Radially expanding interbody spinal fusion implants, instrumentation, and methods of insertion

• US 7,128,760 B2
• Filed: 03/25/2002
• Issued: 10/31/2006
• Est. Priority Date: 03/27/2001
• Status: Expired due to Term

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: Michelson, Gary K.
• Primary Examiner(s): Lewis, Ralph A.
• Application Number:
  US10/105,839
• Publication Number:
  US 20020143401A1
• Time in Patent Office: 1,681 Days
• Field of Search: 623/16.11, 623/17.11, 623/17.15, 623/17.16, 606/61
• US Class Current: 623/17.15
• CPC Class Codes: A61B 17/1757 for the spine
• CPC Class Codes: A61B 2017/0256 for the spine
• 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 2/446 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 2002/30507 using a threaded locking member, e.g. a locking screw or a set screw
• CPC Class Codes: A61F 2002/30538 for adjusting angular orientation
• CPC Class Codes: A61F 2002/30556 for adjusting thickness
• CPC Class Codes: A61F 2002/30579 with mechanically expandable devices, e.g. fixation devices
• CPC Class Codes: A61F 2002/30593 hollow
• CPC Class Codes: A61F 2002/30594 slotted, e.g. radial or meridian slot ending in a polar aperture, non-polar slots, horizontal or arcuate slots
• CPC Class Codes: A61F 2002/30858 Threads interrupted by grooves or sidewalls, e.g. flat sidewalls
• CPC Class Codes: A61F 2002/30861 having threads of increasing or decreasing height
• 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 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2250/0006 for adjusting angular orientation
• CPC Class Codes: A61F 2250/0009 for adjusting thickness
• 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: Y10S 606/907 : Composed of particular material or coated
• CPC Class Codes: Y10S 606/908 : Bioabsorbable material
• CPC Class Codes: Y10S 606/909 : Bone
• CPC Class Codes: Y10S 606/91 : Polymer

Abstract

Interbody spinal fusion implants being at least in part radially expandable at one of the leading or trailing ends to expand both the height and at least a portion of the width of the implant, and instruments and methods for inserting the implants into an implantation space in the spine are disclosed.

Claims

1. An interbody spinal fusion implant for implantation from at least in part a posterior approach at least in part within and across the height of a disc space between two adjacent vertebral bodies of an adult human spine, said implant comprising:

a body having a leading end for insertion first into the disc space, a trailing end opposite said leading end, a mid-longitudinal axis, and a length between said leading and trailing ends of said body, said body having a mid-point bisecting the length of said body, said body having an upper portion adapted to contact one of the adjacent vertebral bodies, a lower portion opposite said upper portion adapted to contact another one of the adjacent vertebral bodies, and at least one side portion between said upper and lower portions, each of said upper, lower, and side portions extending from said trailing end of said body and being spaced apart from one another to form a hollow interior therebetween, said hollow interior being configured to hold at least some bone growth promoting material therein, said upper and lower portions configured to permit for the growth of bone from adjacent vertebral body to adjacent vertebral body through said body of said implant, each of said upper, lower, and side portions configured to move at least in part in a direction away from the mid-longitudinal axis of the body allowing for expansion of the height and at least a portion of the width of said body, said upper, lower, and side portions having a collapsed position relative to one another allowing for a collapsed height and width of said body and an expanded position relative to one another allowing for an expanded height and width of said body, the expanded height and width of said body being greater than the collapsed height and width of said body, respectively; and

an expander at least in part within said hollow interior, said expander configured to cooperatively engage an instrument adapted to be inserted through said trailing end of said body to engage and to move said expander from a position proximate said leading end when said body is in the collapsed position away from said leading end and toward said trailing end of said body to place said body in the expanded position, said expander adapted to contact and to move said upper, lower, and side portions away from the mid-longitudinal axis of said body, said upper, lower, and side portions of said body adapted to cooperatively engage said expander to locate said expander at a fixed position along the length of said body, said fixed position being closer to the mid-point of said implant than said leading end of said implant, said upper, lower, and side portions of said body adapted to resist dislodgment of said expander from that location when said implant is in the expanded position, said expander adapted to hold at least a portion of said upper, lower, and side portions apart so as to maintain the expanded height and width of said body and to resist the collapse of said body to the collapsed body height and width when said body is in the expanded position.

2. The implant of claim 1, wherein said expander includes a threaded opening for threadable engagement with a tool used to move said expander from an initial position to a final position to increase the height and width of said body.

3. The implant of claim 1, wherein said implant in the expanded position has at least one hollow interior portion that is substantially unobstructed by any mechanism to move said expander so as to permit growth of bone from adjacent vertebral body to adjacent vertebral body through said body.

4. The implant of claim 1, wherein each of said upper and lower portions are configured to permit said expander to seat therein in at least said expanded position.

5. The implant of claim 1, wherein said expander has at least one truncated side so as to avoid contact with one of said at least one side portions of said body.

6. The implant of claim 1, wherein said expander is configured to expand the width of said body on one side by contacting only one of said side portions of said body.

7. The implant of claim 1, wherein said expander is configured to receive at least a portion of at least one of said upper, lower, and side portions.

8. The implant of claim 1, wherein at least a portion of said upper, lower, and side portions are separated by a space, said expander includes at least one guide peg extending therefrom and configured to be placed in said space between at least a portion of at least one of said upper, lower, and side portions.

9. The implant of claim 1, wherein said implant includes only a single expander.

10. The implant of claim 1, wherein at least one of said upper, lower, and side portions comprises a plurality of arms separated from one another at least in part by a space, said space being at least one of an opening, slit, and slot.

11. The implant of claim 10, wherein said space is configured to permit for the growth of bone from vertebral body to vertebral body through said body.

12. The implant of claim 10, wherein said arms are of different lengths.

13. The implant of claim 10, wherein said side portion includes at least one arm having a length less than the length of the arms of said upper and lower portions.

14. The implant of claim 13, wherein said arm having a lesser length provides for a reduced width of said leading end of said body relative to the height of said implant in the expanded position.

15. The implant of claim 10, wherein said implant includes opposite side portions.

16. The implant of claim 10, wherein said arms are aligned parallel with the mid-longitudinal axis of said body in the collapsed position.

17. The implant of claim 1, wherein said implant is at least in part open opposite said side portion.

18. The implant of claim 1, wherein at least one of said upper, lower, and side portions has an interior surface, at least a portion of said interior surface forming a ramp adapted to contact said expander.

19. The implant of claim 1, wherein at least one of said upper, lower, and side portions has an interior surface, at least a portion of said interior surface forming a seat adapted to receive and locate said expander along the length of said body.

20. The implant of claim 1, wherein at least one of said upper, lower, and side portions is sufficiently resilient so as to bend to be moved away from said mid-longitudinal axis of said body.

21. The implant of claim 1, wherein said upper, lower, and side portions when said implant is in the collapsed position form a generally cylindrical shape.

22. The implant of claim 1, wherein said upper, lower, and side portions when said implant is in the expanded position form a generally frusto-conical shape.

23. The implant of claim 1, wherein at least one of said upper, lower, and side portions is at least in part concave along at least portion of the length of said body.

24. The implant of claim 1, further in combination with a post adapted to be inserted at least in part within said hollow interior of said body for moving said expander along at least a portion of the length of said body between said upper and lower portions of said implant.

25. The implant of claim 24, wherein said post has a shaft with a first end adapted to be coupled to one of said leading and trailing ends of said body and a second end opposite said first end configured to cooperatively engage a tool used for inserting said post into said body.

26. The implant of claim 25, wherein said shaft is at least in part threaded and said expander has a threaded opening configured to threadably engage said shaft so that rotation of said post within said body moves said expander along at least a portion of the length of said body to force apart said upper, lower, and side portions.

27. The implant of claim 26, wherein at least a portion of shaft of said post is smooth.

28. The implant of claim 26, wherein said threaded part of said shaft of said post extends a distance greater along said shaft than the depth of said threaded opening of said expander.

29. The implant of claim 24, wherein said post is configured to pass through at least a portion of at least one of said leading and trailing ends of said body.

30. The implant of claim 1, wherein said trailing end of said body is configured to cooperatively engage a driver for inserting the implant into the implantation space.

31. The implant of claim 1, wherein said trailing end of said body includes at least one non-threaded opening.

32. The implant of claim 1, further comprising a bone engaging surface formed on the exterior of at least said upper and lower portions for engaging the adjacent vertebral bodies, said bone engaging surface including at least one of a thread, a ratchet, a spline, surface roughenings, and knurling.

33. The implant of claim 1, wherein said implant comprises an artificial material other than bone.

34. The implant of claim 1, wherein at least a portion of said upper, lower, and side portions of said implant include a material selected from at least one of titanium, plastic, stainless steel, and carbon fiber.

35. The implant of claim 1, wherein said implant is made of an artificial material that is stronger than bone.

36. The implant of claim 1 wherein said implant comprises at least in part of one of bone and bone growth promoting material.

37. The implant of claim 36, wherein said bone growth promoting material is selected from one of bone, bone derived products, demineralized bone matrix, ossifying proteins, bone morphogenetic protein, hydroxyapatite, and genes coding for the production of bone.

38. The implant of claim 1, in combination with a bone growth promoting material.

39. The implant of claim 38, wherein said bone growth promoting material is selected from one of bone, bone derived products, demineralized bone matrix, ossifying proteins, bone morphogenetic protein, hydroxyapatite, and genes coding for the production of bone.

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

41. The implant of claim 1, wherein said implant is a source of osteogenesis.

42. The implant of claim 1, wherein said implant comprises at least one of the following materials:

metal, titanium, plastic, and ceramic appropriate for implantation in the human body.

43. The implant of claim 1, wherein said implant is at least in part resorbable.

44. The implant of claim 1, wherein said implant is formed of a porous material.

45. The implant of claim 1, in combination with a chemical substance adapted to inhibit scar formation.

46. The implant of claim 1, in combination with an antimicrobial material.

47. The implant of claim 1, wherein said hollow interior of said implant includes bone growth promoting material selected from one of bone, bone derived products, demineralized bone matrix, ossifying proteins, bone morphogenetic protein, hydroxyapatite, and genes coding for the production of bone.

48. 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.

49. The implant of claim 1, in combination with an implant holder.

50. The implant of claim 1, in combination with an expander driver.

51. The implant of claim 1, in combination with a remover instrument for removing said expander from within said hollow interior of said body.

52. The implant of claim 1, in combination with an instrument for loading bone growth promoting material into at least a portion of the implant.

53. The implant of claim 1, further in combination with at least one of spinal fixation hardware, a bone screw, a plate, a rod, a tether of synthetic chord, and a tether of wire.

54. The implant of claim 1, further comprising a thread formed on the exterior of at least said upper and lower portions for engaging the adjacent vertebral bodies, said thread extending continuously around the mid-longitudinal axis of said implant for at least one complete turn.

55. A system for use in spinal surgery, said system comprising:

a spinal implant having upper and lower portions, and an expander for expanding the height and at least a portion of the width of said implant from a collapsed position to an expanded position;

an inserter guide having a leading end and a trailing end, said leading end of said inserter guide being configured to cooperatively engage the trailing end of the implant, said inserter guide having a hollow interior forming a passage from said trailing end to said leading end through said inserter guide, said passage of said inserter guide having a maximum cross-sectional dimension transverse to a mid-longitudinal axis of said inserter guide that is adapted to be less than a maximum transverse cross-sectional dimension of said implant to which said inserter guide is configured to cooperatively engage;

a post adapted to be inserted at least in part through the trailing end of the implant and into a hollow interior of the implant for moving the expander along at least a portion of the length of the implant between the upper and lower portions of the implant, said post having a leading end configured to cooperatively engage the expander and a trailing end adapted to be coupled to the implant and cooperatively engage an instrument for moving said post; and

an inner shaft configured to be inserted at least in part within said passage of said inserter guide, said inner shaft having a leading end and a trailing end, said leading end of said inner shaft being configured to cooperatively engage the trailing end of said post, said inner shaft adapted to move said post so as to move the expander toward the trailing end of the implant to expand the height and at least a portion of the width of the implant.

56. The system of claim 55, wherein said leading end of said inserter guide includes an implant engaging head to cooperatively engage the implant to hold and manipulate the implant during insertion of the implant into the disc space.

57. The system of claim 56, wherein said implant engaging head includes at least one of a flange and a pin.

58. The system of claim 55, wherein said inserter guide further comprises a handle proximate said trailing end of said inserter guide.

59. The system of claim 55, wherein said trailing end of said inserter guide is funnel-shaped to facilitate the introduction of bone growth promoting material through said passage of said inserter guide and into at least a portion of the spinal implant.

60. The system of claim 55, wherein said inserter guide is configured to be inserted at least in part within a guard for providing protected access to the disc space and the adjacent vertebral bodies.

61. The system of claim 55, further in combination with a guard for providing protected access to the disc space and the adjacent vertebral bodies.

62. The system of claim 55, wherein said inner shaft is adapted to rotate within said inserter guide to rotate said post and move the expander toward the trailing end of the implant to expand the height and at least a portion of the width of the implant.

63. The system of claim 55, wherein said leading end of said inner shaft is adapted hold said post such that upon disengagement of said post from the implant said inner shaft withdraws said post through said inserter guide.

64. The system of claim 63, wherein said leading end of said inner shaft includes at least one of a detent and a spring flange.

65. The system of claim 63, wherein said leading end of said inner shaft forms an interference fit with said post.

66. The system of claim 55, wherein said trailing end of said inner shaft is configured to cooperatively engage a device for rotating said inner shaft.

67. The system of claim 55, further comprising a plunger configured to be inserted at least in part within said passage of said inserter guide, said plunger adapted to advance bone growth promoting material through said passage of said inserter guide and into at least a portion of the implant.

68. The system of claim 67, wherein said plunger has an outer shaft and an inner rod at least in part within said outer shaft in slideable relationship to said outer shaft.

69. The system of claim 68, wherein said outer shaft has a leading end for insertion first into said inserter guide and a trailing end opposite said leading end, said plunger being configured to limit the extension of said inner rod from the leading end of said outer shaft.

70. The system of claim 69, further comprising a clamp having a tightened position for holding said inner rod in fixed relationship to said outer shaft of said plunger and a released position for permitting travel of said inner rod beyond said leading end of said outer shaft of said plunger.

71. The system of claim 70, further comprising a stop to limit travel of said inner rod relative to said outer shaft of said plunger.

72. The system of claim 71, wherein at least a portion of said plunger is configured to extend beyond the leading end of said inserter guide and at least in part within the spinal implant.

73. The system of claim 55, wherein said leading end of said inserter guide has a maximum cross-sectional dimension transverse to the mid-longitudinal axis of said inserter guide that is adapted to be no greater than the maximum transverse cross-sectional dimension of said implant to which said inserter guide is configured to cooperatively engage.

74. An interbody spinal fusion implant for implantation from at least in part a posterior approach at least in part within and across the height of a disc space between two adjacent vertebral bodies of an adult human spine, said implant comprising:

a body having a leading end for insertion first into the disc space, a trailing end opposite said leading end, and a mid-longitudinal axis along the length of said body, said body having an upper portion adapted to contact one of the adjacent vertebral bodies, a lower portion opposite said upper portion adapted to contact another one of the adjacent vertebral bodies, and at least one side portion between said upper and lower portions, each of said upper, lower, and side portions extending from said trailing end of said body and being spaced apart from one another to form a hollow interior therebetween, said hollow interior being configured to hold at least some bone growth promoting material therein, said upper and lower portions configured to permit for the growth of bone from adjacent vertebral body to adjacent vertebral body through said body of said implant, each of said upper, lower, and side portions configured to move at least in part in a direction away from the mid-longitudinal axis of the body allowing for expansion of the height and at least a portion of the width of said body, said upper, lower, and side portions having a collapsed position relative to one another allowing for a collapsed height and width of said body and an expanded position relative to one another allowing for an expanded height and width of said body, the expanded height and width of said body being greater than the collapsed height and width of said body, respectively; and

an expander at least in part within said hollow interior, said expander configured to cooperatively engage an instrument adapted to be inserted through said trailing end of said body to engage and to move said expander from a position proximate said leading end when said body is in the collapsed position away from said leading end and toward said trailing end of said body to place said body in the expanded position, said expander adapted to contact and to move said upper, lower, and side portions away from the mid-longitudinal axis of said body, said upper, lower, and side portions of said body adapted to cooperatively engage said expander to locate said expander at a location along the length of said body between and away from each of said leading and trailing ends and to resist dislodgment of said expander from that location when said implant is in use, said expander adapted to hold at least a portion of said upper, lower, and side portions apart so as to maintain the expanded height and width of said body and to resist the collapse of said body to the collapsed body height and width when said body is in the expanded position, said expander being configured to expand the width of said body on one side by contacting only one of said side portions of said body.

75. The implant of claim 74, wherein said expander includes a threaded opening for threadable engagement with a tool used to move said expander from an initial position to a final position to increase the height and width of said body.

76. The implant of claim 74, wherein said implant in the expanded position has at least one hollow interior portion that is substantially unobstructed by any mechanism to move said expander so as to permit growth of bone from adjacent vertebral body to adjacent vertebral body through said body.

77. The implant of claim 74, wherein at least one of said upper, lower, and side portions comprises a plurality of arms separated from one another at least in part by a space, said side portion including at least one arm having a length less than the length of the amis of said upper and lower portions.

78. The implant of claim 77, wherein said arm having a lesser length provides for a reduced width of said leading end of said body relative to the height of said implant in the expanded position.

79. The implant of claim 74, wherein at least one of said upper, lower, and side portions has an interior surface, at least a portion of said interior surface

forming a seat adapted to receive and locate said expander along the length of said body.

80. The implant of claim 74, further in combination with a post adapted to be inserted at least in part within said hollow interior of said body for moving said expander along at least a portion of the length of said body between said upper and lower portions of said implant.

81. The implant of claim 80, wherein said post has a shaft with a first end adapted to be coupled to one of said leading and trailing ends of said body and a second end opposite said first end configured to cooperatively engage a tool used for inserting said post into said body.

82. The implant of claim 81, wherein said shaft is at least in part threaded and said expander has a threaded opening configured to threadably engage said shaft so that rotation of said post within said body moves said expander along at least a portion of the length of said body to force apart said upper, lower, and side portions.

83. The implant of claim 74, further comprising a bone engaging surface formed on the exterior of at least said upper and lower portions for engaging the adjacent vertebral bodies, said bone engaging surface including at least one of a thread, a ratchet, a spline, surface roughenings, and knurling.

84. The implant of claim 74, in combination with a bone growth promoting material.

85. The implant of claim 84, wherein said bone growth promoting material is selected from one of bone, bone derived products, demineralized bone matrix, ossifying proteins, bone morphogenetic protein, hydroxyapatite, and genes coding for the production of bone.

86. The implant of claim 74, wherein said implant is at least in part resorbable.

87. The implant of claim 74, in combination with a chemical substance adapted to inhibit scar formation.

88. The implant of claim 74, in combination with an antimicrobial material.

89. A method for inserting an interbody spinal fusion implant from at least in part a posterior approach at least in part within and across the height of a disc space between two adjacent vertebral bodies of an adult human spine, the method comprising the steps of:

providing the spinal implant having a body with a leading end for insertion first into the disc space, a trailing end opposite the leading end, a mid-longitudinal axis, upper and lower portions, and at least one side portion, each of the upper, lower, and side portions extending from the trailing end of the body, a hollow interior between said upper and lower portions, and an expander for expanding the height and at least a portion of the width of the body;

preparing an implantation space to receive the implant from a posterior approach to the spine;

inserting the implant at least in part into the implantation space; and

moving the expander from a position proximate one of the ends of the body toward another of the ends of the body along at least a portion of the length of the body of the implant to move the upper and lower portions, and side portion at only one side of the implant in a direction away from the mid-longitudinal axis of the body of the implant to expand the height and at least a portion of the width of the body of the implant.

90. The method of claim 89, wherein the inserting step includes inserting the implant from a posterior lateral approach to the spine.

91. The method of claim 89, wherein the moving step includes pushing the expander along at least a portion of the length of the body of the implant.

92. The method of claim 89, wherein the moving step includes rotating the expander along at least a portion of the length of the body of the implant.

93. The method of claim 92, wherein the moving step includes pulling the expander along at least a portion of the length of said implant.

94. The method of claim 89, wherein the step of inserting includes the step of screwing the implant into the implantation space.

95. The method of claim 89, wherein the step of inserting includes the step of pushing the implant into the implantation space.

96. The method of claim 89, further comprising the step of loading the implant with fusion promoting substance.

97. The method of claim 96, wherein the loading step includes loading the implant with the fusion promoting substance being selected from one of bone, bone derived products, demineralized bone matrix, ossifying proteins, bone morphogenetic protein, hydroxyapatite, and genes coding for the production of bone.