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

• US 8,170,675 B2
• Filed: 09/26/2011
• Issued: 05/01/2012
• 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:
  US13/245,450
• Publication Number:
  US 20120016437A1
• Time in Patent Office: 218 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 method for treating a patient, comprising:

applying or instructing application of an epidural, pulsed electrical signal to the patient'"'"'s spinal cord via at least one implantable electrical lead with at least some electrical contacts on the lead positioned at a vertebral level of from about T9 to about T12, the signal having a frequency of from about 3 kHz to about 20 kHz; and

reducing or inhibiting chronic low-back pain and leg pain in the patient through application of the pulsed electrical signal, without the electrical signal creating paresthesia.

2. The method of claim 1 wherein reducing or inhibiting chronic low-back pain and leg pain includes reducing or inhibiting 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 low-back pain and leg pain signals;

and

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

3. The method of claim 1, further comprising placing or instructing placement of the at least one lead 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 lead, or (b) the lateral location of the at least one lead, or (c) both (a) and (b).

4. 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.

5. The method of claim 4 wherein the epidural position has an axial location and a lateral location, and wherein placing or instructing placement includes identifying the epidural position of the at least one signal delivery device without using patient feedback to iteratively adjust (a) the axial location of the signal delivery device, or (b) the lateral location of the signal delivery device, or (c) both (a) and (b).

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

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

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

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

10. The method of claim 1 wherein applying or instructing application of the electrical signal includes applying or instructing application of the electrical signal with at least one amplitude that is independent of patient position.

11. The method of claim 1 wherein applying or instructing application of the electrical signal includes applying or instructing application of the electrical signal with at least one amplitude that is independent of patient activity.

12. The method of claim 1 wherein applying or instructing application of the electrical signal includes applying or instructing application of the electrical signal with at least one amplitude that is independent of whether the patient is asleep or awake.

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

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

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

16. A method for treating a patient, comprising:

causing a pulsed electrical signal to be applied epidurally to the patient'"'"'s spinal cord via at least one implantable electrical lead, the signal having a frequency of from about 1.5 kHz to about 50 kHz; and

reducing or inhibiting at least one of chronic low-back pain and leg pain in the patient through application of the pulsed electrical signal, without the electrical signal creating paresthesia.

17. The method of claim 16 wherein reducing or inhibiting at least one of chronic low-back pain and leg pain further includes reducing or inhibiting 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 low-back pain and leg pain signals;

and

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

18. The method of claim 16 wherein the at least one lead has a distal portion with one or more electrodes positioned at a vertebral level of from about T9 to about T12.

19. The method of claim 16 wherein the electrical signal is caused to be applied to a dorsal horn region of the spinal cord.

20. The method of claim 16, further comprising placing or instructing placement of the at least one lead 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 lead, or (b) the lateral location of the at least one lead, or (c) both (a) and (b).

21. The method of claim 16, further comprising:

placing or instructing placement of the at least one implantable electrical lead at an epidural position without identifying the position using patient feedback.

22. The method of claim 16 wherein reducing or inhibiting includes reducing or inhibiting both chronic low-back pain and leg pain.

23. The method of claim 22 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.

24. The method of claim 16 wherein causing the electrical signal to be applied to the patient'"'"'s spinal cord includes delivering the electrical signal from a single electrical lead having a single axial row of electrical contacts, to address bilateral patient pain.

25. The method of claim 24, wherein delivering 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.

26. The method of claim 16 wherein the electrical signal has a frequency of from about 5 kHz to about 15 kHz.

27. The method of claim 16 wherein the electrical signal has a frequency of from about 3 kHz to about 15 kHz.

28. The method of claim 16 wherein the electrical signal has a frequency of from about 3 kHz to about 20 kHz.

29. The method of claim 16 wherein the electrical signal has a frequency of from about 3 kHz to about 10 kHz.

30. The method of claim 16 wherein the electrical signal has a frequency of about 10 kHz.

31. The method of claim 16 wherein the electrical signal is caused to be applied with at least one amplitude that is independent of patient position.

32. The method of claim 16 wherein the electrical signal is caused to be applied with at least one amplitude that is independent of patient activity.

33. The method of claim 16 wherein the electrical signal is caused to be applied with at least one amplitude that is independent of whether the patient is asleep or awake.

34. The method of claim 16, further comprising selecting or instructing selection of at least one amplitude at which the electrical signal is applied, from within a range of amplitudes, and further wherein each amplitude within the range is independent of patient position.

35. The method of claim 16, further comprising selecting or instructing selection of at least one amplitude at which the electrical signal is applied, from within a range of amplitudes, and further wherein each amplitude within the range is independent of patient activity.

36. The method of claim 16, further comprising selecting or instructing selection of at least one amplitude at which the electrical signal is applied, from within a range of amplitudes, and further wherein each amplitude within the range is independent of whether the patient is asleep or awake.

37. The method of claim 16, 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.

38. The method of claim 16 wherein application of the electrical signal includes application of the electrical signal at a suprathreshold level.

39. The method of claim 16 wherein application of the electrical signal includes application of a biphasic signal, and wherein individual phases of the signal are applied at approximately equal current amplitudes.

40. A method for treating a patient, comprising:

activating or instructing activation of a signal generator to apply a pulsed electrical signal to the patient'"'"'s spinal cord via at least one implantable signal delivery device at a frequency of from about 1.5 kHz to about 50 kHz; and

administering or instructing administration of the electrical signal without the electrical signal creating paresthesia while reducing or inhibiting at least one of chronic low-back pain and leg pain in the patient through application of the pulsed electrical signal.

41. The method of claim 40 wherein the signal delivery device is positioned at a vertebral level of from about T9 to about T12, and wherein reducing or inhibiting at least one of chronic low-back pain and leg pain includes reducing or inhibiting 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 low back pain and leg pain signals;

and

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

42. The method of claim 40 wherein administering or instructing administration of the electrical signal includes administering or instructing administration of the electrical signal via at least one lead having a distal portion with one or more electrodes positioned at a vertebral level of from about T9 to about T12.

43. The method of claim 40 wherein administering or instructing administration of the electrical signal includes administering or instructing administration of the electrical signal to a dorsal horn region of the spinal cord.

44. The method of claim 40, 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.

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

46. The method of claim 40 wherein reducing or inhibiting includes reducing or inhibiting both chronic low-back pain and leg pain.

47. The method of claim 46 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.

48. The method of claim 40 wherein administering or instructing administration of the electrical signal includes administering or instructing administration of the electrical signal from a single electrical lead having a single axial row of electrical contacts, to address bilateral patient pain.

49. The method of claim 48, wherein administering or instructing administration of the electrical signal from a single lead to address bilateral patient pain includes administering or instructing administration of the electrical signal from a location laterally offset from the patient'"'"'s midline.

50. The method of claim 40 wherein the electrical signal has a frequency of from about 5 kHz to about 15 kHz.

51. The method of claim 40 wherein the electrical signal has a frequency of from about 3 kHz to about 15 kHz.

52. The method of claim 40 wherein the electrical signal has a frequency of from about 3 kHz to about 20 kHz.

53. The method of claim 40 wherein the electrical signal has a frequency of from about 3 kHz to about 10 kHz.

54. The method of claim 40 wherein the electrical signal has a frequency of about 10 kHz.

55. The method of claim 40 wherein administering or instructing administration of the electrical signal includes administering or instructing administration of the electrical signal with at least one amplitude that is independent of patient position.

56. The method of claim 40 wherein administering or instructing administration of the electrical signal includes administering or instructing administration of the electrical signal with at least one amplitude that is independent of patient activity.

57. The method of claim 40 wherein administering or instructing administration of the electrical signal includes administering or instructing administration of the electrical signal with at least one amplitude that is independent of whether the patient is asleep or awake.

58. The method of claim 40, further comprising selecting or instructing selection of at least one amplitude at which the electrical signal is applied, from within a range of amplitudes, and further wherein each amplitude within the range is independent of patient position.

59. The method of claim 40, further comprising selecting or instructing selection of at least one amplitude at which the electrical signal is applied, from within a range of amplitudes, and further wherein each amplitude within the range is independent of patient activity.

60. The method of claim 40, further comprising selecting or instructing selection of at least one amplitude at which the electrical signal is applied, from within a range of amplitudes, and further wherein each amplitude within the range is independent of whether the patient is asleep or awake.

61. The method of claim 40, 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.

62. The method of claim 40 wherein administering or instructing administration of the electrical signal includes administering or instructing administration of the electrical signal at a suprathreshold level.

63. The method of claim 40 wherein administering or instructing administration of the electrical signal includes administering or instructing administration of a biphasic signal, and wherein individual phases of the signal are applied at approximately equal current amplitudes.

64. A method for treating a patient, comprising:

implanting or instructing implantation of at least one electrical lead at an epidural position proximate to the patient'"'"'s spinal cord;

coupling or instructing coupling of a signal generator to the at least one lead; and

activating or instructing activation of the signal generator to apply a pulsed electrical signal to the patient'"'"'s spinal cord via the at least one lead at a frequency of from about 1.5 kHz to about 50 kHz to cause reduction or inhibition of at least one of chronic low-back pain and leg pain in the patient through application of the pulsed electrical signal without the electrical signal creating paresthesia.

65. The method of claim 64 wherein implanting or instructing implantation includes implanting or instructing implantation of the at least one electrical lead with at least some electrical contacts of the lead located at a vertebral level of from about T9 to about T12.

66. The method of claim 64 wherein the electrical signal is applied to a dorsal horn region of the spinal cord.

67. The method of claim 64 wherein the epidural position has an axial location and a lateral location and wherein the method, further comprises:

placing or instructing placement of the at least one lead at the epidural position without using patient feedback to iteratively adjust (a) the axial location of the at least one lead, or (b) the lateral location of the at least one lead, or (c) both (a) and (b).

68. The method of claim 64, further comprising 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.

69. The method of claim 64 wherein activating or instructing activation includes activating or instructing activation to cause reduction or inhibition of both chronic low-back pain and leg pain.

70. The method of claim 64 wherein activating or instructing activation includes activating or instructing activation to cause reduction or inhibition of both chronic low-back pain and leg pain with a single implanted lead.

71. The method of claim 64 wherein implanting or instructing implantation includes implanting or instructing implantation of a single electrical lead having a single axial row of electrical contacts to address bilateral patient pain.

72. The method of claim 71, wherein activating or instructing activation includes activating or instructing activation of the signal generator to apply the electrical signal from a location laterally offset from the patient'"'"'s midline.

73. The method of claim 64, further comprising implanting or instructing implantation of the signal generator in the patient, and wherein the electrical signal is applied or instructed to be applied at a frequency of from about 5 to about 15 kHz.

74. The method of claim 64 wherein the electrical signal has a frequency of from about 3 kHz to about 20 kHz.

75. The method of claim 64 wherein the electrical signal has a frequency of from about 3 kHz to about 15 kHz.

76. The method of claim 64 wherein the electrical signal has a frequency of from about 3 kHz to about 10 kHz.

77. The method of claim 64 wherein the electrical signal is applied with at least one amplitude that is independent of patient position.

78. The method of claim 64 wherein the electrical signal is applied with at least one amplitude that is independent of patient activity.

79. The method of claim 64 wherein the electrical signal is applied with at least one amplitude that is independent of whether the patient is asleep or awake.

80. The method of claim 64, further comprising selecting or instructing selection of at least one amplitude at which the electrical signal is applied, from within a range of amplitudes, and further wherein each amplitude within the range is independent of patient position.

81. The method of claim 64, further comprising selecting or instructing selection of at least one amplitude at which the electrical signal is applied, from within a range of amplitudes, and further wherein each amplitude within the range is independent of patient activity.

82. The method of claim 64, further comprising selecting or instructing selection of at least one amplitude at which the electrical signal is applied, from within a range of amplitudes, and further wherein each amplitude within the range is independent of whether the patient is asleep or awake.

83. The method of claim 64, 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.

84. The method of claim 64 wherein the electrical signal is applied at a suprathreshold level.

85. The method of claim 64 wherein the electrical signal includes a biphasic signal, and wherein individual phases of the signal are applied at approximately equal current amplitudes.