IP Library Granted Patent US 11,235,178
Granted Patent B2
US 11,235,178 · App. 16/121,223 · Granted Feb 1, 2022

Neuromodulation energy application techniques

Inventors: Christopher Michael Puleo (Niskayuna, NY); Yang Zhao (Schenectady, NY); Kirk Dennis Wallace (Schenectady, NY); Ying Fan (Schenectady, NY); Jeffrey Michael Ashe (Gloversville, NY); David Andrew Shoudy (Niskayuna, NY)
Assignee: GENERAL ELECTRIC COMPANY
A61N7/00A61B8/4245A61B8/4254A61B90/361A61B90/37A61B8/4209A61B8/4263A61N2007/0026
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Quick Facts
Patent No.
US 11,235,178
App. No.
16/121,223
Filed
Sep 4, 2018
Granted
Feb 1, 2022
Kind
B2
Art Unit
3793
USPC
601/2
Abstract

Embodiments of the present disclosure relate to techniques for facilitating personalized neuromodulation treatment protocols. In one embodiment, a predetermined treatment position of an energy application device is used to guide future treatments for the patient. In one embodiment, a position of the energy application device relative to the predetermined treatment position is determined. In one embodiment, a total dose of ultrasound energy applied to the region of interest is determined.

Claims (51)

1. A neuromodulation system, comprising:

a noninvasive ultrasound probe comprising an ultrasound transducer configured to apply ultrasound energy to a region of interest in a patient's body in an amount effective to induce neuromodulation of one or more nerve pathways, wherein the region of interest comprises a subregion of an internal organ, and wherein the region of interest comprises an axon terminal that forms a synapse with a non-neuronal cell;

a memory configured to store data associated with a predetermined treatment position of the noninvasive ultrasound probe; and

a controller configured to:

control application of the ultrasound energy to the region of interest via the noninvasive ultrasound probe such that the applied ultrasound energy has a nonablative temporal average intensity less than 35 W/cm 2 ;

receive position information related to the noninvasive ultrasound probe;

determine that a position of the noninvasive ultrasound probe is aligned with the predetermined treatment position of the noninvasive ultrasound probe that is stored in the memory, based on the position information for the noninvasive ultrasound probe; and

permit application of the ultrasound energy via the noninvasive ultrasound probe only when the noninvasive ultrasound probe aligns with the predetermined treatment position.

2. The system of claim 1 , wherein the noninvasive ultrasound probe comprises one or more position sensors configured to generate the position information.

3. The system of claim 2 , wherein the one or more position sensors comprise inertial measurement units.

4. The system of claim 2 , wherein the one or more position sensors are mechanical fixtures with fixed position relative to the patient's body and/or an external device.

5. The system of claim 1 , wherein the noninvasive ultrasound probe comprises an ultrasound imaging transducer configured to generate the position information.

6. The system of claim 1 , wherein the noninvasive ultrasound probe comprises a camera configured to generate the position information, wherein the camera is oriented away from a treatment surface of the noninvasive ultrasound probe.

7. The system of claim 6 , wherein the position information comprises one or more images acquired by the camera, and wherein the controller is configured to determine that the position of the noninvasive ultrasound probe aligns with the predetermined treatment position when the image captures all or part of an indicator of the predetermined treatment position, wherein the indicator is associated with the patient.

8. The system of claim 1 , additionally comprising a steering controller configured to steer all or part of the noninvasive ultrasound probe when in operation, and wherein the controller is configured to drive the steering controller based on the position information.

9. The system of claim 1 , wherein the controller is configured to provide an indication of the position of the noninvasive ultrasound probe relative to the predetermined treatment position.

10. The system of claim 1 , wherein the controller is configured to determine that the position of the ultrasound transducer does not align with the predetermined treatment position based on the position information and to stop or switch off application of the ultrasound energy via the noninvasive ultrasound probe when the noninvasive ultrasound probe does not align with the predetermined treatment position.

11. The system of claim 1 , wherein the controller is configured to provide an indication that the position of the noninvasive ultrasound probe aligns with the predetermined treatment position.

12. The system of claim 1 , wherein the controller is configured to provide an indication that the position of the noninvasive ultrasound probe does not align with the predetermined treatment position.

13. The system of claim 12 , wherein the indication comprises instructions to move the noninvasive ultrasound probe in a direction towards the predetermined treatment position.

14. The system of claim 13 , wherein the instructions comprise one or more of text instructions, arrows, or an image displayed on a display.

15. The system of claim 1 , wherein the controller is configured to calculate an off-target dose of energy applied to areas outside of the region of interest based on the position of the noninvasive ultrasound probe relative to the predetermined treatment position over a time window.

16. The system of claim 1 , wherein the wherein the controller is configured to generate instructions to cause the noninvasive ultrasound probe to activate a feedback while the position of the noninvasive ultrasound probe is aligned with the predetermined treatment position.

17. A neuromodulation system, comprising:

A noninvasive ultrasound probe configured to apply energy to a region of interest in a patient's body, the noninvasive ultrasound probe comprising an ultrasound therapy transducer and at least one position feedback device comprising a position sensor, a position fixture, a camera, an ultrasound imaging transducer, or a combination thereof, the at least one position feedback device configured to generate position information of the noninvasive ultrasound probe, wherein the region of interest comprises a subregion of an internal organ; and

a controller configured to:

control application of the energy to the region of interest via the noninvasive ultrasound probe;

receive the position information of the noninvasive ultrasound probe;

determine a position of the noninvasive ultrasound probe relative to a predetermined treatment position based on the position information;

determine a total dose of the energy applied to the region of interest and an off-target dose of the energy applied to areas outside of the region of interest based on the position of the noninvasive ultrasound probe relative to the predetermined treatment position; and

when the off-target dose is below a threshold and the total dose is below a complete dose:

continue controlling the application of the energy until the total dose corresponds to an energy associated with the complete dose to the region of interest of a treatment protocol stored in a memory; and

shutting off the application of the energy when the total dose corresponds to the complete dose; and

when the off-target dose is above a threshold and when the total dose is below the complete dose: shutting off the application of the energy.

18. A method comprising

positioning an ultrasound transducer of a noninvasive ultrasound probe to deliver ultrasound energy to a region of interest in a patient's body, wherein the region of interest comprises a subregion of an internal organ, and wherein the region of interest comprises an axon terminal that forms a synapse with a non-neuronal cell;

receiving data from a sensor positioned on or in the noninvasive ultrasound probe, the data being indicative of a position of the ultrasound transducer;

determining that the position of the ultrasound transducer aligns with a predetermined treatment position based at least in part on the data from the sensor;

initiating application of the ultrasound energy from the ultrasound transducer to deliver the ultrasound energy to the region of interest in an amount effective to induce neuromodulation of one or more nerve pathways after determining that the position aligns with the predetermined treatment position;

determining a total dose of the ultrasound energy applied to the region of interest based at least in part on the position of the ultrasound transducer relative to the predetermined treatment position;

discontinuing the application of the ultrasound energy from the ultrasound transducer when the total dose is greater than or equal to a predetermined threshold associated with a complete dose of a treatment protocol, the treatment protocol comprising a plurality of doses applied at predetermined intervals and at the predetermined treatment position;

receiving image data of the internal organ;

assessing a tissue displacement based on the image data; and

modifying one or more parameters of the applied ultrasound energy based on the tissue displacement.

19. The method of claim 18 , additionally comprising:

receiving updated data from the sensor;

determining that the ultrasound transducer has moved relative to the patient such that the position of the ultrasound transducer does not align with the predetermined treatment position; and

stopping the application of the ultrasound energy from the ultrasound transducer.

20. The method of claim 18 , comprising providing an indication that the ultrasound transducer is in position or on target when the position of the ultrasound transducer aligns with the predetermined treatment position.

21. The method of claim 18 , wherein the region of interest is a liver.

22. The method of claim 18 , wherein the indication is a haptic effect generated by a vibration actuator on or in the noninvasive ultrasound probe.

Assignments (2)
NUNC PRO TUNC ASSIGNMENT Recorded May 8, 2025
From: GENERAL ELECTRIC COMPANY
To: GE PRECISION HEALTHCARE LLC
Reel/Frame 071225/0218 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 5, 2018
From: PULEO, CHRISTOPHER MICHAEL; ZHAO, YANG; WALLACE, KIRK DENNIS; FAN, YING; ASHE, JEFFREY MICHAEL; SHOUDY, DAVID ANDREW
To: GENERAL ELECTRIC COMPANY
Reel/Frame 046793/0823 →
Continuity (1)
Related Publication 20200069976A1 · Mar 5, 2020
Cited By (2)
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