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

• US 8,396,559 B2
• Filed: 02/16/2012
• Issued: 03/12/2013
• 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:
  US13/398,693
• Publication Number:
  US 20120158093A1
• Time in Patent Office: 390 Days
• Field of Search: 607/46, 607/116, 607/117
• 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 chord modulation for inhibiting pain with reduced side affects 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 chord region to address low back pain without creating unwanted sensory and/or motor side affects. 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 patient treatment method, comprising:

identifying or instructing identification of a target vertebral level, based at least in part on a patient indication;

implanting or instructing implantation of at least one signal delivery device with an electrical contact of the at least one signal delivery device positioned epidurally at the target vertebral level; and

administering or instructing administration of an electrical signal from the at least one signal delivery device at a frequency of from about 1.5 kHz to about 50 kHz to address the patient indication without the electrical signal creating paresthesia.

2. The method of claim 1, further comprising coupling or instructing coupling of the at least one signal delivery device to a signal generator.

3. The method of claim 2 wherein coupling or instructing coupling includes coupling or instructing coupling of the at least one signal delivery device to an external signal generator.

4. The method of claim 2, further comprising implanting or instructing implantation of the signal generator in the patient.

5. The method of claim 1 wherein the patient indication includes low back pain, and wherein implanting or instructing implantation includes implanting or instructing implantation of the at least one signal delivery device at a vertebral level of T9 to T12, inclusive.

6. The method of claim 1 wherein the patient indication includes leg pain, and wherein implanting or instructing implantation includes implanting or instructing implantation of the at least one signal delivery device at a vertebral level of T9 to T12, inclusive.

7. The method of claim 1 wherein the patient indication includes leg pain and low back pain, and wherein implanting or instructing implantation includes implanting or instructing implantation, of the at least one signal delivery device at a vertebral level of T9 to T12, inclusive, to address both the leg pain and the low back pain.

8. The method of claim 1 wherein the patient indication includes pain associated with shingles and the target vertebral level includes an upper thoracic vertebral level.

9. The method of claim 1 wherein the patient indication includes chronic regional pain syndrome, and the target vertebral level includes a cervical vertebral level.

10. The method of claim 9 wherein the cervical vertebral level includes C3 to C7, inclusive.

11. The method of claim 1 wherein the patient indication includes total body pain, and the target vertebral level includes a cervical vertebral level.

12. The method of claim 11 wherein the cervical vertebral level includes C3 to C7, inclusive.

13. The method of claim 1 wherein the patient indication includes angina, and wherein the target vertebral level is from T3 to T6.

14. The method of claim 1, wherein administering or instructing administration includes administering or instructing administration without the electrical signal creating at least one of:

(a) disruptions that are intrinsically detectable by the patient in sensory signals along the spinal cord, other than pain associated with the indication; and

(b) disruptions that are intrinsically detectable by the patient in motor signals along the spinal cord.

15. The method of claim 1 wherein administering or instructing administration includes administering or instructing administration of the electrical signal at a frequency of from about 3 kHz to about 20 kHz.

16. The method of claim 1 wherein administering or instructing administration includes administering of instructing administration of the electrical signal at a frequency of from about 3 kHz to about 15 kHz.

17. The method of claim 1 wherein administering or instructing administration includes administering or instructing administration of the electrical signal at a frequency of from about 5 kHz to about 15 kHz.

18. The method of claim 1 wherein administering or instructing administration includes administering or instructing administration of the electrical signal at a frequency of from about 3 kHz to about 10 kHz.

19. The method of claim 1 wherein administering or instructing administration of the electrical signal includes administering or instructing administration of the electrical signal without the electrical signal creating disruptions that are intrinsically detectable by the patient in sensory signals along the spinal cord, other than to address the patient indication.

20. The method of claim 1 wherein administering or instructing administration of the electrical signal includes administering or instructing administration of the electrical signal without the electrical signal creating disruptions that are intrinsically detectable by the patient in motor signals along the spinal cord.

21. The method of claim 1 wherein administering or instructing administration of the electrical signal includes administering or instructing administration of the electrical signal without the electrical signal creating disruptions that are intrinsically detectable by the patient in sensory signals along the spinal cord, other than to address patient pain.

22. The method of claim 1 wherein the at least one signal delivery device has a distal portion with one or more electrodes positioned at a vertebral level of from about T9 to about T12.

23. The method of claim 1 wherein the patient indication includes pain.

24. The method of claim 23 wherein addressing the patient indication includes reducing or inhibiting both chronic low-back pain and leg pain.

25. The method of claim 24 wherein reducing or inhibiting both chronic low-back pain and leg pain includes reducing or inhibiting both chronic low back pain and leg pain with a single implanted lead.

26. The method of claim 23 wherein addressing the patient indication includes reducing or inhibiting at least one of chronic low-back pain and leg pain.

27. The method of claim 23, further comprising varying or instructing variation of a current amplitude of the electrical signal from a first value at which the patient'"'"'s pain is reduced or inhibited to a second value at which the patient'"'"'s pain is reduced or inhibited, without causing an increase in patient pain, wherein the second value is more than 60% greater than the first value.

28. The method of claim 23 wherein administering or instructing administration of the electrical signal includes delivering the electrical signal from a single electrical lead having a single axial row of electrical contacts, to address bilateral patient pain.

29. The method of claim 28, wherein administering or instructing administration of the electrical signal from a single lead to address bilateral patient pain includes directing the electrical signal from a location laterally offset from the patient'"'"'s midline.

30. The method of claim 23, wherein addressing the patient indication includes reducing or inhibiting both chronic low-back pain and leg pain by application of the same electrical signal to a single contact or set of contacts.

31. The method of claim 23 wherein addressing the patient indication includes reducing or inhibiting pain with a single implanted lead.

32. The method of claim 1 wherein the electrical signal is administered to a dorsal horn region of the spinal cord.

33. The method of claim 1 wherein the electrical signal is administered with at least one amplitude that is independent of patient position.

34. The method of claim 1 wherein the electrical signal is administered with at least one amplitude that is independent of patient activity.

35. The method of claim 1 wherein the electrical signal is administered with at least one amplitude that is independent of whether the patient is asleep or awake.

36. The method of claim 1, further comprising selecting or instructing selection of at least one amplitude at which the electrical signal is directed, from within a range of amplitudes, and further wherein each amplitude within the range is independent of patient position.

37. The method of claim 1, further comprising selecting or instructing selection of at least one amplitude at which the electrical signal is directed, from within a range of amplitudes, and further wherein each amplitude within the range is independent of patient activity.

38. The method of claim 1, further comprising selecting or instructing selection of at least one amplitude at which the electrical signal is directed, from within a range of amplitudes, and further wherein each amplitude within the range is independent of whether the patient is asleep or awake.

39. The method of claim 1 wherein the electrical signal is administered at a suprathreshold level.

40. The method of claim 1 wherein the electrical signal is a biphasic signal, and wherein individual phases of the signal are applied at approximately equal current amplitudes.

41. The method of claim 1, further comprising placing or instructing placement of the at least one signal delivery device at an epidural position having an axial location and a lateral location without using patient feedback to iteratively adjust (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, or (c) both (a) and (b).

42. The method of claim 1, further comprising:

placing or instructing placement of the at least one signal delivery device at an epidural position without identifying the position using patient feedback.

43. The method of claim 1 wherein administering or instructing administration includes administering or instructing administration of the electrical signal at a frequency of about 10 kHz.

44. A method for treating a patient, comprising:

identifying or instructing identification of a target vertebral level, based at least in part on a patient indication that includes pain;

implanting or instructing implantation of at least one signal delivery device with an electrical contact of the at least one signal delivery device positioned epidurally at the target vertebral level;

implanting or instructing implantation of a signal generator in the patient;

coupling or instructing coupling of the signal generator to the at least one signal delivery device; and

activating or instructing activation of the signal generator to apply an electrical signal to the patient'"'"'s spinal cord via the at least one signal delivery device at a frequency of from about 3 kHz to about 20 kHz to reduce or inhibit the pain without the electrical signal creating paresthesia.

45. The method of claim 44 wherein the patient indication includes low back pain, and wherein implanting the at least one signal delivery device includes implanting the signal delivery device at a vertebral level of T9 to T12, inclusive.

46. The method of claim 44 wherein the patient indication includes leg pain, and wherein implanting the at least one signal delivery device includes implanting the signal delivery device at a vertebral level of T9 to T12, inclusive.

47. The method of claim 44 wherein the patient indication includes leg pain and low back pain, and wherein implanting the at least one signal delivery device includes implanting the signal delivery device at a vertebral level of T9 to T12, inclusive to address both the leg pain and the low back pain.

48. The method of claim 44 wherein the patient indication includes pain associated with shingles and the target vertebral level includes an upper thoracic vertebral level.

49. The method of claim 44 wherein the patient indication includes chronic regional pain syndrome, and the target vertebral level includes a cervical vertebral level.

50. The method of claim 49 wherein the cervical vertebral level includes C3 to C7, inclusive.

51. The method of claim 44 wherein the patient indication includes total body pain, and the target vertebral level includes a cervical vertebral level.

52. The method of claim 51 wherein the cervical vertebral level includes C3 to C7, inclusive.

53. The method of claim 44 wherein activating or instructing activation of the signal generator includes activating or instructing activation of the signal generator to deliver the electrical signal at a frequency of about 10 kHz.

54. The method of claim 44 wherein activating or instructing activation of the signal generator includes activating or instructing activation of the signal generator to deliver the electrical signal at a frequency of from about 3 kHz to about 15 kHz.

55. The method of claim 44 wherein activating or instructing activation of the signal generator includes activating or instructing activation of the signal generator to deliver the electrical signal at a frequency of from about 5 kHz to about 15 kHz.

56. The method of claim 44 wherein activating or instructing administration of the signal generator includes activating or instructing activation of the signal generator to apply the electrical signal without the electrical signal creating disruptions that are intrinsically detectable by the patient in sensory signals along the spinal cord, other than to address the patient indication.

57. The method of claim 44 wherein activating or instructing activation of the signal generator includes activating or instructing activation of the signal generator to apply the electrical signal without the electrical signal creating disruptions that are intrinsically detectable by the patient in motor signals along the spinal cord.

58. The method of claim 44 wherein activating or instructing activation of the signal generator includes activating or instructing activation of signal generator to apply the electrical signal without the electrical signal creating disruptions that are intrinsically detectable by the patient in sensory signals along the spinal cord, other than to address patient pain.

59. The method of claim 44 wherein the at least one signal delivery device has a distal portion with one or more electrodes positioned at a vertebral level of from about T9 to about T12.

60. The method of claim 44 wherein reducing or inhibiting the pain includes reducing or inhibiting both chronic low-back pain and leg pain.

61. The method of claim 60 wherein reducing or inhibiting both chronic low-back pain and leg pain includes reducing or inhibiting both chronic low back pain and leg pain with a single implanted lead.

62. The method of claim 44 wherein reducing or inhibiting pain includes reducing or inhibiting at least one of chronic low-back pain and leg pain.

63. The method of claim 44, further comprising varying or instructing variation of current amplitude of the electrical signal from a first value at which the patient'"'"'s pain is reduced or inhibited to a second value at which the patient'"'"'s pain is reduced or inhibited, without causing, an increase in patient pain, wherein the second value is more than 60% greater than the first value.

64. The method of claim 44 wherein, activating or instructing activation of the signal generator to apply the electrical signal includes delivering the electrical signal from a single electrical lead having a single axial row of electrical contacts, to address bilateral patient pain.

65. The method of claim 64, wherein activating or instructing activation of the signal generator to apply the electrical signal from a single lead to address bilateral patient pain includes directing the electrical signal from a location laterally offset from the patient'"'"'s midline.

66. The method of claim 44, wherein reducing or inhibiting the pain includes reducing or inhibiting both chronic low-back pain and leg pain by application of the same electrical signal to a single contact or set of contacts.

67. The method of claim 44 wherein the electrical signal is directed to a dorsal horn region of the spinal cord.

68. The method of claim 44 wherein the electrical signal is directed with at least one amplitude that is independent of patient position.

69. The method of claim 44 wherein the electrical signal is directed with at least one amplitude that is independent of patient activity.

70. The method of claim 44 wherein the electrical signal is directed with at least one amplitude that is independent of whether the patient is asleep or awake.

71. The method of claim 44, further comprising selecting or instructing selection of at least one amplitude at which the electrical signal is directed, from within a range of amplitudes, and further wherein each amplitude within the range is independent of patient position.

72. The method of claim 44, further comprising selecting or instructing selection of at least one amplitude at which the electrical signal is directed, from within a range of amplitudes, and further wherein each amplitude within the range is independent of patient activity.

73. The method of claim 44, further comprising selecting or instructing selection of at least one amplitude at which the electrical signal is directed, from within a range of amplitudes, and further wherein each amplitude within the range is independent of whether the patient is asleep or awake.

74. The method of claim 44 wherein the electrical signal is administered at a suprathreshold level.

75. The method of claim 44 wherein the electrical signal is a biphasic signal, and wherein individual phases of the signal are applied at approximately equal current amplitudes.

76. The method of claim 44 wherein implanting or instructing implantation of the at least one signal delivery device includes implanting or instructing implantation of the at least one signal delivery device at an epidural position having an axial location and a lateral location without using patient feedback to iteratively adjust (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, or (c) both (a) and (b).

77. The method of claim 44 wherein implanting or instructing implantation of the at least one signal delivery device includes implanting or instructing implantation of the at least one signal delivery device at an epidural position without identifying the position using patient feedback.