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

• US 20050182414A1
• Filed: 01/07/2005
• Published: 08/18/2005
• Est. Priority Date: 01/08/2004
• Status: Active Grant

• Current Assignee: Spine Wave Incorporated
• Original Assignee: Spine Wave Incorporated
• Inventors: LoGuidice, Mark D., Manzi, Richard, Wysocki, Steve, Lipschultz, Tyler, Barreiro, Peter, Wilson, Thomas
• Granted Patent: US 7,789,912 B2
• Time in Patent Office: Days
• US Class Current: 606/86.R
• 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:

introducing a solid distraction component within the interior of the bone between opposite surfaces of the bone to maintain the surfaces in a distracted position;

introducing an injection cannula directly into the cancellous portion of the bone adjacent the distraction 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, further comprising:

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

wherein the steps of introducing the distraction component and the injection cannula occur through the same working channel cannula.

9. The method of claim 8, wherein:

the step of introducing a solid 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. 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 into the interior through the working channel cannula to restore the height of the vertebral body; and

injecting a fluent material through the same working channel adjacent the distraction component.

14. The method of claim 13, 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.

15. The method for restoring the height of a vertebral body of claim 13;

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.

16. The method for restoring the height of a vertebral body of claim 15, wherein the step of injecting a fluent material includes extending an injection cannula into the working channel cannula and directly adjacent the distraction component.

17. The method of claim 13, wherein the injecting step includes injecting the fluent material under pressure.

18. The method of claim 17, wherein the injecting step includes injecting the fluent material at a pressure less than a pressure at which extravasion occurs from the bone.

19. The method of claim 13, wherein the fluent material is a hardenable material.

20. The method of claim 19, wherein the hardenable material is a bone cement.

21. The method of claim 13, wherein the fluent material is a non-structural fluid.

22. The method of claim 13, wherein the fluent material is selected from the group containing bone morphogenic protein, osteo-inductive compositions, osteo-conductive compositions and pharmaceutical compositions.

23. The method of claim 13, 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.

24. The method of claim 13, 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.

25. The method of claim 13, 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.

26. A system for restoring the height of a vertebral body, comprising:

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

an inserter for inserting a distraction component through said working channel into the interior of the vertebral body; and

an injection cannula configured to extend through said working channel cannula into the interior of the vertebral body, said injection cannula having a proximal end configured to connect to a source of a fluent material and a distal end defining at least one opening for discharge of the fluent material.

27. The system of claim 26, wherein said injection cannula includes an orientation marker at a proximal portion thereof, said marker aligned with said at least one opening to provide a visual indication of the orientation of the opening within the interior of the vertebral body.

28. The system of claim 26, wherein said injection cannula includes a plurality of openings at said distal end.

29. The system of claim 28, in which the distraction component has a length along its insertion direction, wherein said plurality of openings span a distance along a distal portion of said injection cannula that is substantially equal to the length of the distraction component.

30. The system of claim 26, further comprising a syringe operating as the source of the fluent material.

31. The system of claim 26, wherein said injection cannula includes only one opening at the distal tip thereof, said opening being angled relative to the longitudinal axis of the cannula.

32. The system of claim 26, wherein:

said working channel cannula includes a channel having a channel width;

said inserter has an inserter width less than said channel width; and

the distraction component having a length along its insertion direction and a transverse dimension transverse to said length, said transverse dimension being less than said inserter width.

33. The system of claim 32, wherein said injection cannula is configured to extend into the interior of the vertebral body adjacent to and generally parallel to said length of the distraction component when said injection cannula extends through said working channel cannula.