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

• US 9,333,359 B2
• Filed: 09/30/2014
• Issued: 05/10/2016
• 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:
  US14/503,329
• Publication Number:
  US 20150018896A1
• Time in Patent Office: 588 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 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 patient therapy system for alleviating a patient'"'"'s pain or discomfort without using paresthesia or tingling to mask the patient'"'"'s sensation of pain or discomfort, the system comprising:

a signal generator programmed to generate an electrical 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 at least partially alleviates pain or discomfort without generating or using paresthesia to mask the patient'"'"'s sensation of pain or discomfort; and

an implantable signal delivery device electrically coupleable to the signal generator and configured to deliver the therapy signal to a patient'"'"'s spinal cord region, and wherein the implantable signal delivery device has one or more electrical contacts configured to be positioned laterally from a midline of the patient'"'"'s spinal cord so as to be proximate to a dorsal root, dorsal root entry zone, or dorsal root ganglion.

2. The system of claim 1, wherein the signal generator is implantable.

3. The system of claim 2, further comprising:

a programmer configured to set one or more therapy signal parameters within the implantable signal generator.

4. The system of claim 2, further comprising:

an external power source configured to charge the implantable signal generator via electromagnetic induction.

5. The system of claim 2, further comprising:

an external power source configured to inductively charge the implantable signal generator via RF signals.

6. The system of claim 1, wherein the implantable signal delivery device is a percutaneous lead.

7. The system of claim 1, wherein the implantable signal delivery device is an implantable lead.

8. The system of claim 1, further comprising:

an extension between the implantable signal delivery device and the signal generator.

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

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

11. The system of claim 1, wherein the therapy signal is at an amplitude in an amplitude range between 0.1 mA and 10 mA.

12. A spinal cord modulation system for alleviating a patient'"'"'s pain or discomfort without using paresthesia or tingling to mask the patient'"'"'s sensation of pain or discomfort, the system comprising:

an implantable signal generator programmed to generate an electrical therapy signal; and

a percutaneous lead electrically coupleable to the signal generator and configured to deliver the therapy signal to a patient'"'"'s spinal cord region, and wherein the percutaneous lead is configured to be positioned laterally from a midline of the patient'"'"'s spinal cord so as to be proximate to a dorsal root, dorsal root entry zone, or dorsal root ganglion;

wherein at least a portion of the therapy signal

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

is at an amplitude in an amplitude range between 1 mA and 4 mA, which at least partially alleviates pain or discomfort without generating or using paresthesia to mask the patient'"'"'s sensation of pain or discomfort.

13. The system of claim 12, further comprising:

an external programmer configured to set one or more therapy signal parameters within the implantable signal generator.

14. The system of claim 13, wherein the external programmer communicates wirelessly with the implantable signal generator.

15. The system of claim 13, wherein the external programmer is a patient remote.

16. The system of claim 13, wherein the external programmer is a physician remote.

17. The system of claim 12, further comprising:

an external power source configured to charge the implantable signal generator via electromagnetic induction.

18. The system of claim 12, further comprising:

an external power source configured to charge the implantable signal generator via RF signals.

19. The system of claim 12, further comprising:

an extension between the percutaneous lead and the implantable signal generator.

20. The system of claim 12, wherein the frequency range is between 3 kHz and 15 kHz.

21. The system of claim 12, wherein the therapy signal includes a plurality of pulses having a pulse width between 10 microseconds and 333 microseconds.

22. The system of claim 12, wherein the amplitude range is between 2 mA and 3.5 mA.

23. A spinal cord modulation system for alleviating a patient'"'"'s pain or discomfort without using paresthesia or tingling to mask the patient'"'"'s sensation of pain or discomfort, the system comprising:

a pulse generator configured to generate a paresthesia-free 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 is at an amplitude in an amplitude range between 0.1 mA and 10 mA; and

an implantable signal delivery device having one or more electrical contacts, wherein the implantable signal delivery device is electrically coupleable to the pulse generator and configured to deliver the therapy signal to a location in the patient'"'"'s spinal cord region that is proximate to a dorsal root, dorsal root entry zone, or dorsal root ganglion.

24. The system of claim 23, wherein the pulse generator is implantable.

25. The system of claim 23, further comprising:

an external programmer configured to set one or more therapy signal parameters within the pulse generator.

26. The system of claim 23, wherein the implantable signal delivery device is a percutaneous lead.

27. The system of claim 23, wherein the implantable signal delivery device is a paddle lead.

28. The system of claim 23, further comprising:

an external power source configured to charge the pulse generator via electromagnetic induction.

29. The system of claim 23, further comprising:

an external power source configured to inductively charge the pulse generator via RF signals.

30. The system of claim 23, further comprising:

an extension between the signal delivery device and the pulse generator.

31. The system of claim 23, wherein the amplitude range is between 0.5 mA and 4 mA.

32. A spinal cord modulation system for alleviating a patient'"'"'s pain or discomfort without using paresthesia or tingling to mask the patient'"'"'s sensation of pain or discomfort, the system comprising:

an implantable pulse generator programmed to generate a paresthesia-free electrical 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 is at an amplitude in an amplitude range between 1 mA and 10 mA; and

an implantable signal delivery device having one or more electrical contacts, wherein the implantable signal delivery device is electrically coupleable to the implantable pulse generator and configured to deliver the therapy signal to a location in the patient'"'"'s spinal cord region proximate to a dorsal root, dorsal root entry zone, or dorsal root ganglion.

33. The system of claim 32, further comprising:

an external programmer configured to set one or more therapy signal parameters within the implantable pulse generator.

34. The system of claim 32, wherein the implantable signal delivery device is a percutaneous lead.

35. The system of claim 32, wherein the implantable signal delivery device is a paddle lead.

36. The system of claim 32, further comprising:

an external power source configured to charge the implantable pulse generator via electromagnetic induction.

37. The system of claim 32, further comprising:

an external power source configured to inductively charge the implantable signal generator via RF signals.

38. The system of claim 32, further comprising:

an extension between the implantable signal delivery device and the implantable pulse generator.

39. The system of claim 32, wherein the frequency range is between 3 kHz and 20 kHz.

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

41. The system of claim 32, wherein the amplitude range is between 1 mA and 4 mA.

42. The system of claim 32, wherein the amplitude range is between 2 mA and 3.5 mA.