Mechanical apparatus and method for artificial disc replacement

• US 7,442,210 B2
• Filed: 07/01/2005
• Issued: 10/28/2008
• 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): Robert; Eduardo C
• Assistant Examiner(s): Yang; Andrew
• Application Number:
  US11/173,034
• Publication Number:
  US 20060287727A1
• Time in Patent Office: 1,215 Days
• Field of Search: 623 1711- 1716, 623/23.67, 623/1.11, 623/1.2, 623/1.17, 623/23.7, 604/500, 604/506, 606/279
• 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 2/44 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 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 artificial disc replacement comprising the steps of first delivering a mechanically expandable continuous mesh loop, having an internal chamber, within an intervertebral space, a second step of expanding said mesh loop, without pressurization, in a substantially circumferential manner against the inner annular wall by the use of a control element acting directly on said mesh loop, a third step of introducing a first solution having a biocompatible solvent and a biocompatible polymer into the internal chamber and a fourth step of introducing a second solution into the internal chamber 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.

25. The method of claim 1 including a step of utilizing a control element to assist in mechanically expanding and delivering the expandable mesh within an intervertebral space.

7. The method for artificial disc replacement comprising the steps of first delivering a mechanically expandable continuous mesh loop, having an internal chamber, within an intervertebral space, a second step of expanding said mesh loop, without pressurization, in a substantially circumferential manner against the inner annular wall by the use of a control element acting directly on said mesh, a second step of introducing a solution having a biocompatible solvent and a biocompatible polymer into said mesh loop 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 mechanically expandable continuous mesh loop having an internal chamber and substantially circumferentially positioned within an intervertebral space, whereby expanding or contracting of said mesh loop is accomplished by the use of a control element acting on the mesh without pressurization 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.

32. The method of claim 13 including a step of utilizing a control element to assist in mechanically expanding and delivering the expandable mesh within an intervertebral space.

19. The method for artificial disc replacement comprising the step of dispensing a solution having a biocompatible solvent and a biocompatible polymer within a mechanically expandable continuous mesh loop having an internal chamber that is substantially circumferentially positioned within an intervertebral space, whereby expanding or contracting said mesh loop is accomplished by use of a control element acting on the mesh without pressurization 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.

26. A method for artificial disc replacement comprising the steps of first delivering a mechanically expandable continuous mesh loop having an internal chamber and a central area circumferentially within an intervertebral space, a second step of expanding said mesh loop without pressurization, whereby said mesh loop is accomplished by use of a control element acting on the mesh, a third step of introducing a first solution having a biocompatible solvent and a biocompatible polymer into the central area whereby a semi-solid or solid media is formed within the inter-vertebral space to replace the annulus, nucleus, or annulus and nucleus.

27. The method of claim 26 wherein introducing a 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.

28. The method of claim 26 wherein said first solution comprises a material liquid at least at body temperature of the mammal in which the biocompatible polymer is soluble.

29. The method of claim 28 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.

30. The method of claim 26 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.

31. The method of claim 26 wherein said second solution is formed of solvents selected from the group consisting of water and saline solutions, or combinations thereof.