Mechanical apparatus and method for artificial disc replacement

• US 7,547,319 B2
• Filed: 02/22/2006
• Issued: 06/16/2009
• Est. Priority Date: 06/15/2005
• Status: Expired due to Fees

• Current Assignee: Ouroboros Medical Inc.
• Original Assignee: Ouroboros Medical Inc.
• Inventors: Yuan, Hansen A., Yeung, Anthony Tung, Segal, Jerome, Yurek, Matthew Thomas
• Primary Examiner(s): Robert; Eduardo C
• Assistant Examiner(s): Yang; Andrew
• Application Number:
  US11/359,335
• Publication Number:
  US 20060287730A1
• Time in Patent Office: 1,210 Days
• Field of Search: 606/61, 606/246, 606/279, 623 1711- 1716, 604/500, 604/506
• US Class Current: 606/279
• CPC Class Codes: A61B 17/04 for suturing wounds; Holders or packages for needles or suture materials suture materials A61L17/00
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/842 Flexible wires, bands or straps A61B17/72, A61B17/82, A61B17/86 take precedence
• CPC Class Codes: A61B 17/86 Pins or screws or threaded wires; nuts therefor A61B17/72 take precedence
• CPC Class Codes: A61B 17/869 characterised by an open form, e.g. wire helix
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/441 made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
• CPC Class Codes: A61F 2/4455 for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages intervertebral discs A61F2/442
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2002/2835 Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30075 swellable, e.g. when wetted
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/302 toroidal, e.g. rings
• CPC Class Codes: A61F 2002/30235 tubular, e.g. sleeves
• CPC Class Codes: A61F 2002/30462 retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2002/3052 unrestrained in only one direction, e.g. moving unidirectionally
• CPC Class Codes: A61F 2002/30579 with mechanically expandable devices, e.g. fixation devices
• CPC Class Codes: A61F 2002/30583 : filled with hardenable fluid, e.g. curable in-situ
• CPC Class Codes: A61F 2002/30601 : telescopic
• CPC Class Codes: A61F 2002/4415 : elements of the prosthesis being arranged in a chain like manner
• CPC Class Codes: A61F 2002/4435 : Support means or repair of the natural disc wall, i.e. annulus, e.g. using plates, membranes or meshes
• CPC Class Codes: A61F 2002/444 : for replacing the nucleus pulposus
• CPC Class Codes: A61F 2002/4495 : having a fabric structure, e.g. made from wires or fibres
• CPC Class Codes: A61F 2002/4627 : 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
• CPC Class Codes: A61F 2002/4629 : connected to the endoprosthesis or implant via a threaded connection
• CPC Class Codes: A61F 2210/0004 : bioabsorbable
• CPC Class Codes: A61F 2210/0014 : using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0061 : swellable
• CPC Class Codes: A61F 2210/0085 : hardenable in situ, e.g. epoxy resins
• CPC Class Codes: A61F 2220/0025 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0075 : sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0065 : toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2310/00011 : Metals or alloys
• CPC Class Codes: A61F 2310/00353 : Bone cement, e.g. polymethylmethacrylate or PMMA
• CPC Class Codes: A61F 2310/00359 : Bone or bony tissue
• CPC Class Codes: A61F 2310/00365 : Proteins; Polypeptides; Degradation products thereof

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 diskectomy. The invention includes a delivery catheter and an expandable continuous mesh loop that has a torus configuration with a lumen within the mesh loop and a center 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 from a polymer such as PEEK (polyetheretherketone), nylon, polyurethane, polyester polyethylene, polypropylene or any other biocompatible polymers, or formed from a metallic braid of stainless steel, elgiloy, Nitinol, or any other biocompatible metals.

Claims

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 a circumferentially expandable device into the inter-vertebral space to repair or reinforce a damaged annulus or replace a damaged nucleus, said expandable device comprised of a mechanical expandable continuous mesh loop and a control element, said expandable mesh loop mechanically expanded or contracted with said control element without pressurization;

positioning said mechanically expandable continuous mesh loop within said annulus such that said expansile loop substantially encircles the inside of the annulus; and

mechanically expanding said expandable continuous mesh loop substantially circumferentially within said annular space using said control element that interacts with said mesh for expanding or contracting, said expanded mesh having an inside surface whereby expanding said expansile loop forms an inner central area.

2. The method of treating inter-vertebral disc as recited in claim 1 including the step of subsequently delivering and injecting a suitable biocompatible material into said inner central area to replace at least a portion of said damaged nucleus tissue.

3. The method of treating inter-vertebral disc as recited in claim 2, wherein said biocompatible material 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.

4. The method of treating inter-vertebral disc as recited in claim 2, wherein said biocompatible material is formed of a material that is allowed to expand through the adsorption of liquids such as water selected from the group consisting of polyacrliamide, polyacrylonitrile, polyvinyl alcohol or other biocompatible hydrogels, solid fibrous collagen or other suitable hydrophilic biocompatible material or combinations thereof.

5. The method of treating inter-vertebral disc as recited in claim 2, wherein said biocompatible material is formed of a material selected from the group consisting of steroids, antibiotics, tissue necrosis factor alpha or its antagonists, analgesics, growth factors, genes or gene vectors in solution;

biologic materials (hyaluronic acid, non-crosslinked collagen, fibrin, liquid fat or oils);

Synthetic polymers (polyethylene glycol, liquid silicones, synthetic oils), saline or combinations thereof.

6. The method of treating inter-vertebral disc as recited in claim 2, wherein said biocompatible material is formed of a material selected from the group consisting of bone graft materials such as any described “

bone cements”

or any polymeric bone graft compounds, bone graft materials, bone chips, nylon fibers carbon fibers, glass fibers, collagen fibers, ceramic fibers, polyethylene fibers, poly(ethylene terephthalate), polyglycolides, polylactides, and combinations thereof.

7. The method of treating inter-vertebral disc as recited in claim 1, wherein said spinal disc device is adapted to promote spinal fixation between two adjacent vertebral bodies.

8. The method of treating inter-vertebral disc as recited in claim 1, wherein said spinal disc device is substantially circumferentially deformable to conform to an interior region of a vertebral disc.

9. The method of treating inter-vertebral disc as recited in claim 1, wherein said spinal disc device is adapted to inject a volume of biocompatible material into said inner central area of said expansile loop until a desired disc height is achieved.

10. The method of treating inter-vertebral disc as recited in claim 1, wherein said spinal disc device is adapted to inject a volume of biocompatible material into said inner central area of said expansile loop until a desired disc pressure is achieved.

11. A method for treating an inter-vertebral disc in a patient'"'"'s spine, the disc having an annulus and a nucleus, the method comprising:

enclosing a biomaterial within an internal chamber of a circumferentially configured continuous expansile mesh loop resulting in a preloaded expansile loop;

advancing said preloaded expansile loop device into the inter-vertebral space to repair or circumferentially reinforce a damaged annulus or nucleus; and

mechanically circumferentially expanding, without pressurization, said preloaded expansile loop by using a control element, said preloaded expansile loop circumferentially expanding within said inter-vertebral space to inner portion of the native annulus whereby a bone allograft, autograft or bone cage is maintained within the inner portion of the expansile loop.

12. The method of treating inter-vertebral disc as recited in claim 11, wherein said biomaterial is formed of a material selected from the group consisting of hycirophilic 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.

13. The method of treating inter-vertebral disc as recited in claim 11, wherein said biomaterial is formed of a material that is allowed to expand through the adsorption of liquids such as water selected from the group consisting of polyacrliamide, polyacrylonitrile, polyvinyl alcohol or other biocompatible hydrogels, solid fibrous collagen or other suitable hydrophilic biocompatible material or combinations thereof.

14. The method of treating inter-vertebral disc as recited in claim 11, wherein said biomaterial is formed of a material selected from the group consisting of bone graft materials such as any described “

bone cements”

or any polymeric bone graft compounds, bone graft materials, bone chips, nylon fibers, carbon fibers, glass fibers, collagen fibers, ceramic fibers, polyethylene fibers, poly (ethylene terephthalate), polyglycolides, polylactides, and combinations thereof.

15. The method of treating inter-vertebral disc as recited in claim 11, wherein said spinal disc device is adapted to promote spinal fixation between two adjacent vertebral bodies.

16. The method of treating inter-vertebral disc as recited in claim 11, wherein said spinal disc device is deformable to conform to an interior region of a vertebral disc.

17. An apparatus for treating an inter-vertebral disc in a patient'"'"'s spine, comprising:

An internal shaft member;

said shaft member having a proximal end and a terminal end, said terminal end fitted with a first attachment means;

an inner tubular member, said inner tubular member in coaxial alignment with said shaft member, said inner tubular member having a proximal end and a terminal end;

an outer tubular member, said outer tubular member surrounding at least a portion of said inner tubular member, said outer tubular member having a proximal end and a terminal end;

an expansile continuous mesh loop, said expansile mesh loop having one or more control elements, said one or more control elements functioning to expand or contract said expansile mesh by acting on said mesh loop without pressurization, said expansile mesh exiting said terminal end of said inner tubular member; and

said control elements in close proximity to said expansile mesh entering from said terminal end of said outer tubular member and extending the longitudinal length of said outer tubular member.

18. An apparatus for treating an inter-vertebral disc in a patient'"'"'s spine, comprising;

An internal shaft member;

said shaft member having a proximal end and a terminal end, said terminal end fitted with a first attachment means;

an inner tubular member, said inner tubular member in coaxial alignment with said shaft member, said inner tubular member having a proximal end and a terminal end;

an outer tubular member, said outer tubular member surrounding at least a portion of said inner tubular member, said outer tubular member having a proximal end and a terminal end;

a circumferentially continuous expansile mesh loop, said expansile mesh having one or more control elements, said expansile mesh exiting said terminal end of said inner tubular member;

said control elements in close proximity to said expansile mesh entering from said terminal end of said outer tubular member and extending the longitudinal length of said outer tubular member;

a bone block or bone cage, said bone block or bone cage having a second attachment means on one side; and

said second attachment means designed to become temporarily engaged with said first attachment means.