Self fixing spinal cord stimulation lead and delivery system

• US 7,640,064 B2
• Filed: 09/03/2005
• Issued: 12/29/2009
• Est. Priority Date: 09/03/2005
• Status: Active Grant

• Current Assignee: Cirtec Medical Corp.
• Original Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Inventors: Swoyer, John M.
• Primary Examiner(s): Layno; Carl H.
• Assistant Examiner(s): MORALES, JON ERIC C
• Application Number:
  US11/162,265
• Publication Number:
  US 20070055332A1
• Time in Patent Office: 1,578 Days
• Field of Search: 607/115, 607/116, 607/117, 607/149, 600/372, 600/373, 600/377
• US Class Current: 607/115
• 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 1/057 Anchoring means; Means for fixing the head inside the heart

Abstract

Devices and methods for implanting a spinal neurological lead having at least one wing or flap extending transversely from the lead body. The wing can have a first wrapped configuration in which the wing is constrained against the lead body and a second unwrapped configuration is which the wing is unconstrained and allowed to extend outwardly. The wing can be biased to unwrap such that the wing tips change in angular position when viewed from the end, and in transverse extension when viewed from the top, but not in longitudinal position when viewed from the side. A pusher tube can be used to urge the lead from a delivery catheter, allowing the wing or wings to extend to urge a surface electrode toward the spinal cord, to maintain longitudinal position, and to be passively fixed over time. Leads according to the present invention can provide improved longitudinal stability after the lead electrode position has been properly fixed with respect to the spinal cord.

Claims

1. A system including an implantable medical electrical lead comprising:

a) an elongate lead body having a length extending from a proximal region to a distal region, wherein at least the distal region has a longitudinal center axis;

b) at least one electrical conductor disposed along the length of the lead body;

c) at least one electrode disposed in the lead body distal region and in electrical continuity with the at least one conductor; and

d) at least two fixation flaps not carrying an electrode and supported opposite each other substantially at a tangential location with respect to a periphery of a sidewall of the distal lead region, wherein the tangential location of the fixation flaps is spaced from the longitudinal center axis of the lead body directly opposite the electrode, and wherein when the at least two fixation flaps are in a first position they are constrained close to the lead body, the at least two fixation flaps in the constrained position, do not cover the at least one electrode, and wherein when the at least two fixation flaps are in a second position, they extend away from the lead body and away from each other for urging the electrode toward body tissue.

2. The lead of claim 1 wherein the lead body distal region has a first side and a second side disposed substantially opposite the first side, and wherein the at least one electrode is disposed on the first side with the at least two fixation flaps being secured to the distal region second side.

3. The lead of claim 1 wherein the at least two fixation flaps are supported on opposite sides of an intermediate portion attached to the lead body at the tangential location between the two flaps.

4. The lead of claim 3 wherein each of the at least two fixation flaps have opposing edges on opposite sides of the lead body and wherein the opposing edges are configured to move away from each other when the at least two fixation flaps move from the first position to the second position.

5. The lead of claim 1 wherein the at least two fixation flaps are biased to move from the first position to the second position when unconstrained.

6. The lead of claim 1 wherein the at least two fixation flaps lie in substantially one plane when unconstrained.

7. The lead of claim 1 wherein the at least two fixation flaps are configured to move from the first to the second position by varying in angular position with respect to the lead longitudinal center axis when viewed from the distal end, and to vary in extension distance from the lead longitudinal center axis when viewed from the top, but to not substantially vary in longitudinal position when viewed from the side.

8. The lead of claim 1 wherein the at least two fixation flaps are configured to move from the first to the second position without substantially changing in longitudinal position with respect to the lead and wherein the at least two fixation flaps are wrapped in opposite winding directions relative to each other when in the first position.

9. The lead of claim 1 wherein each of the at least two fixation flaps is configured to move from the first to the second position such that a point on least one of the flap portions moves substantially within a plane that is orthogonal to the lead longitudinal center axis.

10. The lead of claim 1 wherein the at least two fixation flaps are configured to move from the first to the second position such that each of them moves away from a surface of the electrode.

11. The lead of claim 1 wherein each of the fixation flaps is configured to move from the first to the second position such that the fixation flap splays away from the electrode further than the furthest point of the lead body lying in the same transverse plane that includes both the electrode and the furthest point of the lead body.

12. The system of claim 1 further comprising a tubular catheter having a lumen configured to receive the lead while in the lead second position.

13. The system of claim 12 further comprising a pusher element adapted to be disposed along the catheter to urge the lead distally from the delivery catheter.

14. The system of claim 13 wherein the pusher element is a pusher tube adapted to be received over the lead body and within the catheter lumen.

15. The system of claim 12 wherein the catheter has at least one electrically conductive distal region and an electrical conductor disposed along at least some of the catheter length and in electrical communication with the conductive distal region.

16. The system of claim 12 wherein the lead body has a lumen within for at least part of its length, and further comprising a stylet configured to be received within the lead body lumen.

17. The system of claim 16 further comprising a pusher element adapted to be disposed along the lead body to urge the lead distally from the delivery catheter.

18. The lead of claim 1 wherein the at least two fixation flaps arc away from the longitudinal center axis of the lead when unconstrained.

19. The lead of claim 1 wherein the at least two fixation flaps arc towards the longitudinal center axis of the lead when unconstrained.

20. A method for placing an implantable medical lead along a body tissue, the method comprising:

a) advancing a catheter having a lumen into the epidural space with the implantable medical lead disposed within the lumen, wherein the lead has a proximal region, a distal region having a longitudinal center axis, at least one electrode disposed near the distal region, and an electrical conductor extending from the proximal region to the electrode, and wherein the lead has at least two fixation flaps not carrying an electrode and supported opposite each other at a tangential location with respect to a periphery of a sidewall of the distal lead region, wherein the tangential location of the fixation flaps is spaced from the longitudinal center axis directly opposite the electrode and wherein when the lead distal region is housed inside the catheter, the at least two fixation flaps are constrained toward the lead body, the at least two fixation flaps not covering the at least one electrode when they are constrained toward the lead body; and

b) forcing the lead distal region out of the catheter, and into the body tissue with the at least two fixation flaps moving into an unconstrained position extending away from the lead body to thereby help the electrode bear against the body tissue.

21. The method of claim 20 including urging a pusher element disposed along the lead body to force the lead out of the catheter.

22. The method of claim 21 wherein the pusher element is a pusher tube and the forcing includes urging the pusher tube disposed over the lead body and within the catheter lumen to force the lead out of the catheter.

23. The method of claim 22 wherein the lead body includes a removable stylet disposed within during at least some of the forcing.

24. The method of claim 21 wherein the pusher element is a removable stylet disposed within the lead body during at least some of the forcing.

25. The method of claim 21 wherein the forcing includes bringing the pusher tube to bear on the at least two fixation flaps.

26. The method of claim 20 including the step of allowing the at least two fixation flaps to extend is substantially limited to extending such that the flaps not change their longitudinal positions with respect to the lead body during the extension.

27. The method of claim 20 wherein the at least two fixation flaps lie in substantially the same plane when unconstrained.

28. The method of claim 20 including providing the at least two fixation flaps being disposed on an opposite side of the lead body from the electrode with the flaps opening urging the electrode in a direction away from the flaps.

29. The method of claim 20 including providing the catheter having an electrically conductive distal region, and further comprising urging the catheter electrically conductive region near a spinal cord and determining at least one of electrical or physiological properties using the electrically conductive distal portion.

30. The method of claim 29 wherein determining electrical properties includes stimulating the spinal cord using the electrically conductive catheter distal region.

32. The method of claim 20 including the at least two fixation flaps arcing away from the longitudinal center axis of the lead when they are in the unconstrained position.

33. The method of claim 20 including the at least two fixation flaps arcing towards the longitudinal center axis of the lead when they are in the unconstrained position.

31. The method of 20 further comprising urging the lead body partially out of the catheter to dispose the electrode near the body tissue and determining at least one of electrical or physiological properties using the electrode, followed by completely urging the lead body out of the catheter.

34. An implantable medical electrical lead, which comprises:

a) an elongate lead body having a length extending from a proximal region to a distal region, wherein at least the distal region has a longitudinal center axis;

b) at least one electrical conductor disposed along the length of the body;

c) at least one electrode disposed in the lead body distal region an in electrical continuity with the at least one conductor; and

d) at least two fixation flaps not carrying an electrode and supported opposite each other at a tangential location with respect to a periphery of a sidewall of the distal lead region, wherein the tangential location of the fixation flaps is spaced from the longitudinal center axis directly opposite the electrode, and wherein when the at least two fixation flaps are in a constrained position, they are disposed close to the lead body, the at least two fixation flaps do not cover the at least one electrode when in a constrained position and wherein when the at least two fixation flaps are in an unconstrained position, they arc away from the longitudinal center axis of the lead body and away from each other for urging the electrode toward body tissue.