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

• US 10,603,494 B2
• Filed: 09/25/2019
• Issued: 03/31/2020
• 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:
  US16/583,139
• Publication Number:
  US 20200016405A1
• Time in Patent Office: 188 Days
• 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 chord modulation for inhibiting pain with reduced side affects 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 chord region to address low back pain without creating unwanted sensory and/or motor side affects. 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 treating pain in a patient, comprising:

delivering an electrical signal to the patient'"'"'s spinal cord via at least one signal delivery device implantable in the patient'"'"'s epidural space,

wherein the electrical signal has a frequency between 1.5 kHz and 50 kHz, an amplitude between 0.5 mA and 4 mA, and pulses with a pulse width between 10 microseconds and 35 microseconds.

2. The method of claim 1, wherein the frequency is between 3 kHz and 20 kHz.

3. The method of claim 1, wherein the frequency is between 5 kHz and 15 kHz.

4. The method of claim 1, wherein the frequency is between 3 kHz and 10 kHz.

5. The method of claim 1, wherein the frequency is 10 kHz.

6. The method of claim 1, further comprising:

using a programmer to wirelessly select at least one of the frequency, pulse width, or amplitude of the electrical signal.

7. The method of claim 6, further comprising:

using the programmer to transmit one or more of a selected frequency, pulse width, or amplitude to an implanted signal generator, wherein the implanted signal generator generates and delivers the electrical signal to the patient'"'"'s spinal cord via the at least one signal delivery device.

8. A method for treating pain in a patient, comprising:

programming an implanted signal generator to

(i) generate an electrical signal having a frequency between 1.5 kHz and 50 kHz, an amplitude between 0.5 mA and 4 mA, and pulses with pulse widths between 10 microseconds and 35 microseconds, and

(ii) deliver the electrical signal to the patient'"'"'s spinal cord via an implantable signal delivery device implanted within the patient'"'"'s epidural space.

9. The method of claim 8, wherein the frequency is between 3 kHz and 20 kHz.

10. The method of claim 8, wherein the frequency is between 5 kHz and 15 kHz.

11. The method of claim 8, wherein the frequency is between 3 kHz and 10 kHz.

12. A spinal cord modulation system for treating pain in a patient, comprising:

a signal generator that in operation generates an electrical signal,

wherein at least a portion of the electrical signal has a frequency between 1.5 kHz and 50 kHz, an amplitude between 0.5 mA and 4 mA, and a pulse width between 10 microseconds and 35 microseconds; and

an implantable signal delivery device operably coupleable to the signal generator and designed to be implanted within a patient'"'"'s epidural space to deliver the electrical signal from the signal generator to the patient'"'"'s spinal cord region.

13. The system of claim 12, wherein the frequency is between 5 kHz and 15 kHz.

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

15. The system of claim 14, wherein the frequency is between 3 kHz and 10 kHz.

16. The system of claim 12, wherein the signal generator is an external signal generator.

17. The system of claim 16, wherein the frequency is between 3 kHz and 10 kHz.

18. The system of claim 12, wherein the signal delivery device is a percutaneous lead.

19. A spinal cord modulation system for treating pain in a patient, comprising:

a signal generator that in operation generates an electrical signal having a frequency between 1.5 kHz and 50 kHz, an amplitude between 0.5 mA and 4 mA, and pulse widths between 10 microseconds and 35 microseconds; and

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

20. The system of claim 19, wherein the frequency is between 5 kHz and 15 kHz.

21. The system of claim 19, wherein the frequency is 10 kHz.

22. The system of claim 19, wherein the signal generator is an implantable signal generator.

23. The system of claim 22, wherein the frequency is between 3 kHz and 10 kHz.

24. The system of claim 22, wherein the electrical signal includes a plurality of biphasic pulses.

25. The system of claim 22, wherein the amplitude is between 2 mA and 3.5 mA.

26. The system of claim 19, wherein the signal generator is an external signal generator.

27. The system of claim 26, wherein the frequency is between 3 kHz and 10 kHz.

28. The system of claim 26, wherein the amplitude is between 2 mA and 3.5 mA.

29. The system of claim 26, wherein the electrical signal includes a plurality of biphasic pulses.

30. The system of claim 19 wherein the signal delivery device is a percutaneous lead.