High efficiency neurostimulation lead

• US 7,729,781 B2
• Filed: 03/14/2007
• Issued: 06/01/2010
• Est. Priority Date: 03/16/2006
• Status: Active Grant

• Current Assignee: Cirtec Medical Corp.
• Original Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Inventors: Swoyer, John M., Gagnon, Jeffrey S.
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): Stice; Paula J
• Application Number:
  US11/686,322
• Publication Number:
  US 20070219608A1
• Time in Patent Office: 1,175 Days
• Field of Search: 607/96, 607101-102, 607115-122, 607 1- 45, 607/129, 607/137, 600/373, 600/377, 600/381, 600/12, 514/27, 514/283, 514/34, 514/449, 514/575, 128639-642, 606/117, 424/423
• US Class Current: 607/116
• CPC Class Codes: A61N 1/0529 Electrodes for brain stimulation
• CPC Class Codes: A61N 1/0536 Preventing neurodegenerative response or inflammatory reaction
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes

Abstract

Devices and methods for stimulating nerves, such as peripheral nerves are described. Some devices can include small cross-section lead bodies having one or more electrodes in the round distal portion, the electrodes having a substantially planar surface within the distal portion of the lead which is suitable for placement through a cylindrical needle intended to access a spinal region of a patient. Some lead electrodes are covered with a hydrophilic coating at least about 0.001 inches thick. The hydrophilic coating may include a steroid and/or a GABA (gamma-aminobutyric acid) agonist which can elute or diffuse over time, away from the electrode.

Claims

1. An implantable medical lead comprising:

a) an elongate lead body having a lead sidewall comprising a non-conducting material extending from a proximal lead portion to a distal lead portion, wherein a cross-section of the distal lead portion perpendicular to a longitudinal axis thereof has a substantially curved section extending to and meeting with a planar surface;

b) at least one electrical conductor extending between the proximal lead portion and the distal lead portion;

wherein the conductor is embedded within the lead body or extends within a lumen within the lead body; and

c) at least one electrode electrically coupled to the at least one conductor and disposed completely within the planar surface of the lead sidewall in the distal lead portion, the electrode comprising;

i) an electrode substrate having an upper substrate surface and a lower substrate surface, both extending to a substrate sidewall intermediate the upper and lower substrate surfaces, wherein the substrate sidewall defines a first perimeter;

ii) a hydrophilic coating supported on the upper substrate surface, the hydrophilic coating having an upper coating surface and a lower coating surface, both extending to a coating sidewall intermediate the upper and lower coating surfaces, wherein the coating sidewall defines a second perimeter; and

iii) wherein the second perimeter of the hydrophilic coating is spaced inwardly from the first perimeter of the electrode substrate to provide an upper edge of the upper substrate surface that is not contacted by the hydrophilic coating, but is directly contacted by the non-conductive material of the lead body to thereby lock the substrate in place completely within the planar surface of the lead sidewall.

2. The lead of claim 1, wherein the hydrophilic coating has a thickness of at least about 0.0254 mm.

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 wherein 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 GABA agonist.

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

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

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

9. The lead of claim 2, in which the coating has a thickness of at least about 0.127 mm.

10. The lead of claim 2, in which the coating has a thickness from about 0.0254 mm to about 0.254 mm.

11. The lead of claim 1 wherein the at least one planar electrode disposed completely within the planar surface of the lead sidewall has a surface area of less than about 3 square mm.

12. The lead of claim 1 wherein the distal lead portion has a width of less than about 2 mm.

13. The lead of claim 1 wherein the distal lead portion has a width of less than about 1.5 mm.

14. The lead of claim 1 wherein the distal lead portion has a thickness less than about 1 mm.

15. The lead of claim 1 wherein the lead is insertable through a needle intended to access a spinal region of a patient.

16. A method for implanting a medical lead, the method comprising:

a) providing the medical lead comprising;

i) an elongate lead body having a lead sidewall comprising a non-conducting material extending from a proximal lead portion to a distal lead portion, wherein a cross-section of the distal lead portion perpendicular to a longitudinal axis thereof has a substantially curved section extending to and meeting with a planar surface;

ii) at least one electrical conductor extending between the proximal lead portion and the distal lead portion; and

iii) at least one electrode disposed completely within the planar surface of the lead sidewall in the distal lead portion, the at least one electrode being electrically coupled to the at least one conductor, wherein the conductor is embedded within the lead body or extends within a lumen within the lead body;

the electrode further comprising an electrode substrate having an upper substrate surface and a lower substrate surface, both extending to a substrate sidewall intermediate the upper and lower substrate surfaces, wherein the substrate sidewall defines a first perimeter, a hydrophilic coating supported on the upper substrate surface, the hydrophilic coating having an upper coating surface and a lower coating surface, both extending to a coating sidewall intermediate the upper and lower coating surfaces, wherein the coating sidewall defines a second perimeter, and wherein the second perimeter of the hydrophilic coating is spaced inwardly from the first perimeter of the electrode substrate to provide an upper edge of the upper substrate surface that is not contacted by the hydrophilic coating, but is directly contacted by the non-conductive material of the lead body to thereby lock the substrate in place completely within the planar surface of the lead sidewall; and

b) advancing the implantable medical electrical lead to a target site.

17. The method of claim 16 including selecting the target site for peripheral nerve stimulation.

18. The method of claim 17 including selecting the nerve stimulation target from the group consisting of an occipital nerve, a supra orbital nerve, a sub orbital nerve, a pudendal nerve, and combinations thereof.

19. The method of claim 16 including eluting a steroid from the hydrophilic coating disposed over the lead conductor.

20. The method of claim 16 including eluting a GABA agonist from the hydrophilic coating disposed over the lead conductor.

21. The method of claim 20 wherein eluting the GABA agonist includes eluting baclofen.

22. The method of claim 16 including advancing the lead to the target site being the epidural space.

23. The method of claim 16 including advancing the lead to the target site being the intrathecal space.

24. The method of claim 16 further including eluting a GABA agonist within the intrathecal space from the hydrophilic coating.

25. The method of claim 16 including advancing the implantable electrical medical lead through a needle to the target site.

26. The needle of claim 25 wherein the needle being of a size less than 12 gauge.

27. The method of claim 16 including connecting the proximal lead portion to a pulse generator implanted in body tissue.

28. The method of claim 16 including stimulating a body tissue at the target site with electrical current delivered from a pulse generator, through the at least one electrical conductor of the lead and out the at least one electrode.

29. The method of claim 16 including providing, the hydrophilic coating having a thickness of at least about 0.0254 mm.

30. An implantable medical electrical lead, comprising;

a) an elongate lead body having a lead sidewall comprising a non-conducting material extending from a proximal lead portion to a distal lead portion, wherein a cross-section of the distal lead portion perpendicular to a longitudinal axis thereof has a substantially curved section extending to and meeting with a planar surface;

b) at least four electrical conductors extending between the proximal lead portion and the distal lead portion;

wherein the conductor is embedded within the lead body or extends within a lumen within the lead body;

c) at least four electrodes disposed completely within the planar surface of the lead sidewall in the distal lead portion, the at least four electrodes each being electrically coupled to at least one of the at least four conductors, wherein each electrode comprises;

i) an electrode substrate having an upper substrate surface and a lower substrate surface, both extending to a substrate sidewall intermediate the upper and lower substrate surfaces, wherein the substrate sidewall defines a first perimeter;

ii) a hydrophilic coating supported on the upper substrate surface, the hydrophilic coating having an upper coating surface and a lower coating surface, both extending to a coating sidewall intermediate the upper and lower coating surfaces, wherein the coating sidewall defines a second perimeter; and

iii) wherein the second perimeter of the hydrophilic coating is spaced inwardly from the first perimeter of the electrode substrate to provide an upper edge of the upper substrate surface that is not contacted by the hydrophilic coating, but is directly contacted by the non-conductive material of the lead body to thereby lock the substrate in place completely within the planar surface of the lead sidewall.

31. The implantable lead of claim 30 wherein a steroid is disposed within the hydrophilic coating for diffusion therefrom and wherein the steroid is selected from the group consisting of beclamethason, dexamethosone, their derivatives, and combinations thereof.

32. The implantable lead of claim 30 wherein a GABA agonist is disposed within the hydrophilic coating for diffusion therefrom.

33. The lead of claim 30 wherein the lead is insertable through a needle intended to access a spinal region of a patient.

34. The lead of claim 30 further comprising a space between each electrode.