Method and apparatus for spinal augmentation

• US 20020173796A1
• Filed: 04/18/2002
• Published: 11/21/2002
• Est. Priority Date: 02/16/2000
• Status: Active Grant

• Current Assignee: Mis Ip Holdings LLC
• Original Assignee: TranS1 Incorporated (Baxano Surgical, Inc.)
• Inventors: Cragg, Andrew H.
• Granted Patent: US 6,899,716 B2
• Time in Patent Office: Days
• US Class Current: 606/86
• 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

Disclosed are methods and devices for 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. Spinal fusion cages, other fusion implants and/or bone growth material is introduced into at least one vertebral body and/or at least one disc space.

Claims

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

providing an elongate augmentation catheter, having a proximal end, a distal end, and at least one lumen extending therethrough;

advancing the distal end axially through at least one vertebral body and into at least one disc; and

expressing at least a first media from the catheter into the spine.

2. A method of augmenting the spine as in claim 1, wherein the expressing step comprises expressing at least a first media and a second media from the catheter.

3. A method of augmenting the spine as in claim 1, wherein the advancing step comprises advancing the distal end through at least two vertebral bodies.

4. A method of augmenting the spine as in claim 3, wherein the advancing step comprises advancing the distal end through at least four vertebral bodies.

5. A method of augmenting the spine as in claim 1, wherein the first media comprises a nucleus augmentation material.

6. A method of augmenting the spine as in claim 1, wherein the media comprises a bone growth facilitator.

7. A method of augmenting the spine as in claim 1, further comprising the step of introducing a spinal fusion cage axially into the spine.

8. A method of augmenting the spine as in claim 1, wherein the advancing step comprises advancing the catheter through an artificial lumen created axially through the spine.

9. A method of augmenting the spine as in claim 8, further comprising the step of forming the lumen prior to the advancing step.

10. A method of augmenting the spine as in claim 8, further comprising the step of forming the lumen simultaneously with the advancing step.

11. A method of augmenting the spine as in claim 10, wherein the providing step comprises providing a catheter having a cutting tip on the distal end.

13. A method of treating the spine as in claim 12, wherein the access site is on the sacrum.

14. A method of treating the spine as in claim 12, wherein the access site is on the thoracic spine.

15. A method of treating the spine as in claim 12, further comprising the step of introducing the device percutaneously through the skin prior to the advancing step.

16. A method of treating the spine as in claim 12, wherein the further advancing step comprises advancing the device along a linear path through the spine.

17. A method of treating the spine as in claim 12, wherein the further advancing step comprises advancing the device along a nonlinear path through the spine.

18. A method of treating the spine as in claim 12, wherein the expressing step comprises expressing the material into at least two vertebral bodies.

20. A spinal augmentation catheter as in claim 19, further comprising a detachable joint for detaching at least a portion of the tubular body within the spine.

21. A spinal augmentation catheter as in claim 19, further comprising at least one flex point for permitting flexing of the catheter.

22. A spinal augmentation catheter as in claim 19, further comprising at least a third port in communication with the first lumen and spaced axially apart from the first port such that the third port may be positioned within a second vertebral body while the first port is positioned within the first vertebral body.

24. A method of treating the spine as in claim 23, wherein the procedure is a diagnostic procedure.

25. A method of treating the spine as in claim 23, wherein the procedure is a therapeutic procedure.

26. A method of treating the spine as in claim 25, wherein the lumen extends at least as far as the L4 vertebrae.

27. A method of treating the spine as in claim 26, wherein the lumen is linear.

28. A method of treating the spine as in claim 23, wherein the forming step comprises drilling.

29. A method of treating the spine as in claim 25, wherein the procedure comprises removing at least a part of a disc.

30. A method of treating the spine as in claim 25, wherein the procedure comprises removing an entire nucleus.

31. A method of treating the spine as in claim 25, wherein the procedure further comprises inserting a fusion device.

32. A method of treating the spine as in claim 25, wherein the procedure comprises introducing a bone growth material.

12. A method of treating the spine, 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 across a treatment zone;

expressing a bone growth material from the device within the treatment zone; and

deploying at least a portion of the device within the treatment zone.

19. A spinal augmentation catheter, comprising:

an elongate, tubular body, having a proximal end and a distal end;

a first lumen extending through the body;

a second lumen extending through the body;

a first port on the body, in communication with the first lumen; and

a second port on the body, in communication with the second lumen;

wherein the first and second ports are spaced axially apart along the body such that the first port may be positioned within a first vertebral body while the second port is positioned within a first disc space for infusion of a first media into the first vertebral body and a second media into the first disc space.

23. 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 disc and axially into at least one vertebrae;

directly observing the interior of the spine by introducing an endoscope into the lumen; and

performing a procedure using the lumen.

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

identifying a site on the surface of the sacrum;

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

positioning a tubular fusion device within the lumen.

34. A method of treating the spine as in claim 33, wherein the fusion device has an external thread.

35. A method of treating the spine as in claim 33, wherein the fusion device comprises a side wall with a plurality of apertures therethrough.

36. A method of treating the spine as in claim 35, wherein the lumen extends at least as far as the L4 vertebrae.

37. A method of treating the spine as in claim 36, wherein the lumen is linear.

38. A method of treating the spine as in claim 33, wherein the forming step comprises drilling.

39. A method of treating the spine as in claim 35, wherein the procedure additionally comprises the step of removing at least a part of a disc.

40. A method of treating the spine as in claim 35, wherein the procedure additionally comprises the step of removing an entire nucleus.

41. A method of treating the spine as in claim 35, wherein the procedure additionally comprises the step of introducing a bone growth material into the lumen.

42. 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 disc and into at least one vertebrae; and

introducing a fusion implant through the lumen, the implant comprising at least one radially outwardly extending bone engagement structure.

43. A method of fusing the spine as in claim 42, wherein the bone engagement structure comprises a helical thread.

44. A method of fusing the spine as in claim 42, wherein the introducing step further comprises introducing a bone growth material.