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

• US 8,712,533 B2
• Filed: 04/22/2010
• Issued: 04/29/2014
• 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:
  US12/765,747
• Publication Number:
  US 20100274314A1
• Time in Patent Office: 1,468 Days
• Field of Search: 607/2, 607/46, 607115-117, 607/154
• 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 spinal cord modulation system for reducing or eliminating pain in a patient, the system comprising:

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

an implantable signal delivery device electrically coupleable to the signal generator and configured to deliver the therapy signal to the patient'"'"'s spinal cord region.

2. The system of claim 1, wherein the signal generator generates the therapy signal at a duty cycle.

3. The system of claim 2, wherein the duty cycle is 100%.

4. The system of claim 2, wherein the duty cycle is 50-100%.

5. The system of claim 2, wherein the frequency in the frequency range from 1.5 kHz to 100 kHz is applied throughout the length of an on period in the duty cycle.

6. The system of claim 2, wherein the frequency in the frequency range from 1.5 kHz to 100 kHz is applied during a portion of an on period in the duty cycle.

7. The system of claim 1, wherein the frequency range is from 1.5 kHz to 50 kHz.

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

9. The system of claim 1, wherein the therapy signal is delivered at a current amplitude between about 0.1 mA to about 3 mA.

10. The system of claim 1, wherein the therapy signal is delivered at a suprathreshold current amplitude.

11. The system of claim 1, wherein at least a portion of the therapy signal is a square-wave signal.

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

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

14. The system of claim 1, wherein the signal delivery device is an elongated lead having one or more electrodes configured to direct the therapy signal to a target location.

15. The system of claim 1, wherein the signal delivery device is an elongated lead having a bipole arrangement of electrodes.

16. The system of claim 1, wherein at least a portion of the therapy signal has a pulse width in a pulse width range from 25 microseconds to 166 microseconds.

17. The system of claim 1, wherein at least a portion of the therapy signal has a pulse width in a pulse width range from 30 microseconds to 35 microseconds.

18. A spinal cord modulation system for reducing or eliminating pain in a patient, the system comprising:

a signal generator configured to generate a non-paresthesia-producing therapy signal, wherein at least a portion of the therapy signal is at a frequency of 10 kHz; and

an implantable signal delivery device electrically coupleable to the signal generator and configured to deliver the therapy signal to the patient'"'"'s spinal cord.

19. The system of claim 18, wherein at least a portion of the therapy signal has a pulse width in a pulse width range from 25 microseconds to 166 microseconds.

20. The system of claim 18, wherein at least a portion of the therapy signal has a pulse width in a pulse width range from 30 microseconds to 35 microseconds.

21. A spinal cord stimulation 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, wherein at least a portion of the therapy signal is at a frequency in a frequency range from 3 kHz to 20 kHz, and a current amplitude in a current amplitude range from 0.1 mA to 20 mA; and

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

22. The system of claim 21, wherein the implantable signal generator generates the therapy signal at a duty cycle.

23. The system of claim 22, wherein the duty cycle is 100%.

24. The system of claim 22, wherein the duty cycle is 50-100%.

25. The system of claim 22, wherein the frequency in the frequency range from 3 kHz to 20 kHz is applied throughout the length of an on period in the duty cycle.

26. The system of claim 22, wherein the frequency in the frequency range from 3 kHz to 20 kHz is applied during a portion of an on period in the duty cycle.

27. The system of claim 21, wherein the therapy signal is delivered at a current amplitude of about 2.5 mA.

28. The system of claim 21, wherein the therapy signal is delivered at a current amplitude is between about 0.1 mA to about 3 mA.

29. The system of claim 21, wherein the therapy signal is delivered at a suprathreshold current amplitude.

30. The system of claim 21, wherein at least a portion of the therapy signal is a square-wave signal.

31. The system of claim 21, wherein the signal delivery device is a percutaneous lead configured to be implanted in the patient'"'"'s epidural space.

32. The system of claim 21, wherein the signal delivery device is a paddle lead configured to be implanted in a target location.

33. The system of claim 21, wherein the signal delivery device is an elongated lead having one or more electrodes configured to direct the therapy signal to a target location.

34. The system of claim 21, wherein the signal delivery device is an elongated lead having a bipole arrangement of electrodes.

35. The system of claim 21, wherein at least a portion of the therapy signal has a pulse width in a pulse width range from 25 microseconds to 166 microseconds.

36. The system of claim 21, wherein at least a portion of the therapy signal has a pulse width in a pulse width range from 30 microseconds to 35 microseconds.

37. A spinal cord stimulation 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, wherein at least a portion of the therapy signal is at a frequency of 10 kHz, and at a current amplitude in a current amplitude range from 0.1 mA to 20 mA; and

an implantable signal delivery device electrically coupled to the implantable signal generator and configured to deliver the therapy signal to the patient'"'"'s spinal cord.

38. The system of claim 37, wherein at least a portion of the therapy signal has a pulse width in a pulse width range from 25 microseconds to 166 microseconds.

39. The system of claim 37, wherein at least a portion of the therapy signal has a pulse width in a pulse width range from 30 microseconds to 35 microseconds.

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

an implantable signal generator configured to generate a non-paresthesia-producing therapy signal, wherein at least a portion of the therapy signal is a biphasic square-wave signal, at a frequency in a frequency range from 1.5 kHz to 100 kHz, and at a current amplitude of less than about 20 mA; and

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

41. The system of claim 40, wherein the implantable signal generator generates the therapy signal at a duty cycle.

42. The system of claim 41, wherein the duty cycle is 100%.

43. The system of claim 41, wherein the duty cycle is 50-100%.

44. The system of claim 41, wherein the frequency in the frequency range from 1.5 kHz to 100 kHz is applied throughout the length of an on-period in the duty cycle.

45. The system of claim 41, wherein the frequency in the frequency range from 1.5 kHz to 100 kHz is applied during a portion of an on period in the duty cycle.

46. The system of claim 40, wherein the frequency range is from 1.5 kHz to 50 kHz.

47. The system of claim 40, wherein the frequency range is from 3 kHz to 20 kHz.

48. The system of claim 40, wherein the current amplitude is suprathreshold.

49. The system of claim 40, wherein the signal delivery device is a percutaneous lead configured to be implanted in the epidural space.

50. The system of claim 40, wherein the signal delivery device is a paddle lead configured to be implanted in a target location.

51. The system of claim 40, wherein the signal delivery device is an elongated lead having one or more electrodes configured to direct the therapy signal to a target location.

52. The system of claim 40, wherein the signal delivery device is an elongated lead having a bipole arrangement of electrodes.

53. The system of claim 40, wherein at least a portion of the therapy signal has a pulse width in a pulse width range from 25 microseconds to 166 microseconds.

54. The system of claim 40, wherein at least a portion of the therapy signal has a pulse width in a pulse width range from 30 microseconds to 35 microseconds.

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

an implantable signal generator configured to generate a non-paresthesia-producing therapy signal, wherein at least a portion of the therapy signal is a biphasic square-wave signal, at a frequency of 10 kHz, and at a current amplitude between 0.1 mA and 20 mA; and

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

56. The system of claim 55, wherein at least a portion of the therapy signal has a pulse width in a pulse width range from 25 microseconds to 166 microseconds.

57. The system of claim 55, wherein at least a portion of the therapy signal has a pulse width in a pulse width range from 30 microseconds to 35 microseconds.

58. A fully implantable medical device for reducing or eliminating pain in a patient, comprising:

an implantable signal generator having a machine-readable medium containing instructions for generating and transmitting a non-paresthesia-producing spinal modulation signal, wherein at least a portion of the spinal modulation signal is at a frequency in a frequency range from 3 kHz to 20 kHz, with a pulse width in a pulse width range from 25 microseconds to 166 microseconds, and a current amplitude in a current amplitude range from 1 mA to 8 mA; and

an implantable lead electrically coupled to the implantable signal generator and configured to be implanted in the patient'"'"'s epidural space, wherein the implantable lead includes two or more electrodes configured to deliver the transmitted spinal modulation signal to the patient'"'"'s spinal cord.

59. A spinal cord modulation system for reducing or eliminating back or leg pain in a patient, without relying on paresthesia or tingling to mask the patient'"'"'s sensation of the pain, the system comprising:

an implantable signal generator having a housing and one or more processors disposed within the housing, wherein the one or more processors are configured to generate a non-paresthesia-producing therapy signal, wherein at least a portion of the therapy signal is a biphasic square-wave signal, at a frequency in a frequency range from 3 kHz to 15 kHz, with a pulse width in a pulse width range from 30 microseconds to 35 microseconds, and a current amplitude in a current amplitude range from 1 mA to 4 mA; and

an elongated electrical lead electrically coupled to the implantable signal generator and configured to be implanted in the patient'"'"'s epidural space, wherein the electrical lead includes two or more electrodes configured to deliver the therapy signal to the patient'"'"'s spinal cord region in a bipole arrangement.