Left Atrial Appendage Closure With Self-Expanding Anchored Sealing
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Solution Overview
Problem
Existing left atrial appendage closure devices face challenges such as improper sizing and anchoring, migration out of position, and difficulty in delivering devices, which can lead to cardiac tamponade and incomplete sealing, and they often require invasive procedures and long hospital stays.
Innovation Solution
Development of a left atrial appendage closure device with a self-expanding fabric-covered frame and anchoring elements that securely attach to the tissue, allowing for accurate deployment and sealing of the ostium to prevent thrombus embolization, using materials like Nitinol and ePTFE, and a delivery system that ensures precise positioning.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If existing left atrial appendage closure devices are used, then the procedure can be performed with standard devices, but the devices often result in improper sizing and anchoring, migration out of position, and incomplete sealing of the ostium
Solution Approach 1:
The device is divided into distinct functional segments: a delivery catheter for minimally invasive access, an expandable frame with anchoring elements for secure positioning, and a sealing element for ostium closure. This segmentation allows each component to be optimized independently for its specific function while simplifying the overall delivery and deployment process.
Solution Approach 2:
The anchoring elements are pre-configured on the expandable frame before delivery, allowing them to be deployed simultaneously with the sealing element. This preliminary arrangement ensures proper positioning and anchoring are achieved during a single deployment action, preventing migration and ensuring complete sealing without requiring additional adjustment procedures.
2Reliability
If existing closure devices are deployed, then occlusion of the left atrial appendage can be achieved, but the devices require invasive procedures and anticoagulant therapy to prevent clotting
Solution Approach 1:
The sealing element is constructed as a flexible disc or membrane that conformally seals against the ostium of the left atrial appendage. This flexible film structure creates an effective barrier to thrombus embolization while its smooth surface promotes endothelialization, reducing the need for long-term anticoagulant therapy.
Solution Approach 2:
The device combines multiple materials with complementary properties: the expandable frame uses shape memory alloy or superelastic material for self-expansion and radial force, the anchoring elements use barbed or hooked structures for tissue engagement, and the sealing element uses biocompatible polymer or fabric for ostium closure. This composite construction achieves reliable occlusion while minimizing complications.
3Measurement precision
If self-expanding sealing elements and anchoring elements are used, then accurate positioning and secure sealing can be achieved, but the device complexity increases
Solution Approach 1:
The expandable frame transitions from a compressed delivery state to an expanded deployed state, dynamically adapting to the anatomy of the left atrial appendage ostium. This dynamic expansion allows the device to self-position accurately against the ostium while the anchoring elements simultaneously engage the tissue, achieving secure sealing without complex adjustment mechanisms.
Solution Approach 2:
The anchoring elements are designed to self-deploy and self-anchor upon expansion of the frame. The barbed or hooked structures automatically engage the tissue as the frame expands, eliminating the need for separate anchoring actions or complex control mechanisms. This self-service approach maintains positioning accuracy while simplifying the overall device structure.
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 seals the left atrial appendage, preventing thrombus embolization and reducing the risk of stroke, while minimizing invasiveness and improving patient compliance by avoiding the need for long-term anticoagulants and reducing procedural complications.
Implementation Method 1
self-expanding sealing elements and anchoring elements, such as Nitinol frames
Implementation Method 2
anchoring elements, such as Nitinol frames and flexible barbs
Data Source
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AI summary
A device for sealing a left atrial appendage includes an anchor element, a sealing element, and a coupling element. The anchor element is configured to anchor the device to tissue in or adjacent the left atrial appendage. The sealing element is configured to seal the left atrial appendage and prevent thrombus from embolizing therefrom. The coupling element joins the anchor element with the sealing element. A delivery catheter may be used to deliver the sealing device.