# US 12,594,053 B2 · Patient-specific neuromodulation alignment structures

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- Number: US 12,594,053 B2
- Document ID: US12594053B2
- Status: Granted
- Kind: B2
- Application number: 18/520,180
- Filed: 2023-11-27
- Published: 2024-03-21
- Granted: 2026-04-07
- Earliest claimed: 2021-05-13
- Assignees: GE Precision Healthcare LLC
- Applicants: GE Precision Healthcare LLC
- Inventors: David Andrew Shoudy; Craig Patrick Galligan; Weston Blaine Griffin; Jeffrey Michael Ashe; Warren Lee; James Enrico Sabatini
- Web page: https://patentgrep.com/patent/US12594053B2

## CPC

- A61B 8/08: Clinical applications (A61B8/02, A61B8/04, A61B8/06 take precedence)
- A61B 8/4227: {characterised by straps, belts, cuffs or braces}
- A61B 8/4254: {using sensors mounted on the probe}
- A61B 8/4427: {Device being portable or laptop-like}
- A61B 8/4477: {using several separate ultrasound transducers or probes}
- A61N 7/00: Ultrasound therapy (lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 {; using ultrasound for introducing media into the body A61M37/0092})
- A61N 7/02: Localised ultrasound hyperthermia
- A61B 8/429: {characterised by determining or monitoring the contact between the transducer and the tissue}
- A61B 8/4411: {Device being modular}
- A61B 8/4416: {related to combined acquisition of different diagnostic modalities, e.g. combination of ultrasound and X-ray acquisitions}
- A61B 8/46: {Ultrasonic, sonic or infrasonic diagnostic devices with special arrangements for interfacing with the operator or the patient}
- A61B 2090/064: {for measuring force, pressure or mechanical tension}
- A61B 2090/378: {using ultrasound}
- A61N 2007/0026: {Stimulation of nerve tissue}
- A61N 2007/0052: {using the same transducer for therapy and imaging}
- A61N 2007/0078: {with multiple treatment transducers}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)

## Abstract

The present discussion relates to structures and devices to facilitate application of an ultrasound therapy beam to a target anatomic region in a replicable manner. In certain aspects, adjustable positioning structures are described that allow a general probe positioning structure to be configured for a specific patient in a manner that allows the device to be used repeatedly to target the anatomic region, even when in non-clinical settings. In other aspects, a probe positioning structure is fabricated that is specific to a respective patient anatomy, such that use of the probe positioning structure provides repeatable targeting of the target anatomic region, even when in non-clinical settings.

## Claims

### Claim 1

A system, comprising:
an ultrasound probe, wherein, the ultrasound probe comprises one or more ultrasound transducers, wherein the one or more ultrasound transducers are configured to emit a therapy beam and the one or more ultrasound transducers are configured to emit an imaging beam;
a probe holder comprising a probe carriage frame, wherein the probe carriage frame comprises a passage that receives the ultrasound probe, and wherein the probe carriage frame is configured to move in a z-dimension, wherein the z-dimension comprises a linear axial dimension toward or away from a subject;
a wearable device comprising a belt or vest coupled to the probe holder and comprising one or more adjustable fitting features, wherein the one or more adjustable fitting features comprises tensioning features configured to hold the ultrasound probe against the subject with applied pressure; and
wherein the probe holder is configured to reversibly receive the ultrasound probe and to allow movement of the ultrasound probe to change a rock, a tilt, or a spin angular orientation of the ultrasound probe relative to an acoustic window of the wearable device.

### Claim 2 (depends on 1)

The system of claim 1, wherein the one or more adjustable fitting features comprise one or more of straps, clips, ratchets, pull cords, lacing tensioners, or inflatable structures.

### Claim 3 (depends on 1)

The system of claim 1, wherein the one or more ultrasound transducers comprise at least one ultrasound transducer that emits both the imaging beam and the therapy beam.

### Claim 4 (depends on 1)

The system of claim 1, wherein the probe carriage frame is coupled to a rail to allow movement of the probe carriage frame and the ultrasound probe along the rail and towards or away from the acoustic window.

### Claim 5 (depends on 1)

The system of claim 1, wherein the probe carriage frame is coupled to a spherical joint to allow movement of the probe carriage frame and the ultrasound probe to change one or more of the rock, the tilt, or the spin angular orientation.

### Claim 6 (depends on 5)

The system of claim 5, comprising a joint clamp that is configured to reversibly secure the spherical joint in position.

### Claim 7 (depends on 1)

The system of claim 1, wherein the probe carriage frame is configured to be reversibly locked in position and/or orientation to secure an ultrasound probe position and/or orientation.

### Claim 8 (depends on 1)

The system of claim 1, wherein the wearable device is configured to conformally fit to the subject.

### Claim 9

A method of configuring a wearable device, comprising:
applying the wearable device to a subject, wherein the wearable device comprises a belt or a vest, wherein an ultrasound probe is coupled to a positioning structure of the wearable device via a probe holder, and wherein the ultrasound probe comprises one or more ultrasound transducers, wherein the one or more ultrasound transducers are configured to emit a therapy beam and the one or more ultrasound transducers are configured to emit an imaging beam;
adjusting the probe holder relative to the subject to change a rock, a tilt, or a spin angular orientation of the ultrasound probe, wherein the probe holder comprises a probe carriage frame, wherein the probe carriage frame comprises a passage that receives the ultrasound probe, and wherein the probe carriage frame is configured to move in a z-dimension, wherein the z-dimension comprises a linear axial dimension toward or away from the subject;
determining one or more fitting parameters of the wearable device, the positioning structure, or the ultrasound probe when aligned to an anatomic target region of the subject, wherein the wearable device comprises one or more adjustable fitting features, wherein the one or more adjustable fitting features comprise tensioning features configured to hold the ultrasound probe against the subject with applied pressure; and
saving the one or more fitting parameters for use when the wearable device is subsequently applied to the subject for a therapy session.

### Claim 10 (depends on 9)

The method of claim 9, wherein saving the one or more fitting parameters comprises locking the ultrasound probe in place using a locking mechanism to fix a position of a frame of the probe holder relative to the wearable device.

### Claim 11 (depends on 10)

The method of claim 10 wherein the locking mechanism is provided as part of the probe holder that allows movement of the ultrasound probe in x-, y-, and z-dimensions and orientation angles, wherein the locking mechanism locks the ultrasound probe into the position in the x-, y-, and z-dimensions as well as locking an orientation of the ultrasound probe.

### Claim 12 (depends on 9)

The method of claim 9, wherein, while performing the step of adjusting, guidance is received based on one or both of image data or sensor data of the ultrasound probe.

### Claim 13 (depends on 9)

The method of claim 9, wherein the adjusting comprises moving a frame of the probe holder relative to the wearable device to adjust the ultrasound probe.

### Claim 14 (depends on 13)

The method of claim 13, wherein the moving is along a rail coupled to the frame.

### Claim 15 (depends on 13)

The method of claim 13, wherein the adjusting comprises using a spherical joint.

### Claim 16 (depends on 9)

The method of claim 9, wherein the probe holder comprises a frame configured to move relative to the positioning structure when a lock of the probe holder is in an unlocked position and wherein the frame is in a fixed position relative to the positioning structure when the lock of the probe holder is in a locked position.

### Claim 17 (depends on 16)

The method of claim 16, wherein the lock comprises a clamp.

### Claim 18 (depends on 17)

The method of claim 17, wherein the clamp locks a spherical joint.