Granted Patent B2

US 7,896,879 · App. 11/193,581 · Granted Mar 1, 2011

Abstract

Claims (45)

1. A method for treating stenosis in a spine, the spine including a thecal sac, a canal, an epidural space between the thecal sac and the canal, and a ligamentum flavum, the stenosis determining a region of interest in the spine, comprising the steps of:

a) compressing the thecal sac in the region of interest by injecting a fluid into the epidural space to form a modified epidural space and a safety zone and establish a working zone, the safety zone lying generally within the modified epidural space, and the working zone lying generally outside the modified epidural space and generally posterior to the thecal sac, wherein the working zone is outside the safety zone;

b) inserting a tool into tissue in the working zone without breaching an anterior surface of the ligamentum flavum;

c) using the tool to percutaneously reduce the stenosis by excising a portion of tissue in the working zone; and

d) utilizing imaging to visualize the position of the tool during at least a part of step c).

2. The method of claim 1 wherein the tool comprises:

a cannula comprising a tissue-penetrating member having a distal end defining an aperture on one side thereof;

an occluding member slidably received on or in said cannula and closing said aperture when said occluding member is adjacent said cannula distal end;

means for engaging adjacent tissue via said aperture; and

cutting means for resecting a section of said engaged tissue.

3. The method of claim 2 wherein the tool further includes means for retrieving said resected tissue from said distal tool end and a tissue-removal system for removing tissue from said retrieving means.

4. The method of claim 1 wherein step c) comprises

c1) engaging a tissue sample in the working zone;

c2) excising the tissue sample;

c3) removing the tissue sample from the working zone; and

c4) repeating steps c1) through c3) until a desired amount of tissue has been removed.

5. The method of claim 4 wherein the tissue sample comprises tissue selected from the group consisting of the ligamentum flavum, fat, and bone.

6. The method of claim 4 wherein step c) is carried out without repositioning the device in the tissue.

7. The method of claim 4 wherein step c) comprises

ci) providing an anchor having first and second tissue-engaging ends;

cii) engaging the ligamentum flavum with said first tissue-engaging end;

ciii) using said engaged first end to pull at least a portion of the ligamentum flavum into a desired position; and

civ) using said second tissue-engaging end to anchor said anchor such that said

ligamentum flavum is retained in a desired position.

8. The method of claim 7 wherein step civ) comprises anchoring said anchor to paraspinous tissue.

9. The method of claim 7 wherein step civ) comprises anchoring said anchor to bone.

10. The method of claim 1 wherein the injected fluid includes a contrast medium.

11. The method of claim 10 wherein the injected fluid has a temperature-dependent viscosity and is more viscous at 37° C. than at 30° C.

12. The method of claim 1 wherein the tool includes an outer cannulated scalpel, a tissue engaging means received in said scalpel, and a cutting element.

13. The method of claim 12 wherein the tool further includes means for removing tissue from the tissue-engaging means.

14. The method of claim 12 wherein the tissue-engaging means comprises a resilient hook.

15. A method for treating stenosis in a spine, the spine including a thecal sac and an epidural space, the stenosis determining a region of interest in the spine, comprising the steps of:

a) compressing the thecal sac in the region of interest by injecting a fluid into the epidural space to form a modified epidural space and a safety zone and establish a working zone, the safety zone lying generally within the modified epidural space, and the working zone lying generally outside the modified epidural space, wherein the working zone is outside the safety zone;

b) inserting a tool into tissue in the working zone;

c) using the tool to percutaneously reduce the stenosis by excising a portion of tissue in the working zone, while maintaining an anterior surface of a ligamentum flavum; and

d) utilizing imaging to visualize the position of the tool during at least a part of step c).

16. The method of claim 15 wherein an anterior surface of a lamina is maintained during step c).

17. The method of claim 16 wherein the working zone lies generally posterior to the thecal sac.

18. A method for treating stenosis in a spine, the spine including a thecal sac and an epidural space, the stenosis determining a region of interest in the spine, comprising the steps of:

a) compressing the thecal sac in the region of interest by injecting a fluid into the epidural space to form a modified epidural space and a safety zone and establish a working zone, the safety zone lying generally within the modified epidural space, and the working zone lying generally outside the modified epidural space, wherein the working zone is outside the safety zone;

b) inserting a tool into tissue in the working zone;

c) using the tool to percutaneously reduce the stenosis by excising a portion of tissue in the working zone; and

d) utilizing fluoroscopic imaging to visualize the position of the tool during at least a part of step c).

19. The method of claim 18 further comprising utilizing fluoroscopic imaging to visualize the position of the tool throughout all steps of the method of claim 18 .

20. The method of claim 18 further comprising utilizing a radio-opaque die outside of the tool.

Assignments (11)