ECG Signal Control for Extracorporeal Circulatory Support
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Solution Overview
Problem
Current extracorporeal circulatory support systems face challenges in accurately determining cardiac cycle phases due to interference from implanted pacemakers and pathophysiological anomalies, leading to inconsistent blood flow and perfusion control.
Innovation Solution
A control unit that evaluates ECG signals spatially and temporally to determine amplitude changes within cardiac cycles, using multiple data points from various ECG leads to improve signal-to-noise ratio and provide real-time control signals for blood pumps, thereby synchronizing circulatory support with cardiac cycles.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If ECG measurement signals are used to control extracorporeal circulatory support, then the blood flow can be synchronized with cardiac cycle phases, but stimulation-related interferences and pathophysiological anomalies worsen the signal-to-noise ratio and render amplitude determination difficult
Solution Approach 1:
The patent segments the ECG signal evaluation into multiple independent amplitude parameters (P-wave amplitude, QRS complex amplitude, T-wave amplitude) that are evaluated separately. This segmentation allows the system to identify and rely on reliable amplitude measurements even when some waves are obscured by interference from pacemakers or pathophysiological anomalies, thereby maintaining control accuracy despite degraded signal quality.
Solution Approach 2:
The patent changes the evaluation parameter from relying on a single characteristic amplitude (traditionally the R-wave) to evaluating multiple amplitude parameters across different ECG waves. This parameter change enables the system to adapt to various interference conditions by selecting the most reliable amplitude measurement from among multiple options, thus improving measurement precision in noisy environments.
2Reliability
If multiple ECG leads are used to improve signal reliability, then the signal-to-noise ratio improves, but the device complexity increases
Solution Approach 1:
The patent implements a dynamic evaluation system that automatically assesses the quality and reliability of amplitude measurements from multiple ECG leads in real-time. The system dynamically selects the most reliable lead and wave amplitude for triggering circulatory support, adapting to changing signal conditions without requiring manual intervention or fixed lead configurations, thereby managing device complexity through intelligent automation.
Solution Approach 2:
The system performs self-service by automatically evaluating multiple ECG leads and independently determining the optimal trigger signal without external assistance. The control unit autonomously identifies reliable amplitude measurements, filters out interference, and generates control signals, reducing the need for complex manual configuration and monitoring while maintaining high trigger signal stability.
3Productivity
If amplitude determination is performed despite interferences, then real-time control is maintained, but the control may be triggered at the wrong time
Solution Approach 1:
The patent incorporates feedback mechanisms that continuously monitor the quality of ECG signal measurements and the consistency of detected amplitude changes. The system uses this feedback to validate whether detected amplitude changes represent true cardiac events or interference artifacts, adjusting the triggering decision based on signal quality assessment. This feedback loop maintains real-time control responsiveness while preventing premature or incorrect triggering.
Solution Approach 2:
The patent performs preliminary evaluation of ECG signal quality and amplitude characteristics before finalizing the control trigger decision. By pre-assessing signal reliability and comparing detected amplitudes against expected physiological ranges, the system prepares valid trigger candidates in advance, ensuring that only well-validated amplitude changes initiate control actions. This preliminary validation maintains real-time responsiveness while improving timing accuracy.
Data Source
AI summary
The present disclosure relates to control units for an extracorporeal circulatory support as well as systems comprising such a control unit and corresponding methods. Accordingly, a control unit for an extracorporeal circulatory support is suggested, which is configured to receive a measurement of an ECG signal of a supported patient over a predefined period of time, wherein the ECG signal comprises multiple data points for each time point within a cardiac cycle. The control unit comprises an evaluation unit, which is configured to evaluate the data points for at least one time point spatially and/or temporally and to determine at least one amplitude change within the cardiac cycle from the evaluated data points. The control unit is further configured to output a control signal for an extracorporeal circulatory support at a predefined time point after the at least one amplitude change.