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

• US 8,694,109 B2
• Filed: 12/21/2012
• Issued: 04/08/2014
• 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:
  US13/725,770
• Publication Number:
  US 20130110196A1
• Time in Patent Office: 473 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 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 configuring a signal generator to deliver a therapy signal to a patient'"'"'s spinal cord region the method comprising:

programming or instructing the programming of the signal generator to

(1) generate a non-paresthesia-producing therapy signal, wherein at least a portion of the therapy signal has a frequency in a frequency range of from about 1.5 kHz to about 100 kHz; and

(2) deliver the therapy signal to the patient'"'"'s spinal cord region via an implantable signal delivery device.

2. The of claim 1, further comprising:

identifying or instructing identification of the frequency as one that at least partially reduces the patient'"'"'s sensation of pain without generating paresthesia.

3. The method of claim 2, wherein the frequency is between about 3 kHz and about 20 kHz.

4. The method of claim 2, wherein identifying or instructing identification is performed prior to programming or instructing programming.

5. The method of claim 1, further comprising implanting instructing or instructing implantation of the implantable signal deliver device proximate to a vertebral level between about T9 and about T12, and wherein the therapy signal at least partially reduces the patient'"'"'s sensation of pain in the lower back or leg.

6. The method of claim 1, further comprising implanting instructing or instructing implantation of the implantable signal deliver device proximate to a thoracic vertebral level, and wherein and the therapy signal at least partially reduces the patient'"'"'s sensation of pain associated with shingles.

7. The method of claim 1, further comprising implanting or instructing implantation of the implantable signal deliver device proximate to a vertebral level between about C3 and about C7, and wherein the therapy signal at least partially reduces the patient'"'"'s sensation of pain associated with chronic regional pain syndrome.

8. A method for configuring a signal generator to deliver a therapy signal to a patient'"'"'s spinal cord region, wherein the signal generator is electrically coupleable to at least one implantable signal delivery device, and wherein the implantable signal delivery device is implantable proximate to the patient'"'"'s spinal cord region, the method comprising:

programming or instructing the programming of the signal generator to

(1) generate a therapy signal, wherein at least a portion of the therapy signal is at a suprathreshold current amplitude in an amplitude range of from about 0.5 mA to about 6 mA and a frequency of about 10 kHz; and

(2) deliver the therapy signal to the patient'"'"'s spinal cord region, via the at least one implantable signal delivery device, wherein the signal does not induce paresthesia in the patient.

9. The method of claim 8, wherein the therapy signal at least partially reduce the patient'"'"'s sensation of pain without affecting neural transmissions of touch or heat.

10. The method of claim 8, further comprising:

programming or instructing the programming of the signal generator to generate the therapy signal with at least a portion of the therapy signal being a bi-phasic square-wave.

11. The method of claim 10, further comprising:

programming or instructing the programming of the signal generator to apply the therapy signal at a duty cycle.

12. The method of claim 10, wherein at least a portion of the therapy signal has a pulse width between about 25 microseconds and about 166 microseconds.

13. The method of claim 12, further comprising:

programming or instructing the programming of the signal generator to apply the therapy signal at a duty cycle.

14. A method for configuring a signal generator to deliver a therapy signal to a patient'"'"'s spinal cord region, wherein the signal generator is electrically coupleable to at least one implantable signal delivery device, and wherein the implantable signal delivery device is implantable proximate to the patient'"'"'s spinal cord region, the method comprising:

programming or instructing the programming of the signal generator to generate and deliver a therapy signal to the patient'"'"'s spinal cord region, via the at least one implantable signal delivery device, wherein at least a portion of the therapy signal has

a frequency in a frequency range of from about 1.5 kHz to about 50 kHz,

a current amplitude in an amplitude range of from about 0.1 mA to about 6 mA,

a pulse width between about 10 microseconds and about 333 microseconds, and

at least partially reduces the patient'"'"'s sensation of pain without generating paresthesia.

15. The method of claim 14, wherein the frequency is set to about 10 kHz and the pulse width is between about 30 microseconds and about 35 microseconds.

16. The method of claim 15, further comprising:

programming or instructing the programming of the signal generator to apply the therapy signal at a duty cycle.

17. The method of claim 14, further comprising implanting or instructing implantation of the signal deliver device proximate to a vertebral level between about T9 and about T10, and wherein the therapy signal at least partially reduces the patient'"'"'s sensation of pain in the lower back or leg.

18. The method of claim 14, further comprising implanting or instructing implantation of the signal deliver device is proximate to a thoracic vertebral level, and wherein the therapy signal at least partially reduces the patient'"'"'s sensation of pain associated with shingles.

19. The method of claim 14, further comprising implanting or instructing implantation of the signal deliver device proximate to a vertebral level between about C3 and about C7, and wherein the therapy signal at least partially reduces the patient'"'"'s sensation of pain associated with chronic regional pain syndrome.

20. The method of claim 14, further comprising:

programming or instructing the programming of the signal generator to apply the therapy signal at a duty cycle.

21. The method of claim 14, wherein the frequency range is from about 3 kHz to about 20 kHz and the pulse width is between about 25 microseconds and about 166 microseconds.

22. The method of claim 14, wherein the frequency range is from about 5 kHz to about 15 kHz.

23. A method for configuring a signal generator to deliver a therapy signal to a patient'"'"'s spinal cord region, wherein the signal generator is electrically coupleable to at least one implantable signal delivery device, and wherein the implantable signal delivery device is implantable proximate to a vertebral level between about T9 and about T12 in the patient'"'"'s spinal cord region, the method comprising:

(1) identifying or instructing identification of a frequency for a therapy signal as one that at least partially reduces the patient'"'"'s sensation of pain without generating paresthesia, wherein the frequency is in a frequency range of from about 3 kHz to about 20 kHz; and

(2) programming or instructing the programming of the signal generator to

(a) generate the therapy signal, wherein at least a portion of the therapy signal is at the identified frequency, and wherein at least a portion of the therapy signal is

a bi-phasic square-wave with

a current amplitude in an amplitude range of from about 0.5 mA to about 4 mA, and

a pulse width between about 25 microseconds and about 166 microseconds; and

(b) deliver the therapy signal via the at least one implantable signal delivery device.

24. The method of claim 23, wherein the therapy signal at least partially reduces the patient'"'"'s sensation of pain without affecting neural transmissions of touch or heat.

25. The method of claim 24, further comprising implanting or instructing implantation of the signal deliver device is proximate to the vertebral level between about T9 and about T10.

26. The method of claim 25, wherein the identified frequency is about 10 kHz.

27. The method of claim 26, further comprising:

programming or instructing the programming of the signal generator to apply the therapy signal at a duty cycle.

28. The method of claim 23, wherein at least a portion of the therapy signal has a pulse width between about 30 microseconds and about 35 microseconds.

29. The method of claim 23, wherein the identified frequency is between about 5 kHz and about 15 kHz.