HIGH EFFICIENCY NEUROSTIMULATION LEAD

Abstract

Devices and methods for stimulating nerves, such as peripheral nerves. Some devices can include small cross-section lead bodies having one or more electrodes in the distal portion, the electrodes having a substantially flat surface and being suitable for placement through a 12 gauge needle or smaller. Some lead electrodes are covered with a hydrophilic coating at least about 0.001 inch thick. The hydrophilic coating may include a steroid and/or a GABBA agonist which can elute or diffuse over time, away from the electrode.

Description

DESCRIPTION OF THE DRAWINGS

FIG. 1 is a fragmentary, perspective view of a lead distal region in one embodiment, having substantially planar, nominally square shaped electrodes.

FIG. 2 is a fragmentary, front view of a lead distal region in one embodiment, having substantially planar, nominally rectangular electrodes.

FIG. 3 is a fragmentary, side, cross-sectional view of the lead distal region of FIG 2, having a polymeric, hydrophilic layer over the electrode metal surface.

FIG. 4 is a perspective view of one electrode of FIG. 3, having the polymeric hydrophilic layer disposed over the metallic electrode surface.

FIG. 5 is a fragmentary, bottom view of a lead according to the present invention having a distal region with four electrodes and a proximal region with four conductor rings.

Claims

1. An Implantable medical electrical lead comprising. an elongate body having a proximal portion, a distal portion, and at least one electrical conductor extending between the proximal portion and the distal portion;a first electrode disposed in the distal portion, the first electrode having a substantially flat., planar surface and being electrically coupled to the at least one conductor,where the lead elongate body and electrode are sized small enough in cross-sectional profile to be insertable through a 12 gauge needle.

2. The lead of claim 1, further comprising a hydrophilic coating over the flat electrode surface, the coating having a thickness of at least about 0.001 inch.

3. The lead of claim 2, further comprising a substance disposed within the hydrophilic coating for diffusion out of the hydrophilic coating., where the substance is a steroid.

4. The lead of claim 3, in which the steroid is selected from the group consisting of beclamethason, dexamethosone, and their derivatives, and combinations thereof.

5. The lead of claim 2, further comprising a substance disposed within the hydrophilic coating for diffusion out of the hydrophilic coating, where the substance is a GABBA agonist.

6. The lead of claim 5, in which the GABBA agonist includes baclofen.

7. The lead of claim 2, further comprising a steroid disposed within the hydrophilic coating for diffusion out of the hydrophilic coating

8. The lead of claim 2, further comprising a GABBA agonist disposed within the hydrophilic coating for diffusion out of the hydrophilic coating.

9. The lead of claim 2, further comprising a steroid and a GABBA agonist disposed within the hydrophilic coating for diffusion out of the hydrophilic coating.

10. The lead of claim 2, in which the hydrophilic coating is swellable in water.

11. The lead of claim 2, in which the coating has a thickness of at least about 0.005 inch.

12. The lead of claim 2, in which the coating has a thickness of between about 0.001 and 0.01 inch.

13. The lead of claim 1, in which the lead conductor has surface area of less than about 3 square mm.

14. The lead of claim 1, in which the lead distal region has a width of less than about 2 mm.

15. The lead of claim 1, in which the lead distal region has a width of less than about 1.5 mm.

16. The lead of claim 1, in which the lead distal portion has a thickness substantially perpendicular to the conductor flat surface, where the thickness is less than about 1 mm.

17. A method for implanting a medical electrical lead, the method comprising: advancing an implantable medical electrical lead through a needle smaller than about 12 gauge to a target site, the lead includingan elongate body having a proximal portion, a distal portion, and at least one electrical conductor extending between the proximal portion and the distant portion, anda first electrode disposed in the distal portion, the first electrode having a substantially flat, planar surface and being electrically coupled to the at least one conductor,where the lead elongate body and electrode are sized small enough in cross sectional profile to be insertable through a 12 gauge needle.

18. The method of claim 17 in which the target site is selected for peripheral nerve stimulation.

19. The method of claim 18 in which the nerve stimulation target is selected from the group consisting of occipital, supra orbital, sub orbital, and pudendal nerve stimulation, and combinations thereof.

20. The method of claim 17, further comprising eluting a steroid from a hydrophilic coating disposed over the lead conductor.

21. The method of claim 17, further comprising eluting a GABBA agonist from a hydrophilic coating disposed over the lead conductor.

22. The method of claim 21, in which the GABA agonist eluting includes eluting baclofen.

23. The method of claim 17, in which the target site is the epidural space.

24. The method of claim 17, in which the target site is the intrathecal space.

25. The method of claim 24, further including eluting a GABA agonist within the intrathecal space.

26. An Implantable medical electrical lead comprising: an elongate body having a proximal portion, a distal portion, and at least four electrical conductors extending between the proximal portion and the distal portion;at least four electrodes disposed in the distal portion, the at least four electrodes each having a substantially flat, planar surface and being electrically coupled to at least one of the at least four conductors,where the lead elongate body and electrodes are sized small enough in cross-sectional profile to be insertable through a 12 gauge needle; anda hydrophilic coating over the flat electrode surfaces, the coating having a thickness of at least about 0.001 inch.

27. The implantable lead of claim 26, in which the electrodes have a substance disposed within the hydrophilic coating for diffusion out of the hydrophilic coating, where the substance is a steroid selected from the group consisting of beclamethason, dexamethosone, and their derivatives and combinations thereof.

28. The implantable lead of claim 26, in which the electrodes have a substance disposed within the hydrophilic coating for diffusion out of the hydrophilic coating, where the substance is a GABBA agonist.