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

• US 8,868,192 B2
• Filed: 01/24/2014
• Issued: 10/21/2014
• 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:
  US14/164,082
• Publication Number:
  US 20140142657A1
• Time in Patent Office: 270 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. An epidural spinal cord stimulation system for reducing or eliminating pain in a patient without using paresthesia to treat the patient, the system comprising:

a programmer having a therapy program that, when executed, directs delivery of a therapy signal by a spinal cord modulator to a signal delivery device configured to deliver the therapy signal to the patient'"'"'s spinal cord, wherein the therapy signal at least partially reduces pain without generating paresthesia, and wherein the therapy signal includes a plurality of sequential biphasic pulses, with the pulses having pulse widths in a pulse width range from 25 microseconds to 166 microseconds.

2. The system of claim 1, wherein:

the spinal cord modulator includes an implantable signal generator configured to receive selectable parameters from the programmer; and

the signal delivery device includes an elongated epidural electrical lead system coupled to the implantable signal generator.

3. The system of claim 2, wherein the implantable signal generator generates the therapy signal at a duty cycle.

4. The system of claim 3, wherein the duty cycle is 50-100%.

5. 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.

6. The system of claim 1, wherein at least a portion of the therapy signal is at a frequency in a frequency range from 3 kHz to 20 kHz.

7. The system of claim 1, wherein at least a portion of the therapy signal is at a frequency in a frequency range from 5 kHz to 15 kHz.

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

9. The system of claim 1, wherein the therapy signal is at a current amplitude in a range from 0.1 mA to 20 mA.

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

11. An epidural spinal cord modulation system for treating back and/or leg pain of a patient without requiring paresthesia mapping of the patient to implant and configure the modulation system, the system comprising:

a programmer having a therapy program that, when executed, directs delivery of a therapy signal by a spinal cord modulator to a signal delivery device configured to deliver the therapy signal to the patient'"'"'s spinal cord, wherein the therapy signal is a non-paresthesia producing therapy signal having a plurality of sequential biphasic square-wave pulses, with the pulses having pulse widths in a pulse width range from 30 microseconds to 35 microseconds, and wherein the therapy signal is at a current amplitude in a current amplitude range from 0.5 mA to 10 mA, and wherein the programmer is configured to transmit the program to the spinal cord modulator.

12. The system of claim 11, wherein:

the spinal cord modulator includes an implantable signal generator configured to receive selectable parameters from the programmer; and

the signal delivery device includes an elongated epidural electrical lead system coupled to the implantable signal generator with the two or more electrodes in a bipole arrangement.

13. The system of claim 12, wherein the implantable signal generator generates the therapy signal at a duty cycle.

14. The system of claim 13, wherein the duty cycle is 50-100%.

15. The system of claim 11, wherein at least a portion of the therapy signal is at a frequency in a frequency range from 3 kHz to 20 kHz.

16. The system of claim 11, wherein at least a portion of the therapy signal is at a frequency of 10 kHz.

17. The system of claim 13, wherein the therapy signal is delivered at a frequency in a frequency range from 3 kHz to 20 kHz throughout the length of an on-period in the duty cycle.

18. The system of claim 11, wherein the current amplitude range is from 0.5 mA to 4 mA.

19. An epidural spinal cord stimulation system for reducing or eliminating pain in a patient without using paresthesia to treat the patient, the system comprising:

a programmer having a therapy program that, when executed, directs delivery of a therapy signal by a spinal cord modulator to a signal delivery device configured to deliver the therapy signal to the patient'"'"'s spinal cord, wherein the therapy signal includes a plurality of sequential biphasic square-wave pulses, with the pulses having pulse widths in a pulse width range from 25 microseconds to 166 microseconds, and wherein the therapy signal is at a current amplitude in a range from 0.5 mA to 10 mA so as to provide pain relief for the patient without generating paresthesia.

20. The system of claim 19, wherein:

the spinal cord modulator includes an implantable signal generator configured to receive selectable parameters from the programmer; and

the signal delivery device includes an elongated epidural electrical lead system coupled to the implantable signal generator.

21. The system of claim 19, wherein at least a portion of the therapy signal is at a frequency in a frequency range from 1.5 kHz to 100 kHz.

22. The system of claim 19, wherein at least a portion of the therapy signal is at a frequency in a frequency range from 3 kHz to 20 kHz.

23. The system of claim 19, wherein at least a portion of the therapy signal is at a frequency in a frequency range from 5 kHz to 15 kHz.

24. The system of claim 19, wherein at least a portion of the therapy signal is at a frequency of 10 kHz.