Mechanical apparatus and method for artificial disc replacement

• US 20060287727A1
• Filed: 07/01/2005
• Published: 12/21/2006
• Est. Priority Date: 06/15/2005
• Status: Active Grant

• Current Assignee: Ouroboros Medical Inc.
• Original Assignee: Ouroboros Medical Inc.
• Inventors: Segal, Jerome, Yurek, Matthew Thomas
• Granted Patent: US 7,442,210 B2
• Time in Patent Office: Days
• US Class Current: 623/17.120
• 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 2/44 for the spine, e.g. vertebrae, spinal discs
• 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. A method for artificial disc replacement comprising the steps of introducing a first solution having a biocompatible solvent and a biocompatible polymer into the inter-vertebral space and a second step of introducing an second solution into the inter-vertebral space whereby a semi-solid or solid media is formed within the inter-vertebral space to replace the annulus, nucleus, or annulus and nucleus.

2. The method of claim 1 wherein introducing the second solution includes the step of precipitating the biocompatible polymer from the first solution so that the biocompatible polymer solidifies within the inter-vertebral space and the biocompatible solvent disperses into body tissues.

3. The method of claim 1 wherein said first solution comprises a material liquid at least at body temperature of the mammal in which the biocompatible polymer is soluble.

4. The method of claim 3 wherein said material liquid is formed from a material selected from the group consisting of dimethylsulfoxide, analogues/homologues of dimethylsulfoxide, ethanol, ethyl lactate, acetone, or combinations thereof.

5. The method of claim 1 wherein one or more of said biocompatible polymers are 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.

6. The method of claim 1 wherein said second solution is formed of solvents selected from the group consisting of water and saline solutions, or combinations thereof.

7. The method for artificial disc replacement comprising the step of introducing a solution having a biocompatible solvent and a biocompatible polymer into the inter-vertebral space whereby body fluids replace the solvent and a semi-solid or solid media is formed within the inter-vertebral space to replace the annulus, nucleus, or annulus and nucleus.

8. The method of claim 7 wherein said body fluids precipitate the biocompatible polymer from the solution so that the biocompatible polymer solidifies within the inter-vertebral space and the biocompatible solvent disperses into body tissues.

9. The method of claim 7 wherein said solution comprises a material liquid at least at body temperature of the mammal in which the biocompatible polymer is soluble.

10. The method of claim 9 wherein said liquid material is formed from a material selected from the group consisting of dimethylsulfoxide, analogues/homologues of dimethylsulfoxide, ethanol, ethyl lactate, acetone, or combinations thereof.

11. The method of claim 7 wherein one or more of said biocompatible polymers are 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.

12. The method of claim 7 wherein the body fluids are formed of solvents selected from the group consisting of water and saline solutions, or combinations thereof.

13. A method for artificial disc replacement comprising the steps of dispensing a first solution having a biocompatible solvent and a biocompatible polymer within a flexible and expandable expansile loop that is positioned within the inter-vertebral space and a second step of introducing an second solution into the inter-vertebral space whereby a semi-solid or solid media is formed within the inter-vertebral space to replace the annulus,-nucleus, or annulus and nucleus.

14. The method of claim 13 wherein introducing the second solution includes the step of precipitating the biocompatible polymer from the first solution so that the biocompatible polymer solidifies within the inter-vertebral space and the biocompatible solvent disperses in the body tissues.

15. The method of claim 13 wherein said solution comprises a material liquid at least at body temperature of the mammal in which the biocompatible polymer is soluble.

16. The method of claim 15 wherein said material liquid is formed from a material selected from the group consisting of dimethylsulfoxide, analogues/homologues of dimethylsulfoxide, ethanol, ethyl lactate, acetone, or combinations thereof.

17. The method of claim 13 wherein one or more of said biocompatible polymer are 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.

18. The method of claim 13 wherein said second solution is formed of solvents selected from the group consisting of water and saline solutions, or combinations thereof.

19. The method for artificial disc replacement comprising the step of dispensing a solution having a biocompatible solvent and a biocompatible polymer within a flexible and expandable expansile loop that is positioned within the inter-vertebral space whereby body fluids replace the solvent and a non-biodegradable semi-solid or solid media is formed within the inter-vertebral space to replace the annulus, nucleus, or annulus and nucleus.

20. The method of claim 19 wherein introducing the body fluids precipitate the biocompatible polymer from the solution so that the biocompatible polymer solidifies in the inter-vertebral space and the biocompatible solvent disperses in the body tissues.

21. The method of claim 19 wherein said solution comprises a material liquid at least at body temperature of the mammal in which the biocompatible polymer is soluble.

22. The method of claim 21 wherein said liquid material is formed from a material selected from the group consisting of dimethylsulfoxide, analogues/homologues of dimethylsulfoxide, ethanol, ethyl lactate, acetone, or combinations thereof.

23. The method of claim 19 wherein one or more of said biocompatible polymers are 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.

24. The method of claim 19 wherein the body fluids are formed of solvents selected from the group consisting of water and saline solutions, or combinations thereof.