DELIVERY DEVICES, SYSTEMS AND METHODS FOR STIMULATING NERVE TISSUE ON MULTIPLE SPINAL LEVELS

• US 20080140169A1
• Filed: 12/06/2007
• Published: 06/12/2008
• Est. Priority Date: 12/06/2006
• Status: Active Grant

• Current Assignee: TC1 LLC (Abbott Laboratories Incorporated)
• Original Assignee: Spinal Modulation, Inc. (Abbott Laboratories Incorporated)
• Inventors: IMRAN, Mir A.
• Granted Patent: US 8,983,624 B2
• Time in Patent Office: Days
• US Class Current: 607/117
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/36062 Spinal stimulation
• CPC Class Codes: A61N 1/36071 Pain

Abstract

Devices, systems and methods are provided for simultaneously stimulating the spinal anatomy at various locations, such as spinal levels, along the spinal cord. By stimulating multiple levels of the spinal column with the use of a single device, a single access path is created to an implantable pulse generator (IPG) rather than individual access paths for each lead at each spinal level to an IPG. By reducing the number of pathways, the procedure complexity, time and recovery are reduced. In addition, some embodiments provide additional specificity within each targeted level, such as selective stimulation of specific tissue, such as the dorsal root ganglion.

Claims

1. A delivery device for delivering elements to nerve tissue on different spinal levels, the device comprising:

an elongate structure shaped for positioning within an epidural space, wherein the elongate structure has a first opening alignable with a first spinal level and a second opening concurrently alignable with a second spinal level, and

wherein the elongate structure includes at least one lumen configured to allow passage of at least one element through the first opening toward nerve tissue on the first spinal level and passage of at least one element through the second opening toward nerve tissue on the second spinal level.

2. A delivery device as in claim 1, wherein the elongate structure comprises a first portion having the first opening and a second portion having the second opening, wherein the first and second portions move relative to each other so as to adjust a distance between the openings.

3. A delivery device as in claim 2, wherein the first and second spinal levels are not adjacent to each other.

4. A delivery device as in claim 1, wherein the openings face lateral to a midline of the epidural space.

5. A delivery device as in claim 1, wherein the first opening faces a direction on the first spinal level and another opening faces in a substantially opposite direction on the first spinal level.

6. A delivery device as in claim 1, wherein a distance between the openings is fixed.

7. A delivery device as in claim 1, wherein the openings face longitudinal to a midline of the epidural space.

8. A delivery device as in claim 1, wherein the at least one lumen comprises an individual lumen extending to the first opening and an individual lumen extending to the second opening.

9. A delivery device as in claim 1, wherein the first opening is shaped to allow longitudinal translation of the at least one element within the first opening.

10. A delivery device as in claim 9, wherein the first opening has an oblong shape.

11. A delivery device as in claim 1, further comprising a mechanism to fix the at least one element in relation to the elongate structure.

12. A system for treating nerve tissue on different spinal levels, the system comprising:

an elongate structure shaped for positioning within an epidural space, wherein the elongate structure has a first opening alignable with a first spinal level and a second opening concurrently alignable with a second spinal level;

a first element extendable through the first opening and positionable so as to treat nerve tissue on the first spinal level; and

a second element extendable through the second opening and positionable so as to treat nerve tissue on the second spinal level.

13. A system as in claim 12, wherein the first element comprises a lead having at least one electrode.

14. A system as in claim 13, wherein the first element is positionable so as to selectively stimulate a dorsal root ganglion on the first spinal level.

15. A system as in claim 12, wherein the first element comprises an agent delivery device.

16. A system as in claim 12, wherein at least a portion of the first element is steerable.

17. A system as in claim 12, wherein the first element extends through a lumen in the elongate structure and wherein the first element is rotatable within the lumen.

18. A system as in claim 12, wherein the first element is longitudinally translatable within the first opening.

19. A system as in claim 12, wherein the elongate structure comprises a first portion having the first opening and a second portion having the second opening, wherein the first and second portions move relative to each other so as to adjust a distance between the openings.

20. A system as in claim 12, wherein the first and second spinal levels are not adjacent to each other.

21. A system as in claim 12, wherein the elongate structure includes a third opening concurrently alignable with the first spinal level and a third element extendable through the third opening and positionable so as to treat nerve tissue on the first spinal level.

22. A system as in claim 21, wherein the first element and third element comprise leads each having at least one electrode and wherein the first element is positionable so as to selectively stimulate dorsal root ganglion on the first spinal level and the third element is positionable so as to selectively stimulate a different dorsal root ganglion on the first spinal level.

23. A method for delivering elements to nerve tissue on different spinal levels comprising:

advancing an elongate structure into an epidural space, wherein the elongate structure has a first opening and a second opening; and

positioning the elongate structure so that the first opening substantially aligns with a first spinal level the second opening substantially aligns with a second spinal level.

24. The method of claim 23, further comprising extending a first element through the first opening toward a nerve tissue on the first spinal level.

25. The method of claim 24, wherein the first element comprises a lead having at least one electrode, the method further comprising stimulating the nerve tissue on the first spinal level.

26. The method of claim 25, wherein the nerve tissue comprises a dorsal root ganglion.

27. The method of claim 24, further comprising manipulating the first element to direct the distal end toward the nerve tissue on the first spinal level.

28. The method of claim 27, wherein manipulating comprises advancing, retracting, torqueing, curving or steering the first element.

29. The method of claim 24, wherein the first element comprises an agent delivery device, the method further comprising delivering an agent to the nerve tissue on the first spinal level with the use of the agent delivery device.

30. The method of claim 24, further comprising extending a second element through the second opening toward a nerve tissue on the second spinal level.

31. The method of claim 23, wherein the elongate structure comprises a first portion having the first opening and a second portion having the second opening, and wherein positioning comprises moving at least one of the portions in relation to the other.

32. The method of claim 23, wherein positioning comprises moving the openings in relation to each other.

33. The method of claim 23, wherein the first and second spinal levels are not adjacent to each other.

34. The method of claim 23, wherein the elongate structure has a third opening, and wherein positioning comprises aligning the third opening with the first spinal level.

35. The method of claim 34, further comprising

extending a first element through the first opening toward a nerve tissue on the first spinal level, and

extending a third element through the third opening toward a different nerve tissue on the first spinal level.

36. The method of claim 35, wherein the nerve tissue on the first spinal level comprises a dorsal root ganglion and the different nerve tissue on the first spinal level comprises a different dorsal root ganglion.

37. A system for treating nerve tissue on different spinal levels, the system comprising:

an elongate member shaped for positioning within an epidural space; and

a first lead having a lumen and at least one electrode, wherein the first lead is configured to track over the elongate member by passing the elongate member through the lumen so that the at least one electrode is positioned near a nerve tissue on a first spinal level.

38. The system of claim 37, wherein the elongate member comprises a rail, rod or guidewire.

39. The system of claim 37, further comprising a second lead having a lumen and at least one electrode, wherein the second lead is configured to track over the elongate member by passing the elongate member through its lumen so that its at least one electrode is positioned near a nerve tissue on a second spinal level.

40. The system of claim 39, wherein the first and second spinal levels are not adjacent to each other.

41. The system of claim 37, wherein the nerve tissue comprises a dorsal root ganglion.

42. The system of claim 37, further comprising an anchoring device configured to anchor the elongate member to a vertebrae.

43. A method of treating nerve tissue on different spinal levels, the method comprising:

advancing an elongate member into an epidural space;

tracking a first lead having at least one electrode over the elongate member; and

positioning the at least one electrode near a nerve tissue on a first spinal level.

44. A method as in claim 43, further comprising implanting the elongate member in the epidural space.

45. A method as in claim 44, wherein implanting comprises anchoring the elongate member to a vertebrae.

46. A method as in claim 44, further comprising tracking a second lead having at least one electrode over the elongate member.

47. A method as in claim 46, further comprising positioning the at least one electrode of the second lead near a nerve tissue on a second spinal level.