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

• US 8,355,792 B2
• Filed: 04/13/2012
• Issued: 01/15/2013
• 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:
  US13/446,944
• Publication Number:
  US 20120197369A1
• Time in Patent Office: 277 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:

percutaneously placing or instructing percutaneous placement of at least one signal delivery device at an implanted position along the patient'"'"'s spinal cord 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; and

causing or instructing causation of an electrical signal to be applied to the patient'"'"'s spinal cord via the at least one signal delivery device, the signal having a frequency of from about 1.5 kHz to about 50 kHz.

2. The method of claim 1, further comprising placing or instructing placement of the at least one signal delivery device at a target vertebral level to treat the patient, based at least in part on a patient indication identified prior to the placement process.

3. The method of claim 2 wherein the target vertebral level is a vertebral level predetermined prior to the placement process.

4. The method of claim 2 wherein the patient indication includes at least one of low-back pain and leg pain.

5. The method of claim 2 wherein the patient indication includes both low-back pain and leg pain.

6. The method of claim 1, 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 1 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 placing or instructing placement includes placing or instructing placement without conducting or instructing conduction of a mapping process that correlates reduction or elimination of patient pain with the position of the at least one signal delivery device.

9. The method of claim 1 wherein the patient feedback includes the patient reporting whether or not pain inhibition or reduction is achieved as a function of changes in the position of the at least one signal delivery device.

10. The method of claim 1 wherein the electrical signal is delivered from only a single bipole arrangement of two electrodes.

11. The method of claim 1, further comprising:

coupling or instructing coupling of the at least one signal delivery device to an implanted signal generator without undergoing a trial period during which, after placement of the at least one signal delivery device, the at least one signal delivery device is percutaneously coupled to an external signal generator.

12. The method of claim 1 wherein the electrical signal is directed without the electrical signal creating paresthesia.

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

14. The method of claim 1, further comprising selecting or instructing selection of an amplitude of the electrical signal independent of patient position.

15. The method of claim 1, further comprising selecting or instructing selection of an amplitude of the electrical signal independent of patient activity.

16. The method of claim 1, further comprising selecting or instructing selection of an amplitude of the electrical signal independent of whether the patient is asleep or awake.

17. The method of claim 1 wherein placing or instructing placement includes placing or instructing placement of a single electrical lead having a single axial row of electrical contacts to reduce or inhibit bilateral patient pain.

18. The method of claim 1 wherein placing or instructing placement includes placing or instructing placement of the at least one signal delivery device to apply the electrical signal from a location laterally offset from a midline of the patient'"'"'s spinal cord to reduce or inhibit bilateral patient pain.

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

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

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

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

23. The method of claim 1, wherein placing or instructing placement includes placing or instructing placement without conducting or instructing conduction of a trial-and-error optimization process.

24. The method of claim 1, wherein the at least one signal delivery device includes at least three electrodes, and wherein the placement process includes the selection of at least two electrodes for delivery of the electrical signal.

25. The method of claim 1, wherein the at least one signal delivery device includes at least three electrodes, and wherein the placement process includes the selection of at least two electrodes for delivery of the electrical signal in a bipole arrangement.

26. A method for treating a patient, comprising:

percutaneously placing or instructing percutaneous placement of at least one signal delivery device at an implanted position along the patient'"'"'s spinal cord 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; and

causing or instructing causation of an electrical signal to be applied to the patient'"'"'s spinal cord via the at least one signal delivery device to cause pain in the patient to be reduced or inhibited, the signal having a frequency of from about 1.5 kHz to about 50 kHz.

27. The method of claim 26, further comprising placing or instructing placement of the at least one signal delivery device at a target vertebral level to treat the patient, based at least in part on a patient indication identified prior to the placement process.

28. The method of claim 27 wherein the target vertebral level is a vertebral level predetermined prior to the placement process.

29. The method of claim 27 wherein the patient indication includes at least one of low-back pain and leg pain.

30. The method of claim 27 wherein the patient indication includes both low-back pain and leg pain.

31. The method of claim 26 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.

32. The method of claim 26 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.

33. The method of claim 26 wherein placing or instructing placement includes placing or instructing placement without conducting or instructing conduction of a mapping process that correlates reduction or elimination of patient pain with the position of the at least one signal delivery device.

34. The method of claim 26 wherein the patient feedback includes the patient reporting whether or not pain inhibition or reduction is achieved as a function of changes in the position of the at least one signal delivery device.

35. The method of claim 26, further comprising:

coupling or instructing coupling of the at least one signal delivery device to an implanted signal generator without undergoing a trial period during which, after placement of the at least one signal delivery device, the at least one signal delivery device is percutaneously coupled to an external signal generator.

36. The method of claim 26 wherein the electrical signal is directed without the electrical signal creating paresthesia.

37. The method of claim 26 wherein the electrical signal is directed to a dorsal horn region of the spinal cord.

38. The method of claim 26, further comprising selecting or instructing selection of an amplitude of the electrical signal independent of patient position.

39. The method of claim 26, further comprising selecting or instructing selection of an amplitude of the electrical signal independent of patient activity.

40. The method of claim 26, further comprising selecting or instructing selection of an amplitude of the electrical signal independent of whether the patient is asleep or awake.

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

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

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

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

45. The method of claim 26, wherein placing or instructing placement includes placing or instructing placement without conducting or instructing conduction of a trial-and-error optimization process.

46. The method of claim 26, wherein the at least one signal delivery device includes at least three electrodes, and wherein the placement process includes the selection of at least two electrodes for delivery of the electrical signal.

47. The method of claim 26, wherein the at least one signal delivery device includes at least three electrodes, and wherein the placement process includes the selection of at least two electrodes for delivery of the electrical signal in a bipole arrangement.

48. A method for treating a patient, comprising:

percutaneously placing or instructing percutaneous placement of at least one signal delivery device at an implanted position along the patient'"'"'s spinal cord 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; and

activating or instructing activation of a signal generator to apply an electrical signal to the patient'"'"'s spinal cord via at the least one signal delivery device, the signal having a frequency of from about 1.5 kHz to about 50 kHz.

49. The method of claim 48, 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.

50. The method of claim 48 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.

51. The method of claim 48 wherein placing or instructing placement includes placing or instructing placement without conducting or instructing conduction of a mapping process that correlates reduction or elimination of patient pain with the position of the at least one signal delivery device.

52. The method of claim 48 wherein the patient feedback includes the patient reporting whether or not pain inhibition or reduction is achieved as a function of changes in the position of the at least one signal delivery device.

53. The method of claim 48, further comprising:

coupling or instructing coupling of the at least one signal delivery device to an implanted signal generator without undergoing a trial period during which, after placement of the at least one signal delivery device, the at least one signal delivery device is percutaneously coupled to an external signal generator.

54. The method of claim 48 wherein the electrical signal is directed without the electrical signal creating paresthesia.

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

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

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

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

59. The method of claim 48, wherein placing or instructing placement includes placing or instructing placement without conducting or instructing conduction of a trial-and-error optimization process.

60. The method of claim 48, wherein the at least one signal delivery device includes at least three electrodes, and wherein the placement process includes the selection of at least two electrodes for delivery of the electrical signal.

61. The method of claim 48, wherein the at least one signal delivery device includes at least three electrodes, and wherein the placement process includes the selection of at least two electrodes for delivery of the electrical signal in a bipole arrangement.

62. A method for treating a patient, comprising:

percutaneously placing or instructing percutaneous placement of at least one signal delivery device at an implanted position along the patient'"'"'s spinal cord without using or instructing use of patient feedback during the placement process to at least assist in selecting the position; and

activating or instructing activation of a signal generator to apply an electrical signal to the patient'"'"'s spinal cord via the at least one signal delivery device to cause pain in the patient to be reduced or inhibited, the signal having a frequency of from about 1.5 kHz to about 50 kHz.

63. The method of claim 62 wherein placing or instructing placement includes placing or instructing placement without conducting or instructing conduction of a mapping process that correlates reduction or elimination of patient pain with the position of the at least one signal delivery device.

64. The method of claim 62 wherein the patient feedback includes the patient reporting whether or not pain inhibition or reduction is achieved as a function of changes in the position of the at least one signal delivery device.

65. The method of claim 62, further comprising:

coupling or instructing coupling of the at least one signal delivery device to an implanted signal generator without undergoing a trial period during which, after placement of the at least one signal delivery device, the at least one signal delivery device is percutaneously coupled to an external signal generator.

66. The method of claim 62 wherein the electrical signal is directed without the electrical signal creating paresthesia.

67. The method of claim 62 wherein the electrical signal has a frequency of from about 5 kHz to about 15 kHz.

68. The method of claim 62 wherein the electrical signal has a frequency of from about 3 kHz to about 15 kHz.

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

70. The method of claim 62 wherein the electrical signal has a frequency of from about 3 kHz to about 10 kHz.

71. The method of claim 62, wherein placing or instructing placement includes placing or instructing placement without conducting or instructing conduction of a trial-and-error optimization process.

72. The method of claim 62, wherein the at least one signal delivery device includes at least three electrodes, and wherein the placement process includes the selection of at least two electrodes for delivery of the electrical signal.

73. The method of claim 62, wherein the at least one signal delivery device includes at least three electrodes, and wherein the placement process includes the selection of at least two electrodes for delivery of the electrical signal in a bipole arrangement.

74. A method for treating a patient, comprising:

percutaneously placing or instructing percutaneous placement of at least one signal delivery device at a position along the patient'"'"'s spinal cord 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;

coupling or instructing coupling of the at least one signal delivery device to an implanted signal generator without undergoing a trial period during which, after placement of the at least one signal delivery device, the at least one signal delivery device is percutaneously coupled to an external signal generator; and

causing or instructing causation of an electrical signal to be applied to the patient'"'"'s spinal cord via the at least one signal delivery device, the signal having a frequency of from about 1.5 kHz to about 50 kHz.

75. The method of claim 74 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.

76. The method of claim 74 wherein placing or instructing placement includes placing or instructing placement without conducting or instructing conduction of a mapping process that correlates reduction or elimination of patient pain with the position of the at least one signal delivery device.

77. The method of claim 74 wherein the electrical signal is directed without the electrical signal creating paresthesia.

78. The method of claim 74 wherein the electrical signal has a frequency of from about 5 kHz to about 15 kHz.

79. The method of claim 74 wherein the electrical signal has a frequency of from about 3 kHz to about 15 kHz.

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

81. The method of claim 74 wherein the electrical signal has a frequency of from about 3 kHz to about 10 kHz.

82. The method of claim 74, wherein placing or instructing placement includes placing or instructing placement without conducting or instructing conduction of a trial-and-error optimization process.

83. The method of claim 74, wherein the at least one signal delivery device includes at least three electrodes, and wherein the placement process includes the selection of at least two electrodes for delivery of the electrical signal.

84. The method of claim 74, wherein the at least one signal delivery device includes at least three electrodes, and wherein the placement process includes the selection of at least two electrodes for delivery of the electrical signal in a bipole arrangement.