# US 12,109,031 B2 · System and method for local electrophysiological characterization of cardiac substrate using multi-electrode catheter

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- Number: US 12,109,031 B2
- Document ID: US12109031B2
- Status: Granted
- Kind: B2
- Application number: 16/593,631
- Filed: 2019-10-04
- Published: 2020-08-13
- Granted: 2024-10-08
- Earliest claimed: 2014-02-25
- Assignees: St. Jude Medical, Cardiology Division, Inc.
- Applicants: St. Jude Medical, Cardiology Division, Inc.
- Inventors: D. Curtis Deno; Ram K. Balachandran
- Web page: https://patentgrep.com/patent/US12109031B2

## CPC

- A61B 5/287: Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
- A61B 5/062: {using magnetic field}
- A61B 5/068: {using impedance sensors}
- A61B 5/339: Displays specially adapted therefor
- A61B 5/341: Vectorcardiography [VCG]
- A61B 5/367: Electrophysiological study [EPS], e.g. electrical activation mapping or electro-anatomical mapping
- A61B 5/6852: {Catheters}
- A61B 5/6858: {with a distal basket, e.g. expandable basket}
- A61B 5/6859: {with multiple distal splines}
- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61M 25/0127: {Magnetic means; Magnetic markers}
- A61B 5/0044: {for the heart}
- A61B 5/7239: {using differentiation including higher order derivatives}
- A61B 2018/00577: {Ablation}
- A61B 2018/00839: {Bioelectrical parameters, e.g. ECG, EEG}
- A61B 2562/0214: Capacitive electrodes
- A61B 2562/046: in a matrix array
- A61M 2025/0166: {Sensors, electrodes or the like for guiding the catheter to a target zone, e.g. image guided or magnetically guided}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

A system for determining electrophysiological data comprising an electronic control unit configured to acquire electrophysiology signals from a plurality of electrodes (130) of one or more catheters, select at least one clique of electrodes from the plurality of electrodes (136) to determine a plurality of local E field data points, determine the location and orientation of the plurality of electrodes, process the electrophysiology signals from the at least one clique from a full set of bipole subcliques to derive the local E field data points associated with the at least one clique of electrodes, derive at least one orientation independent signal from the at least one clique of electrodes (138) from the information content corresponding to weighted parts of electrogram signals, and display or output catheter orientation independent electrophysiologic information to a user or process.

## Claims

### Claim 1

A system for determining electrophysiological data comprising:
an electronic control unit configured to:
acquire electrophysiology signals from a plurality of electrodes of one or more catheters;
select at least one clique of electrodes from the plurality of electrodes to determine a plurality of local electric (E) field data points, wherein the at least one clique of electrodes comprises three electrodes;
process the electrophysiology signals from the at least one clique to derive the plurality of local E field data points associated with the at least one clique of electrodes, wherein each of the electrodes comprising the at least one clique of electrodes is associated with at least one of the plurality of local E field data points;
derive at least one orientation-independent bipolar electrophysiology signal from the plurality of local E field data points associated with the at least one clique of electrodes; and
output catheter-orientation-independent electrophysiologic information to a user or process.

### Claim 2 (depends on 1)

The system according to claim 1, wherein the electronic control unit is further configured to determine the location and orientation of the plurality of electrodes.

### Claim 3 (depends on 2)

The system according to claim 2, wherein the electronic control unit is further configured to use at least one criteria to determine whether each of the at least one clique is in contact with a target surface.

### Claim 4 (depends on 3)

The system according to claim 3, wherein the at least one criteria comprises at least one of an angular deviation, the characteristics of tangent bipole vector (Et), and a scalar version of Et along a unit activation direction (Ea) from a clique of the at least one clique.

### Claim 5 (depends on 3)

The system according to claim 3, wherein the at least one criteria comprises an amplitude of a unipolar signal obtained from each of the electrodes in a clique of the at least one clique and the morphology of unipolar signals obtained from the electrodes in the clique of the at least one clique.

### Claim 6 (depends on 3)

The system according to claim 3, wherein the electronic control unit is configured to receive one or more criteria from the user or process to determine whether each of the at least one clique is in contact with the target surface.

### Claim 7 (depends on 1)

The system according to claim 1, wherein the catheter-orientation-independent electrophysiologic information output by the electronic control unit is beat-by-beat information.

### Claim 8 (depends on 1)

The system according to claim 1, wherein the electronic control unit is further configured to:
weight the E field data points; and
derive the orientation-independent electrophysiologic information from the weighted E field data points.

### Claim 9 (depends on 8)

The system according to claim 8, wherein the electronic control unit is configured to derive at least one of a substrate voltage amplitude, local activation timing, or conduction velocity from the weighted E field data points.

### Claim 10 (depends on 8)

The system according to claim 8, wherein the plurality of E field data points form an E field loop, and wherein the electronic control unit is further configured to weight each of the E field data points based on the distance of point in the E field from an isoelectric origin.

### Claim 11 (depends on 8)

The system according to claim 8, wherein the plurality of E field data points form an E field loop, and wherein the electronic control unit is further configured to weight the data points in the E field loop based on |d/dt(E(t))|.

### Claim 12 (depends on 8)

The system according to claim 8, wherein the plurality of E field data points form an E field loop, and wherein the weight of the E field data points is determined from a weighting function that increases the weight in a region corresponding to the zero-crossing of Ea.

### Claim 13 (depends on 1)

The system according to claim 1, wherein the at least one clique of electrodes comprises a plurality of adjacent cliques.

### Claim 14 (depends on 13)

The system according to claim 13, wherein the electronic control unit is further configured to compute a local velocity vector for each of the plurality of adjacent cliques.

### Claim 15 (depends on 14)

The system according to claim 14, wherein the electronic control unit is further configured to determine a divergence and curl path integral and a path length.

### Claim 16 (depends on 14)

The system according to claim 14, wherein the electronic control unit is further configured to determine whether a uniform propagation, a rotor, a focal source, a collision site, or a scar is present within the plurality of adjacent cliques.

### Claim 17 (depends on 16)

The system according to claim 16, wherein the electronic control unit is further configured to score each of the plurality of adjacent cliques.

### Claim 18 (depends on 17)

The system according to claim 17, wherein the electronic control unit is further configured to compare the score of each of the plurality of adjacent cliques to at least one template.

### Claim 19 (depends on 13)

The system according to claim 13, wherein the electronic control unit is configured to calculate a score for a target clique from at least one clique adjacent to the target clique.

### Claim 20

A method for determining electrophysiological data comprising:
acquiring electrophysiology signals from a plurality of electrodes of one or more catheters;
selecting at least one clique of electrodes from the plurality of electrodes to determine a plurality of local E field data points, wherein the at least one clique comprises three electrodes;
processing the electrophysiology signals from the at least one clique to derive the plurality of local E field data points associated with the at least one clique of electrodes, wherein each of the electrodes comprising the at least one clique of electrodes is associated with at least one of the plurality of local E field data points;
deriving at least one orientation-independent bipolar electrophysiology signal from the plurality of local E field data points associated with the at least one clique of electrodes; and
outputting catheter-orientation-independent electrophysiologic information to a user or process.
