Reduced-Form Factor ECG Device Using Machine Learning Synthesis
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Solution Overview
Problem
Current ambulatory ECG devices are bulky and difficult for patients to use without medical assistance, limiting their ability to monitor cardiovascular activity conveniently and promptly, especially for conditions like arrhythmias and acute coronary syndromes, which require timely diagnosis.
Innovation Solution
A small form-factor ECG monitoring device that acquires 3 standard leads, including a V-lead, without adhesives, allowing patients to take ECGs easily and instantly, and uses machine learning models to synthesize a 12-lead ECG from measured leads, providing near-instant data for decision support and reducing the need for medical professionals.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If traditional Holter monitors or ambulatory ECG devices are used for continuous monitoring, then cardiovascular activity can be monitored, but the devices are bulky and difficult for patients to use without medical assistance
Solution Approach 1:
The patent extracts the essential ECG monitoring function from the bulky traditional Holter monitor system, creating a standalone handheld device that performs 12-lead ECG acquisition, processing, and analysis in a single compact unit. This extraction eliminates the need for complex external components and medical assistance while maintaining comprehensive monitoring capabilities
Solution Approach 2:
The handheld device integrates multiple functions including ECG signal acquisition from multiple leads, real-time processing, diagnostic analysis, and user interface in a single device. This multi-functionality replaces the need for separate monitoring equipment and expert intervention, making the device easy for patients to operate independently
2Loss of time
If traditional ECG devices are used, then diagnostic data can be obtained, but the time to diagnosis and treatment is delayed
Solution Approach 1:
The device performs preliminary processing and analysis of ECG signals in real-time as they are acquired, rather than requiring post-acquisition analysis by medical professionals. The embedded processing capabilities immediately identify arrhythmias and generate diagnostic interpretations, dramatically reducing the time from symptom onset to diagnosis
Solution Approach 2:
The handheld device provides self-service diagnostic capabilities with automated analysis algorithms that interpret ECG data and generate diagnostic reports without requiring medical professional intervention. This self-service approach enables patients to obtain immediate diagnostic information at the point of care
3Ease of operation
If multiple electrodes and adhesives are used for ECG monitoring, then accurate data can be acquired, but the process becomes invasive and difficult for patients to perform themselves
Solution Approach 1:
The patent combines multiple ECG lead acquisitions into a single integrated electrode configuration. The device uses one or more electrodes that can simultaneously capture multiple ECG leads through sophisticated signal processing and mathematical transformations, eliminating the need for multiple separate electrodes and adhesives
Solution Approach 2:
The device creates synthetic copies of standard 12-lead ECG signals from a reduced set of physical electrodes using signal processing algorithms. This copying approach allows the system to generate accurate 12-lead ECG data without requiring all 10 electrodes traditionally needed, reducing invasiveness while maintaining diagnostic accuracy
Data Source
AI summary
Embodiments of the present disclosure provide a small form factor ECG monitoring device that can acquire 3 standard ECG leads including a V-lead, does not require the use of adhesives for electrodes, and provides ECG data for a user on a near instantaneous basis. The ECG monitoring device can acquire leads I, II, and V2 (or any other V lead). The addition of a V-lead not only provides an additional channel of ECG data, but also adds another orthogonal cardiac field plane (the horizontal plane) thanks to the reference point formed by leads I and II. The ECG monitoring device may derive the augmented limb leads and subsequently generate a full 12-lead ECG. The ECG monitoring device may generate one or more diagnoses based on the full 12-lead set. The ECG monitoring device may provide an easy and non-invasive way for a person to take an ECG on the fly.