Flexible Ablation Catheter for Continuous Lesion Creation
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Solution Overview
Problem
Current ablation systems for treating cardiac arrhythmias, such as atrial fibrillation, face challenges in precision, control, and efficiency, particularly in creating continuous lesions in the left atrium, especially around pulmonary veins, due to anatomical variations and the need for complex motions and additional equipment, which can lead to increased procedure time and risk of complications like perforation.
Innovation Solution
The development of an ablation device with a flexible ablating portion that can form a substantially planar geometric shape to create continuous lesions, allowing for self-alignment and precise positioning, and a steering system with deflectable distal portions and flexible joints to facilitate accurate placement and movement, enabling the creation of area ablations that form continuous barriers.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If point ablation systems are used to create lesions by dragging the tip electrode and burning at each location, then precision control of ablation points is achieved, but procedure time increases significantly and productivity decreases
Solution Approach 1:
The ablation catheter is divided into multiple discrete ablation electrodes arranged in a linear array along the distal portion. This segmentation allows each electrode to independently ablate tissue at its specific location, enabling simultaneous creation of multiple ablation points along the linear trajectory without requiring repeated dragging and burning operations.
Solution Approach 2:
The linear array of ablation electrodes maintains continuous contact with the target tissue along an extended linear path, allowing continuous ablation action across multiple points simultaneously. This eliminates the discontinuous nature of point-by-point ablation and enables uninterrupted creation of continuous lesions through a single catheter position.
2Productivity
If linear ablation systems are used to create long linear lesions, then productivity improves with faster procedure times, but device complexity increases and guidance control becomes more difficult
Solution Approach 1:
The linear ablation system is segmented into multiple discrete electrodes arranged in a linear array, with each electrode capable of independent activation. This segmentation allows the system to create continuous linear lesions through sequential or simultaneous activation of individual electrodes along the linear trajectory, reducing the need for complex guidance systems while maintaining productivity.
3Adaptability or versatility
If complex motions in at least two planes are used to move the ablating device between ablation sites, then flexibility and adaptability improve, but ease of operation decreases due to difficulty in controlling multiple planes
Solution Approach 1:
The ablation catheter incorporates multiple independently controllable ablation electrodes along its linear array. This segmentation allows the system to adapt to different anatomical configurations and ablation site requirements by selectively activating specific electrodes, while maintaining simple uniplanar guidance control through the delivery system.
Solution Approach 2:
The ablation capability is extended along the longitudinal dimension of the catheter through the linear array of electrodes, transforming the ablation process from point-based to linear/area-based. This dimensional extension allows the system to reach multiple ablation sites along a single linear trajectory without requiring complex multi-planar motions, thereby improving ease of operation while maintaining adaptability.
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
This solution enhances precision and reduces procedure time by allowing for the creation of continuous lesions with minimal coarse movements, reducing the need for complex equipment and minimizing the risk of complications, while providing tactile feedback for safer operations.
Implementation Method 1
Ablation devices and systems, such as those described herein, may be used to deliver electromagnetic energy to, and/or create area ablations in, biological tissues
Data Source
AI summary
The present invention discloses devices and methods for creating multiple lesions using ablation devices in anatomical regions such as the heart, for example to treat cardiac arrhythmias. The present invention discloses methods and devices to create continuous lesions using area ablation devices. The present invention discloses various embodiments of reference assemblies for accurately positioning ablation devices having ablating portions, especially deployable ablation portions adapted for area ablation. The ablation devices are positioned using the reference assemblies in the anatomy to create one or more lesions. The present invention also discloses several method embodiments for creating continuous lesions using deployable ablating portions to produce two or more overlapping lesions.