Granted Patent B2

US 12,402,839 · App. 18/762,061 · Granted Sep 2, 2025

Inventors: Jay M. Edelberg (Princeton, NJ); Tassos Gianakakos (Paradise Valley, AZ)

Assignee: Prolaio, Inc.

A61B5/7267A61B5/0205A61B5/256A61B5/339A61B5/353A61B5/355A61B5/358A61B5/361A61B5/363A61B5/366A61B5/7275A61B5/743A61B5/7435G16H10/40G16H10/60G16H15/00G16H20/00G16H50/30G16H80/00

Abstract

Claims (31)

1. A method for determining a cardiac health status for a subject, the method comprising:

a. sensing a subject with an electrocardiogram (ECG) device to obtain ECG data, wherein the ECG device is wearable, mobile, and configured to perform ambulatory measurements of the subject;

b. extracting one or more P wave parameters associated with the ECG data;

c. detecting left atrial enlargement (LAE) within the subject by applying a first decision engine with the extracted one or more P wave parameters from the ECG data;

d. determining, based on the LAE detection, a cardiac health status for the subject by applying a second decision engine, the cardiac health status comprising at least one of (i) a first cardiac condition or (ii) a first risk score for developing the first cardiac condition by the subject, wherein the first cardiac condition comprises atrial fibrillation;

e. determining, based on the at least one of (i) the first cardiac condition or (ii) the first risk score, an adjusted cardiac health status by applying a third decision engine, the adjusted cardiac health status comprising at least one of (i) a second cardiac condition or (ii) a second risk score for developing the second cardiac condition by the subject, wherein the second cardiac condition comprises at least one of cardiomyopathy or diastolic dysfunction; and

f. outputting onto a display interface at least one of the cardiac health status, the first cardiac condition, the first risk score, the adjusted cardiac health status, the second cardiac condition, or the second risk score.

2. The method of claim 1 , wherein one or both of the first decision engine and the second decision engine comprises a trained model, a decision tree, an analytical expression, or a combination thereof.

3. The method of claim 1 , wherein detecting LAE in the subject comprises applying, by the first decision engine, one or more clinical biomarker data, one or more imaging data, one or more clinical data, or a combination thereof.

4. The method of claim 1 , wherein determining the cardiac health status comprises applying, by the second decision engine, one or more clinical biomarker data, one or more imaging data, one or more clinical data, the extracted one or more parameters, or a combination thereof.

5. The method of claim 1 , wherein, to determine the adjusted cardiac health status, the third decision engine applies at least one of clinical biomarker data, imaging data, one or more clinical parameters for the subject, the extracted one or more parameters, or a combination thereof.

6. The method of claim 5 , wherein the clinical biomarker data comprise data for one or more of B-type natriuretic peptide (BNP), N-terminal (NT)-pro hormone BNP (NT-proBNP), or cardiac troponin.

7. The method of claim 5 , wherein the imaging data comprises one or both of an echocardiogram image or a cardiac MRI.

8. The method of claim 5 , wherein the one or more clinical parameters comprise one or more of age, sex, weight, body mass index, height, physiological data, exercise testing results, heart rate, activity levels, velocity, sleep data, or a combination thereof.

9. The method of claim 1 , wherein the ECG device comprises a 12-lead device, a 6-lead device, a 1-lead device, or a 2-lead device.

10. The method of claim 1 , wherein the extracted one or more P wave parameters include at least one of P wave maximal width, variability in P wave width, P wave maximal area, variability in P wave area, or P wave slopes.

11. A system for determining a cardiac health status for a subject, the system comprising:

an electrocardiogram (ECG) device for sensing a subject to obtain ECG data, wherein the ECG device is wearable, mobile, and configured to perform ambulatory measurements of the subject;

one or more processors;

one or more memories storing instructions that, when executed by the one or more processors, cause the system to perform operations including:

a. extracting one or more P wave parameters associated with the ECG data;

b. detecting left atrial enlargement (LAE) within the subject by applying a first decision engine with the extracted one or more P wave parameters from the ECG data;

c. determining, based on the LAE detection, a cardiac health status for the subject by applying a second decision engine, the cardiac health status comprising at least one of (i) a first cardiac condition or (ii) a first risk score for developing the first cardiac condition by the subject, wherein the first cardiac condition comprises atrial fibrillation; and

d. determining, based on the at least one of (i) the first cardiac condition or (ii) the first risk score, an adjusted cardiac health status by applying a third decision engine, the adjusted cardiac health status comprising at least one of (i) a second cardiac condition or (ii) a second risk score for developing the second cardiac condition by the subject, wherein the second cardiac condition comprises at least one of cardiomyopathy or diastolic dysfunction; and

a display interface for outputting at least one of the cardiac health status, the first cardiac condition, the first risk score, the adjusted cardiac health status, the second cardiac condition, or the second risk score.

12. The system of claim 11 , wherein, to detect LAE in the subject, the first decision engine applies at least one of clinical biomarker data, imaging data, clinical data, or a combination thereof.

13. The system of claim 11 , wherein, to determine the cardiac health status, the second decision engine applies at least one of clinical biomarker data, imaging data, clinical data, the extracted one or more parameters, or a combination thereof.

14. The system of claim 11 , wherein one or both of the first decision engine and the second decision engine comprises a trained model, a decision tree, an analytical expression, or a combination thereof.

15. The system of claim 11 , wherein, to determine the adjusted cardiac health status, the third decision engine applies at least one of clinical biomarker data, imaging data, clinical parameters for the subject, the extracted one or more parameters, or a combination thereof.

16. The system of claim 11 , wherein the ECG device comprises a 12-lead device, a 6-lead device, a 1-lead device, or a 2-lead device.

17. The system of claim 11 , wherein the extracted one or more P wave parameters include at least one of P wave maximal width, variability in P wave width, P wave maximal area, variability in P wave area, or P wave slopes.

Assignments (1)

Continuity (5)

References Cited (225)