Left Atrial Appendage Closure Device With Pressure Sensing
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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, leading to stroke or heart attack risks.
Innovation Solution
A medical system comprising a left atrial appendage closure device with an expandable framework, a proximal hub, and a sensor, which shifts between configurations, and a core wire for deployment, featuring a threaded connection mechanism for controlled release and a sensor for pressure sensing.
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 due to the need for expandable framework and deployment mechanisms
Solution Approach 1:
The closure device is nested within the delivery catheter during delivery, with the expandable framework collapsed inside the catheter lumen. The distal portion of the catheter contains the closure device in a compact state, and the core wire is nested within the catheter lumen. This nesting allows the complex expandable structure to be delivered through a relatively simple catheter without requiring external manipulation during delivery.
Solution Approach 2:
The closure device transitions from a static collapsed state during delivery to a dynamic expanded state at the target site. The expandable framework can change configuration from a compressed cylindrical form within the catheter to an expanded occlusive structure at the left atrial appendage, allowing the device to adapt its form factor to different functional requirements.
2Reliability
If a sensor is integrated into the closure device for real-time monitoring, then patient safety is enhanced, but the device complexity increases
Solution Approach 1:
The sensor is integrated into the proximal hub of the closure device, merging the monitoring function with the structural component. The proximal hub serves dual purposes: providing structural support for the expandable framework and housing the sensor that monitors pressure or other physiological parameters. This integration eliminates the need for separate sensor housing and reduces overall device complexity.
Solution Approach 2:
The proximal hub is designed as a multi-functional component that provides both mechanical support for the closure device structure and houses the sensor for physiological monitoring. This universal component performs multiple functions (structural support, sensor housing, potential anchoring) rather than requiring separate dedicated components for each function.
3Manufacturing precision
If a threaded connection mechanism is used for controlled release of the closure device, then deployment precision is improved, but the ease of operation decreases
Solution Approach 1:
The threaded connection mechanism replaces simple friction-fit or snap-fit release mechanisms with a more precise mechanical engagement system. The threads provide controlled, incremental disengagement as the core wire is withdrawn, allowing precise control over the release timing and position. This mechanical substitution trades simplicity for precision in the deployment process.
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
Effectively occludes the left atrial appendage, reduces thrombi formation, and provides real-time monitoring, enhancing patient safety by minimizing stroke and heart attack risks.
Implementation Method 1
the sensor is a pressure sensor configured to sense a fluid pressure within a space facing a proximal end of the sensor when the left atrial appendage closure device is in a released configuration
Implementation Method 2
the expandable framework being configured to shift between a collapsed delivery configuration and an expanded deployed configuration
Implementation Method 3
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
Data Source
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.


