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

• US 9,327,126 B2
• Filed: 10/10/2014
• Issued: 05/03/2016
• 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:
  US14/512,340
• Publication Number:
  US 20150032183A1
• Time in Patent Office: 571 Days
• Field of Search: 607/2, 607/46, 607115-117, 607/154
• 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.

Claims

1. A method for alleviating pain or discomfort in a patient, without using paresthesia or tingling to mask the patient'"'"'s sensation of pain or discomfort, via a spinal cord stimulation system, wherein the system includes a pulse generator configured to generate an electrical therapy signal and a signal delivery device configured to deliver the electrical therapy signal to the patient'"'"'s spinal cord region, wherein the signal delivery device is positioned laterally from a midline of the patient'"'"'s spinal cord region so as to be proximate to a dorsal root, dorsal root entry zone, or dorsal root ganglion, the method comprising:

configuring the system to deliver a non-paresthesia-producing therapy signal, wherein at least a portion of the therapy signal is at

a frequency in a frequency range between 1.5 kHz and 100 kHz, and

an amplitude in an amplitude range between 0.1 mA and 20 mA, and

wherein the therapy signal at least partially alleviates pain or discomfort without generating or using paresthesia to mask the patient'"'"'s sensation of pain or discomfort.

2. The method of claim 1, wherein the electrical therapy signal is delivered to the patient'"'"'s spinal cord region via a percutaneous lead.

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

4. The method of claim 1, wherein the frequency range is between 3 kHz and 20 kHz.

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

6. The method of claim 1, wherein the portion of the therapy signal has an amplitude in an amplitude range between 0.1 mA and 10 mA.

7. The method of claim 1, wherein the therapy signal includes a plurality of pulses having a pulse width between 10 microseconds and 333 microseconds.

8. The method of claim 1, further comprising:

programming an external programmer to set a duty cycle for the therapy signal.

9. The method of claim 1, further comprising:

programming an external programmer to adjust one or more therapy signal parameters within the pulse generator.

10. The method of claim 1, further comprising:

updating the therapy signal parameters via an external programmer.

11. A method for alleviating pain or discomfort in a patient, without using paresthesia or tingling to mask the patient'"'"'s sensation of pain or discomfort, via a spinal cord stimulation system, wherein the system includes a pulse generator configured to generate an electrical therapy signal and a signal delivery device configured to deliver the electrical therapy signal to the patient'"'"'s spinal cord region, wherein the signal delivery device is positioned laterally from a midline of the patient'"'"'s spinal cord region so as to be proximate to a dorsal root, dorsal root entry zone, or dorsal root ganglion, the method comprising:

configuring the system to deliver a non-paresthesia-producing therapy signal,

wherein at least a portion of the therapy signal is at

a frequency in a frequency range between 1.5 kHz and 50 kHz, and

an amplitude range between 1 mA and 10 mA, and

wherein the therapy signal at least partially alleviates pain or discomfort without generating or using paresthesia to mask the patient'"'"'s sensation of pain or discomfort.

12. The method of claim 11, wherein the electrical therapy signal is delivered to the patient'"'"'s spinal cord region via a percutaneous lead.

13. The method of claim 11, wherein the frequency range is between 3 kHz and 20 kHz.

14. The method of claim 11, wherein the frequency range is between 3 kHz and 15 kHz.

15. The method of claim 11, wherein the frequency is 10 kHz.

16. The method of claim 11, wherein the amplitude range is between 1 mA and 4 mA.

17. The method of claim 11, wherein the amplitude range is between 2 mA and 3.5 mA.

18. The method of claim 11, wherein the therapy signal includes a plurality of pulses having a pulse width between 10 microseconds and 333 microseconds.

19. The method of claim 11, further comprising:

programming an external programmer to activate and stop the pulse generator from delivering electrical therapy signals.

20. The method of claim 11, further comprising:

programming an external programmer to update one or more therapy signal parameters within the pulse generator.

21. A method for alleviating pain or discomfort in a patient, without using paresthesia or tingling to mask the patient'"'"'s sensation of pain or discomfort, via a spinal cord stimulation system, wherein the system includes a signal generator configured to generate an electrical therapy signal and a signal delivery device configured to deliver the electrical therapy signal to the patient'"'"'s spinal cord region, wherein the signal delivery device is positioned laterally from a midline of the patient'"'"'s spinal cord region so as to be proximate to a dorsal root, dorsal root entry zone, or dorsal root ganglion, the method comprising:

configuring the system to deliver a non-paresthesia-producing therapy signal,

wherein at least a portion of the therapy signal is at

a frequency in a frequency range between 5 kHz and 15 kHz, and

an amplitude in an amplitude range between 0.5 mA and 4 mA,

wherein the therapy signal at least partially alleviates pain or discomfort without generating or using paresthesia to mask the patient'"'"'s sensation of pain or discomfort.

22. The method of claim 21, wherein the electrical therapy signal is delivered to the patient'"'"'s spinal cord region via a percutaneous lead.

23. The method of claim 21, wherein the frequency range is between 3 kHz and 10 kHz.

24. The method of claim 21, wherein the frequency is 10 kHz.

25. The method of claim 21, wherein the amplitude range is between 2 mA and 3.5 mA.

26. The method of claim 21, wherein the amplitude range is between 0.5 mA and 2.5 mA.

27. The method of claim 21, wherein the therapy signal includes a plurality of pulses having a pulse width between 10 microseconds and 333 microseconds.

28. The method of claim 21, wherein the therapy signal includes a plurality of pulses having a pulse width between 25 microseconds and 166 microseconds.

29. The method of claim 21, further comprising:

programming an external programmer to deliver the therapy signal at a duty cycle.

30. The method of claim 21, further comprising:

programming an external programmer to update one or more therapy signal parameters within the signal generator.

31. A method for programming a spinal cord stimulation system to alleviate pain or discomfort in a patient without using paresthesia or tingling to mask the patient'"'"'s sensation of pain or discomfort, wherein a percutaneous lead is positioned in the patient'"'"'s spinal cord region so as to be proximate to a dorsal root, dorsal root entry zone, or dorsal root ganglion, the method comprising:

programming a signal generator to deliver a non-paresthesia-producing electrical therapy signal;

wherein at least a portion of the electrical therapy signal is at

a frequency in a frequency range between 3 kHz and 20 kHz, and

an amplitude in an amplitude range between 1 mA and 4 mA, and

wherein the electrical therapy signal at least partially alleviates pain or discomfort without generating or using paresthesia to mask the patient'"'"'s sensation of pain or discomfort.

32. The method of claim 31, wherein the frequency range is between 3 kHz and 15 kHz.

33. The method of claim 31, wherein the frequency range is between 3 kHz and 10 kHz.

34. The method of claim 31, wherein the frequency is 10 kHz.

35. The method of claim 31, wherein the amplitude range is between 2 mA and 3.5 mA.

36. The method of claim 31, wherein the therapy signal includes a plurality of pulses having a pulse width between 10 microseconds and 333 microseconds.

37. The method of claim 31, further comprising:

programming an external programmer to start and stop the signal generator from delivering electrical therapy signals.

38. The method of claim 31, further comprising:

applying a charge to the signal generator via electromagnetic induction with an external power source.

39. The method of claim 31, further comprising:

applying a charge to the signal generator via RF signals with an external power source.

40. The method of claim 31, further comprising:

programming an external programmer to adjust one or more therapy signal parameters within the signal generator.

41. The method of claim 31, further comprising:

updating the therapy signal parameters via an external programmer.