Expandable Occlusion Device Sealing Left Atrial Appendage
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Solution Overview
Problem
The left atrial appendage (LAA) in patients with atrial fibrillation experiences stagnant blood pooling, leading to thrombi formation, which can break loose and cause stroke or heart attack, as existing medical devices are inadequate in effectively controlling thrombus formation within the LAA.
Innovation Solution
A medical device with an expandable member, comprising inflation cavities and valve members, is designed to expand and seal the opening of the LAA, using different inflation media to ensure effective occlusion and promote endothelial growth, thereby reducing thrombi formation and risk of embolic events.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If the LAA is left open in patients with atrial fibrillation, then blood flow is maintained, but thrombi formation occurs due to stagnant blood pooling
Solution Approach 1:
The patent extracts the problematic LAA from the circulatory system by deploying an occlusive device that seals the LAA ostium, effectively removing the LAA's connection to blood flow while maintaining overall circulatory continuity. This extraction eliminates the thrombi formation risk in the LAA without disrupting systemic blood flow.
Solution Approach 2:
The occlusive device acts as an intermediary element between the LAA and the circulatory system. It provides a controlled interface that prevents thrombi formation by blocking the LAA ostium while allowing the rest of the circulatory system to function normally, thus mediating between the need to prevent clots and maintain blood flow.
2Object-affected harmful factors
If existing occlusion devices are used to seal the LAA, then thrombi formation is reduced, but the devices are inadequate in effectively controlling thrombus formation
Solution Approach 1:
The patent employs a dynamic occlusion system that can transition between open and closed states. The occlusive device includes mechanisms for deployment and retrieval, allowing it to adapt to different clinical scenarios and ensure effective thrombus control while maintaining flexibility in treatment approach.
Solution Approach 2:
The occlusive device utilizes parameter changes in the inflation medium, specifically employing a two-phase system where the medium transitions from liquid to solid state. This phase change enables the device to achieve reliable occlusion by transforming the physical properties of the filling material to ensure complete sealing of the LAA ostium.
3Object-affected harmful factors
If the LAA is occluded to prevent thrombi, then stroke and heart attack risk is lowered, but the device must ensure complete sealing from the circulatory system
Solution Approach 1:
The occlusive device employs composite construction combining different materials with complementary properties. The device structure integrates materials that provide both structural support for sealing and biocompatibility for long-term implantation, ensuring complete occlusion while minimizing adverse reactions.
Solution Approach 2:
The patent incorporates a cushioning mechanism in the form of a compliant sealing interface that anticipates and compensates for variations in LAA anatomy and movement. This prior cushioning ensures complete sealing by providing a tolerance buffer that maintains contact between the occlusive device and the LAA ostium despite physiological variations.
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 thrombi formation by sealing the LAA, lowering the risk of stroke and heart attack by promoting endothelial growth and ensuring the LAA is removed from the circulatory system.
Implementation Method 1
Over time, the exposed surface(s) spanning the ostium of the left atrial appendage becomes covered with tissue (a process called endothelization), effectively removing the left atrial appendage from the circulatory system
Data Source
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AI summary
An example medical device (400) for occluding the left atrial appendage is disclosed. The example medical device for occluding the left atrial appendage includes an expandable member (402) having a first end region and a second end region. The expandable member comprises at least one inflation cavity (408, 434) and at least one valve member (422, 432) configured to selectively seal the inflation cavity. A first inflation media may be disposed within the at least one inflation cavity and a second inflation media may be disposed within the at least one inflation cavity. The second inflation media may be different from the first inflation media. The expandable member may be configured to expand and seal the opening of the left atrial appendage.