osseuse ; si le praticien décide de restaurer la mobilité, il introduit dans la cavité 20 un bloc 3 constitué de polymère (s) biocompatible (s) ou de tout autre matériau viscoélastique biocompatible. Une fois préparé, le praticien met en place l'implant 1 qu'il fixe avec les vis à os 4 aux corps vertébraux, au travers des orifices 15 des pattes de fixation 13,14. Il referme ensuite la voie d'abord.The cavity 20 is suitable for receiving the block 3. The choice of the composition of the block 3 depends on the will of the surgeon to obtain either a fusion between the two vertebrae within the framework of an arthrodesis, or to restore mobility between the two vertebrae. In the first case, block 3 will consist of bone graft and / or any other substance promoting bone regrowth. In the second case, the block 3 will consist of one or more biocompatible polymers or any other biocompatible viscoelastic material. The block 3 has an external surface complementary to that of the cavity for a perfect match with the shape of the cavity 20 which is delimited by the profile of the blade of the body 2: the surface 10a is complementary to the lower bearing face 10 of the body 2. The surface 12a is complementary to the upper bearing face 12 of the body 2 and consists of two sections 16a, 17a complementary to the sections 16, 17 of the bearing face 12. Similarly, the surface 11a is complementary to the internal face of the posterior wall 11 of the body 2. The implant 1 is placed in the patient's body via an anterior approach which allows direct access to the vertebral bodies, and this, on their front side. The practitioner performs a discectomy of the damaged intervertebral disc then sharpens the lower trays of the upper vertebra, and the upper of the lower vertebra delimiting the disc space. After having checked the size of this disc space thus cleared, the practitioner prepares the implant 1 for implantation: if the practitioner decides to perform a fusion, he introduces into the cavity 20 a block 3 of graft and / or any other substance promoting bone regrowth; if the practitioner decides to restore mobility, he introduces into the cavity 20 a block 3 consisting of biocompatible polymer (s) or any other biocompatible viscoelastic material. Once prepared, the practitioner sets up the implant 1 which he fixes with the bone screws 4 to the vertebral bodies, through the orifices 15 in the fixing lugs 13, 14. He then closes the lane first.
Dans un second mode de réalisation illustré par les figures 6 et 7, le corps 102 de l'implant est toujours formé d'une lame qui décrit un chemin ressemblant à un « U » . Il comporte toujours une face d'appui inférieure 110 similaire à la face d'appui 10 précédente, un mur postérieur 111 similaire au mur 11 précédent, une face d'appui supérieure 112 similaire à la face d'appui supérieure 12 précédente. La fixation à la vertèbre sus-jacente s'effectue par une patte de fixation 113 prolongeant la face d'appui supérieure 112. La fixation à la vertèbre sous-jacente s'effectue par deux pattes de fixation 114 prolongeant la face d'appui inférieure 110. Les moyens d'ancrages sont identiques que ceux du mode de réalisation précédent. La lame a ici une forme en « U » et non plus une forme en « α » de sorte que les deux branches su « U » ne se croisent pas, comme dans le mode précédent. La lame en « U » du corps 112 délimite un cavité 20 identique apte à recevoir le bloc 3. La mise en place de ce second mode de réalisation ne diffère pas de la mise en place du premier mode de réalisation.In a second embodiment illustrated in Figures 6 and 7, the body 102 of the implant is always formed of a blade which describes a path resembling a "U". It always has a lower bearing face 110 similar to the previous bearing face 10, a rear wall 111 similar to the previous wall 11, an upper bearing face 112 similar to the upper upper bearing face 12. The attachment to the overlying vertebra is effected by a fixing lug 113 extending the upper support face 112. The attachment to the underlying vertebra is effected by two fixing lugs 114 extending the lower support face 110. The anchoring means are identical to those of the previous embodiment. The blade here has a "U" shape and no longer an "α" shape so that the two branches of "U" do not cross, as in the previous mode. The U-shaped blade of the body 112 delimits an identical cavity 20 capable of receiving the block 3. The installation of this second embodiment does not differ from the implementation of the first embodiment.
La lame peut être remplacée par un ressort hélicoïdal apte à recevoir un bloc de biomatériaux en son âme.The blade can be replaced by a helical spring capable of receiving a block of biomaterials at its core.
Les vis osseuses peuvent comporter un mécanisme de blocage vis-à-vis des pattes de fixation pour éviter leur recul .The bone screws may include a blocking mechanism vis-à-vis the fixing lugs to prevent their recoil.
Les vis osseuses peuvent être polyaxiales vis-à- vis des pattes de fixation. The bone screws can be polyaxial with respect to the fixing lugs.

Claims

Revendications claims
1. Implant intervertébral comprenant un corps rigide (2 ;102) présentant deux faces d'appui sur les plateaux de deux vertèbres adjacentes et une cavité (20) de réception d'un bloc (3) de matériau, caractérisé en ce que le corps est deformable élastiquement avant réception du bloc, en permettant de rapprocher les deux faces d'appui l'une de l'autre. 1. Intervertebral implant comprising a rigid body (2; 102) having two bearing faces on the plates of two adjacent vertebrae and a cavity (20) for receiving a block (3) of material, characterized in that the body is elastically deformable before reception of the block, allowing the two bearing faces to be brought closer to one another.
2. Implant selon la revendication 1 caractérisé en ce que le corps est d'une seule pièce.2. Implant according to claim 1 characterized in that the body is in one piece.
3. Implant selon la revendication 1 ou 2 caractérisé en ce que le corps comporte une lame pliée formant les faces d'appui. 3. Implant according to claim 1 or 2 characterized in that the body comprises a folded blade forming the bearing faces.
4. Implant selon la revendication 3 caractérisé en ce que la lame présente une épaisseur non uniforme le long de la lame.4. Implant according to claim 3 characterized in that the blade has a non-uniform thickness along the blade.
5. Implant selon la revendication 3 ou 4 caractérisé en ce que la lame définit au moins en partie la cavité.5. Implant according to claim 3 or 4 characterized in that the blade at least partially defines the cavity.
6. Implant selon l'une des revendications 1 à 5 caractérisé en ce que le corps présente une zone de jonction des faces d'appui.6. Implant according to one of claims 1 to 5 characterized in that the body has a junction area of the bearing faces.
7. Implant selon la revendication 6 caractérisé en ce que la zone de jonction et les faces d'appui donnent au corps un profil en « U ».7. Implant according to claim 6 characterized in that the junction zone and the bearing faces give the body a "U" profile.
8. Implant selon l'une des revendications 1 à 7 caractérisé en ce qu'au moins une des faces d'appui comporte un profil adapté et complémentaire au profil du plateau vertébral avec lequel elle est destinée à entrer en contact. 8. Implant according to one of claims 1 to 7 characterized in that at least one of the bearing faces has a profile adapted and complementary to the profile of the vertebral plate with which it is intended to come into contact.
9. Implant selon l'une des revendications 1 à 8 caractérisé en ce que le corps comporte des moyens d'ancrage à une face des vertèbres contiguë au plateau vertébral . 9. Implant according to one of claims 1 to 8 characterized in that the body comprises means for anchoring to a face of the vertebrae contiguous to the vertebral plateau.
10. Implant selon l'une des revendications 1 à 9 caractérisé en ce que le corps comporte au moins deux pattes d'ancrage aux vertèbres respectives, chaque patte s' étendant en continuité de matière avec une seule des faces d' appui10. Implant according to one of claims 1 to 9 characterized in that the body comprises at least two anchoring lugs to the respective vertebrae, each lug extending in continuity of material with only one of the bearing faces
11. Implant selon la revendication 10 caractérisé en ce que chaque patte s'étend en continuité de matière avec la face d' appui destinée à être en appui sur le plateau de la vertèbre associé à cette patte.11. Implant according to claim 10 characterized in that each lug extends in continuity of material with the bearing face intended to be in abutment on the plate of the vertebra associated with this lug.
12. Implant selon la revendication 10 caractérisé en ce que chaque patte s'étend en continuité de matière avec la face d' appui destinée à être en appui sur le plateau vertébral associé à l'autre patte.12. Implant according to claim 10 characterized in that each leg extends in continuity of material with the bearing face intended to be supported on the vertebral plate associated with the other leg.
13. Implant selon l'une des revendications 10 à 12 caractérisé en ce que chaque patte de fixation comporte au moins un orifice destiné à recevoir une vis osseuse .13. Implant according to one of claims 10 to 12 characterized in that each fixing lug comprises at least one orifice intended to receive a bone screw.
14. Implant selon l'une des revendications 1 à 13 caractérisé en ce qu'il comprend un bloc en matériau non rigide. 14. Implant according to one of claims 1 to 13 characterized in that it comprises a block of non-rigid material.
15. Implant selon la revendication 14 caractérisé en ce que le bloc comporte du greffon osseux et/ou toute substance favorisant la repousse osseuse15. Implant according to claim 14 characterized in that the block includes bone graft and / or any substance promoting bone regrowth
16. Implant selon la revendication 14 caractérisé en ce que le bloc comporte du ou des polymères biocompatibles et/ou tout autre matériau viscoélastique biocompatible . 16. Implant according to claim 14 characterized in that the block comprises biocompatible polymer (s) and / or any other biocompatible viscoelastic material.
PCT/FR2001/000515 2000-02-24 2001-02-22 Intervertebral implant with rigid body and support surfaces WO2001062190A1 (en)

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FR2805457A1 (en) 2001-08-31
FR2805457B1 (en) 2002-10-11

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