Expandable Electrode Array for Selective Electroporation Ablation
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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 uniform energy delivery and lesion formation.
Innovation Solution
A medical device with an expandable element and multiple electrodes, coupled with an energy generator and processing circuitry, selectively delivers electroporation energy based on impedance measurements to ensure uniform electrode-tissue contact and proximity, allowing for enhanced lesion formation and mapping.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If electroporation energy is delivered to create lesions, then lesion formation is achieved, but collateral damage to non-targeted tissue occurs
Solution Approach 1:
The expandable element with multiple electrodes enables localized energy delivery to specific tissue regions. Each electrode can be independently controlled to deliver electroporation energy only to targeted areas, creating precise lesions while leaving surrounding non-targeted tissue unaffected. This localizes the therapeutic effect and minimizes collateral damage.
Solution Approach 2:
The delivery system is divided into multiple separate electrodes on the expandable element rather than a single energy source. This segmentation allows independent control of each electrode, enabling selective energy delivery to different tissue locations and preventing unintended damage to adjacent non-targeted structures.
2Object-affected harmful factors
If electroporation energy is delivered in short bursts, then thermal damage to non-target tissue is reduced, but adequate lesion formation becomes challenging
Solution Approach 1:
The expandable element with multiple electrodes enables continuous and uniform energy delivery across the entire treated area. By activating multiple electrodes simultaneously or in sequence, the system maintains continuous electroporation action throughout the target tissue, ensuring adequate lesion formation without requiring prolonged exposure that would cause thermal damage.
Solution Approach 2:
The system dynamically adjusts energy delivery parameters including pulse duration, amplitude, and electrode activation patterns. This dynamic control allows optimization of each electroporation burst to achieve sufficient lesion formation while keeping individual pulse durations short enough to avoid thermal damage to non-target tissue.
3Manufacturing precision
If expandable element with multiple electrodes is used, then uniform energy delivery is achieved, but device complexity increases
Solution Approach 1:
The expandable element serves multiple functions: it provides structural support, enables uniform expansion against tissue for consistent electrode positioning, and houses multiple electrodes for distributed energy delivery. This multi-functionality achieves uniform energy delivery without requiring separate complex positioning mechanisms.
Solution Approach 2:
The expandable element dynamically adjusts its configuration by expanding or contracting to optimize electrode-tissue contact. This dynamic adaptation ensures uniform spacing and contact pressure across all electrodes during the procedure, achieving consistent energy delivery while maintaining a relatively simple device structure that can be controlled through inflation/deflation mechanisms.
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 uniform energy delivery and minimizing collateral damage through selective electrode activation based on contact and proximity, improving ablation outcomes.
Implementation Method 1
a medical device configured to electroporate tissue, the medical device including an expandable element, the expandable element having a plurality of electrodes
Implementation Method 2
each of the plurality of electrodes is configured to record at least one impedance measurement, the processing circuitry being configured to receive the at least one impedance measurement from each of the plurality of electrodes
Data Source
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.