Multi-Chamber LAA Occluder for Complex Ostium Sealing
Solution Overview
Problem
The left atrial appendage in patients with atrial fibrillation experiences stagnant blood pooling, leading to thrombus formation and potential thromboembolic events due to irregular contractions, which existing medical devices have not adequately addressed.
Innovation Solution
A medical device with an expandable member comprising multiple inflation chambers and valves, designed to expand and seal the left atrial appendage ostium, promoting endothelialization and preventing thrombus formation by closing off the appendage from the circulatory system.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a single-chamber expandable device is used to occlude the left atrial appendage, then the device structure is simple, but it cannot adequately fill complex or bifurcated appendage geometries
Solution Approach 1:
The expandable device is divided into multiple independent inflation chambers (first inflation chamber and second inflation chamber) that can be inflated separately or simultaneously. This segmentation allows different regions of the device to adapt to different geometries of the left atrial appendage, including complex or bifurcated structures, while maintaining overall device functionality.
2Adaptability or versatility
If multiple inflation chambers are used to improve sealing in complex geometries, then adaptability increases, but the risk of incomplete inflation or thrombus formation in under-inflated regions increases
Solution Approach 1:
The multiple inflation chambers are fluidly connected through a common inflation catheter system that allows inflation medium to flow between chambers. This merging of the inflation system ensures that when one chamber is inflated, the pressure can equilibrate to other chambers, reducing the risk of incomplete inflation and ensuring reliable occlusion of the entire left atrial appendage.
Solution Approach 2:
The device incorporates pressure equalization mechanisms that provide feedback between inflation chambers. As one chamber inflates, the pressure changes are transmitted to other chambers through the fluid connection, automatically adjusting inflation levels to ensure complete and uniform occlusion without requiring complex external monitoring.
3Manufacturing precision
If separate inflation systems are used for each chamber to ensure independent control, then inflation precision is improved, but device complexity and procedural time increase
Solution Approach 1:
The inflation system is designed with a universal catheter that can inflate multiple chambers through a single access point. The catheter structure includes multiple ports or channels that can deliver inflation medium to different chambers sequentially or simultaneously, providing precise control over each chamber's inflation while maintaining a relatively simple single-catheter configuration.
4Reliability
If the device is designed to fully expand to seal the ostium, then occlusion effectiveness is improved, but the risk of device embolization or malpositioning increases
Solution Approach 1:
The device is deployed in a compressed state within the delivery catheter, allowing precise navigation to the target site before expansion. The compression members and delivery system are designed to maintain the device in a stable, compact configuration during insertion and positioning, reducing the risk of premature expansion or malpositioning before the device is ready for occlusion.
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
The device effectively reduces thrombus formation and thromboembolic risk by sealing the left atrial appendage, facilitating endothelial growth and ensuring blood flow stability.
Implementation Method 1
the expandable member is designed to shift between a first unexpanded configuration and a second expanded configuration
Implementation Method 2
a first one-way valve configured to permit an inflation material to flow between the first chamber and the second chamber, wherein the first one-way valve is configured to open when the first chamber is inflated to a first threshold inflation pressure
Data Source
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AI summary
An example medical device for occluding the left atrial appendage is disclosed. The example medical device includes an expandable member including a first balloon defining a first inflation chamber and a second balloon defining a second inflation chamber. Further, the second inflation chamber is positioned adjacent to the first inflation chamber, the first inflation chamber is in fluid communication with the second inflation chamber and the expandable member is designed to shift between a first configuration and a second expanded configuration. Additionally, the first balloon is designed to fill a first region of the left atrial appendage and the second balloon is designed to fill a second region of the left atrial appendage. The medical device also includes a first inflation valve member extending at least partially into the first inflation chamber and the expandable member is configured to expand and seal the opening of the left atrial appendage.