Apparatus including a guard member having a passage with a non-circular cross section for providing protected access to the spine

• US 7,431,722 B1
• Filed: 06/06/2000
• Issued: 10/07/2008
• Est. Priority Date: 02/27/1995
• Status: Expired due to Fees

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: Michelson, Gary Karlin
• Primary Examiner(s): BROWN, MICHAEL A
• Application Number:
  US09/497,590
• Time in Patent Office: 3,045 Days
• Field of Search: 606/60, 606/61, 606/80, 606/96, 606/97, 623/17.1
• US Class Current: 606/60
• CPC Class Codes: A61B 17/025 Joint distractors
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/1757 for the spine
• CPC Class Codes: A61B 17/32 Surgical cutting instruments A61B18/042 takes precedence; suture cutters A61B17/0467; instruments for ligaturing or cutting A61B17/128; instruments for rupturing the amniotic membrane A61B17/4208; specially adapted knives for eye surgery A61F9/0133
• 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 17/8888 at its central region
• CPC Class Codes: A61B 2017/0256 for the spine
• CPC Class Codes: A61B 2017/922 Devices for impaction, impact element
• CPC Class Codes: A61B 2090/036 abutting on tissue or skin
• CPC Class Codes: A61F 2/30744 End caps, e.g. for closing an endoprosthetic cavity
• 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 2/4603 for insertion or extraction of endoprosthetic joints or of accessories thereof
• CPC Class Codes: A61F 2/4611 of spinal 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 2002/30143 hexagonal
• CPC Class Codes: A61F 2002/30224 cylindrical
• CPC Class Codes: A61F 2002/30235 tubular, e.g. sleeves
• CPC Class Codes: A61F 2002/30405 made by screwing complementary threads machined on the parts themselves
• CPC Class Codes: A61F 2002/30426 Bayonet coupling
• CPC Class Codes: A61F 2002/30593 : hollow
• CPC Class Codes: A61F 2002/30774 : internally-threaded
• CPC Class Codes: A61F 2002/30785 : parallel
• CPC Class Codes: A61F 2002/30787 : inclined obliquely with respect to each other
• CPC Class Codes: A61F 2002/30797 : internally-threaded
• CPC Class Codes: A61F 2002/30836 : knurled
• CPC Class Codes: A61F 2002/3085 : with a threaded, e.g. self-tapping, bone-engaging surface, e.g. external surface
• CPC Class Codes: A61F 2002/30904 : serrated profile, i.e. saw-toothed
• 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 2002/4619 : for extraction
• 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 2002/4629 : connected to the endoprosthesis or implant via a threaded connection
• CPC Class Codes: A61F 2002/4649 : Bone graft or bone dowel harvest sites
• CPC Class Codes: A61F 2002/4681 : by applying mechanical shocks, e.g. by hammering
• CPC Class Codes: A61F 2002/4687 : Mechanical guides for implantation instruments
• CPC Class Codes: A61F 2220/0025 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2230/0017 : Angular shapes
• CPC Class Codes: A61F 2230/0069 : cylindrical

Abstract

Apparatus and a method of inserting spinal implants is disclosed in which an intervertebral space is first distracted, a hollow sleeve having teeth at one end is then driven into the vertebrae adjacent that disc space. A drill is then passed through the hollow sleeve removing disc and bone in preparation for receiving the spinal implant which is then inserted through the sleeve. Apparatus and a method of inserting spinal implants is disclosed in which an intervertebral space is first distracted to restore the normal angular relationship of the vertebrae adjacent to that disc space. An extended outer sleeve having extended portions capable of maintaining the vertebrae distracted in their normal angular relationship is then driven into the vertebrae adjacent that disc space. A drill is then passed through the hollow sleeve removing disc and bone in preparation for receiving the spinal implant which is then inserted through the sleeve.

Claims

1. An apparatus for use in human spinal surgery across a disc space between two adjacent vertebral bodies, comprising:

a guard member having a distal end, a proximal end, and a mid-longitudinal axis through said distal and proximal ends, said guard member having a passage for providing protected access to the disc space and the adjacent vertebral bodies, said passage having a cross section transverse to the mid-longitudinal axis having a width and a height transverse to the width, the width of said passage being greater than the height of said passage along at least a portion of said passage; and

an extension extending from said distal end of said guard member for insertion into the disc space between the adjacent vertebral bodies, said extension having a portion for bearing against each of the adjacent vertebral bodies, said portion of said extension having an upper surface adapted to contact one of the adjacent vertebral bodies and a lower surface adapted to contact the other of the adjacent vertebral bodies, said portion of said extension having a height between said upper and lower surfaces and a length sufficient to properly align and distance apart the adjacent vertebral bodies from at least in part within the disc space between the adjacent vertebral bodies.

2. The apparatus of claim 1, further comprising a second extension extending from said distal end of said guard member for insertion into the disc space and for bearing against the adjacent vertebral bodies.

3. The apparatus of claim 2, wherein said extensions are diametrically opposed to each other and spaced apart from one another to provide access to the adjacent vertebral bodies from within the disc space.

4. The apparatus of claim 1, wherein the height of said extension has at least a portion that approximates the height of the normal disc space between the adjacent vertebral bodies.

5. The apparatus of claim 2, wherein said extensions have the same height.

6. The apparatus of claim 1, wherein said upper and lower surfaces for bearing against the adjacent vertebral bodies diverge away from said guard member along at least a portion of their length.

7. The apparatus of claim 1, wherein said upper and lower surfaces for bearing against the adjacent vertebral bodies converge away from said guard member along at least a portion of their length.

8. The apparatus of claim 1 further comprising means for penetrating at least one of the two adjacent vertebral bodies.

9. The apparatus of claim 8, wherein said penetrating means includes a prong for penetrably engaging at least one of the adjacent vertebral bodies.

10. The apparatus of claim 8, wherein said penetrating means includes teeth for the insertion into the two adjacent vertebral bodies.

11. The apparatus of claim 8, wherein said penetrating means is located at said distal end of said guard member.

12. The apparatus of claim 8, wherein said penetrating means has a tapered leading end to facilitate placement of at least one of said penetrating means into at least one of the two adjacent vertebral bodies.

13. The apparatus of claim 1, wherein said extension has a tapered leading end to facilitate placement of said extension into the disc space.

14. The apparatus of claim 1, in combination with a spinal fusion implant.

15. The apparatus of claim 14, in combination with a fusion promoting material.

16. The apparatus of claim 15, wherein said fusion promoting material is bone.

17. The apparatus of claim 1, wherein said guard member has an outer perimeter transverse to the mid-longitudinal axis with a width and a height transverse to the width, the width of the outer perimeter being greater than the height of the outer perimeter along at least a portion of the mid-longitudinal axis.

18. The apparatus of claim 1, wherein said guard member has a generally rectangular outer perimeter transverse to the mid-longitudinal axis along a least a portion of the mid-longitudinal axis.

19. The apparatus of claim 1, wherein said guard member is a hollow sleeve.

20. The apparatus of claim 1, wherein said distal end of said guard member is contoured to the curvature of the adjacent vertebral bodies against which said guard member is adapted to be placed.

21. The apparatus of claim 1, further comprising a footplate proximate said distal end of said guard member.

22. The apparatus of claim 1, wherein said proximal end of said guard member has an increased outer dimension.

23. The apparatus of claim 1, wherein said proximal end of said guard member is configured to cooperatively engage an impaction member for receiving an impaction force for driving said guard member into the spine.

24. The apparatus of claim 1, further comprising a cap adapted to engage said proximal end of said guard member.

25. The apparatus of claim 1, in combination with a bone removal device having a portion sized for movement through said passage for forming through said guard member an implantation space at least in part across the surgically corrected height of the disc space.

26. The combination of claim 25, wherein said bone removal device is one of a drill, a trephine, a reamer, an end mill, a chisel, and a burr.

27. The combination of claim 25, further in combination with a spinal insert adapted for insertion into the implantation space formed by said bone removal device.

28. The combination of claim 27, wherein said spinal insert is one of a dowel, an interbody spinal implant, and an interbody spinal fusion implant.

29. The combination of claim 27, wherein said spinal insert comprises at least in part bone.

30. The combination of claim 27, wherein said spinal insert is a bone graft.

31. The combination of claim 27, further in combination with a fusion promoting substance.

32. The combination of claim 31, wherein said fusion promoting substance is bone.

33. The combination of claim 31, further in combination with a press for compressing said fusion promoting substance into said spinal insert.

34. The combination of claim 27, further in combination with an implant driver configured to insert said spinal insert into the implantation space formed by said bone removal device.

35. The combination of claim 25, further in combination with an instrument for removing from the spine the bone cut by said bone removal device.

36. The apparatus of claim 1, in combination with a tap for insertion through said guard member for tapping the two adjacent vertebral bodies.

37. The apparatus of claim 1, in combination with a distractor adapted to urge apart the adjacent vertebral bodies.

38. The combination of claim 37, wherein said distractor is an interbody distractor.

39. The combination of claim 37, further in combination with at least a second distractor, said at least second distractor being differently sized relative to said distractor to form a set of distractors of graduated sizes.

40. An apparatus for use in human spinal surgery across a disc space between two adjacent vertebral bodies, comprising:

a guard member having a distal end, a proximal end, and a mid-longitudinal axis through said distal and proximal ends, said guard member having a passage with a cross section transverse to the mid-longitudinal axis for providing protected access to the disc space and the adjacent vertebral bodies, said cross section of said passage being non-circular along at least a portion of the mid-longitudinal axis; and

an extension extending from said distal end of said guard member for insertion into the disc space between the adjacent vertebral bodies, said extension having a portion for bearing against each of the adjacent vertebral bodies, said portion of said extension having an upper surface adapted to contact one of the adjacent vertebral bodies and a lower surface adapted to contact the other of the adjacent vertebral bodies, said portion of said extension having a height between said upper and lower surfaces and a length sufficient to properly align and distance apart the adjacent vertebral bodies from at least in part within the disc space between the adjacent vertebral bodies.

41. The apparatus of claim 40, further comprising a second extension extending from said distal end of said guard member for insertion into the disc space and for bearing against the adjacent vertebral bodies.

42. The apparatus of claim 41, wherein said extensions are diametrically opposed to each other and spaced apart from one another to provide access to the adjacent vertebral bodies from within the disc space.

43. The apparatus of claim 41, wherein said extensions have the same height.

44. The apparatus of claim 40, wherein the height of said extension has at least a portion that approximates the height of the normal disc space between the adjacent vertebral bodies.

45. The apparatus of claim 40, wherein said upper and lower surfaces for bearing against the adjacent vertebral bodies diverge away from said guard member along at least a portion of their length.

46. The apparatus of claim 40, wherein said upper and lower surfaces for bearing against the adjacent vertebral bodies converge away from said guard member along at least a portion of their length.

47. The apparatus of claim 40 further comprising means for penetrating at least one of the two adjacent vertebral bodies.

48. The apparatus of claim 47, wherein said penetrating means includes a prong for penetrably engaging at least one of the adjacent vertebral bodies.

49. The apparatus of claim 47, wherein said penetrating means includes teeth for the insertion into the two adjacent vertebral bodies.

50. The apparatus of claim 47, wherein said penetrating means is located at said distal end of said guard member.

51. The apparatus of claim 47, wherein said penetrating means has a tapered leading end to facilitate placement of at least one of said penetrating means into at least one of the two adjacent vertebral bodies.

52. The apparatus of claim 40, wherein said extension has a tapered leading end to facilitate placement of said extension into the disc space.

53. The apparatus of claim 40, in combination with a spinal fusion implant.

54. The apparatus of claim 53, in combination with a fusion promoting material.

55. The apparatus of claim 54, wherein said fusion promoting material is bone.

56. The apparatus of claim 40, wherein said guard member has an outer perimeter transverse to the mid-longitudinal axis with a width and a height transverse to the width, the width of the outer perimeter being greater than the height of the outer perimeter along at least a portion of the mid-longitudinal axis.

57. The apparatus of claim 40, wherein said guard member has a generally rectangular outer perimeter transverse to the mid-longitudinal axis along a least a portion of the mid-longitudinal axis.

58. The apparatus of claim 40, wherein said guard member is a hollow sleeve.

59. The apparatus of claim 40, wherein said distal end of said guard member is contoured to the curvature of the adjacent vertebral bodies against which said guard member is adapted to be placed.

60. The apparatus of claim 40, further comprising a footplate proximate said distal end of said guard member.

61. The apparatus of claim 40, wherein said proximal end of said guard member has an increased outer dimension.

62. The apparatus of claim 40, wherein said proximal end of said guard member is configured to cooperatively engage an impaction member for receiving an impaction force for driving said guard member into the spine.

63. The apparatus of claim 40, further comprising a cap adapted to engage said proximal end of said guard member.

64. The apparatus of claim 40, in combination with a bone removal device having a portion sized for movement through said passage for forming through said guard member an implantation space at least in part across the surgically corrected height of the disc space.

65. The combination of claim 64, wherein said bone removal device is one of a drill, a trephine, a reamer, an end mill, a chisel, and a burr.

66. The combination of claim 64, further in combination with a spinal insert adapted for insertion into the implantation space formed by said bone removal device.

67. The combination of claim 66, wherein said spinal insert is one of a dowel, an interbody spinal implant, and an interbody spinal fusion implant.

68. The combination of claim 66, wherein said spinal insert comprises at least in part bone.

69. The combination of claim 66, wherein said spinal insert is a bone graft.

70. The combination of claim 66, further in combination with a fusion promoting substance.

71. The combination of claim 70, wherein said fusion promoting substance is bone.

72. The combination of claim 70, further in combination with a press for compressing said fusion promoting substance into said spinal insert.

73. The combination of claim 66, further in combination with an implant driver configured to insert said spinal insert into the implantation space formed by said bone removal device.

74. The combination of claim 64, further in combination with an instrument for removing from the spine the bone cut by said bone removal device.

75. The apparatus of claim 40, in combination with a tap for insertion through said guard member for tapping the two adjacent vertebral bodies.

76. The apparatus of claim 40, in combination with a distractor adapted to urge apart the adjacent vertebral bodies.

77. The combination of claim 76, wherein said distractor is an interbody distractor.

78. The combination of claim 76, further in combination with at least a second distractor, said at least second distractor being differently sized relative to said distractor to form a set of distractors of graduated sizes.