Pulsed-Field Tissue Ablation for Pulmonary Vein Isolation
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Solution Overview
Problem
Conventional ablation procedures for atrial fibrillation and hypertension, such as pulmonary vein ablation, suffer from side effects like pulmonary vein stenosis, neointimal hyperplasia, and emboli generation, with partial-circumferential ablation being less effective.
Innovation Solution
The use of non-thermal pulsed electrical fields (PEF) for electroporation, combined with optional pharmacological agents and tissue stretching, to perform transcatheter ablation procedures, minimizing collateral damage and reducing vein stenosis.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional thermal ablation (radiofrequency or cryoablation) is used to treat atrial fibrillation, then effective isolation of pulmonary veins can be achieved, but pulmonary vein stenosis, neointimalhyperplasia, and collateral damage to surrounding tissues occur
Solution Approach 1:
The patent changes the fundamental parameter of ablation energy from thermal (radiofrequency or cryo) to non-thermal pulsed electrical fields. This parameter change enables cell membrane disruption through electroporation without the thermal damage that causes stenosis and collateral injury, thus resolving the contradiction between treatment efficacy and harmful side effects
Solution Approach 2:
The patent replaces the thermal/physical destruction mechanism with an electrical field-based mechanism. Instead of using heat or cold to destroy tissue, the invention uses pulsed electrical fields to create pores in cell membranes, achieving ablation through electrochemical changes rather than thermal mechanics, thereby eliminating thermal damage pathways
2Object-affected harmful factors
If partial-circumferential ablation is performed to reduce stenosis risk, then pulmonary vein stenosis is reduced, but effectiveness in eliminating atrial fibrillation decreases
Solution Approach 1:
By changing from thermal to non-thermal ablation parameters, the invention enables full-circumferential ablation without the stenosis risk that forced partial-circumferential approaches. The non-thermal mechanism spares the vein wall structure while achieving complete electrical isolation, resolving the trade-off between circumference of ablation and stenosis risk
3Reliability
If conventional ablation procedures are used, then pulmonary vein isolation can be achieved, but emboli generation and electrolysis with bubble formation occur
Solution Approach 1:
The patent replaces thermal ablation with electrical field-based electroporation, eliminating the high-temperature conditions that cause tissue vaporization, charring, and gas bubble formation. This substitution removes the source of emboli generation while maintaining effective vein isolation
Solution Approach 2:
The invention converts the potential harm of electrical energy into a beneficial non-thermal ablation mechanism. By using controlled pulsed electrical fields rather than uncontrolled thermal energy, the technique achieves isolation without the harmful byproducts of thermal decomposition
Data Source
AI summary
This document provides devices and methods for the treatment of heart conditions, hypertension, and other medical disorders. For example, this document provides devices and methods for treating atrial fibrillation by performing thoracic vein ablation and/or electroporation procedures, including pulmonary vein myocardium ablation. In some embodiments, the ablation and/or electroporation is delivered in differing areas in and/or around the pulmonary vein in coordination with each other for enhanced efficacy.


