ECG-Guided Electroporation Pulse Timing for Arrhythmia Safety
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Solution Overview
Problem
Existing electroporation systems fail to account for irregular heart rhythms, particularly arrhythmias, leading to potential fatal or minor events by delivering pulses during unsafe phases of the heart's electrical cycle, such as the T wave, which can cause malignant arrhythmias.
Innovation Solution
An electroporation delivery system that utilizes an electrocardiogram and processing device to measure heart activity, calculate rolling averages of heartbeat durations and R wave amplitudes, and deliver pulses only during safe phases of the heart cycle, ensuring the delivery system is safe for patients with irregular heart rhythms.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If electroporation pulse is delivered using traditional algorithms based on QRS complex timing, then treatment efficiency is improved, but patient safety deteriorates due to risk of delivering pulses during T wave in arrhythmia patients
Solution Approach 1:
The system continuously monitors the ECG signal and uses real-time feedback from the detected QRS complex and T wave timing to dynamically adjust pulse delivery decisions. The algorithm compares the timing of the electroporation pulse against the detected cardiac cycle phase, and only permits pulse delivery when the cardiac phase is safe, thereby resolving the contradiction between treatment efficiency and patient safety.
Solution Approach 2:
The pulse delivery algorithm transitions from a static, fixed timing approach to a dynamic, adaptive approach that responds to real-time variations in heart rhythm. By continuously adjusting the pulse delivery timing based on detected arrhythmia patterns and cardiac cycle variability, the system maintains treatment efficiency while adapting to changing cardiac conditions to ensure safety.
2Ease of operation
If electroporation pulse is delivered during irregular heartbeat with wider R wave, then treatment proceeds according to standard protocol, but pulse may occur during T wave causing malignant arrhythmias
Solution Approach 1:
The system performs preliminary detection and analysis of the QRS complex width and morphology before committing to pulse delivery. By identifying arrhythmia patterns in advance through ECG monitoring and analyzing R wave characteristics, the algorithm can predict potentially dangerous timing scenarios and prevent pulse delivery during unsafe cardiac phases, thereby eliminating the harmful effect before it can occur.
Solution Approach 2:
The algorithm implements a preventive mechanism that actively counteracts the potential harmful effect by blocking pulse delivery when arrhythmia patterns are detected. The system anticipates the danger of T wave stimulation in arrhythmia patients and applies a counter-action by withholding the pulse until safe timing is confirmed, thus preventing malignant arrhythmias before they can be induced.
3Device complexity
If electroporation system uses simple timing algorithm, then device complexity is reduced, but ability to handle arrhythmia patients deteriorates
Solution Approach 1:
The ECG-based timing algorithm serves multiple functions: it provides basic rhythm monitoring, detects arrhythmia patterns, determines safe pulse delivery windows, and adapts to various heart rate conditions. By integrating these multiple capabilities into a single algorithmic framework that processes the same ECG signal, the system achieves versatility in handling both normal and arrhythmic patients without proportionally increasing device complexity.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Ensures safe electroporation pulse delivery by avoiding delivery during unsafe heart phases, reducing the risk of arrhythmias and ensuring patient safety during procedures near the heart.
Implementation Method 1
one or more sensors operatively connected to the electrocardiogram for measuring electrical activity QRS complex of a patient's heart
Implementation Method 2
Reversible electroporation (RE) may be typically used for drug delivery to a selected tissue area by applying direct-current through electrodes. Irreversible electroporation (IRE) is typically used as a soft tissue ablation technique
Data Source
Figure 1A~1B
Figure 2A
Figure 2B
AI summary
The present disclosure relates generally to electroporation systems and utilizing algorithms for electroporation pulse delivery including a patient's EKG/EGM monitoring. In some embodiments, an electroporation delivery system may include an electrocardiogram operatively connected to a processing device and a memory. One or more sensors may be operatively connected to the electrocardiogram for measuring electrical activity QRS complex of a patient's heart. One or more electrodes for treatment may be disposed in, at, or near the patient's heart, the one or more electrodes operatively connected to a pulse delivery mechanism. The electroporation delivery system may be configured to determine whether an electroporation pulse is deliverable to a patient based on the electrocardiogram.