Apparatus and method for linking spinal implants

• US 6,136,001 A
• Filed: 07/31/1998
• Issued: 10/24/2000
• Est. Priority Date: 03/28/1994
• Status: Expired due to Term

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Gary K. Michelson
• Inventors: Michelson, Gary Karlin
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): HO, TAN-UYEN THI
• Application Number:
  US09/126,585
• Time in Patent Office: 816 Days
• Field of Search: 606/61, 606/60, 606/72, 623/17, 623/16
• US Class Current: 606/247
• CPC Class Codes: A61B 17/025 Joint distractors
• CPC Class Codes: A61B 17/0642 for bones, e.g. for osteosynthesis or connecting tendon to bone
• CPC Class Codes: A61B 17/1757 for the spine
• CPC Class Codes: A61B 17/7059 Cortical plates A61B17/7007, A61B17/7058 take precedence
• CPC Class Codes: A61B 17/809 with bone-penetrating elements, e.g. blades or prongs bone staples A61B17/0642; intramedullary nails with a plate at an end A61B17/7233
• CPC Class Codes: A61B 17/86 Pins or screws or threaded wires; nuts therefor A61B17/72 take precedence
• CPC Class Codes: A61B 17/8665 Nuts
• 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, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/0256 for the spine
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body
• 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: A61F 2/30767 Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
• CPC Class Codes: A61F 2/30965 Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
• 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 2/4455 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 2/446 having a circular or elliptical cross-section substantially parallel to the axis of the spine, e.g. cylinders or frustocones
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30235 : tubular, e.g. sleeves
• CPC Class Codes: A61F 2002/30329 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2002/30433 : using additional screws, bolts, dowels, rivets or washers e.g. connecting screws
• 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 2002/30836 : 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 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 2220/0041 : using additional screws, bolts, dowels or rivets, e.g. connecting screws
• 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 2310/00059 : Chromium or Cr-based alloys
• CPC Class Codes: A61F 2310/00796 : Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite

Abstract

A spinal fixation device for stabilizing one or more segments of the human spine and for preventing the dislodgement of intervertebral spinal fusion implants, which remains permanently fixated once applied. The spinal fixation device of the present invention comprises of a staple member made of material appropriate for human surgical implantation which is of sufficient length to span the disc space between two adjacent vertebrae and to engage, via essentially perpendicular extending projections, the vertebrae adjacent to that disc space. A portion of the staple of the spinal fixation device interdigitates with an already implanted intervertebral spinal fusion implant which itself spans the disc space to engage the adjacent vertebrae, and the spinal fixation deice is bound to the spinal fusion implant by a locking means. The spinal fixation device of the present invention is of great utility in restraining the vertebrae adjacent to the spinal fusion implant from moving apart as the pine is extended and also serves as an anchor for a multi-segmental spinal alignment means for aligning more that one segment of the spine.

Claims

1. A multi-segmental spinal alignment apparatus for linking segments of the spine, comprising:

a first spinal implant adapted to be surgically implanted at least in part within a first disc space between two adjacent vertebrae in a segment of the spine, said first spinal implant being adapted to contact both of the vertebrae adjacent to the first disc space when the disc space has been restored to approximate a normal height for the disc space, said first spinal implant having an end configured to receive a connector;

a second spinal implant adapted to be surgically implanted at least in part within a second disc space between two adjacent vertebrae in another segment of the spine, said second spinal implant being adapted to contact both of the vertebrae adjacent to the second disc space when the disc space has been restored to approximate a normal height for the disc space; and

a connector attached to said first and second spinal implants for connecting said first and second spinal implants.

2. The apparatus of claim 1, wherein said second spinal implant has an end portion configured to receive said connector.

3. The apparatus of claim 2, wherein each of said end portions has an aperture for receiving said connector.

4. The apparatus of claim 3, wherein said apertures are generally aligned along the longitudinal axis of the spine.

5. The apparatus of claim 1, wherein each of said end portions are detachable.

6. The apparatus of claim 1, wherein each of said end portions is a coupler.

7. The apparatus of claim 6, wherein each of said couplers are detachable.

8. The apparatus of claim 6, wherein each of said couplers includes an aperture generally along the longitudinal axis of the spine for receiving said connector.

9. The apparatus of claim 6, wherein each of said couplers has a head and a shank, said head having an aperture for receiving the connector.

10. The apparatus of claim 9, wherein each of said first and second implants has an aperture for receiving said shanks.

11. The apparatus of claim 10, wherein said shanks and said apertures have cooperating threads.

12. The apparatus of claim 1, wherein said first and second implants include upper and lower portions with at least one opening in each of said upper and lower portions for permitting bone growth from one of the adjacent vertebrae through said spinal implant to the other of the adjacent vertebrae.

13. The apparatus of claim 12, further comprising a hollow interior within each of said first and second implants for holding bone growth promoting material, said hollow interior being in communication with at least one opening in each of said upper an lower portions.

14. The apparatus of claim 1, wherein said first and second implants include upper and lower portions that are arcuate.

15. The apparatus of claim 1, wherein said first and second implants further comprise a protrusion for engaging the adjacent vertebrae.

16. The apparatus of claim 15, wherein said protrusion is a thread.

17. The apparatus of claim 1, wherein said connector is selected from one of a rod, a cable, a plate, and a bar.

18. The apparatus of claim 1, further comprising means for adjusting the length of said connector between said first and second spinal implants for aligning segments of the spine.

19. The apparatus of claim 18, wherein said length adjusting means includes a threaded member on said connector for varying the length of said connector between said first and second spinal implants.

20. The apparatus of claim 18 further comprising a means for locking said length adjusting means at a selected length.

21. The apparatus of claim 1, further comprising a third spinal implant adapted to be surgically implanted in the first disc space, a fourth spinal implant adapted to be surgically implanted in the second disc space, and a second connector attached to both of said third and fourth implants.

22. The apparatus of claim 21, wherein said first and second connectors are adapted to be placed on one side of the spine.

23. The apparatus of claim 21, wherein said first and second connectors are adapted to be placed on opposite sides of the spine.

24. The apparatus of claim 21, wherein said first and second connectors are selected from one of a rod, a cable, a plate, and a bar.

25. The apparatus of claim 1, wherein said first and second spinal implants include an artificial material other than bone.

26. The apparatus of claim 1, wherein said implants are configured for implantation across a disc space in the thoracolumbar region of the human spine.

27. A multi-segmental spinal alignment apparatus for linking multiple implants surgically implanted in the human spine, comprising:

a first spinal implant adapted to be surgically implanted within a first location of the spine;

a second spinal implant adapted to be surgically implanted within a second location of the spine, each of said first and second spinal implants having opposed arcuate portions over at least a portion of their length and at least one opening in each of said opposed arcuate portions along the length of said implants for permitting growth of bone into and through said implants, said implants having a hollow interior for holding bone growth promoting material, said hollow interior of each of said implants being in communication with at least one opening in each of said opposed arcuate portions; and

a protrusion extending from the exterior of each of said implants for engaging bone in the spine; and

a connector having a width and a length, said connector being attached along its length to each of said implants for connecting said implants together, each of said implants having a width greater than said width of said connector measured transverse to the longitudinal axis of the spine.

28. The apparatus of claim 27, wherein at least one of said insertion and trailing ends are open for loading bone growth promoting materials into said hollow interior.

29. The apparatus of claim 28, further comprising an end cap for closing said open end.

30. The apparatus of claim 27, wherein each of said implants has an end portion configured to receive said connector.

31. The apparatus of claim 27, wherein each of said implants has an end portion configured to couple to said connector.

32. The apparatus of claim 31, wherein each of said end portions has an aperture for receiving said connector.

33. The apparatus of claim 31, wherein said apertures are generally aligned along the longitudinal axis of the spine.

34. The apparatus of claim 27, wherein each of said end portions is detachable.

35. The apparatus of claim 27, wherein each of said end portions is a coupler.

36. The apparatus of claim 35, wherein each of said couplers is detachable.

37. The apparatus of claim 35, wherein each of said couplers include an aperture generally along the longitudinal axis of the spine for receiving said connector.

38. The apparatus of claim 35, wherein each of said couplers have a head and a shank, said head having an opening for receiving the connector.

39. The apparatus of claim 38, wherein each of said implants has an aperture for receiving said shank.

40. The apparatus of claim 39, wherein said shank and said apertures have cooperating threads.

41. The apparatus of claim 27, wherein said protrusion of said opposed arcuate portions is a thread.

42. The apparatus of claim 27, wherein said connector is selected from one of a rod, a cable, a plate, and a bar.

43. The apparatus of claim 27, further comprising means for adjusting the length of said connector between said implants for aligning segments of the spine.

44. The apparatus of claim 43, wherein said length adjusting means includes a threaded member on said connector for varying the length of said connector between said implants.

45. The apparatus of claim 43, further comprising means for locking said length adjusting means at a selected length.

46. The apparatus of claim 27, further comprising a third spinal implant adapted to be surgically implanted in a third location in the spine, a fourth spinal implant adapted to be surgically implanted in a fourth location in the spine, and a second connector attached to both of said third and fourth implants.

47. The apparatus of claim 46, wherein said first and second connectors are adapted to be placed on one side of the spine.

48. The apparatus of claim 46, wherein said first and second connectors are adapted to be placed on opposite sides of the spine.

49. The apparatus of claim 46, wherein said second connector is selected from one of a rod, a cable, a plate, and a bar.

50. The apparatus of claim 27, wherein said implants include an artificial material other than bone.

51. A multi-segmental spinal alignment apparatus for linking segments of the spine, comprising:

a first spinal implant adapted to be surgically implanted at least in part within a first disc space between two adjacent vertebrae in a segment of the spine, said first spinal implant being adapted to contact both of the vertebrae adjacent to the first disc space when the disc space has been restored to approximate a normal height of the disc space;

a second spinal implant adapted to be surgically implanted at least in part within a second disc space between two adjacent vertebrae in another segment of the spine, said second spinal implant being adapted to contact both of the vertebrae adjacent to the second disc space when the disc space has been restored to approximate a normal height of the disc space;

a connector having a length sufficient to span the distance from said first disc space to said second disc space to connect said implants; and

a plurality of couplers for coupling said connector to each of said spinal implants.

52. The apparatus of claim 51, wherein each of said spinal implants has an end portion configured to receive said at least one of said couplers.

53. The apparatus of claim 51, wherein each of said implants has an end portion configured to couple to said at least one of said couplers.

54. The apparatus of claim 52, wherein each of said couplers has an aperture for receiving said connector.

55. The apparatus of claim 54, wherein said apertures are generally aligned along the longitudinal axis of the spine.

56. The apparatus of claim 52, wherein each of said couplers is detachable.

57. The apparatus of claim 52, wherein each of said couplers has a head and a shank, said head having an opening for receiving the connector.

58. The apparatus of claim 57, wherein each of said implants have an aperture for receiving said shank.

59. The apparatus of claim 58, wherein each of said shanks and each of said apertures has cooperating threads.

60. The apparatus of claim 51, wherein said implants include upper and lower portions with a plurality of openings for permitting bone growth from one of the adjacent vertebrae through each of said implants to the other of the adjacent vertebra.

61. The apparatus of claim 60, further comprising a hollow interior for holding bone growth promoting material, said hollow interior within each of said implants being in communication with at least two of said plurality of openings.

62. The apparatus of claim 51, wherein said implants include upper and lower portions that are arcuate.

63. The apparatus of claim 51, wherein said implants further comprise a protrusion for engaging the adjacent vertebrae.

64. The apparatus of claim 63, wherein said protrusion of said implants is a thread.

65. The apparatus of claim 51, wherein said connector is selected from one of a rod, a cable, a plate, and a bar.

66. The apparatus of claim 51, further comprising means for adjusting the length of said connector between said implants for aligning segments of the spine.

67. The apparatus of claim 66, wherein said length adjusting means includes a threaded member on said connector for varying the length of said connector between said implants.

68. The apparatus of claim 66, including means for locking said length adjusting means at a selected length.

69. The apparatus of claim 51, further comprising a third spinal implant adapted to be surgically implanted in the first disc space, a fourth spinal implant adapted to be surgically implanted in the second disc space, and a second connector having a length sufficient to span the distance between said first and second disc spaces to connect said third and fourth spinal implants.

70. The apparatus of claim 69, wherein said first and second connectors are adapted to be placed on one side of the spine.

71. The apparatus of claim 69, wherein said first and second connectors are adapted to be placed on opposite sides of the spine.

72. The apparatus of claim 69, wherein said first and second connectors are selected from one of a rod, a cable, a plate, and a bar.

73. The apparatus of claim 51, wherein said implants include an artificial material other than bone.

74. The apparatus of claim 51, wherein said implants are configured for implantation across a disc space in the thoracolumbar region of the human spine.

75. A method for linking multiple segments of a human spine, comprising the steps of:

implanting a first spinal implant adapted to be surgically implanted at least in part within a first disc space between two adjacent vertebrae in a segment of the spine, said first spinal implant being adapted to contact both of the vertebrae adjacent to the first disc space when the disc space has been restored to approximate a normal height for the disc space, said first spinal implant having a trailing end configured to receive a connector;

implanting a second spinal implant adapted to be surgically implanted at least in part within a second disc space between two adjacent vertebrae in a segment of the spine, said second spinal implant being adapted to contact both of the vertebrae adjacent to the second disc space, when the disc space has been restored to approximate a normal height for the disc space; and

attaching a connector to both of said first and second spinal implants.

76. The method of claim 75, further comprising the step of positioning said implants in spatial relationship to each other.

77. The method of claim 75, wherein the step of implanting said second implant includes implanting said second implant having a trailing end configured to receive a connector.

78. The method of claim 76, wherein the positioning step includes the sub-step of varying the length of the connector between said implants.

79. The method of claim 76, wherein the positioning step includes the sub-step of aligning segments of the spine.

80. The method of claim 76, further comprising the step of locking said implants in a fixed spatial relationship to each other.

81. The method of claim 75, further comprising the steps of implanting a third spinal implant in the first disc space and implanting a fourth spinal implant in the second disc space.

82. The method of claim 81, wherein the attaching step includes attaching a second connector to both of said third and fourth spinal implants.

83. The method of claim 81, further comprising the step of positioning on the same side of the spine first and second connectors for connecting spinal implants.

84. The method of claim 81, further comprising the step of positioning on opposite sides of the spine first and second connectors for connecting spinal implants.

85. The method of claim 75, further comprising the step of tensioning said connector between said implants.

86. The method of claim 75, wherein the attaching step includes the sub-step of connecting at least three spinal implants in a series along segments of the spine.

87. The method of claim 75, wherein the implanting steps include implanting said spinal implants including an artificial material other than bone.

88. The method of claim 75, wherein the implanting steps include implanting said implants across a disc space in the thoracolumbar region of the human spine.

89. A method for linking multiple segments of the spine, comprising the steps of:

implanting a first spinal implant adapted to be surgically implanted in a first location of the spine, said first spinal implant having a maximum width and opposed arcuate portions over at least a portion of its length and a plurality of openings along the length of said implant passing therethrough for permitting growth of bone into said first implant, said first implant having a hollow interior for holding bone growth promoting material, said hollow interior being in communication with at least two of said plurality of openings, and a protrusion extending from the exterior of said first implant for engaging bone in the spine;

implanting a second spinal implant adapted to be surgically implanted in a second location in the spine, said second implant having a maximum width and opposed arcuate portions over at least a portion of its length and a plurality of openings along the length of said second implant passing therethrough for permitting growth of bone into said second implant, said second implant having a hollow interior for holding bone growth promoting material, said hollow interior being in communication with at least two of said plurality of openings, and a protrusion extending from the exterior of said second implant for engaging bone in the spine; and

aligning a connector to both of said implants, said connector having a width measured transverse to the longitudinal axis of the spine less than the maximum width of each of said implants.

90. The method of claim 89, wherein the implanting steps include the sub-step of implanting said implants having at least one of said insertion and trailing ends open for loading bone growth promoting materials into said hollow interior.

91. The method of claim 90, further comprising the step of providing an end cap for closing said open end.

92. The method of claim 89, further comprising the step of positioning said implants in spatial relationship to each other.

93. The method of claim 92, wherein the positioning step includes the sub-step of varying the length of the connector between said implants.

94. The method of claim 92, wherein the positioning step includes the sub-step of aligning segments of the spine.

95. The method of claim 92, further comprising the step of locking said implants in a fixed spatial relationship to each other.

96. The method of claim 89, further comprising the steps of implanting a third spinal implant at a third location in the spine and implanting a fourth spinal implant at a fourth location in the spine.

97. The method of claim 96, wherein the attaching step includes attaching a second connector to both of said third and fourth spinal implants.

98. The method of claim 96, further comprising the step of positioning on the same side of the spine first and second connectors for connecting spinal implants.

99. The method of claim 96, further comprising the step of positioning on opposite sides of the spine first and second connectors for connecting implants.

100. The method of claim 89, further comprising the step of tensioning said connector between said implants.

101. The method of claim 89, wherein the attaching step includes the sub-step of connecting at least three spinal implants in a series along segments of the spine.

102. The method of claim 89, wherein the implanting steps include implanting said spinal implants including an artificial material other than bone.

103. An apparatus for linking multiple spinal implants, comprising:

a first spinal implant adapted to be surgically implanted at least in part within a disc space between two adjacent vertebrae in a segment of the spine, said first spinal implant being adapted to contact both of the vertebrae adjacent to the disc space;

a second spinal implant adapted to be surgically implanted at least in part within the same disc space in which said first spinal implant is to be implanted, said second spinal implant being adapted to contact both of the vertebrae adjacent to the disc space; and

a connector attached to said first and second spinal implants for connecting said first and second spinal implants.

104. The apparatus of claim 103, wherein each of said implants has an end portion configured to couple to said connector.

105. The apparatus of claim 104, wherein each of said implants has an end portion configured to receive said connector.

106. The apparatus of claim 104, wherein each of said end portions has an opening for receiving said connector.

107. The apparatus of claim 104, wherein said end portions are detachable.

108. The apparatus of claim 104, wherein each of said end portions is a coupler.

109. The apparatus of claim 108, wherein each of said couplers are detachable.

110. The apparatus of claim 108, wherein each of said couplers has a head and a shank, said head having an opening for receiving the connector.

111. The apparatus of claim 110, wherein each of said implants has an aperture for receiving said shank.

112. The apparatus of claim 111, wherein said shanks and said apertures have cooperating threads.

113. The apparatus of claim 103, wherein said implants include upper and lower portions with a plurality of openings for permitting bone growth from one of the adjacent vertebrae through each of said implants to the other of the adjacent vertebrae.

114. The apparatus of claim 113, further comprising a hollow interior within each of said implants for holding bone growth promoting material, said hollow interior being in communication with at least two of said plurality of openings.

115. The apparatus of claim 103, wherein said implants have upper and lower portions that are arcuate.

116. The apparatus of claim 103, wherein said implants further comprise a protrusion for engaging the adjacent vertebrae.

117. The apparatus of claim 116, wherein said protrusion of said upper and lower portions of said implants is a thread.

118. The apparatus of claim 103, wherein said connector is selected from one of a rod, a cable, a plate, and a bar.

119. The apparatus of claim 103, wherein said implants include artificial material other than bone.

120. The apparatus of claim 103, wherein said implants are configured for implantation across a disc space in the thoracolumbar region of the human spine.

121. An method for linking multiple spinal implants in the spine, comprising the steps of:

implanting a first spinal implant within a disc space between two adjacent vertebrae in a segment of the spine, said first spinal implant being adapted to contact both of the vertebrae adjacent to the disc space;

implanting a second spinal implant within the same disc space in which said first spinal implant is to be implanted, said second spinal implant being adapted to contact both of the vertebrae adjacent to the disc space; and

connecting said implants with a connector.

122. The method of claim 121, wherein the implanting steps include implanting said implants having an end portion configured to couple to said connector.

123. The method of claim 121, wherein the implanting steps include implanting each of said implants having an end portion configured to receive said connector.

124. The method of claim 121, wherein the connecting step includes the sub-step of preventing rotation of said implants with said connector.

125. The method of claim 121, wherein the implanting steps include implanting said spinal implants including an artificial material other than bone.

126. The method of claim 121, wherein the implanting steps include implanting said implants across a disc space in the thoracolumbar region of the human spine.