DEVICES AND METHODS FOR STABILIZING A SPINAL REGION

• US 20100114098A1
• Filed: 07/13/2007
• Published: 05/06/2010
• Est. Priority Date: 07/13/2006
• Status: Active Grant

• Current Assignee: K2M, Inc (Stryker Corporation)
• Original Assignee: Highgate Orthopedics, Inc.
• Inventors: Carl, Allen
• Granted Patent: US 8,579,903 B2
• Time in Patent Office: Days
• US Class Current: 606/80
• CPC Class Codes: A61B 17/1642 for producing a curved bore
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/3472 for bones, e.g. intraosseus injections
• CPC Class Codes: A61B 17/70 Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
• CPC Class Codes: A61B 17/8605 Heads, i.e. proximal ends projecting from bone
• CPC Class Codes: A61B 17/863 with thread interrupted or changing its form along shank, other than constant taper
• CPC Class Codes: A61B 2017/00331 with preformed bends
• CPC Class Codes: A61B 2017/00867 shape memory effect

Abstract

Disclosed are apparatuses and methods for delivering implants through a posterior aspect of a vertebral body such as a pedicle and placing the implant or performing a procedure into the anterior aspect of the vertebral body. A representative apparatus includes an outer cannula, and advancer tube and a drill assembly. It is envisioned that at least one of the outer cannula, the advancer tube or the drill assembly can be viewed in vivo using for example, a CT scan or fluoroscope. The present invention is also directed to an apparatus for forming an arcuate channel in bone material. The apparatus includes and advancer tube and a drill assembly.

Claims

1. An apparatus for forming an arcuate channel in one or more segments of a bone, bony structure or vertebrae of a spine, the apparatus comprising:

a) an outer cannula having a proximal end and a distal end and a passageway extending therebetween;

b) an advancer tube adapted and configured for being slidably received with the passageway of the outer cannula and having a central bore extending longitudinally from its proximal end to its distal end, the advancer tube being configured to have at least one preformed arcuate segment when in an unconstrained configuration, the advancer tube able to be constrained to a second configuration when inserted into the passageway of the outer cannula, and wherein the advancer tube returns to its unrestrained configuration when at least a portion of the tube is outside the passageway of the outer cannula; and

c) a drill assembly which includes a drill bit and a drive cable, the drill bit being attached to the drive cable and operatively positioned proximate to the distal end of the advancer tube, the drive cable extending from the drill bit axially through the central bore of the advancer tube, wherein the drill bit and drive cable are rotationally movable with respect to the advancer tube and when the advancer tube is moved distally with respect to the outer cannula and at least a portion of the preformed arcuate segment of the advancer tube is in the unconstrained configuration, the drill bit moves distally and traverses an arcuate path.

2. An apparatus as recited in claim 1, wherein the outer cannula is rigid and made from surgical steel.

3. An apparatus as recited in claim 1, wherein the advancer tube is made from a shape memory alloy.

4. An apparatus as recited in claim 3, wherein the advancer tube is made from a nickel-titanium alloy.

5. An apparatus as recited in claim 1, wherein the advancer tube is made from a metal alloy selected from the group consisting of Copper-Aluminum-Nickel, Copper-Aluminum-Zinc, Copper-Tin or Copper-Zinc.

6. An apparatus as recited in claim 1, wherein the advancer tube is made from a plastic material.

7. An apparatus as recited in claim 1, wherein the preformed arcuate segment of the advancer tube defines a bend of between about 10 and about 110 degrees.

8. An apparatus as recited in claim 7, wherein the preformed arcuate segment of the advancer tube defines a bend of between about 80 and about 100 degrees.

9. An apparatus as recited in claim 1, wherein at least one of the outer cannula, the advancer tube or the drill assembly can be viewed in vivo using a CT scan.

10. An apparatus as recited in claim 1, further comprising means associated with the proximal end of the advancer tube for determining the plane of the at least one arcuate segment.

11. An apparatus as recited in claim 1, wherein the constrained configuration of the advancer tube is substantially straight.

12. A apparatus for forming an arcuate channel in bone material, the apparatus comprising:

a) an advancer tube adapted and configured for being received within an access hole formed in a bone, bony structure or vertebrae of a spine, the advancer tube having a central bore extending longitudinally from its proximal end to its distal end, the advancer tube being configured to have at least one preformed arcuate segment when in an unconstrained configuration, the advancer tube able to be constrained to a second configuration when inserted into the passageway formed in a bone, bony structure or vertebrae of a spine, and wherein the advancer tube returns to its unrestrained configuration when at least a portion of the tube is positioned outside the passageway of formed in a bone, bony structure or vertebrae of a spine; and

c) a drill assembly which includes a drill bit and a drive cable, the drill bit being attached to the drive cable and operatively positioned proximate to the distal end of the advancer tube, the drive cable extending from the drill bit axially through the central bore of the advancer tube, wherein the drill bit and drive cable are rotationally movable with respect to the advancer tube and when the advancer tube is moved distally with respect to the passageway formed in a bone, bony structure or vertebrae of a spine and at least a portion of the preformed arcuate segment of the advancer tube is in the unconstrained configuration, the drill bit moves distally and traverses an arcuate path.

13. A method for treating the spinal region of a patient after open surgery is performed to expose a portion of the patient'"'"'s spine, comprising the steps of:

a) drilling an access hole into the patient'"'"'s vertebrae which extends from a pedicle into the marrow of a vertebral body to a first depth;

b) inserting a cannula into the access hole, the outer cannula having a proximal end and a distal end and a passageway extending therebetween;

c) slidably inserting an advancer tube into the passageway of the outer cannula;

the advancer tube having a central bore extending longitudinally from its proximal end to its distal end and having at least one preformed arcuate segment when in an unconstrained configuration, the advancer tube able to be constrained to a second configuration when inserted into the passageway of the cannula, and wherein the advancer tube returns to its unrestrained configuration when at least a portion of the tube is outside the passageway of the cannula;

c) inserting a drill assembly into the central bore of the advancer tube, the drill assembly including a drill bit and a drive cable, the drill bit being attached to the drive cable and operatively positioned proximate to the distal end of the advancer tube, the drive cable extending from the drill bit axially through the central bore of the advancer tube, wherein the drill bit and drive cable are rotationally movable with respect to the advancer tube; and

d) sliding the advancer tube and drill bit distally with respect to the cannula to a second depth such that at least a portion of the tube is in the unconstrained configuration and the drill bit moves distally in arcuate path trough an endplate of the vertebral body into the intervertebral disc.

14. An apparatus for forming an arcuate channel in one or more segments of a bone, bony structure or vertebrae of a spine, the apparatus comprising:

a) an outer cannula having a proximal end and a distal end and a passageway extending therebetween;

b) an advancer tube adapted and configured for being slidably received with the passageway of the outer cannula and having a central bore extending longitudinally from its proximal end to its distal end, the advancer tube being configured to have at least one preformed arcuate segment when in an unconstrained configuration, the advancer tube able to be constrained to a second configuration when inserted into the passageway of the outer cannula, and wherein the advancer tube returns to its unrestrained configuration when at least a portion of the tube is outside the passageway of the outer cannula; and

c) a medical implement which is adapted and configured for being inserted into the central bore of the advancer tube such that when a least a portion of the preformed arcuate segment of the advancer tube is in the unconstrained configuration and projecting past the distal end of the outer cannula, a portion of the medical implement is guided in an arcuate path by the advancer tube.

15. A method of treating the spinal region of a patient comprising:

a) creating an first access hole through a pedicle of a vertebral body;

b) advancing an instrument through the hole and within the vertebral body to a location adjacent a vertebral endplate;

c) creating an second access hole through the vertebral endplate;

d) advancing the instrument through the second hole and within an intervertebral disc; and

e) performing a procedure.

16. The method in claim 15 wherein the adjacent endplate is a superior endplate or an inferior endplate.

17. The method in claim 15 wherein the access holes are created through drilling or boring.

18. The method in claim 15 wherein the access holes are created through punching or piercing.

19. The method in claim 15 wherein the access holes are created through chemical breakdown or dissolving of bone.

20. The method in claim 15 wherein the location adjacent a vertebral endplate is proximal to an anterior portion of the vertebral body.

21. The method in claim 15 wherein the location adjacent a vertebral endplate is proximal to a medial of the vertebral body.

22. The method in claim 15 wherein the second access hole is through cancelous bone.

23. The method in claim 15 wherein the second access hole is through cortical bone.

24. The method in claim 15 wherein the procedure comprises a fusion.

25. The method in claim 15 wherein the procedure comprises delivering harvested bone.

26. The method in claim 15 wherein the procedure comprises delivering an expansion device operable to increase the distance between adjacent endplates.

27. The method in claim 15 wherein the procedure comprises at least a partial discectomy.

28. The method in claim 15 wherein the procedure comprises preparing an implant delivery site.

29. The method in claim 15 wherein the procedure comprises engaging said adjacent vertebral body endplate;

advancing through said second access hole an expansion member;

expanding the expansion member through an intervertebral space; and

contacting and displacing a second vertebral endplate thereby increasing the intervertebral space.

30. The method in claim 15 wherein the access holes are created through the destruction of tissue through heating, ablating, cooling, or electrifying.

31. The method in claim 15 wherein the procedure comprises joint motion preservation.

32. The method in claim 15 wherein the procedure comprises disc repair.

33. The method in claim 15 wherein the procedure comprises disc replacement.

34. A method of treating the spinal region of a patient comprising:

a) accessing a posterior aspect of a vertebral body;

b) advancing an implant delivery device transversely through said body;

c) advancing said device vertically through an adjacent endplate of said vertebral body and into an intervertebral disc; and

d) delivering the implant.

35. The method in claim 34, further comprising the step of preparing the intervertebral disc and adjacent endplate to accept the delivery of said implant.

36. The method in claim 34, further comprising the step of advancing an implant delivery device transversely through a pedicle of a vertebral body.

37. The method in claim 34, wherein the implant is a fusion cage.

38. The method in claim 34, wherein the delivery device comprises a sleeve and a advanceable arcuate probe having boring mechanism at its distal end.

39. The method in claim 34, wherein the implant is at least a partial disc replacement.

40. An apparatus for forming an arcuate channel in one or more segments of a bone, bony structure or vertebrae of a spine, the apparatus comprising:

a) an outer cannula having a proximal end and a distal end and a passageway extending therebetween;

b) an advancer wire adapted and configured for being slidably received with the passageway of the outer cannula and configured to have at least one preformed arcuate segment when in an unconstrained configuration, the advancer wire able to be constrained to a second configuration when inserted into the passageway of the outer cannula, and wherein the advancer wire returns to its unrestrained configuration when at least a portion of the wire is outside the passageway of the outer cannula; and

c) a drill assembly which includes a drill bit and a tubular drive cable, the drill bit being attached to the drive cable and operatively positioned proximate to the distal end of the advancer wire, the drive cable extending from the drill bit axially over the advancer wire, wherein the drill bit and drive cable are rotationally movable with respect to the advancer wire;

wherein when the drill bit is moved distally and at least a portion of the preformed arcuate segment of the advancer wire is in the unconstrained configuration and exterior to the outer cannula, the drill bit follows the curved path defined by the unconstrained arcuate segment of the advancer wire.