Foldable Spline Ablation Catheter for Deeper Cardiac Lesions
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Solution Overview
Problem
Existing pulsed electric field ablation technologies face challenges in generating deep lesions in thicker cardiac tissues due to significant current flow through conductive fluids, resulting in suboptimal lesion characteristics.
Innovation Solution
A focal ablation device with a foldable membrane and deployable spline assembly, configured to enhance electric field intensity and direct it deeper into tissue, utilizing a signal generator to deliver hierarchical pulse waveforms for irreversible electroporation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If high voltage pulses are applied for pulsed field ablation, then cell membrane breakdown and cell death occur through irreversible electroporation, but significant current flows through conductive fluid medium rather than tissue resulting in suboptimal lesion characteristics
Solution Approach 1:
The patent introduces an electric field shaping element as an intermediary component between the electrodes and the tissue. This element modifies the electric field distribution to redirect current flow away from the conductive fluid medium and concentrate it through the tissue, thereby improving lesion generation effectiveness while reducing energy loss through the fluid.
Solution Approach 2:
The patent applies local quality by creating a non-uniform electric field distribution through the use of shaped electrodes or electric field shaping elements. The electric field is concentrated in specific regions where tissue ablation is desired, while minimizing current flow through the surrounding conductive fluid medium. This localized field concentration improves lesion characteristics without requiring uniform high current throughout the entire fluid medium.
2Length of moving object
If conventional ablation device designs are used, then current delivery is simplified, but the ability to generate deep lesions in thicker tissue is insufficient
Solution Approach 1:
The patent segments the electrode structure into multiple components including shaping elements and potentially multiple electrode arrays. This segmentation allows the electric field to be shaped and directed deeper into the tissue to achieve greater lesion depth. The segmented structure enables independent optimization of different field regions while managing overall device complexity through modular design.
Solution Approach 2:
The patent introduces electric field shaping elements that add a geometric dimension to the electrode-tissue interface. By shaping the electric field in three-dimensional space rather than using simple planar electrodes, the device can direct energy deeper into the tissue. This dimensional approach to field shaping enables greater lesion depth without proportionally increasing device complexity.
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 device generates deeper lesions by up to 20% deeper than conventional methods, effectively treating thicker cardiac tissues like the left ventricle.
Implementation Method 1
Pulsed electric field ablation utilizing 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
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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.