# US 12,178,604 B2 · Devices and methods for determination of electrical dipole densities on a cardiac surface

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- Number: US 12,178,604 B2
- Document ID: US12178604B2
- Status: Granted
- Kind: B2
- Application number: 17/063,901
- Filed: 2020-10-06
- Published: 2021-05-27
- Granted: 2024-12-31
- Earliest claimed: 2013-09-13
- Assignees: Acutus Medical, Inc.
- Applicants: Acutus Medical, Inc.
- Inventors: Randell L. Werneth; Graydon E. Beatty; Christoph Scharf; Gunter Scharf; J. Christopher Flaherty
- Web page: https://patentgrep.com/patent/US12178604B2

## CPC

- A61B 5/4836: {Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence)}
- A61B 3/113: for determining or recording eye movement
- A61B 5/0036: {including treatment, e.g., using an implantable medical device, ablating, ventilating}
- A61B 5/0205: Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
- A61B 5/1072: {measuring distances on the body, e.g. measuring length, height or thickness (A61B5/1076 takes precedence)}
- A61B 5/282: Holders for multiple electrodes (for introduction into the body A61B5/287)
- A61B 5/287: Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
- A61B 5/318: Heart-related electrical modalities, e.g. electrocardiography [ECG]
- A61B 5/33: specially adapted for cooperation with other devices
- A61B 5/339: Displays specially adapted therefor
- A61B 5/6805: {Vests, e.g. shirts or gowns}
- A61B 6/032: {Transmission computed tomography [CT]}
- A61B 8/0883: {for diagnosis of the heart}
- A61B 8/12: in body cavities or body tracts, e.g. by using catheters
- A61B 8/4416: {related to combined acquisition of different diagnostic modalities, e.g. combination of ultrasound and X-ray acquisitions}
- A61B 8/464: {involving a plurality of displays}
- A61B 8/565: {involving data transmission via a network}
- A61B 18/02: by cooling, e.g. cryogenic techniques
- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61B 18/1815: {using microwaves}
- A61B 18/20: using laser
- A61B 2018/00994: {combining two or more different kinds of non-mechanical energy or combining one or more non-mechanical energies with ultrasound}
- A61B 2562/046: in a matrix array
- A61B 2576/023: for the heart
- G16H 30/40: for processing medical images, e.g. editing
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

Disclosed are devices, systems, and methods for determining the dipole densities on a cardiac surface using a plurality of electrodes, including electrodes positioned on a torso of a patient.

## Claims

### Claim 1

A device that generates a table of dipole densities ν(P′,t) at locations P′ on an epicardial surface of a given heart of a patient at times t, comprising:
a) a measuring and recording unit that measures and records electric potential data Ve at given positions P proximate the patient's torso surface, wherein the measuring and recording unit further comprises:
one or more ultrasound transducers adapted to be positioned in contact with the torso surface or sufficiently proximate to emit a monitorable signal, the one or more ultrasound transducers being configured to emit waves toward the epicardial surface;
one or more ultrasound sensors adapted to be positioned in contact with the torso surface or sufficiently proximate to detect a monitorable signal, the one or more ultrasound sensors being configured to receive reflections of the waves from the epicardial surface and produce sensor data;
an array of multiple electrodes adapted to be positioned in contact with the torso surface or sufficiently proximate to sense the electric potential data Ve;
at least one probe electrode configured to be positioned within a chamber of the patient's heart configured to record intracardial potential data;
at least one wearable garment comprising at least one of the multiple electrodes, at least one of the one or more ultrasound transducers, and at least one of the one or more ultrasound sensors; and
b) a processor that is configured to:
receive sensor data from the one or more ultrasound sensors included with the wearable garment and generate distance measurements from the epicardial surface; and
generate the table of dipole densities ν(P′,t) at locations P′ on the epicardial surface of the heart of the patient at time t, wherein the table is based on the recorded electric potential data Ve, the intracardial potential data, and the distance measurements generated by the one or more ultrasound sensors.

### Claim 2 (depends on 1)

The device of claim 1, wherein at least one of the sensors and at least one of the transducers comprises a single component.

### Claim 3 (depends on 1)

The device of claim 1, wherein the processor is further configured to calculate a table of dipole densities ν(P′,t) at locations P′ on an endocardial surface of the heart of the patient at time t.

### Claim 4 (depends on 1)

The device of claim 1, wherein the at least one probe electrode configured to be positioned within a chamber of the patient's heart comprises an array of electrodes.

### Claim 5 (depends on 1)

The device of claim 1, wherein the wearable garment is configured to urge at least one of the multiple electrodes, the one or more ultrasound transducers, and/or the one or more ultrasound sensors against the patient's torso surface with a consistent position to prevent movement.

### Claim 6 (depends on 1)

The device of claim 1, wherein the processor is configured to generate the distance measurements by analyzing at least one of: a timing of a received signal; a recorded signal amplitude; a sensor recorded angle; or signal frequency changes.

### Claim 7 (depends on 1)

The device of claim 1, wherein the at least one wearable garment is selected from the group consisting of: a vest; a shirt; a bib; an arm band; a torso band; and/or combinations thereof.

### Claim 8 (depends on 1)

The device of claim 1, wherein the device is configured to diagnose at least one of: an arrhythmia; ischemia; or compromised myocardial function.

### Claim 9 (depends on 1)

The device of claim 1, wherein the device is configured to treat at least one of: an arrhythmia; ischemia; or compromised myocardial function.

### Claim 10 (depends on 1)

The device of claim 1, wherein the table of dipole densities ν(P′,t) is determined by a number of polygonal shaped projections, the number determined by the size of the epicardial surface.

### Claim 11 (depends on 10)

The device of claim 10, wherein the polygonal shaped projections are selected from the group consisting of: triangles; squares; tetrahedral shapes; hexagonal shapes; any other suitable shape compatible with finite elements method; and/or combinations thereof.

### Claim 12 (depends on 1)

The device of claim 1, wherein the device is further configured to determine properties of a cardiac wall.

### Claim 13 (depends on 12)

The device of claim 12, wherein the properties include cardiac wall thickness information.

### Claim 14 (depends on 12)

The device of claim 12, wherein the properties include precise foci, conduction-gaps, and/or conduction channels position information.

### Claim 15 (depends on 1)

The device of claim 1, further comprising a converter configured to convert the electric potentials Ve into digital voltage data.