Mechanical apparatus and method for artificial disc replacement

• US 8,021,426 B2
• Filed: 06/15/2005
• Issued: 09/20/2011
• Est. Priority Date: 06/15/2005
• Status: Expired due to Fees

• Current Assignee: Ouroboros Medical Inc.
• Original Assignee: Ouroboros Medical Inc.
• Inventors: Segal, Jerome, Yurek, Matthew Thomas
• Primary Examiner(s): Barrett; Thomas C.
• Assistant Examiner(s): Yang; Andrew
• Application Number:
  US11/153,776
• Publication Number:
  US 20060287726A1
• Time in Patent Office: 2,288 Days
• Field of Search: 606/246, 606/279, 623 1711- 1716
• US Class Current: 623/17.12
• 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: 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 2002/4435 : 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 2310/00365 : Proteins; Polypeptides; Degradation products thereof

Abstract

The present invention relates to a device and method which may be used to reinforce the native annulus during spinal surgery. The device is a catheter based device which is placed into the inter-vertebral space following discectomy performed by either traditional surgical or endoscopic approaches. The distal end of the catheter is comprised of an expansile loop which may be increased in diameter by advancement of a portion of the catheter via its proximal end, such proximal end remaining external to the body. The expansile loop may be formed of a woven or braided material and may be made of a polymer such as nylon, polyurethane, polyester, polyethylene, polypropylene or any of the well known and biocompatible polymers. Alternatively the expansile portion of the catheter may be formed from a metallic braid of stainless steel, elgiloy, Nitinol, or other biocompatible metals. The expansile loop may be formed such that when the loop is diametrically contracted the loop feeds into its other end, similar to a snake eating its own tail. Stabilization of the outer portion of the loop and pulling out the inner portion will thereby increase the overall diameter of the loop while maintaining it as a closed loop or torus. The present invention comprises four embodiments and can be used 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.

Claims

1. An spinal disc device comprising:

a flexible expansile loop, said expansile loop having an interior section, an outer section, said expansile loop composed of a woven, knitted or braided material in a tubular or a flatten form, whereby a portion of said interior section is contained within or engaged to a portion of said outer section, said expansile loop further having an interior chamber and an inner central opening, wherein said expansile loop is designed to be delivered or injected with a biocompatible material(s); and

one or more flexible control elements, said one or more control elements are designed to mechanically expand said expansile loop without pressurization within an inter-vertebral disc.

2. The spinal disc device as recited in claim 1, further comprising an delivery sheath, said delivery sheath having an inner lumen.

3. The spinal disc device as recited in claim 2, whereby said spinal disc device is contained within said inner lumen of said delivery sheath when said spinal disc device is in a contracted delivery configuration.

4. The spinal disc device as recited in claim 1, wherein said expansile loop is composed of braided material in a tubular form.

5. The spinal disc device as recited in claim 1, wherein said expansile loop is composed from a polymeric material.

6. The spinal disc device as recited in claim 1, wherein said expansile loop is composed from a metallic material.

7. The spinal disc device as recited in claim 1, wherein said control elements are composed from a polymeric material.

8. The spinal disc device as recited in claim 1, wherein said control elements are composed from a metallic material.

9. The spinal disc device as recited in claim 3, wherein said spinal disc device attains an expanded configuration when expelled from said outer sheath.

10. The spinal disc device as recited in claim 1 wherein said expansile loop forms a substantially circular shape when said interior section coaxially engages said outer section.

11. The spinal disc device as recited in claim 1, further comprising an inner chamber which is substantially continuous around said substantially circular shape.

12. The spinal disc device as recited in claim 1, further comprising the function to deliver within said inner chamber a biocompatible material to the inter-vertebral space.

13. The spinal disc device as recited in claim 11, wherein said inner chamber is filled with a polymeric material.

14. The spinal disc device as recited in claim 12, wherein one or more of said biocompatible 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.

15. The spinal disc device as recited in claim 12, wherein one or more of said biocompatible materials 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.

16. The spinal disc device as recited in claim 12, wherein one or more biocompatible materials 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.

17. The spinal disc device as recited in claim 12, wherein one or more biocompatible materials 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, nylon fibers, carbon fibers, glass fibers, collagen fibers, ceramic fibers, polyethylene fibers, poly(ethylene terephthalate), polyglycolides, polylactides, and combinations thereof.

18. The spinal disc device as recited in claim 1, wherein said spinal disc device is adapted to promote spinal fixation between two adjacent vertebral bodies.

19. The spinal disc device as recited in claim 1, wherein said spinal disc device is deformable to conform to an interior region of a vertebral disc.

20. The spinal disc device as recited in claim 12, wherein said spinal disc device is adapted to inject a volume of biocompatible material into said inner chamber of said expansile loop until a desired disc height is achieved.

21. The spinal disc device as recited in claim 12, wherein said spinal disc device is adapted to inject an volume of biocompatible material into said inner chamber of said expansile loop until a desired disc pressure is achieved.

22. The spinal disc device as recited in claim 1, wherein said one or more control elements are designed to be removed from said expansile loop.