FR2639823A1 - Replacement of the nucleus of the intervertebral disc by a polyurethane polymerised in situ - Google Patents

Replacement of the nucleus of the intervertebral disc by a polyurethane polymerised in situ Download PDF

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Publication number
FR2639823A1
FR2639823A1 FR8816184A FR8816184A FR2639823A1 FR 2639823 A1 FR2639823 A1 FR 2639823A1 FR 8816184 A FR8816184 A FR 8816184A FR 8816184 A FR8816184 A FR 8816184A FR 2639823 A1 FR2639823 A1 FR 2639823A1
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Prior art keywords
bag
polyurethane
tube
nucleus
mixture
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Granted
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FR8816184A
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French (fr)
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FR2639823B1 (en
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4603—Special 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
    • A61F2/4611—Special 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/441—Joints for the spine, e.g. vertebrae, spinal discs made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A61L27/18—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The 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
    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30581—Special structural features of bone or joint prostheses not otherwise provided for having a pocket filled with fluid, e.g. liquid
    • A61F2002/30583—Special structural features of bone or joint prostheses not otherwise provided for having a pocket filled with fluid, e.g. liquid filled with hardenable fluid, e.g. curable in-situ
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/442—Intervertebral or spinal discs, e.g. resilient
    • A61F2002/444—Intervertebral or spinal discs, e.g. resilient for replacing the nucleus pulposus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2002/4635—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor using minimally invasive surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2002/465—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor using heating means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0085—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof hardenable in situ, e.g. epoxy resins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/38—Materials or treatment for tissue regeneration for reconstruction of the spine, vertebrae or intervertebral discs

Abstract

The invention consists of a method, a device and a product permitting replacement of the nucleus of the intervertebral disc after enucleation of the latter. The method consists in polymerising, in the cavity 4, a mixture 7 resulting in the formation of a polymer. The device consists of a bag 1 attached to a tube 2. The mixture 7, injected into the bag 1, reacts to form a polyurethane. A device 3 permits closure of the bag 1. The device permits restoration of the functions of the intervertebral articulation.

Description

La présente invention concerne un dispositif permettant le remplacement d'une partie (le nucléus) des disques intervertébraux par un matériau implanté. The present invention relates to a device for replacing a part (the nucleus) of the intervertebral discs with an implanted material.

Un polyuréthane (10) est polymérisé directement dans la cavité (4) crée à l'occasion d'une nucléotomie ou d'une chémonucléolyse. A polyurethane (10) is polymerized directly in the cavity (4) created during a nucleotomy or a chemonucleolysis.

Ce dispositif vise à rétablir les fonctions de mobilité et d'amortissement des disques lésés sans mettre en place une prothèse totale du disque intervertébral. This device aims to restore the mobility and damping functions of the injured discs without installing a total prosthesis of the intervertebral disc.

Le dispositif comporte un sac (1) en polyéthylène étanche et vide d'air, fixé sur l'extrémité (8) du tube (2). The device comprises a bag (1) of airtight and airtight polyethylene, fixed to the end (8) of the tube (2).

Le tube (2) présente une extrémité (8) et une extrémité (9). The tube (2) has an end (8) and an end (9).

Le tube (2) présente à son extrémité (8) une résistance chauffante (3) permettant la fermeture du sac (1) par thermo-soudure
Le tube (2) est introduit par le trocart (5) dans la cavité (4) résultant de l'élimination du nucléus
La voie d'accès est la meme que celle utilisée pour la nucléotomie ou la chémonucléolyse.The tube (2) has at its end (8) a heating resistance (3) allowing the closure of the bag (1) by heat sealing
The tube (2) is introduced through the trocar (5) into the cavity (4) resulting from the elimination of the nucleus
The access route is the same as that used for nucleotomy or chemonucleolysis.

Un mélange (7) de monomères et de catalyseurs est injecté au travers du tube (2) à l'intérieur du sac (1) afin de combler la cavité (4). A mixture (7) of monomers and catalysts is injected through the tube (2) inside the bag (1) in order to fill the cavity (4).

Après soudure du sac (1), grâce à la résistance (3), la polymérisation se poursuit à 370 pendant 30 minutes environ. After sealing the bag (1), thanks to the resistance (3), the polymerization continues at 370 for approximately 30 minutes.

Elle aboutit à la formation d'un polyuréthane (10) selon la formule de la figure 3.It results in the formation of a polyurethane (10) according to the formula in FIG. 3.

Le tube et le trocart sont ensuite retirés. The tube and the trocar are then removed.

Une variante consiste à injecter des microbilles (11) du polyuréthane (10) à l'intérieur du sac (1). A variant consists in injecting microbeads (11) of polyurethane (10) inside the bag (1).

La figure 1 représente en coupe le tube (2) et le trocart (5). Figure 1 shows in section the tube (2) and the trocar (5).

La figure 2 représente le disque intervertébral en coupe axiale et les trois étapes de la polymérisation in situ dans la cavité (4). Figure 2 shows the intervertebral disc in axial section and the three stages of in situ polymerization in the cavity (4).

La figure 3 représente la réaction chimique aboutissant à la formation du polyuréthane (10).  Figure 3 shows the chemical reaction leading to the formation of polyurethane (10).

La figure 4 représente la variante. Figure 4 shows the variant.

Le sac (1) est constitué d'un film de polyéthylène imperméable dont l'épaisseur est de 0,1 mm. Son volume atteint 2 cm3 environ après expansion. The bag (1) consists of a waterproof polyethylene film whose thickness is 0.1 mm. Its volume reaches approximately 2 cm3 after expansion.

Le tube (2) a une dimension de 25 cm de longueur pour un diamètre de 3 mm. Il peut etre réalisé en acier inoxydable. The tube (2) has a dimension of 25 cm in length for a diameter of 3 mm. It can be made of stainless steel.

La réaction chimique aboutissant à la formation du polyuréthane (10) résulte du mélange (7) suivant
Hylene W (marque déposée) I NCO.The chemical reaction leading to the formation of the polyurethane (10) results from the following mixture (7)
Hylene W (registered trademark) I NCO.

Butanediol 1-4 0,5 OH. Butanediol 1-4 0.5 OH.

Polymeg 1000 (marque déposée) 0,5 OH. Polymeg 1000 (registered trademark) 0.5 OH.

Dilaurate de dimethyl étain 0,02 X du mélange. 0.02 X dimethyl tin dilaurate of the mixture.

Le dispositif peut etre réalisé sous forme d'un kit stérile, pret à l'emploi, permettant le réchauffement préalable des monomères utilisés. The device can be produced in the form of a sterile kit, ready to use, allowing the prior heating of the monomers used.

Le dispositif, selon l'invention, est destiné à etre placé par des médecins et chirurgiens après nucléotomie ou chémonucléolyse dans le but de rétablir la fonction articulaire intervertébrale.  The device according to the invention is intended to be placed by doctors and surgeons after nucleotomy or chemonucleolysis in order to restore the intervertebral joint function.

Claims (6)

REVENDICATIONS 1) Dispositif chirurgical pour la mise en place d'une prothèse du nucleus d'un disque intervertébral, après nucléotomie ou chémonucléolysée et formation résultante d'une cavité (4) dans le disque. Ce dispositif est caractérisé en ce qu'il comporte un tube (2) apte à entre inséré dans un trocart (5). 1) Surgical device for placing a nucleus prosthesis of an intervertebral disc, after nucleotomy or chemonucleolysis and resulting formation of a cavity (4) in the disc. This device is characterized in that it comprises a tube (2) capable of entering inserted into a trocar (5). Le tube (2# présente une extrémité antérieure (8) garnie d'un sac (1) expansible et une extrémité postérieure (9) reliée à un moyen d'injection d'un d'un produit permettant d'expanser le sac (1) dans la cavité (4)The tube (2 # has an anterior end (8) provided with an expandable bag (1) and a posterior end (9) connected to a means for injecting a product allowing the bag (1) to be expanded. ) in the cavity (4) 2) Dispositif chirurgical selon la revendication 1, caractérisé en ce que te produit Introduit dans le sac (1) soit ou bien un mélange apte à se polymériser, ou bien des microbilles de polyuréthan-e.  2) Surgical device according to claim 1, characterized in that the product introduced into the bag (1) is either a mixture capable of polymerizing, or microbeads of polyurethane. 3) Dispositif selon l'une des revendications 1 et 2, caractérise en ce que l'extrémité antérieure (8) du tube (2) est équipés de tiens chauffants aptes à provoquer le scellement du sac (1)..  3) Device according to one of claims 1 and 2, characterized in that the anterior end (8) of the tube (2) is equipped with heating pads capable of causing the sealing of the bag (1) .. 4) Dispositif selon l'une quelconque des revendications 1 à 3 caractérise en ce que le sac (1) est en polyéthylène. 4) Device according to any one of claims 1 to 3 characterized in that the bag (1) is made of polyethylene. 5) Dispositif selon la revendication 1, caractérisé en ce que le mélange apte à se polymériser comprend au moins un isocyanate, au moins un pclyol et au moins un catalyseur approprié. 5) Device according to claim 1, characterized in that the mixture capable of polymerizing comprises at least one isocyanate, at least one pclyol and at least one suitable catalyst. 6) Dispositif selon la revendication 5, caractérisé en ce que le mélange d'isocyanate, polyol et catalyseur est adapté à se polymérise à 37çlc, en environ 30 minutes.  6) Device according to claim 5, characterized in that the mixture of isocyanate, polyol and catalyst is adapted to polymerize at 37 cc, in about 30 minutes.
FR8816184A 1988-12-06 1988-12-06 Replacement of the nucleus of the intervertebral disc by a polyurethane polymerised in situ Granted FR2639823A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
FR8816184A FR2639823A1 (en) 1988-12-06 1988-12-06 Replacement of the nucleus of the intervertebral disc by a polyurethane polymerised in situ

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
FR8816184A FR2639823A1 (en) 1988-12-06 1988-12-06 Replacement of the nucleus of the intervertebral disc by a polyurethane polymerised in situ

Publications (2)

Publication Number Publication Date
FR2639823A1 true FR2639823A1 (en) 1990-06-08
FR2639823B1 FR2639823B1 (en) 1994-12-23

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Cited By (73)

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US5047055A (en) * 1990-12-21 1991-09-10 Pfizer Hospital Products Group, Inc. Hydrogel intervertebral disc nucleus
WO1992010982A1 (en) * 1990-12-21 1992-07-09 Howmedica Inc. Hydrogel intervertebral disc nucleus
US5171278A (en) * 1991-02-22 1992-12-15 Madhavan Pisharodi Middle expandable intervertebral disk implants
EP0621020A1 (en) * 1993-04-21 1994-10-26 SULZER Medizinaltechnik AG Intervertebral prosthesis and method of implanting such a prosthesis
FR2705351A1 (en) * 1993-05-18 1994-11-25 Garcia Alain A method of making and preserving a polymerizable mixture leading to a polyurethane for filling biological cavities.
US5390683A (en) * 1991-02-22 1995-02-21 Pisharodi; Madhavan Spinal implantation methods utilizing a middle expandable implant
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US5549679A (en) * 1994-05-20 1996-08-27 Kuslich; Stephen D. Expandable fabric implant for stabilizing the spinal motion segment
ES2094077A1 (en) * 1993-04-19 1997-01-01 Lopez Rudolf Morgenstern Prosthesis for intervertebral disc nuclei and process for using same
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