FR2866227A1 - Intervertebral annulus prosthesis, has shape of ring, made of monoblock deformable viscoelastic material, with fixing unit connected to connection rod and permitting rod to be pushed in intervertebral cavity where it is compressed - Google Patents

Intervertebral annulus prosthesis, has shape of ring, made of monoblock deformable viscoelastic material, with fixing unit connected to connection rod and permitting rod to be pushed in intervertebral cavity where it is compressed Download PDF

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Publication number
FR2866227A1
FR2866227A1 FR0401555A FR0401555A FR2866227A1 FR 2866227 A1 FR2866227 A1 FR 2866227A1 FR 0401555 A FR0401555 A FR 0401555A FR 0401555 A FR0401555 A FR 0401555A FR 2866227 A1 FR2866227 A1 FR 2866227A1
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Prior art keywords
prosthesis
intervertebral
ring
insert
anulus
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Granted
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FR0401555A
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French (fr)
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FR2866227B1 (en
Inventor
Frederic Fortin
Johann Robin
Huec Jean Charles Le
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Individual
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Individual
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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
    • A61F2/46Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4603Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof
    • A61F2/4611Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof of spinal prostheses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30108Shapes
    • A61F2002/3011Cross-sections or two-dimensional shapes
    • A61F2002/30182Other shapes
    • A61F2002/30187D-shaped or half-disc-shaped
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    • 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
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    • A61F2002/30108Shapes
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    • A61F2002/30224Three-dimensional shapes cylindrical
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    • A61F2002/30329Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30476Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements locked by an additional locking mechanism
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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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    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30535Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30563Special structural features of bone or joint prostheses not otherwise provided for having elastic means or damping means, different from springs, e.g. including an elastomeric core or shock absorbers
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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
    • A61F2/30Joints
    • A61F2/30767Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30772Apertures or holes, e.g. of circular cross section
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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
    • A61F2/30Joints
    • A61F2/30767Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30772Apertures or holes, e.g. of circular cross section
    • A61F2002/30774Apertures or holes, e.g. of circular cross section internally-threaded
    • 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
    • A61F2002/4435Support means or repair of the natural disc wall, i.e. annulus, e.g. using plates, membranes or meshes
    • 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
    • A61F2002/444Intervertebral or spinal discs, e.g. resilient for replacing the nucleus pulposus
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    • 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
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    • A61F2/4603Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof
    • A61F2002/4625Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof with relative movement between parts of the instrument during use
    • A61F2002/4627Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof with relative movement between parts of the instrument during use with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument
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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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    • A61F2/46Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4603Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof
    • A61F2002/4629Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof connected to the endoprosthesis or implant via a threaded connection
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    • A61F2220/00Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • AHUMAN NECESSITIES
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    • A61F2230/0069Three-dimensional shapes cylindrical

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Transplantation (AREA)
  • Neurology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Prostheses (AREA)

Abstract

The prosthesis has a ring (11) with an insert (12) having an internal threading (121) connected to a connection rod (21). The internal threading permits the rod to be pushed in an intervertebral cavity where it is compressed. The ring is made of a monoblock deformable viscoelastic material (M). The assembly of components having the same function of compressing the prosthesis is placed in a compartment of an insertion device. The connection rod slides through a hole (111) that is perforated transversely in the plane of the prosthesis. The assembly of components having the same function of compressing the prosthesis is transferred to an implantation site and the rod is then removed from the site. An independent claim is also included for an insertion device for implantation of intervertebral annulus prosthesis.

Description

PROTHÈSE D'ANULUS INTERVERTEBRALINTERVERTEBRAL ANULUS PROSTHESIS

i r rr Domaine de l'invention: La présente invention concerne une prothèse d'anulus de disque intervertébral associée à ses moyens d'insertion. Cette prothèse après insertion et enlèvement des moyens d'insertion se substitue à danulus préalablement retiré de la cavité existante après une ablation partielle ou totale de ce dernier cette. prothèse est monobloc compressible grâce au matériau qui la constitue qui lui permet de passer par déformation dans un tube d'insertion pour ensuite se déployer dans la cavité de lanulus qu'elle remplace.  FIELD OF THE INVENTION The present invention relates to an intervertebral disk anulus prosthesis associated with its insertion means. This prosthesis after insertion and removal of the insertion means is substituted for danulus previously removed from the existing cavity after a partial or total removal of the latter. prosthesis is compressible monoblock thanks to the material that constitutes it which allows it to pass by deformation in an insertion tube and then to deploy in the cavity of lanulus that it replaces.

Art Antérieur: nous rappellerons brièvement la constitution d'un disque intervertébral liant deux corps vertébraux Depuis les travaux de Van Steen Brugghe en 1956 de nombreux brevets mentionnent des réalisations diverses de disque intervertébral Actuellement,les concepts de prothèses discales peuvent se répartir selon trois groupes: les prothèses totales de disques invertébraux les prothèses de nucleus pulposus les prothèses d'anulus fibrosus Divers systèmes de prothèses existent sur le marché; ce sont des dispositifs composés de différents éléments, qui sont difficilement implantables, car imposant des actes chirurgicaux lourds et traumatisants, ils sont employés lorsque le disque intervertébral à traiter est déjà très altéré. L'assemblage complexe de ces pièces multiples que constituent cette variété de système réduit la qualité et l'efficacité de fonctionnement dans le temps.  Art Anterior: we will briefly recall the constitution of an intervertebral disc linking two vertebral bodies Since the works of Van Steen Brugghe in 1956 many patents mention various achievements of intervertebral disc Currently, the concepts of disc prostheses can be divided into three groups: the total prostheses of the intervertebral discs the prostheses of nucleus pulposus the prostheses of anulus fibrosus Various systems of prostheses exist on the market; they are devices composed of different elements, which are difficult to implant because imposing heavy and traumatic surgical procedures, they are used when the intervertebral disc to be treated is already very altered. The complex assembly of these multiple parts that make up this variety of system reduces the quality and efficiency of operation over time.

Il existe encore d'autres dispositifs qui sont en général des prothèses partielles de disque intervertébral, plus facile à implanter et donc moins traumatisante pour le patient. Elles sont composées d'un nombre restreint d'éléments ce qui assure une meilleure longévité "in vivo ". ces systèmes peuvent être utilisés avant que ne survienne une sérieuse dégradation importante du disque à soigner, ce qui a l'avantage de préserver plus longtemps l'intégrité de l'articulation déficiente. Le disque intervertébral présente essentiellement deux zones distinctes caractéristiques: une partie gélatineuse appelée noyau pulpeux ou nucleus pulposus et une partie annulaire: anneau fibreux ou anulus fibrosus.  There are still other devices that are generally partial dentures intervertebral disk, easier to implant and therefore less traumatic for the patient. They are composed of a limited number of elements which ensures a better longevity "in vivo". these systems can be used before there is a serious serious degradation of the disc to be treated, which has the advantage of preserving longer the integrity of the deficient joint. The intervertebral disk has essentially two distinct characteristic zones: a gelatinous part called nucleus pulposus or nucleus pulposus and an annular part: fibrous ring or anulus fibrosus.

De cette constitution découlent naturellement deux types d'implant partiels possibles: La prothèse de nucleus pulposus et la prothèse d'annulus fibrosus qui remplace tout ou partie de 1'anulus fibrosus du disque intervertébral, et qui est l'objet de la présente invention.Nous examinerons comment se distingue la présente invention,vis à vis de deux documents considérés comme très proches: Premier document document Fortin ( PCT:W0 /024368).  From this constitution naturally arise two possible partial implant types: the nucleus pulposus prosthesis and the annulus fibrosus prosthesis which replaces all or part of the anulus fibrosus of the intervertebral disk, and which is the subject of the present invention. We will examine how the present invention differs, with respect to two documents considered very close: First document Fortin document (PCT: W0 / 024368).

Ce document décrit et revendique: " une prothèse de nucleus son dispositif d'insertion et son procédé de mise en place ", les moyens qui constituent la prothèse de cette demande de brevet sont différents en forme et en nombre de ceux de la présente invention; seuls les aspects compressibilité et déformations sont commun aux deux inventions.  This document describes and claims: "a nucleus prosthesis its insertion device and its delivery method", the means which constitute the prosthesis of this patent application are different in shape and number from those of the present invention; only the compressibility and deformation aspects are common to both inventions.

Deuxième document: brevet allemand étendu en Europe sous le N EP 938110291 dont la procédure européenne ne semble pas avoir été poursuivie.  Second document: German patent extended in Europe under the number EP 938110291 whose European procedure does not seem to have been continued.

Dans cette invention, on remplace l'anulus par un sac qui contieni des sphères en matière plastique, ces dernières sont implantées du logement évidé de l'anulus fibrosus par un tube d'insertion de faible diamètre. Pour combler le cavité on insère les sphères une à une, jusqu'au maximum de remplissage qui ne peut être géométriquement parfait.  In this invention, the anulus is replaced by a bag which contains plastic spheres, the latter are implanted hollow housing of the anulus fibrosus by a small diameter insertion tube. To fill the cavity we insert the spheres one by one, up to the maximum filling that can not be geometrically perfect.

Dans la présente invention nous désignerons la prothèse d'anulus intervertébral comme la prothèse remplaçant l'anulus fibrosus.La prothèse d'anulus intervertébral objet de la présente invention est différente des prothèses citées dans les antériorités, par le fait, que la partie essentielle de la prothèse est faite en un seul bloc, contrairement à celles des antériorités qui sont faites à partir d'éléments assemblés et qui de ce fait présente des risques de désolidarisation et de mauvais comportement dans le temps, dégradation partielle de certains de leurs éléments, notamment au niveau des interfaces. Aucune des deux précédentes inventions n'atteignent la nouveauté ni l'activité inventive de la présente, puisque les moyens sont différents en nombre et forme dans chaque cas. De plus, il a fallu tester différentes formes de prothèses pour satisfaire.au problème à résoudre: faire passer la prothèse d'anulus par le tuyau d'insertion, que celle-ci remplisse bien la cavité à combler et qu'elle ne se détériore pas ni à l'insertion ni au cours du vieillissement, ceci grâce à de nombreux essais sur la prothèse Les dessins servant à la compréhension de l'invention sont donnés à titre d'exemples illustratifs et non limitatifs: La figure 1 de la planche 1/6 présente une vue en perspective du système d'insertion et de la prothèse d'anulus.  In the present invention we will designate the intervertebral anulus prosthesis as the prosthesis replacing the anulus fibrosus. The intervertebral anulus prosthesis object of the present invention is different from the prostheses mentioned in the prior art, by the fact that the essential part of the prosthesis is made in a single block, unlike those of anteriorities which are made from assembled elements and which therefore presents risks of uncoupling and bad behavior over time, partial degradation of some of their elements, in particular at the interfaces. Neither of the two previous inventions achieve the novelty or the inventive step of the present, since the means are different in number and form in each case. In addition, it was necessary to test different forms of prostheses to satisfy the problem to be solved: to pass the anulus prosthesis through the insertion tube, that it fills the cavity well to fill and that it does not deteriorate not at the insertion or during aging, this through many tests on the prosthesis The drawings used for understanding the invention are given by way of illustrative and non-limiting examples: Figure 1 of the board 1 / 6 shows a perspective view of the insertion system and the anulus prosthesis.

La figure 2 de la planche 2/6 est une vue éclatée de la prothèse d'anulus et de son dispositif de guidage.  Figure 2 of the board 2/6 is an exploded view of the anulus prosthesis and its guide device.

2.5 La figure 3 de la planche 3/6 est une vue éclatée de la prothèse d'anulus et des moyens qui lui sont associés La figure 4 de la planche 3/6 est une vue en perspective d'un exemple d'insert La figure 5 de la planche 3/6 est une vue de la prothèse 30 assemblée avec l'ensemble de ses moyens La figure 6 de la planche 3/6 est une vue en coupe de la prothèse assemblée La figure 7 de la planche 3/6 est une vue en perspective d'un autre type d'insert.  2.5 Figure 3 of the plate 3/6 is an exploded view of the prosthesis anulus and means associated with it Figure 4 of the plate 3/6 is a perspective view of an example of an insert Figure 5 of the plate 3/6 is a view of the prosthesis 30 assembled with all of its means FIG. 6 of the plate 3/6 is a sectional view of the assembled prosthesis FIG. 7 of the plate 3/6 is a perspective view of another type of insert.

La figure 8 de la planche 4/6 est une vue uniquement en perspective de la prothèse avec son insert clipsé.  Figure 8 of the 4/6 board is a perspective view only of the prosthesis with its clipped insert.

La figure 9 de la planche 4/6 est une vue en coupe et en 5 perspective de la prothèse avec son insert clipsé.  Figure 9 of Plate 4/6 is a sectional and perspective view of the prosthesis with its clipped insert.

La figure 10 de la planche 4/6 uniquement est une vue en coupe de la prothèse avec son insert clipsé.  Figure 10 of the plate 4/6 only is a sectional view of the prosthesis with its clipped insert.

Les figures 11 à 14 de la planche 5/6 donnent les étapes 10 d'insertion La figure 15 de la planche 6/6 montre les phases de mise en place de la prothèse d'anulus intervertébral La prothèse d'anulus intervertébral 1 comprend les moyens essentiels suivants: un anneau 11 fabriqué dans un matériau de préférence viscoélastique dans lequel est intégré au moins un moyen de fixation du type insert 12 en matériau plus rigide que l'anneau 11 qui le reçoit, ledit insert 12 étant muni d'un taraudage 121 permettant de recevoir sur une tige de liaison 21 servant au guidage de la prothèse et comportant à son extrémité un filetage 210.  FIGS. 11 to 14 of plate 5/6 give the insertion steps FIG. 15 of plate 6/6 shows the phases of insertion of the intervertebral anulus prosthesis. The intervertebral anulus prosthesis 1 comprises the following essential means: a ring 11 made of a preferably viscoelastic material in which is integrated at least one fastening means of the insert type 12 of more rigid material than the ring 11 which receives it, said insert 12 being provided with a tapping 121 for receiving on a connecting rod 21 for guiding the prosthesis and having at its end a thread 210.

L'anneau viscoélastique 11 est perforé dans son épaisseur parallèlement a son plan transverse par un trou 111. Ce trou 111 laisse passer la tige 21 autorisant ainsi son coulissement dans l'anneau viscoélastique 11 lors de sa compression lorsque la prothèse 1 est logée dans un compartiment 22 élément du dispositif d'insertion 2.  The viscoelastic ring 11 is perforated in its thickness parallel to its transverse plane by a hole 111. This hole 111 passes the rod 21 thus allowing it to slide in the viscoelastic ring 11 during its compression when the prosthesis 1 is housed in a compartment 22 element of the insertion device 2.

Cette prothèse 1 est monobloc annulaire, elle comporte une cavité centrale 110, et elle présente grâce à son matériau de fabrication M une grande ' aptitude à la compressibilité et à la déformation donc une adaptation parfaite à tout type de cavité , sa tige de guidage et son insert permettent de maîtriser parfaitement l'insertion.  This prosthesis 1 is annular monobloc, it comprises a central cavity 110, and it has thanks to its manufacturing material M a great ability to compressibility and deformation therefore a perfect fit to any type of cavity, its guide rod and its insert makes it possible to perfectly control the insertion.

La prothèse d'anulus 1 est introduite par son dispositif d'insertion 2 qui comprend lui-même: la tige de liaison ou de guidage 21 qui coulisse dans une canule 23 à l'extrémité de laquelle vient se loger sans dépassement dans un compartiment 22 et par compression la prothèse d'anulus 1.  The prosthesis anulus 1 is introduced by its insertion device 2 which itself comprises: the connecting rod or guide 21 which slides in a cannula 23 at the end of which is housed without exceeding in a compartment 22 and by compression the anulus prosthesis 1.

Une poignée 24 amovible,ou solidaire de la tige 21 permet de propulser la prothèse hors de la canule 23 vers le site d'implantation La tige de liaison 21 est munie à son extrémité du filetage 210 qui permet un vissage de ladite tige 21 sur le taraudage 121 de l'insert 12. L'anneau viscoélastique 11 est de préférence fabriqué dans un matériau qui permet d'obtenir: -de grandes déformations de la forma annulaire de l'anneau 11 par compression sans que puissent se produire des ruptures ou des fluages pendant les phases de compression, d'insertion et de fonctionnement "in situ" . -un recouvrement de la forme optimale de la cavité à remplir une fois la prothèse d'anulus 1 insérée.  A handle 24 removable or integral with the rod 21 can propel the prosthesis out of the cannula 23 to the implantation site The connecting rod 21 is provided at its end with the thread 210 which allows a screwing of said rod 21 on the The viscoelastic ring 11 is preferably made of a material which makes it possible to obtain: large deformations of the annular forma of the ring 11 by compression, without any ruptures or failures occurring. fluings during the compression, insertion and "in situ" operation phases. a covering of the optimal shape of the cavity to be filled once the anulus prosthesis 1 has been inserted.

Le matériau utilisé de préférence pour cette prothèse a fait l'objet d'une demande de brevet; dépôt FR 0311286, il s'agit d'un polycarbonate uréthane présentant les caractéristiques:hautes performances mécaniques, viscoélastiques, biocompatibilité, tous les tests obligatoires dans ce domaine ayant été effectués avec succès.  The material preferably used for this prosthesis has been the subject of a patent application; deposit FR 0311286, it is a urethane polycarbonate with the characteristics: high mechanical performance, viscoelastic, biocompatibility, all mandatory tests in this area have been successfully completed.

La forme Fa du moyen viscoélastique 11, qui constitue l'essentiel de la prothèse d'anulus est adaptée au site d'implantation et conforme à la partie supplantée ou substituée; ce moyen 11 partie déformable est monobloc, ceci afin d'éviter tout risque d'expulsion du moyen hors du disque intervertébral.  The shape Fa of the viscoelastic means 11, which constitutes the essential part of the anulus prosthesis, is adapted to the implantation site and conforms to the part supplanted or substituted; this means 11 deformable part is monobloc, this in order to avoid any risk of expulsion of the means out of the intervertebral disc.

L'anneau viscoélastique 11 monobloc,grâce a sa forme Fa annulaire, possède une continuité de matière sur tout son périmètre, il ne possède donc pas d'extrémités susceptibles de provoquer des discontinuités aux interfaces avec les éléments "in vivo" préjudiciables au bon fonctionnement ou qui favoriseraient des des risques d'expulsion de la prothèse.  The one-piece viscoelastic ring 11, thanks to its annular shape Fa, has a continuity of material over all its perimeter, it therefore has no ends likely to cause discontinuities at the interfaces with the elements "in vivo" prejudicial to the proper functioning or that would promote risks of expulsion of the prosthesis.

La tige d'insertion 21 traversant le moyen 1 l fait un angle Sz par rapport à l'axe XX' de symétrie du moyen 11, cette obliquité facilite l'insertion qui n'est plus gênée par les éléments anatomiques 5 qui pourraient se trouver dans l'axe d'insertion Le moyen de fixation de la tige 21 sur l'anneau 11 est un taraudage 121 qui peut être pratiqué directement dans la masse de de l'anneau ou dans un insert 12 rapporté sur cet anneau 11.  The insertion rod 21 passing through the means 11 is at an angle Sz relative to the axis XX 'of symmetry of the means 11, this obliquity facilitates the insertion which is no longer impeded by the anatomical elements 5 which could be found in the axis of insertion The fixing means of the rod 21 on the ring 11 is a tapping 121 which can be made directly in the mass of the ring or in an insert 12 attached to the ring 11.

Dans le cas ou l' insert 12 est rapporté, il s'agit aussi d'une pièce de préférence monobloc à section extérieure 122 non circulaire, présentant au moins un méplat,évitant ainsi la mise en rotation de la tige de liaison 21 qui ne pourrait ni se visser pour l'insertion ni se dévisser après pour l'enlèvement.  In the case where the insert 12 is attached, it is also a preferably one-piece piece 122 outer section with non-circular, having at least one flat, thus avoiding the rotation of the connecting rod 21 which does not could neither screw for insertion nor unscrew afterwards for removal.

Les deux extrémités de l'insert 12 présentent deux épaulements 123a et b évitant également sa désolidarisation vis à vis du moyen 11 viscoélastique. Cet insert 12 peut également venir se clipser sur le moyen 11 (anulus) par simple déformation.Sur cedit moyen 11 a été préalablement prévu un amincissement 112 ( enlèvement de matière) sur lequel viennent se rabattre les extrémités (124a, b,c et d) de l'insert 12.  Both ends of the insert 12 have two shoulders 123a and b also avoiding its detachment vis-a-vis the viscoelastic means 11. This insert 12 can also be clipped onto the means 11 (anulus) by simple deformation.On this said means 11 has been previously provided a thinning 112 (removal of material) on which are folded the ends (124a, b, c and d). ) of the insert 12.

Cet amincissement (figures 9 et 10) permet une répartition homogène des efforts en compression qui s'exercent sur l'anneau 11 pendant son fonctionnement sans provoquer de contraintes élevées pouvant créer une rupture au niveau de l'insert 12.  This thinning (FIGS. 9 and 10) allows a homogeneous distribution of the compressive forces exerted on the ring 11 during its operation without causing high stresses that can create a rupture at the level of the insert 12.

Par ailleurs la présence des extrémités déformables (124 a,b,c et d) de l'insert 12 rabattues par sertissage sur l'amincissement 112 de l'anneau 11 viscoélastique, optimisent son ancrage sur ledit anneau 11 en évitant äinsi le déchaussement dudit insert 12 3 0 vis à vis du moyen 11 Enfin nous décrirons pour bien comprendre l'invention: le procédé P de mise en place qui comprend cinq phases essentielles, (fig 15), il possède une grande facilité de mise en oeuvre.  Moreover, the presence of the deformable ends (124 a, b, c and d) of the insert 12 folded by crimping on the thinning 112 of the viscoelastic ring 11, optimizes its anchoring on said ring 11 thus avoiding the loosening of said insert 12 3 0 vis-a-vis the means 11 Finally we describe to understand the invention: the method P implementation which comprises five essential phases (Figure 15), it has a great ease of implementation.

Phase 1 insertion par compression du moyen 11 dans le compartiment 22 (figure 11) Phase 2 Introduction du compartiment 22 équipé de sa prothèse au niveau de la cavité du disque intervertébral, cavité formée par enlèvement de l'anulus( tout ou partie) (figurel2) Phase 3:Poussée de la prothèse 1 vers son site d'im- plantation à l'aide de la tige 22 Phase 4:Déploiement de la prothèse 1 qui vient occuper complètement la partie en forme d'anneau ( anulus), ceci grâce aux propriétés mécaniques et viscoélastiques du matériau M qui la constitue.  Phase 1 insertion by compression of the means 11 in the compartment 22 (FIG. 11) Phase 2 Introduction of the compartment 22 equipped with its prosthesis at the cavity of the intervertebral disc, cavity formed by removal of the anulus (all or part) (FIG. ) Phase 3: Push prosthesis 1 to its implantation site using the rod 22 Phase 4: Deployment of prosthesis 1 which completely occupies the ring-shaped part (anulus), thanks to the mechanical and viscoelastic properties of the material M which constitutes it.

Phase 5:Enlèvement du dispositif d'insertion 2 par dévissage de la tige d'insertion 21 préalablement décrite La simplicité de fabrication et de mise en oeuvre de cette invention en fait une prothèse d'anulus choisie de préférence par les opérateurs, le risque d'erreur sur la mise en place, étant faible, la durée de l'opération étant réduite par des manipulations aisées,sa durée de vie étant optimisée.  Phase 5: Removal of the insertion device 2 by unscrewing the insertion rod 21 previously described The simplicity of manufacture and implementation of this invention makes it an anulus prosthesis preferably chosen by the operators, the risk of error on implementation, being low, the duration of the operation being reduced by easy handling, its life is optimized.

Claims (5)

REVENDICATIONS -------------------------CLAIMS ------------------------- 1- prothèse d'anulus intervertébral (1) caractérisée en ce qu'elle est monobloc en forme d'anneau (11) , qu'elle présente une grande aptitude à la compressibilité et à la déformation, grâce à son matériau de fabrication (M) qui lui permet une adaptation parfaite à tout type d'évidement intervertébral et qu'elle comporte un moyen de fixation (121) qui peut être relié à une tige de liaison (21), cedit moyen (121) étant de préférence un taraudage appartenant à l'anneau (11) de la prothèse (1) permettant à la tige (21) de la pousser dans la cavité centrale alors qu'elle est compressée un trou (111) perforé transversalement dans le plan de la prothèse,qui permet à la tige (21) de coulisser au travers du trou (111), l'ensemble de ces moyens ayant comme fonction de pouvoir comprimer la prothèse pour la loger sans dépassement dans un compartiment (22) d'un dispositif d'insertion (2) associé ensuite de la transférer de son logement vers le site d'implantation, ceci sans risque de détérioration.  1- intervertebral anulus prosthesis (1) characterized in that it is a monobloc ring-shaped (11), it has a great ability to compressibility and deformation, thanks to its manufacturing material (M ) which allows a perfect adaptation to any type of intervertebral recess and that it comprises a fixing means (121) which can be connected to a connecting rod (21), said means (121) preferably being a tapping belonging to the ring (11) of the prosthesis (1) allowing the rod (21) to push it into the central cavity while it is compressed a hole (111) perforated transversely in the plane of the prosthesis, which allows the the rod (21) to slide through the hole (111), all of these means having the function of being able to compress the prosthesis to accommodate it without passing in a compartment (22) of an insertion device (2) associated then to transfer it from his home to the implantation site, c without risk of deterioration. retirer la tige de liaison (21) servant au guidage à la poussée, jusqu' à son site d'implantation.  remove the connecting rod (21) for thrust guidance, to its site of implantation. 2- prothèse d'anulus intervertébral (1) selon la revendication 1 caractérisée en ce que l'anneau (11) est réalisé en matériau viscoélastique déformable monobloc (M) et que la forme (Fa) de l'anneau viscoélastique (11) est sans discontinuité de matière et adaptée au site d'insertion, conforme à la partie substituée, cette forme annulaire (Fa) permet d'éviter d'une part l'expulsion du moyen (11) hors du disque intervertébral,et d'obtenir d'autre part une bonne stabilité de la prothèse sur le site grâce à sa continuité de matière sur tout le périmètre de l'anneau (11) 3- prothèse d'anulus intervertébral (1) selon l'une quelconque des précédentes revendications caractérisée en ce que le moyen de fixation (121) est intégré â un insert (12) 4- prothèse d'anulus intervertébral (1) selon la revendication 3 caractérisée en ce que l'insert (12) est une pièce monobloc à section extérieure (122) non circulaire présentant au moins un méplat, pour éviter la mise en rotation de la tige de liaison (21) qui ne pourrait ni se visser pour l'insertion ni se dévisser après l'insertion pour l'enlèvement de la tige de liaison (21) les deux extrémités de l'insert rigide (12) présentant au moins deux épaulements (123a et b) évitant également sa désolidarisation vis à vis du moyen (11) viscoélastique.  2- intervertebral anulus prosthesis (1) according to claim 1 characterized in that the ring (11) is made of monobloc deformable viscoelastic material (M) and that the shape (Fa) of the viscoelastic ring (11) is without discontinuity of material and adapted to the insertion site, in accordance with the substituted part, this annular shape (Fa) makes it possible to avoid, on the one hand, the expulsion of the means (11) from the intervertebral disc, and to obtain on the other hand a good stability of the prosthesis on the site thanks to its continuity of material over the entire perimeter of the ring (11) 3- intervertebral anulus prosthesis (1) according to any one of the preceding claims characterized in that that the securing means (121) is integrated with an insert (12) 4- intervertebral anulus prosthesis (1) according to claim 3 characterized in that the insert (12) is a one-piece piece with an outer section (122) non-circular having at least one flat, to avoid the has rotated the connecting rod (21) which could neither screw for insertion nor unscrew after insertion for the removal of the connecting rod (21) the two ends of the rigid insert ( 12) having at least two shoulders (123a and b) also avoiding its detachment vis-a-vis the means (11) viscoelastic. 5- prothèse d'anulus intervertébral (1) selon la revendication 3 caractérisée en ce que l'insert (12) peut également venir se clipser sur le moyen (11) par simple déformation, un amincissement (112) ayant été prévu sur cedit moyen pour permettre le rabattement des extrémités (124a,b,c et d) de l'insert (12), ce moyen (112) permettant une répartition des efforts en compression sur l'anulus (11) sans provoquer des contraintes élevées pouvant entraîner une rupture au niveau de l'insert (12) ou du matériau (M) de l'anneau (11) et la présence des extrémités déformables (124 a, b, c et d) de l'insert (12) rabattues par sertissage sur l'amincissement (112) de l'anneau (11) viscoélastique optimisent l'ancrage dudit insert 12 sur ledit anneau (11) en évitant ainsi son déchaussement.  5-intervertebral anulus prosthesis (1) according to claim 3 characterized in that the insert (12) can also be clipped on the means (11) by simple deformation, a thinning (112) having been provided on said means to allow the ends (124a, b, c and d) of the insert (12) to be folded, this means (112) allowing a distribution of the compressive forces on the anulus (11) without causing high stresses which may lead to rupture at the level of the insert (12) or the material (M) of the ring (11) and the presence of the deformable ends (124 a, b, c and d) of the insert (12) folded by crimping on the thinning (112) of the viscoelastic ring (11) optimizes the anchoring of said insert 12 on said ring (11) thus avoiding its loosening. 6- Dispositif d'insertion (2) pour l'implantation de la prothèse d'anulus intervertébral selon l'une des revendications précédentes caractérisé en ce qu'il possède une poignée (24)fixe ou amovible, solidaire de la tige de liaison ( 21) qui permet de propulser la prothèse hors du compartiment (22) de la canule (23) vers le site d'implantation avec une grande facilité.  6- insertion device (2) for implantation of the intervertebral anulus prosthesis according to one of the preceding claims characterized in that it has a handle (24) fixed or removable, integral with the connecting rod ( 21) which makes it possible to propel the prosthesis out of the compartment (22) of the cannula (23) towards the implantation site with great ease. 7-Dispositif d'insertion (2) pur l'implantation de la prothèse d'anulus intervertébral selon la revendication 6 caractérisé en ce que la tige de liaison (21) est munie à son extrémité du filetage ( 210) qui permet un vissage et un dévissage de ladite tige (21) sur le taraudage (121) prévu dans le moyen annulaire (11) 8 -Dispositif d'insertion (2) pur l'implantation de la prothèse d'anulus intervertébral selon les revendication 6 ou 7 caractérisé en ce que sa tige de liaison (21) traversant le moyen (11) fait un angle Q par rapport à l'axe XX' de symétrie du moyen (11) , cette obliquité facilite l'insertion qui n'est plus gênée par les éléments anatomiques se trouvant dans l'axe d'insertion. 25  7-insertion device (2) for implantation of the intervertebral anulus prosthesis according to claim 6 characterized in that the connecting rod (21) is provided at its end thread (210) which allows screwing and unscrewing said rod (21) on the tapping (121) provided in the annular means (11) 8 -Insertion device (2) for implanting the intervertebral anulus prosthesis according to claim 6 or 7 characterized in that its connecting rod (21) passing through the means (11) makes an angle Q with respect to the axis XX 'of symmetry of the means (11), this obliquity facilitates the insertion which is no longer impeded by the elements anatomical in the insertion axis. 25
FR0401555A 2004-02-17 2004-02-17 PROSTHESIS OF ANULUS INTERVERTEBRAL Expired - Fee Related FR2866227B1 (en)

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