Mechanical apparatus and method for artificial disc replacement

Abstract

The present invention relates to a device and method to 1) facilitate disk fusing, 2) perform an artificial replacement of the nucleus, 3) perform an artificial replacement of the annulus, or 4, perform an artificial replacement of both the nucleus and annulus. The device is designed to be placed into the inter-vertebral space following diskoctomy. The invention includes a delivery catheter and an expandable continuous mesh loop that has a torus configuration with a lumen within the mesh and a central hole. The mesh loop can be diametrically increased or contracted in diameter by the control element acting on the mesh loop. The mesh loop may be formed of a woven or braided material for a polymer such as PEEK (polyetheretherketone), nylon, polyurethane, polyester, polyethylene, polypropylene or any other biocompatible polymer, or formed from a metallic braid of stainless steel, Elgiloy, Nitinol, or any other biocompatible metal.

1 . A method for treating an inter-vertebral disc in a patient's spine, the disc having an annulus and a nucleus, the method comprising:
 inserting an artificial disc replacement device to repair or replace damaged or extracted nucleus tissue;   positioning a continuous mesh loop in the inter-vertebral space such that said continuous mesh loop substantially encircles the nucleus space;   said continuous mesh loop having an inner chamber;   mechanically expanding the continuous mesh loop using a control element that interacts with said continuous mesh loop within said nucleus space to the limits of the remaining annulus, prior to injecting any biomaterial into said inner chamber; and   delivering and injecting a suitable biomaterial into said inner chamber in order to replace at least a portion of removed or damaged nucleus tissue.   
     
     
         2 . A method for treating an inter-vertebral disc in a patient's spine, the disc having an annulus and a nucleus, the method comprising:
 inserting an artificial disc replacement device into the inter-vertebral space in order to reinforce or repair damaged annular tissue;   positioning a continuous mesh loop around the inside of said annular tissues such that the continuous mesh loop circumferentially encircles an annular space;   expanding the continuous mesh loop within said vertebral space to the limits of the remaining annulus fiborosis without first pressurizing the continuous mesh loop or first injecting material into said inner chamber;   inserting an artificial nucleus replacement device to an area of the damaged or removed nucleus pulposis;   positioning said continuous mesh loop around said nucleus replacement such that the continuous mesh loop substantially encircles said nucleus device; and   further mechanically expanding the continuous mesh loop around said nucleus space and device using a control element that interacts with said continuous mesh loop.   
     
     
         3 . A method for treating an inter-vertebral disc in a patient's spine, the disc having an annulus and a nucleus, the method comprising:
 inserting an artificial disc replacement device into the inter-vertebral space in order to reinforce or repair damaged annular tissue;   positioning a continuous mesh loop around the inside of said annular tissues such that the continuous mesh loop circumferentially encircles an annular space;   using a control element that interacts with said continuous mesh loop to expand said continuous mesh loop within said vertebral space to the limits of the remaining annulus fiboros without first injecting material into said inner chamber;   inserting or injecting an artificial nucleus replacement device to a the area of the damaged or removed nucleus pulposis;   positioning said continuous mesh loop around said nucleus replacement such that the continuous mesh loop substantially encircles said nucleus device;   further mechanically expanding the continuous mesh loop around said nucleus space and device; and   delivering and injecting a suitable biomaterial to replace at least a portion of said nucleus tissue.   
     
     
         4 . A method for treating an inter-vertebral disc in a patient's spine, the disc having an annulus and a nucleus, the method comprising:
 Surgically removing at least a portion of the native nucleus between the adjacent vertebrae;   Said artificial disc replacement device comprising a continuous mesh loop capable of expanding without pressurization or injection of material;   inserting an artificial disc replacement device within the inter-vertebral space between two adjacent vertebrae;   positioning said continuous mesh loop within said inter-vertebral space;   using a control element that interacts with said continuous mesh loop mechanically expanding said continuous mesh loop such that an outside surface expands to the limits of the inner portion of a native annulus;   expanding the continuous mesh loop such that an inside surface expands to the limits of the area previously occupied by the native nucleus; and   delivering and injecting a suitable biomaterial to facilitate the fusion of said two adjacent vertebrae.   
     
     
         5 . A method for treating an inter-vertebral disc in a patient's spine, the disc having an annulus and a nucleus, the method comprising:
 Surgically removing at least a portion of the native nucleus between the adjacent vertebrae;   inserting an artificial disc replacement device within the inter-vertebral space between two adjacent vertebrae, said artificial disc replacement device comprising a mechanically expansile continuous mesh loop capable of expanding without pressurization or injection of material, said artificial disc replacement device having a central area, said artificial disc replacement device enclosing an nucleus replacement material within said central area, said nucleus replacement material having a central waist and two terminal areas;   positioning said mechanically expansile continuous mesh loop within said inter-vertebral space;   diametrically expanding the continuous mesh loop using a control element that interacts with said continuous mesh loop such that an outside surface expands to the limits of the inner portion of a native annulus;   expanding the continuous mesh loop such that the control element disproportionately contracts said nuclear replacement material whereby said control element constricts said central waist more than said terminal ends.   
     
     
         6 . The method as recited in  claim 5 , wherein said nuclear replacement materials is formed of a material selected from the group consisting of hydrophilic polymers, hydrogels, homopolymer hydrogels, copolymer hydrogels, multi-polymer hydrogels, or interpenetrating hydrogels, acrylonitrile, acrylic acid, acrylimide, acrylimidine, including but not limited to PVA, PVP, PHEMA, PNVP, polyacrylainides, poly(ethylene oxide), polyvinyl alcohol, polyarylonitrile, and polyvinyl pyrrolidone, silicone, polyurethanes, polycarbonate-polyurethane (e.g., Corethane) other biocompatibile polymers, or combinations thereof. 
     
     
         7 . A method for treating an inter-vertebral disc in a patient's spine, the method comprising:
 inserting an artificial disc replacement device within the inter-vertebral space said artificial disc replacement device having a central area, said artificial disc replacement device enclosing an nucleus replacement material within said central area, said nucleus replacement material having a centrally located waist and two terminal end areas;   positioning said mechanically expansile continuous mesh loop within said inter-vertebral space;   diametrically expanding the expansile continuous mesh loop with a control element that interacts with said expansile continuous mesh loop such that an outside surface of the continuous mesh loop expands to the limits of the inner portion of a native annulus, whereby said expanding disproportionately contracts said nuclear replacement material such that said expansile continuous mesh loop constricts said centrally located waist more than said terminal ends.   
     
     
         8 . The method as recited in  claim 7 , wherein said nuclear replacement materials is formed of a material selected from the group consisting of hydrophilic polymers, hydrogels, homopolymer hydrogels, copolymer hydrogels, multi-polymer hydrogels, or interpenetrating hydrogels, acrylonitrile, acrylic acid, acrylimide, acrylimidine, including but not limited to PVA, PVP, PHEMA, PNVP, polyacrylainides, poly(ethylene oxide), polyvinyl alcohol, polyarylonitrile, and polyvinyl pyrrolidone, silicone, polyurethanes, polycarbonate-polyurethane (e.g., Corethane) other biocompatibile polymers, or combinations thereof. 
     
     
         9 . A method for treating an inter-vertebral disc in a patient's spine, the method comprising:
 inserting an artificial disc replacement device within the inter-vertebral space, said artificial disc replacement device having a central area and a central lumen;   positioning said mechanically expansile continuous mesh loop within said inter-vertebral space;   expanding the expansile continuous mesh loop with a control element that interacts with said expansile continuous mesh loop to a first configuration such that an outside surface of the expansile continuous mesh loop expands to the limits of the inner portion of a native annulus;   injecting said nucleus replacement within said central lumen, said nucleus replacement material having a centrally located waist and two terminal end areas;   expanding the expansile continuous mesh loop to a second configuration whereby said expanding disproportionately contracts said nuclear replacement material such that said expansile loop constricts a centrally located waist more than said terminal ends.   
     
     
         10 . The method as recited in  claim 9 , wherein said nuclear replacement materials is formed of a material selected from the group consisting of hydrophilic polymers, hydrogels, homopolymer hydrogels, copolymer hydrogels, multi-polymer hydrogels, or interpenetrating hydrogels, acrylonitrile, acrylic acid, acrylimide, acrylimidine, including but not limited to PVA, PVP, PHEMA, PNVP, polyacrylainides, poly(ethylene oxide), polyvinyl alcohol, polyarylonitrile, and polyvinyl pyrrolidone, silicone, polyurethanes, polycarbonate-polyurethane (e.g., Corethane) other biocompatibile polymers, or combinations thereof. 
     
     
         11 . A method for treating an inter-vertebral disc as recited in  claim 1 , further comprising;
 withdrawing said control element from said expandable loop after the last step of expanding the expansile continuous mesh loop.   
     
     
         12 . A method for treating an inter-vertebral disc as recited in  claim 2 , further comprising;
 withdrawing said control element from said expandable loop after the last step of mechanically expanding the expansile loop.   
     
     
         13 . A method for treating an inter-vertebral disc as recited in  claim 3 , further comprising;
 withdrawing said control element from said continuous mesh loop after the step of mechanically expanding the continuous mesh loop.   
     
     
         14 . A method for treating an inter-vertebral disc as recited in  claim 4 , further comprising;
 withdrawing said control element from said continuous mesh loop after the step of expanding the continuous mesh loop.   
     
     
         15 . A method for treating an inter-vertebral disc as recited in  claim 5 , further comprising;
 withdrawing said control element from said mechanically expansile continuous mesh after the last step of expanding the mechanically expansile continuous mesh.   
     
     
         16 . A method for treating an inter-vertebral disc as recited in  claim 7 , further comprising;
 withdrawing said control element from said mechanically expansile continuous mesh after the last step of diametrically expanding the mechanically expansile continuous mesh.   
     
     
         17 . A method for treating an inter-vertebral disc as recited in  claim 9 , further comprising;
 withdrawing said control element from said expandable loop after the last step of expanding the mechanically expansile continuous mesh.