Foldable Membrane Catheter for Deeper Pulsed-Field Ablation
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Solution Overview
Problem
Pulsed electric field ablation in the presence of conductive fluids like blood results in suboptimal lesion formation in thicker tissues due to current flow through the fluid rather than the tissue, necessitating improved ablation device designs for deeper tissue penetration.
Innovation Solution
The use of a catheter with a foldable membrane and deployable spline assembly, where the membrane is made of insulative material and attached to the splines, redirects electric field lines to enhance lesion depth by increasing intensity distal to the electrodes, facilitating deeper lesion generation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Length of stationary object
If high voltage pulses are applied in the presence of conductive fluid (blood), then ablation can be performed, but current flows through the fluid rather than tissue resulting in suboptimal lesion depth
Solution Approach 1:
An electrically insulative membrane is introduced as an intermediary component between the electrodes and the conductive fluid. This membrane redirects electric field lines away from the fluid pathway and concentrates them through the tissue, thereby reducing current loss through the fluid while enhancing lesion depth in the tissue.
Solution Approach 2:
The invention changes the electrical parameter distribution by introducing an insulative membrane with specific dielectric properties. This membrane modifies the electric field configuration, transforming the current flow pattern from one that preferentially follows the conductive fluid path to one that penetrates deeper into the tissue, thereby improving lesion depth without increasing overall energy consumption.
2Length of stationary object
If a foldable membrane is added to redirect electric field lines, then lesion depth is enhanced, but device complexity increases
Solution Approach 1:
The membrane is designed with foldable and deployable characteristics, allowing it to transition from a compact stored configuration to an expanded operational configuration. This dynamic design enables the complex membrane structure to be easily navigated through catheters and deployed only when needed at the target site, thereby managing device complexity while achieving the desired electric field redirection for deeper lesions.
Solution Approach 2:
The foldable membrane is nested within the catheter structure in a compact form during delivery. Upon deployment, it expands to its functional configuration. This nesting approach allows the complex membrane component to be integrated into the catheter system without significantly increasing the overall device size or complexity during the delivery phase, while providing the full benefit of electric field redirection when deployed.
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 described catheter design achieves deeper lesion formation by up to 20% compared to devices without the membrane, effectively addressing the challenge of suboptimal lesion depth in thicker cardiac tissues.
Implementation Method 1
Pulsed electric field ablation using application of high voltage pulses has been demonstrated to be suitable for the rapid and effective ablation of cardiac tissue as well as other target anatomy. Pulsed electric field energy delivery utilizes brief pulses of high voltage that generate locally high electric fields that can drive the breakdown of cell membranes and result in cell death
Implementation Method 2
the foldable membrane is formed of an electrically insulative material
Implementation Method 3
brief pulses of high voltage that generate locally high electric fields that can drive the breakdown of cell membranes and result in cell death, a process also referred to as irreversible electroporation
Data Source
AI summary
An endocardial catheter comprises an outer shaft having an outer shaft lumen, an inner shaft slidably disposed within the outer shaft lumen, a spline assembly comprising a plurality of flexible splines each having a spline proximal end attached to a distal end of the outer shaft, an opposite spline distal end attached to a distal end of the inner shaft, and an electrode, wherein the plurality of splines collectively define an interior space of the spline assembly, and a foldable membrane disposed within the interior space of the spline assembly, the foldable membrane having an outer edge portion attached to one or more of the splines. The foldable membrane comprises an electrically insulative material.