Methods of performing procedures in the spine

• US 20020016583A1
• Filed: 05/03/2001
• Published: 02/07/2002
• Est. Priority Date: 02/16/2000
• Status: Active Grant

• Current Assignee: Quandary Medical LLC (The Quandary Group LLC)
• Original Assignee: TranS1 Incorporated (Baxano Surgical, Inc.)
• Inventors: Cragg, Andrew H.
• Granted Patent: US 7,014,633 B2
• Time in Patent Office: Days
• US Class Current: 604/500
• CPC Class Codes: A61B 1/3135 for examination of the epidural or the spinal space
• CPC Class Codes: A61B 17/1642 for producing a curved bore
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/1757 for the spine
• CPC Class Codes: A61B 17/22032 having inflatable gripping elements balloon catheters A61M25/10
• 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 17/70 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 17/7097 Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants disc prostheses made of inflatable chambers or pockets filled with fluid A61F2/441; replacing the nucleus pulposus A61F2002/444
• 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 17/8805 for introducing fluid filler into bone or extracting it A61B17/7097, A61B17/8833 take precedence
• 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 17/8819 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 17/8855 inflatable, e.g. kyphoplasty balloons
• CPC Class Codes: A61B 2017/00261 Discectomy
• CPC Class Codes: A61B 2017/003 Steerable
• 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: 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 2002/2821 : Bone stimulation by electromagnetic fields or electric current for enhancing ossification
• 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 2002/30075 : swellable, e.g. when wetted
• CPC Class Codes: A61F 2002/30092 : using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/30291 : spirally-coiled, i.e. having a 2D spiral cross-section
• 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 2002/30566 : Helical springs
• 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 2002/30841 : Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
• CPC Class Codes: A61F 2002/3085 : with a threaded, e.g. self-tapping, bone-engaging surface, e.g. external surface
• CPC Class Codes: A61F 2002/30879 : Ribs
• CPC Class Codes: A61F 2002/30884 : Fins or wings, e.g. longitudinal wings for preventing rotation within the bone cavity
• CPC Class Codes: A61F 2002/30892 : parallel
• CPC Class Codes: A61F 2002/30925 : etched
• CPC Class Codes: A61F 2002/3097 : using laser
• 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 2002/4495 : having a fabric structure, e.g. made from wires or fibres
• 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 2210/0061 : swellable
• CPC Class Codes: A61F 2230/0091 : helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2310/00353 : Bone cement, e.g. polymethylmethacrylate or PMMA
• CPC Class Codes: A61N 5/1027 : Interstitial radiation therapy

Abstract

Disclosed are methods of accessing and treating the spine, while minimizing trauma to surrounding tissue. A device is introduced through tissue, to an access point on the spine. The device is thereafter advanced axially within the spine, from the access point across a treatment zone. In one application, the access point is on the anterior surface of the spine, and, in another application, the access point is on the posterior surface of the spine. The lumen created through the spine across the treatment zone may be either substantially linear, or curved.

Claims

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

identifying a site on the anterior surface of the sacrum;

forming a lumen from the site through the sacrum, through a disk and into at least one vertebrae; and

performing a procedure using the lumen.

2. A method of treating the spine as in claim 1, wherein the procedure is a diagnostic procedure.

3. A method of treating the spine as in claim 1, wherein the procedure is a therapeutic procedure.

4. A method of treating the spine as in claim 3, wherein the lumen extends at least as far as the L4 vertebrae.

5. A method of treating the spine as in claim 4, wherein the lumen is linear.

6. A method of treating the spine as in claim 1, wherein the forming step comprises drilling.

7. A method of treating the spine as in claim 3, wherein the procedure comprises removing at least a part of a disk.

8. A method of treating the spine as in claim 3, wherein the procedure comprises removing an entire nucleus.

9. A method of treating the spine as in claim 3, wherein the procedure comprises inserting a fixation device.

10. A method of treating the spine as in claim 3, wherein the procedure comprises introducing a bone growth facilitator.

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

identifying a site on the posterior surface of the sacrum;

forming a nonlinear lumen from the site through the sacrum, through a disk and through at least one lumbar vertebrae; and

performing a procedure using the lumen.

12. A method of treating the spine as in claim 11, wherein the procedure is a diagnostic procedure.

13. A method of treating the spine as in claim 11, wherein the procedure is a therapeutic procedure.

14. A method of treating the spine as in claim 13, wherein the lumen extends at least as far as the L4 vertebrae.

15. A method of treating the spine as in claim 11, wherein the forming step comprises drilling.

16. A method of treating the spine as in claim 13, wherein the procedure comprises removing at least a part of a disk.

17. A method of treating the spine as in claim 13, wherein the procedure comprises removing an entire nucleus.

18. A method of treating the spine as in claim 13, wherein the procedure comprises inserting a fixation device.

19. A method of treating the spine as in claim 13, wherein the procedure comprises introducing a bone growth facilitator.

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

identifying a site on the skin of a patient, within about 5 cm from the coccyx;

providing a percutaneous access at the site and through tissue to the sacrum;

creating a lumen through the sacrum and at least one lumbar vertebrae; and

using the lumen to perform a procedure.

21. A method of treating the spine as in claim 20, wherein the lumen is at least about 5 cm in length.

22. A method of treating the spine as in claim 21, wherein the lumen is at least about 10 cm in length.

23. A method of treating the spine as in claim 20, wherein the lumen is linear.

24. A method of treating the spine as in claim 20, wherein the lumen is curved.

25. A method of treating the spine as in claim 20, wherein the lumen extends at least as far as the thoracic spine.

27. A method of treating the spine as in claim 26, wherein the distance is at least about 10 cm.

28. A method of treating the spine as in claim 26, wherein the access site is on the sacrum.

29. A method of treating the spine as in claim 26, wherein the access site is on the thoracic spine.

30. A method of treating the spine as in claim 26, further comprising the step of introducing the device percutaneously through the skin prior to the advancing step.

31. A method of treating the spine as in claim 26, wherein the further advancing step comprises advancing the device along a linear path through the spine.

32. A method of treating the spine as in claim 26, wherein the further advancing step comprises advancing the device along a nonlinear path through the spine.

33. A method of treating the spine as in claim 26, wherein the treating step comprises implanting a fixation device.

35. A method of treating the spine as in claim 34, wherein the passageway has a length of at least about 10 times its width.

36. A method of treating the spine as in claim 34, wherein the passageway passes through the skin within about 5 cm of the coccyx.

37. A method of treating the spine as in claim 34, wherein the passageway enters the spine on the anterior side.

38. A method of treating the spine as in claim 34, wherein the passageway enters the spine on the posterior side.

39. A method of treating the spine as in claim 34, wherein the introducing step comprises introducing a fixation device.

26. A method of treating the spine at a treatment site which is spaced apart from an access site, comprising the steps of:

identifying an access site on the spine;

advancing a device through the access site and into the spine;

further advancing the device axially through the spine for a distance across a treatment zone; and

treating the spine in the treatment zone;

wherein the distance is at least about 5 cm.

34. A method of treating the spine comprising creating a minimally invasive passageway through tissue and into the spine, wherein the passageway has a longitudinal axis and a length of at least about 5 times its width, and introducing at least one device through the passageway to treat the spine, wherein an extension of the axis extends through at least two intervertebral disks.

40. A method of performing a procedure on the spine at a procedure site which is spaced apart from an access site, comprising the steps of:

identifying an access site on the spine;

advancing a device through the access site and into the spine;

further advancing the device axially through at least one vertebrae and at least one disk to the procedure site; and

performing a procedure at the procedure site;

wherein the access site is on a healthy portion of the spine, and the procedure site is on an unhealthy or compromised portion of the spine.

41. A method of performing a procedure as in claim 40, wherein the access site is on a sacral vertebrae.

42. A method of performing a procedure as in claim 40, wherein the procedure site is in a disk.

43. A method of performing a procedure from the inside of the spine, while minimizing the cross sectional area of an access pathway to the procedure site, comprising the steps of:

advancing a device through an access pathway in the spine to a procedure site, while the device has a first, reduced crossing profile; and

enlarging the crossing profile of a portion of the device at the treatment site to perform the procedure;

wherein the advancing step comprises advancing the device through at least one vertebrae and at least one disk.

44. A method of performing a procedure from the inside of the spine as in claim 43, wherein the enlarging step comprises advancing a portion of the device radially outwardly from a longitudinal axis of the device, to perform the procedure.

46. A method of fusing the spine as in claim 45, wherein the introducing step comprises introducing an elongate metal fusion device.

47. A method of fusing the spine as in claim 45, wherein the introducing step comprises introducing a cure in place media.

49. A method of accessing the spine as in claim 48, wherein the advancing step comprises advancing the distal end of the access device both distally and laterally as the distal end moves along the anterior surface of the sacrum.

50. A method of accessing the spine as in claim 48, wherein the introducing step comprises introducing a blunt needle trocar.

51. A method of accessing the spine as in claim 48, wherein the introducing step comprises introducing the access device through the paracoccygeal space.

52. A method of accessing the spine as in claim 48, wherein the second site is anterior to S2.

53. A method of accessing the spine as in claim 48, further comprising the step of positioning a tubular sheath through the tissue tract to the second site.

54. A method of accessing the spine as in claim 53, further comprising the step of introducing a fixation device through the sheath.

55. A method of accessing the spine as in claim 54, wherein the fixation device is positioned across at least the S1 and L5 vertebrae.

56. A method of accessing the spine as in claim 55, wherein the fixation device is positioned across at least the S1, L5 and L4 vertebrae.

58. A method of positioning a linear access sheath as in claim 57, wherein the advancing step comprises advancing the sheath through an incision.

59. A method of positioning a linear access sheath as in claim 57, wherein the advancing step comprises advancing the sheath through a percutaneous puncture.

60. A method of positioning a linear access sheath as in claim 57, wherein the fixing step comprises threadably engaging the distal end of the sheath in an aperture in the S2.

45. A method of fusing the spine, comprising the steps of:

identifying a site on the anterior surface of the sacrum;

forming a lumen from the site through the sacrum, through a disk and into at least one vertebrae; and

introducing a fusion implant through the lumen.

48. A method of accessing the spine through a site on the anterior of the sacrum, comprising the steps of:

introducing an access device through a tissue tract from the surface of the skin to a first site on the anterior of the sacrum;

advancing the access device along the anterior surface of the sacrum to a second site; and

entering the sacrum at the second site.

57. A method of positioning a linear access sheath from a paracoccygeal entrance point to the S2 vertebrae, comprising the steps of:

introducing an access device through tissue in the paracoccygeal space;

advancing the distal end of the access device into contact with the sacrum;

sweeping the distal end along the anterior surface of the sacrum towards the S2 vertebrae, thereby displacing anatomical structures from the path of the access device; and

fixing the distal end of the access device with respect to the S2 vertebrae.