Systems and methods for spinal fixation

• US 6,923,811 B1
• Filed: 05/10/2000
• Issued: 08/02/2005
• Est. Priority Date: 05/10/1999
• Status: Expired due to Term

• Current Assignee: K2M, Inc (Stryker Corporation)
• Original Assignee: Spray Venture Partners
• Inventors: Winkler, Josef K., Carl, Allen, Hart, Ricky D.
• Primary Examiner(s): Manahan, Todd E.
• Assistant Examiner(s): Priddy, Michael B.
• Application Number:
  US10/019,265
• Time in Patent Office: 1,910 Days
• Field of Search: 606/60, 606/61, 606/72, 606/74, 606/75, 606/167, 606/170, 606/180, 606/185, 623 1711- 1716
• US Class Current: 623/17.11
• CPC Class Codes: A61B 17/15 Guides therefor arrangements for guiding straight saw blades in general B23D51/025
• CPC Class Codes: A61B 17/1604 Chisels; Rongeurs; Punches; Stamps
• CPC Class Codes: A61B 17/1642 for producing a curved bore
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/1757 for the spine
• CPC Class Codes: A61B 17/320016 Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes A61B10/0233, A61B17/29, A61B17/3207 take precedence
• CPC Class Codes: A61B 17/70 Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
• CPC Class Codes: A61B 17/7011 Longitudinal element being non-straight, e.g. curved, angled or branched adjustable length longitudinal elements A61B17/7014; A61B17/7019 takes precedence, e.g. coil springs
• CPC Class Codes: A61B 17/7083 Tools for guidance or insertion of tethers, rod-to-anchor connectors, rod-to-rod connectors, or longitudinal elements
• CPC Class Codes: A61B 17/92 Impactors or extractors, e.g. for removing intramedullary devices insertion or extraction of artificial joints A61F2/4603
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2017/0256 for the spine
• CPC Class Codes: A61B 2090/08021 of the patient or his organs
• CPC Class Codes: A61F 2/4455 for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages intervertebral discs A61F2/442
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• 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 2002/4687 Mechanical guides for implantation instruments
• CPC Class Codes: A61F 2310/00365 Proteins; Polypeptides; Degradation products thereof

Abstract

Featured are a method and apparatus for fixing adjacent vertebrate of a spine that avoids the need and associated problems with prior cage or straight rod and screw systems. Methods and apparatus of the invention utilize a new implant member, which preferably is arcuate. Preferred methods of the invention for stabilizing adjacent vertebrae of the spine, include steps of providing a positioning apparatus including two guide sleeves, each guide sleeve having a long axis and locating the two guide sleeves with respect to the adjacent vertebrae such that a vertex formed by the long axis of each guide sleeve is located in the intervertebral space for the adjacent vertebrae. The method further includes forming an aperture in each of the adjacent vertebrae using the guide sleeves and inserting an implant into the apertures formed in each of the adjacent vertebrae so that the implant extends between the adjacent vertebrae and through the intervertebral space. In an alternative method a cutting fixture including a pivot arm is secured to the adjacent vertebrae and a cutting device is secured to the pivot arm. The pivot arm and cutting device are configured and arranged so that rotation of the pivot arm about a particularly located pivot point allows the cutting device to form the aperture in each of the adjacent vertebrae. Another alternative method for fixing adjacent vertebrate of a spine includes the step of forming a common channel in and between the adjacent vertebrae and inserting a biscuit implant in the common so as to bridge between the adjacent vertebrae.

Claims

1. A spinal intravertebral prosthetic system, comprising:

an intravertebral prosthetic device;

an arcuate implant member of a size sufficient to extend between two adjacent vertebrate;

wherein the intravertebral prosthetic device is configured to receive therein a portion of the arcuate implant member; and

wherein the portion of the arcuate implant member that passes through the intravertebral prosthetic device is made from a compressible material.

2. The spinal intravertebral prosthetic system of claim 1 wherein the compressible material is one of silicon, elastomeric polymers, polyurethances and copolymers thereof, hydrogels, collagen, bioabsorbables, compositions, a metallic spring or coil, or a material that allows continual mobility between the vertebral bodies.

3. The spinal intravertebral prosthetic system of claim 2 wherein the intravertebral prosthetic device comprises a compressible material.

4. The spinal intravertebral prosthetic system of claim 3 wherein the compressible material is one of silicon, elastomeric polymers, polyurethanes and copolymers thereof, hydrogels, collagen or bioabsorbables.

5. The spinal intravertebral prosthetic system of claim 1, wherein the implant includes a non-flexible portion made of a material conducive to attachment to the vertebrae.

6. The spinal intravertebral prosthetic system of claim 5, wherein the non-flexible portion of the implant is made from one or more of a metal, bone, morphogenic protein, carbon fiber composite, nitinol, a biodegradable material, collagen or collagen coated metal or bone.

7. The spinal intravertebral prosthetic system of claim 1, wherein the compressible portion of the implant is disposed between end sections, each end section being made of non-flexible material conducive to attachment to the vertebrae.

8. The spinal intravertebral prosthetic system of claim 7, wherein the non-flexible material is made from one or more of a metal, bone, morphogenic protein, carbon fiber composite, nitinol, a biodegradable material, collagen or collagen coated metal or bone.

9. A spinal intravertebral prosthetic device kit comprising:

an intravertebral prosthetic device;

an arcuate fixation member;

wherein the intravertebral prosthetic device is configured to receive therein a portion of the arcuate fixation member; and

wherein the portion of the fixation member that passes through the intravertebral prosthetic device, is made from a compressible material.

10. The implantable spinal intravertebral prosthetic device kit of claim 9, wherein the arcuate fixation member is configured to also extend through a preformed aperture in each of the two adjacent vertebrae.

11. A spinal intravertebral prosthetic device kit comprising:

a positioning apparatus including;

two guide sleeves, each guide sleeve having a long axis,

a cross member,

an intravertebral spacer,

wherein the guide sleeves are pivotably mounted to the cross member, and

wherein the intravertebral spacer is spaced from the cross member and interconnected thereto so as to be between the pivots points for the guide sleeves;

an intravertebral prosthetic device;

a fixation member; and

wherein a portion of the fixation member, passing through the intravertebral prosthetic device is made from a compressible material.

12. The spinal intravertebral prosthetic device kit of claim 11 wherein the compressible material is one of silicon, elastomeric polymers, polyurethances and copolymers thereof, hydrogels, collagen, bioabsorbables, compositions, a metallic spring or coil, or a material that allows continual mobility between the vertebral bodies.

13. The spinal intravertebral prosthetic device kit of claim 12 wherein the intravertebral prosthetic device comprises a compressible material.

14. The spinal intravertebral prosthetic device kit of claim 13 wherein the compressible material is one of silicon, elastomeric polymers, polyurethanes and copolymers thereof, hydrogels, collagen or bioabsorbables.

15. The spinal intravertebral prosthetic device kit of claim 11, wherein the fixation member includes a non-flexible portion made of a material conducive to attachment to the vertebrae.

16. The spinal intravertebral prosthetic device kit of claim 15, wherein the non-flexible portion is made from one or more of a metal, bone, morphogenic protein, carbon fiber composite, nitinol, a biodegradable material, collogen or collagen coated metal or bone.

17. The spinal intravertebral prosthetic device kit of claim 11, wherein the compressible portion of the fixation member is disposed between end sections, each end section being made of non-flexible material conducive to attachment to the vertebrae.

18. The spinal intravertebral prosthetic device kit of claim 17, wherein the non-flexible material is one or more of a metal, bone, morphogenic protein, carbon fiber composite, nitinol, a biodegradable material, collagen or collagen coated metal or bone.

19. The spinal intravertebral prosthetic device kit of claim 11, wherein the fixation member is arcuate.

20. A spinal system comprising:

an arcuate member and an intravertebral prosthetic device that are capable of being surgically implanted in a mammalian spine;

wherein the arcuate member extends between two adjacent vertebrae when implanted,

wherein the intravertebral prosthetic device is configured to receive therein a portion of the arcuate implant member;

wherein the arcuate member is configured so as to extend through a preformed aperture in each of the two adjacent vertebrae; and

wherein the portion of the arcuate implant member that passes through the intravertebral prosthetic device is made from a compressible material.

21. The spinal system of claim 20, wherein the intravertebral prosthetic device comprises a compressible material.

22. An implantable spinal intravertebral prosthetic system, comprising:

an intravertebral prosthetic device;

an arcuate implant member of a size sufficient to extend between two adjacent vertebrae;

wherein the intravertebral prosthetic device is configured to receive therein a portion of the arcuate implant member;

wherein the implant member is sized so as to extend through a pre-formed aperture in each of the two adjacent vertebrae; and

wherein the arcuate implant member is configured so as to have a uniform outer diameter.

23. The implantable spinal intravertebral prosthetic system of claim 22, wherein the preformed aperture in each of the adjacent vertebrae is of a constant radius and wherein the arcuate implant member is configured so as to extend through each constant radius preformed aperture.

24. The implantable spinal intravertebral prosthetic system of claim 22, wherein the arcuate implant member is configured so as to be secured by fixation points within the adjacent vertebrae.

25. The implantable spinal intravertebral prosthetic system of claim 22, wherein the arcuate implant member is configured and sized so as to be a load bearing member.

26. An implantable spinal intravertebral prosthetic system, comprising:

an intravertebral prosthetic device;

an arcuate implant member of a size sufficient to extend between two adjacent vertebrae;

wherein the intravertebral prosthetic device is configured to receive therein a portion of the arcuate implant member;

wherein the implant member is sized so as to extend through a pre-formed aperture in each of the two adjacent vertebrae; and

a plurality of securing mechanisms one for each of the adjacent vertebrae, each securing mechanism being configured so as to secure the securing mechanism to one of the adjacent vertebrae, wherein the arcuate implant member is configured so as to be secured to each of the adjacent vertebrae by the plurality of securing mechanisms.

27. The implantable spinal intravertebral prosthetic system of claim 26, wherein each end portion of the arcuate implant member is configured so as to be secured respectively to one of the adjacent vertebrae by one of the plurality of securing mechanisms, thereby further securing the arcuate implant member to the adjacent vertebrae.

28. An implantable spinal intravertebral prosthetic system, comprising:

an intravertebral prosthetic device;

an arcuate implant member of a size sufficient to extend between two adjacent vertebrate vertebrae;

wherein the intravertebral prosthetic device is configured to receive therein a portion of the arcuate implant member;

wherein the implant member is sized so as to extend through a pre-formed aperture in each of the two adjacent vertebrae; and

wherein the portion of the arcuate implant member that is received in the intravertebral prosthetic device, is made from a compressible material.

29. The implantable spinal intravertebral prosthetic system of claim 28 wherein the intravertebral prosthetic device comprises a compressible material.

30. An implantable spinal intravertebral prosthetic system, comprising:

an intravertebral prosthetic device;

an arcuate implant member of a size sufficient to extend between two adjacent vertebrate;

a plurality of securing mechanisms one for each of the adjacent vertebrae, each securing mechanism being configured so as to secure the securing mechanism to one of the adjacent vertebrae;

wherein the intravertebral prosthetic device is configured to receive therein a portion of the arcuate implant member; and

wherein each of the plurality of securing mechanisms is configured so as to mechanically engage separate portions of the arcuate implant member, thereby securing the arcuate implant member to each of the adjacent vertebrae.

31. The implantable spinal intravertebral prosthetic system of claim 30, wherein the arcuate implant member is sized so as to extend through a pre-formed aperture in each of the two adjacent vertebrae.

32. The implantable spinal intravertebral prosthetic system of claim 30, wherein each of the plurality of securing mechanisms are configured so as to be threadably secured respectively in one of the adjacent vertebrae.

33. The implantable spinal intravertebral prosthetic system of claim 30, wherein the portion of the arcuate implant member that passes through the intravertebral prosthetic device, is made from a compressible material.

34. The implantable spinal intravertebral prosthetic system of claim 33 wherein the intravertebral prosthetic device comprises a compressible material.

35. A method for securing an intravertebral prosthetic device between vertebrae, comprising the steps of:

implanting an arcuate fixation member between the vertebrae, where each end of the fixation member is secured to one of the vertebrae; and

passing a portion of the arcuate fixation member through the intravertebral prosthetic device,

wherein at least the portion of the fixation member that is passing through the intravertebral prosthetic device is made from a compressible material.

36. A method for securing an intravertebral prosthetic device between adjacent vertebrae, comprising:

implanting an arcuate fixation member between the vertebrae;

passing a portion of the arcuate fixation member through the intravertebral prosthetic device;

wherein a portion of the fixation member is made from a compressible material; and

wherein the fixation member is implanted through a preformed aperture in each of the adjacent vertebrae.

37. The method of claim 36 wherein the pre-formed aperture in one of the adjacent vertebrae is a partially pre-formed aperture.

38. The method of claim 36 wherein the preformed aperture has been drilled in each of the adjacent vertebrae.

39. The method of claim 36 wherein the fixation member is the sole apparatus employed to maintain the location and orientation of the intravertebral prosthetic device.

40. The method of claim 36 wherein the compressible material is one of silicon, elastomeric polymers, polyurethances and copolymers thereof, hydrogels, collagen, bioabsorbables, compositions, a metallic spring or coil, or a material that allows continual mobility between the vertebral bodies.

41. The method of claim 40 wherein the intravertebral prosthetic device comprises a compressible material.

42. The method of claim 41 wherein the compressible material is one of silicon, elastomeric polymers, polyurethanes and copolymers thereof, hydrogels, collagen or bioabsorbables.

43. The method of claim 36, wherein the fixation member includes a non-flexible portion made of a material conducive to attachment to the vertebrae.

44. The method of claim 43, wherein the non-flexible portion of the fixation member is made from one or more of a metal, bone, morphogenic protein, carbon fiber composite, nitinol, a biodegradable material, collagen or collagen coated metal or bone.

45. The method of claim 36, wherein the compressible portion of the fixation member is disposed between end sections, each end section being made of non-flexible material conducive to attachment to the vertebrae.

46. The method of claim 45, wherein the non-flexible material is made from one or more of a metal, bone, morphogenic protein, carbon fiber composite, nitinol, a biodegradable material, collagen or collagen coated metal or bone.

47. The method of claim 36 wherein the fixation member is one of solid, hollow or with ingrowth fenestrations and screw holes or expansion bolts or staples.

48. A method for securing an intravertebral prosthetic device of a spine, comprising:

providing a positioning apparatus including two guide sleeves, each guide sleeve having a long axis;

locating the two guide sleeves with respect to the adjacent vertebrae such that a vertex formed by the long axis of each guide sleeve is located in the intervertebral space of the adjacent vertebrae;

forming an aperture in each of the adjacent vertebrae using at least one of the guide sleeves;

inserting an implant into the apertures formed in each of the adjacent vertebrae so that the implant extends between the adjacent vertebrae and through the intervertebral space and so a portion of the implant passes through the intravertebral prosthetic device, wherein the portion of the implant is made from a compressible material.

49. The method of claim 48 wherein said step of forming includes forming an arcuate aperture in each of the adjacent vertebrae such that the arcuate apertures in the adjacent vertebrae have a common axis of rotation.

50. The method of claim 48 wherein the implant is inserted through a through aperture in one of the adjacent vertebrae and in a partially formed aperture in the other of the adjacent vertebrae.

51. The method of claim 48 wherein the implant is the sole apparatus employed to maintain the location and orientation of the intravertebral prosthetic device.

52. The method of claim 48 wherein the compressible material is one of silicon, elastomeric polymers, polyurethances and copolymers thereof, hydrogels, collagen, bioabsorbables, compositions, a metallic spring or coil, or a material that allows continual mobility between the vertebral bodies.

53. The method of claim 52 wherein the intravertebral prosthetic device comprises a compressible material.

54. The method of claim 53 wherein the compressible material is one of silicon, elastomeric polymers, polyurethanes and copolymers thereof, hydrogels, collagen or bioabsorbables.

55. The method of claim 48, wherein the implant includes a non-flexible portion made of a material conducive to attachment to the vertebrae.

56. The method of claim 55, wherein the non-flexible portion of the implant is made from one or more of a metal, bone, morphogenic protein, carbon fiber composite, nitinol, a biodegradable material, collagen or collagen coated metal or bone.

57. The method of claim 48, wherein the compressible portion of the implant is disposed between end sections, each end section being made of non-flexible material conducive to attachment to the vertebrae.

58. The method of claim 57, wherein the non-flexible material is made from one or more of a metal, bone, morphogenic protein, carbon fiber composite, nitinol, a biodegradable material, collagen or collagen coated metal or bone.

59. The method of claim 48 wherein the step of inserting includes:

inserting a beginning end of the implant into an entrance opening of one of the adjacent vertebrae;

applying a force to the portion of the implant extending from the entrance opening so as to drive the implant beginning end though the aperture in the aperture of said one of the adjacent vertebrae, through the intervertebral space and into the aperture in the other of the adjacent vertebrae.

60. A method for securing an intravertebral prosthetic device, comprising:

providing a positioning apparatus including a pivot arm that is rotatable about a pivot point;

locating the positioning apparatus with respect to the adjacent vertebrae such that the pivot point is disposed between the adjacent vertebrae;

forming an aperture in each of the adjacent vertebrae responsive to rotation of the pivot arm about the pivot point, one of the apertures being formed is a through aperture; and

inserting an implant into the apertures formed in each of the adjacent vertebrae so that the implant extends between the adjacent vertebrae and through the intervertebral space and passes through a portion of the intravertebral prosthetic device, wherein a portion of the fixation member is made from a compressible material.

61. The method of claim 60 wherein said aperture in each of the adjacent vertebrae is arcuate.

62. The method of claim 60 wherein the compressible material is one of silicon, elastomeric polymers, polyurethances and copolymers thereof, hydrogels, collagen, bioabsorbables, compositions, a metallic spring or coil, or a material that allows continual mobility between the vertebral bodies.

63. The method of claim 62 wherein the intravertebral prosthetic device comprises a compressible material.

64. The method of claim 63 wherein the compressible material is one of silicon, elastomeric polymers, polyurethanes and copolymers thereof, hydrogels, collagen or bioabsorbables.

65. The method of claim 60, wherein the implant includes a non-flexible portion made of a material conducive to attachment to the vertebrae.

66. The method of claim 65, wherein the non-flexible portion of the implant is made from one or more of a metal, bone, morphogenic protein, carbon fiber composite, nitinol, a biodegradable material, collagen or collagen coated metal or bone.

67. The method of claim 60, wherein the compressible portion of the implant is disposed between end sections, each end section being made of non-flexible material conducive to attachment to the vertebrae.

68. The method of claim 67, wherein the non-flexible material is made from one or more of a metal, bone, morphogenic protein, carbon fiber composite, nitinol, a biodegradable material, collagen or collagen coated metal or bone.

69. The method of claim 60, wherein the step of forming includes forming by one of drilling or ablation of the bone by an energy source.

70. The stabilizing method of claim 60 wherein the apparatus being provided further includes a drill that is affixed to the pivot arm such that when the pivot arm rotates about the pivot point the drill follows a defined arcuate cutting path.

71. The method of claim 70 wherein the drill includes a curved drilling element.

72. The method of claim 71 wherein the curved drilling element comprises a curved cannula, a flexible member disposed within the curved cannula, and a cutting burr affixed to an end of the flexible member, the flexible burr for cutting an arcuate aperture in each of the adjacent vertebrae.

73. The method of claim 70 wherein the step of forming includes rotating the pivot arm so that a through aperture is formed in one of the adjacent vertebrae and so a partially formed aperture is formed in the other of the adjacent vertebrae.

74. The method of claim 70 wherein the step of forming includes rotating the pivot arm so that a through aperture is formed in each of the adjacent vertebrae.

75. A method for locating compressible material in an intravertebral space between vertebral endplates of a spine, said method comprising the steps of:

creating an arcuate preformed aperture in a vertebral body that extends through the vertebral endplate of the spine;

placing compressible material though the preformed aperture such that the compressible material is disposed between the vertebral endplates; and

filling at least a portion of the preformed aperture with an arcuate member of a non-compressible material.