Self-broaching, rotatable, push-in interbody spinal fusion implant and method for deployment thereof

• US 6,537,320 B1
• Filed: 10/29/1999
• Issued: 03/25/2003
• Est. Priority Date: 10/30/1998
• Status: Expired due to Term

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Gary K. Michelson
• Inventors: Michelson, Gary K.
• Primary Examiner(s): Willse, David H.
• Assistant Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US09/429,628
• Time in Patent Office: 1,243 Days
• Field of Search: 623/17-1-
• US Class Current: 623/17.11
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• 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 2/447 substantially parallelepipedal, e.g. having a rectangular or trapezoidal cross-section
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2002/2817 Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• 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 2002/2839 Bone plugs or bone graft dowels
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30113 circular
• CPC Class Codes: A61F 2002/30143 hexagonal
• CPC Class Codes: A61F 2002/30151 rhomboidal or parallelogram-shaped
• CPC Class Codes: A61F 2002/30153 rectangular
• CPC Class Codes: A61F 2002/3021 frustoconical
• CPC Class Codes: A61F 2002/30224 cylindrical
• CPC Class Codes: A61F 2002/30261 parallelepipedal
• CPC Class Codes: A61F 2002/30405 made by screwing complementary threads machined on the parts themselves
• CPC Class Codes: A61F 2002/30487 Circumferential cooperating grooves and beads on cooperating lateral surfaces of a mainly longitudinal connection
• CPC Class Codes: A61F 2002/3052 unrestrained in only one direction, e.g. moving unidirectionally
• CPC Class Codes: A61F 2002/30593 : hollow
• CPC Class Codes: A61F 2002/30604 : modular
• CPC Class Codes: A61F 2002/30774 : internally-threaded
• CPC Class Codes: A61F 2002/30777 : Oblong apertures
• CPC Class Codes: A61F 2002/30785 : parallel
• CPC Class Codes: A61F 2002/30789 : perpendicular with respect to each other
• CPC Class Codes: A61F 2002/30795 : Blind bores, e.g. of circular cross-section
• CPC Class Codes: A61F 2002/30805 : Recesses of comparatively large area with respect to their low depth
• CPC Class Codes: A61F 2002/30827 : Plurality of grooves
• CPC Class Codes: A61F 2002/30845 : with cutting edges
• CPC Class Codes: A61F 2002/30884 : Fins or wings, e.g. longitudinal wings for preventing rotation within the bone cavity
• CPC Class Codes: A61F 2002/30892 : parallel
• 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 2002/4485 : comprising three or more adjacent spinal implants
• CPC Class Codes: A61F 2002/4638 : Tools for performing screwing, e.g. nut or screwdrivers, or particular adaptations therefor
• CPC Class Codes: A61F 2210/0004 : bioabsorbable
• CPC Class Codes: A61F 2220/0025 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2230/0006 : circular
• CPC Class Codes: A61F 2230/0017 : Angular shapes
• CPC Class Codes: A61F 2230/0019 : rectangular
• CPC Class Codes: A61F 2230/0067 : conical
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2230/0082 : parallelepipedal
• CPC Class Codes: A61F 2250/0063 : Nested prosthetic parts
• 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 2310/00029 : Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium
• CPC Class Codes: A61F 2310/00179 : Ceramics or ceramic-like structures
• CPC Class Codes: A61F 2310/00293 : containing a phosphorus-containing compound, e.g. apatite
• CPC Class Codes: A61F 2310/00359 : Bone or bony tissue
• CPC Class Codes: Y10S 623/908 : Bone

Abstract

An interbody spinal fusion implant for insertion across a disc space between adjacent vertebral bodies of a human spine has a body two top side and two bottom side junctions, with at least a pair of diagonally opposed junctions having a distance therebetween that does not significantly exceed the implant body height. The implant also includes one or more bone penetrating protrusions extending outwardly from at least the upper and lower walls of the implant. The implant is inserted on its side between adjacent vertebral bodies and then rotated 90 degrees into place. The protrusions penetrate the endplates upon rotation, thereby securing the implant within the spine. The implant has at least one passage therethrough from the upper wall to the lower wall to promote fusion through the implant. Because of the specialized opposed junctions overdistraction between the adjacent vertebral bodies is avoided when the implant is rotated from an initial insertion position to a final deployed position. In one suggested implant set, two implants are rotated in opposite directions into their respective final deployed positions, and a third specialized implant is positioned therebetween to lock the three implants together along cooperating surfaces. A method for deploying the push-in implants is also disclosed.

Claims

1. An interbody spinal fusion implant for insertion across a disc space between adjacent vertebral bodies of a human spine, the implant comprising:

a body having an insertion end, a trailing end, an upper wall, a lower wall, and opposed side walls, said body having a cross-section with a height measured between said upper and lower walls and a width measured between said side walls, said side walls intersecting said upper and lower walls at four junctions, a first pair of diagonally opposed junctions having a distance therebetween substantially the same as the height of said body, a second pair of diagonally opposed junctions having a distance therebetween greater than the distance between said first pair of diagonally opposed junctions; and

fins extending outwardly from said opposed upper and lower walls adapted to penetrate and extend within the vertebral endplates of the adjacent vertebral bodies upon rotation of the implant approximately 90 degrees from an initial insertion position to a final deployed position.

2. The implant of claim 1, wherein said side walls have a distance therebetween adapted to contact the adjacent vertebral bodies upon initial insertion of said implant into the spine.

3. The implant of claim 1, wherein each of said side walls are planar.

4. The implant of claim 3, wherein said side walls are generally parallel to one another.

5. The implant of claim 1, wherein the shape of each of said side walls is substantially a parallelogram.

6. The implant of claim 1, wherein said upper and lower walls have a distance therebetween adapted to support the vertebral endplates of the adjacent vertebral bodies upon rotation of said implant from an initial insertion position to a deployed position in the disc space.

7. The implant of claim 1, wherein the adjacent vertebral bodies are spaced apart at least in part further in the final deployed position than in the initial insertion position.

8. The implant of claim 1, wherein said upper and lower walls have at least one opening allowing for communication between said upper and lower walls, said opening being capable of containing fusion promoting materials for promoting bone ingrowth through said implant from the vertebral endplate of one of the adjacent vertebral bodies to the vertebral endplate of the other of said adjacent vertebral bodies for fusion of said adjacent vertebral bodies.

9. The implant of claim 1, wherein said first pair of diagonally opposed junctions are arcuate.

10. The implant of claim 9, wherein said arcuate junctions are arcs of radii.

11. The implant of claim 10, wherein said arcs of radii are each of the same radius.

12. The implant of claim 10, wherein said arcs of radii have a radius defining a portion of the same circle.

13. The implant of claim 10, wherein said arcs of radii comprise chords of a circle.

14. The implant of claim 13, wherein said arcs of radii comprise chords of the same circle.

15. The implant of claim 13, wherein said arcs of radii comprise quadrants of the same circle.

16. The implant of claim 13, wherein the distance between said arcs of radii generally approximates the height of said body.

17. The implant of claim 10, wherein the distance between said arcs of radii is slightly less than the height of said body.

18. The implant of claim 10, wherein the distance between said arcs of radii is slightly greater than the height of said body.

19. The implant of claim 16, wherein the h eight of said body is no greater than the width of said body, and said fins extend from said upper and lower walls a height sufficient to make the overall height of said implant, when in the final deployed position as measured across the fins, greater than the width of said body.

20. The implant of claim 16, wherein the height of said body is greater than the width of said body, and said fins extend from said upper and lower walls.

21. The implant of claim 1, wherein said first pair of diagonally opposed junctions are chamfered.

22. The implant of claim 1, wherein said second pair of diagonally opposed junctions are corners.

23. The implant of claim 22, wherein each of said corners form approximately a 90 degree angle.

24. The implant of claim 22, wherein each of said corners form an angle between 45 and 135 degrees.

25. The implant of claim 1, wherein said second pair of diagonally opposed junctions are chamfered.

26. The implant of claim 1, wherein said second pair of diagonally opposed junctions are radiused.

27. The implant of claim 1, wherein said fins have a height measured from the longitudinal central axis of said implant, said height being substantially uniform along a portion of the length of said implant.

28. The implant of claim 1, wherein said fins have a height measured from each of said upper and lower walls, respectively, said height being substantially constant along the length of said implant.

29. The implant of claim 1, wherein said fins have a sharp leading edge for penetrating the vertebral endplates upon rotation of said implant.

30. The implant of claim 1, wherein said fins are protrusions.

31. The implant of claim 1, wherein said fins are evenly spaced along at least a portion of said upper and lower walls.

32. The implant of claim 1, wherein said implant is configured to have a single direction of rotation such that in rotating said implant 45 degrees said first pair of diagonally opposed junctions has a diagonal substantially the same as the height of said body of said implant contacting the adjacent vertebral bodies prior to rotation.

33. The implant of claim 1, wherein said implant is configured to have a single direction of rotation such that in rotating said implant 45 degrees said first pair of diagonally opposed junctions has a diagonal slightly less than the width of said body of said implant contacting the adjacent vertebral bodies prior to rotation.

34. The implant of claim 1, wherein said implant is configured to have a single direction of rotation such that in rotating said implant 45 degrees said first pair of diagonally opposed junctions has a diagonal slightly greater than the width of said body of said implant contacting the adjacent vertebral bodies prior to rotation.

35. The implant of claim 1, wherein said body has a hollow portion.

36. The implant of claim 35, wherein said hollow portion is adapted to contain fusion promoting material.

37. The implant of claim 35, wherein said upper and lower walls have at least one opening passing therethrough in communication with said hollow portion.

38. The implant of claim 37, wherein said side walls have at least one opening passing therethrough in communication with said hollow portion.

39. The implant of claim 1, wherein said implant is capable of retaining fusion promoting material.

40. The implant of claim 35, wherein at least one of said leading end and said trailing end of said body has an opening in communication with said hollow portion and adapted to cooperatively engage a cap.

41. The implant of claim 40, further comprising a removable cap for closing said opening in at least one of said leading end and said trailing end of said body.

42. The implant of claim 37, wherein at least some of said openings have a maximum cross sectional dimension of approximately 0.5 mm to 5 mm.

43. The implant of claim 37, wherein at least some of said openings are greater than microscopic size.

44. The implant of claim 37, wherein said at least one opening includes a plurality of openings of which a portion are less than 15 microns across their largest dimension.

45. The implant of claim 37, wherein at least some of said openings pass through said upper and lower walls forming channels through said body.

46. The implant of claim 1, wherein said body has a plurality of openings passing therethrough adapted to allow bone to grow through said implant from one of the adjacent vertebral bodies to another of the adjacent vertebral bodies.

47. The implant of claim 1, wherein said implant is made of a material that is stronger than bone.

48. The implant of claim 1, wherein said implant is made of a material that is harder than bone.

49. The implant of claim 1, wherein said implant is made of a surgical grade implant material that is metallic.

50. The implant of claim 1, wherein at least a portion of said body is porous.

51. The implant of claim 1, wherein at least a portion of said body is treated to promote bone ingrowth between said implant and one of the vertebral bodies.

52. The implant of claim 1, for use in the lumbar spine wherein said body has a length in the range of 20-34 mm.

53. The implant of claim 52, wherein said side walls are spaced from one another in the range of 6-20 mm.

54. The implant of claim 52, wherein said upper and lower walls are spaced from one another in the range of 6-20 mm.

55. The implant of claim 52, wherein said fins have a height extending from said upper and lower walls in the range of 1-5 mm.

56. The implant of claim 1, wherein at least one of said ends includes an engagement portion for engaging an instrument for the insertion of said implant.

57. The implant of claim 1, wherein said implant comprises a material other than bone.

58. The implant of claim 1, wherein said implant comprises bone.

59. The implant of claim 58, wherein said bone includes cortical bone.

60. The implant of claim 58, wherein said implant comprises bone growth promoting material.

61. The implant of claim 60, wherein said bone growth promoting material is selected from one of bone morphogenetic protein, hydroxyapatite, and genes coding for the production of bone.

62. The implant of claim 1, wherein said implant is treated with a bone growth promoting substance.

63. The implant of claim 1, wherein said implant is at least in part bioabsorbable.

64. The implant of claim 1, wherein said implant comprises metal.

65. The implant of claim 64, wherein said metal is ASTM material suitable for use in said implant.

66. The implant of claim 64, wherein said implant includes titanium.

67. The implant of claim 1, wherein said implant comprises a plastic material.

68. The implant of claim 1, wherein said implant comprises a ceramic material.

69. The implant of claim 1, wherein said implant is formed of a material that intrinsically participates in the growth of bone from one of the adjacent vertebral bodies to the other of the adjacent vertebral bodies.

70. The implant of claim 1, wherein at least a portion of said implant is treated to promote bone ingrowth between said implant and said adjacent vertebral bodies.

71. An interbody spinal implant set for insertion across a disc space between adjacent vertebral bodies of a human spine, the implant set comprising:

a first implant comprising;

a body having an insertion end, a trailing end, opposed side walls, and upper and lower walls, said body having a cross-section with a height measured between said upper and lower walls and a width measured between said side walls, said side walls intersecting said upper and lower walls at four junctions, a first pair of diagonally opposed junctions having a distance therebetween substantially the same as the height of said body, a second pair of diagonally opposed junctions having a distance therebetween greater than the distance of said first pair of diagonally opposed junctions; and

fins extending outwardly from said opposed upper and lower walls adapted to penetrate the vertebral endplates of the adjacent vertebral bodies upon rotation of the implant in a first direction substantially 90 degrees from an initial insertion position to a final deployed position; and

a second implant comprising;

a body having an insertion end, a trailing end, opposed side walls, and upper and lower walls, said body having a cross-section with a height measured between said upper and lower walls and a width measured between said side walls, said side walls intersecting said upper and lower walls at four junctions, a first pair of diagonally opposed junctions having a distance therebetween less than the height of said body, a second pair of diagonally opposed junctions having a distance therebetween greater than the distance between said first pair of diagonally opposed junctions; and

fins extending outwardly from said opposed upper and lower walls adapted to penetrate the vertebral endplates of the adjacent vertebral bodies upon rotation of the implant in a second direction opposite said first direction and substantially 90 degrees from an initial insertion position to a final deployed position.

72. The implant set of claim 71, further comprising a third implant for placement between said first and second implants, said third implant having contacting surfaces for contacting one of said opposed side walls of each of said first and second implants.

73. The implant set of claim 72, wherein said contacting surfaces of said third implant interconnect with said first and second implants.

74. The implant set of claim 72, wherein said contacting surfaces of said third implant include ridges facing opposite the direction of insertion for inhibiting said third implant from expulsion once inserted between said adjacent vertebral bodies.

75. The implant set of claim 74, wherein said side wall of each of said first and second implants facing toward said third implant includes ridges cooperatively oriented for interlocking with said ridges of said third implant.

76. The implant set of claim 71, wherein said side walls of each of said first and second implants have a distance therebetween adapted to contact the adjacent vertebral bodies upon initial insertion of said implant into the spine.

77. The implant set of claim 71, wherein each of said side walls of said first and second implants are planar.

78. The implant set of claim 77, wherein said side walls of each of said first and second implants are generally parallel to one another.

79. The implant set of claim 71, wherein said upper and lower walls of each of said first and second implants have a distance therebetween adapted to support the vertebral endplates of the adjacent vertebral bodies upon rotation of said implant from an initial insertion position to a deployed position in the disc space.

80. The implant set of claim 71, wherein said upper and lower walls of each of said first and second implants have at least one opening allowing for communication between said upper and lower walls, said opening being capable of containing fusion promoting materials for promoting bone ingrowth through said implant from the vertebral endplate of one of the adjacent vertebral bodies to the vertebral endplate of the other of said adjacent vertebral bodies for fusion of the adjacent vertebral bodies.

81. The implant set of claim 71, wherein said first pair of diagonally. opposed junctions of each of said first and second implants are arcs of radii.

82. The implant set of claim 81, wherein the distance between said arcs of radii of each of said first and second implants generally approximates the height of said body.

83. The implant set of claim 81, wherein the distance between said arcs of radii of each of said first and second implants is slightly less than the height of said body.

84. The implant set of claim 81, wherein the distance between said arcs of radii of each of said first and second implants is slightly greater than the height of said body.

85. The implant set of claim 71, wherein the height of said body of said first and second implants is no greater than the width of said body of said first and second implants, respectively, and said fins extend from said upper and lower walls of each of said first and second implants a height sufficient to make the overall height of said first and second implants, when in the final deployed position as measured across the fins, greater than the width of said body.

86. The implant set of claim 71, wherein the height of said body of said first and second implants is greater than the width of said body of said first and second implants, respectively, and said fins extend from said upper and lower walls of each of said first and second implants a height sufficient to make the overall height of said first and second implants, when in the final deployed position as measured across the fins, greater than the width of said body.

87. The implant set of claim 71, wherein said first pair of diagonally opposed junctions of at least one of said first and second implants are chamfered.

88. The implant set of claim 71, wherein said second pair of diagonally opposed junctions of at least one of said first and second implants are corners.

89. The implant set of claim 71, wherein said second pair of diagonally opposed junctions of at least one of said first and second implants are chamfered.

90. The implant set of claim 71, wherein said second pair of diagonally opposed junctions of at least one of said first and second implants are radiused.

91. The implant set of claim 71, wherein said fins of said first and second implants have a sharp leading edge for penetrating the vertebral endplates upon rotation of said implant.

92. The implant set of claim 71, wherein said fins of said first and second implants are protrusions.

93. The implant set of claim 71, wherein each of said first and second implants are configured to have a single direction of rotation such that in rotating each of said implants 45 degrees said first pair of diagonally opposed junctions of each of said first and second implants has a diagonal substantially the same as the width of said body of said first and second implants, respectively, contacting the adjacent vertebral bodies prior to rotation.

94. The implant set of claim 71, wherein each of said first and second implants are configured to have a single direction of rotation such that in rotating each of said implants 45 degrees said first pair of diagonally opposed junctions of each of said first and second implants has a diagonal slightly less than the width of said body of said first and second implants, respectively, contacting the adjacent vertebral bodies prior to rotation.

95. The implant set of claim 71, wherein each of said first and second implants are configured to have a single direction of rotation such that in rotating each of said implants 45 degrees said first pair of diagonally opposed junctions of each of said first and second implants has a diagonal slightly greater than the width of said body of said first and second implant, respectively, contacting the adjacent vertebral bodies prior to rotation.

96. The implant set of claim 71, wherein said body of at least one of said first and second implants has a hollow portion.

97. The implant set of claim 96, wherein said hollow portion of said at least one of said first and second implants is adapted to contain fusion promoting material.

98. The implant set of claim 96, wherein said upper and lower walls of at least one of said first and second implants have at least one opening passing therethrough in communication with said hollow portion.

99. The implant set of claim 71, wherein at least one of said first and second implants is capable of retaining fusion promoting material.

100. The implant set of claim 96, wherein at least one of said leading end and said trailing end of said body of at least one of said first and second implants has an opening in communication with said hollow portion and adapted to cooperatively engage a cap.

101. The implant set of claim 100, further comprising a removable cap for closing said opening in at least one of said leading end and said trailing end of said body of at least one of said first and second implants.

102. The implant set of claim 71, wherein at least one of said first and second implants is made of a surgical grade implant material that is metallic.

103. The implant set of claim 71, wherein at least a portion of said body of at least one of said first and second implants is porous.

104. The implant set of claim 71, wherein at least a portion of said body of at least one of said first and second implants is treated to promote bone ingrowth between said at least one implant and one of said vertebra.

105. The implant set of claim 71, wherein at least one of said ends of said first and second implants includes an engagement portion for engaging an instrument for the insertion of said first and second implant.