Methods and instrumentation for the surgical correction of human thoracic and lumbar spinal disease from the antero-lateral aspect of the spine

• US 5,772,661 A
• Filed: 02/27/1995
• Issued: 06/30/1998
• Est. Priority Date: 06/13/1988
• Status: Expired due to Term

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Gary K. Michelson
• Inventors: Michelson, Gary Karlin
• Primary Examiner(s): Brown, Michael A.
• Application Number:
  US08/394,836
• Time in Patent Office: 1,219 Days
• Field of Search: 606/60, 606/61, 606/72-79, 623/16, 623/17
• US Class Current: 606/86.00A
• 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 17/1604 Chisels; Rongeurs; Punches; Stamps
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/17 Guides or aligning means for drills , mills, pins or wires
• CPC Class Codes: A61B 17/1757 for the spine
• CPC Class Codes: A61B 17/32 Surgical cutting instruments A61B18/042 takes precedence; suture cutters A61B17/0467; instruments for ligaturing or cutting A61B17/128; instruments for rupturing the amniotic membrane A61B17/4208; specially adapted knives for eye surgery A61F9/0133
• CPC Class Codes: A61B 17/320016 Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes A61B10/0233, A61B17/29, A61B17/3207 take precedence
• 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 17/8875 Screwdrivers, spanners or wrenches
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2017/00261 Discectomy
• 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: A61B 2017/922 Devices for impaction, impact element
• CPC Class Codes: A61B 2090/036 : abutting on tissue or skin
• CPC Class Codes: A61F 2/30744 : End caps, e.g. for closing an endoprosthetic cavity
• CPC Class Codes: A61F 2/30767 : 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 2/4603 : for insertion or extraction of endoprosthetic joints or of accessories thereof
• CPC Class Codes: A61F 2/4611 : of spinal prostheses
• CPC Class Codes: A61F 2002/2835 : Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
• CPC Class Codes: A61F 2002/30062 : (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30143 : hexagonal
• CPC Class Codes: A61F 2002/30224 : cylindrical
• CPC Class Codes: A61F 2002/30235 : tubular, e.g. sleeves
• CPC Class Codes: A61F 2002/30329 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2002/30405 : made by screwing complementary threads machined on the parts themselves
• CPC Class Codes: A61F 2002/30426 : Bayonet coupling
• CPC Class Codes: A61F 2002/30433 : using additional screws, bolts, dowels, rivets or washers e.g. connecting screws
• CPC Class Codes: A61F 2002/30593 : hollow
• CPC Class Codes: A61F 2002/30772 : Apertures or holes, e.g. of circular cross section
• CPC Class Codes: A61F 2002/30774 : internally-threaded
• CPC Class Codes: A61F 2002/30785 : parallel
• CPC Class Codes: A61F 2002/30787 : inclined obliquely with respect to each other
• CPC Class Codes: A61F 2002/30797 : internally-threaded
• CPC Class Codes: A61F 2002/30836 : knurled
• CPC Class Codes: A61F 2002/3085 : with a threaded, e.g. self-tapping, bone-engaging surface, e.g. external surface
• CPC Class Codes: A61F 2002/30904 : serrated profile, i.e. saw-toothed
• CPC Class Codes: A61F 2002/448 : comprising multiple adjacent spinal implants within the same intervertebral space or within the same vertebra, e.g. comprising two adjacent spinal implants
• CPC Class Codes: A61F 2002/449 : comprising multiple spinal implants located in different intervertebral spaces or in different vertebrae
• CPC Class Codes: A61F 2002/4619 : for extraction
• CPC Class Codes: A61F 2002/4627 : with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument
• CPC Class Codes: A61F 2002/4629 : connected to the endoprosthesis or implant via a threaded connection
• CPC Class Codes: A61F 2002/4649 : Bone graft or bone dowel harvest sites
• CPC Class Codes: A61F 2002/4681 : by applying mechanical shocks, e.g. by hammering
• CPC Class Codes: A61F 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 2230/0017 : Angular shapes
• 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

An improved method and instrumentation for performing spinal surgery, including discectomy, interbody fusion and rigid internal fixation of the spine, from the lateral aspect of the spine is disclosed. The surgical procedure can be performed through a very small incision. The instrumentation of the present invention, all of which is inserted from a lateral position into the spine in the preferred embodiment, comprises a guide pin, a distractor, an extended outer sleeve, an inner sleeve an adjustable drill and an implant driver. The distractor of the present invention is driven into the disc for spacing apart and realigning the adjacent vertebrae. It further functions as an alignment rod for inserting the extended outer sleeve which is a hollow tubular member capable of maintaining said spacing and alignment of two adjacent vertebrae and defines a protected space through which subsequent instruments which may include, but are not limited to, a drill and a diameter reducing inner sleeve may be passed, as well as a spinal implant. The remainder of the surgical procedure consisting of the removal of spinal material across the disc, fusion, and rigid internal stabilization via the implant may all be performed via the closed space within the extended outer sleeve.

Claims

1. A method for inserting an interbody intraspinal implant into a disc space between adjacent vertebrae located within a human thoracic and lumbar spine having an anterior aspect and a posterior aspect being divided by a plane through transverse processes of the adjacent vertebrae, and having a lateral aspect, the method comprising the steps of:

penetrating from a position anterior to the transverse processes the lateral aspect of a spinal disc intermediate the adjacent vertebrae;

removing from between the adjacent vertebrae at least a portion of the spinal disc to form a laterally facing opening; and

inserting from a position anterior to the transverse processes of the adjacent vertebrae said implant into the laterally facing opening.

2. The method of claim 1 further comprising the step of positioning an extended outer sleeve in contact with the lateral aspect of the spine.

3. The method of claim 2 further comprising the step of engaging said extended outer sleeve to the spine.

4. The method of claim 3 in which the engaging step includes the sub-step of penetratingly engaging said extended outer sleeve into the spine.

5. The method of claim 3 in which the engaging into the step includes the sub-step of engaging disc space said extended outer sleeve having at least one distal extension.

6. The method of claim 3 further comprising the step of driving said extended outer sleeve having at least one extended member into the spinal disc from the lateral aspect of the spine in at least a partially side to side direction across the spinal disc.

7. The method of claim 6 in which the driving step includes the sub-step of guarding the spinal cord with said extended member.

8. The method of claim 6 in which the driving step includes the sub-step of guarding the neural and vascular structures along the posterior and anterior aspects of the spine with said extended member.

9. The method of claim 3 further comprising the step of distracting the adjacent vertebrae with said extended outer sleeve.

10. The method of claim 3 in which said extended outer sleeve includes means for corrective realignment of the vertebrae adjacent the disc space.

11. The method of claim 3 further comprising the step of disassociating said extended outer sleeve having a proximal portion oriented furthest from the spine from a distal portion of said extended outer sleeve being adjacent and oriented lateral to the spine such that said proximal portion is removed and said distal portion is left in place for at least a portion of said method.

12. The method of claim 3 in which a portion of said extended outer sleeve protrudes outside the body of a patient for at least a portion of said method.

13. The method of claim 3 in which the step of engaging includes the sub-stem of engaging said extended outer sleeve being at least in part tubular.

14. The method of claim 3 in which the removing step includes the sub-step of forming said opening through said extended outer sleeve and across the disc space and into the two adjacent vertebrae.

15. The method of claim 3 further comprising the step of inserting hand-held instruments through said extended outer sleeve to remove a portion of the spinal disc.

16. The method of claim 15 further comprising the step of passing an endoscopic viewing device through said extended outer sleeve to observe the removal of a portion of the spinal disc.

17. The method of claim 3 in which the inserting step includes the sub-step of inserting said implant through said extended outer sleeve.

18. The method of claim 3 wherein the step of removing includes the sub-steps of inserting a drill through at least a portion of said extended outer sleeve, drilling at least a portion of the spinal disc and at least a portion of bone from each of the adjacent vertebrae, and removing said drill.

19. The method of claim 18 further comprising the step of removing any debris left in a space formed by the step of drilling following the step of removing said drill.

20. The method of claim 18 in which the step of inserting a drill includes the sub-step of passing said drill through a hollow inner sleeve fitting at least in part around said drill, said inner sleeve having at least a portion thereof fitting within said extended outer sleeve.

21. The method of claim 3 further comprising the step of inserting an inner sleeve member into said extended outer sleeve prior to the removing step.

22. The method of claim 21 further comprising the step of removing said hollow inner sleeve member from said extended outer sleeve prior to the step of inserting said implant.

23. The method of claim 21 in which the step of removing includes the sub-steps of passing a drill through said inner sleeve member and penetrating said drill across at least a part of the spinal disc in at least a partial side to side direction across the adjacent vertebrae.

24. The method of claim 21 further comprising the step of inserting into the lateral aspect of a spinal disc a distractor having a penetrating portion prior to the step of inserting said extended outer sleeve.

25. The method of claim 2 further comprising the steps of making at least one incision along the lateral chest wall of a patient and driving said extended outer sleeve through said incision to the lateral aspect of the thoracic portion of the spine.

26. The method of claim 35 further comprising the step of tapping the opening to provide threads on at least a portion of the adjacent vertebrae prior to the step of inserting said implants.

27. The method of claim 2 further comprising the step of tapping the opening by passing a tap through at least a portion of said extended outer sleeve.

28. The method of claim 1 further comprising the steps of driving toward the lateral aspect of the spine an extended outer sleeve having means for distracting the disc space between the two adjacent vertebrae and inserting the distraction means into the disc space.

29. The method of claim 2 further comprising the steps of inserting a guide pin into the disc space between the adjacent vertebrae prior to the step of positioning said extended outer sleeve;

placing over said guide pin an alignment rod having a penetrating portion and a passageway for receiving said guide pin; and

inserting said penetrating portion into the disc space.

30. The method of claim 1 in which the inserting step includes the sub-step of inserting said implant oriented at least partially in a side to side direction across the disc space and occupies at least in part a portion of a space created by the removal of said portion of said spinal disc.

31. The method of claim 1 in which the step of inserting includes the sub-step of engaging said implant into at least a portion of each of the adjacent vertebrae.

32. The method of claim 1 in which said implant is inserted in at least a partial side to side direction across the disc space and into contact with the adjacent vertebrae.

33. The method of claim 1 in which the removing step includes the sub-step of drilling the opening.

34. The method of claim 33 in which the removing step includes the sub-step of limiting the penetration of said drill.

35. The method of claim 1 in which the removing step includes the sub-step of removing at least a portion of bone from at least one of the adjacent vertebrae.

36. The method of claim 35 in which said sub-step of removing a portion of bone includes the sub-step of using one of a drill, a router, and a mill.

37. The method of claim 1 in which said removing step includes the sub-step of chiseling to form the opening.

38. The method of claim 1 further comprising the step of inserting from a position anterior to the transverse processes an alignment rod into the lateral aspect of the spine.

39. The method of claim 38 in which said alignment rod extends from the spinal disc and protrudes outside of the patient'"'"'s body.

40. The method of claim 38 further comprising the step of placing an extended outer sleeve over said alignment rod.

41. The method of claim 38 in which the step of inserting said alignment rod includes the sub-step of inserting said alignment rod being at least in part hollow.

42. The method of claim 41 further comprising the steps of inserting into the lateral aspect of the spinal disc a guide pin having at least a portion extending laterally from the spinal disc, and placing said alignment rod over said guide pin.

43. The method of claim 38 in which the step of inserting said alignment rod includes the sub-step of inserting into the disc space an intervertebral distractor that spaces apart the adjacent vertebrae.

44. The method of claim 38 in which the step of inserting said alignment rod includes the sub-step of inserting said alignment rod having a distal end portion for insertion into the spinal disc and distracting the two adjacent vertebrae.

45. The method of claim 1 further comprising the step of distracting the adjacent vertebrae prior to the stem of removing.

46. The method of claim 1 further comprising the step of inserting a distractor into the disc space between the adjacent vertebrae to provide for appropriate spacing of the disc space between the vertebrae.

47. The method of claim 46 in which the step of inserting said distractor includes the sub-step of inserting said distractor having a first extended member for insertion in the disc space.

48. The method of claim 47 in which the step of inserting said distractor includes the sub-step of inserting said distractor having a second extended member for insertion in the disc space.

49. The method of claim 1 further comprising the step of inserting a guide pin from a position anterior to the transverse processes of the adjacent vertebrae into the lateral aspect of the spinal disc.

50. The method of claim 47 further comprising the steps of placing over said guide pin a hollow distractor having a penetrating portion and a passageway for receiving said guide pin and inserting said penetrating portion into the disc space between the two adjacent vertebrae.

51. The method of claim 1 further comprising the step of making at least one incision into the lateral aspect of the body of a patient for the purpose of accessing the lateral aspect of the spine.

52. The method of claim 1 further comprising the step of accessing the lateral aspect of at least one spinal disc in the lumbar spine and at least a portion of the two vertebrae adjacent the disc by a retroperitoneal surgical dissection.

53. The method of claim 1 further comprising the step of tapping the opening to provide threads on at least a portion of the adjacent vertebrae prior to the step of inserting said implants.

54. The method of claim 1 further comprising the step of utilizing an endoscope during at least a portion of the method.

55. The method of claim of 1 further comprising the step of utilizing a radiographic imaging device during at least a portion of the method.

56. The method of claim 1 further comprising the steps of coupling a spinal fixation device to said implant and engaging said spinal fixation device to the adjacent vertebrae.

57. The method of claim 1 in which the step of inserting said implant includes the sub-step of inserting said implant having a width that occupies more than one half of the depth of the spinal disc, said depth measured from the anterior aspect to the posterior aspect of the spinal disc.

58. The method of claim 1 in which the step of inserting includes the sub-step of inserting at least two implants.

59. The method of claim 58 in which the sub-step of inserting said at least two implants includes inserting implants having a combined width that is greater than one half the depth of the spinal disc, said depth being measured from the anterior aspect to the posterior aspect of the spinal disc.

60. The method of claim 1 in which the inserting step includes the sub-step of inserting said implant having a width of at least 20 millimeters.

61. The method of claim 46 in which the step of inserting a distractor includes the sub-step of inducing angulation to the adjacent vertebrae.

62. The method of claim 61 in which the inducing angulation sub-step includes the sub-step of restoring lordosis to the adjacent vertebrae.

63. The method of claim 61 in which the inducing angulation sub-step includes the sub-step of restoring kyphosis to the adjacent vertebrae.

64. The method of claim 61 in which the inducing angulation sub-step includes the sub-step of correcting scoliosis of the adjacent vertebrae.

65. The method of claim 1 in which the removing step includes the sub-step of removing bone from the vertebrae along a substantial portion of the transverse width of the vertebrae.

66. The method of claim 1 in which the step of inserting includes the sub-step of inserting said implant having a length greater than one half of the depth of the spinal disc.

67. The method of claim 1 further comprising the step of attaching a driving member to said implant prior to the step of inserting.

68. A method for inserting an interbody intraspinal implant into a disc space between adjacent vertebrae located within a human thoracic and lumbar spine having an anterior aspect and a posterior aspect being divided by a plane through transverse processes of the adjacent vertebrae, and having a lateral aspect, the method comprising the steps of:

engaging from a position anterior to the transverse processes of the adjacent vertebrae into the lateral aspect of the spine a tubular member;

removing from a position anterior to the transverse processes of the adjacent vertebrae at least a portion of the spinal disc through said tubular member to form a laterally facing opening; and

inserting from a position anterior to the transverse processes of the adjacent vertebrae at least one implant into the laterally facing opening.

69. The method of claim 68 in which the removing step includes the sub-step of removing at least a portion of bone from at least one of the adjacent vertebrae.

70. The method of claim 69 in which the insertion step includes the sub-step of penetrating said implant into the bone of each of the adjacent vertebrae.

71. The method of claim 68 in which the inserting step further comprises the sub-step of inserting said implant through said tubular member.

72. A method for inserting an interbody intraspinal implant into a disc space between adjacent vertebrae located within a human thoracic and lumbar spine having an anterior aspect and a posterior aspect being divided by a plane through transverse processes of the adjacent vertebrae, and having a lateral aspect, the method comprising the steps of:

driving from a position anterior to the transverse processes of the adjacent vertebrae toward the lateral aspect of a spinal disc intermediate the adjacent vertebrae an extended outer sleeve having means for penetrably engaging the spine along its lateral aspect;

removing from a position anterior to the transverse processes of the adjacent vertebrae through said extended outer sleeve at least a portion of the spinal disc to create a space; and

inserting from a position anterior to the transverse processes into the lateral aspect of the spine at least one implant, said implant occupying at least in part the space created by the removing step.

73. The method of claim 72 in which the removing step includes the sub-step of removing at least a portion of bone from at least one of the adjacent vertebrae.

74. The method of claim 73 in which the insertion step includes the sub-step of penetrating said implant into the bone of each of the adjacent vertebrae.

75. The method of claim 72 in which the inserting step further comprises the sub-step of inserting said implant through said extended outer sleeve.

76. The method of claim 76 in which the driving step includes the sub-step of penetrating the disc space with said engaging means, and wherein said engaging means includes a disc penetrating extension.

77. The method of claim 76 in which the sub-step of penetrating includes the sub-step of urging apart the adjacent vertebrae with said disc penetrating extension.

78. A method for inserting an interbody spinal implant into a disc space between two adjacent vertebrae located within a human thoracic and lumbar spine having an anterior aspect and a posterior aspect being divided by a plane through transverse processes of the adjacent vertebrae, and having a lateral aspect, the method comprising the steps of:

inserting from a position anterior to the transverse processes of the adjacent vertebrae a distractor into the lateral aspect of the disc space to provide for appropriate spacing apart of the adjacent vertebrae;

inserting from a position anterior to the transverse processes of the adjacent vertebrae an extended outer sleeve into contact with the lateral aspect of the spine;

driving said extended outer sleeve into engagement with the spine;

removing said distractor;

removing from a position anterior to the transverse processes of the adjacent vertebrae at least a portion of a spinal disc intermediate the adjacent vertebrae to form a lateral facing opening;

inserting from a position anterior to the transverse processes of the adjacent vertebrae an implant into the disc space intermediate the adjacent vertebrae through the laterally facing opening; and

removing the extended outer sleeve.

79. The method of claim 78 further comprising the step of inserting an alignment rod having a said penetrating portion into the disc space prior to the step of inserting a distractor.

80. The method of claim 78 in which the step of inserting a distractor includes the sub-step of inserting a said distractor having first and second extended members for distracting the disc space between two adjacent vertebrae.

81. The method of claim 78 further comprising the step of inserting an inner sleeve into the extended outer sleeve.

82. The method of claim 78 including the step of inserting a drill into the inner sleeve.

83. The method of claim 78 in which the step of removing at least a portion of the spinal disc includes the sub-step of forming a hole across the disc space and into the two adjacent vertebrae.

84. The method of claim 78 in which said distractor includes an alignment rod.

85. The method of claim 78 in which the step of removing at least a portion of the spinal disc includes the sub-step of removing at least a portion of bone from at least one of the adjacent vertebrae.

86. The method of claim 78 in which the inserting step further comprises the sub-step of inserting said implant through said extended outer sleeve.

87. The method of claim 85 in which the insertion step includes the sub-step of penetrating said implant into the bone of each of the adjacent vertebrae.