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

• US 8,718,782 B2
• Filed: 03/14/2013
• 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:
  US13/831,057
• Publication Number:
  US 20130204322A1
• Time in Patent Office: 418 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 modulation system for reducing or eliminating pain in a patient, the system comprising:

a signal generator configured to generate a non-paresthesia-producing therapy signal in accordance with a therapy signal parameter, wherein the therapy signal parameter includes at least a portion of the therapy signal being set at a frequency in a frequency range from 1.5 kHz to 100 kHz;

an implantable signal delivery device electrically coupled to the signal generator and configured to deliver the therapy signal to the patient'"'"'s spinal cord region; and

a programmer in communication with the signal generator and having instructions that, when executed, program the signal generator to generate the therapy signal without the use of paresthesia mapping to set an amplitude of the therapy signal.

2. The system of claim 1, wherein the frequency range is from 3 kHz to 20 kHz.

3. The system of claim 1, wherein the frequency range is from 5 kHz to 15 kHz.

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

5. A spinal cord modulation system for reducing or eliminating pain in a patient without relying on paresthesia or tingling to mask the patient'"'"'s sensation of the pain, the system comprising:

an implantable signal generator configured to generate a non-paresthesia-generating therapy signal, wherein at least a portion of the therapy signal is at a frequency in a frequency range from 1.5 kHz to 100 kHz;

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

an external programmer programmed with instructions that, when executed, wirelessly communicate with the implantable signal generator and program the implantable signal generator to generate the therapy signal in accordance with one or more therapy signal parameters without the use of paresthesia-mapping patient feedback in the setting of the one or more of the therapy signal parameters.

6. The system of claim 5, wherein the frequency range is from 3 kHz to 20 kHz.

7. The system of claim 5, wherein the frequency range is from 3 kHz to 15 kHz.

8. The system of claim 5, wherein the frequency range is from 5 kHz to 15 kHz.

9. The system of claim 5, wherein the frequency range is from 3 kHz to 10 kHz.

10. The system of claim 5, wherein at least a portion of the therapy signal is at a frequency of 10 kHz.

11. The system of claim 5, wherein the signal delivery device is a percutaneous lead configured to be implanted in the patient'"'"'s epidural space.

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

13. The system of claim 5, wherein the signal delivery device is an elongated lead having one or more electrodes configured to direct the therapy signal to a target location in the patient'"'"'s spinal cord.

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

an implantable signal generator configured to generate a non-paresthesia-generating therapy signal, wherein at least a portion of the therapy signal is at a frequency in a frequency range from 1.5 kHz to 50 kHz;

an implantable signal delivery device having two or more electrical contacts for delivery of the therapy signal generated by the implantable signal generator, wherein the signal delivery device is electrically coupleable to the implantable signal generator; and

an external programmer in wireless communication with the implantable signal generator and configured to program the implantable signal generator so as to identify which of the electrical contacts to use in delivery of the therapy signal without using paresthesia mapping in the identification of the electrical contacts used to deliver the therapy signal.

15. The system of claim 14, wherein the frequency range is from 3 kHz to 15 kHz.

16. The system of claim 14, wherein the frequency range is from 5 kHz to 15 kHz.

17. The system of claim 14, wherein the frequency range is from 3 kHz to 10 kHz.

18. The system of claim 14, wherein at least a portion of the therapy signal is at a frequency of 10 kHz.

19. A spinal cord modulation system for reducing or eliminating patient pain, the system comprising:

an implantable signal generator configured to generate a non-paresthesia-producing therapy signal, wherein at least a portion of the therapy signal includes (i) a frequency in a frequency range from 1.5 kHz to 100 kHz, (ii) a pulse width between 10 microseconds and 333 microseconds, and (iii) a current amplitude between 0.1 mA and 20 mA;

two percutaneous leads electrically coupleable to the implantable signal generator and configured to be implanted in the patient'"'"'s epidural space, wherein each percutaneous lead includes four or more electrodes for delivering the therapy signal to the patient'"'"'s spinal cord; and

an external programmer in wireless communication with the implantable signal generator and having instructions that, when executed, program the implantable signal generator to thereby identify at least two electrodes to deliver the therapy signal without using paresthesia-mapping patient feedback in the identification of the electrodes used to deliver the therapy signal.

20. The system of claim 19, wherein the frequency range is from 3 kHz to 15 kHz.

21. The system of claim 19, wherein the frequency range is from 5 kHz to 15 kHz.

22. The system of claim 19, wherein the frequency range is from 3 kHz to 10 kHz.

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