Apparatus and method for injecting fluent material at a distracted tissue site

• US 7,789,912 B2
• Filed: 01/07/2005
• Issued: 09/07/2010
• Est. Priority Date: 01/08/2004
• Status: Active Grant

• Current Assignee: Spine Wave Incorporated
• Original Assignee: Spine Wave Incorporated
• Inventors: Manzi, Richard, LoGuidice, Mark D., Wysocki, Steve, Lipschultz, Tyler, Barreiro, Peter, Wilson, Thomas
• Primary Examiner(s): Robert; Eduardo C
• Assistant Examiner(s): Carter; Tara R
• Application Number:
  US11/031,562
• Publication Number:
  US 20050182414A1
• Time in Patent Office: 2,069 Days
• Field of Search: 606/90, 606 92- 94, 606/105, 606/86.R, 606300-321, 128/877, 623/16.11, 623 1711- 1716, 623/22.39, 623/23.37
• US Class Current: 623/17.11
• CPC Class Codes: A61B 17/70 Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
• 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 17/8852 capable of being assembled or enlarged, or changing shape, inside the bone or disc

Abstract

A system and method is provided for distracting opposite surfaces from the interior of a bone, such as a vertebral body. A working channel cannula provides a working channel through which an inserter and an injection cannula can simultaneously pass. The inserter transports a plurality of wafers into the interior of the bone to form a load-bearing stack bearing against the opposite surfaces. The injection cannula is used to inject a fluent material into and/or around the stack. In certain embodiments, the fluent material is a load-bearing or hardenable material, such as bone cement. In other embodiments, the fluent material can be a BMP, HAP, or other osteo-inductive, osteo-conductive, or pharmaceutical compositions. A syringe containing the fluent material is engaged to the injection cannula and is operable to inject the fluent material into the vertebral body under controlled pressure.

Claims

1. A method for distracting surfaces of a bone comprising the steps of:

providing access to the interior of the bone through a working channel cannula;

introducing through said working channel cannula an elongate distraction component, having a length between a distal end and a proximal end, into the interior of the bone between opposite surfaces of the bone to maintain the surfaces in a distracted position, the component positioned within the interior of the bone with the distal end disposed distal from said proximal end;

introducing through said working channel cannula an elongate injection cannula having at least one opening directly into the cancellous portion of the bone and moving said injection cannula alongside the length of and exterior to the distraction component such that said at least one opening moves distally beyond the proximal end of said component; and

injecting a fluent material through the injection cannula directly into the interior of the bone adjacent the distraction component.

2. The method of claim 1, wherein the injecting step includes injecting the fluent material under pressure.

3. The method of claim 2, wherein the injecting step includes injecting the fluent material at a pressure less than a pressure at which extravasion occurs from the bone.

4. The method of claim 1, wherein the fluent material is a hardenable material.

5. The method of claim 4, wherein the hardenable material is a bone cement.

6. The method of claim 1, wherein the fluent material is a non-structural fluid.

7. The method of claim 1, wherein the fluent material is selected from the group containing hydroxyapatite, bone morphogenic protein, osteo-inductive compositions, osteo-conductive compositions and pharmaceutical compositions.

8. The method of claim 1, wherein:

said working channel cannula has a central axis and a transverse extent;

said injection cannula has an outer dimension less than said transverse extent; and

the step of introducing the injection cannula includes placing the longitudinal axis of said injection cannula in an offset relationship relative to the central axis of said working channel cannula.

9. The method of claim 8, wherein:

the step of introducing the distraction component is accomplished with an inserter configured to extend through the working channel cannula; and

the inserter is removed prior to the step of introducing the injection cannula.

10. The method of claim 1, wherein:

the injection cannula includes a plurality of openings; and

the injecting step includes positioning the injection cannula so that the plurality of openings are oriented so that fluent material is injected therethrough directly adjacent the distraction component.

11. The method of claim 1, wherein:

the injection cannula includes a single opening at the distal tip of the cannula, the opening being angled; and

the injecting step includes positioning the injection cannula so that the angled opening is oriented so that fluent material is injected therethrough directly adjacent the distraction component.

12. The method of claim 1, wherein the injecting step includes:

engaging a syringe containing the fluent material to the injection cannula; and

depressing the plunger of the syringe to inject the fluent material through the injection cannula.

13. The method of claim 1, wherein said opening is at the distal tip of said cannula such the fluent material flows longitudinally from said cannula.

14. The method of claim 13, further including an opening disposed radially though said cannula such that fluent material flows radially from said cannula.

15. The method of claim 1, wherein said opening is disposed radially through said cannula such that fluent material flows radially from said cannula.

16. The method of claim 15, wherein there are a plurality of such radially disposed openings spaced along said cannula, said openings being arranged in a common orientation facing upwardly relative to said distraction component.

17. The method of claim 1, wherein the step of introducing an injection cannula includes moving the cannula such that said opening is positioned closer to the distal end of said distraction component than to the proximal end.

18. The method of claim 1, wherein the step of introducing an injection cannula includes introducing the cannula directly into and in contact with the cancellous portion of the bone.

19. A method for restoring the height of a vertebral body comprising the steps of:

engaging a working channel cannula to the vertebral body to access the interior of the vertebral body;

introducing a distraction component having a distal end, a proximal end and opposing sides therebetween into the interior through the working channel cannula to restore the height of the vertebral body;

providing an injection cannula having at least one opening and including an orientation marker aligned with said at least one opening;

introducing said injection cannula through the working channel and directly into the cancellous bone portion of the vertebral body at a selected orientation determined in part by the orientation of said marker and placing said at least one opening adjacent and exterior to one of sides of the distraction component between said distal end and said proximal end; and

injecting a fluent material into said injection cannula and through said at least one opening adjacent the distraction component.

20. The method of claim 19, wherein:

the step of introducing a distraction component is accomplished with an inserter configured to extend through the working channel cannula; and

the inserter is removed prior to the step of injecting the fluent material.

21. The method of claim 19, wherein:

the distraction component includes a plurality of stacked wafers; and

the step of introducing the distraction component includes extending a wafer introducer into the working channel cannula and operating the wafer introducer to introduce the plurality of stacked wafers into the interior space.

22. The method of claim 19, wherein the injecting step includes injecting the fluent material under pressure.

23. The method of claim 22, wherein the injecting step includes injecting the fluent material at a pressure less than a pressure at which extravasion occurs from the bone.

24. The method of claim 19, wherein the fluent material is a hardenable material.

25. The method of claim 24, wherein the hardenable material is a bone cement.

26. The method of claim 19, wherein the fluent material is a non-structural fluid.

27. The method of claim 19, wherein the fluent material is selected from the group containing bone morphogenic protein, osteo-inductive compositions, osteo-conductive compositions and pharmaceutical compositions.

28. The method of claim 19, wherein:

the injection cannula includes a plurality of openings; and

the injecting step includes positioning the injection cannula so that the plurality of openings are oriented so that fluent material is injected therethrough directly adjacent the distraction component.

29. The method of claim 19, wherein:

the injection cannula includes a single opening at the distal tip of the cannula, the opening being angled; and

the injecting step includes positioning the injection cannula so that the angled opening is oriented so that fluent material is injected therethrough directly adjacent the distraction component.

30. The method of claim 19, wherein the injecting step includes:

engaging a syringe containing the fluent material to the injection cannula; and

depressing the plunger of the syringe to inject the fluent material through the injection cannula.

31. A method for restoring the height of a vertebral body comprising the steps of:

engaging a working channel cannula to the vertebral body to access the interior of the vertebral body;

introducing a distraction component having a distal end, a proximal end and opposing sides therebetween into the interior of the vertebral body through the working channel cannula to restore the height of the vertebral body, said distal end of said distraction component generally facing an anterior direction of the spine;

providing a system, including an injection cannula, capable of selectively injecting fluent material along both sides of said distraction component;

introducing said injection cannula having at least one opening through the working channel directly into the cancellous bone portion of the vertebral body along one selected side of said distraction component and placing said at least one opening adjacent to said one side of the distraction component between said distal end and said proximal end; and

injecting a fluent material into said injection cannula and through said at least one opening adjacent the distraction component.

32. The method of claim 31, wherein said injection cannula is of dimension to allow transverse manipulation of said injection cannula within said working channel to position said injection cannula to either side of said distraction component.