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

• US 9,480,842 B2
• Filed: 10/27/2014
• Issued: 11/01/2016
• 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): Wu, Eugene T
• Application Number:
  US14/525,134
• Publication Number:
  US 20150045854A1
• Time in Patent Office: 736 Days
• Field of Search: 607/2, 607/46, 607115-117, 607/154
• US Class Current: 1/1
• 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

A spinal cord modulation system is disclosed. While in one embodiment the system is used for the treatment of pain, other embodiments are also provided. In particular embodiments, the spinal cord modulation system generates and delivers an electrical therapy signal at a frequency of 10 kHz to address pain without creating unwanted sensory and/or motor side effects. The system may further include various signal delivery devices to deliver the therapy signal to a patient'"'"'s spinal cord region.

Claims

1. A spinal cord modulation system, comprising:

a signal generator configured to generate a therapy signal having a frequency of 10 kHz, an amplitude up to 6 mA, and pulses having a pulse width between 30 microseconds and 35 microseconds; and

an implantable signal delivery device electrically coupleable to the signal generator and configured to be implanted within a patient'"'"'s epidural space to deliver the therapy signal from the signal generator to the patient'"'"'s spinal cord.

2. The system of claim 1, wherein the current amplitude is between 0.5 and 4 mA.

3. The system of claim 1, wherein the therapy signal includes a plurality of biphasic pulses.

4. The system of claim 1, wherein the signal generator is an implantable signal generator.

5. The system of claim 1, wherein the signal generator is an external signal generator.

6. The system of claim 1, wherein the implantable signal delivery device is a percutaneous lead.

7. The system of claim 1, wherein the implantable signal delivery device is a paddle lead.

8. The system of claim 1, wherein the signal generator is configured to deliver the therapy signal in accordance with a duty cycle.

9. The system of claim 1 wherein the signal generator is programmed with instructions that, when executed, generate the therapy signal and deliver the therapy signal to the patient'"'"'s spinal cord via the implantable signal delivery device.

10. A spinal cord modulation system, comprising:

a signal generator configured to generate a therapy signal having a frequency of 10 kHz, an amplitude between 1 mA and 6 mA, and pulses having a pulse width between 30 microseconds and 35 microseconds; and

an implantable signal delivery device configured to electrically couple to the signal generator and configured to be implanted in a patient'"'"'s epidural space to deliver the therapy signal from the signal generator to the patient'"'"'s spinal cord.

11. The system of claim 10, wherein the therapy signal includes a plurality of biphasic pulses.

12. The system of claim 10, wherein the signal generator is an implantable signal generator.

13. The system of claim 10, wherein the signal generator is an external signal generator.

14. The system of claim 10, wherein the implantable signal delivery device is a percutaneous lead.

15. The system of claim 10, wherein the implantable signal delivery device is a paddle lead.

16. The system of claim 10, wherein the signal generator is programmed with instructions that, when executed, generate the therapy signal and deliver the therapy signal to the patient'"'"'s spinal cord via the implantable signal delivery device.

17. The system of claim 10, further comprising:

a physician'"'"'s programmer configured to be in wireless communication with the signal generator to remotely update signal delivery parameters of the therapy signal.

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

a signal generator configured to generate a therapy signal in accordance with a therapy regimen, wherein at least a portion of the therapy signal is at a frequency of 10 kHz, includes pulses with pulse widths between 30 microseconds and 35 microseconds, and has a current amplitude up to 6 mA;

an implantable signal delivery device configured to electrically couple to the signal generator and configured to be implanted in the patient'"'"'s epidural space to deliver the therapy signal to the patient'"'"'s spinal cord; and

a programmer configured to be in wireless communication with the signal generator and configured to program the therapy regimen within the signal generator.

19. The system of claim 18, wherein the current amplitude is between 1 mA and 6 mA.

20. The system of claim 18, wherein the signal generator is an implantable signal generator.

21. The system of claim 18 wherein the signal generator is programmed with instructions that, when executed, generate the therapy signal and deliver the therapy signal to the patient'"'"'s spinal cord via the implantable signal delivery device.

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

a signal generator configured to generate a therapy signal in accordance with one or more therapy signal parameters;

an implantable signal delivery device configured to electrically couple to the signal generator and configured to be implanted in the patient'"'"'s epidural space to deliver the therapy signal to the patient'"'"'s spinal cord; and

a programmer configured to be in wireless communication with the signal generator and configured to modify at least one of the one or more therapy signal parameters in the signal generator,

wherein the one or more therapy signal parameters include, for at least a portion of the therapy signal,

(a) a frequency of 10 kHz,

(b) an amplitude up to 6 mA, and

(c) pulses with a pulse width between 30 microseconds and 35 microseconds.

23. The system of claim 22, wherein the amplitude is between 1 mA and 6 mA.

24. The system of claim 22, wherein the signal generator is an implantable signal generator.

25. The system of claim 22, wherein the signal generator is an external signal generator.

26. The system of claim 22, wherein the signal generator is programmed with instructions that, when executed, generate the therapy signal and deliver the therapy signal to the patient'"'"'s spinal cord via the implantable signal delivery device.