US 12,402,823 B2
Hand held device for automatic cardiac risk and diagnostic assessment
Alexei Shvilkin, Chestnut Hill, MA (US); Ljupco Hadzievski, Belgrade (RS); Vladan Vukcevic, Belgrade (RS); Sanja Grujovic Zdolsek, Zemun (RS); and Bosko Bojovic, Belgrade (RS)
Assigned to HeartBeam, Inc., Santa Clara, CA (US)
Filed by HeartBeam, Inc., Santa Clara, CA (US)
Filed on May 25, 2023, as Appl. No. 18/324,111.
Application 18/324,111 is a continuation of application No. 17/296,669, granted, now 11,701,049, previously published as PCT/US2019/061906, filed on Nov. 18, 2019.
Claims priority of provisional application 62/780,782, filed on Dec. 17, 2018.
Claims priority of provisional application 62/780,131, filed on Dec. 14, 2018.
Prior Publication US 2023/0414150 A1, Dec. 28, 2023
Int. Cl. A61B 5/00 (2006.01); A61B 5/28 (2021.01); A61B 5/332 (2021.01); G16H 50/30 (2018.01)
CPC A61B 5/332 (2021.01) [A61B 5/28 (2021.01); A61B 5/7275 (2013.01); G16H 50/30 (2018.01)] 21 Claims
OG exemplary drawing
 
1. A method of automatically assessing a patient's risk of an acute cardiac event, the method comprising:
receiving, in a processor, risk assessment information comprising risk factors;
determining a multi-level pre-existing risk (PER) score based on the risk assessment information;
contacting a patient's chest with first and second electrodes of a handheld apparatus operated by a patient;
contacting at least one finger from each hand of the patient with third and fourth electrodes of the handheld apparatus;
receiving, through the first, second, third, and fourth electrodes, three cardiac lead signals from the patient;
receiving, from the handheld apparatus, a sample electrocardiogram (ECG) based on the cardiac lead signals;
receiving, from the patient, a current symptoms indication, wherein the current symptoms indication includes one or more self-reported patient symptoms;
determining, in the processor, a multi-level cardiac signals risk (CSR) score from the sample ECG and a baseline ECG, and a multi-level chest pain risk (CPR) score indicating a level of cardiac risk based on the current symptoms indication, and determining a multi-level post-test risk (PTR) score based on a plurality of distinct combinations of the CSR score, the PER score, and the CPR score; and
presenting, to the patient, a diagnostic report and patient action instruction based on the post-test risk score.