Self-Expandable Stent Assembly for Real-Time Arrhythmogenic Foci Mapping
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Solution Overview
Problem
Current catheter ablation methods for atrial fibrillation, particularly those based on pulmonary vein isolation, are ineffective in accurately determining the precise location of arrhythmogenic foci, leading to recurrent conduction issues and atrial fibrillation events, as they lack real-time monitoring and precise localization capabilities.
Innovation Solution
A self-expandable stent assembly with electrodes is deployed within the heart to receive electrical signals, allowing for the determination of arrhythmogenic foci by generating relative movement between the stent and a sheath, maintaining engagement during the procedure, and using tethering or inhibitors to ensure the stent remains in the sheath for retrieval.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a self-expandable stent assembly with electrodes is deployed within the heart, then accurate localization of arrhythmogenic foci is enabled, but device complexity increases
Solution Approach 1:
The device is segmented into distinct functional modules: a collapsible stent assembly with electrodes for signal detection, a delivery catheter with sheath for minimally invasive insertion, and a control system for deployment and retrieval. This segmentation allows each component to be optimized independently while maintaining overall system functionality, enabling accurate localization without excessive complexity.
Solution Approach 2:
The stent assembly serves multiple functions: it provides structural support to maintain atrial geometry, contains electrodes for electrical signal detection, and acts as a mounting platform for signal processing electronics. This multi-functionality reduces the need for separate devices, thereby improving measurement precision without proportionally increasing device complexity.
2Reliability
If the stent assembly remains engaged with the sheath during the procedure, then retrieval is ensured, but ease of operation is reduced
Solution Approach 1:
The connection between the stent assembly and sheath is designed to be dynamic rather than fixed. The stent can be selectively deployed from the sheath during the procedure and then re-engaged for retrieval. This dynamic configuration allows operators to access the stent for signal collection while maintaining the ability to retrieve it, balancing reliability with ease of operation.
Solution Approach 2:
The sheath acts as an intermediary component that facilitates both deployment and retrieval of the stent assembly. During the procedure, the sheath can be retracted to allow stent deployment, then re-advanced to engage with the stent for retrieval. This intermediary mechanism ensures reliable retrieval while maintaining operational flexibility.
3Measurement precision
If real-time electrical signal monitoring is implemented, then arrhythmogenic foci location is accurately determined, but device complexity increases
Solution Approach 1:
The electrodes for electrical signal detection are integrated directly into the stent structure, merging the sensing function with the structural support function. This integration eliminates the need for separate sensing catheters or probes, reducing overall device complexity while enabling accurate real-time monitoring of electrical signals to locate arrhythmogenic foci.
Solution Approach 2:
The stent assembly is equipped with onboard electronics that autonomously process and analyze electrical signals in real-time. The device self-monitors its own position and the electrical activity around it, reducing the need for external monitoring equipment and simplifying the overall system while maintaining high measurement precision.
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 localization of arrhythmogenic foci, improving the effectiveness of atrial fibrillation treatment by providing real-time mapping and reducing recurrence of atrial fibrillation events.
Implementation Method 1
a self-expanding stent assembly with electrodes is deployed within the heart to receive electrical signals, allowing for the determination of arrhythmogenic foci by generating relative movement between the stent and a sheath
Implementation Method 2
coupling a plurality of electrodes to a device body to form at least a portion of the locator assembly... receiving electrical signals from the heart with the plurality of electrodes of the locator assembly
Data Source
AI summary
A method for deploying a locator assembly (500) in or near a heart (101) includes coupling a plurality of electrodes (102) to a device body (512) to form at least a portion of the locator assembly (500), the device body (512) including a self-expandable stent; positioning the device body (512) within an inner cavity (523A) of a sheath (523); inserting the locator assembly (500) within the heart (101); generating relative movement between the locator assembly (500) and the sheath (523) so that at least a portion of the device body (512) is no longer positioned within the inner cavity (523A); receiving electrical signals from the heart (101) with the plurality of electrodes (102); and determining a location of arrhythmogenic foci (732) with the locator assembly (500) based at least in part on the electrical signals received from the heart (101), the device body (512) remaining engaged with the inner cavity (523A) of the sheath (523) while the locator assembly (500) is being used to determine the location of the arrhythmogenic foci (732).