PERCUTANEOUS ELECTRODE ARRAY AND SYSTEM

• US 20090005844A1
• Filed: 06/26/2008
• Published: 01/01/2009
• Est. Priority Date: 06/27/2007
• Status: Active Grant

• Current Assignee: Cirtec Medical Corp.
• Original Assignee: Quan Emerteq Corporation
• Inventors: GAGNON, Jeff S., FARRELL, Richard M., SWOYER, John M.
• Granted Patent: US 8,090,450 B2
• Time in Patent Office: Days
• US Class Current: 607/116
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy

Abstract

Lead devices and methods for neurostimulation are described. Some of the neurostimulation leads provided have multiple, distal region electrode contacts arranged in an array capable of providing steerable spinal cord stimulation. In one use, a collapsed introducer sheath is disposed over a dilator and advanced to a spinal cord target site through a 14-gauge needle into the epidural space. The dilator is removed and the introducer is expanded to its full width. A neurological lead according to the present invention advanced through the introducer to near the target site and the introducer removed. The lead is wider than it is high and has a row of lower electrodes flanked by right and left side electrodes in groups of three. The lower electrodes serve as cathodes and the right and left electrodes are return anodes.

Claims

1. An implantable medical electrical lead, the lead comprising:

a) an elongate body having a length extending from a proximal region to a distal region, wherein in cross-section transverse to its length, the lead body comprises an upper side, a lower side, a right side, and a left side;

b) at least one first, center electrode supported by the lower side at the distal region of the lead body;

c) at least one second, right electrode supported by the right side at the distal region of the lead body; and

d) at least one third, left electrode supported by the left side at the distal region of the lead body.

2. The lead of claim 1 wherein the at least one first, second and third electrodes are aligned with each other along a transverse axis, perpendicular to a longitudinal axis of the lead body.

3. The lead of claim 2 wherein the plurality of first, second and third electrodes are in groups of three.

4. The lead of claim 1 wherein there are more center electrodes than right and left electrodes.

5. The lead of claim 1 wherein there are fewer center electrodes than right and left electrodes.

6. The lead of claim 1 wherein the plurality of first, second and third electrodes are individually, electrically addressable through conductors extending to the lead body proximal region.

7. The lead of claim 1 wherein the second, right side electrodes and the third, left side electrodes extend to the upper side of the lead.

8. The lead of claim 1 wherein the second, right side electrodes and the third, left side electrodes extend to the lower side of the lead.

9. The lead of claim 1 wherein the lead body distal region has an aspect ratio of width to height of from about 1.5 to 10.

10. The lead of claim 1 wherein the at least one first, second and third electrodes are centered along the respective lower, right and left sides of the lead body.

11. The lead of claim 1 wherein the at least one first electrode is a cathode and the at least one second and third electrodes are return anodes.

12. The lead of claim 1 wherein the at least one first electrode is an anode and the at least one second and third electrodes are cathodes.

13. An implantable medical electrical lead, the lead comprising:

a) an elongate body having a length extending from a proximal region to a distal region, wherein in cross-section transverse to its length, the lead body comprises an upper side, a lower side, a right side, and a left side;

b) a plurality of first, center electrode supported by the lower side at the distal region of the lead body;

c) a plurality of second, right electrode supported by the right side at the distal region of the lead body;

d) a plurality of third, left electrode supported by the left side at the distal region of the lead body; and

e) wherein the first, second and third electrodes are aligned with each other in groups of three along a transverse axis, perpendicular to a longitudinal axis of the lead body.

14. A method for electrically stimulating a target body site, comprising the steps of:

a) providing a lead comprising;

i) an elongate body having a length extending from a proximal region to a distal region, wherein in cross-section transverse to its length, the lead body comprises an upper side, a lower side, a right side, and a left side;

ii) at least one first, center electrode supported by the lower side at the distal region of the lead body;

iii) at least one second, right electrode supported by the right side at the distal region of the lead body; and

iv) at least one third, left electrode supported by the left side at the distal region of the lead body;

b) advancing a collapsed introducer through a needle lumen to the body site, the introducer having a lumen housing a dilator therein;

c) retracting the dilator from the introducer;

d) advancing the electrical lead through the introducer;

e) retracting the introducer and leaving the lead in place adjacent to the target body site with the at least one first, center electrode facing a body portion to be electrically stimulated and flanked on its right and left sides by the at least one second and thirds electrodes; and

g) delivering electrical energy from the first, center electrode into the target body site with the second and third electrode serving as returns for the electrical energy.

15. The method of claim 14 including aligning the at least one first, second and third electrodes with each other along a transverse axis, perpendicular to a longitudinal axis of the lead body.

16. The method of claim 15 including grouping the plurality of first, second and third electrodes in groups of three.

17. The method of claim 14 including providing the plurality of first, second and third electrodes being individually, electrically addressable through conductors extending to the lead body proximal region.

18. The method of claim 14 including providing the second, right side electrodes and the third, left side electrodes extending to the upper side of the lead.

19. The method of claim 14 including providing the second, right side electrodes and the third, left side electrodes extending to the lower side of the lead.

20. The method of claim 14 including providing the lead body distal region having an aspect ratio of width to height of from about 1.5 to 10.

21. The method of claim 14 including centering the at least one first, second and third electrodes along the respective lower, right and left sides of the lead body.

22. The method of claim 14 including providing the at least one first electrode as a cathode and the at least one second and third electrodes as return anodes.

23. The method of claim 14 including providing the at least one first electrode as an anode and the at least one second and third electrodes as cathodes.

24. The method of claim 14 including providing more center electrodes than right and left electrodes.

25. The method of claim 14 including providing fewer center electrodes than right and left electrodes.