Transverse tripole neurostimulation methods, kits and systems

• US 9,050,455 B2
• Filed: 10/21/2005
• Issued: 06/09/2015
• Est. Priority Date: 10/21/2004
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Olsen, James M., King, Gary W.
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): Dinga, Roland
• Application Number:
  US11/256,220
• Publication Number:
  US 20060122678A1
• Time in Patent Office: 3,518 Days
• Field of Search: 607/117, 607/46
• US Class Current: 1/1
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system

Abstract

An implantable neurostimulation lead kit adapted for tripolar electric simulation and/or field steering using percutaneously implantable electric stimulation leads. The kit includes three electric stimulation leads that are adapted to provide an electrode array defining, for example, a plurality of electrode sets that may be used to provide tripolar stimulation and/or electric field steering. A method of electrically stimulating the spinal cord is also described.

Claims

1. A method of electrically stimulating the spinal cord with first, second and third electric stimulation leads, each of the first, second and third leads having a distal end portion with a plurality of stimulation electrodes therealong, the method comprising:

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

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

(2) the plurality of stimulation electrodes of the first and second electric stimulation leads defining a plurality of transverse pairs of stimulation electrodes, one stimulation electrode of each transverse pair being located on the first lead and the other stimulation electrode of each transverse pair being located on the second lead, such that each transverse pair of stimulation electrodes defines a transverse line generally transverse relative to the spinal cord; and

(3) the plurality of stimulation electrodes of the third lead defining a plurality of longitudinal pairs of adjacent stimulation electrodes corresponding to the transverse pairs of transverse stimulation electrodes of the first and second leads, thus forming a plurality of electrode sets each defined by one longitudinal pair and one transverse pair, wherein within each set

(i) a distal stimulation electrode of the longitudinal pair is positioned distally of the transverse line defined by the transverse pair of that electrode set and

(ii) a proximal stimulation electrode of such longitudinal pair is positioned proximally of the transverse line defined by the transverse pair of that electrode set; 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 lead within at least one of the electrode sets.

2. The method of claim 1 in which the plurality of electrode sets forms:

a plurality of first electrode sets in which the transverse pair defines a transverse line that is generally perpendicular relative to the spinal cord; and

a plurality of second electrode sets in which the transverse pair defines a transverse line that is generally diagonal relative to the spinal cord;

wherein any combination of a first electrode set and second electrode set may share some but not all of the stimulation electrodes of the first and second electrode sets of the combination; and

wherein the step 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 lead within at least one of the electrode sets includes programming active stimulation electrodes of at least one of the first or second electrode sets.

3. The method of claim 2 in which the step of programming active stimulation electrodes of at least one of the first and second electrode sets includes programming active stimulation electrodes of at least one of the first electrode sets.

4. The method of claim 3 in which the step of programming active stimulation electrodes of at least one of the first electrode sets includes programming all of the stimulation electrodes of such first electrode set as active to provide a transverse electric field oriented generally perpendicular to with respect to the spinal cord.

5. The method of claim 3 in which the step of programming active stimulation electrodes of at least one of the first electrode sets includes programming the stimulation electrodes of the transverse pair and only one of the stimulation electrodes of the longitudinal pair of such first electrode set as active to provide a transverse electric field having a longitudinal component but otherwise oriented generally perpendicular to with respect to the spinal cord.

6. The method of claim 2 in which the step of programming active stimulation electrodes of at least one of the first and second electrode sets includes programming active stimulation electrodes of at least one of the second electrode sets.

7. The method of claim 6 in which the step of programming active stimulation electrodes of at least one of the second electrode sets includes programming all of the stimulation electrodes of such second electrode set as active.

8. The method of claim 6 in which the step of programming active stimulation electrodes of at least one of the second electrode sets includes programming the stimulation electrodes of the transverse pair and only one of the stimulation electrodes of the longitudinal pair of such second electrode set as active.

9. The method of claim 1 further comprising using medical imaging techniques to verify the position of the first, second and third electric stimulation leads.

10. The method of claim 9 in which:

step (a) includes implanting the third electric stimulation lead before implanting the first and second electric stimulation leads;

the step of using medical imaging techniques to verify the position of the first, second and third electric stimulation leads includes determining the distance between the distal portion of the third electric stimulation lead and the spinal cord; and

step (a) further including positioning the distal portion of the first and second electric stimulation leads in the epidural space of a patient each at a distance from the distal portion of the third electric stimulation lead about the same as the distance between the distal portion of the third lead and the spinal cord.

11. The method of claim 10 in which the step of using medical imaging techniques to verify the position of the first, second and third electric stimulation leads further includes determining the distance between the distal portion of the first and second leads from the third lead and verifying that such distance is about the same as the distance between the distal portion of the third lead and the spinal cord.

12. The method of claim 11 in which the step of using medical imaging techniques to verify the position of the first, second and third electric stimulation leads includes verifying that the first electrode sets are arranged in a pattern relative to the spinal cord in which the transverse lines defined by the transverse pairs of the first electrode set are actually reasonably close to perpendicular relative to the spinal cord.

13. The method of claim 1 in which voltage or current of each of the stimulation electrodes programmed in the programming step are independently controlled.

14. The method of claim 13 in which voltage or current of at least two of the stimulation electrodes programmed in the programming step are independently controlled to provide field steering.

15. The method of claim 14 in which voltage or current of at least one of the stimulation electrodes of the first electric stimulation lead and at least one of the stimulation electrodes of the second electric stimulation lead are programmed in the programming step are independently controlled to provide field steering.