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

• US 7,410,501 B2
• Filed: 08/10/2004
• Issued: 08/12/2008
• 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:
  US10/914,846
• Publication Number:
  US 20050010295A1
• Time in Patent Office: 1,463 Days
• Field of Search: 623/16.11, 623/17.11, 623/17.15, 623/17.16, 606/61, 606/247, 606/249, 606/248
• 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 an anterior 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 a base proximate said leading end, 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 base 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 said 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 contact an instrument adapted to be inserted through said trailing end of said body to move said expander from a position proximate said trailing end when said body is in the collapsed position away from said trailing end and toward said base 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 expander configured to expand the width of said body on one side by contacting only one of said side portions 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.

2. The implant of claim 1, wherein said expander is adapted to cooperatively engage 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 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.

4. 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.

5. The implant of claim 1, wherein each of said upper and lower portions are adapted to cooperate with and to fixedly locate said expander therebetween.

6. The implant of claim 5, wherein each of said upper and lower portions are configured to permit said expander to seat therein in at least said expanded position.

7. 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.

8. 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.

9. 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.

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

11. 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.

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

13. The implant of claim 11, wherein said arms are of different lengths.

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

15. The implant of claim 11, 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.

16. The implant of claim 11, wherein said implant includes opposite side portions.

17. The implant of claim 11, wherein said arms are aligned parallel with the mid-longitudinal axis of said body in the collapsed position.

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

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 ramp adapted to contact said expander.

20. 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.

21. 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.

22. 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.

23. 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.

24. 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 a portion of the length of said body.

25. 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.

26. The implant of claim 25, 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.

27. The implant of claim 26, 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.

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

29. The implant of claim 25, 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. A method for inserting an interbody spinal fusion implant from at least in part an anterior 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:

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 leading 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 an anterior approach to the spine;

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

engaging the instrument to the free end of at least two of the upper, lower, and side portions proximate the trailing end of the implant and inserting a portion of the instrument through the trailing end of the implant; and

moving the expander from a position proximate the trailing end toward the leading end of the body along at least a portion of the length of the body of the implant to move the upper, lower, and side portions 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.

55. The method of claim 54, wherein the moving the expander includes moving the side portion at only one side of the implant to expand the width of the implant

56. The method of claim 54, wherein the moving the expander includes moving the side portions at both sides of the implant to expand the width of the implant.

57. The method of claim 54, wherein the moving the expander includes utilizing a post inserted at least in part within the body of the implant to move the expander along at least a portion of the length of the body of the implant.

58. The method of claim 57, wherein the moving the expander includes rotating the post to move the expander along the mid-longitudinal axis of the body of the implant

59. The method of claim 58, wherein the moving the expander includes linear advancement of the radial expansion without substantial rotation of the expander about the post.

60. The method of claim 54, wherein the moving the expander includes moving the upper, lower, and side portions of the body of the implant in a radial direction away from the mid-longitudinal axis of the body of the implant.

61. The method of claim 54, further comprising the step of positioning into a disc space between adjacent vertebral bodies a guard having an extension for insertion into the disc space previously occupied by the disc and for bearing against end plates of adjacent vertebral bodies of the spine to generally restore the spacing of the disc space between the adjacent vertebral bodies.

62. The method of claim 61, further comprising the step of forming, through the guard, the implantation space across at least the height of the disc space.

63. The method of claim 62, wherein the step of inserting the implant includes the step of using an implant holder to insert the implant into the implantation space through the guard.

64. The method of claim 61, wherein the preparing an implantation space includes spacing the adjacent vertebral bodies apart.

65. The method of claim 54, wherein the preparing an implantation space includes forming the implantation space with a bone removal instrument.

66. The method of claim 65, wherein the forming the implantation space includes one of milling, drilling, reaming, chiseling, and trephining the implantation space.

67. The method of claim 54, wherein the inserting the implant includes inserting the implant from an anterior lateral approach to the spine.

68. The method of claim 54, wherein the moving the expander includes pushing the expander along at least a portion of the length of the body of the implant.

69. The method of claim 54, wherein the moving the expander includes rotating expander along at least a portion of the length of the body of the implant.

70. The method of claim 69, wherein the moving the expander includes pulling the expander along at least a portion of the length of said implant.

71. The method of claim 54, wherein the inserting the implant includes screwing the implant into the implantation space.

72. The method of claim 54, wherein the inserting the implant includes pushing the implant into the implantation space.

73. The method of claim 54, wherein the step of inserting the implant includes the step of driving the implant into the implantation space with an implant holder.

74. The method of claim 54, further comprising inserting a second implant into the implantation space, the mid-longitudinal axes of the implants being offset from the mid-saggital axis of the disc space.

75. The method of claim 54, further comprising loading the implant with a fusion promoting substance.

76. The method of claim 75, wherein the loading the implant includes the step of compressively loading the implant with the fusion promoting substance.

77. The method of claim 75, wherein the compressively loading includes pressing the fusion promoting substance into the implant.

78. The method of claim 75, wherein the loading the implant 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.

79. The method of claim 75, wherein at least a portion of the loading the implant occurs after the step of inserting the implant.

80. The method of claim 79, wherein the loading the implant 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.

81. The method of claim 54, further comprising the step of using an implant holder to insert the implant into the implantation space.

82. The method of claim 81, further comprising the step of passing fusion promoting substance through a passage in the implant holder and into the implant.

83. The method of claim 82, further comprising the step of using an expander driver to move the fusion promoting substance through the passage of the implant holder and into the interior of the implant.

84. The method of claim 54, further comprising treating the implant with a fusion promoting substance.

85. The method of claim 54, wherein the implant is in combination with a chemical substance adapted to inhibit scar formation.

86. The method of claim 54, wherein the implant is in combination with an antimicrobial material.

87. The method of claim 54, wherein the inserting the implant includes inserting the implant comprising a fusion promoting substance.

88. The method of claim 54, wherein the inserting the implant includes inserting the implant comprising a bone ingrowth surface.

89. The method of claim 54, wherein the inserting the implant includes the step of inserting the implant comprised at least in part of one of bone and bone growth promoting material.

90. The method of claim 54, wherein the implant is in combination with at least one of a fusion promoting substance, bone, bone growth promoting material, bone derived products, demineralized bone matrix, ossifying proteins, bone morphogenetic protein, hydroxyapatite, and genes coding for the production of bone.

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

a spinal implant having an expander for expanding the height and at least a portion of the width of the implant from a collapsed position to an expanded position, said implant having upper, lower, and side portions comprising a plurality of arms separated by spaces and a hollow interior between said upper, lower, and side portions; and

an inserter for inserting said spinal implant at least in part within a disc space between two adjacent vertebral bodies of the human spine, said inserter having a leading end and a trailing end opposite said leading end, said leading end of said inserter having a plurality of spaced apart portions, said inserter including a projection extending from said leading end of said inserter and between said spaced apart portions, said spaced apart portions of said inserter configured to fit in the spaces between said arms of said spinal implant and at least a portion of said projection being configured fit at least in part within said hollow interior of said implant and to bear against at least one of said spaced apart portions to cooperatively engage said inserter to said implant.

92. The apparatus of claim 91, wherein at least a portion of said leading end of said inserter has a hollow interior.

93. The apparatus of claim 91, wherein said leading end includes a longitudinal bore extending into at least a portion of said inserter.

94. The apparatus of claim 91, wherein at least a portion of said leading end of said inserter is tapered to facilitate insertion between said arms of said implant.

95. An interbody spinal fusion implant for implantation from at least in part an anterior 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 a base proximate said leading end, 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 base of said body and terminating in a free end proximate said trailing end of said implant, each of said upper, lower, and side portions being spaced apart from one another across the mid-longitudinal axis to form a hollow interior and being spaced apart from one another along a perimeter of said trailing end to form slots therebetween, said implant being adapted to receive an instrument configured to be inserted into said hollow interior proximate said trailing end and configured to be inserted into at least one of said slots to cooperatively engage at least two of said upper, lower, and side portions proximate said free ends, 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 said 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 contact the instrument to move said expander from a position proximate said trailing end when said body is in the collapsed position away from said trailing end and toward said base 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 expander configured to expand the width of said body on one side by contacting only one of said side portions 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.

96. A method for inserting an interbody spinal fusion implant from at least in part an anterior 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:

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 leading 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 an anterior approach to the spine;

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

moving the expander from a position proximate the trailing end toward the leading end of the body along at least a portion of the length of the body of the implant to move the upper, lower, and side portions 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; and

moving the side portion at only one side of the implant to expand the width of the implant.