LAA Occlusion Device with Independent Electrode Energy Control
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Solution Overview
Problem
Existing devices for occluding the left atrial appendage (LAA) face challenges due to non-uniform wall thickness and varying electrical parameters, leading to incomplete ablation and potential damage to adjacent structures during pulsed field ablation, as they do not adapt energy delivery to the specific anatomy of the subject.
Innovation Solution
A device with a tissue ablation system that measures electrical parameters around the LAA circumference, allowing for independent energization of electrodes to deliver a non-uniform pulsed field ablation, adjusting power based on tissue impedance to ensure effective occlusion without damaging surrounding tissues.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If uniform pulsed field ablation is applied around the LAA wall, then complete ablation is achieved, but adjacent structures may be damaged due to non-uniform wall thickness
Solution Approach 1:
The patent applies different energy levels to different segments of the LAA wall based on locally measured electrical parameters and wall thickness. Each electrode delivers customized pulsed field energy tailored to the specific anatomical characteristics of that region, ensuring complete ablation where needed while protecting adjacent structures from excessive energy exposure.
Solution Approach 2:
The system dynamically adjusts the electrical parameters (voltage, pulse duration, energy delivery) of the pulsed field ablation based on real-time measurements of wall thickness and electrical parameters at each LAA segment. This parameter customization allows the ablation to adapt to anatomical variations and achieve effective occlusion without causing harm.
2Reliability
If higher energy is delivered to achieve complete ablation, then occlusion efficacy is improved, but risk of damaging surrounding tissues increases
Solution Approach 1:
The patent implements localized energy delivery where each electrode segment independently adjusts its energy output based on local tissue characteristics. This ensures that higher energy is delivered only where anatomical variations require it for complete ablation, while other segments receive appropriate lower energy levels, thereby maintaining occlusion efficacy while minimizing risk to surrounding tissues.
Solution Approach 2:
The system incorporates real-time feedback from electrical parameter measurements and wall thickness data to dynamically control energy delivery. The measured electrical parameters at each location feed back to the control system, which then adjusts the pulsed field energy levels to achieve complete ablation while preventing excessive energy exposure that could damage surrounding structures.
3Device complexity
If a single energy level is used for pulsed field ablation, then device complexity is reduced, but ablation uniformity deteriorates due to varying tissue properties
Solution Approach 1:
The patent divides the LAA circumference into multiple independent electrode segments, each capable of independent energy delivery control. This segmentation allows the system to address varying tissue properties at different locations by delivering customized energy levels to each segment, achieving uniform ablation results despite anatomical variations while maintaining manageable device complexity through modular architecture.
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 device achieves tailored tissue ablation, reducing the risk of over-treatment and improving the efficacy of occluding the LAA by adapting energy delivery to the specific anatomy, thereby enhancing the safety and effectiveness of the procedure.
Implementation Method 1
The plurality of tissue ablation elements is configured to contact the wall of the left atrial appendage to ablate the wall tissue by pulsed field ablation
Data Source
AI summary
A device (10) to occlude the left atrial appendage (1) of a heart of a subject comprises an implantable occlusion apparatus (30) configured for radial expansion upon deployment to fluidically occlude the left atrial appendage, an elongated catheter member (80) having a distal end attachable to the implantable occlusion apparatus for transluminal delivery of the implantable occlusion apparatus to the left atrial appendage, a tissue energising module (20) having a plurality of electrodes (26) disposed around a circumference of the implantable occlusion apparatus in which each electrode is configured to contact a wall of the left atrial appendage at a tissue focal point upon deployment of the implantable occlusion apparatus, and an electrical controller (40) including a pulsed field energy delivery generator operably attachable to an electrical power source (50) and the plurality of electrodes and configured to energise the electrodes in a pulsed field ablation modality. The electrical controller is configured to independently energise each of the plurality of electrodes to apply a non-uniform pulsed field ablation treatment circumferentially around the wall of the left atrial appendage.