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

• US 8,886,326 B2
• Filed: 01/24/2014
• Issued: 11/11/2014
• 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:
  US14/164,044
• Publication Number:
  US 20140142673A1
• Time in Patent Office: 291 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 spinal cord stimulation system, the system comprising:

an implantable signal generator configured to generate a non-paresthesia-producing therapy signal, wherein the therapy signal includes a plurality of sequential biphasic pulses having pulse widths in a pulse width range from 25 microseconds to 166 microseconds; and

a signal delivery device configured to be electrically coupled to the implantable signal generator and to deliver the therapy signal to a target location in the patient'"'"'s spinal cord.

2. The system of claim 1, wherein at least a portion of the therapy signal is at a frequency in a frequency range from 1.5 kHz to 100 kHz.

3. The system of claim 2, wherein the frequency range is from 3 kHz to 20 kHz.

4. The system of claim 1, wherein at least a portion of the therapy signal is at a frequency of 10 kHz.

5. The system of claim 1, wherein at least a portion of the therapy signal is delivered at a current amplitude in a current amplitude range from 0.5 mA to 10 mA.

6. The system of claim 1, wherein the target location is at a vertrebral level between T9 and T12, inclusive.

17. The system of claim 5, wherein the signal delivery device is a paddle lead configured to be surgically implanted proximate to a target location.

7. A spinal cord stimulation system for reducing or eliminating pain in a patient, the system comprising:

an implantable signal generator configured to generate a therapy signal at an amplitude that at least partially reduces the, patient'"'"'s sensation of pain without generating paresthesia, wherein the therapy signal includes a plurality of sequential biphasic pulses having a pulse width in a pulse width range from 25 microseconds to 166 microseconds, and the amplitude is in a current amplitude range from 0.1 mA to 20 mA; and

a signal delivery device electrically coupleable to the implantable signal generator and configured to deliver the therapy signal to the patient'"'"'s spinal cord.

8. The system of claim 7, wherein the implantable signal generator generates the therapy signal at a duty cycle.

9. The system of claim 8, wherein at least a portion of the therapy signal is at a frequency in a frequency range from 3 kHz to 20 kHz and is applied throughout the length of an on period in the duty cycle.

10. The system of claim 8, wherein at least a portion of the therapy signal is at a frequency in a frequency range from 3 kHz to 20 kHz and is applied during a portion of an on period in the duty cycle.

11. The system of claim 8, wherein the duty cycle is 50-100%.

12. The system of claim 7, wherein at least a portion of the therapy signal is at a frequency in a frequency range from 3 kHz to 20 kHz.

13. The system of claim 7, wherein the current amplitude range is from 0.5 mA to 10 mA.

14. The system of claim 7, wherein the current amplitude is suprathreshold.

15. The system of claim 7, wherein at least a portion of the therapy signal is a biphasic square-wave signal.

16. The system of claim 7, wherein the signal delivery device is a percutaneous lead configured to be implanted in the patient'"'"'s epidural space.

18. A spinal cord modulation system for reducing or eliminating back and/or leg pain in a patient, without using paresthesia or tingling to mask the patient'"'"'s sensation of the pain, the system comprising:

an implantable signal generator having a housing and one or more processors disposed within the housing, wherein the one or more processors are configured to generate a therapy signal that at least partially reduces the patient'"'"'s sensation of pain without generating paresthesia, wherein the therapy signal includes a plurality of sequential biphasic square-wave pulses, with the pulses having a pulse width in a pulse width range from 25 microseconds to 166 microseconds, and a current amplitude in a current amplitude range from 0.5 mA to 10 mA; and

an elongated electrical lead electrically coupled to the implantable signal generator and configured to be implanted in the patient'"'"'s epidural space, wherein the electrical lead includes two or more electrodes configured to deliver the therapy signal to the patient'"'"'s spinal cord.

19. The system of claim 18, wherein the implantable signal generator generates the therapy signal at a duty cycle.

20. The system of claim 19, wherein a frequency in a frequency range from 1.5 kHz to 100 kHz is applied throughout the length of an on-period in the duty cycle.

21. The system of claim 19, wherein a frequency in a frequency range from 1.5 kHz to 100 kHz is applied during a portion of an on period in the duty cycle.

22. The system of claim 19, wherein the duty cycle is 50-100%.

23. The system of claim 18, wherein at least a portion of the therapy signal is at a frequency in a frequency range from 1.5 kHz to 100 kHz.

24. The system of claim 23, wherein the frequency range is from 3 kHz to 20 kHz.

25. The system of claim 18, wherein at least a portion of the therapy signal is at a frequency of 10 kHz.

26. The system of claim 18, wherein the current amplitude range is from 0.5 mA to 4 mA.

27. The system of claim 18, wherein the pulse width range is from 30 microseconds to 35 microseconds.

28. The system of claim 18, wherein the current amplitude is suprathreshold.

29. The system of claim 18, wherein the elongated electrical lead is a percutaneous lead.

30. The system of claim 18, wherein the elongated electrical lead is a paddle lead configured to be surgically implanted proximate to a target location in the patient'"'"'s epidural space.