Percutaneous vertebral fusion system

• US 6,821,277 B2
• Filed: 12/21/2000
• Issued: 11/23/2004
• Est. Priority Date: 06/23/2000
• Status: Active Grant

• Current Assignee: University of Southern California
• Original Assignee: University of Southern California
• Inventors: Teitelbaum, George P.
• Primary Examiner(s): Bennett, Henry
• Assistant Examiner(s): ODLAND, KATHRYN P
• Application Number:
  US09/747,066
• Publication Number:
  US 20020082598A1
• Time in Patent Office: 1,433 Days
• Field of Search: 606/61, 606/62, 606/63, 606/71, 606/73, 606/86, 606/60, 606/59
• US Class Current: 606/86.00A
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/1697 specially adapted for wire insertion
• CPC Class Codes: A61B 17/1757 for the spine
• CPC Class Codes: A61B 17/1796 for holes for sutures or flexible wires
• CPC Class Codes: A61B 17/60 for external osteosynthesis, e.g. distractors, contractors
• CPC Class Codes: A61B 17/7002 Longitudinal elements, e.g. rods
• CPC Class Codes: A61B 17/7008 with parts of, or attached to, the longitudinal elements, bearing against an outside of the screw or hook heads, e.g. nuts on threaded rods A61B17/7007 takes precedence
• CPC Class Codes: A61B 17/7083 Tools for guidance or insertion of tethers, rod-to-anchor connectors, rod-to-rod connectors, or longitudinal elements
• CPC Class Codes: A61B 17/864 hollow, e.g. with socket or cannulated
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61F 2/4611 of spinal prostheses

Abstract

A method of repositioning or fixing a first vertebrae or portion of a first vertebrae comprising fixing a bone screw in the first vertebrae and a bone screw in a second vertebrae, where each bone screw has a portal, and inflating an inflatable balloon between the portals, thereby creating a rigid structure between the bone screws.

Claims

1. A method of repositioning or fixing one or more unstable, separated or displaced vertebrae or one or more portions of one or more vertebrae in a patient'"'"'s vertebral column, the method comprising:

(a) identifying a patient who is a suitable candidate for undergoing the method;

(b) making a stab incision in the patient'"'"'s skin overlying the patient'"'"'s vertebral column at or near the level of the vertebrae or portion of vertebrae to be repositioned or fixed;

(c) creating a first tract from the incision to the posterior periosteal surface of the vertebrae;

(d) incising the periosteum and extending the first tract into the cortex of the vertebrae;

(e) inserting a first guidewire into the first tract;

(f) advancing a bone screw comprising a portal and a tip, and screwdriver over the first guidewire;

(g) applying torque to the bone screw using the screwdriver, thereby fixing part of the tip of the bone screw into the vertebrae while the portal of the bone screw is exterior and dorsal to the vertebrae and the portal is open parallel to the long axis of the vertebrae column;

(h) removing the screwdriver and the first guidewire;

(i) repeating (c) through (h) for at least one vertebrae which is neither unstable, separated or displaced and which is adjacent to the vertebrae or portion of the vertebrae that is being repositioned or fixed, or repeating (c) through (h) for the cranial-ward portion of the sacrum of the patient;

(j) inserting an inflatable connection rod comprising a proximal end, a distal end and an inflatable balloon between the proximal end and the distal end, between the portals of the bone screws; and

(k) inflating the inflatable balloon thereby creating a rigid structure between the inflated inflatable connection rod and the bone screws;

thereby repositioning or fixing the one or more unstable, separated or displaced vertebrae or the one or more portions of one or more vertebrae unilaterally.

2. The method of claim 1, where identifying a patient who is a suitable candidate comprises identifying a patient who has one or more unstable vertebrae, one or more portions of a vertebrae at least partly separated from the remainder of the vertebrae with potential or complete separation, or who has one or more vertebrae or a portion of one or more vertebrae displaced from its normal position relative to the vertebrae column, or who has one or more portions of a vertebrae at least partly separated from the remainder of the vertebrae and displaced from its normal position relative to the vertebrae column;

and

where the patient has either pain, loss of function or real or potential instability which is likely due to the separation or displacement, or separation and displacement.

3. The method of claim 1, further comprising enlarging the first tract from the incision to the posterior periosteal surface using a high-pressure fascial dilator balloon after creating the first tract.

4. The method of claim 1, where inserting an inflatable connection rod comprises:

(i) percutaneously inserting a hollow needle and advancing the hollow needle to the portal of one of the bone screws;

(ii) introducing a second guidewire through the lumen of the hollow needle and into the portal of one of the bone screws; and

(iii) passing the second guidewire through all of the portals in the bone screws, thereby creating a second tract.

5. The method of claim 4, further comprising:

(i) dilating the second tract created by the second guidewire using a high pressure balloon;

(ii) passing an introducer sheath over the guidewire along the entire guidewire second tract;

(iii) removing the guidewire; and

(iv) advancing the inflatable connection rod through the introducer sheath until the inflatable connection rod advances between the bone screw portals.

6. The method of claim 4, further comprising using a guidewire directing device to direct the advancing second guidewire through at least one bone screw portal.

7. The method of claim 4, further comprising using a guidewire capture device to pull the second guidewire through the patient'"'"'s skin.

8. The method of claim 1, where inflating the inflatable balloon comprises inflating the balloon with a rapid setting, liquid polymer.

9. The method of claim 8, where the liquid polymer is light activated polymer.

10. The method of claim 8, further comprising repeating (c) through (h) for one additional vertebrae, where the one additional vertebrae is either unstable, separated or displaced, or where one ore more portions of the one additional vertebrae is unstable, separated or displaced.

11. The method of claim 1, further comprising repeating (b) through (k) on the opposite side of the spinous processes of the patient'"'"'s vertebrae column, thereby repositioning or fixing the one or more unstable, separated or displaced vertebrae or the one or more portions of one or more vertebrae bilaterally.

12. The method of claim 1, further comprising using a directing sheath to position the bone screws.

13. The method of claim 1, where the bone screw comprises a central lumen and where the method further comprises injecting bone matrix material into the central lumen.

14. A method of repositioning or fixing a first vertebrae that is unstable, separated or displaced or that has one or more unstable, separated or displaced portions, the method comprising:

(a) fixing one or more than one bone screw in the first vertebrae and one or more than one bone screw in a second vertebrae;

(b) inserting an inflatable balloon between the portal of the bone screw in the first vertebrae and the portal of the bone screw in the second vertebrae; and

(c) inflating the inflatable balloon thereby creating a rigid structure between the balloon and the bone screws;

thereby repositioning or fixing the first vertebrae or portion of the first vertebrae.

15. The method of claim 14, further comprising advancing each bone screw over a guidewire before (a).

16. The method of claim 14, where (a) comprises applying torque to each bone screw using a screwdriver advanced over a guidewire.

17. The method of claim 14, where (c) comprises inflating the balloon with a rapid setting, liquid polymer.

18. The method of claim 14, further comprising repeating (a) through (c) on the opposite side of the spinous processes of the patient'"'"'s vertebrae column, thereby bilaterally repositioning or fixing the one or more unstable, separated or displaced vertebrae or the one or more portions of one or more vertebrae.

19. The method of claim 14, further comprising using a directing sheath to position the bone screws before (a).

20. A method of repositioning or fixing a first vertebrae that is unstable, separated or displaced or that has one or more unstable, separated or displaced portions, the method comprising:

fixing a first bone screw having a portal in the first vertebrae;

fixing a second bone screw having a portal in a second vertebrae; and

inserting a guidewire through a tissue tract and through the portal of the first bone screw in the first vertebrae and through the portal of the second bone screw in the second vertebrae.

21. The method of claim 20, further comprising advancing each bone screw over a guidewire before the bone screw is fixed in a vertebrae.

22. The method of claim 20, wherein fixing each bone screw comprises applying torque to each bone screw using a driver advanced over a guidewire.

23. The method of claim 20, further comprising inserting an inflatable balloon between the portal of the first bone screw in the first vertebrae and the portal of the second bone screw in the second vertebrae.

24. The method of claim 23, further comprising inflating the inflatable balloon.

27. The method of claim 23, additionally comprising inflating the inflatable balloon by introducing a curable media into the inflatable balloon.

28. The method of claim 23, additional comprising inflating the inflatable balloon by introducing a rapid setting, liquid polymer into the inflatable balloon.

29. The method of claim 20, wherein the first and second vertebrae are adjacent each other.

30. The method of claim 20, wherein the method is accomplished percutaneously.

31. The methods of claim 20, additionally comprising the step of advancing an implant through the portal in the first bone screw and the portal in the second bone screw.

25. A method of repositioning or fixing one or more unstable, separated or displaced vertebrae or one or more portions of one or more vertebrae in a patient'"'"'s vertebral column, the method comprising:

identifying a patient who is a suitable candidate for undergoing the method;

making a stab incision in the patient'"'"'s skin overlying the patient'"'"'s vertebral column at or near the level of the vertebrae or portion of vertebrae to be repositioned or fixed;

creating a first tract from the incision to the posterior periosteal surface of the vertebrae;

incising the periosteum and extending the first tract into the cortex of the vertebrae;

inserting a first guidewire into the first tract;

advancing a bone screw comprising a portal and a tip, and a driver over the first guidewire;

applying torque to the bone screw using the driver, thereby fixing part of the tip of the bone screw into the vertebrae while the portal of the bone screw is exterior and dorsal to the vertebrae and the portal is open parallel to the long axis of the vertebrae column;

removing the driver and the first guidewire;

repeating (c) through (h) for at least one vertebrae which is neither unstable, separated or displaced and which is adjacent to the vertebrae or portion of the vertebrae that is being repositioned or fixed, or repeating (c) through (h) for the cranial-ward portion of the sacrum of the patient; and

inserting a guidewire between the portals of the bone screws.

26. A method of repositioning or fixing a first vertebrae that is unstable, separated or displaced or that has one or more unstable, separated or displaced portions, the method comprising:

fixing a first bone screw having a portal in the first vertebrae;

fixing a second bone screw having a portal in a second vertebrae;

inserting an inflatable balloon through the portal of the first bone screw in the first vertebrae and through the portal of the second bone screw in the second vertebrae; and

inflating the balloon.

32. The method of claim 26, wherein inflating the inflatable balloon comprises introducing a curable media into the inflatable balloon.

33. The method of claim 26, wherein inflating the inflatable balloon comprises introducing a rapid setting, liquid polymer into the inflatable balloon.

34. The method of claim 26, wherein the first and second vertebrae are adjacent each other.

35. The method of claim 26, wherein the method is accomplished percutaneously.