Expandable Cardiac Locator Assembly for Precise Arrhythmia Mapping
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Solution Overview
Problem
Current anatomically-based catheter ablation methods for atrial fibrillation are ineffective in accurately determining the precise location of arrhythmogenic foci, leading to recurrent conduction and atrial fibrillation events, as they lack real-time monitoring and standardization, and are not representative of the overall patient population.
Innovation Solution
A locator assembly with a device body and electrodes that can be expanded and anchored in the heart to map electrophysiological signals, providing precise localization of arrhythmogenic foci through bipolar electrodes and telemetry monitoring.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If anatomically-based catheter ablation is performed using pulmonary vein isolation, then the procedure can be standardized and performed on a broad patient population, but it fails to accurately determine the precise location of arrhythmogenic foci, leading to recurrent conduction and atrial fibrillation events
Solution Approach 1:
The patent replaces the mechanical/anatomical approach (pulmonary vein isolation based on anatomical location) with an electrical field-based approach (bipolar voltage mapping). Instead of mechanically isolating pulmonary veins based on anatomical assumptions, the system uses electrical field measurements to identify and treat the actual arrhythmogenic foci, thereby achieving both standardization through automated voltage analysis and high precision through direct electrical measurement of arrhythmia origins.
2Measurement precision
If real-time monitoring of arrhythmogenic foci is implemented, then precise location determination is achieved, but the device complexity and procedural time increase significantly
Solution Approach 1:
The locator assembly is designed as a multi-functional device that combines mapping electrodes, ablation electrodes, and structural support elements into a single catheter. This universal design allows the same device to perform multiple functions (mapping, localization, and treatment) without requiring separate complex systems, thereby achieving precise real-time monitoring while controlling overall device complexity.
Solution Approach 2:
The patent employs a nested structure where the locator assembly with its electrodes and mapping components is contained within a catheter shaft. The mapping electrodes are nested along the catheter body, and the ablation electrodes are integrated within the same assembly. This nesting allows the complex functional components to be delivered through a relatively simple catheter delivery system, reducing the apparent complexity at the delivery stage while maintaining full functionality upon deployment.
3Adaptability or versatility
If pulmonary vein isolation is performed as a standardized approach, then the procedure can be applied to the overall patient population, but it is ineffective for patients whose arrhythmogenic foci are located outside the pulmonary veins
Solution Approach 1:
The patent replaces the anatomically-based mechanical isolation approach with an electrical field-based mapping approach that is not constrained by anatomical locations. The bipolar voltage mapping can identify arrhythmogenic foci anywhere in the atria by detecting abnormal electrical patterns, making the system equally effective for patients with foci in pulmonary veins, left atrial appendage, or other atrial locations, thereby achieving both broad applicability and high cure effectiveness.
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
Enables accurate mapping of atrial fibrillation episodes during daily life, improving treatment efficacy by precisely identifying the arrhythmogenic foci, reducing recurrence, and enhancing catheter ablation effectiveness.
Implementation Method 1
a plurality of electrodes that receive electrical signals from the heart to determine the location of the arrhythmogenic foci
Implementation Method 2
the device body is movable between (i) a contracted state wherein the device body is contracted, and (ii) an expanded state wherein the device body is expanded outwardly from the contracted state so that the device body has an increased circumference
Implementation Method 3
at least one of the inner layer and the outer layer include an eluting drug that is configured to counteract a pro-thrombotic and an inflammatory potential of the locator assembly
Data Source
AI summary
A locator assembly (100) for determining a location of an arrhythmogenic foci (632) in or near a heart (101). The locator assembly (100) having a longitudinal axis (100a) and a circumference (100c). The locator assembly (100) includes a device body (112) and a plurality of components that are coupled to the device body (112). The plurality of components are distributed about the longitudinal axis (100a) and the circumference (100c). The device body (112) is movable between (i) a contracted state wherein the device (112) body is contracted, and (ii) an expanded state wherein the device body (112) is expanded outwardly from the contracted state so that the device body (112) has an increased circumference (100c).