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

• US 8,718,781 B2
• Filed: 12/27/2012
• Issued: 05/06/2014
• 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:
  US13/728,965
• Publication Number:
  US 20130123879A1
• Time in Patent Office: 495 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 spinal cord modulation system to deliver a therapy signal to a patient'"'"'s spinal cord region for reducing or eliminating pain in the patient without performing a paresthesia mapping procedure, wherein the spinal cord modulation system includes

an implantable signal delivery device, and

a signal generator electrically coupleable to the implantable signal delivery device,

the method comprising:

programming the signal generator to

(a) 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 1.5 kHz to 100 kHz, and

(b) deliver the therapy signal to a location in the patient'"'"'s spinal cord region, via the signal generator, without using paresthesia mapping to identify the location.

2. The method of claim 1, wherein the therapy signal at least partially reduces a sensation of pain in the patient.

3. The method of claim 2, wherein the programming is performed without the patient reporting whether or not

(1) pain reduction is achieved while in an operating room, or

(2) a sensation of paresthesia at least partially masks the sensation of pain, or

(3) both (1) and (2).

4. The method of claim 3, further comprising:

programming the signal generator to generate the therapy signal with at least a portion of the therapy signal having a frequency in a frequency range of from 3 kHz to 20 kHz.

5. The method of claim 4, further comprising:

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

6. The method of claim 5, further comprising:

programming the signal generator to generate the therapy signal with at least a portion of the therapy signal having a frequency of 10 kHz.

7. The method of claim 6, further comprising:

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

8. The method of claim 6, further comprising:

programming the signal generator to generate the therapy signal with at least a portion of the therapy signal having a pulse width of 30 microseconds to 35 microseconds.

21. The method of claim 1, wherein the therapy signal at least partially reduces the patient'"'"'s sensation of pain without affecting neural transmissions of touch or heat.

9. A method for configuring a spinal cord modulation system to deliver a therapy signal to a patient'"'"'s spinal cord region without performing a paresthesia mapping procedure, wherein the spinal cord modulation system includes

an implantable signal delivery device, and

a signal generator electrically coupleable to the implantable signal delivery device,

the method comprising:

programming the signal generator to

(a) generate a therapy signal, wherein at least a portion of the therapy signal is at a frequency in a frequency range of from 1.5 kHz to 50 kHz and a current amplitude that at least partially reduces a sensation of pain in the patient without generating paresthesia, and

(b) deliver the therapy signal to a location in the patient'"'"'s spinal cord region, via the implantable signal delivery device, without using paresthesia mapping to identify the location.

10. The method of claim 9, wherein the implantable signal delivery device is percutaneously implanted proximate to the patient'"'"'s spinal cord.

11. The method of claim 10, wherein the programming is performed without the patient reporting whether or not

(1) pain reduction is achieved while in an operating room, or

(2) a sensation of paresthesia at least partially masks the sensation of pair, or

(3) both (1) and (2).

12. The method of claim 11, wherein the frequency range is from 3 kHz to 20 kHz.

13. The method of claim 12, further comprising:

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

14. The method of claim 13, further comprising:

programming the signal generator to generate the therapy signal with at least a portion of the therapy signal having a frequency of 10 kHz.

15. The method of claim 14, further comprising:

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

16. A method for configuring a spinal cord modulation system to deliver a therapy signal to a patient'"'"'s spinal cord region without performing a paresthesia mapping procedure, wherein the spinal cord modulation system includes

an implantable signal delivery device implantable in the patient'"'"'s spinal cord region, proximate to a vertebral level in a range of from about T9 to about T12, wherein the implantable signal delivery device includes three or more electrical contacts, and

a signal generator electrically coupleable to the implantable signal delivery device to generate a therapy signal and deliver the therapy signal to the patient'"'"'s spinal cord region via at least two of the electrical contacts of the implantable signal delivery device,

the method comprising:

programming the signal generator to generate a non-paresthesia-producing therapy signal, wherein at least a portion of the therapy signal is a bi-phasic square-wave having

a frequency in a frequency range of from 3 kHz to 20 kHz,

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

a pulse width in a pulse width range of from 25 microseconds to 166 microseconds.

17. The method of claim 16, wherein the therapy signal at least partially reduces a sensation of pain in the patient.

18. The method of claim 17, wherein the signal delivery device is implanted proximate to a vertebral level between about T9 and about T10.

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

20. The method of claim 19, further comprising:

programming the signal generator to generate the therapy signal at a duty cycle.

22. A method for configuring a spinal cord modulation system to deliver a therapy signal to a patient'"'"'s spinal cord region without performing a paresthesia mapping procedure, wherein the spinal cord modulation system includes

an implantable signal delivery device for implantation proximate to the patient'"'"'s spinal cord region, wherein the implantable signal delivery device includes a plurality of electrical contacts, and

a signal generator adapted to be electrically coupled to the implantable signal delivery device, to generate a therapy signal, and to deliver the therapy signal to the patient'"'"'s spinal cord region via at least two of the plurality of electrical contacts, the method comprising:

programming the signal generator to

(a) generate a non-paresthesia-producing therapy signal, wherein at least a portion of the therapy signal

(i) has a frequency in a frequency range of from 1.5 kHz to 50 kHz,

(ii) has a current amplitude in an amplitude range of from 0.1 mA to 6 mA,

(iii) has a pulse width between 10 microseconds and 333 microseconds, and

(iv) at least partially reduces a sensation of pain in the patient, and

(b) deliver the therapy signal via the at least two electrical contacts of the implantable signal delivery device without using paresthesia mapping to select the at least two electrical contacts used to deliver the therapy signal.

23. The method of claim 22, wherein the programming is performed without an operating room mapping process.

24. The method of claim 22, wherein the programming is performed without the patient reporting whether or not a sensation of paresthesia at least partially masks the sensation of pain.

25. The method of claim 22, wherein the implantable signal delivery device is implanted proximate to a vertebral level between about T9 and about T10, and the therapy signal at least partially reduces a sensation of pain in the patient'"'"'s lower back or leg.

26. The method of claim 22, wherein the implantable signal delivery device is implanted proximate to a thoracic vertebral level, and the therapy signal at least partially reduces a sensation of pain in the patient associated with shingles.

27. The method of claim 22, wherein the implantable signal delivery device is implanted proximate to a vertebral level between about C3 and about C7, and the therapy signal at least partially reduces a sensation of pain in the patient associated with chronic regional pain syndrome.

28. The method of claim 22, wherein the frequency range is from 3 kHz to 20 kHz, and the pulse width is between 25 microseconds and 166 microseconds.

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

30. The method of claim 22, wherein the frequency is 10 kHz, and the pulse width is 30 microseconds to 35 microseconds.