Expandable Flexible Electrode Assembly for Cardiac Ablation
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Solution Overview
Problem
Existing catheter devices for thermal ablation procedures, such as pulmonary vein isolation for atrial fibrillation, are cumbersome, stiff, and inefficient due to bulky electrodes, leading to complex and time-consuming procedures with limited conformability to the 3D anatomy of the heart, requiring multiple catheters and extensive repositioning for effective lesion creation.
Innovation Solution
A catheter and electrode assembly featuring an expandable membrane with a flexible, branching circuit that unfolds to form a large surface area of radiofrequency ablation electrodes and sensing electrodes, allowing for conformability to complex anatomies and reduced procedure time through minimally-invasive delivery and precise energy transmission.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Area of stationary object
If bulky electrodes are used for thermal ablation, then lesion area is increased, but device complexity and procedure time increase
Solution Approach 1:
The electrode array is divided into multiple independently controllable electrode segments that can be selectively activated. This segmentation allows creation of large lesion areas through coordinated activation of multiple electrodes while maintaining manageable device complexity through modular control architecture
Solution Approach 2:
The electrode array is configured to expand from a compact delivery profile into a three-dimensional arrangement with electrodes positioned at different heights and radial distances. This dimensional transformation enables large surface area coverage for extensive lesion creation while maintaining small catheter profile for minimally invasive delivery
2Device complexity
If single electrode tip catheter is used, then device simplicity is maintained, but procedure time and operational complexity increase
Solution Approach 1:
Multiple electrode functions (ablation, sensing, mapping) are merged into a single catheter assembly with an array of electrodes that can perform multiple operations simultaneously or sequentially, eliminating the need for multiple separate catheters and reducing procedure time
Solution Approach 2:
The electrode array catheter is designed with universal functionality to perform ablation, electrical mapping, and sensing operations through the same device platform, allowing operators to switch between functions without changing catheters and significantly reducing overall procedure time
3Strength
If stiff electrodes are used, then structural integrity is maintained, but conformability to 3D anatomy is reduced
Solution Approach 1:
The electrode array structure transitions from a rigid delivery state to a flexible deployed state, allowing the electrode assembly to dynamically adapt its shape to conform to complex 3D cardiac anatomy while maintaining sufficient structural integrity to deliver and position the electrodes accurately
Solution Approach 2:
The electrode array is constructed with flexible support structures and thin-film electrode elements that can bend and conform to irregular cardiac surfaces, replacing traditional stiff wire electrodes while maintaining adequate mechanical strength through optimized material selection and structural design
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 flexible electrode assembly enables efficient and precise energy delivery over large surfaces, reducing procedure time and skill requirements by conforming to the heart's anatomy, allowing for effective ablation with fewer catheter manipulations and improved lesion creation.
Implementation Method 1
thermal ablation therapy can be used to heat a target tissue with a surgical instrument such as a needle or probe electrode coupled to an energy source that heats the probe tip, the target tissue, or both
Implementation Method 2
The planar conducting layer is electrically coupled to a plurality of radio frequency ablation electrodes
Implementation Method 3
an expandable electrode structure coupled to the distal portion, wherein the expandable electrode structure comprises an expandable membrane with an expanded configuration
Data Source
AI summary
A tissue electrode assembly includes a membrane configured to form an expandable, conformable body that is deployable in a patient. The assembly further includes a flexible circuit positioned on a surface of the membrane and comprising at least one base substrate layer, at least one insulating layer and at least one planar conducting layer. An electrically-conductive electrode covers at least a portion of the flexible circuit and a portion of the surface of the membrane not covered by the flexible circuit, wherein the electrically-conductive electrode is foldable upon itself with the membrane to a delivery conformation having a diameter suitable for minimally-invasive delivery of the assembly to the patient.