Selective high frequency spinal cord modulation for inhibiting pain with reduced side effects, and associated systems and methods

• US 8,359,103 B2
• Filed: 04/13/2012
• Issued: 01/22/2013
• Est. Priority Date: 04/22/2009
• Status: Active Grant

• Current Assignee: Nevro Corporation
• Original Assignee: Nevro Corporation
• Inventors: Alataris, Konstantinos, Walker, Andre B., Parker, Jon, Chitre, Yougandh, Park, Sangsoo Wesley, Thacker, James R.
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Wu, Eugene
• Application Number:
  US13/446,992
• Publication Number:
  US 20120203319A1
• Time in Patent Office: 284 Days
• Field of Search: 607/2, 607/46, 607115-117
• 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 1/06 for high-frequency therapy
• CPC Class Codes: A61N 1/323 Interference currents, i.e. treatment by several currents summed in the body
• 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
• CPC Class Codes: A61N 1/36062 Spinal stimulation
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36089 Addiction or withdrawal from substance abuse such as alcohol or drugs
• CPC Class Codes: A61N 1/36128 Control systems
• CPC Class Codes: A61N 1/36132 using patient feedback
• CPC Class Codes: A61N 1/36157 Current A61N1/3616 takes precedence
• CPC Class Codes: A61N 1/3616 Voltage density or current density
• CPC Class Codes: A61N 1/36164 Sub-threshold or non-excitatory signals non-excitatory signals to the heart A61N1/3628
• CPC Class Codes: A61N 1/36167 Timing, e.g. stimulation onset
• CPC Class Codes: A61N 1/36171 Frequency
• CPC Class Codes: A61N 1/36175 Pulse width or duty cycle
• CPC Class Codes: A61N 1/36178 Burst or pulse train parameters
• CPC Class Codes: A61N 1/36182 Direction of the electrical field, e.g. with sleeve around stimulating electrode
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer
• CPC Class Codes: A61N 1/37241 : providing test stimulations
• CPC Class Codes: A61N 1/37247 : User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 1/37264 : Changing the program; Upgrading firmware
• CPC Class Codes: A61N 1/3787 : from an external energy source
• CPC Class Codes: G01R 21/133 : by using digital technique

Abstract

Selective high-frequency spinal cord modulation for inhibiting pain with reduced side effects and associated systems and methods are disclosed. In particular embodiments, high-frequency modulation in the range of from about 1.5 KHz to about 50 KHz may be applied to the patient'"'"'s spinal cord region to address low back pain without creating unwanted sensory and/or motor side effects. In other embodiments, modulation in accordance with similar parameters can be applied to other spinal or peripheral locations to address other indications.

Claims

1. A method for treating a patient, comprising:

treating or instructing treatment of a contralateral patient indication by delivering or instructing delivery of an electrical signal to a patient'"'"'s spinal cord from only one or more positions that are lateral relative to a midline of the patient'"'"'s spinal cord via at least one implantable signal delivery device, the signal having a frequency of from about 1.5 kHz to about 50 kHz.

2. The method of claim 1 wherein the electrical signal is directed from a single electrical lead having a single axial row of electrical contacts.

3. The method of claim 1 wherein the electrical signal causes bilateral patient pain to be reduced or inhibited.

4. The method of claim 1 wherein the electrical signal reduces or inhibits contralateral pain without the electrical signal creating paresthesia.

5. The method of claim 1, further comprising:

placing or instructing placement of the at least one signal delivery device at the position lateral of the spinal cord midline as at least part of a placement process without using or instructing use of patient feedback during the placement process to at least assist in selecting the position.

6. The method of claim 5 wherein the position has an axial location and a lateral location, and wherein placing or instructing placement includes selecting or instructing selection of the position of the at least one signal delivery device without using or instructing use of patient feedback to adjust one of (a) the axial location of the at least one signal delivery device, or (b) the lateral location of the at least one signal delivery device.

7. The method of claim 6 wherein the position has an axial location and a lateral location, and wherein placing or instructing placement includes selecting or instructing selection of the position of the at least one signal delivery device without using or instructing use of patient feedback to adjust both (a) the axial location of the at least one signal delivery device, and (b) the lateral location of the at least one signal delivery device.

8. The method of claim 1 wherein the electrical signal has a frequency of from about 5 kHz to about 15 kHz.

9. The method of claim 1 wherein the electrical signal has a frequency of from about 3 kHz to about 15 kHz.

10. The method of claim 1 wherein the electrical signal has a frequency of from about 3 kHz to about 20 kHz.

11. The method of claim 1 wherein the electrical signal has a frequency of from about 3 kHz to about 10 kHz.

12. The method of claim 1 wherein the electrical signal has a frequency of about 10 kHz.

13. The method of claim 1 wherein the electrical signal reduces or inhibits at least one of low-back pain and leg pain.

14. The method of claim 1 wherein the electrical signal reduces or inhibits both low-back pain and leg pain.

15. A method for treating a patient, comprising:

reducing or inhibiting, or instructing reduction or inhibition of, contralateral pain in the patient by delivering or instructing delivery of an electrical signal to the patient'"'"'s spinal cord from only one or more positions that are lateral relative to a midline of the patient'"'"'s spinal cord via at least one implantable signal delivery device, the signal having a frequency of from about 1.5 kHz to about 50 kHz.

16. The method of claim 15 wherein the electrical signal reduces or inhibits bilateral pain.

17. The method of claim 15 wherein the electrical signal reduces or inhibits pain in the patient without creating paresthesia.

18. The method of claim 15 wherein the electrical signal is directed from a single electrical lead having a single axial row of electrical contacts.

19. The method of claim 15, further comprising:

placing or instructing placement of the at least one signal delivery device at the position lateral of the spinal cord midline as at least part of a placement process without using or instructing use of patient feedback during the placement process to at least assist in selecting the position.

20. The method of claim 15 wherein the electrical signal has a frequency of from about 5 kHz to about 15 kHz.

21. The method of claim 15 wherein the electrical signal has a frequency of from about 3 kHz to about 15 kHz.

22. The method of claim 15 wherein the electrical signal has a frequency of from about 3 kHz to about 20 kHz.

23. The method of claim 15 wherein the electrical signal has a frequency of from about 3 kHz to about 10 kHz.

24. The method of claim 15 wherein the electrical signal has a frequency of about 10 kHz.

25. The method of claim 15 wherein the electrical signal reduces or inhibits at least one of low-back pain and leg pain.

26. A method for treating a patient, comprising:

reducing or inhibiting, or instructing reduction or inhibition of, contralateral patient pain by activating or instructing activation of a signal generator to apply an electrical signal to the patient'"'"'s spinal cord from only one or more epidural locations that are lateral relative to a midline of the patient'"'"'s spinal cord via at least one implantable signal delivery device, the signal having a frequency of from about 1.5 kHz to about 50 kHz.

27. The method of claim 26 wherein the electrical signal reduces or inhibits bilateral pain.

28. The method of claim 26 wherein the electrical signal reduces or inhibits patient pain without creating paresthesia.

29. The method of claim 26 wherein the electrical signal is directed from a single electrical lead having a single axial row of electrical contacts.

30. The method of claim 26, further comprising:

placing or instructing placement of the at least one signal delivery device at the position lateral of the spinal cord midline as at least part of a placement process without using or instructing use of patient feedback during the placement process to at least assist in selecting the position.

31. The method of claim 26 wherein the electrical signal has a frequency of from about 5 kHz to about 15 kHz.

32. The method of claim 26 wherein the electrical signal has a frequency of from about 3 kHz to about 15 kHz.

33. The method of claim 26 wherein the electrical signal has a frequency of from about 3 kHz to about 20 kHz.

34. The method of claim 26 wherein the electrical signal has a frequency of from about 3 kHz to about 10 kHz.

35. The method of claim 26 wherein the electrical signal has a frequency of about 10 kHz.

36. The method of claim 26 wherein the electrical signal reduces or inhibits at least one of low-back pain and leg pain.

37. A method for treating a patient, comprising:

reducing or inhibiting, or instructing reduction or inhibition of, contralateral pain in the patient by activating or instructing activation of an implanted signal generator to apply an electrical signal to the patient'"'"'s spinal cord from only one or more epidural locations that are lateral relative to a midline of the patient'"'"'s spinal cord via at least one implantable signal delivery device, the signal having a frequency of from about 1.5 kHz to about 50 kHz.

38. The method of claim 37 wherein the electrical signal reduces or inhibits bilateral pain.

39. The method of claim 37 wherein the electrical signal reduces or inhibits pain in the patient without creating paresthesia.

40. The method of claim 37 wherein the electrical signal is directed from a single electrical lead having a single axial row of electrical contacts.

41. The method of claim 37, further comprising:

placing or instructing placement of the at least one signal delivery device at the position lateral of the spinal cord midline as at least part of a placement process without using or instructing use of patient feedback during the placement process to at least assist in selecting the position.

42. The method of claim 37 wherein the electrical signal has a frequency of from about 5 kHz to about 15 kHz.

43. The method of claim 37 wherein the electrical signal has a frequency of from about 3 kHz to about 15 kHz.

44. The method of claim 37 wherein the electrical signal has a frequency of from about 3 kHz to about 20 kHz.

45. The method of claim 37 wherein the electrical signal has a frequency of from about 3 kHz to about 10 kHz.

46. The method of claim 37 wherein the electrical signal has a frequency of about 10 kHz.

47. The method of claim 37 wherein the electrical signal reduces or inhibits at least one of low-back pain and leg pain.

48. A method for treating a patient, comprising:

delivering or instructing delivery of an electrical signal to a patient'"'"'s spinal cord from a position lateral relative to a midline of the patient'"'"'s spinal cord via at least one implantable signal delivery device to treat a contralateral patient indication, the signal having a frequency of from about 1.5 kHz to about 50 kHz and being directed from a single electrical lead having a single axial row of electrical contacts.

49. The method of claim 48 wherein the electrical signal reduces or inhibits contralateral pain without the electrical signal creating paresthesia.

50. The method of claim 48, further comprising:

placing or instructing placement of the at least one signal delivery device at the position lateral of the spinal cord midline as at least part of a placement process without using or instructing use of patient feedback during the placement process to at least assist in selecting the position.

51. The method of claim 48 wherein the electrical signal has a frequency of from about 5 kHz to about 15 kHz.

52. The method of claim 48 wherein the electrical signal has a frequency of from about 3 kHz to about 15 kHz.

53. The method of claim 48 wherein the electrical signal has a frequency of from about 3 kHz to about 20 kHz.

54. The method of claim 48 wherein the electrical signal has a frequency of from about 3 kHz to about 10 kHz.

55. The method of claim 48 wherein the electrical signal has a frequency of about 10 kHz.

56. The method of claim 48 wherein the electrical signal reduces or inhibits at least one of low-back pain and leg pain.

57. A method for treating a patient, comprising:

delivering or instructing delivery of an electrical signal to a patient'"'"'s spinal cord from a position lateral relative to a midline of the patient'"'"'s spinal cord via at least one implantable signal delivery device to treat a contralateral patient indication, the signal having a frequency of from about 1.5 kHz to about 50 kHz, and wherein the electrical signal reduces or inhibits contralateral pain without the electrical signal creating paresthesia.

58. The method of claim 57 wherein the electrical signal is directed from a single electrical lead having a single axial row of electrical contacts.

59. The method of claim 57, further comprising:

placing or instructing placement of the at least one signal delivery device at the position lateral of the spinal cord midline as at least part of a placement process without using or instructing use of patient feedback during the placement process to at least assist in selecting the position.

60. The method of claim 57 wherein the electrical signal has a frequency of from about 5 kHz to about 15 kHz.

61. The method of claim 57 wherein the electrical signal has a frequency of from about 3 kHz to about 15 kHz.

62. The method of claim 57 wherein the electrical signal has a frequency of from about 3 kHz to about 20 kHz.

63. The method of claim 57 wherein the electrical signal has a frequency of from about 3 kHz to about 10 kHz.

64. The method of claim 57 wherein the electrical signal has a frequency of about 10 kHz.

65. The method of claim 57 wherein the electrical signal reduces or inhibits at least one of low-back pain and leg pain.