Multichannel apparatus for epidural spinal cord stimulator

• US 5,501,703 A
• Filed: 01/24/1994
• Issued: 03/26/1996
• Est. Priority Date: 01/24/1994
• Status: Expired due to Term

• Current Assignee: Terry L. Wiles
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Holsheimer, Jan, Struijk, Johannes J.
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): Parker, Marianne
• Application Number:
  US08/185,616
• Time in Patent Office: 792 Days
• Field of Search: 607/39-58, 607/62-64, 607/66-74, 607/116-118, 128/642
• US Class Current: 607/46
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/36071 Pain

Abstract

Apparatus for multi-channel transverse epidural spinal cord stimulation uses a multi-channel pulse generator driving a plurality of electrodes mounted near the distal end of a lead. These electrodes are mounted in one or more lines, generally perpendicular to the lead axis, and have a planar surface along one surface of the lead. The lead is implanted adjacent to spinal cord dura mater with the electrodes transverse and facing the spinal cord. Pulses generated by the pulse generator for each channel are normally simultaneous, of equal amplitude and of equal duration, however the pulse generator is arranged such that pulses for each channel can selectably alternate in time, can selectably be of unequal amplitude, or both. The changes in pulse timing and magnitude permit shifting the electrical stimulation field and the resulting paresthesia pattern after installation to accommodate improper lead placement or postoperative dislocation and to minimize unwanted motor responses.

Claims

1. An apparatus for stimulating neural tissue in a spinal column comprising:

a) a source of electrical pulses having a plurality of channels through which electrical pulses produced by the source of electrical pulses are passed, the source of electrical pulses producing output pulses in each of the channels, the source of electrical pulses having means for independently changing parameters of the output pulses in each channel;

b) a lead adapted to be implanted near the spinal column, the lead connected to the source of electrical pulses, the lead having a proximal and a distal end and a first axis extending parallel to the spinal column when the lead is implanted near the spinal column, the lead having at least a first, a second and a third electrode located substantially in line near the distal end of the lead, the first, second and third electrodes located generally along a second axis that is generally perpendicular to the first axis of the lead, the lead having at least the first and third electrodes each connected to a different channel of the source of electrical pulses and the second electrode being generally centered with respect to the first and third electrodes so that cathode/anode pairs are formed between each of the first and second electrodes and the second and third electrodes, respectively, the source of electrical pulses producing pulses delivered through the channels to at least the respective first and third electrodes, the pulses through the channels to the respective first and third electrodes overlapping in time during at least a portion of each pulse.

2. Apparatus as in claim 1 whereto the source of electrical pulses has means for independently changing timing of the production of each output pulse of each channel with respect to the production of each output pulse of other channels.

3. Apparatus as in claim 1 wherein at least one of the electrodes is generally planar having a first dimension perpendicular to the first axis of the lead and having a second dimension parallel to the first axis of the lead.

4. Apparatus as in claim 1 wherein the source of electrical pulses has two channels and the lead has three electrodes.

9. Apparatus as in claim 1 wherein the source of electrical pulses has means for electrically disconnecting any output channel from a connected electrode.

11. Apparatus as in claim 1 wherein the electrodes connected to a channel output of the source of electrical pulses are spaced apart by a distance about equal to the distance of separation of the dorsal root entry zones of the spinal column near where the lead is implanted.

5. An apparatus for stimulating neural tissue in a spinal column, the spinal column having a dorsal column, the dorsal column having dorsal root entry zones, the apparatus comprising:

a) a neurological source of electrical pulses having a plurality of channels, the source of electrical pulses producing output pulses in each of the channels, the source of electrical pulses having means for independently changing parameters of the output pulses in each channel;

b) an implantable lead adapted to be implanted near the spinal column, the lead connected to the source of electrical pulses, the lead having a proximal and a distal end, an outer surface and a first axis extending parallel to the direction of elongation of the spinal column when the lead is implanted near the spinal column, the lead having at least three electrodes near the distal end of the lead extending along the outer surface of the lead along a second axis that is generally perpendicular to the first axis of the lead, the lead having a first class of electrodes located along two sides of the first axis oi the lead and a second class of electrodes located generally along the first axis of the lead, each electrode of the first class of electrodes being connected to a different channel output of the source of electrical pulses, and each electrode of the second class of electrodes being connected to the common voltage reference of the source of electrical pulses, the source of electrical pulses producing pulses in the first class of electrodes that overlap in time during at least a portion of each pulse.

6. Apparatus as in claim 5 wherein the source of electrical pulses has means for independently changing the timing of the output pulse of a channel with respect to the other channels.

7. Apparatus as in claim 5 wherein the outer surface of the electrodes is planar having a first dimension perpendicular to the first axis of the lead and having a second dimension parallel to the first axis of the lead.

8. Apparatus as in claim 7 wherein the first class of electrodes have a predetermined second dimension and wherein the second class of electrodes have a smaller second dimension than the second dimension of the first class of electrodes.

10. Apparatus as in claim 5 wherein the source of electrical pulses has means for electrically disconnecting any channel and the common voltage reference from a connected electrode.

12. Apparatus as in claim 5 wherein the electrodes in the first class of electrodes are spaced apart by a distance about equal to the separation of the dorsal root entry zones of the spinal column near where the lead is implanted.

13. A system for causing excitation in nerve fibers of a spinal column or other neural tissue of a spinal cord, the spinal column having epidural and intrathecal space and dura, the spinal column having a dorsal column, the dorsal column having dorsal root entry zones, the system comprising:

a. an electrode array comprising a first, a second and a third electrode, the second and third electrodes located on either side of the first electrode, each electrode adapted to be placed in the epidural or intrathecal space of the spinal column;

b. a source of electrical pulses connected to and sending pulses to the electrodes so that cathode/anode pairs are formed between the first and second electrodes and the first and third electrodes, respectively, the pulses sent to the electrodes by the source of electrical pulses to form the cathode/anode pairs overlapping in time for at least a portion of each pulse;

whereby, an electric field of variable strength and location is generated in the neural tissue.

14. The system of claim 13 wherein the source of electrical pulses produces pulses of variable amplitude and the source of electrical pulses sends electrical pulses of variable amplitude to the electrodes.

15. The system of claim 13 wherein the source of electrical pulses produces pulses of variable pulse width and the source of electrical pulses sends electrical pulses of variable pulse width to the electrodes.

16. The system of claim 13 wherein the second and third electrodes are spaced apart by a distance about equal to the separation of the dorsal root entry zones of the spinal column near where the electrode array is placed.

17. The system of claim 13 wherein the pulse width of each of the pulses produced by the source of electrical pulses is identical.

18. The system of claim 13 wherein the amplitude of each of the pulses produced by the source of electrical pulses is identical.

19. The system of claim 13 wherein the electrode array has a generally planar configuration.

20. The system of claim 13 wherein the electrode array substantially conforms to the dura of the spinal column where the electrode array is placed.

21. The system of claim 13 wherein the first, second and third electrodes are located generally along a common axis.

22. A system for causing excitation in nerve fibers of a spinal column or other neural tissue of a spinal cord, the spinal column having a dorsal column, the dorsal column having dorsal root entry zones, the spinal column having epidural and

intrathecal spaces and dura, the system comprising:

a. an electrode array comprising at least a first, a second and a third electrode, the second and third electrodes located on either side of the first electrode, each electrode adapted to be placed in the epidural or intrathecal space of the spinal column, the second and third electrodes being spaced apart by a distance about equal to the separation of the dorsal root entry zones of the spinal column near where the electrode array is placed, the first, second and third electrodes being located generally along a common axis;

b. a source of electrical pulses connected to and sending pulses to the electrodes so that cathode/anode pairs are formed between the first and second electrodes and the first and third electrodes, respectively, the pulses sent to the electrodes by the source of electrical pulses to form the cathode/anode pairs overlapping in. time for at least a portion of each pulse, the source of electrical pulses sending electrical pulses of variable parameters to the electrodes;

whereby, an electric field of variable strength and location is generated in the neural tissue.

23. The system of claim 22 wherein the source of electrical pulses produces pulses of variable amplitude and the source of electrical pulses sends electrical pulses of variable amplitude to the electrodes.

24. The system of claim 22 wherein the source of electrical pulses produces pulses of variable pulse width and the source of electrical pulses sends electrical pulses of variable pulse width to the electrodes.

25. The system of claim 22 wherein the electrode array has a generally planar configuration.

26. The system of claim 22 wherein the electrode array substantially conforms to the dura of the spinal column where the electrode array is placed.

27. A system for causing excitation in nerve fibers of a spinal column or other neural tissue of a spinal cord, the spinal column having a dorsal column, the dorsal column having dorsal root entry zones, the spinal column having epidural and intrathecal spaces and dura, the system comprising:

a. an electrode array comprising at least a first, a second and a third electrode, the second and third electrodes located on either side of the first electrode, each electrode adapted to be placed in the epidural or intrathecal space of the spinal column;

b. a source of electrical pulses connected to and sending pulses to the second and third electrodes, the source of electrical pulses producing and sending electrical pulses of variable parameters, the pulses sent to the second and third electrodes by the source of electrical pulses overlapping in time for at least a portion of each pulse;

c. a common voltage reference connected to the first electrode;

whereby, an electric field of variable strength and location is generated in the neural tissue.

28. The system of claim 27 wherein the source of electrical pulses produces pulses of variable amplitude and the source of electrical pulses sends electrical pulses of variable amplitude to the second and third electrodes.

29. The system of claim 27 wherein the source of electrical pulses produces pulses of variable pulse width and the source of electrical pulses sends electrical pulses of variable pulse width to the second and third electrodes.

30. The system of claim 27 wherein the electrode array has a generally planar configuration.

31. The system of claim 27 wherein the electrode array substantially conforms to the dura of the spinal column where the electrode array is placed.

32. The system of claim 27 wherein the first, second and third electrodes are located generally along a common axis.

33. A system for creating and controlling electric fields in neural tissue comprising:

a. an electrode array comprising at least a first, a second and a third electrode, the second and third electrodes located on either side of the first electrode, the electrodes adapted to be placed near the neural tissue at an optimal distance from the neural tissue;

b. a source of electrical pulses having at least two channels, each channel producing and sending pulses to the second and third electrodes, the source of electrical pulses producing electrical pulses in each channel of variable parameters, the pulses sent to the second and third electrodes by the source of electrical pulses overlapping in time for at least a portion of each pulse;

c. a common voltage. reference connected to the first electrode;

whereby, an electric field of variable strength and location is generated in the neural tissue.

34. The system of claim 33 wherein the source of electrical pulses produces pulses of variable amplitude and the source of electrical pulses sends electrical pulses of variable amplitude to the second and third electrodes.

35. The system of claim 33 whereto the source of electrical pulses produces pulses of variable pulse width and the source of electrical pulses sends electrical pulses of variable pulse width to the second and third electrodes.

36. The system of claim 33 wherein the pulse width of each of the pulses produced by the source of electrical pulses is identical.

37. The system of claim 33 wherein the amplitude of each of the pulses produced by the source of electrical pulses is identical.

38. The system of claim 33 wherein the electrode array has a generally planar configuration.

39. The system of claim 33 wherein the first, second and third electrodes are located generally along a common axis.

40. A method of controlling a volume of neural tissue stimulation in a spinal column or other neural tissue of a spinal cord, the spinal column having epidural and intrathecal spaces and a dorsal column, the dorsal column having dorsal root entry zones, the spinal column having a midline, the method comprising the steps of:

a. placing a first electrode near the midline of the spinal column near the neural tissue to be stimulated at an optimal distance from the neural tissue to be stimulated;

b. placing a second electrode in a preferred location near the neural tissue to be stimulated at an optimum distance from the neural tissue to be stimulated, the second electrode located on a first side of the first electrode so that the second electrode is located on a first side of the midline of the spinal column;

c. placing a third electrode in a preferred location near the neural tissue to be stimulated at an optimal distance from the neural tissue to be stimulated, the third electrode located on a second side of the first electrode opposite the second electrode so that the third electrode is located on a second side of the midline of the spinal column opposite the first side of the midline of the spinal column;

d. creating a cathode/anode relationship between the first electrode and the second electrode;

e. creating a cathode/anode relationship between the first electrode and the third electrode;

f. presenting electrical pulses at each cathode/anode relationship created in steps d. and e., the pulses presented at each cathode/anode relationship overlapping in time during at least a portion of each pulse.

41. The method of claim 40 wherein the electrical pulses presented at each cathode/anode relationship in step f. are variable in amplitude.

42. The method of claim 40 wherein the electrical pulses presented at each cathode/anode relationship in step f. are variable in pulse width.

43. The method of claim 40 wherein, in step d., the first electrode is the cathode and the second electrode is the anode.

44. The method of claim 40 wherein, in step e., the first electrode is the cathode and the third electrode is the anode.

45. The method of claim 40 wherein steps a., b. and c. include placing the first, second and third electrodes in either the epidural or intrathecal space of the spinal column.

46. The method of claim 40 wherein steps b. and c. include placing the second and third electrode, respectively, in either the epidural or intrathecal space of the spinal column near the dorsal root entry zones of the spinal column.

47. The method of claim 40 wherein the pulses presented at each cathode/anode relationship in step f. have a pulse width and the pulse width of the pulses presented at each cathode/anode relationship in step f. is identical.

48. The method of claim 40 wherein the pulses presented at each cathode/anode relationship in step f. have an amplitude and the amplitude of the pulses presented at each cathode/anode relationship in step f. is identical.

49. The method of claim 40 wherein the first, second and third electrodes placed in steps a., b. and c., respectively, are placed in a generally planar configuration.

50. The method of claim 40 wherein the first, second and third electrodes placed in steps a., b. and c. are placed generally along a common axis.

51. A method of controlling a volume of neural tissue stimulation in a spinal column or other neural tissue of a spinal cord, the spinal column having epidural and. intrathecal spaces and a dorsal columm the dorsal column having dorsal root entry zones, the spinal column having a midline, the method comprising the steps of:

a. placing a first electrode near the midline of the spinal column near the neural tissue to be stimulated at an optimal distance from the neural tissue to be stimulated and in either the epidural or intrathecal space of the spinal column;

b. placing a second electrode in a preferred location near the neural tissue to be stimulated at an optimum distance from the neural tissue to be stimulated and in either the epidural or intrathecal space of the spinal column near a dorsal root entry zone of the spinal column, the second electrode located on a first side of the first electrode so that the second electrode is located on a first side of the midline of the spinal column;

c. placing a third electrode in a preferred location near the neural tissue to be stimulated at an optimal distance from the neural tissue to be stimulated and in either the epidural or intrathecal space of the spinal column near a dorsal root entry of the spinal column different from the dorsal root entry zone in step b., the third electrode located on a second side of the first electrode opposite the second electrode so that the third electrode is located on a second side of the midline of the spinal column opposite the first side of the midline of the spinal column;

d. creating a cathode/anode relationship between the first electrode and the second electrode, the first electrode being the cathode and the second electrode being the anode;

e. creating a cathode/anode relationship between the first electrode and the third electrode, the first electrode being the cathode and the third electrode being the anode;

f. presenting electrical pulses at each cathode/anode relationship created in steps d. and e. , the pulses presented at each cathode/anode relationship overlapping in time during at least a portion of each pulse.

52. The method of claim 51 wherein the first, second and third electrodes placed in steps a., b. and c., respectively, are placed in a generally planar configuration.

53. The method of claim 51 wherein the first, second and third electrodes placed in steps a., b. and c. are placed generally along a common axis.

54. A method of controlling a volume of neural tissue stimulation in a spinal column or other neural tissue of a spinal column the spinal column having epidural and intrathecal spaces and a dorsal column the dorsal column having dorsal root entry zones, the spinal column having a midline, the method comprising the steps of:

a. placing a first electrode near the midline of the spinal column near the neural tissue to be stimulated at an optimal distance from the neural tissue to be stimulated;

b. placing a second electrode in a preferred location near the neural tissue to be stimulated at an optimum distance from the neural tissue to be stimulated, the second electrode located on a first side of the first electrode so that the second electrode is located on a first side of the midline of the spinal column;

c. placing a third electrode in a preferred location near the neural tissue to be stimulated at an optimal distance from the neural tissue to be stimulated, the third electrode located on a second side of the first electrode opposite the second electrode so that the third electrode is located on a second side of the midline of the spinal column opposite the first side of the midline of the spinal column;

d. connecting the first electrode to a common voltage reference;

e. connecting a different channel of a source of electrical pulses having at least two channels to each of the second and third electrodes, respectively, the source of electrical pulses capable of producing electrical pulses in each channel of variable parameters;

f. producing electrical pulses in each channel of variable parameters, the pulses produced in each channel overlapping in time during at least a portion of each pulse.

55. The method of claim 54 wherein the step of producing electrical pulses includes the step of producing electrical pulses of variable amplitude.

56. The method of claim 54 wherein the step of producing electrical pulses includes the step of producing electrical pulses of variable pulse width.

57. The method of claim 54 wherein steps a., b. and c. include placing the first, second and third electrodes in either the epidural or intrathecal space of the spinal column.

58. The method of claim 54 wherein steps b. and c. include placing the second and third electrode, respectively, in either the epidural or intrathecal space of the spinal column near the dorsal root entry zones of the spinal column.

59. The method of claim 54 wherein the pulse width of each of the pulses produced in step f. is identical.

60. The method of claim 54 wherein the amplitude of each of the pulses produced in step f. is identical.

61. The method of claim 54 wherein the first, second and third electrodes placed in steps a., b. and e., respectively, are placed in a generally planar configuration.

62. The method of claim 54 wherein the first, second and third electrodes placed in steps a., b. and c. are placed generally along a common axis.

63. A lead adapted to be implanted near a spinal column the lead comprising a proximal and having a distal end and a first axis extending parallel the spinal column when the lead is implanted near the spinal column, the lead having at least a first, a second and a third electrode, the first, second and third electrode being aligned substantially in line near the distal end of the lead and being aligned generally along a second axis that is generally perpendicular to the first axis of the lead, the first and second electrodes each being connectable to a different channel of a source of electrical pulses having at least three different channels, the third electrode being generally centered with respect to the first and second electrodes, the third electrode being connectable to a channel of the source of electrical pulses different from the channels that the first and second electrodes are connectable to.

64. A lead adapted to be implanted near a spinal column the lead comprising a proximal and a distal end and a first axis extending parallel to the spinal column when the lead is implanted near the spinal column, the lead having at least a first, a second and a third electrode, the first, second and third electrode being aligned substantially in line near the distal end of the lead and being aligned generally along a second axis that is generally perpendicular to the first axis of the lead, the first and second electrodes each being connectable to a different channel of a source of electrical pulses having at least two different channels, the third electrode being generally centered with respect to the first and second electrodes, the third electrode being connectable to a reference voltage.

65. A lead adapted to be implanted near a spinal column, the lead comprising a proximal and a distal end and a first axis extending parallel to the spinal column when the lead is implanted near the spinal column, the lead having at least a first, a second and a third electrode, the first, second and third electrode being aligned substantially in line near the distal end of the lead and being aligned generally along a second axis that is generally perpendicular to the first axis of the lead, the first and second electrodes each being connectable to a different channel of a source of electrical pulses having at least two different channels, the third electrode being generally centered with respect to the first and second electrodes, the third electrode being connectable to an electrical ground.

66. An apparatus for stimulating neural tissue in a spinal column comprising:

a) a source of electrical pulses having a plurality of channels through which electrical pulses produced by the source of electrical pulses are passed, the source of electrical pulses producing output pulses in each of the channels, the source of electrical pulses having means for independently changing parameters of the output pulses in each channel;

b) a lead adapted to be implanted near the spinal column, the lead connected to the source of electrical pulses, the lead having a proximal and a distal end and a first axis extending parallel to the spinal column when the lead is implanted near the spinal column, the lead having at least a first, a second and a third electrode located substantially in line near the distal end of the lead, the second electrode being smaller than either the first or third electrodes, the first, second and third electrodes located generally along a second axis that is generally perpendicular to the first axis of the lead, the lead having at least the first and third electrodes each connected to a different channel of the source of electrical pulses and the second electrode being generally centered with respect to the first and third electrodes so that cathode/anode pairs are formed between each of the first and second electrodes and the second and third electrodes, respectively, the source of electrical pulses producing pulses delivered through the channels to at least the respective first and third electrodes, the pulses through the channels to the respective first and third electrodes overlapping in time during at least a portion of each pulse.

67. Apparatus as in claim 66 wherein the source of electrical pulses has means for independently changing timing of the production of each output pulse of each channel with respect to the production of each output pulse of other channels.

68. Apparatus as in claim 66 wherein at least one of the electrodes is generally planar having a first dimension perpendicular to the first axis of the lead and having a second dimension parallel to the first axis of the lead.

69. An apparatus for stimulating neural tissue in a spinal column comprising:

a) a source of electrical pulses having a plurality of channels through which electrical pulses produced by the source of electrical pulses are passed, the source of electrical pulses producing output pulses in each of the channels, the source of electrical pulses having means for independently changing parameters of the output pulses in each channel, the source of electrical pulses having a common voltage reference;

b) a lead adapted to be implanted near the spinal column, the lead connected to the source of electrical pulses, the lead having a proximal and a distal end and a first axis extending parallel to the spinal column when the lead is implanted near the spinal column, the lead having at least a first, a second and a third electrode located substantially in line near the distal end of the lead, the first, second and third electrodes located generally along a second axis that is generally perpendicular to the first axis of the lead, the lead having at least the first and third electrodes each connected to a different channel of the source of electrical pulses and the second electrode being generally centered with respect to the first and third electrodes so that cathode/anode pairs are formed between each of the first and second electrodes and the second and third electrodes, respectively, the second electrode being connected to the common voltage reference, the source of electrical pulses producing pulses delivered through the channels to at least the respective first and third electrodes, the pulses through the channels to the respective first and third electrodes overlapping in time during at least a portion of each pulse.

70. An apparatus for stimulating neural tissue in a spinal column comprising:

a) a source of electrical pulses having a plurality of channels through which electrical pulses produced by the source of electrical pulses are passed, the source of electrical pulses producing output pulses in each of the channels, the source of electrical pulses having means for independently changing parameters of the output pulses in each channel;

b) a lead adapted to be implanted near the spinal column, the lead connected to the source of electrical pulses, the lead having a proximal and a distal end and a first axis extending parallel to the spinal column when the lead is implanted near the spinal column, the lead having at least a first, a second and a third electrode located substantially in line near the distal end of the lead, the first, second and third electrodes located generally along a second axis that is generally perpendicular to the first axis of the lead, the lead having at least the first and third electrodes each connected to a different channel of the source of electrical pulses and the second electrode being generally centered with respect to the first and third electrodes so that cathode/anode pairs are formed between each of the first and second electrodes and the second and third electrodes, respectively, the source of electrical pulses producing pulses delivered through the channels to at least the respective first and third electrodes, the pulses through the channels to the respective first and third electrodes overlapping in time during at least a portion of each pulse, the first, second and third electrodes being generally planar and having a first dimension perpendicular to the first axis of the lead and having a second dimension parallel to the first axis of the lead, wherein the second electrode has a smaller second dimension than the second dimensions of either the first or third electrodes.