Delivery devices, systems and methods for stimulating nerve tissue on multiple spinal levels

• US 8,983,624 B2
• Filed: 12/06/2007
• Issued: 03/17/2015
• 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.
• Primary Examiner(s): Bertram, Eric D.
• Assistant Examiner(s): Bays, Pamela M
• Application Number:
  US11/952,053
• Publication Number:
  US 20080140169A1
• Time in Patent Office: 2,658 Days
• Field of Search: 607/2, 607/3, 607/45, 607/46, 607115-118
• 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:

a shaft shaped for positioning within an epidural space, wherein the shaft has a first portion having a first opening in the shaft and a second portion having a distal opening and a second opening in the shaft, wherein the first portion is able to move telescopically through the distal opening so as to move the first opening beyond and relative to the second portion so as to adjust the distance between the first and second openings so as to concurrently align the first opening with a first spinal level and the second opening with a second spinal level, and

wherein the shaft 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, wherein the at least one element comprises a lead or an agent delivery device.

2. A delivery device as in claim 1, wherein the first and second spinal levels are not adjacent to each other.

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

4. 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.

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

6. 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.

7. 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.

8. A delivery device as in claim 7, wherein the first opening has an oblong shape.

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

10. A device as in claim 1, wherein the nerve tissue on the first spinal level comprises a first dorsal root ganglion.

11. A device as in claim 1, wherein the nerve tissue on the second spinal level comprises a second dorsal root ganglion.

12. A device as in claim 1, wherein the nerve tissue on the first spinal level comprises a first dorsal root ganglion and the nerve tissue on the second spinal level comprises a second dorsal root ganglion.

13. A device as in claim 1, wherein the shaft includes a third opening concurrently alignable with the first spinal level.

14. A device as in claim 13, wherein the shaft allows passage of a third element through the third opening so as to treat other nerve tissue on the first spinal level.

15. A device as in claim 14, wherein the nerve tissue on the first spinal level comprises a dorsal root ganglion and the other nerve tissue on the first spinal level comprises another dorsal root ganglion on the first spinal level.

16. A device as in claim 1, wherein at least one of the portions is comprised of a flexible polymer.

17. A device as in claim 1, wherein at least one of the portions is supportable by a stylet during placement.

18. A device as in claim 1, wherein at least one of the portions has an oval or rectangular shape.

19. A device as in claim 1, wherein at least one of the portions has a circular or square shape.

20. A system as in claim 1, wherein the shaft includes a tissue anchor to anchor the shaft to surrounding tissue.

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

a shaft shaped for positioning within an epidural space, wherein the shaft has a first portion having a first opening in the shaft and a second portion having a distal opening and a second opening in the shaft, wherein the first portion is able to move telescopically through the distal opening so as to move the first opening beyond and relative to the second portion so as to adjust the distance between the first and second openings so as to concurrently align the first opening with a first spinal level and the second opening with a second spinal level, and

wherein the shaft 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, wherein the at least one element comprises a lead or an agent delivery device;

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.

22. A system as in claim 21, wherein the first element comprises a lead having at least one electrode.

23. A system as in claim 22, wherein the first element is positionable so as to selectively stimulate a dorsal root ganglion on the first spinal level.

24. A system as in claim 21, wherein the second element comprises a lead having at least one electrode.

25. A system as in claim 24, wherein the second element is positionable so as to selectively stimulate a dorsal root ganglion on the first spinal level.

26. A system as in claim 21, wherein the first and/or second element comprises an agent delivery device.

27. A system as in claim 21, wherein at least one of the elements is steerable.

28. A system as in claim 21, wherein at least one of the elements extends through a lumen in the shaft and wherein the at least one of the elements is rotatable within the lumen.

29. A system as in claim 21, wherein at least one of the elements is longitudinally translatable within its associated opening.

30. A system as in claim 21, wherein the first and second spinal levels are not adjacent to each other.

31. A system as in claim 21, 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.

32. A system as in claim 31, 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.

33. A system as in claim 21, wherein at least one of the elements comprises a lead having one or more electrodes comprising a pointed tip which is used to contact or pierce tissue.

34. A system as in claim 21, wherein at least one of the elements comprises a lead having one or more electrodes comprising an array along a flat portion of the lead.

35. A system as in claim 21, wherein at least one of the elements comprises a lead having one or more electrodes comprising an array at least partially extending around the circumference of the lead.

36. A system as in claim 21, wherein at least one of the elements comprises a lead having a distal end or electrode shaped so as to wrap around a dorsal root ganglion.

37. A system as in claim 21, wherein at least one of the elements comprises a lead having an electrode having a coil shape.

38. A system as in claim 21, further comprising a mechanism to fix at least one element in relation to the shaft.

39. A system as in claim 21, wherein the shaft includes a tissue anchor to anchor the shaft to surrounding tissue.