Mechanical apparatus and method for artificial disc replacement

• US 20060287726A1
• Filed: 06/15/2005
• 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 8,021,426 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 2/441 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 and expandable expansile loop, said expansile loop having an interior section in slidable cooperation with an outer section, said expansile loop further having an interior chamber;

said outer section of said expansile loop having a inside surface and an outer opening;

said interior section of said expansile loop having an outside surface and a distal end; and

a flexible control element, said control element having a distal end, a distal section, and a proximal section, said distal end of said control element attached to said distal end of said interior section of said expansile loop, said control element looping around said inside surface of said outer section of said expansile loop whereby said distal section of said control element is located within said interior chamber and said proximal section of said control element exits said expansile loop at said outer opening.

2. The spinal disc device as recited in claim 1, further comprising an outer sheath, said outer 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 outer 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. An spinal disc device comprising:

a flexible and expandable expansile loop, said expansile loop having an interior section in slidable cooperation with an outer section, said expansile loop further having an interior chamber;

said outer section of said expansile loop having a inside surface and an outer opening;

said interior section of said expansile loop having an outside surface and a distal end; and

a flexible control element, said control element having a distal end, a distal section, and a proximal section, said distal end of said control element exits the distal end of said expansile loop and is attached to an outer catheter element.

23. The spinal disc device as recited in claim 22, further comprising an outer sheath, said outer sheath having an inner lumen.

24. The spinal disc device as recited in claim 22, whereby said spinal disc device is contained within said inner lumen of said outer sheath when said spinal disc device is in a contracted delivery configuration.

25. The spinal disc device as recited in claim 22, wherein said expansile loop is composed of braided material in a tubular form.

26. The spinal disc device as recited in claim 22, wherein said expansile loop is composed from a polymeric material.

27. The spinal disc device as recited in claim 22, wherein said expansile loop is composed from a metallic material.

28. The spinal disc device as recited in claim 22, wherein said control elements are composed from a polymeric material.

29. The spinal disc device as recited in claim 22, wherein said control elements are composed from a metallic material.

30. The spinal disc device as recited in claim 24, wherein said spinal disc device attains an expanded configuration when expelled from said outer sheath.

31. The spinal disc device as recited in claim 22 wherein said expansile loop forms a substantially circular shape when said interior section coaxially engages said outer section.

32. The spinal disc device as recited in claim 22, further comprising an inner chamber which is substantially continuous around said substantially circular shape.

33. The spinal disc device as recited in claim 22, further comprising the function to deliver within said inner chamber a biocompatible material to the inter-vertebral space.

34. The spinal disc device as recited in claim 32, wherein said inner chamber is filled with a polymeric material.

35. The spinal disc device as recited in claim 33, 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.

36. The spinal disc device as recited in claim 33, 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.

37. The spinal disc device as recited in claim 33, 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.

38. The spinal disc device as recited in claim 33, 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.

39. The spinal disc device as recited in claim 22, wherein said spinal disc device is adapted to promote spinal fixation between two adjacent vertebral bodies.

40. The spinal disc device as recited in claim 22, wherein said spinal disc device is deformable to conform to an interior region of a vertebral disc.

41. The spinal disc device as recited in claim 34, 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.

42. The spinal disc device as recited in claim 34, 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.

43. An spinal disc device comprising:

a flexible and expandable expansile loop, said expansile loop having an interior section in slidable cooperation with an outer section, said expansile loop further having an interior chamber;

said outer section of said expansile loop having a inside surface and an outer opening;

said interior section of said expansile loop having an outside surface and a distal end;

a first flexible control element, said control element having a distal end, a distal section, and a proximal section, said distal end of said control element attached to said distal end of said interior section of said expansile loop, said control element looping around said inside surface of said outer section of said expansile loop whereby said distal section of said control element is located within said interior chamber and said proximal section of said control element exits said expansile loop at said outer opening; and

a second flexible control element, said control element having a distal end, said distal end of said control element attached to said distal end of said interior section of said expansile loop.

44. The spinal disc device as recited in claim 43, further comprising an outer sheath, said outer sheath having an inner lumen.

45. The spinal disc device as recited in claim 44, whereby said spinal disc device is contained within said inner lumen of said outer sheath when said spinal disc device is in a contracted delivery configuration.

46. The spinal disc device as recited in claim 43, wherein said expansile loop is composed of braided material in a tubular form.

47. The spinal disc device as recited in claim 43, wherein said expansile loop is composed from a polymeric material.

48. The spinal disc device as recited in claim 43, wherein said expansile loop is composed from a metallic material.

49. The spinal disc device as recited in claim 43, wherein said control elements are composed from a polymeric material.

50. The spinal disc device as recited in claim 43, wherein said control elements are composed from a metallic material.

51. The spinal disc device as recited in claim 45, wherein said spinal disc device attains an expanded configuration when expelled from said outer sheath.

52. The spinal disc device as recited in claim 43, wherein said expansile loop forms a substantially circular shape when said interior section coaxially engages said outer section.

53. The spinal disc device as recited in claim 43, further comprising an inner chamber which is substantially continuous around said substantially circular shape.

54. The spinal disc device as recited in claim 43, further comprising the function to deliver within said inner chamber a biocompatible material to the inter-vertebral space.

55. The spinal disc device as recited in claim 52, wherein said inner chamber is filled with a polymeric material.

56. The spinal disc device as recited in claim 54, 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.

57. The spinal disc device as recited in claim 54, 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.

58. The spinal disc device as recited in claim 54, 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.

59. The spinal disc device as recited in claim 54, 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.

60. The spinal disc device as recited in claim 43, wherein said spinal disc device is adapted to promote spinal fixation between two adjacent vertebral bodies.

61. The spinal disc device as recited in claim 43, wherein said spinal disc device is deformable to conform to an interior region of a vertebral disc.

62. The spinal disc device as recited in claim 54, 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.

63. The spinal disc device as recited in claim 54, 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.

64. An spinal disc device comprising:

a flexible and expandable expansile loop, said expansile loop having an interior section in slidable cooperation with an outer section, said expansile loop further having an interior chamber;

said outer section of said expansile loop having a inside surface and an outer opening;

said interior section of said expansile loop having an outside surface and a distal end;

said outer section having a portion invaginated within itself; and

a flexible control element, said control element having a distal end, said distal end of said control element attached to said distal end of said interior section of said expansile loop.

65. The spinal disc device as recited in claim 64, further comprising an outer sheath, said outer sheath having an inner lumen.

66. The spinal disc device as recited in claim 65, whereby said spinal disc device is contained within said inner lumen of said outer sheath when said spinal disc device is in a contracted delivery configuration.

67. The spinal disc device as recited in claim 64, wherein said expansile loop is composed of braided material in a tubular form.

68. The spinal disc device as recited in claim 64, wherein said expansile loop is composed from a polymeric material.

69. The spinal disc device as recited in claim 64, wherein said expansile loop is composed from a metallic material.

70. The spinal disc device as recited in claim 64, wherein said control elements are composed from a polymeric material.

71. The spinal disc device as recited in claim 64, wherein said control elements are composed from a metallic material.

72. The spinal disc device as recited in claim 66, wherein said spinal disc device attains an expanded configuration when expelled from said outer sheath.

73. The spinal disc device as recited in claim 64 wherein said expansile loop forms a substantially circular shape when said interior section coaxially engages said outer section.

74. The spinal disc device as recited in claim 64, further comprising an inner chamber which is substantially continuous around said substantially circular shape.

75. The spinal disc device as recited in claim 64, further comprising the function to deliver within said inner chamber a biocompatible material to the inter-vertebral space.

76. The spinal disc device as recited in claim 74, wherein said inner chamber is filled with a polymeric material.

77. The spinal disc device as recited in claim 75, 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.

78. The spinal disc device as recited in claim 75, 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.

79. The spinal disc device as recited in claim 75, 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.

80. The spinal disc device as recited in claim 75, 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.

81. The spinal disc device as recited in claim 64, wherein said spinal disc device is adapted to promote spinal fixation between two adjacent vertebral bodies.

82. The spinal disc device as recited in claim 64, wherein said spinal disc device is deformable to conform to an interior region of a vertebral disc.

83. The spinal disc device as recited in claim 75, 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.

84. The spinal disc device as recited in claim 75, 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.

85. 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 to repair or reinforce a damaged annulus fiborosis;

positioning an mechanically expansile loop circumferentially around said annular tissues such that said expansile loop substantially encircles the inside of the annular space;

said mechanically expansile loop not requiring pressurization or injection of material to expand circumferentially or diametrically to fill the inter-vertebral space; and

expanding said mechanically expansile loop within said annular space to reinforce said annulus fibrosis.

86. The method of claim 85 including the step of subsequently delivering and injecting a suitable biomaterial to replace at least a portion of said damaged annular tissue.

87. 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 mechanically expansile loop in the inter-vertebral space such that said mechanically expansile loop substantially encircles the nucleus space;

said mechanically expansile loop having an inner chamber;

mechanically expanding the expansile 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.

88. 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 mechanically expansile loop around the inside of said annular tissues such that the expansile loop circumferentially encircles an annular space;

expanding the mechanically expansile loop within said vertebral space to the limits of the remaining annulus fiborosis without first pressurizing the expansile 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 expansile loop around said nucleus replacement such that the expansile loop substantially encircles said nucleus device; and

further mechanically expanding the expansile loop around said nucleus space and device.

89. 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 mechanically expansile loop around the inside of said annular tissues such that the expansile loop circumferentially encircles an annular space;

expanding the mechanically expansile loop within said vertebral space to the limits of the remaining annulus fiboros without first pressurizing the expansile loop or 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 expansile loop around said nucleus replacement such that the expansile loop substantially encircles said nucleus device;

further mechanically expanding the expansile loop around said nucleus space and device; and

delivering and injecting a suitable biomaterial to replace at least a portion of said nucleus tissue.

90. 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 mechanically expansile 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 mechanically expansile loop within said inter-vertebral space;

mechanically expanding the expansile loop such that an outside surface expands to the limits of the inner portion of a native annulus;

expanding the expansile 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.

91. 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 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 loop within said inter-vertebral space;

diametrically expanding the expansile loop such that an outside surface expands to the limits of the inner portion of a native annulus;

expanding the expansile 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.

92. The method as recited in claim 91, 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.

93. 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 loop within said inter-vertebral space;

diametrically expanding the expansile loop with a control element such that an outside surface of the expansile loop expands to the limits of the inner portion of a native annulus, further constricting said central region of said expansile loop, whereby said central region becomes disproportionately contracted around said nuclear replacement material such that said expansile loop constricts said centrally located waist more than said terminal ends.

94. The method as recited in claim 93, 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.

95. 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;

positioning said mechanically expansile loop within said inter-vertebral space;

expanding the expansile loop with a control element to a first configuration such that an outside surface of the expansile 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 loop to a second configuration whereby said expanding disproportionately contracts said nuclear replacement material such that said expansile loop constricts said centrally located waist more than said terminal ends.

96. The method as recited in claim 95, 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.

97. An spinal disc device comprising:

a flexible and expandable expansile loop, said expansile loop having an interior section in slidable cooperation with an outer section, said expansile loop further having an interior chamber;

said outer section of said expansile loop having a inside surface and an outer opening;

said interior section of said expansile loop having an outside surface, and inside surface, and a distal end;

a central area located within said inside surface of said interior section, said central area having a centrally located waist and two terminal areas; and

means for contracting said central area whereby said means disproportionately contracts said central area whereby said centrally located waist results is a smaller diameter than the diameter of said terminal areas.