Percutaneous electrode array and system

• US 8,090,450 B2
• Filed: 06/26/2008
• Issued: 01/03/2012
• Est. Priority Date: 06/27/2007
• Status: Active Grant

• Current Assignee: Cirtec Medical Corp.
• Original Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Inventors: Swoyer, John M., Farrell, Richard M., Gagnon, Jeff S.
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Stice, Paula J
• Application Number:
  US12/146,961
• Publication Number:
  US 20090005844A1
• Time in Patent Office: 1,286 Days
• Field of Search: 607/115, 607/117, 607/55, 607136-137, 600377-378
• US Class Current: 607/117
• 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, transverses to its length, the distal region of the lead body comprises a planar upper side, a planar lower side, a radiused right side, and a radiused left side with the radiused right and left sides extending to and meeting with the planar upper and lower sides to provide the distal lead region with an oval-shape in cross-section;

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,

e) wherein the second and third electrodes are of an opposite polarity in comparison to the first electrode, and

f) wherein a portion of at least one of the second, and third electrodes extends onto the lower side of the lead adjacent to the opposite polarity first electrode, and

g) 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.

2. The lead of claim 1 wherein there are a plurality of the first, second and third electrodes in groups of three.

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

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

6. The lead of claim 1 wherein the second, right side electrode and the third, left side electrode extend to the planar upper side of the lead.

7. 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.

9. 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.

10. 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.

4. The lead of claim I wherein there are fewer center electrodes than right and left electrodes.

8. The lead of claim I 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. 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, transverses to its length, the distal region of the lead body comprises a planar upper side, a planar lower side, a radiused right side, and a radiused left side with the radiused right and left sides extending to and meeting with the planar upper and lower sides to provide the distal lead region with an oval-shape in cross-section;

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,

f) wherein the second and third electrodes are of an opposite polarity in comparison to the first electrode, and

g) wherein a portion of both of the second and third electrodes extends onto the lower side of the lead adjacent to the opposite polarity first electrode, and

h) 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.

12. 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, transverses to its length, the distal region of the lead body comprises a planar upper side, a planar lower side, a radiused right side, and a radiused left side with the radiused right and left sides extending to and meeting with the planar upper and lower sides to provide the distal lead region with an oval-shape in cross-section;

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,

e) wherein the second and third electrode are of an opposite polarity in comparison to the first electrode, and

f) wherein a portion of both of the second and third electrodes extends onto the lower side of the lead adjacent to the opposite polarity first electrode, and

g) 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.

13. The lead of claim 12 wherein there are a plurality of the first, second and third electrodes in groups of three.

14. The lead of claim 12 wherein there are more center electrodes than right and left electrodes.

15. The lead of claim 12 wherein there are fewer center electrodes than right and left electrodes.

16. The lead of claim 12 wherein the at least one of the first, second and third electrodes are individually, electrically addressable through conductors extending to the lead body proximal region.

17. The lead of claim 12 wherein the second, right side electrode and the third, left side electrode extend to the planar upper side of the lead.

18. The lead of claim 12 wherein the lead body distal region has an aspect ratio of width to height of from about 1.5 to 10.

19. The lead of claim 12 wherein the at least one first, second and third electrodes are centered along the respective lower, right and left sides of the lead body.

20. The lead of claim 12 wherein the at least one first electrode is a cathode and the at least one second and third electrodes are return anodes.

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