Biphasic Test Pulse Lead Anomaly Detection
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Solution Overview
Problem
Current methods for detecting anomalies in implantable cardiac leads, such as insulation failures, are inadequate for early detection and often result in false negatives or false positives, posing risks to patient safety, especially since high-voltage shocks can cause catastrophic failures.
Innovation Solution
A system and method for detecting lead anomalies using short-duration, high-voltage biphasic test pulses that minimize patient sensation by limiting charge delivery and employing an overcurrent circuit to detect anomalies, without the need for additional high-energy switches or modifications to common defibrillation circuits.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If high-voltage test pulses are used to detect lead anomalies, then detection sensitivity is improved, but patient sensation and risk of catastrophic failure increase
Solution Approach 1:
The patent applies periodic action by using biphasic test pulses with alternating polarities. The first phase delivers a high-voltage test pulse to detect insulation failures, while the second phase delivers an opposite polarity pulse to cancel out nerve activations and minimize patient sensation. This periodic alternating action allows sensitive detection while reducing harmful effects.
Solution Approach 2:
The patent applies preliminary anti-action by delivering a cancellation pulse of opposite polarity immediately after the high-voltage test pulse. This cancellation pulse is designed to neutralize the physiological effects of the first pulse before they can cause patient sensation or tissue damage, thereby preventing harmful effects while maintaining detection sensitivity.
2Measurement precision
If conventional lead testing methods are used, then device complexity is reduced, but detection precision and reliability deteriorate
Solution Approach 1:
The patent applies universality by designing the biphasic test pulse circuit to serve multiple functions: it can detect insulation failures, minimize patient sensation, and integrate with existing ICD defibrillation circuitry. The same H-bridge circuit used for defibrillation delivers both the high-voltage test pulse and the cancellation pulse, eliminating the need for separate testing hardware.
Solution Approach 2:
The patent merges the lead testing function with the existing defibrillation delivery circuitry. The H-bridge circuit that normally delivers therapeutic shocks is repurposed to deliver biphasic test pulses for lead integrity testing. This combination eliminates the need for additional high-energy switches or separate testing circuits, reducing overall device complexity while improving detection accuracy.
3Object-affected harmful factors
If short-duration test pulses are used, then patient sensation is minimized, but charge delivery limitation becomes more critical
Solution Approach 1:
The patent applies feedback by using an overcurrent circuit that monitors charge delivery during the biphasic test pulse sequence. The system measures the actual charge delivered and uses this information to control and limit the energy output, ensuring that even short-duration pulses remain within safe charge limits while maintaining effectiveness for anomaly detection.
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
Enables sensitive and specific detection of implantable cardiac lead anomalies at the subclinical stage, reducing the risk of unnecessary shocks and improving patient safety by identifying issues before they become clinical problems.
Implementation Method 1
A high-voltage capacitor, connected to a high-voltage transformer, is charged and then delivers a short-duration, high-voltage test pulse
Implementation Method 2
An overcurrent circuit, electrically connected in series between the H-bridge and the high-voltage capacitor, is configured to detect current above a threshold
Data Source
AI summary
Systems and methods for detecting lead anomalies by detecting overcurrent conditions caused by the delivery of high voltage test pulses configured to minimize patient sensation. Patient sensation is minimized by limiting the total charge delivered in either a positive or negative test pulse by limiting duration, and/or by cancelling nerve activations by delivery of an opposite phase cancellation pulse as part of a biphasic test pulse. Embodiments include high-speed H-bridge switches, and micro-coulomb test capacitors to control total charge and duration. Embodiments detect anomalies when an overcurrent circuit detects a current above a threshold passing through an electrode that is not directly energized.