Deployable Electrode Basket for Pulmonary Vein Isolation Confirmation
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Solution Overview
Problem
Existing ablation devices for atrial fibrillation lack a means to quickly and easily confirm electrical isolation of pulmonary veins without the need for catheter exchanges, which can introduce air into the left atrium and increase procedure time and risk.
Innovation Solution
A deployable electrode structure on an endoscopically guided laser ablation catheter with an inflatable balloon and axially translatable nose tip, allowing electrodes to deploy and confirm electrical isolation without catheter exchange, and deliver various ablative energies like radiofrequency or electroporative energy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If catheter exchange is used to confirm electrical isolation, then confirmation capability is achieved, but procedure time increases and air introduction risk increases
Solution Approach 1:
The patent combines the ablation catheter with electrodes into a single integrated device. The ablation catheter includes an ablation portion with an energy source and an electrode portion with multiple electrodes that can be deployed to confirm electrical isolation. This merging eliminates the need to exchange catheters between ablation and confirmation steps, thereby reducing procedure time while maintaining reliable confirmation capability.
Solution Approach 2:
The ablation catheter is designed with multi-functionality to serve both ablation and electrical isolation confirmation. The single catheter device can deliver ablation energy through the ablation portion and simultaneously perform electrophysiological mapping through the deployable electrodes, making it a universal tool that eliminates the need for separate catheters and reduces overall procedure time.
2Reliability
If catheter exchange is used to confirm electrical isolation, then confirmation capability is achieved, but air introduction risk increases
Solution Approach 1:
By merging the ablation and confirmation functions into a single catheter device, the patent eliminates the need for catheter exchange. The ablation catheter with integrated electrodes allows operators to confirm electrical isolation without removing the catheter from the patient, thereby preventing air introduction that would occur during catheter exchange while maintaining reliable confirmation capability.
3Adaptability or versatility
If electrodes are added to ablation catheter, then confirmation and energy delivery capability is improved, but device complexity increases
Solution Approach 1:
The patent segments the catheter into distinct functional portions: an ablation portion for energy delivery and an electrode portion for electrical isolation confirmation. The electrode portion can be deployed or retracted as needed, allowing the device to adapt between ablation-only mode and ablation-plus-confirmation mode. This segmentation provides versatility while managing complexity through modular design.
Solution Approach 2:
The electrode portion is designed to be dynamically deployable and retractable. The electrodes can be deployed when confirmation is needed and retracted when only ablation is required. This dynamic capability allows the device to adapt to different procedural needs, enhancing versatility while controlling complexity through on-demand configuration rather than permanent multi-function integration.
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
Enables rapid confirmation of electrical isolation and delivery of diverse ablative energies, reducing procedure time and risk by eliminating the need for catheter exchanges and enhancing safety and efficiency.
Implementation Method 1
an inflatable balloon coupled at a first end to the outer catheter shaft; an axially translatable nose tip to which a second end of the inflatable balloon is coupled
Implementation Method 2
endoscopically guided laser ablation catheter for use in ablation and electrophysiological mapping
Implementation Method 3
using the electrodes to monitor the electrograms originating in the pulmonary veins
Data Source
AI summary
A balloon catheter includes an inflatable balloon coupled to an outer catheter shaft and an axially translatable nose tip coupled to the inflatable balloon. An electrode basket surrounds the balloon and has a plurality of first splines and a plurality of second splines. The plurality of splines includes a first reference spline on which a first radiopaque marker is formed, a second reference spline on which a second radiopaque marker is formed and a third reference spline on which a third radiopaque marker is formed, the second radiopaque marker being located a first angular distance in a first direction from the first radiopaque marker and the third radiopaque marker being located the first angular distance in a second direction from the first radiopaque marker, wherein the second radiopaque marker is located proximal to the first radiopaque marker and the third radiopaque marker is located distal to the first radiopaque marker.