Planar Multi-Electrode Catheter with Two-Sided Mapping
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Solution Overview
Problem
Current multi-electrode catheters for treating cardiac arrhythmia lack high-density signal mapping capabilities, which are essential for precise identification and ablation of unwanted electrical pathways in the heart, due to limitations in electrode spacing and density.
Innovation Solution
The development of a planar multi-electrode catheter with a two-sided, multi-layered end effector configuration, featuring a support frame and flexible membranes with closely spaced electrodes, along with integrated sensors and conductive traces, allows for high-density electrode placement and improved signal mapping and ablation capabilities.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional single-sided electrode catheters are used, then the device complexity is low, but the mapping precision and electrode density are insufficient for high-resolution signal acquisition
Solution Approach 1:
The patent transitions from traditional single-sided electrode arrangement to a two-sided planar end effector configuration, adding a dimensional aspect to electrode placement. This allows electrodes to be positioned on both sides of the end effector, effectively doubling the mapping capacity and resolution without proportionally increasing overall device complexity.
Solution Approach 2:
The end effector is divided into multiple functional layers including first membrane with first electrodes, second membrane with second electrodes, and intermediate components like support frame and insulation layers. This segmentation enables independent optimization of each layer's electrode density and spacing, achieving high overall mapping precision while managing device complexity through modular construction.
2Measurement precision
If electrodes are spaced farther apart, then the device complexity is reduced, but the signal mapping resolution deteriorates
Solution Approach 1:
By utilizing both sides of the end effector for electrode placement, the patent effectively doubles the number of sensing points within the same physical footprint. This dimensional approach achieves high signal mapping resolution without requiring excessively small electrode spacing, as the density is increased through bilateral placement rather than solely through miniaturization.
Solution Approach 2:
The use of flexible membrane structures as the substrate for electrode mounting allows for ultra-tight spacing of electrodes while maintaining structural integrity. The membrane's flexibility enables the electrodes to be positioned extremely close together (ultra-tight spacing) without rigid structural constraints, achieving high mapping resolution with manageable device complexity.
3Measurement precision
If ultra-tight electrode spacing is implemented, then the mapping resolution is improved, but the manufacturing precision requirements increase
Solution Approach 1:
The flexible membrane substrate provides a compliant platform that can accommodate ultra-tight electrode spacing while being more tolerant of manufacturing variations than rigid substrates. The membrane's flexibility allows for slight variations in electrode placement without compromising overall array integrity or function, reducing the stringent manufacturing precision requirements that would otherwise be necessary.
Solution Approach 2:
The electrode array is segmented into multiple independent layers (first membrane with first electrodes, second membrane with second electrodes), allowing each layer to be manufactured and positioned independently. This segmentation enables modular assembly where each layer can be optimized separately, reducing the cumulative manufacturing precision requirements compared to a single monolithic high-density array.
4Measurement precision
If a two-sided multi-layered end effector is used, then the ablation precision is improved, but the device complexity increases
Solution Approach 1:
The two-sided multi-layered end effector is divided into distinct functional segments: first membrane layer with first electrodes for initial mapping, second membrane layer with second electrodes for complementary mapping, support frame for structural integrity, and insulation layers for electrical isolation. This segmentation allows each component to be optimized for its specific function, improving overall ablation precision while managing complexity through modular design that can be manufactured and assembled independently.
Solution Approach 2:
The multi-layered end effector structure serves multiple functions simultaneously: the first and second membranes provide dual-sided mapping capabilities, the support frame provides structural support and positioning, and the insulation layers prevent electrical interference. This multi-functionality integrates mapping, positioning, and electrical isolation functions into a single unified structure, improving ablation precision without requiring separate devices for each function.
Data Source
AI summary
Catheters are presented herein having planar end effectors of various configurations, generally providing a two-sided and multi-layered platform for electrodes and sensors. In some examples, the end effector has a support frame (e.g. nitinol) between a pair of flexible circuits. The end effector can also include a polymer (e.g. silicone, LCP, etc.) between the flexible circuits and encapsulating the support frame. This platform facilitates positioning of electrodes on either side (including both sides) of the end effector in a variety of spacings and facilitates ultra-tight electrode spacing and/or a large area electrode. Sensors (ultrasound transducers, navigation coils, etc.) can be layered within the end effector between outer surfaces of the flexible circuits in a variety of configurations.