Mapping and ablation system suitable for linear pulsed-field cardiac ablation
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Solution Overview
Problem
Existing tissue ablation techniques, such as radio frequency ablation and cryogenic ablation, suffer from prolonged processing times, high surgical complexity, and unreliable positioning, leading to incomplete ablation and gaps in treated areas.
Innovation Solution
A catheter system utilizing pulsed-field energy with at least two ablation electrodes, configured to deliver high-voltage pulses along a main axis, creating an electric field intensity of 400 V/cm at 5 mm depth, enabling irreversible electroporation for precise and contiguous tissue ablation without the need for repositioning.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If radio frequency ablation is performed point-by-point sequentially, then tissue ablation can be achieved, but processing time is prolonged and surgical complexity increases
Solution Approach 1:
The catheter incorporates multiple ablation electrodes (at least two, preferably at least six) arranged along the main axis, dividing the ablation task into parallel segments rather than sequential point-by-point treatment. This allows simultaneous activation of multiple electrodes to create contiguous ablation regions, dramatically reducing processing time while maintaining complete tissue coverage.
Solution Approach 2:
Multiple ablation electrodes are combined into a single catheter shaft, enabling simultaneous delivery of pulsed-field energy to multiple tissue locations. The electrodes work together to create a continuous ablation zone along the catheter's main axis, merging what would otherwise require multiple separate positioning and treatment steps.
2Reliability
If radio frequency ablation is performed point-by-point sequentially, then tissue ablation can be achieved, but surgical complexity increases due to sequential positioning requirements
Solution Approach 1:
The catheter is segmented into multiple functional electrodes along its length, each capable of independent or coordinated activation. This segmentation allows the device to cover multiple target locations simultaneously, eliminating the need for repeated positioning maneuvers and reducing surgical complexity.
Solution Approach 2:
The multi-electrode catheter serves multiple ablation functions from a single device deployment. The same catheter can treat multiple tissue segments along its axis without requiring更换 or repositioning, providing universal coverage that simplifies the surgical procedure.
3Manufacturing precision
If cryogenic linear catheter is used, then linear ablation can be achieved, but the catheter becomes stiff causing surgical complexities
Solution Approach 1:
The invention uses pulsed-field energy parameters (high-voltage pulses of at least 1000 V, preferably at least 3000 V) instead of cryogenic temperatures to achieve ablation. This parameter change allows the use of softer, more flexible catheter materials that can navigate vascular structures easily while still delivering precise linear ablation through electrical field control.
4Manufacturing precision
If cryogenic linear catheter is used, then linear ablation can be achieved, but reliable positioning in target area is not ensured
Solution Approach 1:
Switching from cryogenic thermal ablation to pulsed-field electrical ablation allows for more reliable positioning. The electrical field can be precisely controlled and delivered through flexible catheter materials, ensuring consistent energy delivery to the target tissue regardless of minor positioning variations, thereby improving both positioning reliability and ablation precision.
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 allows for efficient, reliable, and rapid tissue ablation with reduced surgical complexity by ensuring complete coverage and minimizing gaps, leveraging irreversible electroporation to program cell death along the catheter's axis.
Implementation Method 1
Pulsed-field ablation (PFA) renders the targeted tissue non-viable by means of irreversible electroporation (IRE). The electric fields set out by the applied PF energy create pores in the targeted cardiac cell membrane.
Implementation Method 2
A catheter for ablating a tissue using pulsed-field (PF) energy configured for connection to a high-voltage generator for generating PF energy
Data Source
AI summary
The present disclosure relates to a catheter (C) for ablating a tissue comprising: at least two ablation electrodes (A1, A2) configured for applying a pulse of an electrical energy to the tissue: wherein the catheter is configured such that, in an ablation position of the catheter, the ablation electrodes (A1, A2) contact the tissue along a main axis (z) of the catheter.