Neurostimulation waveforms having a base component and a high frequency component, and associated systems and methods

Patent metadata

Field	Value
Publication number	US-12133981-B2
Application number	US-202217837726-A
Country	US
Kind code	B2
Filing date	Jun 10, 2022
Priority date	Jun 11, 2021
Publication date	Nov 5, 2024
Grant date	Nov 5, 2024

Abstract

The present technology provides systems and methods for directly suppressing nerve cells by delivering electrical stimulation having relatively long pulse widths and at amplitudes below an activation threshold of the nerve cells. For example, some embodiments include delivering a therapy signal having individual pulses with pulse widths of between about 5 ms and 100 ms. Directly suppressing the nerve cells is expected to reduce the transmission of pain signals.

First claim

We claim:

1. A patient treatment system, comprising:
a signal generator having a computer readable storage medium with instructions that, in operation, generate a therapy signal having a base component and a high frequency component, wherein—
the base component has pulses with a non-zero amplitude and a pulse width in a pulse width range of from about 5 ms to about 2 seconds, and
the high frequency component includes high frequency pulses having a frequency in a frequency range of from about 1.2 KHz to about 100 KHz, wherein the high frequency pulses have an origin at the non-zero amplitude of the base component; and

a signal delivery element coupleable to the signal generator, wherein the signal delivery element is positionable proximate a spinal cord region, and, in operation, delivers the therapy signal to the spinal cord region.

2. The patient treatment system of claim 1 wherein the pulse width of the base component pulses is in a pulse width range of from about 5 ms to about 100 ms.

3. The patient treatment system of claim 1 wherein the pulse width of the base component pulses is in a pulse width range of from about 50 ms to about 2 seconds.

4. The patient treatment system of claim 1 wherein the pulse width of the base component pulses is in a pulse width range of from about 100 ms to about 2 seconds.

5. The patient treatment system of claim 1 wherein the pulse width of the base component pulses is in a pulse width range of from about 500 ms to about 2 seconds.

6. The patient treatment system of claim 1 wherein the high frequency pulses have an amplitude greater than the non-zero amplitude of the base component pulses.

7. The patient treatment system of claim 1 wherein the high frequency pulses have a frequency of 10 KHz.

8. The patient treatment system of claim 1 wherein the high frequency pulses have a pulse width in a pulse width range of between about 10 microseconds and about 333 microseconds.

9. A patient treatment system, comprising:
a signal generator having a computer readable storage medium with instructions that, in operation, generate a therapy signal having a base component and a high frequency component, wherein—
base component has pulses with a non-zero amplitude and a pulse width in a pulse width range of from about 5 ms to about 2 seconds, and
the high frequency component includes bursts of high frequency pulses, wherein the high frequency pulses have a frequency in a frequency range of from about 1.2 kHz to about 100 kHz and an origin at the non-zero amplitude of the base component, and wherein adjacent bursts of high frequency pulses are separated by a quiescent interval during which no high frequency pulses are delivered; and

a signal delivery element coupleable to the signal generator, wherein the signal delivery element is positionable proximate a spinal cord region, and, in operation, delivers the therapy signal to the spinal cord region.

10. The patient treatment system of claim 1 wherein the base component pulses include a plurality of biphasic pulses having an anodic pulse phase and a cathodic pulse phase, and wherein at least one of the anodic pulse phase or the cathodic pulse phase has the pulse width in the pulse width range from about 5 ms to about 2 seconds.

11. The patient treatment system of claim 10 wherein the high frequency pulses occur during the anodic pulse phase and/or the cathodic pulse phase.

12. The patient treatment system of claim 10 wherein the base component pulses include an interphase interval between the anodic pulse phase and the cathodic pulse phase, and wherein the high frequency pulses do not occur during the interphase interval.

13. The patient treatment system of claim 10 wherein adjacent bi-phasic pulses of the plurality of biphasic pulses of the base component pulses are separated by an interpulse interval, and wherein the high frequency pulses do not occur during the interpulse interval.

14. The patient treatment system of claim 10 wherein the high frequency pulses include bursts of high frequency pulses, wherein adjacent bursts of high frequency pulses are separated by a quiescent interval during which no high frequency pulses are delivered.

15. The patient treatment system of claim 14 wherein at least two bursts of high frequency pulses occur during each anodic pulse phase and/or each cathodic pulse phase.

16. The patient treatment system of claim 1 wherein the base component pulses include a plurality of monophasic pulses having the non-zero amplitude.

17. The patient treatment system of claim 1 wherein the therapy signal at least partially suppresses at least a subset of neurons in the spinal cord region.

18. The patient treatment system of claim 17 wherein the subset of neurons includes WDR neurons.

19. The patient treatment system of claim 17 wherein the subset of neurons includes NS neurons.

20. The patient treatment system of claim 17 wherein the subset of neurons includes both WDR neurons and NS neurons.

21. The patient treatment system of claim 1 wherein the signal delivery element includes an electrode, and wherein the non-zero amplitude of the base component pulses is selected to be at or below a maximum amplitude of the therapy signal that the electrode can tolerate based at least in part on the pulse width, the electrode material, and/or the surface area of the electrode.

22. A method for treating a patient, comprising:
programming a signal generator to deliver a therapy signal to a target neural population in the patient's spinal cord region via at least one implanted signal delivery element, wherein the therapy signal includes (i) a base component having pulses with a non-zero amplitude and a pulse width in a pulse width range of from about 5 ms to about 2 seconds, and (ii) a high frequency component including high frequency pulses having a frequency in a frequency range of from about 1.2 kHz to about 100 kHz, wherein the high frequency pulses have an origin at the non-zero amplitude of the base component.

23. A method for treating a patient, comprising:
applying a therapy signal to the patient via a treatment system, wherein the treatment system includes a signal delivery element positioned proximate a spinal cord region of the patient, and wherein the therapy signal includes (i) a base component having pulses with a non-zero amplitude and a pulse width in a pulse width range of from about 5 ms to about 2 seconds, and (ii) a high frequency component including high frequency pulses having a frequency in a frequency range of from about 1.2 KHz to about 100 kHz, wherein the high frequency pulses have an origin at the non-zero amplitude of the base component.

24. The method of claim 22 wherein the pulse width of the base component pulses is in a pulse width range of from about 500 ms to about 2 seconds.

25. The method of claim 22 wherein the high frequency pulses have an amplitude greater than the non-zero amplitude of the base component pulses.

26. The method of claim 22 wherein the high frequency pulses have a frequency of 10 KHz.

27. The method of claim 22 wherein the high frequency pulses have a pulse width in a pulse width range of between about 10 microseconds and about 333 microseconds.

28. The method of claim 22 wherein the base component pulses include a plurality of biphasic pulses having an anodic pulse phase and a cathodic pulse phase, and where

Assignees

• Nevro Corp

Inventors

• Lee Dongchul
• Bradley Kerry

Classifications

• A61N1/36171

  Frequency · CPC title

• A61N1/36062

  Spinal stimulation · CPC title

• A61N1/36175

  Pulse width or duty cycle · CPC title

• A61N1/0551 Primary

  Spinal or peripheral nerve electrodes · CPC title

• A61N1/36071 Primary

  Pain · CPC title