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

• US 9,387,327 B2
• Filed: 10/23/2014
• Issued: 07/12/2016
• 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): Wu, Eugene
• Application Number:
  US14/522,405
• Publication Number:
  US 20150045853A1
• Time in Patent Office: 628 Days
• US Class Current: 1/1
• 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. Particular embodiments include applying a paresthesia-inducing signal with a frequency of less than 1.2 kHz.

Claims

1. A method of programming a spinal cord stimulation system to provide pain relief to a patient, wherein the spinal cord stimulation system includes a pulse generator configured to generate at least one electrical signal, a signal delivery device electrically coupleable to the pulse generator and configured to deliver the at least one electrical signal to the patient'"'"'s spinal cord region, and an external programmer configured to transmit to the pulse generator a first programming instruction to generate a paresthesia-inducing electrical signal and a second programming instruction to generate a non-paresthesia-inducing electrical signal, the method comprising:

using the external programmer to program the pulse generator to generate at least one electrical signal having one or more electrical signal parameters including

a first frequency in a first frequency range of less than 1.2 kHz when the at least one electrical signal is the paresthesia-inducing electrical signal, and

a second frequency in a second frequency range between 1.5 kHz and 100 kHz when the at least one electrical signal is the non-paresthesia-inducing electrical signal; and

programming the pulse generator to deliver the at least one electrical signal to the patient'"'"'s spinal cord region via the signal delivery device.

2. The method of claim 1 wherein the pulse generator is programmable to generate the paresthesia-inducing electrical signal at a first time, and the non-paresthesia-inducing electrical signal at a second time.

3. The method of claim 1, wherein the first frequency is below 500 Hz.

4. The method of claim 1, wherein the second frequency range is between 1.5 kHz and 50 kHz.

5. The method of claim 1, wherein the second frequency is 10 kHz.

6. The method of claim 1, wherein an amplitude of the non-paresthesia-inducing signal is in an amplitude range between 0.1 mA and 20 mA.

7. The method of claim 1, wherein an amplitude of the non-paresthesia-inducing signal is in an amplitude range between 0.5 mA and 10 mA.

8. The method of claim 1, wherein a pulse width of the non-paresthesia-inducing signal is in a pulse width range between 25 microseconds and 166 microseconds.

9. The method of claim 1, wherein a pulse width of the non-paresthesia-inducing signal is in a pulse width range between 50 microseconds and 166 microseconds.

10. The method of claim 1, further comprising:

using the external programmer to configure the pulse generator to deliver the at least one electrical signal to a vertebral level between T9 and T12, inclusive, by selecting one or more contacts of the signal delivery device to deliver the at least one electrical signal.

11. The method of claim 1, further comprising:

using the external programmer to configure the pulse generator to deliver the at least one electrical signal to a dorsal root, dorsal entry zone, or dorsal root ganglion by selecting one or more contacts of the signal delivery device to deliver the at least one electrical signal.

12. The method of claim 1, further comprising:

adjusting the one or more signal parameters via the external programmer.

13. The method of claim 1 wherein the signal delivery device is coupled to the pulse generator.

14. A method of programming a spinal cord stimulation system to provide pain relief to a patient, wherein the spinal cord stimulation system includes a pulse generator, and a signal delivery device electrically coupleable to the pulse generator and configured to deliver at least one electrical signal to the patient'"'"'s spinal cord region, the method comprising:

using an external programmer to select one or more electrical signal parameters for the at least one electrical signal;

wherein the external programmer is configured to transmit a first programming instruction to generate a paresthesia-inducing electrical signal and a second programming instruction to generate a non-paresthesia-inducing electrical signal; and

wherein the one or more electrical signal parameters include

a first frequency in a first frequency range of less than 1.2 kHz when the at least one electrical signal is the paresthesia-inducing signal, and

a second frequency in a second frequency range between 1.5 kHz and 100 kHz when the at least one electrical signal is the non-paresthesia-inducing signal; and

using the external programmer to configure the pulse generator to deliver the at least one electrical signal to the patient'"'"'s spinal cord region via the signal delivery device.

15. The method of claim 14 wherein the pulse generator is configurable to generate the paresthesia-inducing electrical signal at a first time, and the non-paresthesia-inducing electrical signal at a second time.

16. The method of claim 14, wherein the first frequency range is between 40 Hz and 500 Hz.

17. The method of claim 14, wherein the second frequency range is between 3 kHz and 20 kHz.

18. The method of claim 14, wherein the second frequency is 10 kHz.

19. The method of claim 14, wherein an amplitude of the non-paresthesia-inducing signal is in an amplitude range between 0.1 mA and 20 mA.

20. The method of claim 14, wherein an amplitude of the non-paresthesia-inducing signal is in an amplitude range between 0.5 mA and 10 mA.

21. The method of claim 14, wherein a pulse width of the non-paresthesia-inducing signal is in a pulse width range between 25 microseconds and 166 microseconds.

22. The method of claim 14, wherein a pulse width of the non-paresthesia-inducing signal is in a pulse width range between 50 microseconds and 166 microseconds.

23. The method of claim 14, further comprising:

using the external programmer to configure the pulse generator to deliver the at least one electrical signal to a vertebral level between T9 and T12, inclusive, by selecting one or more contacts of the signal delivery device to deliver the at least one electrical signal.

24. The method of claim 14, further comprising:

using the external programmer to configure the pulse generator to deliver the at least one electrical signal to a dorsal root, dorsal entry zone, or dorsal root ganglion by selecting one or more contacts of the signal delivery device to deliver the at least one electrical signal.

25. The method of claim 14, further comprising:

updating the signal parameters via the external programmer.

26. The method of claim 14 wherein the signal delivery device is coupled to the pulse generator.

27. A method of programming a spinal cord stimulation system to provide pain relief to a patient, wherein the spinal cord stimulation system includes a signal generator, and a signal delivery device electrically coupleable to the signal generator and configured to deliver at least one electrical signal to the patient'"'"'s spinal cord region, the method comprising:

using an external programmer to select one or more electrical signal parameters for the at least one electrical signal;

wherein the external programmer is configured to transmit a first programming instruction to generate a paresthesia-inducing electrical signal and a second programming instruction to generate a non-paresthesia-inducing electrical signal; and

wherein the one or more electrical signal parameters include

a first frequency in a first frequency range of less than 500 Hz when the at least one electrical signal is the paresthesia-inducing signal, and

a second frequency in a second frequency range between 3 kHz and 20 kHz when the at least one electrical signal is the non-paresthesia-inducing signal; and

using the external programmer to configure the signal generator to deliver the at least one electrical signal to the patient'"'"'s spinal cord region via the signal delivery device.

28. The method of claim 27 wherein the signal generator is configurable to generate the paresthesia-inducing electrical signal at a first time, and the non-paresthesia-inducing electrical signal at a second time.

29. The method of claim 27, wherein the second frequency range is between 3 kHz and 15 kHz.

30. The method of claim 27, wherein the second frequency is 10 kHz.

31. The method of claim 27, wherein an amplitude of the non-paresthesia-inducing signal is in an amplitude range between 0.1 mA and 20 mA.

32. The method of claim 27, wherein an amplitude of the non-paresthesia-inducing signal is in an amplitude range between 0.5 mA and 10 mA.

33. The method of claim 27, wherein a pulse width of the non-paresthesia-inducing signal is in a pulse width range between 25 microseconds and 166 microseconds.

34. The method of claim 27, wherein a pulse width of the non-paresthesia-inducing signal is in a pulse width range between 50 microseconds and 166 microseconds.

35. The method of claim 27, further comprising:

using the external programmer to configure the signal generator to deliver the at least one electrical signal to a vertebral level between T9 and T12, inclusive, by selecting one or more contacts of the signal delivery device to deliver the at least one electrical signal.

36. The method of claim 27, further comprising:

using the external programmer to configure the signal generator to deliver the at least one electrical signal to a dorsal root, dorsal entry zone, or dorsal root ganglion by selecting one or more contacts of the signal delivery device to deliver the at least one electrical signal.

37. The method of claim 27, further comprising:

updating the signal parameters via the external programmer.

38. The method of claim 27 wherein the signal delivery device is coupled to the signal generator.

39. A method of programming a spinal cord stimulation system to provide pain relief to a patient, wherein the spinal cord stimulation system includes a signal generator, and a signal delivery device electrically coupleable to the signal generator and configured to deliver at least one electrical signal to the patient'"'"'s spinal cord region, the method comprising:

placing a programmer in wireless communication with the signal generator, wherein the programmer is configured to transmit a first programming instruction to generate a paresthesia-inducing electrical signal and a second programming instruction to generate a non-paresthesia-inducing electrical signal;

using the programmer to select a plurality of electrical signal parameters, wherein the plurality of electrical signal parameters includes a frequency, an amplitude, and a pulse width,

wherein when the at least one electrical signal is the paresthesia-inducing signal, the programmer is used to set

the frequency to less than 1.2 kHz,

the amplitude to between 1 mA and 20 mA, and

the pulse width to between 10 microseconds and 1,000 microseconds, and

wherein when the at least one electrical signal is the non-paresthesia-inducing signal, the programmer is used to set

the frequency to between 3 kHz and 20 kHz,

the amplitude to between 0.1 mA and 20 mA, and

the pulse width to between 25 microseconds and 166 microseconds; and

using the programmer to configure the signal generator to deliver the at least one electrical signal to the patient'"'"'s spinal cord region via the signal delivery device.

40. The method of claim 39 wherein the signal generator is configurable to generate the paresthesia-inducing electrical signal at a first time, and the non-paresthesia-inducing electrical signal at a second time.

41. The method of claim 39, wherein the frequency range of the paresthesia-inducing signal is between 40 Hz and 500 Hz.

42. The method of claim 39, wherein the frequency range of the non-paresthesia-inducing signal is between 3 kHz and 15 kHz.

43. The method of claim 39, wherein the frequency of the non-paresthesia-inducing signal is 10 kHz.

44. The method of claim 39, wherein the amplitude of the non-paresthesia-inducing signal is in an amplitude range between 0.1 mA and 10 mA.

45. The method of claim 39, wherein the amplitude of the non-paresthesia-inducing signal is in an amplitude range between 0.5 mA and 10 mA.

46. The method of claim 39, wherein the pulse width of the non-paresthesia-inducing signal is in a pulse width range between 33 microseconds and 100 microseconds.

47. The method of claim 39, wherein the pulse width of the non-paresthesia-inducing signal is in a pulse width range between 50 microseconds and 166 microseconds.

48. The method of claim 39, further comprising:

using the programmer to configure the signal generator to deliver the at least one electrical signal to a vertebral level between T9 and T12, inclusive, by selecting one or more contacts of the signal delivery device to deliver the at least one electrical signal.

49. The method of claim 39, further comprising:

using the programmer to configure the signal generator to deliver the at least one electrical signal to a dorsal root, dorsal entry zone, or dorsal root ganglion by selecting one or more contacts of the signal delivery device to deliver the at least one electrical signal.

50. The method of claim 39, further comprising:

adjusting the signal parameters via the programmer.

51. The method of claim 39 wherein the signal delivery device is coupled to the signal generator.