Methods and systems for peripheral nerve modulation using non ablative focused ultrasound with electromyography (EMG) monitoring

Patent metadata

Field	Value
Publication number	US-11020617-B2
Application number	US-201916265827-A
Country	US
Kind code	B2
Filing date	Feb 1, 2019
Priority date	Jul 27, 2016
Publication date	Jun 1, 2021
Grant date	Jun 1, 2021

Abstract

Techniques for modulating peripheral nerves using focused ultrasound (FUS) are provided. Methods include locating a peripheral nerve in a subject using an imaging probe, providing a FUS having one or more ultrasound parameters to a location on the peripheral nerve, and modulating the peripheral nerve. The methods can further include eliciting and measuring a physiological response from the FUS modulation, generating tissue deformation in the vicinity of the FUS modulation, and imaging the nerve and the tissue deformation simultaneously with FUS modulation. Systems for use in the modulation of peripheral nerves are also provided.

First claim

What is claimed is:

1. A method for modulation of a peripheral nerve in a subject using a focused ultrasound (FUS) assembly having one or more ultrasound parameters, comprising:
adjusting the one or more ultrasound parameters to adapt a FUS for a location on the peripheral nerve, wherein the one or more ultrasound parameters are adjusted to induce a displacement of the peripheral nerve ranging from about 8.5 μm to about 422 μm and elicit an electromyography (EMG) activity at the peripheral nerve without damaging or ablating the peripheral nerve;
modulating the peripheral nerve with the FUS with the adjusted one or more ultrasound parameters; and
acquiring images of the displacement through a displacement estimation and EMG signals from muscle tissue of the subject to determine a physiological response induced by the FUS.

2. The method of claim 1 , wherein the modulating comprises stimulating or exciting the peripheral nerve with the FUS.

3. The method of claim 1 , wherein the modulating comprises inhibiting activities of the peripheral nerve.

4. The method of claim 1 , further comprising locating the peripheral nerve using an imaging probe prior to adjusting the one or more ultrasound parameters.

5. The method of claim 4 , wherein the imaging probe comprises a B-mode imaging probe.

6. The method of claim 1 , wherein the peripheral nerve comprises a sciatic nerve, a median nerve, an ulnar nerve, a tibial nerve, or a sacral nerve.

7. The method of claim 1 , wherein the FUS assembly comprises a focused ultrasound (FUS) transducer with a 3.57 MHz center frequency, a 0.46×3.55 mm focal area and a 35 mm focal depth, a 20 MHz function waveform generator, and a 150 W amplifier.

8. The method of claim 1 , wherein the one or more ultrasound parameters comprise at least one of a peak negative pressure, a stimulation duration, a duty cycle, and a pulse repetition frequency (PRF).

9. The method of claim 8 , wherein the peak negative pressure is from about 1.1 MPa to about 8.8 MPa.

10. The method of claim 8 , wherein the stimulation duration is from about 0.8 ms to about 1 s.

11. The method of claim 8 , wherein the duty cycle is from about 15% to about 100%.

12. The method of claim 8 , wherein the PRF is from about 1 kHz to about 50 kHz.

13. The method of claim 8 , wherein the peak negative pressure is from about 3.2 MPa to about 5.7 MPa, the stimulation duration is from about 0.8 ms to about 10.5 ms, the duty cycle is from about 35% to about 100%, and the PRF is from about 1 kHz to about 50 kHz.

14. The method of claim 1 , further comprising eliciting and measuring the physiological response during or after FUS modulation by measuring the EMG signals.

15. The method of claim 14 , further comprising modulating the one or more ultrasound parameters to change timing of the physiological response.

16. The method of claim 1 , further comprising imaging the peripheral nerve and the nerve displacement simultaneously with FUS modulation.

17. The method of claim 1 , further comprising monitoring a thermal effect elicited by the FUS modulation.

18. A system for modulating a peripheral nerve in a subject using focused ultrasound (FUS), comprising:
an imaging probe for locating the peripheral nerve;
an ultrasound assembly, including a focused ultrasound (FUS) transducer, a function generator, and an amplifier, for providing a FUS having one or more ultrasound parameters to a location on the peripheral nerve, wherein the ultrasound assembly is configured to adjust one or more ultrasound parameters to induce a displacement of the peripheral nerve ranging from about 8.5 μm to about 422 μm without damaging or ablating the peripheral nerve and elicit electromyography (EMG) signals from muscle tissue of the subject;
a processor, coupled to the ultrasound assembly, for adjusting the one or more ultrasound parameters to adapt the FUS for a location on the peripheral nerve and acquire images of the displacement through a displacement estimation and the EMG signals from the muscle tissue of the subject to determine a physiological response induced by the FUS.

19. The system of claim 18 , wherein the FUS comprises a transducer with a 3.57 MHz center frequency, a 0.46×3.55 mm focal area and a 35 mm focal depth.

20. The system of claim 18 , wherein the function generator comprises a 20 MHz function waveform generator, and the amplifier comprises a 150 W amplifier.

21. The system of claim 18 , further comprising a mechanical positioning system for placing the ultrasound assembly and the imaging probe.

22. The system of claim 18 , further comprising an imaging system, operatively coupled to the processor and the imaging probe, for recording and displaying the peripheral nerve and/or surrounding tissue during FUS modulation.

23. The system of claim 22 , wherein the imaging probe comprises a pulse-echo image transducer.

24. The system of claim 22 , wherein the imaging system is configured to perform a displacement estimation.

25. The system of claim 22 , wherein the imaging system is configured to perform a strain estimation.

26. The system of claim 22 , wherein the imaging system comprises at least one electroencephalogram (EEG) electrode for recording somatosensory evoked potential responses by the FUS transducer.

Assignees

• Univ Columbia

Inventors

• Konofagou Elisa E
• Downs Matthew
• Lee Stephen
• Kim Min Gon
• Kamimura Hermes Arytto Salles

Classifications

• A61B5/395

  Details of stimulation, e.g. nerve stimulation to elicit EMG response · CPC title

• A61B5/369

  Electroencephalography [EEG] · CPC title

• A61B5/389 Primary

  Electromyography [EMG] · CPC title

• A61N2007/0026

  Stimulation of nerve tissue · CPC title

• A61B5/4836

  Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence) · CPC title