Transverse tripole neurostimulation methods, kits and systems

• US 20060122678A1
• Filed: 10/21/2005
• Published: 06/08/2006
• 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.
• Granted Patent: US 9,050,455 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 1/36017 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. An implantable neurostimulation lead kit comprising first, second and third implantable electric stimulation leads, each of the first, second and third leads having a distal end portion and a plurality of stimulation electrodes spaced apart along the distal end portion thereof, the stimulation electrodes of the first and second leads having substantially similar center-to-center spacing of adjacent electrodes, and the stimulation electrodes of the third lead having a center-to-center spacing of adjacent electrodes that is approximately one half of the center-to-center spacing of adjacent electrodes of the first and second leads.

2. The kit according to claim 1 in which the plurality of stimulation electrodes for the first and second leads includes the same number of electrodes.

3. The kit according to claim 2 in which the plurality of stimulation electrodes for the third lead includes double the number of electrodes for either the first or second leads.

4. The kit according to claim 3 in which the plurality electrodes for each of the first and second leads comprises four electrodes, and the plurality of electrodes for the third lead comprises eight electrodes.

5. The kit according to claim 4 in which each of the first, second and third leads comprises a generally cylindrical implantable electric stimulation lead adapted for percutaneous implantation.

6. The kit according to claim 5 in which each of the first, second and third leads further includes:

a proximal end portion a plurality of electrical contacts arranged along the distal end portion adapted for electrical connection with a lead extension or implantable pulse generator; and

means for electrical communication between stimulation electrodes and electrical contacts.

7. The kit according to claim 6 in which each of the first, second and third leads have a length that adapts the first, second and third leads to be arranged in the epidural space to form a generally parallel array with the distal end portions being arranged in a side-by-side spaced-apart array.

8. The kit of claim 1 further comprising instructions for use of the kit, the instructions specifying use of the kit consistent with the following steps:

percutaneously implanting first, second and third leads in the epidural space of a patient; and

programming the stimulation electrodes to create a tripole in which at least one electrode is active on each of the first, second and third leads.

9. The kit of claim 1 further comprising a label or instructions for use with the kit, the label or instructions describing use of the kit to form a tripole stimulation pattern.

10. A combination of the kit according to claim 7 and an implantable pulse generator electrically coupled to the electrical contacts of the first, second and third leads.

11. The combination of claim 8 further comprising at least one lead extension electrically coupling the electrical contacts of the first, second and third leads with the implantable pulse generator.

12. 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 space apart therealong, the stimulation electrodes of the first and second leads having substantially similar center-to-center spacing of adjacent electrodes, and the stimulation electrodes of the third lead having a center-to-center spacing of adjacent electrodes that is approximately one half of the center-to-center spacing of adjacent electrodes of the first and second leads, 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 leads forming a generally parallel lead array in the epidural space in which the third lead is disposed between the first and second leads, and

(2) the plurality of stimulation electrodes on the first, second and third electric stimulation leads form a plurality of electrode sets wherein each electrode set is arranged in a generally diamond-shaped array and comprises;

(i) a transverse pair of stimulation electrodes, one stimulation electrode of such transverse pair being on each of the first and second electric stimulation leads; and

(ii) a longitudinal pair of stimulation electrodes on the third electric stimulation lead wherein the two stimulation electrodes of the longitudinal pair are adjacent one another; 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.

13. The method of claim 12 in which the plurality of electrode sets forms:

a plurality of first electrode sets in which the transverse pair of each first electrode set 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 first electrode set 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 electric stimulation leads within at least one of the electrode sets includes programming active stimulation electrodes of at least one of the first or second electrode sets.

14. The method of claim 13 in which the step of 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.

15. The method of claim 14 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.

16. The method of claim 15 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.

17. The method of claim 14 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.

18. The method of claim 17 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.

19. The method of claim 17 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.

20. The method of claim 14 further comprising using medical imaging techniques to verify the position of the first, second and third electric stimulation leads.

21. The method of claim 20 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.

22. The method of claim 21 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.

23. The method of claim 22 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.

24. The method of claim 14 in which voltage or current of each of the stimulation electrodes programmed in the programming step are independently controlled.

25. The method of claim 24 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.

26. The method of claim 25 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.

27. The method of claim 12 wherein each of the first, second and third stimulation leads have a generally cylindrical configuration of the type adapted for implantation in percutaneous implantation procedures, step (a) including implanting the first, second and third stimulation leads in a percutaneous implantation procedure.

28. 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.

29. The method of claim 28 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.

30. The method of claim 29 in which the step of 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.

31. The method of claim 30 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.

32. The method of claim 30 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.

33. The method of claim 29 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.

34. The method of claim 33 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.

35. The method of claim 33 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.

36. The method of claim 28 further comprising using medical imaging techniques to verify the position of the first, second and third electric stimulation leads.

37. The method of claim 36 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.

38. The method of claim 37 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.

39. The method of claim 38 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.

40. The method of claim 28 in which voltage or current of each of the stimulation electrodes programmed in the programming step are independently controlled.

41. The method of claim 40 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.

42. The method of claim 41 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.

43. A method of electrically stimulating the spinal cord with a stimulation electrode array, the method comprising:

(a) implanting the stimulation electrode array in the epidural space of a patient such that;

(1) the stimulation electrode array is arranged in first, second and third generally parallel columns with the third column being arranged between the first and second columns, each of the first, second and third columns being formed by a plurality of stimulation electrodes with the stimulation electrodes of the first and second columns having substantially similar center-to-center spacing of adjacent electrodes, and the stimulation electrodes of the third column having a center-to-center spacing of adjacent electrodes that is approximately one half of the center-to-center spacing of adjacent electrodes of the first and second columns, and

(2) the plurality of stimulation electrodes on the first, second and third columns form a plurality of electrode sets wherein each electrode set is arranged in a generally diamond-shaped array and comprises;

(i) a transverse pair of stimulation electrodes, one stimulation electrode of such transverse pair being located in the first column and the other stimulation electrode of the transverse pair being located n the second column; and

(ii) a longitudinal pair of stimulation electrodes located in the third column wherein the two stimulation electrodes of the longitudinal pair are adjacent one another; 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 columns within at least one of the electrode sets.

44. The method of claim 43 in which the plurality of electrode sets forms:

a plurality of first electrode sets in which the transverse pair of each first electrode set 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 first electrode set 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 columns within at least one of the electrode sets includes programming active stimulation electrodes of at least one of the first or second electrode sets.

45. The method of claim 44 in which the step of 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.

46. The method of claim 45 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.

47. The method of claim 45 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.

48. The method of claim 44 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.

49. The method of claim 48 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.

50. The method of claim 48 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.

51. The method of claim 43 in which voltage or current of each of the stimulation electrodes programmed in the programming step are independently controlled.

52. The method of claim 51 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.

53. The method of claim 52 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.