Left Atrial Appendage Closure With Pressure-Sensing Deployment
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Solution Overview
Problem
Existing medical devices for closing the left atrial appendage in patients with atrial fibrillation are inadequate in preventing thrombi formation and migration, necessitating improved devices and methods for deployment and manufacturing.
Innovation Solution
A medical system comprising an expandable framework with a proximal hub and a sensor, deployable via a catheter, featuring a threaded connection mechanism for controlled deployment and a sensor for pressure sensing within the left atrial appendage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a left atrial appendage closure device is deployed to close off the left atrial appendage, then thrombi formation is reduced, but the device complexity increases
Solution Approach 1:
The closure device is divided into multiple functional components: an expandable framework with multiple struts, separate occluding elements, and integrated sensors. This segmentation allows each component to perform its specific function efficiently while enabling modular deployment and retrieval mechanisms that manage complexity through functional division.
Solution Approach 2:
The delivery catheter system employs a nested configuration where the collapsecage and closure device are contained within the delivery catheter lumen. The core wire runs through the delivery catheter, and the entire assembly can be withdrawn in a coordinated manner. This nesting allows complex structures to be delivered through a relatively simple catheter system.
2Loss of information
If a sensor is integrated into the expandable framework for pressure sensing, then real-time monitoring capability is provided, but the device complexity increases
Solution Approach 1:
The sensor is integrated directly into the expandable framework structure, merging the monitoring function with the structural component. This integration allows the framework to serve dual purposes: providing mechanical support for closure and housing the sensor for pressure monitoring, thereby reducing overall system complexity compared to separate monitoring devices.
Solution Approach 2:
The expandable framework is designed to perform multiple functions: it provides the structural basis for occluding the left atrial appendage, serves as a platform for mounting occluding elements, and integrates sensor housing for pressure monitoring. This multi-functionality reduces the need for separate components and simplifies the overall device architecture.
3Manufacturing precision
If a threaded connection mechanism is used for controlled deployment, then deployment precision is improved, but the ease of operation decreases
Solution Approach 1:
The threaded connection mechanism replaces simpler mechanical coupling methods with a screw-thread-based system that provides controlled engagement and disengagement. This allows for precise positioning of the expandable framework relative to the proximal hub during deployment, while the self-threading action reduces the manual dexterity required compared to precision alignment mechanisms.
Data Source
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AI summary
A medical system may include a left atrial appendage closure device including an expandable framework and a proximal hub disposed along a central longitudinal axis of the expandable framework, the expandable framework being configured to shift between a collapsed delivery configuration and an expanded deployed configuration; wherein the left atrial appendage closure device includes a sensor at least partially disposed within an interior of the expandable framework and axially movable relative to the proximal hub; wherein the proximal hub includes a first threaded connection structure; and a delivery catheter including a core wire extending axially within a lumen of the delivery catheter, the core wire having a second threaded connection structure at a distal end thereof configured to releasably engage the first threaded connection structure in an unreleased configuration and the second threaded connection structure is disengaged from the first threaded connection structure in a released configuration.