Implantable Medical Electrical Leads, Kits, Systems and Methods of Use Thereof

• US 20070168008A1
• Filed: 12/04/2006
• Published: 07/19/2007
• Est. Priority Date: 10/21/2004
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Olsen, James
• Granted Patent: US 9,079,018 B2
• Time in Patent Office: Days
• US Class Current: 607/117
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy

Abstract

Implantable medical electrical leads, kits, systems and methods of use thereof for electrically stimulating the spinal cord with a plurality of electric stimulation leads. Directional stimulation electrodes are disposed along the distal end portions of the leads to form an electrode array in the epidural space of a patient with at least first, second and third directional stimulation electrodes being oriented at determined angular orientations relative to the spinal cord or each other. The stimulation electrodes may be programmed to create a tripole in which at least the first, second and third directional stimulation electrodes are active.

Claims

1. A method of electrically stimulating the spinal cord with a plurality of electric stimulation leads, each of the electric stimulation leads having a distal end portion with a generally cylindrical cross section on which one or more directional stimulation electrode(s) are disposed, wherein said one or more directional stimulation electrode(s) form an electrode array including at least first, second and third directional stimulation electrodes with at least one of the first, second and third directional stimulation electrodes on a different electric stimulation lead than the other of the first, second and third directional stimulation electrodes, the method comprising:

(a) implanting the plurality of electric stimulation leads in the epidural space of a patient with;

(1) the plurality of electric stimulation leads forming a lead array in the epidural space, and

(2) the first, second and third directional stimulation electrodes being oriented at determined angular orientations relative to the spinal cord; and

(b) programming the stimulation electrodes to create a tripole in which the first, second and third directional stimulation electrodes are active.

2. The method of claim 1 in which the plurality of electric stimulation leads comprises at least first, second and third electric stimulation leads wherein the first directional stimulation electrode is disposed on the first electric stimulation lead, the second directional stimulation electrode is disposed on the second electric stimulation lead, and the third directional stimulation electrode is disposed on the third electric stimulation lead, the step (a) of implanting the plurality of electric stimulation leads in the epidural space of a patient further including:

forming a lead array in the epidural space in which the third electric stimulation lead is disposed between the first and second electric stimulation leads.

3. The method of claim 2 in which the step (b) of programming the stimulation electrodes to create a tripole in which the first, second and third directional stimulation electrodes are active includes:

independently varying the voltage or current amplitude of electric pulses overlapping in time on the first and second directional stimulation electrodes.

4. The method of claim 3 in which the step (b) of programming the stimulation electrodes to create a tripole in which the first, second and third directional stimulation electrodes are active further includes:

programming the first and second directional stimulation electrodes as anodes and the third directional stimulation electrode is programmed as a cathode.

5. The method of claim 2 in which the step (a) of implanting the plurality of electric stimulation leads in the epidural space of a patient further includes:

aligning the first, second and third directional stimulation electrodes generally in a direction transverse relative to the spinal cord.

6. The method of claim 2 in which the step (a) of implanting the plurality of electric stimulation leads in the epidural space of a patient further includes:

orienting the third directional stimulation electrode in the direction generally facing the spinal cord; and

orienting the first and second directional stimulation electrodes at oblique angles relative to the third directional stimulation electrode.

7. The method of claim 7 wherein the first and second directional stimulation electrodes each an exposed, tissue-stimulating portion extending less than half of the circumference of the distal ends of the first and second electric stimulation leads respectively, and the third directional stimulation electrode has an exposed, tissue-stimulating portion extending more than half of the circumference of the distal end of the third electric stimulation lead.

8. A method of electrically stimulating the spinal cord with first, second and third electric stimulation leads, each of the first, second and third electric stimulation leads having a distal end portion with a generally cylindrical cross section and at least one stimulation electrode having an exposed, tissue-stimulating portion extending over less than half of the circumference of the distal end portion, the method comprising:

(a) implanting the first, second and third electric stimulation leads in the epidural space of a patient with;

(1) the first, second and third electric stimulation leads forming a lead array in the epidural space in which the third electric stimulation lead is disposed between the first and second electric stimulation leads, and

(2) the exposed, tissue-stimulating portions of the electrodes of each electric stimulation lead being oriented at determined angular orientations relative to the spinal cord; and

(b) programming the stimulation electrodes to create a tripole in which at least one electrode is active on each of the first, second and third electric stimulation leads wherein the stimulation electrodes programmed as active constitute a first active electrode on the first electric stimulation lead, a second active electrode on the second electric stimulation lead and a third active electrode on the third electric stimulation lead.

9. The method of claim 8 in which the step (b) of programming the stimulation electrodes to create a tripole in which at least one electrode is active on each of the first, second and third electric stimulation leads includes:

varying voltage or current amplitude of electric pulses overlapping in time on the first and second active stimulation electrodes independently of one another.

10. The method of claim 9 in which the step (b) of programming the stimulation electrodes to create a tripole in which at least one electrode is active on each of the first, second and third electric stimulation leads further includes:

programming the first and second active electrodes as anodes and the third active electrode is programmed as a cathode.

11. The method of claim 8 in which the step (a) of implanting the first, second and third electric stimulation leads in the epidural space of a patient further includes:

aligning the first, second and third active electrodes generally in a direction transverse relative to the spinal cord.

12. The method of claim 11 in which the step (a) of implanting the first, second and third electric stimulation leads in the epidural space of a patient further includes:

orienting the third active electrode in the direction generally facing the spinal cord; and

orienting the first and second active electrodes at oblique angles relative to the third directional stimulation electrode.

13. The method of claim 8 in which each of the first, second and third active electrodes constitute ring electrodes which are shielded to provide electrical insulation over a portion of the electrode with the exposed, tissue-stimulating portion of the electrode being exposed through a window that remains unshielded.

14. The method of claim 8 in which the first, second and third active electrodes each constitute an arcuate member extending less than half of the circumference of the distal end portion of the first, second or third electric stimulation lead, respectively.

15. A method of electrically stimulating the spinal cord with first and second electric stimulation leads, each of the first and second electric stimulation leads having a distal end portion with a generally cylindrical cross section, the first electric stimulation lead having a first stimulation electrode on the distal end portion thereof with an exposed, tissue-stimulating portion extending over less than half the circumference of the distal end portion, and the second electric stimulation lead having second and third stimulation electrodes on the distal end portion thereof with each of the second and third stimulation electrodes having an exposed, tissue-stimulating portion extending over less than half of the circumference of the distal end portion, the method comprising:

(a) implanting the first and second electric stimulation leads in the epidural space of a patient with;

(1) the first and second electric stimulation leads forming a lead array in the epidural space, and

(2) the exposed, tissue-stimulating portions of the first, second and third stimulation electrodes being oriented at determined angular orientations relative to the spinal cord; and

(b) programming the stimulation electrodes to create a tripole in which the first, second and third stimulation electrodes are active.

16. The method of claim 15 in which the step (b) of programming the stimulation electrodes to create a tripole in which the first, second and third stimulation electrodes are active includes:

varying voltage or current amplitude of electric pulses overlapping in time on the first and second stimulation electrodes independently of one another.

17. The method of claim 16 in which the step (b) of programming the stimulation electrodes to create a tripole in which the first, second and third stimulation electrodes are active further includes:

programming the first and second stimulation electrodes as anodes and the third stimulation electrode as a cathode.

18. The method of claim 15 wherein the first electric stimulation lead further includes a fourth stimulation electrode on the distal end portion thereof with an exposed, tissue-stimulating portion extending over less than half the circumference of the distal end portion;

the step (a) of implanting the first and second electric stimulation leads in the epidural space of a patient further includes;

orienting the first and second electric stimulation leads such that;

the third and fourth stimulation electrodes are disposed at an oblique angle to one another in the direction generally facing the spinal cord;

the first stimulation electrode is disposed in a direction generally facing away from the second stimulation lead; and

the second stimulation electrode is disposed in a direction generally facing away from the first stimulation lead.

19. The method of claim 18 wherein the step of orienting the first and second electric stimulation leads includes:

orienting the first and second electric stimulation leads such that;

the first stimulation electrode is disposed at an oblique angle generally facing away from the second stimulation lead; and

the second stimulation electrode is disposed at an oblique angle generally facing away from the first stimulation lead.

20. The method of claim 18 wherein:

the step (a) of implanting the first and second electric stimulation leads in the epidural space of a patient further including aligning the third and fourth stimulation electrodes longitudinally within the epidural space relative to one another with the first and second stimulation electrodes offset longitudinally relative to the third and fourth stimulation electrodes; and

the step (b) of programming the stimulation electrodes to create a tripole in which the first, second and third stimulation electrodes are active includes;

connecting the third and fourth stimulation electrodes in parallel electrical communication as a common split return path; and

programming the first and second stimulation electrodes as anodes and independently controlling and varying the voltage of the first and second stimulation electrodes.

21. The method of claim 15 in which each of the first, second and third stimulation electrodes constitute ring electrodes which are shielded to provide electrical insulation over a portion of the electrode with the exposed, tissue-stimulating portion of the electrode being exposed through a window that remains unshielded.

22. The method of claim 15 in which the first, second and third stimulation electrodes each constitute an arcuate member extending less than half of the circumference of the distal end portion of the first or second electric stimulation lead.

23. A method of electrically stimulating the spinal cord with first, second and third electric stimulation leads, each of the first, second and third electric stimulation leads having a distal end portion with a generally cylindrical cross section on which one or more stimulation electrode(s) are disposed including first and second directional stimulation electrodes on the first and second electric stimulation leads, respectively, and a third stimulation electrode on the third stimulation lead, the method comprising:

(a) implanting the plurality of electric stimulation leads in the epidural space of a patient with;

(1) the plurality of electric stimulation leads forming a lead array in the epidural space with the third stimulation lead disposed between the first and second stimulation lead, and

(2) the first and second directional stimulation electrodes being oriented at determined angular orientations relative to the spinal cord; and

(b) programming the stimulation electrodes to create a tripole in which the first, second and third stimulation electrodes are active.