Method and apparatus for spinal distraction and fusion

• US 6,921,403 B2
• Filed: 12/03/2002
• Issued: 07/26/2005
• Est. Priority Date: 02/16/2000
• Status: Expired due to Term

• Current Assignee: Mis Ip Holdings LLC
• Original Assignee: TranS1 Incorporated (Baxano Surgical, Inc.)
• Inventors: Assell, Robert L., Cragg, Andrew H., Dickhudt, Eugene A.
• Primary Examiner(s): Philogene, Pedro
• Application Number:
  US10/309,416
• Publication Number:
  US 20030158557A1
• Time in Patent Office: 966 Days
• Field of Search: 606/86, 606/61, 606/105, 623/17.11, 623/17.16, 623/17.12, 623/17.13, 623/17.14, 623/17.15
• US Class Current: 606/86.00R
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/1757 for the spine
• CPC Class Codes: A61B 17/32002 with continuously rotating, oscillating or reciprocating cutting instruments
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 17/66 Alignment, compression or distraction mechanisms
• CPC Class Codes: A61B 17/70 Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
• CPC Class Codes: A61B 17/7055 connected to sacrum, pelvis or skull
• CPC Class Codes: A61B 17/7061 for stabilising vertebrae or discs by improving the condition of their tissues, e.g. using implanted medication or fluid exchange intraosseous injection devices A61B17/3472
• CPC Class Codes: A61B 17/7098 wherein the implant is permeable or has openings, e.g. fenestrated screw hollow surgical screws A61B17/864
• CPC Class Codes: A61B 17/8811 characterised by the introducer tip, i.e. the part inserted into or onto the bone
• CPC Class Codes: A61B 17/8816 characterised by the conduit, e.g. tube, along which fluid flows into the body or by conduit connections
• CPC Class Codes: A61B 17/8819 characterised by the introducer proximal part, e.g. cannula handle, or by parts which are inserted inside each other, e.g. stylet and cannula A61B17/8825 takes precedence
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2017/00261 Discectomy
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00734 battery operated
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/2905 flexible
• CPC Class Codes: A61B 2017/320012 Brushes
• CPC Class Codes: A61B 2017/320733 with a flexible cutting or scraping element, e.g. with a whip-like distal filament member
• CPC Class Codes: A61B 2017/564 : Methods for bone or joint treatment
• CPC Class Codes: A61F 2/30723 : Plugs or restrictors for sealing a cement-receiving space tools for inserting plugs A61F2/4614; sealing collars for use during cementing A61B17/8808
• CPC Class Codes: A61F 2/441 : made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
• 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 2/4465 : having a circular or kidney shaped cross-section substantially perpendicular to the axis of the spine
• CPC Class Codes: A61F 2/4601 : for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
• CPC Class Codes: A61F 2/4611 : of spinal prostheses
• CPC Class Codes: A61F 2002/2817 : Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• CPC Class Codes: A61F 2002/2835 : Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
• CPC Class Codes: A61F 2002/30092 : using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/30233 : Stepped cylinders, i.e. having discrete diameter changes
• CPC Class Codes: A61F 2002/30235 : tubular, e.g. sleeves
• CPC Class Codes: A61F 2002/3055 : for adjusting length
• CPC Class Codes: A61F 2002/30563 : having elastic means or damping means, different from springs, e.g. including an elastomeric core or shock absorbers
• CPC Class Codes: A61F 2002/30593 : hollow
• CPC Class Codes: A61F 2002/30677 : Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30774 : internally-threaded
• CPC Class Codes: A61F 2002/30784 : Plurality of holes
• CPC Class Codes: A61F 2002/3085 : with a threaded, e.g. self-tapping, bone-engaging surface, e.g. external surface
• CPC Class Codes: A61F 2002/30859 : having threaded portions of different pitches
• CPC Class Codes: A61F 2002/30879 : Ribs
• 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 2002/4627 : 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 2210/0014 : using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2310/00023 : Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/00796 : Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite
• CPC Class Codes: A61F 2310/00976 : Coating or prosthesis-covering structure made of proteins or of polypeptides, e.g. of bone morphogenic proteins BMP or of transforming growth factors TGF
• CPC Class Codes: Y10S 606/907 : Composed of particular material or coated
• CPC Class Codes: Y10S 606/908 : Bioabsorbable material

Abstract

The invention provides an implantable spinal distraction/fusion rod with varied thread pitch and diameters along different portions of its length that it is capable of distracting two or more vertebral bodies relative to each other and/or facilitating the procedure of fusing the vertebral bodies together from within the spine. The present invention also provides for methods of using the rod to distract and/or fuse two or more vertebral bodies from within the spine.

Claims

1. An axially-extending implantable rod for adjusting a distance between two adjacent vertebral bodies in a spine, said rod having an elongated body comprising:

a first section near a leading end of the rod that has a first threading for directly engaging with a first vertebral body;

a second section near a trailing end of the rod that has a second threading having a base diameter and a major diameter for directly engaging with a second vertebral body that is located proximally relative to the first vertebral body; and

an intermediate section extending between the first section and the second section;

at least one transverse aperture extending through the body in the intermediate section;

wherein a first major diameter of the first threading is less than the base diameter of the second threading;

wherein a first thread pitch in the first section is finer relative to a second thread pitch in the second section such that advancement of the first section distally into the first vertebral body by rotation causes an increase in distance between the first and second vertebral bodies.

2. An implantable distraction device as in claim 1, wherein the first major diameter is within the range of from about 10 mm to about 15 mm.

3. An implantable distraction device as in claim 2, wherein the second major diameter is no greater than about 98 % of the first major diameter.

4. An implantable distraction device as in claim 1, wherein the elongate body has a length within the range of from about 1.25 inches to about 2.25 inches.

5. An implantable distraction device as in claim 1, wherein each of the proximal thread and the distal thread has an axial length within the range of from about 0.5 inches to about 1.25 inches.

6. An implantable distraction device as in claim 1, wherein the intermediate section has an axial length within the range of from about 0.25 inches to about 0.5 inches.

7. An implantable distraction device as in claim 1, wherein the elongate body comprises stainless steel.

8. An implantable distraction device as in claim 1, wherein the elongate body comprises titanium.

9. An implantable distraction device as in claim 1, wherein the elongate body comprises a bioabsorbable material.

10. An implantable distraction device as in claim 1, wherein the elongate body comprises a lumen extending axially at least part way through the length of the elongate body.

11. An implantable distraction device as in claim 10, wherein the elongate body further comprises a plurality of side apertures in communication with the lumen.

12. An implantable distraction device as in claim 1, wherein each of the proximal thread and the distal thread extends counterclockwise around the body.

13. An implantable distraction device as in claim 1, wherein each of the proximal thread and the distal thread extends clockwise around the body.

14. An implantable distraction device as in claim 1, wherein each of the proximal thread and the distal thread are self tapping.

15. An implantable distraction device as in claim 2, wherein the first major diameter is within the range of from about 12 mm to about 13 mm.

16. An implantable distraction device as in claim 1, wherein the first major diameter is about 9 mm.

17. An implantable distraction device as in claim 1, wherein the second pitch is less than the first pitch.

18. An implantable distraction device as in claim 1, wherein the first pitch is within the range of from about 10 to about 15 turns per inch.

19. An implantable distraction device as in claim 1, wherein the second pitch is within the range of from about 10 to about 20 turns per inch.

20. An implantable distraction device as in claim 1, wherein the second pitch is at least about 105 % of the first pitch.

21. An implantable distraction device as in claim 1, wherein the second pitch is at least about 110 % of the first pitch.

22. An implantable distraction device as in claim 1, wherein the second pitch is at least about 125 % of the first pitch.

23. An implantable distraction device as in claim 1, further comprising a releasable coupling, for releasably engaging a rotatable driver tool.

24. A method of treating the spine, comprising the steps of:

determining a desired change in disc height between targeted vertebral bodies, wherein the targeted vertebral bodies comprise a proximal body and a distal body;

selecting an axially-extending rod with appropriate thread pitches in a distal section and a proximal section to achieve the desired change in height;

accessing the targeted bodies by creating an axial bore that extends in the distal direction from a sacral target point to a disc space between the targeted bodies;

extending the axial bore in the distal direction to create an extended portion of the axial bore, wherein the extended portion has a smaller diameter than the portion of the axial bore extending from the sacral target point to the disc space between the targeted bodies;

advancing and implanting the selected rod into the targeted bodies to achieve the desired change in disc height.

25. A method of treating the spine as in claim 24, wherein the step of accessing the targeted vertebral bodies comprises identifying the sacral target point on the anterior surface of the sacrum.

26. A method of treating the spine as in claim 25, wherein the step of extending the axial bore comprises forming a lumen from the sacral target point, through the proximal body and into the distal body.

27. A method of treating the spine as in claim 26, wherein the step of advancing and implanting the selected rod comprises introducing the selected rod into the lumen.

28. A method of treating the spine as in claim 27, wherein the step of advancing and implanting the selected rod comprises engaging a proximal end of the selected rod with respect to the proximal body, and engaging a distal end of the selected rod with respect to the distal body.

29. A method of treating the spine as in claim 28, wherein the step of advancing and implanting the selected rod comprises manipulating the selected rod to increase a distance between the proximal and distal vertebral bodies.

30. A method of treating the spine as in claim 29, wherein the lumen extends at least as far as the L4 vertebrae.

31. A method of treating the spine as in claim 30, wherein the lumen is linear.

32. A method of treating the spine as in claim 27, wherein the forming step comprises drilling.

33. A method of treating the spine as in claim 29, additionally comprising the step of removing at least a part of a disc from between the proximal and distal vertebral bodies.

34. A method of treating the spine as in claim 29, additionally comprising the step of removing an entire nucleus from between the proximal and distal vertebral bodies.

35. A method of treating the spine as in claim 29, additionally comprising the step of introducing a bone growth facilitator through the lumen.

36. A method of treating the spine as in claim 35, wherein the bone growth facilitator is introduced through the selected rod.

37. A method of treating the spine as in claim 29, further comprising the step of removing the selected rod from the lumen after increasing the distance between the proximal and distal vertebral bodies.

38. A method of treating the spine as in claim 29, further comprising the step of disengaging the selected rod from a selected rod delivery tool, to implant the selected rod within the lumen.

39. A method of treating the spine as in claim 24, wherein the step of accessing the targeted vertebral bodies comprises identifying the sacral target point on the posterior surface of the sacrum.

40. A method of treating the spine as in claim 39, wherein the step of extending the axial bore comprises forming a nonlinear lumen from the sacral target point, through the sacrum, through a proximal vertebral body and into a distal vertebral body.

41. A method of treating the spine as in claim 40, wherein the step of advancing and implanting the selected rod comprises introducing the selected rod into the lumen.

42. A method of treating the spine as in claim 41, wherein the step of advancing and implanting the selected rod comprises engaging a proximal end of the selected rod with respect to the proximal body, and engaging a distal end of the selected rod with respect to the distal body.

43. A method of treating the spine as in claim 42, wherein the step of advancing and implanting the selected rod comprises manipulating the selected rod to increase a distance between the proximal and distal vertebral bodies.

44. A method of treating the spine as in claim 43, wherein the lumen extends at least as far as the L4 vertebrae.

45. A method of treating the spine as hi claim 43, additionally comprising the step of removing at least a part of a disc from between the proximal and distal vertebral bodies.

46. A method of treating the spine as in claim 43, additionally comprising the step of removing an entire nucleus from between the proximal and distal vertebral bodies.

47. A method of treating the spine as in claim 43, additionally comprising the step of introducing a bone growth facilitator through the lumen.

48. A method of treating the spine as in claim 47, wherein the bone growth facilitator is introduced through the selected rod.

49. A method of treating the spine as in claim 24, wherein the step of advancing and implanting the selected rod comprises rotating the selected rod to increase a distance between the proximal and distal vertebral bodies.

50. A method of treating the spine as in claim 24, wherein the proximal section of the selected rod comprises a first thread having a first pitch and a first major diameter, wherein the distal section of the selected rod comprises a second thread having a second pitch and a second diameter, wherein the first pitch is different than the second pitch and the first major diameter is greater than the second major diameter.

51. A method of treating the spine as in claim 50, wherein the first major diameter is within the range of from about 10 mm to about 15 mm.

52. A method of treating the spine as in claim 51, wherein the second major diameter is no greater than about 98 % of the first major diameter.

53. A method of treating the spine as in claim 50, wherein the selected rod has a length within the range of from about 1.25 inches to about 2.25 inches.

54. A method of treating the spine as in claim 50, wherein each of the proximal section and the distal section has an axial length within the range of from about 0.5 inches to about 1.25 inches.

55. A method of treating the spine as in claim 50, wherein the selected rod further comprises an intermediate section in between the proximal and distal sections.

56. A method of treating the spine as in claim 55, wherein the intermediate section has an axial length within the range of about 0.25 inches to about 0.5 inches.

57. A method of treating the spine as in claim 50, wherein the selected rod comprises stainless steel.

58. A method of treating the spine as in claim 50, wherein the selected rod comprises titanium.

59. A method of treating the spine as in claim 50, wherein the selected rod comprises a bioabsorbable material.

60. A method of treating the spine as in claim 50, wherein the selected rod comprises a lumen extending axially at least part way through the length of the selected rod.

61. A method of treating the spine as in claim 60, wherein the selected rod further comprises a plurality of side apertures in communication with the lumen.

62. A method of treating the spine as in claim 50, wherein each of the first thread and the second thread extends counterclockwise around the selected rod.

63. A method of treating the spine as in claim 50, wherein each of the first thread and the second thread extends clockwise around the selected rod.

64. A method of treating the spine as in claim 50, wherein each of the first thread and the second thread are self tapping.

65. A method of treating the sine as in claim 50, wherein diameter is within the range of from about 12 mm to about 13 mm.

66. A method of treating the spine as in claim 50, wherein the second major diameter is about 9 mm.

67. A method of treating the spine as in claim 50, wherein the second pitch is less than the first pitch.

68. A method of treating the spine as in claim 50, wherein the first pitch is within the range of from about 10 to about 15 turns per inch.

69. A method of treating the spine as in claim 50, wherein the second pitch is within the range of from about 10 to about 20 turns per inch.

70. A method of treating the spine as in claim 50, wherein the second pitch is at least about 105 % of the first pitch.

71. A method of treating the spine as in claim 50, wherein the second pitch is at least about 110 % of the first pitch.

72. A method of treating the spine as in claim 50, wherein the second pitch is at least about 125 % of the first pitch.

73. A method of treating the spine as in claim 50, wherein the selected rod further comprises a releasable coupling, for releasably engaging a rotatable driver tool.

74. A method of treating the spine as in claim 24, additionally comprising the step of introducing a media between the proximal vertebral body and the distal vertebral body.

75. A method of treating the spine as in claim 74, wherein the media comprises an osteogenic agent.

76. A method of treating the spine as in claim 24, wherein the step of advancing and implanting the selected rod comprises rotating at least a portion of the selected rod in a first direction to increase a distance between the proximal and distal vertebral bodies.

77. A method of treating the spine as in claim 76, wherein tho step of advancing and implanting the selected rod further comprises rotating at least a portion of the selected rod in a second direction to decrease the distance between the proximal and distal vertebral bodies.