Flexible Catheter Radial Electrode Geometry for Signal Fidelity
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Solution Overview
Problem
Current medical devices for obtaining monophasic action potential electrograms in treating atrial fibrillation face challenges in achieving accurate signal fidelity and effective tissue contact, leading to suboptimal treatment of irregular heartbeats and increased risks of blood clots and stroke.
Innovation Solution
A catheter design featuring a flexible body with a distal assembly having multiple MAP recording electrodes positioned radially around the longitudinal axis, a reference electrode, and a radio-frequency ablation electrode, ensuring radial symmetry and improved tissue contact through a flexible and resilient distal section, facilitating precise signal recording and treatment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a catheter uses a rigid structure to maintain electrode position, then measurement precision is improved, but ease of operation deteriorates due to difficulty in navigating through body passages
Solution Approach 1:
The catheter employs a flexible distal assembly that can dynamically adapt its shape to conform to cardiac tissue surfaces while maintaining electrode-tissue contact. The flexibility allows the catheter to navigate complex body passages and heart geometry, while the electrodes maintain stable positioning through elastic contact rather than rigid fixation.
Solution Approach 2:
The distal assembly utilizes flexible materials and thin-film construction to create a compliant structure that can bend and conform to irregular tissue surfaces. This flexible shell approach allows the electrodes to maintain close contact with the tissue for accurate signal recording while enabling easy navigation through the cardiovascular system.
2Device complexity
If the catheter uses a simple single-electrode design, then device complexity is reduced, but measurement precision deteriorates due to insufficient spatial sampling of electrical activity
Solution Approach 1:
The catheter divides the recording function into multiple segmented electrodes arranged in a radial pattern around the distal tip. This segmentation allows simultaneous recording from multiple spatial locations, providing comprehensive sampling of electrical activity across the tissue surface while maintaining a relatively simple overall device structure.
Solution Approach 2:
The electrode array transitions from a single-point measurement to a three-dimensional radial arrangement, capturing electrical signals from multiple angular directions simultaneously. This dimensional expansion provides spatial context and improves mapping accuracy without significantly increasing device complexity.
3Ease of operation
If the catheter uses a flexible distal assembly to improve tissue contact, then ease of operation is improved, but stability of the object's composition deteriorates due to potential electrode displacement
Solution Approach 1:
The distal assembly employs a curved or radially symmetric electrode arrangement that naturally conforms to the curved surfaces of cardiac tissue. This spherical/geometric adaptation provides stable contact points that resist displacement while maintaining flexibility, as the curved geometry distributes contact forces more evenly across the tissue surface.
Solution Approach 2:
The catheter design allows the distal assembly to change its physical parameters (shape, curvature, contact pressure) in response to tissue interaction forces. This parametric adaptability enables the flexible assembly to maintain stable electrode positioning by automatically adjusting its configuration to match the underlying tissue topology.
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 catheter design enhances signal fidelity and treatment efficacy by allowing for stable tissue contact and accurate mapping of electrical activity, improving the identification and treatment of electrical tissue disorders, thereby reducing the risk of blood clots and stroke.
Implementation Method 1
contact with positive pressure produces a monophasic action potential signal, which may be used to map proper and improper electrically functioning areas
Implementation Method 2
Ablation electrodes may be provided in the distal assembly, and the flexible and resilient distal section facilitates contact with tissue to be ablated
Data Source
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AI summary
Catheters and methods for obtaining monophasic action potential ("MAP") electrograms include a flexible catheter body defining a longitudinal axis, and a distal assembly affixed to the catheter body distal end defining a distal tip. The distal assembly has at least three MAP recording electrodes, and at least one reference electrode for determining reference potential. The recording electrodes are each positioned a radial distance from the longitudinal axis in at least three different radial directions, defining a recording geometry substantially having radial symmetry. The reference electrode is a longitudinal distance from the recording geometry. Optional features include a steerable catheter shaft, one or more radio-frequency ablation electrodes, and a dedicated pacing electrode. Different possible embodiments include a dome housing having the recording electrodes in a fixed spatial arrangement, and a distal loop assembly having an array of electrodes on at least three flexible loop elements.