SPINAL IMPLANTS AND METHODS

• US 20090171461A1
• Filed: 11/19/2008
• Published: 07/02/2009
• Est. Priority Date: 08/26/2005
• Status: Abandoned Application

• Current Assignee: Magellan Spine Technologies, Inc.
• Original Assignee: Magellan Spine Technologies, Inc.
• Inventors: Nguyen, Khoi, Lenker, Jay A., Davis, Peter Gregory, Valko, Jeffrey J., CONNER, E. Scott, Lake, Matthew Scott
• Application Number:
  US12/274,349
• Publication Number:
  US 20090171461A1
• Time in Patent Office: Days
• US Class Current: 623/17.110
• CPC Class Codes: A61B 17/1615 Drill bits, i.e. rotating tools extending from a handpiece to contact the worked material
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 2017/00261 Discectomy
• CPC Class Codes: A61B 2090/061 for measuring dimensions, e.g. length
• CPC Class Codes: A61B 2090/062 penetration depth
• 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 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2/4684 Trial or dummy 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 2002/30112 Rounded shapes, e.g. with rounded corners
• CPC Class Codes: A61F 2002/30113 circular
• CPC Class Codes: A61F 2002/30242 spherical
• CPC Class Codes: A61F 2002/30383 made by laterally inserting a protrusion, e.g. a rib into a complementarily-shaped groove
• 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 2002/30481 using a locking clip
• CPC Class Codes: A61F 2002/30565 having spring elements
• CPC Class Codes: A61F 2002/30574 with an integral complete or partial collar or flange
• CPC Class Codes: A61F 2002/30576 with extending fixation tabs
• CPC Class Codes: A61F 2002/30593 : hollow
• CPC Class Codes: A61F 2002/30604 : modular
• CPC Class Codes: A61F 2002/30616 : Sets comprising a plurality of prosthetic parts of different sizes or orientations
• CPC Class Codes: A61F 2002/30787 : inclined obliquely with respect to each other
• CPC Class Codes: A61F 2002/3085 : with a threaded, e.g. self-tapping, bone-engaging surface, e.g. external surface
• CPC Class Codes: A61F 2002/30892 : parallel
• 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 2002/4629 : connected to the endoprosthesis or implant via a threaded connection
• CPC Class Codes: A61F 2002/4677 : using a guide wire
• CPC Class Codes: A61F 2220/0025 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• 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 2230/0004 : Rounded shapes, e.g. with rounded corners
• CPC Class Codes: A61F 2230/0006 : circular
• CPC Class Codes: A61F 2230/0071 : spherical
• CPC Class Codes: A61F 2310/00011 : Metals or alloys

Abstract

Spinal implants are disclosed that can be used for annular repair, facet unloading, disc height preservation, disc decompression, or for sealing a portal through which a nucleus an intervertebral implant was placed. In some embodiments, an implant is placed within the intervertebral disc space, primarily within the region of the annulus fibrosus. In some embodiments, the implant is expandable. In some embodiments, the implant has a sealing tail structure comprising a tail flange and a linkage. In some embodiments, the sealing tail structure limits the extrusion or expulsion of disc material, either annulus fibrosus or nucleus, into the posterior region of the spine where it could impinge on nerves. In some embodiments, the tail structure is retained in place within the annulus fibrosus by means of an anchor. In some embodiments, the anchor is constructed from multiple components.

Claims

1. An implant, for at least one of (i) treating an annular defect in an intervertebral disc between adjacent vertebrae of a patient, and (ii) maintaining a height between the adjacent vertebrae, comprising:

a head portion, sized and shaped to be positioned within the intervertebral disc space between the adjacent vertebrae and configured to engage tissue in the intervertebral disc space;

a tail portion; and

a coupling member that couples the tail portion to the head portion;

wherein, when the head portion is positioned between the adjacent vertebrae, the tail portion contacts a surface of the annulus fibrosus of the intervertebral disc and forms a barrier that prevents substantial expulsion of material from within the disc past the barrier.

2. The implant of claim 1, wherein the coupling member is configured to allow the tail portion to move relative to the anchor.

3. The implant of claim 1, wherein, when the head portion is positioned between the adjacent vertebrae, at least one of the tail portion and the coupling member maintains a height between the adjacent vertebrae.

4. The implant of claim 1, wherein the head portion is configured to engage at least one of the adjacent vertebrae.

6. The implant of claim 1, wherein the barrier is formed, at least in part, by the coupling member.

8. The implant of claim 1, wherein the a head portion comprises a plurality of slits disposed about a perimeter of the head portion.

9. The implant of claim 1, where the tail portion comprises a swellable polymer configured, when hydrated, to substantially fill a space between the adjacent vertebrae.

11. The implant of claim 1, wherein the head portion is moveable from a first configuration to a second configuration;

wherein the first configuration is configured to permit placement of the implant within the intervertebral disc space; and

wherein the second configuration is configured to fix the implant in place within the intervertebral disc space following implantation.

12. The implant of claim 1, further comprising:

a lumen extending through at least one of the head portion and the tail portion; and

at least one injection port fluidly connected to the lumen;

wherein the at least one injection port is configured to permit passage of an injectable material from outside the implant into the lumen.

15. The implant of claim 1, wherein at least one of the head portion and tail portion is configured to unload compressive forces exerted on spinal facets.

16. The implant of claim 1, wherein at least one of the head portion and tail portion is configured to decompress impinged spinal nerves upon implantation of the implant.

18. The implant of claim 1, wherein the head portion comprises a layer of bone growth factor on at least a portion of an outer surface.

20. The implant of claim 1, wherein the coupling member comprises a screw thread, and the tail portion is rotatably advanceable along the coupling member.

21. The implant of claim 1, wherein at least a portion of the head portion is configured to be embedded through an endplate of, and into, at least one of the adjacent vertebrae.

22. The implant of claim 1, wherein at least a portion of the head portion is configured to be embedded into each of the adjacent vertebrae.

24. The implant of claim 1, wherein the head portion comprises at least one of a hook and a barb, configured to be embedded into at least one of the adjacent vertebrae.

26. The implant of claim 1, wherein the head portion comprises no more than one spike, configured to be embedded into either a superior or an inferior vertebra.

27. The implant of claim 1, wherein the head portion comprises a spike, wherein the spike comprises a flexible shaft having column strength and tensile strength such that the spike can be advanced from the tail flange area and deflect either superiorly or inferiorly to embed within either of the adjacent vertebrae.

28. The implant of claim 1, wherein the coupling member is configured to fix the tail portion in a position relative to the head portion.

29. The implant of claim 1, wherein at least one of the coupling member and the tail portion comprises a ratchet, configured to fix the tail portion in a position relative to the head portion.

30. The implant of claim 1, wherein the coupling member threadably engages the tail portion to fix the tail portion in a position relative to the head portion.

31. The implant of claim 1, wherein the coupling member locks with the tail portion to fix the tail portion in a position relative to the head portion.

32. The implant of claim 1, wherein the at least one coupling member further comprises a bias member configured to provide a force that maintains effective contact between the tail portion and the surface of the disc.

33. The implant of claim 1, wherein the bias member pulls the head portion toward the tail portion to assist in the preventing substantial expulsion of material from within the disc.

34. The implant of claim 1,

wherein the head portion has a height and a width that are each substantially transverse to a long axis of the head portion;

wherein the height and the width are such that, when the head is in a first rotational position with respect to the long axis, the head portion passes into the intervertebral disc space as the head portion is advanced between the adjacent vertebrae;

wherein, when the head portion is in the intervertebral disc space and is rotated into a second rotational position with respect to the long axis, the head portion engages tissue in intervertebral disc space, substantially conforming a height of a region of the intervertebral disc space to the height of the head portion.

35. The implant of claim 34, wherein the height and the width are such that, when the head is in the first rotational position with respect to the long axis, the head portion passes into the intervertebral disc space as the head portion is advanced substantially along the long axis between the adjacent vertebrae.

36. The implant of claim 34, wherein an angle of rotation between the first rotational position and the second rotational position is about 90°

.

37. The implant of claim 34, wherein the engaged tissue in the intervertebral disc space comprises at least one of the adjacent vertebrae.

38. The implant of claim 34, wherein, after the head portion is rotated into the second rotational position, a portion of the implant maintains a height between the adjacent vertebrae.

39. The implant of claim 34, further comprising:

a lumen extending through at least one of the head portion and the tail portion; and

at least one injection port fluidly connected to the lumen;

wherein the at least one injection port is configured to permit passage of an injectable material from outside the implant into the lumen.

5. (canceled)

7. (canceled)

10. (canceled)

13. (canceled)

14. The implant of claim 13, wherein the head portion and the tail portion interact so as to preserve substantially a normal physiological range of motion of the adjacent vertebrae after implantation of the implant in the intervertebral disc space.

17. (canceled)

19. (canceled)

23. (canceled)

25. (canceled)

40. An implant, for at least one of (i) treating an annular defect in an intervertebral disc between adjacent vertebrae of a patient, and (ii) maintaining a height between the adjacent vertebrae, comprising:

a spacer, sized and shaped to be positioned within the intervertebral disc space between the adjacent vertebrae to engage at least one of the adjacent vertebrae;

wherein, when the implant is positioned between the adjacent vertebrae, a portion of the implant engages tissue in intervertebral disc space and forms a barrier that prevents substantial expulsion of material from within the disc past the barrier;

wherein the spacer has a height and a width that are each substantially transverse to a long axis of the spacer;

wherein the height and the width are such that, when the spacer is in a first rotational position with respect to the long axis, the spacer passes into the intervertebral disc space as the spacer is advanced substantially along the long axis between the adjacent vertebrae;

wherein, when the spacer is in the intervertebral disc space and is rotated into a second rotational position with respect to the long axis, the spacer engages tissue in intervertebral disc space, substantially conforming a height of a region of the intervertebral disc space to the height of the spacer.

41. The implant of claim 40, wherein an angle of rotation between the first rotational position and the second rotational position is about 90°

.

42. The implant of claim 40, wherein the engaged tissue in the intervertebral disc space comprises at least one of the adjacent vertebrae.

43. The implant of claim 40, wherein, after the spacer is rotated into the second rotational position, a portion of the implant maintains a height between the adjacent vertebrae.

44. An implant, for at least one of (i) treating an annular defect in an intervertebral disc between two adjacent vertebrae of a patient, and (ii) maintaining a height between the adjacent vertebrae, comprising:

an anchoring member, configured to be positioned in the intervertebral disc space between the adjacent vertebrae, a portion of the anchoring member being configured to engage tissue in the intervertebral disc space; and

a tail portion, coupled to the at least one anchoring member, such that when the portion is embedded into the at least one of the adjacent vertebrae, the tail portion contacts a surface of the annulus fibrosus of the intervertebral disc and forms a barrier that prevents substantial expulsion of material from the disc past the tail portion; and

at least one coupling member that couples the anchoring member to the tail portion and fixes the tail portion in a position relative to the head, such that the tail portion contacts the surface of the disc.

45. The implant of claim 44, wherein, when the anchoring member is positioned between the adjacent vertebrae, at least one of the tail portion and the at least one coupling member maintains a height between the adjacent vertebrae.

46. The implant of claim 44, wherein the anchoring member is configured to engage at least one of the adjacent vertebrae.

47. The implant of claim 44, wherein the portion of the anchoring member is configured to embed into each of the two adjacent vertebrae.

48. The implant of claim 44, wherein the portion of the anchoring member is comprises at least one of a spike, a hook, and a barb.

49. The implant of claim 44, wherein the at least one coupling member further comprises a bias member configured to provide a force that maintains effective contact between the tail portion and the surface of the disc.

50. (canceled)

51. (canceled)

52. (canceled)

53. (canceled)

54. (canceled)

55. (canceled)

56. (canceled)

57. (canceled)

58. (canceled)

59. (canceled)

60. A method, for at least one of (i) treating an annular defect in an intervertebral disc between adjacent vertebrae of a patient, and (ii) maintaining a height between the adjacent vertebrae, comprising:

inserting a portion of an implant, in a first configuration, through an opening in the intervertebral disc and into the intervertebral disc space between the adjacent vertebrae;

transforming the portion, in the intervertebral disc space, from the first configuration to a second configuration that substantially inhibits the portion from exiting the intervertebral disc space through the opening;

engaging another portion of the implant with the disc, such that the other portion forms a barrier effective to prevent substantial expulsion of material from the disc.

61. The method of claim 60, wherein the transforming comprises rotating the portion in the intervertebral disc space.

62. The method of claim 60, wherein the transforming comprises transforming a shape memory material in the portion.

63. A method, for at least one of (i) treating an annular defect in an intervertebral disc between adjacent vertebrae of a patient, and (ii) maintaining a height between the adjacent vertebrae, comprising:

providing an implant having a head portion coupled to a tail portion, wherein the head portion has a long axis;

inserting the head portion, in substantially a first rotational position with respect to the long axis, into the intervertebral disc space between the adjacent vertebrae;

when the head portion is in the intervertebral disc space, rotating at least the head portion from the first rotational position to a second rotational position with respect to the long axis, thereby engaging at least one of the adjacent vertebrae with the head portion; and

engaging the disc with the tail portion, such that the tail portion forms a barrier effective to prevent substantial expulsion of material from the disc.

64. The method of claim 63, wherein the rotating comprises rotating at least the head portion about 90°

.

65. The method of claim 63, further comprising injecting a substance through a lumen in the implant from outside the spine, through the lumen, and into the intervertebral disc space.

66. The method of claim 63, wherein the inserting comprises advancing the head portion in a direction substantially along the long axis into the intervertebral disc space.

67. A method, for at least one of (i) treating an annular defect in an intervertebral disc between adjacent vertebrae of a patient, and (ii) maintaining a height between the adjacent vertebrae, comprising:

providing an implant having a long axis;

inserting the implant, in substantially a first rotational position with respect to the long axis, into the intervertebral disc space between the adjacent vertebrae;

when the implant is at least partially in the intervertebral disc space, rotating the implant from the first rotational position to a second rotational position with respect to the long axis, thereby engaging tissue in the intervertebral disc space with the implant; and

engaging the disc with the implant so as to form a barrier effective to prevent substantial expulsion of material from the disc.

68. The method of claim 67, wherein the rotating comprises rotating the implant about 90°

.

69. The method of claim 67, wherein engaged tissue in the intervertebral disc space comprises at least one of the adjacent vertebrae.

70. The method of claim 67, wherein, after the rotating, a portion of the implant maintains a height between the adjacent vertebrae.

71. (canceled)

72. (canceled)