Prosthetic nucleus apparatus

• US 20050113919A1
• Filed: 10/22/2004
• Published: 05/26/2005
• Est. Priority Date: 02/16/2000
• Status: Active Grant

• Current Assignee: Mis Ip Holdings LLC
• Original Assignee: TranS1 Incorporated (Baxano Surgical, Inc.)
• Inventors: Assell, Robert L., Cragg, Andrew H., Ainsworth, Steven D., Wessman, Bradley J., Dickhudt, Eugene A.
• Granted Patent: US 7,717,958 B2
• Time in Patent Office: Days
• US Class Current: 623/17.110
• CPC Class Codes: A61B 17/70 Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
• CPC Class Codes: A61B 17/864 hollow, e.g. with socket or cannulated
• CPC Class Codes: A61B 17/8685 comprising multiple separate parts
• CPC Class Codes: A61F 2/30742 Bellows or hose-like seals; Sealing membranes A61B17/8808 takes precedence; sealing membranes for retaining bone substitute A61F2/2846
• CPC Class Codes: A61F 2/30744 End caps, e.g. for closing an endoprosthetic cavity
• CPC Class Codes: A61F 2/441 made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
• CPC Class Codes: A61F 2/442 Intervertebral or spinal discs, e.g. resilient non-disc-shaped intervertebral inflatable pockets A61F2/441; non-disc-shaped intervertebral fusion implants A61F2/4455
• CPC Class Codes: A61F 2/4425 made of articulated components
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2002/30014 differing in elasticity, stiffness or compressibility
• 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 2002/30224 cylindrical
• CPC Class Codes: A61F 2002/30242 spherical
• CPC Class Codes: A61F 2002/30289 helically-coiled
• CPC Class Codes: A61F 2002/30331 made by longitudinally pushing a protrusion into a complementarily-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2002/30405 made by screwing complementary threads machined on the parts themselves
• CPC Class Codes: A61F 2002/30448 using adhesives
• CPC Class Codes: A61F 2002/30462 retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2002/30495 using a locking ring
• CPC Class Codes: A61F 2002/30507 : using a threaded locking member, e.g. a locking screw or a set screw
• CPC Class Codes: A61F 2002/30563 : having elastic means or damping means, different from springs, e.g. including an elastomeric core or shock absorbers
• CPC Class Codes: A61F 2002/30565 : having spring elements
• CPC Class Codes: A61F 2002/30566 : Helical springs
• CPC Class Codes: A61F 2002/30571 : Leaf springs
• 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 2002/30604 : modular
• CPC Class Codes: A61F 2002/30677 : Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/3085 : with a threaded, e.g. self-tapping, bone-engaging surface, e.g. external surface
• CPC Class Codes: A61F 2002/30859 : having threaded portions of different pitches
• CPC Class Codes: A61F 2002/3097 : using laser
• CPC Class Codes: A61F 2002/443 : having two transversal endplates and at least one intermediate component
• 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 2002/4667 : for measuring torque
• CPC Class Codes: A61F 2210/0004 : bioabsorbable
• 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 2220/0033 : made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2220/005 : using adhesives
• 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 2230/0069 : cylindrical
• CPC Class Codes: A61F 2230/0071 : spherical
• CPC Class Codes: A61F 2230/0091 : helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/0018 : differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2310/00017 : Iron- or Fe-based alloys, e.g. stainless steel
• CPC Class Codes: A61F 2310/00029 : Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium
• CPC Class Codes: A61F 2310/0097 : Coating or prosthesis-covering structure made of pharmaceutical products, e.g. antibiotics

Abstract

A spinal mobility preservation apparatus and methods are disclosed. The spinal mobility preservation apparatus may include a proximal body, an intermediate body, a distal body, and an expandable membrane. The proximal body and the distal body secure the mobility preservation apparatus to adjacent vertebral bodies. At least one of an intermediate body and an expandable membrane secure the proximal body to the distal body and provide a degree of support to a spinal motion segment defined by the adjacent vertebral bodies. A single proximal body and an expandable membrane may also compose a spinal mobility preservation apparatus. The proximal body secured to one of a superior or an inferior vertebral body and the expandable membrane extending into the intervertebral disc space to support the spinal motion segment.

Claims

1. An implantable spinal mobility preservation apparatus, comprising:

a proximal body defining a proximal lumen, including a first retention structure, and having a first end and a second end; and

an expandable membrane, the expandable membrane secured to the body and extending from the first end of the body.

2. An implantable spinal mobility preservation apparatus, as in claim 1, with the retention structure comprising a first thread.

3. An implantable spinal mobility preservation apparatus, as in claim 1, wherein the expandable membrane defines an expansion chamber in fluid communication with the proximal lumen.

4. An implantable spinal mobility preservation apparatus, as in claim 3, further comprising prosthetic nucleus material positioned within an expansion chamber defined by the expandable membrane.

5. An implantable spinal mobility preservation apparatus, as in claim 1, further comprising the body having internal threading within the lumen.

6. An implantable spinal mobility preservation apparatus, as in claim 5, further comprising a plug secured within the lumen.

7. An implantable spinal mobility preservation apparatus, as in claim 6, further comprising prosthetic nucleus material positioned within an expansion chamber defined by the expandable membrane.

8. An implantable spinal mobility preservation apparatus, as in claim 1, further comprising the lumen configured to receive a driver.

9. An implantable spinal mobility preservation apparatus, as in claim 1, further comprising the lumen extending co-axially through the body and with the lumen in fluid communication with the expansion chamber.

10. An implantable spinal mobility preservation apparatus, as in claim 1, wherein at least a portion of the expandable membrane is compliant.

11. An implantable spinal mobility preservation apparatus, as in claim 7, wherein a first portion of the expandable membrane configured to face in the direction of an adjacent vertebral body end plate is relatively more compliant than a second portion of the expandable membrane configured to face in the direction of the annulus.

12. An implantable spinal mobility preservation apparatus, as in claim 1, wherein the expandable membrane comprises an elastomeric material.

13. An implantable spinal mobility preservation apparatus, as in claim 1, wherein the expandable membrane comprises a silicone.

14. An implantable spinal mobility preservation apparatus, as in claim 1, wherein the expandable membrane comprises a moisture-permeable bioabsorbable material.

15. An implantable spinal mobility preservation apparatus, as in claim 1, wherein the expandable membrane comprises a woven fabric of polymeric fibers.

16. An implantable spinal mobility preservation apparatus, as in claim 15, wherein the woven fabric of polymeric fibers are semi-permeable.

17. An implantable spinal mobility preservation apparatus, as in claim 15, wherein the woven fabric of polymeric fibers are microporous.

18. An implantable spinal mobility preservation apparatus, as in claim 1, wherein the expandable membrane comprises a silicone.

19. An implantable spinal mobility preservation apparatus, as in claim 4, wherein the prosthetic nucleus material is a saline solution an elastomeric solid.

20. An implantable spinal mobility preservation apparatus, as in claim 4, wherein the prosthetic nucleus material is a saline solution.

21. An implantable spinal mobility preservation apparatus, as in claim 4, wherein the prosthetic nucleus material is a viscoelastic gel.

22. An implantable spinal mobility preservation apparatus, as in claim 4, wherein the prosthetic nucleus material comprises a hydrogel.

23. An implantable spinal mobility preservation apparatus, as in claim 4, wherein the prosthetic nucleus material comprises a silicone.

24. An implantable spinal mobility preservation apparatus, as in claim 4, wherein the prosthetic nucleus material comprises a polyurethane.

25. An implantable spinal mobility preservation apparatus, as in claim 23, wherein the expandable membrane comprises a silicone.

26. An implantable spinal mobility preservation apparatus, as in claim 7, wherein the compliancy of a radial surface of the expandable membrane is less than the compliancy of at least one of a superior surface and an inferior surface of the expandable membrane.

27. An implantable spinal mobility preservation apparatus, as in claim 7, wherein the expandable membrane supporting the radial surface has a greater thickness than a superior surface and an inferior surface of the expandable membrane.

28. An implantable spinal mobility preservation apparatus, as in claim 3, further comprising a collar secured to the radial surface of the expandable membrane.

29. An implantable spinal mobility preservation apparatus, as in claim 3, wherein the expandable membrane comprises a polymeric balloon.

30. An implantable spinal mobility preservation apparatus, as in claim 3, wherein the expandable membrane comprises a compliant balloon.

31. An implantable spinal mobility preservation apparatus, as in claim 3, wherein the expansion chamber defined by the expandable membrane is at least partially filled with the prosthetic nucleus material, and wherein the physical properties of the combination of the expandable membrane and the prosthetic nucleus material enable the expandable membrane to transfer a component of axial compression into lateral force for absorption by the annulus.

32. An implantable spinal mobility preservation apparatus, as in claim 3, wherein the proximal surface and the distal surface of the expandable membrane have a greater compliancy than the radial surface.

33. An implantable spinal mobility preservation apparatus, as in claim 4, wherein the prosthetic nucleus material is modulus matched to a natural disc material.

34. An implantable spinal mobility preservation apparatus, as in claim 33, wherein the natural disc material comprises the nucleus.

35. An implantable spinal mobility preservation apparatus, as in claim 33, wherein the natural disc material comprises the intervertebral disc.

36. An implantable spinal mobility preservation apparatus, as in claim 3, wherein the expandable membrane is semi-elastic and is configured to have a predetermined maximum stretching capacity along the horizontal plane.

37. An implantable spinal mobility preservation apparatus, as in claim 3, wherein the expandable membrane has a predetermined maximum stretching capacity along the horizontal plane.

38. An implantable spinal mobility preservation apparatus, as in claim 3, wherein the expandable membrane is expandable radially.

39. An implantable spinal mobility preservation apparatus as in claim 3, wherein a collar is secured around the perimeter of the expandable membrane.

40. An implantable spinal mobility preservation apparatus as in claim 3, wherein a collar is integral with the perimeter of the expandable membrane.

41. An implantable spinal mobility preservation apparatus, as in claim 1, having an aspect ratio of greater than 1.

42. A method for supporting the spine, comprising:

providing an implantable spinal mobility preservation apparatus having a body including a retention structure and having a first end and a second end and an expandable membrane, the expandable membrane secured to the body and extending from the first end of the body

forming an axial bore through a vertebral body;

removing at least a portion of a nucleus pulposus of the intervertebral disc through the axial bore to form a disc space; and

axially inserting the implantable spinal mobility preservation apparatus through the axial bore;

securing the proximal body of the implantable mobility preservation apparatus in the vertebral body; and

providing a prosthetic nucleus material through the lumen into the expansion chamber of the spinal mobility preservation apparatus.

43. An implantable spinal mobility preservation apparatus, comprising:

a proximal body including a retention structure and having a first end and a second end and the body defining a proximal lumen; and

an expandable membrane, the expandable membrane secured to the proximal body and extending from the first end of the proximal body with the expandable membrane defines an expansion chamber and having prosthetic nucleus material positioned within an expansion chamber; and

a plug secured within the proximal lumen.

44. An implantable spinal mobility preservation apparatus, comprising:

a proximal body having a substantially radially symmetrical shape about a longitudinal axis and including a first end and a second end, the body including threads to rotatably position the body through a central bore in a vertebral body, and the proximal body defining a proximal lumen in fluid communication with the second end of the proximal body; and

an expandable membrane defining an expansion chamber, the expandable membrane secured to the proximal body and extending from the second end of the proximal body with the expansion chamber of the expandable membrane in fluid communication with the proximal lumen of the proximal body.

45. An implantable spinal mobility preservation apparatus, as in claim 44, further comprising prosthetic nucleus material positioned within the expansion chamber defined by the expandable membrane.

46. An implantable spinal mobility preservation apparatus, as in claim 44, further comprising the proximal body having internal threading within the lumen.

47. An implantable spinal mobility preservation apparatus, as in claim 46, further comprising a plug secured within the proximal lumen.

48. An implantable spinal mobility preservation apparatus, as in claim 47, further comprising prosthetic nucleus material positioned within the expansion chamber defined by the expandable membrane.

49. An implantable spinal mobility preservation apparatus, as in claim 44, further comprising the proximal lumen configured to receive a driver.

50. An implantable spinal mobility preservation apparatus, as in claim 44, further comprising the proximal lumen extending co-axially through the body.

51. An implantable spinal mobility preservation apparatus, as in claim 44, wherein at least a portion of the expandable membrane is compliant.

52. An implantable spinal mobility preservation apparatus, as in claim 45, wherein a first portion of the expandable membrane configured to face in the direction of an adjacent vertebral body end plate is relatively more compliant than a second portion of the expandable membrane configured to face in the direction of the annulus.

53. An implantable spinal mobility preservation apparatus, as in claim 44, wherein the expandable membrane comprises an elastomeric material.

54. An implantable spinal mobility preservation apparatus, as in claim 44, wherein the expandable membrane comprises a silicone.

55. An implantable spinal mobility preservation apparatus, as in claim 44, wherein the expandable membrane comprises a moisture-permeable bioabsorbable material.

56. An implantable spinal mobility preservation apparatus, as in claim 44, wherein the expandable membrane comprises a woven fabric of polymeric fibers.

57. An implantable spinal mobility preservation apparatus, as in claim 56, wherein the woven fabric of polymeric fibers are semi-permeable.

58. An implantable spinal mobility preservation apparatus, as in claim 56, wherein the woven fabric of polymeric fibers are microporous.

59. An implantable spinal mobility preservation apparatus, as in claim 45, wherein the prosthetic nucleus material is a saline solution an elastomeric solid.

60. An implantable spinal mobility preservation apparatus, as in claim 45, wherein the prosthetic nucleus material is a saline solution.

61. An implantable spinal mobility preservation apparatus, as in claim 45, wherein the prosthetic nucleus material is a viscoelastic gel.

62. An implantable spinal mobility preservation apparatus, as in claim 45, wherein the prosthetic nucleus material comprises a hydrogel.

63. An implantable spinal mobility preservation apparatus, as in claim 45, wherein the prosthetic nucleus material comprises a silicone.

64. An implantable spinal mobility preservation apparatus, as in claim 45, wherein the prosthetic nucleus material comprises a polyurethane.

65. An implantable spinal mobility preservation apparatus, as in claim 63, wherein the expandable membrane comprises a silicone.

66. An implantable spinal mobility preservation apparatus, as in claim 45, wherein the compliancy of a radial surface of the expandable membrane is less than the compliancy of at least one of a superior surface and an inferior surface of the expandable membrane.

67. An implantable spinal mobility preservation apparatus, as in claim 45, wherein the expandable membrane supporting the radial surface has a greater thickness than a superior surface and an inferior surface of the expandable membrane.

68. An implantable spinal mobility preservation apparatus, as in claim 45, further comprising a collar secured to the radial surface of the expandable membrane.

69. An implantable spinal mobility preservation apparatus, as in claim 45, wherein the expandable membrane comprises a polymeric balloon.

70. An implantable spinal mobility preservation apparatus, as in claim 45, wherein the expandable membrane comprises a compliant balloon.

71. An implantable spinal mobility preservation apparatus, as in claim 45, wherein the expansion chamber defined by the expandable membrane is at least partially filled with the prosthetic nucleus material, and wherein the physical properties of the combination of the expandable membrane and the prosthetic nucleus material enable the expandable membrane to transfer a component of axial compression into lateral force for absorption by the annulus.

72. An implantable spinal mobility preservation apparatus, as in claim 45, wherein the proximal surface and the distal surface of the expandable membrane have a greater compliancy than the radial surface.

73. An implantable spinal mobility preservation apparatus, as in claim 45, wherein the prosthetic nucleus material is modulus matched to a natural disc material.

74. An implantable spinal mobility preservation apparatus, as in claim 73, wherein the natural disc material comprises the nucleus.

75. An implantable spinal mobility preservation apparatus, as in claim 73, wherein the natural disc material comprises the intervertebral disc.

76. An implantable spinal mobility preservation apparatus, as in claim 45, wherein the expandable membrane is semi-elastic and is configured to have a predetermined maximum stretching capacity along the horizontal plane.

77. An implantable spinal mobility preservation apparatus, as in claim 45, wherein the expandable membrane has a predetermined maximum stretching capacity along the horizontal plane.

78. An implantable spinal mobility preservation apparatus, as in claim 45, wherein the expandable membrane is expandable radially.

79. An implantable spinal mobility preservation apparatus as in claim 45, wherein a collar is secured around the perimeter of the expandable membrane.

80. An implantable spinal mobility preservation apparatus as in claim 45, wherein a collar is integral with the perimeter of the expandable membrane.

81. An implantable spinal mobility preservation apparatus as in claim 45, wherein the prosthetic nucleus material comprises a hydrogel.

82. An implantable spinal mobility preservation apparatus, as in claim 44, having an aspect ratio of greater than 1.

83. A method for supporting the spine, comprising:

providing an implantable spinal mobility preservation apparatus having a proximal body having a substantially radially symmetrical shape about a longitudinal axis and including a first end and a second end, the body including threads to rotatably position the proximal body through a central bore in a vertebral body, and the body defining a proximal lumen in fluid communication with the second end of the body, and an expandable membrane defining an expansion chamber, the expandable membrane secured to the proximal body and extending from the second end of the body with the expansion chamber of the expandable membrane in fluid communication with the proximal lumen of the proximal body;

forming an axial bore through a vertebral body;

removing at least a portion of a nucleus pulposus of the intervertebral disc through the axial bore to form a disc space; and

axially inserting the implantable spinal mobility preservation apparatus through the axial bore;

securing the proximal body of the implantable mobility preservation apparatus in the vertebral body; and

providing a prosthetic nucleus material through the proximal lumen into the expansion chamber of the spinal mobility preservation apparatus.

84. An implantable spinal mobility preservation apparatus, comprising:

a proximal body having a substantially radially symmetrical shape about a longitudinal axis and including a first end and a second end, the body including threads to rotatably position the body through a central bore in a vertebral body, and the body defining a proximal lumen in fluid communication with the second end of the body;

an expandable membrane defining an expansion chamber, the expandable membrane secured to the proximal body and extending from the second end of the body with the expansion chamber of the expandable membrane in fluid communication with the lumen of the proximal body;

prosthetic nucleus material positioned within the expansion chamber defined by the expandable membrane; and

a plug secured within the proximal lumen.

85. An implantable spinal mobility preservation apparatus, comprising:

a proximal body having substantially radially symmetrical shape about a longitudinal axis and including a first end and a second end, the proximal body including threads to rotatably position the proximal body in a central bore in a body of a vertebra, and the body defining a lumen in fluid communication between the first end and the second end of the proximal body; and

a plug secured within the proximal lumen of the proximal body.

86. An implantable spinal mobility preservation apparatus, as in claim 85, further comprising prosthetic nucleus material positioned within at least a portion of the proximal lumen.

87. An implantable spinal mobility preservation apparatus, as in claim 85, further comprising the body having internal threading within the proximal lumen.

88. An implantable spinal mobility preservation apparatus, as in claim 87, further comprising the plug secured within the proximal lumen by the internal threading.

90. An implantable spinal mobility preservation apparatus, as in claim 85, having an aspect ratio of greater than 1.

90-1. A method for supporting the spine, comprising:

providing an implantable apparatus having a proximal body having substantially radially symmetrical shape about a longitudinal axis and including a first end and a second end, the proximal body including threads to rotatably position the body in a central bore in a body of a vertebra, and the proximal body defining a proximal lumen in fluid communication between the first end and the second end of the body; and

a plug secured within the proximal lumen of the proximal body;

forming an axial bore through a vertebral body;

removing at least a portion of a nucleus pulposus of the intervertebral disc through the axial bore to form a disc space; and

axially inserting the implantable spinal mobility preservation apparatus through the axial bore;

securing the proximal body of the implantable mobility preservation apparatus in the vertebral body; and

providing a prosthetic nucleus material through the proximal lumen of the implantable apparatus into the disc space.