Method and system for fusing a spinal region

• US 6,805,697 B1
• Filed: 02/19/2002
• Issued: 10/19/2004
• Est. Priority Date: 05/07/1999
• Status: Expired due to Term

• Current Assignee: University of Virginia Patent Foundation (University of Virginia)
• Original Assignee: University of Virginia Patent Foundation (University of Virginia)
• Inventors: Helm, Gregory A., Hankins, Gerald R., Kallmes, David F., Jensen, Mary E.
• Primary Examiner(s): Shaver, Kevin
• Assistant Examiner(s): Priddy, Michael B.
• Application Number:
  US09/959,798
• Time in Patent Office: 973 Days
• Field of Search: 623/11.11, 623/17.11, 623/23.61, 623/23.62, 606/1, 606/76, 606/79, 606/80, 606/86, 606/90, 606/92, 606/96, 606/97, 606/99
• US Class Current: 606/92
• 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 2017/00261 Discectomy
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/0256 for the spine
• CPC Class Codes: A61B 2090/3945 Active visible markers, e.g. light emitting diodes
• CPC Class Codes: A61B 34/10 Computer-aided planning, simulation or modelling of surgical operations
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61F 2/44 for the spine, e.g. vertebrae, spinal discs
• 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 2/4601 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 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/30583 filled with hardenable fluid, e.g. curable in-situ
• CPC Class Codes: A61F 2002/30677 : Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• 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 2002/4632 : using computer-controlled surgery, e.g. robotic surgery
• CPC Class Codes: A61F 2002/4635 : using minimally invasive surgery
• CPC Class Codes: A61F 2002/4687 : Mechanical guides for implantation instruments
• CPC Class Codes: A61F 2210/0004 : bioabsorbable
• CPC Class Codes: A61F 2210/0085 : hardenable in situ, e.g. epoxy resins
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2310/00293 : containing a phosphorus-containing compound, e.g. apatite
• CPC Class Codes: A61F 2310/00353 : Bone cement, e.g. polymethylmethacrylate or PMMA
• CPC Class Codes: A61F 2310/00365 : Proteins; Polypeptides; Degradation products thereof

Abstract

A method and system for fusing a region in the spine involve the use of at least one guide tube (10a) to pass instruments and substances into the spinal region in a minimally invasive manner. In the preferred practice of the method, a guide tube is anchored to a vertebra and the guide tube is moved to thereby position the vertebra. A steerable drilling tool (20a) is passed through the guide tube and steered into position to abrade at least a portion of an intervertebral disc, thereby creating a cavity in the disc. A flowing substance is passed into the cavity and permitted to solidify to establish fusion in the cavity. Optionally, an uninflated balloon (40) is inserted into the cavity and the balloon is filled with the flowing substance to contain the flowing substance.

Claims

1. A system for use in a spinal procedure, the system comprising:

a steerable drilling tool having a rotatable bit configured to abrade at least one of vertebral material and disc material; and

at least one guide tube having a proximal end portion, a distal end portion, at least one lumen extending from the proximal end portion to the distal end portion, the lumen being configured to allow for passage of the steerable drilling tool therethrough.

2. The system of claim 1, wherein the distal end portion of the guide tube includes at least one thread configured to permit releasable anchoring of the guide tube in at least one vertebra.

3. The system of claim 1, wherein the guide tube further includes at least one tracking element configured to interact with a computer controlled surgical navigation system for determining the position of the guide tube with respect to a known reference.

4. The system of claim 1, wherein the steerable drilling tool includes a tubular member having at least one axially movable steering element, axial movement of the steering element varying position of a distal insertion end of the tubular member with respect to a remainder of the tubular member.

5. The system of claim 4, wherein the drilling tool further includes a flexible, rotatable drive member in the tubular member and a drill bit at a distal insertion end of the drive member, rotation of the drive member rotating the drill bit.

6. The system of claim 1, further comprising a tracking element on the drilling tool, the tracking element being configured to interact with a computer controlled surgical navigation system to determine the location of a drill bit relative to a known reference point.

7. The system of claim 1, further comprising a balloon implant configured to be filled with material to provide fusion in a cavity formed at least in an intervertebral disc.

8. The system of claim 7, wherein the balloon implant is made of a biodegradable substance.

9. The system of claim 8, wherein the biodegradable substance includes collagen.

10. The system of claim 7, wherein the balloon implant contains growth factors.

11. The system of claim 7, wherein the balloon implant contains genetically modified cells.

12. The system of claim 1, wherein the drilling tool further includes at least one lumen for coupling to a suction source.

13. A method of fusing a spinal region, the method comprising:

releasably anchoring a guide tube in at least one vertebra adjacent to a disc;

removing at least a nucleus of the disc to form a cavity extending in at least the disc;

moving the guide tube when the guide tube is anchored in the vertebra to thereby change position of the vertebra; and

flowing a flowable fusion substance into the cavity, the fusion substance being configured to solidify to provide fusion in the cavity.

14. The method of claim 13, wherein the movement of the guide tube includes at least one of distracting the vertebra away from the disc with a distraction tool and rotating the vertebra.

15. The method of claim 13, wherein the guide tube further includes at least one tracking element, and wherein the method further comprises determining the location of the guide tube relative to a known reference point with a computer controlled surgical navigation system configured to interact with the tracking element.

16. The method of claim 13, further comprising inserting an inflatable implant in the cavity, and wherein the flowing of the flowable fusion substance includes passing the fusion substance into the inflatable implant to inflate the implant in the cavity.

17. The method of claim 13, wherein the removing does not remove any circumferential segment of the annulus fibrosis of the disc.

18. The method of claim 13, wherein the removing includes removing material from the medullary area of the at least one vertebra.

19. The method of claim 18, wherein the disc is located between first and second vertebrae and the cavity extends between the first and second vertebrae, and the method further comprises releasably anchoring a second guide tube in the second vertebra, and wherein the moving includes moving at least one of the first and second guide tubes to thereby position the first and second vertebrae with respect to one another.

20. A method of fusing a spinal region, the method comprising:

contacting a guide tube against at least one vertebra;

inserting a steerable drilling tool through the guide tube;

steering the steerable drilling tool toward a disc;

abrading at least a portion of the end plates of the disc with the drilling tool;

removing at least the abraded end plates of the disc and a nucleus of the disc to form a cavity extending in at least the disc; and

flowing a flowable fusion substance into the cavity, the fusion substance being configured to solidify to provide fusion in the cavity.

21. The method of claim 20, further comprising releasably anchoring the guide tube in the at least one vertebra.

22. The method of claim 21, wherein an insertion end of the guide tube includes at least one thread, and wherein the anchoring includes threading the insertion end of the guide tube in the at least one vertebra.

23. The method of claim 21, further comprising moving the guide tube when the guide tube is anchored in the vertebra to thereby position the vertebra.

24. The method of claim 23, wherein the movement of the guide tube includes at least one of distracting the vertebra away from the disc with a distraction tool and rotating the vertebra.

25. The method of claim 20, wherein the guide tube further includes at least one tracking element, and wherein the method further comprises determining the location of the guide tube relative to a known reference point with a computer controlled surgical navigation system configured to interact with the tracking element.

26. The method of claim 20, wherein the steerable drilling tool includes a tubular member having at least one axially movable steering element, and wherein the steering comprises axially moving the steering element to vary position of a distal insertion end of the tubular member with respect to a remainder of the tubular member.

27. The method of claim 26, wherein the drilling tool further includes a flexible, rotatable drive member in the tubular member and a drill bit at a distal insertion end of the drive member, and wherein the abrading includes rotating the drive member to rotate the drill bit.

28. The method of claim 20, wherein the removing of the end plates and nucleus includes removing disc material with at least one of suction and irrigation.

29. The method of claim 20, further comprising inserting an inflatable implant in the cavity, and wherein the flowing of the flowable fusion substance includes passing the fusion substance into the inflatable implant to inflate the implant in the cavity.

30. The method of claim 20, wherein the flowable substance includes a solidifying agent comprising polymethacrylate.

31. The method of claim 20, wherein the flowable substance includes material for inducing bone growth.

32. The method of claim 31, wherein the bone growth inducing material is chosen from morphogenic protein, fibroplast growth factor, genetically modified cells, and stem cells.

33. The method of claim 20, wherein the method further comprises inserting a balloon into the cavity, inflating the balloon with a contrast agent, and viewing the balloon with imaging equipment to evaluate the cavity.

34. The method of claim 20, wherein the removing does not remove any circumferential segment of the annulus fibrosis of the disc.

35. The method of claim 20, wherein the abrading includes abrading material in the medullary area of the at least one vertebra.

36. The method of claim 35, wherein the disc is located between first and second vertebrae and the cavity extends between the first and second vertebrae, and wherein the method further comprises contacting a second guide tube against the second vertebra, and wherein the inserting includes inserting the drilling tool through at least one of the first and second guide tubes and wherein the removing includes removing at least one of vertebra material and disc material via at least one of the first and second tubes.

37. The method of claim 36, wherein the method further comprises releasably anchoring the first guide tube in the first vertebra, releasably anchoring the second guide tube in the second vertebra, and moving at least one of the first and second guide tubes to thereby position the first and second vertebrae with respect to one another.

38. The method of claim 37, wherein at least one of the first and second guide tubes includes a tracking element and wherein the method further comprises determining the location of said at least one guide tube relative to a known reference point with a computer controlled surgical navigation system configured to interact with the tracking element.

39. The method of claim 37, wherein at least one of the first and second guide tubes includes a tracking element and wherein the method further comprises determining the location of said at least one guide tube relative to a known reference point with a computer controlled surgical navigation system configured to interact with the tracking element.

40. The method of claim 20, wherein the method includes determining the location of a drill bit on the drilling tool by determining the location of the drill bit relative to a known reference point with a computer controlled surgical navigation system.