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

• US 8,989,865 B2
• Filed: 09/14/2012
• Issued: 03/24/2015
• 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:
  US13/620,235
• Publication Number:
  US 20130172955A1
• Time in Patent Office: 921 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 100 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 spinal cord modulation system for reducing or eliminating pain in a patient, the system comprising:

a signal generator configured to generate a therapy signal in accordance with a therapy regimen, wherein at least a portion of the therapy signal is at a frequency in a frequency range from 1.5 kHz to 50 kHz;

an implantable signal delivery device electrically coupled to the signal generator and configured to deliver the therapy signal to one or more target locations of the patient'"'"'s spinal cord; and

a programmer in wireless communication with the signal generator and configured to program the therapy regimen within the signal generator, wherein the therapy signal regimen includes

(a) a target location, and

(b) a current amplitude that at least partially reduces the patient'"'"'s sensation of pain without generating a sensation of paresthesia.

2. The system of claim 1, wherein the frequency range is from 3 kHz to 20 kHz.

3. The system of claim 1, wherein the frequency range is from 3 kHz to 15 kHz.

4. The system of claim 1, wherein the frequency range is from 5 kHz to 15 kHz.

5. The system of claim 1, wherein the frequency range is from 3 kHz to 10 kHz.

6. The system of claim 1, wherein the portion of the therapy signal is at a frequency of 10 kHz.

7. The system of claim 1, wherein the current amplitude is less than 20 mA.

8. The system of claim 1, wherein the current amplitude is less than 10 mA.

9. The system of claim 1, wherein the current amplitude is less than 8 mA.

10. The system of claim 1, wherein the current amplitude is between 0.1 mA and 20 mA.

11. The system of claim 1, wherein the current amplitude is between 0.5 mA and 10 mA.

12. The system of claim 1, wherein the implantable signal delivery device is a percutaneous lead configured to be implanted in the epidural space.

13. The system of claim 1, wherein the implantable signal delivery device is a paddle lead configured to be implanted at the target location.

14. The system of claim 1, wherein the target location is at a vertebral level ranging from T9 to T12.

15. The system of claim 1, wherein the target location is at a vertebral level ranging from T9 to T10.

16. A spinal cord modulation system for reducing or eliminating pain in a patient without relying on paresthesia or tingling to mask the patients sensation of the pain, the system comprising:

an implantable signal generator configured to generate a therapy signal in accordance with one or more therapy signal parameters;

a signal delivery device electrically coupled to the implantable signal generator and configured to deliver the therapy signal to the patient'"'"'s spinal cord region; and

an external programmer in wireless communication with the implantable signal generator and configured to modify the one or more therapy signal parameters in the implantable signal generator,

wherein the one or more therapy signal parameters include at least a portion of the therapy signal being

(a) at a frequency in a frequency range from 1.5 kHz to 100 kHz, and

(b) at a current amplitude that at least partially reduces the patients sensation of pain without generating a sensation of paresthesia or tingling in the patient.

17. The system of claim 16, wherein the signal delivery device is an elongated lead having one or more electrodes positioned to direct the therapy signal to a target location.

18. The system of claim 17, wherein the target location is at a vertebral level ranging from T9 to T12.

19. The system of claim 17, wherein the target location is at a vertebral level ranging from T9 to T10.

20. The system of claim 16, wherein the frequency range is from 1.5 kHz to 50 kHz.

21. The system of claim 16, wherein the frequency range is from 3 kHz to 20 kHz.

22. The system of claim 16, wherein the frequency range is from 3 kHz to 15 kHz.

23. The system of claim 16, wherein the frequency range is from 5 kHz to 15 kHz.

24. The system of claim 16, wherein the frequency range is from 3 kHz to 10 kHz.

25. The system of claim 16, wherein the portion of the therapy signal is at a frequency of 10 kHz.

26. The system of claim 16, wherein the current amplitude is less than 20 mA.

27. The system of claim 16, wherein the current amplitude is less than 10 mA.

28. The system of claim 16, wherein the current amplitude is less than 8 mA.

29. The system of claim 16, wherein the current amplitude is between 0.1 mA and 20 mA.

30. The system of claim 16, wherein the current amplitude is between 0.5 mA and 10 mA.

31. The system of claim 16, wherein the signal delivery device is a percutaneous lead configured to be implanted in the patient'"'"'s epidural space.

32. The system of claim 16, wherein the signal delivery device is a paddle lead configured to be implanted at a target location.

33. The system of claim 16, wherein the therapy signal parameters are programmed to be modified without the use of patient feedback.

34. A system for reducing or eliminating pain in a patient, the system comprising:

an external signal generator configured to generate a non-paresthesia-producing therapy signal in accordance with a therapy regimen, wherein at least a portion of the therapy signal is at a frequency in a frequency range from 1.5 kHz to 100 kHz;

an implantable signal delivery device configured to deliver the therapy signal from the signal generator to at least one target location at the patient'"'"'s spinal cord region; and

an extension coupleable between the external signal generator and the signal delivery device to transmit the therapy signal from the signal generator to the signal delivery device.

35. The system of claim 34, wherein the therapy regimen includes delivering the therapy signal at a duty cycle.

36. The system of claim 35, wherein the duty cycle is 50-100%.

37. The system of claim 34, wherein the frequency range is from 1.5 kHz to 50 kHz.

38. The system of claim 34, wherein the frequency range is from 3 kHz to 20 kHz.

39. The system of claim 34, wherein the frequency range is from 3 kHz to 15 kHz.

40. The system of claim 34, wherein the frequency range is from 5 kHz to 15 kHz.

41. The system of claim 34, wherein the frequency range is from 3 kHz to 10 kHz.

42. The system of claim 34, wherein the frequency is 10 kHz.

43. The system of claim 34, wherein a current amplitude of the therapy signal is between 0.5 mA and 10 mA.

44. The system of claim 34, wherein a current amplitude of the therapy signal is between 0.5 mA and 4 mA.

45. The system of claim 34, wherein the therapy signal includes a plurality of pulses having a pulse width between 10 microseconds and 333 microseconds.

46. The system of claim 34, wherein the therapy signal includes a plurality of pulses having a pulse width between 25 microseconds and 166 microseconds.

47. The system of claim 34, wherein the therapy signal includes a plurality of pulses having a pulse width between 33 microseconds and 100 microseconds.

48. The system of claim 34, wherein the therapy signal includes a plurality of pulses having a pulse width between 33 microseconds and 35 microseconds.

49. The system of claim 34, further comprising a patient remote having a wireless transmitter configured to transmit instructions to the external signal generator.

50. The system of claim 34 wherein the implantable signal delivery device is a percutaneous lead configured to be implanted in the patient'"'"'s epidural space.

51. The system of claim 34, wherein the implantable signal delivery device is a paddle lead configured to be implanted at the at least one target location.

52. A system for reducing or eliminating pain in a patient, the system comprising:

an implantable signal generator configured to generate a non-paresthesia-producing therapy signal in accordance with a therapy regimen, wherein at least a portion of the therapy signal is at a frequency in a frequency range from 1.5 kHz to 100 kHz;

an implantable signal delivery device configured to deliver the therapy signal from the implantable signal generator to at least one target location at the patients spinal cord region; and

an extension coupleable between the implantable signal generator and the signal delivery device to transmit the therapy signal from the signal generator to the signal delivery device.

53. The system of claim 52, wherein the therapy regimen includes delivering the therapy signal at a duty cycle.

54. The system of claim 53, wherein the duty cycle is 50-100%.

55. The system of claim 52, wherein the frequency range is from 1.5 kHz to 50 kHz.

56. The system of claim 52, wherein the frequency range is from 3 kHz to 20 kHz.

57. The system of claim 52, wherein the frequency range is from 3 kHz to 15 kHz.

58. The system of claim 52, wherein the frequency range is from 5 kHz to 15 kHz.

59. The system of claim 52, wherein the frequency range is from 3 kHz to 10 kHz.

60. The system of claim 52, wherein the frequency is 10 kHz.

61. The system of claim 52, wherein a current amplitude of the therapy signal is between 0.5 mA and 10 mA.

62. The system of claim 52, wherein a current amplitude of the therapy signal is between 0.5 mA and 4 mA.

63. The system of claim 52, wherein the therapy signal includes a plurality of pulses having a pulse width between 10 microseconds and 333 microseconds.

64. The system of claim 52, wherein the therapy signal includes a plurality of pulses having a pulse width between 25 microseconds and 166 microseconds.

65. The system of claim 52, wherein the therapy signal includes a plurality of pulses having a pulse width between 33 microseconds and 100 microseconds.

66. The system of claim 52, wherein the therapy signal includes a plurality of pulses having a pulse width between 33 microseconds and 35 microseconds.

67. The system of claim 52, further comprising a patient remote having a wireless transmitter and configured to transmit instructions to the implantable signal generator.

68. The system of claim 52, wherein the implantable signal generator includes a rechargeable battery, and wherein the system further comprises an external charger configured to wirelessly recharge the battery.

69. The system of claim 52, wherein the implantable signal delivery device is a percutaneous lead configured to be implanted in the patient'"'"'s epidural space.

70. The system of claim 52, wherein the implantable signal delivery device is a paddle lead configured to be implanted at the at least one target location.