Expandable Electrode Arrays for Selective Cardiac Electroporation
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Solution Overview
Problem
Existing cardiac ablation procedures face challenges in creating adequate, circumferential, and transmural lesions while minimizing collateral damage to non-targeted tissue, particularly with energy modalities like electroporation, which may not ensure irreversible electroporation of all cells and can cause thermal damage.
Innovation Solution
A medical system with an expandable element and multiple electrodes, equipped with processing circuitry, delivers electroporation energy selectively based on impedance measurements to ensure uniform electrode spacing and contact with target tissue, allowing for enhanced lesion formation and tissue mapping.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If electroporation energy is delivered to create lesions in cardiac tissue, then irreversible electroporation of cells is achieved, but collateral damage to non-targeted tissue may occur
Solution Approach 1:
The patent applies local quality by delivering electroporation energy selectively to specific electrodes based on their individual impedance measurements. The system identifies which electrodes are in contact with target tissue versus non-targeted tissue, and only delivers energy to electrodes contacting the target tissue. This localized approach ensures irreversible electroporation of intended cells while avoiding collateral damage to surrounding non-targeted tissue.
Solution Approach 2:
The patent implements feedback by continuously monitoring impedance measurements from each electrode and using this information to control energy delivery. The processing circuitry receives impedance data from all electrodes, determines which electrodes are appropriately positioned on target tissue, and adjusts energy delivery accordingly. This feedback mechanism ensures that electroporation energy is only applied where intended, preventing collateral damage while achieving reliable cell electroporation.
2Object-affected harmful factors
If electroporation energy is delivered in short bursts to minimize thermal damage, then thermal damage to non-target tissue is reduced, but adequate lesion formation may still be challenging
Solution Approach 1:
The patent applies segmentation by dividing the electroporation energy delivery into multiple short bursts delivered through multiple electrodes rather than continuous delivery through a single electrode. The system delivers a sequence of electroporation energy bursts to different electrodes, which collectively create adequate lesions while keeping each individual burst short enough to minimize thermal damage to non-target tissue.
Solution Approach 2:
The patent implements periodic action by delivering electroporation energy in a sequence of periodic bursts rather than continuous delivery. Each electrode receives periodic pulses of electroporation energy, allowing tissue cooling between bursts and preventing excessive thermal accumulation. This periodic delivery pattern achieves adequate lesion formation while minimizing thermal damage to surrounding non-target tissue.
3Reliability
If multiple electrodes are used on an expandable element to improve lesion formation, then lesion coverage is enhanced, but uniform electrode spacing and contact with target tissue becomes more difficult to ensure
Solution Approach 1:
The patent applies self-service by using the impedance measurement capability of each electrode to automatically identify its own contact status with target tissue. Each electrode measures its own impedance, and the processing circuitry uses these self-reported measurements to determine which electrodes are properly positioned on the target tissue. This self-service approach eliminates the need for external verification of electrode placement, ensuring uniform spacing and contact while maintaining expanded lesion coverage.
4Productivity
If electroporation energy is delivered to all electrodes simultaneously, then energy delivery efficiency is improved, but risk of delivering energy to misplaced electrodes increases
Solution Approach 1:
The patent applies local quality by delivering electroporation energy to individual electrodes based on their specific impedance characteristics rather than uniform delivery to all electrodes. The system evaluates each electrode's impedance measurement locally and determines energy delivery on a per-electrode basis, ensuring that only electrodes with appropriate impedance values (indicating proper contact with target tissue) receive energy. This localized quality control maintains energy delivery efficiency while preventing harmful energy delivery to misplaced electrodes.
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
The system enhances lesion formation efficiency and patient safety by ensuring precise energy delivery to individual electrodes, improving ablation outcomes and reducing collateral damage.
Implementation Method 1
A medical device is disclosed for electroporating tissue... deliver electroporation energy to the plurality of electrodes... irreversible electroporation of all cells
Implementation Method 2
each of the plurality of electrodes being configured to record impedance measurements... receive data from the plurality of electrodes... data includes impedance measurements
Data Source
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AI summary
A method, system, and device for electroporation. A system may include a medical device with a plurality of electrodes borne on an expandable element and an energy generator in communication with the electrodes. The energy generator may have processing circuitry configured to selectively deliver electroporation energy to at least one of the electrodes. The processing circuitry may determine whether an alert condition is present and, if so, cease the delivery of electroporation energy to one or more electrodes identified as the cause of the alert condition and/or prevent the delivery of electroporation energy to the one or more electrodes identified as the cause of the alert condition. The energy generator may also be configured to deliver electroporation energy in a sequence of a plurality of energy delivery patterns to enhance lesion formation.