Intervertebral Disc Restoration

• US 20080195210A1
• Filed: 03/01/2006
• Published: 08/14/2008
• Est. Priority Date: 03/01/2005
• Status: Abandoned Application

• Current Assignee: Columna Pty Ltd.
• Original Assignee: Columna Pty Ltd.
• Inventors: Milijasevic, Zoran, Diwan, Ashish, Appleyard, Richard Charles
• Application Number:
  US11/817,586
• Publication Number:
  US 20080195210A1
• Time in Patent Office: Days
• US Class Current: 623/17.16
• CPC Class Codes: A61F 2/441 made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
• 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 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/30133 kidney-shaped or bean-shaped
• CPC Class Codes: A61F 2002/30136 undulated or wavy, e.g. serpentine-shaped or zigzag-shaped
• CPC Class Codes: A61F 2002/30289 helically-coiled
• CPC Class Codes: A61F 2002/30291 spirally-coiled, i.e. having a 2D spiral cross-section
• CPC Class Codes: A61F 2002/30583 filled with hardenable fluid, e.g. curable in-situ
• CPC Class Codes: A61F 2002/30586 having two or more inflatable pockets or chambers
• CPC Class Codes: A61F 2002/30588 filled with solid particles
• CPC Class Codes: A61F 2002/30594 slotted, e.g. radial or meridian slot ending in a polar aperture, non-polar slots, horizontal or arcuate slots
• CPC Class Codes: A61F 2002/4415 elements of the prosthesis being arranged in a chain like manner
• CPC Class Codes: A61F 2002/444 for replacing the nucleus pulposus
• CPC Class Codes: A61F 2002/448 comprising multiple adjacent spinal implants within the same intervertebral space or within the same vertebra, e.g. comprising two adjacent spinal implants
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0085 hardenable in situ, e.g. epoxy resins
• CPC Class Codes: A61F 2230/0004 Rounded shapes, e.g. with rounded corners
• CPC Class Codes: A61F 2230/0015 Kidney-shaped, e.g. bean-shaped
• 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

Abstract

An intervertebral disc implant (10) includes an envelope (12) of a stretchable and elastically deformable elastomeric material. The envelope includes an attaching formation (74) for attachment of an introducer (76) to enable the envelope, in a collapsed state, to be introduced into a volume of an intervertebral disc that has undergone a nucleotomy. A filler material (14) is receivable in the envelope via the introducer to cause the envelope to expand elastically to conform substantially to the volume in which the envelope is received.

Claims

1. An intervertebral disc implant which includes:

an envelope of a stretchable and elastically deformable elastomeric material, the envelope including an attaching formation for attachment to an introducer to enable the envelope, in a collapsed state, to be introduced into a volume of an intervertebral disc that has undergone a nucleotomy; and

a filler material receivable in the envelope via the introducer to cause the envelope to expand elastically to conform substantially to the volume in which the envelope is received, in use.

2. The implant of claim 1 in which the envelope is of a silicone material.

3. The implant of claim 1 in which the attaching formation comprises a filler tube mountable to the introducer, the attaching formation including a closure device to inhibit back flow of filler material.

4. The implant of claims 1 in which the filler material comprises a plurality of discrete, biocompatible elements.

5. The implant of claim 4 in which the elements includes, singly or in combination, beads, elongate elements and expansible elements.

6. The implant of claim 5 in which the elongate elements are selected from the group consisting of fibres, lengths of filamentary elements, bristle carrying elements and helical elements.

7. The implant of claim 4 in which the discrete elements are arranged in suspension in a filler within the volume.

8. The implant of claim 7 in which the filler is an elastomeric, curable filler.

9. The implant of claim 5 in which each expansible element is configured to change from a first configuration for insertion into the envelope to a second configuration which causes the envelope to conform substantially to the volume.

10. The implant of claim 9 in which each expansible element is configured to be received, in its first configuration, in the introducer for introduction into the envelope.

11. The implant of claim 9 in which each expansible element, in its rest condition, adopts the second configuration.

12. The implant of claim 4 in which the filler material is a foamed material which is introduced in a compressed state via the introducer into the interior of the envelope where it expands to its relaxed state to cause the envelope to conform to the volume.

13. The implant of claim 12 in which the foamed material is a polymeric material.

14. The implant of claim 4 in which the filler material comprises a plurality of discrete bands of a resiliently flexible material.

15. The implant of claim 14 in which the bands are configured to be arranged concentrically within the envelope.

16. The implant of claim 1 in which the envelope carries at least one layer of a tissue ingrowth material.

63. A system for implanting an intervertebral disc implant as claimed in any one of the preceding claims, the system including:

an introducer having a proximal and a distal end, a mount for the envelope of the implant being arranged at or adjacent the distal end of the introducer;

a source of filler material connectable to the proximal end of the introducer; and

a displacement mechanism for displacing the filler material along the introducer to be ejected from the introducer into the envelope, in use.

64. The system of claim 63 in which the introducer comprises at least one tubular member.

65. The system of claim 64 in which the introducer comprises at least two tubular members arranged in a telescopic fashion, the tubular members being reciprocally displaceable relative to one another.

66. The system of claim 65 in which an innermost of the tubular members carries the displacement mechanism.

67. The system of claim 66 in which the displacement mechanism comprises a ratchet arrangement for urging the filler material along the introducer into the envelope.

17. An intervertebral disc implant which includes:

an envelope, the envelope including an attaching formation for attachment to an introducer to enable the envelope, in a collapsed state, to be introduced into a volume of an intervertebral disc that has undergone a nucleotomy; and

a filler material receivable in the envelope after placement of the envelope in the volume of the disc, in use, to cause expansion of the envelope to conform to the volume, the filler material comprising a plurality of discrete, elongate elements introducible, via the introducer, into an interior of the envelope.

18. The implant of claim 17 in which the envelope is of an expansible material.

19. The implant of claim 18 in which the envelope carries at least one layer of a tissue ingrowth material.

20. The implant of claim 17 in which the envelope defines a filler opening and includes a closure element for closing the opening after introduction of the filler material.

21. The implant of claim 17 in which the elongate elements are selected from the group consisting of fibres, lengths of filamentary elements, bristle carrying elements and helical elements.

22. The implant of claim 17 in which the elongate elements are arranged in suspension in a filler within the volume.

23. The implant of claim 22 in which the filler is an elastomeric, curable filler.

24. The implant of claim 17 in which the elongate elements comprise a plurality of discrete bands of a resiliently flexible material.

25. The implant of claim 24 in which the bands are configured to be arranged concentrically within the envelope.

26. The implant of claim 17 in which the elongate elements are expansible elements.

27. The implant of claim 26 in which each expansible element is configured to change from a first configuration for insertion into the envelope to a second configuration which causes the envelope to conform substantially to the volume.

28. The implant of claim 27 in which each expansible element is configured to be received, in its first configuration, in the introducer for introduction into the envelope.

29. The implant of claim 25 in which each expansible element, in its rest condition, adopts the second configuration.

30. An intervertebral disc implant which includes:

an envelope of a stretchable and elastically deformable elastomeric material, the envelope including an attaching formation for attachment to an introducer to enable the envelope, in a collapsed state, to be introduced into a volume of an intervertebral disc that has undergone a nucleotomy; and

a filler material receivable in the envelope via the introducer to cause the envelope to expand elastically to conform substantially to the volume in which the envelope is received, in use, the filler material being a foamed material which is introduced in a compressed state via the introducer into the interior of the envelope where it expands to its relaxed state to cause the envelope to conform to-the volume.

31. The implant of claim 30 in which the foamed material is a polymeric material.

32. The implant of claim 30 in which the envelope carries at least one layer of a tissue ingrowth material.

33. The implant of claim 30 in which the envelope defines a filler opening and includes a closure element for closing the opening after introduction of the packing material.

34. An intervertebral disc implant which includes:

an envelope, the envelope including an attaching formation for attachment to an introducer to enable the envelope, in a collapsed state, to be introduced, in a minimally invasive manner, into a volume of an intervertebral disc that has undergone a nucleotomy; and

a filler material receivable in the envelope after placement of the envelope in the volume of the disc, in use, to cause expansion of the envelope to conform to the volume, the filler material comprising, in combination, a curable filler material and a plurality of discrete, biocompatible elements contained, in use, in the filler material within the envelope.

35. The implant of claim 34 in which the envelope is of an expansible material.

36. The implant of claim 35 in which the envelope carries at least one layer of a tissue ingrowth material.

37. The implant of claim 34 in which the envelope defines a filler opening and includes a closure element for closing the opening after introduction of the packing material.

38. The implant of claim 34 in which the elements includes, singly or in combination, beads, elongate elements and expansible elements.

39. The implant of claim 38 in which the elongate elements are selected from the group consisting of fibres, lengths of filamentary elements, bristle carrying elements and helical elements.

40. The implant of claim 38 in which each expansible element is configured to change from a first configuration for insertion into the envelope to a second configuration which causes the envelope to conform substantially to the volume.

41. The implant of claim 40 in which each expansible element is configured to be received, in its first configuration, in the introducer for introduction into the envelope.

42. The implant of claim 40 in which each expansible element, in its rest condition, adopts the second configuration.

43. The implant of claim 34 in which the filler is an elastomeric, curable filler.

44. An intervertebral disc implant which includes:

an envelope of a stretchable and elastically deformable elastomeric material, the envelope including an attaching formation for attachment to an introducer to enable the envelope, in a collapsed state, to be introduced into a volume of an intervertebral disc that has undergone a nucleotomy; and

a filler material receivable in the envelope via the introducer to cause the envelope to expand elastically to conform substantially to the volume in which the envelope is received, in use, the filler material being an elastomeric material having a viscosity of at least 500000 cP.

45. The implant of claim 44 in which the elastomeric material is a silicone.

46. The implant of claim 44 in which the envelope carries at least one layer of a tissue ingrowth material.

47. The implant of claim 44 in which the envelope defines a filler opening and includes a closure element for closing the opening after introduction of the packing material.

51. The implant of claim 47 in which the filler material receivable in at least one of the chambers differs from the filler material that is receivable in at least one other of the chambers.

52. The implant of claim 47 in which the envelope includes an attaching formation for attachment to a tubular introducer to enable the envelope, in a collapsed state, to be introduced into the volume of the disc.

53. The implant of claim 52 in which each chamber in which filler material is receivable has a filler mechanism associated with it.

54. The implant of claim 53 in which the filler mechanism is a one-way device that, upon closure, inhibits back flow of filler material.

55. The implant of claim 54 in which the filler mechanism of an outer chamber of the envelope is implemented as the attaching formation.

56. The implant of claim 47 in which the envelope carries at least one layer of a tissue ingrowth material.

57. A system for implanting an intervertebral disc implant, the system comprising:

an implant as claimed in claim 53; and

an introducer, the introducer comprising a plurality of filler tubes, each tube communication independently of any other tube with its associated chamber of the envelope for charging filler material into the associated chamber.

48. An intervertebral disc implant which includes:

an envelope receivable in a volume of an intervertebral disc that has undergone a nucleotomy, the envelope defining a plurality of chambers, the chambers being configured so that, when at least certain of the chambers contain a filler material, the envelope conforms substantially to the volume of the disc;

a filler material receivable in the at least certain of the chambers; and

at least one of the chambers having a filler mechanism associated with it.

49. The implant of claim 48 in which the chambers are defined by wall portions of the envelope, wall portions of some of the chambers being of a different wall thickness than wall portions of other chambers.

50. The implant of claim 48 in which the chambers are defined by wall portions of the envelope, wall portions of some of the chambers being of a different material than wall portions of other chambers.

58. An intervertebral disc implant which includes at least one element which changes from a first configuration for insertion into a volume of an intervertebral disc that has undergone a nucleotomy to a second configuration in which the at least one element conforms substantially to the volume, the at least one element being configured to be received, in its first configuration, in an introducer to be inserted into the volume of the disc.

59. The implant of claim 58 in which the at least one element, in its first configuration, is elongate and, in its second configuration, adopts a shape conforming substantially to the volume.

60. The implant of claim 58 in which the at least one element includes a biocompatible, shape memory alloy which causes the element to adopt its second configuration in the volume after ejection from the introducer.

61. The implant of claim 60 in which the at least one element, in its relaxed state, is in the first configuration, the at least one element including a retention device for retaining the at least one element in the second configuration after ejection from the introducer.

62. The implant of claim 58 which includes:

an envelope receivable in a collapsed state in the volume; and

a plurality of the elements receivable in the envelope, the plurality of elements causing the envelope to expand substantially to conform to the volume.

68. A method of implanting an intervertebral disc implant into an intervertebral disc, the method including:

percutaneously performing a nucleotomy on the disc to remove a nucleus pulposus of the disc to create a volume;

inserting an envelope of the implant into the volume;

charging an interior of the envelope with filler material in a manner to allow the envelope to expand to conform substantially to the volume; and

causing the interior of the envelope to be closed off to retain the filler material within the envelope, the filler material being selected to mimic natural biomechanical characteristics of the nucleus pulposus of the disc.

69. The method of claim 68 which includes inserting the envelope into the volume using an introducer, the envelope being placed in a collapsed state on a distal end of the introducer and inserted percutaneously through an opening in an annulus of the disc.

70. The method of claim 69 which includes charging the filler material into the interior of the envelope through the introducer.

71. The method of claim 70 which includes closing off the interior of the envelope by sealing a wall of the envelope.

72. The method of claim 71 which includes closing off the interior of the envelope by the action of withdrawing the introducer from the envelope.

73. A method of implanting an intervertebral disc implant into an intervertebral disc, the method including:

percutaneously performing a nucleotomy on the disc to remove a nucleus pulposus of the disc to create a volume;

inserting an introducer into an opening formed in an annulus of the disc; and

introducing into the volume, via the introducer, at least one element which changes from a first configuration, in which the at least one element is able to be inserted into the introducer, to a second configuration in which the at least one element conforms substantially to the volume.

74. The method of claim 73 which includes using a single element which, in its second configuration, conforms substantially to the volume of the disc.

75. The method of claim 73 which includes using a plurality of elements which together, when each such element is in its second configuration, conform substantially to the volume of the disc.

76. The method of claim 75 which includes, prior to insertion of the elements in the volume, introducing an envelope, in a collapsed state, into the volume and introducing the elements into the envelope to cause the envelope to expand to conform substantially to the volume of the disc.

77. The method of claim 76 which includes, after introduction of the elements into the envelope, closing off a filler opening of the envelope.

78. The method of claim 77 which includes closing off the filler opening of the envelope by withdrawal of the introducer from the filler opening of the introducer.

79. An introducer for introducing an intervertebral disc implant into a disc that has undergone a nucleotomy, the introducer including:

at least two sleeves arranged telescopically with respect to each other; and

a displacement mechanism arranged on an operatively inner surface of an innermost one of the sleeves for assisting in displacing filler material along the sleeves into an interior of the disc, in use.

80. The introducer of claim 79 in which the displacement mechanism comprises a ratchet arrangement for urging the filler material along the sleeve.