Flexible systems for spinal stabilization and fixation

• US 7,229,441 B2
• Filed: 02/26/2002
• Issued: 06/12/2007
• Est. Priority Date: 02/28/2001
• Status: Expired due to Fees

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: Trieu, Hai, Serbousek, Jon
• Primary Examiner(s): Philogene; Pedro
• Application Number:
  US10/083,199
• Publication Number:
  US 20020120270A1
• Time in Patent Office: 1,932 Days
• Field of Search: 606/61, 606/69, 606/70, 606/71, 606/60, 606/72, 606/73, 606/232, 623/17.11
• 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 17/0642 for bones, e.g. for osteosynthesis or connecting tendon to bone
• CPC Class Codes: A61B 17/7022 Tethers, i.e. longitudinal elements capable of transmitting tension only, e.g. straps, sutures or cables A61B17/702 takes precedence
• CPC Class Codes: A61B 17/7059 Cortical plates A61B17/7007, A61B17/7058 take precedence
• CPC Class Codes: A61B 17/7062 Devices acting on, attached to, or simulating the effect of, vertebral processes, vertebral facets or ribs rib fixation devices A61B17/8076; Tools for such devices
• CPC Class Codes: A61B 17/8085 with pliable or malleable elements or having a mesh-like structure, e.g. small strips A61B17/8071, A61B17/8076 take precedence
• CPC Class Codes: A61B 17/8695 Washers surrounding screw head in plate hole A61B17/8047, between bone plate and bone A61B17/8028
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61B 2017/0648 threaded, e.g. tacks with a screw thread
• CPC Class Codes: A61B 2017/7073 with intervertebral connecting element crossing an imaginary spinal median surface
• CPC Class Codes: A61F 2/08 Muscles; Tendons; Ligaments sutures A61B17/04
• CPC Class Codes: A61F 2/0811 Fixation devices for tendons or ligaments
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/44 for the spine, e.g. vertebrae, spinal discs
• 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 2/446 having a circular or elliptical cross-section substantially parallel to the axis of the spine, e.g. cylinders or frustocones
• 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 2002/30235 tubular, e.g. sleeves
• CPC Class Codes: A61F 2002/30593 : hollow
• 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 2210/0004 : bioabsorbable
• CPC Class Codes: A61F 2210/0014 : using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2230/0069 : cylindrical
• 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 2310/00293 : containing a phosphorus-containing compound, e.g. apatite
• CPC Class Codes: A61F 2310/00359 : Bone or bony tissue

Abstract

Systems for spinal stabilization and fixation replace, reconstruct or augment the spinal ligamentous and/or bony tissues resected during surgical procedures. The spinal stabilization system includes at least an implant configured to span the intervertebral disc space with at least one of its ends attached to a respective vertebral body by at least one anchor. The system has a low profile conformable to the spinal anatomy.

Claims

1. A spine stabilization system, comprising:

an implant having a first end and an opposite second end, at least a portion of one of said first and second ends structure for positioning in use in a tunnel formed in a first vertebral body; and

at least one anchor securing the at least a portion of one of the first and second ends of the implant against being pulled from the tunnel within the first vertebral body without protruding from the first vertebral body for attaching said at least a portion of said one of said first and second ends of said implant to the first vertebral body when positioned in the tunnel with said implant including a body having a length and structure to extend from the tunnel along an outer surface of the first vertebral body to a second vertebral body.

2. The system of claim 1, wherein said at least one anchor extends along and threadingly engages said one of said first and second ends of said implant.

3. The system of claim 1, wherein the other of said first and second ends of said implant is structured for positioning in a second tunnel formed in the second vertebral body and further comprising a second anchor engageable to the second vertebral body for attaching said implant to the second vertebral body.

4. The system of claim 3, further comprising a device positionable in a spinal disc space between the first vertebral body and the second vertebral body.

5. The system of claim 1, wherein the tunnel forms an angle relative to an axial plane of the spinal column in the range of 0 degrees to 80 degrees.

6. The system of claim 5, wherein said angle is in the range of about 25 degrees to about 65 degrees.

7. The system of claim 1, wherein said at least one anchor is selected from the group consisting of:

an interference screw, a suture anchor, a button, a spiked washer, and a pin fastener.

8. The system of claim 3, wherein said implant is flexible.

9. The system of claim 8, wherein said implant extends along the anterior faces of the first vertebral body and the second vertebral body when attached thereto.

10. The system of claim 8, wherein said implant extends along the lateral faces of the first vertebral body and the second vertebral body when attached thereto.

11. The system of claim 8, wherein said implant extends between a pedicle of the first vertebral body and a pedicle of the second vertebral body when attached thereto.

12. The system of claim 8, wherein said implant comprises a synthetic resorbable material selected from the group consisting of:

polylactide, polyglycolide, tyrosine-derived polycarbonate, polyanhydride, polyorthoester, polyphosphazene, calcium phosphate, hydroxyapatite, bioactive glass and combinations thereof.

13. The system of claim 8, wherein said implant comprises a natural resorbable material selected from the group consisting of:

autograft, allograft, xenograft, soft tissues, connective tissues, demineralized bone matrix, and combinations thereof.

14. The system of claim 8, wherein said implant comprises a nonresorbable material selected from the group consisting of:

polyethylene, polyester, polyvinyl alcohol, polyacrylonitrile, polyamide, polytetrafluorethylene, poly-paraphenylene terephthalamide, cellulose, shape-memory alloys, titanium, titanium alloys, stainless steel, and combinations thereof.

15. The system of claim 1, wherein said at least one anchor is positionable in a second tunnel that intersects the tunnel in which said one end of said implant is positioned.

16. The system of claim 15, wherein the tunnel extends from an anterior face of the first vertebral body and the second tunnel extends from a lateral face of the first vertebral body.

17. The system of claim 15, wherein the tunnel extends from an anterior face of the first vertebral body and the second tunnel extends from an antero-lateral face of the first vertebral body.

18. The system of claim 17, wherein the tunnel is curved toward the second tunnel and the second tunnel extends obliquely relative to the saggital plane.

19. The system of claim 15, wherein:

the tunnel extends from an anterior face of the first vertebral body adjacent one vertebral endplate at a first angle relative to the axial plane of the spinal column; and

the second tunnel extends from the anterior face of the first vertebral body adjacent the other endplate at a second angle relative to the axial plane of the spinal column.

20. The system of claim 19, wherein said first angle and said second angle are equal.

21. The system of claim 1, wherein:

the tunnel extends through the first vertebral body from a first opening adjacent one endplate of the first vertebral body to a second opening adjacent the other endplate of the first vertebral body; and

said one end of said implant is positionable from the first opening through the tunnel and for attachment to the first vertebral body at the second opening with said at least one anchor.

22. The system of claim 21, wherein said first opening opens at the one vertebral endplate.

23. The system of claim 1, further comprising:

a second implant having a first end and an opposite second end, at least a portion of said first and second ends of the second implant being positionable in a second tunnel formed in the first vertebral body; and

a second anchor engageable to the first vertebral body for attaching said second implant to the first vertebral body.

24. The system of claim 23, wherein:

said implant is attachable along the anterior face of the first vertebral body on one side of the sagittal plane; and

said second implant is attachable along the anterior face of the first vertebral body on the other side of the sagittal plane.

25. The system of claim 23, wherein:

at least a portion of the other of said first and second ends of said implant is positionable in a third tunnel formed in a second vertebral body and further comprising a third anchor for attaching said implant to the second vertebra; and

at least a portion of the other of said first and second ends of said second implant is positionable in a fourth tunnel formed in the second vertebral body and further comprising a fourth anchor for attaching said second implant to the second vertebra.

26. The system of claim 25, wherein said implant and said second implant are parallel to one another.

27. The system of claim 25, wherein said implant and said second implant cross over one another.

28. The system of claim 25, wherein each of said at least one anchor, said second anchor, said third anchor and said fourth anchor are interference screws positionable in respective ones of the tunnel, the second tunnel, the third tunnel, and the fourth tunnel in engagement with the respective ends of said implant and said second implant.

29. The system of claim 1, further comprising:

a second tunnel formed in the first vertebral body and spaced from the tunnel;

a third tunnel extending through a second vertebral body from a first opening adjacent one endplate of the second vertebral body to a second opening adjacent the one endplate of the second vertebral body, wherein said implant is positionable through the third tunnel and at least a portion of the other of said first and second ends is positionable in the second tunnel, and further comprising a second anchor engageable to the first vertebral body for attaching said other end of said implant to the first vertebral body.

30. The system of claim 1, wherein the tunnel extends between a first opening adjacent an endplate of the first vertebral body and a second opening adjacent the endplate of the first vertebral body, and further comprising a second tunnel extending through a second vertebral body from a third opening adjacent one endplate of the second vertebral body to a fourth opening adjacent the one endplate of the second vertebral body, wherein said implant is positionable through the second tunnel and the other of said first and second ends is positionable into the first tunnel and overlaps said one end of said implant when attached to the first vertebral body.

31. The system of claim 1, wherein said at least one anchor extends along said one end of said implant.

32. The system of claim 1, wherein said at least one anchor intersects said one end of said implant.

33. The system of claim 1, wherein said at least one anchor is attached to said one end of said implant.

34. The system of claim 1, further comprising a second tunnel formed in the first vertebral body spaced from the tunnel, and wherein said one end of said implant has a second portion positionable in the second tunnel and attached thereto with a second anchor engaged to the first vertebral body.

35. The system of claim 1, wherein said implant comprises a substantially inelastic material.

36. The system of claim 1, wherein said implant comprises a substantially flexible material.

37. A spine stabilization system, comprising:

an implant having a first end and an opposite second end, at least one of said first and second ends being positionable in a tunnel formed in a first vertebral body; and

at least one anchor securing the at least one of the first and second ends of the implant against being pulled from the tunnel within the first vertebral body without protruding from the first vertebral body, wherein said implant includes a portion between said first and second ends sized to extend from the first vertebral body to a second vertebral body, said one of said first and second ends and said portion of said implant are flexible and angled relative to one another and said portion includes a length sized to extend from the first vertebral body toward the second vertebral body with the one of the first and second ends and said portion being structured to conform to an outer surface of the vertebral body when oriented for positioning into the first vertebral body in the tunnel.

38. The system of claim 37, wherein said at least one anchor is sized to not protrude from the first vertebral body when in engagement with said one of said first and second ends.

39. The system of claim 37, wherein the other of said first and second ends of said implant is positionable in a second tunnel formed in the second vertebral body and further comprising a second anchor engageable to the second vertebral body in the tunnel for attaching said implant to the second vertebral body, wherein said at least one anchor and said second anchor are each sized to not protrude from the respective vertebral bodies when positioned therein in engagement with said implant.

40. The system of claim 39, wherein the first and second ends extend in opposite directions from one another and are angled relative to said portion such that when engaged to the respective vertebral bodies the first and second ends each form an angle ranging from about 0 degrees to about 80 degrees relative to an axial plane taken at an entry location of the respective first and second ends into the respective vertebral body.

41. The system of claim 40, wherein said angles are in the range of about 25 degrees to about 65 degrees.

42. The system of claim 39, further comprising a device positionable in a spinal disc space between the first vertebral body and the second vertebral body.

43. The system of claim 39, wherein said at least one anchor is selected from the group consisting of:

an interference screw, a suture anchor, a button, a spiked washer, and a pin fastener.

44. The system of claim 39, wherein said implant is flexible.

45. The system of claim 44, wherein said implant extends along and is conformable to anterior faces of the first vertebral body and the second vertebral body when positioned in the tunnels.

46. The system of claim 37, wherein said at least one anchor extends along said one of said first and second ends of said implant when engaged thereto.

47. The system of claim 37, wherein said at least one anchor is attached to said one of said first and second ends of said implant.

48. The system of claim 37, wherein said implant comprises a substantially inelastic material.

49. The system of claim 37, wherein said implant comprises a substantially flexible material.

50. The system of claim 37, wherein said at least one anchor extends along and threadingly engages said one of said first and second ends of said implant.

51. A spine stabilization system, comprising:

an implant having a flexible, conformable body extending between a first end and an opposite second end, at least a portion of one of said first and second ends including means for conforming to a first vertebral body in a tunnel formed in a first vertebral body; and

at least one anchor securing the at least a portion of one of the first and second ends of the implant against being pulled from the tunnel within the first vertebral body in without protruding from the first vertebral body, said at least one anchor and said one of said first and second ends being configured to engage one another in the tunnel with said means for conforming further having a length extending from the tunnel to conform to an outer surface of the first vertebral body outside the tunnel.

52. The system of claim 51, wherein said one of said first and second ends and said at least one anchor form an acute angle relative to an axial plane of the spinal column when engaged to the first vertebral body, wherein said angle is in the range of about 25 degrees to about 65 degrees.

53. The system of claim 51, wherein the other of said first and second ends of said implant is positionable in a second tunnel formed in a second vertebral body and further comprising a second anchor engageable to the second vertebral body for attaching said implant to the second vertebral body.

54. The system of claim 53, wherein when in the respective tunnels each of said first and second ends of said implant extends in a direction opposite one another and at an acute angle relative to an axial plane of the spinal column taken between the vertebral bodies.

55. The system of claim 54, wherein the angle of the first and second ends relative to the axial plane is in the range from about 25 degrees to about 65 degrees.

56. The system of claim 53, further comprising a device positionable in a spinal disc space between the first vertebral body and the second vertebral body.

57. The system of claim 53, wherein said body is structured for positioning on anterior faces of the first vertebral body and the second vertebral body when said first and second ends are positioned in respective ones of said tunnels.

58. The system of claim 51, wherein said at least one anchor extends along and threadingly engages said one of said first and second ends of said implant.