Devices and methods for annular repair of intervertebral discs

• US 7,753,941 B2
• Filed: 09/17/2004
• Issued: 07/13/2010
• Est. Priority Date: 04/04/2000
• Status: Active Grant

• Current Assignee: KRT Investors, Inc.
• Original Assignee: Anulex Technologies, Inc.
• Inventors: Keith, Peter T., Atkinson, Robert E.
• Primary Examiner(s): Barrett; Thomas C
• Assistant Examiner(s): Araj; Michael J
• Application Number:
  US10/943,525
• Publication Number:
  US 20050049592A1
• Time in Patent Office: 2,125 Days
• Field of Search: 623 1711- 1716, 606/246, 606/279, 606/99
• US Class Current: 606/279
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 17/3472 for bones, e.g. intraosseus injections
• 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 17/8897 Guide wires or guide pins
• CPC Class Codes: A61B 18/08 by means of electrically-heated probes
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00261 Discectomy
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2090/037 with a frangible part, e.g. by reduced diameter
• 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 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/30579 with mechanically expandable devices, e.g. fixation devices
• CPC Class Codes: A61F 2002/30841 Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
• 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 2002/4627 : 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 2210/0004 : bioabsorbable
• CPC Class Codes: A61F 2210/0023 : operated at different temperatures whilst inside or touching the human body, heated or cooled by external energy source or cold supply
• CPC Class Codes: A61F 2310/00017 : Iron- or Fe-based alloys, e.g. stainless steel
• CPC Class Codes: A61F 2310/00023 : Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/00976 : Coating or prosthesis-covering structure made of proteins or of polypeptides, e.g. of bone morphogenic proteins BMP or of transforming growth factors TGF

Abstract

Devices and methods for treating a damaged intervertebral disc to reduce or eliminate associated back pain. The present invention provides disc reinforcement therapy (DRT) which involves implanting one or more reinforcement members in and preferably around the annulus of the disc. The reinforcement members may be used to stabilize the annulus and/or compresses a portion of the annulus so as to reduce a bulge and/or close a fissure. The implantable devices and associated delivery tools may incorporate heating capabilities to thermally treat the annular tissue. Alternatively or in combination, other devices may be specifically employed for such thermal treatment.

Claims

1. A method of treating an intervertebral disc having an annulus and a nucleus, comprising:

providing a first elongate member having a proximal end and a sharp tissue penetrating distal end;

inserting the distal end of the first member into the annulus tissue, including piercing the annulus tissue with the sharp tissue penetrating distal end;

providing a second elongate member having a proximal end and a distal portion configured to receive the first elongate member;

positioning the distal receiving portion of the second member proximate the disc;

passing the distal end of the first member through disc tissue; and

receiving the first member in the distal receiving portion of the second member.

2. A method as in claim 1, wherein the distal receiving portion of the second member is inserted into the disc prior to receiving the first member.

3. A method as in claim 1, wherein the distal receiving portion receives a distal portion of the first member.

4. A method as in claim 1, wherein the distal receiving portion receives the distal end of the first member.

5. A method as in claim 1, wherein the receiving portion includes an opening sized to accommodate the first member.

6. A method as in claim 5, wherein the receiving portion includes a lumen sized to accommodate the first member.

7. A method as in claim 6, wherein the first member is advanced through the lumen of the second member.

8. A method as in claim 1, further comprising a flexible elongate line connected to a proximal portion of the first member.

9. A method as in claim 8, wherein the flexible elongate line comprises a suture.

10. A method as in claim 8, wherein the line passes through disc tissue.

11. A method as in claim 10, wherein the line passes through disc tissue along a path defined by the first member and the second member.

12. A method as in claim 11, wherein the line is looped through and around disc tissue.

13. A method as in claim 12, wherein the line has end portions residing outside the disc and a mid portion residing in the disc.

14. A method as in claim 13, wherein the end portions of the line are secured.

15. A method as in claim 14, wherein the end portions are tied.

16. A method as in claim 14, wherein the end portions are secured to a pledget.

17. A method as in claim 1, wherein the first member has a curved distal end.

18. A method as in claim 17, wherein the curved distal end has a curvature, and wherein the distal end of the first member passes through disc tissue along a path with a similar curvature.

19. A method as in claim 18, wherein the curved path is aligned with the receiving portion of the second member.

20. A method as in claim 1, wherein the first member enters the disc along a first path defined by the first member and exits the disc along a second path defined by the second member.

21. A method as in claim 1, wherein the first member enters and exits the disc along a path defined by the second member.

22. A method as in claim 1, wherein the first member comprises a stylet.

23. A method as in claim 1, wherein the first member comprises a hollow stylet.

24. A method as in claim 1, wherein the second member includes two lumens.

25. A method as in claim 1, wherein the first member is delivered via a hollow guide tube.

26. A method of treating an intervertebral disc having an annulus and a nucleus, comprising:

providing a first elongate member having a proximal end, a curved distal portion defining a curvature, and a sharp tissue penetrating distal end;

inserting the distal end of the first member into the annulus tissue, including piercing the annulus with the sharp tissue penetrating distal end;

providing a second elongate member having a proximal end and a distal portion configured to receive the first elongate member;

positioning the distal receiving portion of the second member proximate the disc in alignment with the curvature of the first member;

passing the distal end of the first member through disc tissue along a curved path; and

receiving the distal end of first member in the distal receiving portion of the second member.

27. A method as in claim 26, wherein the distal receiving portion of the second member is inserted into the disc prior to receiving the first member.

28. A method as in claim 26, wherein the receiving portion includes an opening sized to accommodate the first member.

29. A method as in claim 28, wherein the receiving portion includes a lumen sized to accommodate the first member.

30. A method as in claim 26, wherein the first member is advanced through the lumen of the second member.

31. A method as in claim 26, further comprising a flexible elongate line connected to a proximal portion of the first member.

32. A method as in claim 31, wherein the flexible elongate line comprises a suture.

33. A method as in claim 31, wherein the line passes through disc tissue.

34. A method as in claim 33, wherein the line passes through disc tissue along a path defined by the first member and the second member.

35. A method as in claim 34, wherein the line is looped through and around disc tissue.

36. A method as in claim 35, wherein the line has end portions residing outside the disc and a mid portion residing in the disc.

37. A method as in claim 36, wherein the end portions of the line are secured.

38. A method as in claim 37, wherein the end portions are tied.

39. A method as in claim 37, wherein the end portions are secured to a pledget.

40. A method as in claim 26, wherein the first member enters the disc along a first path defined by the first member and exits the disc along a second path defined by the second member.

41. A method as in claim 26, wherein the first member enters and exits the disc along a path defined by the second member.

42. A method as in claim 26, wherein the first member comprises a stylet.

43. A method as in claim 26, wherein the first member comprises a hollow stylet.

44. A method as in claim 26, wherein the second member includes two lumens.

45. A method as in claim 26, wherein the first member is delivered via a hollow guide tube.

46. A method of treating an intervertebral disc having an annulus and a nucleus, comprising:

providing a first elongate member having a proximal end and a sharp tissue penetrating distal end;

providing a flexible elongate line connected to the first member;

inserting the distal end of the first member into the annulus tissue, including piercing the annulus tissue with the sharp distal end;

providing a second elongate member having a proximal end and a distal portion configured to receive the first elongate member;

positioning the distal receiving portion of the second member proximate the disc;

passing the distal end of the first member through disc tissue;

receiving the first member in the distal receiving portion of the second member; and

passing the line through disc tissue.

47. A method as in claim 46, wherein the line is looped through and around disc tissue.

48. A method as in claim 46, wherein the distal receiving portion of the second member is inserted into the disc prior to receiving the first member.

49. A method as in claim 46, wherein the distal receiving portion receives a distal portion of the first member.

50. A method as in claim 46, wherein the distal receiving portion receives the distal end of the first member.

51. A method as in claim 46, wherein the receiving portion includes an opening sized to accommodate the first member.

52. A method as in claim 51, wherein the receiving portion includes a lumen sized to accommodate the first member.

53. A method as in claim 52, wherein the first member is advanced through the lumen of the second member.

54. A method as in claim 46, wherein the flexible elongate line comprises a suture.

55. A method as in claim 46, wherein the line passes through disc tissue along a path defined by the first member and the second member.

56. A method as in claim 46, wherein the line is looped through and around disc tissue.

57. A method as in claim 46, wherein the line has end portions residing outside the disc and a mid portion residing in the disc.

58. A method as in claim 57, wherein the end portions of the line are secured.

59. A method as in claim 58, wherein the end portions are tied.

60. A method as in claim 58, wherein the end portions are secured to a pledget.

61. A method as in claim 46, wherein the first member has a curved distal end.

62. A method as in claim 61, wherein the curved distal end has a curvature, and wherein the distal end of the first member passes through disc tissue along a path with a similar curvature.

63. A method as in claim 62, wherein the curved path is aligned with the receiving portion of the second member.

64. A method as in claim 46, wherein the first member enters the disc along a first path defined by the first member and exits the disc along a second path defined by the second member.

65. A method as in claim 46, wherein the first member enters and exits the disc along a path defined by the second member.

66. A method as in claim 46, wherein the first member comprises a stylet.

67. A method as in claim 46, wherein the first member comprises a hollow stylet.

68. A method as in claim 46, wherein the second member includes two lumens.

69. A method as in claim 46, wherein the first member is delivered via a hollow guide tube.