Paravalvular Leak Occlusive Device with Compliant Waist
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Solution Overview
Problem
Existing methods for addressing paravalvular leaks, such as surgical reattachment and embolic material use, are inadequate due to variability in gap shape and size, leading to complications like blood regurgitation and clotting.
Innovation Solution
A paravalvular leak occlusive device with adjustable metallic wire or fabric mesh, featuring proximal and distal flanges and a compliant waist region, is deployed via a catheter to seal the gap between the heart valve and vessel, utilizing adjustment mechanisms like springs or hydrogel expansion to conform to the geometry.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If embolic material is used to fill the gap, then the leakage can be addressed, but the material may migrate and create clot complications elsewhere in the vasculature
Solution Approach 1:
The device is designed with differentiated regions: flanged ends for anchoring and a compliant waist region for conforming to the gap geometry. This local differentiation allows the device to provide secure occlusion at the leakage site without migrating to other vasculature locations, thereby preventing clot complications while maintaining reliable leak sealing.
Solution Approach 2:
The device incorporates an adjustment mechanism with a compliant waist region that can dynamically adapt to varying gap sizes and shapes. This dynamic capability allows the device to conform precisely to the target leakage area while maintaining stability in place, preventing migration and associated clot complications.
2Reliability
If larger embolic materials are used to fill the gap, then the leakage can be addressed, but they are difficult to conform to the shape of the leakage region
Solution Approach 1:
The device features a compliant waist region with different mechanical properties compared to the flanged ends. The waist region is designed to be highly compliant and adaptable to various gap geometries, while the flanged ends provide structural stability for anchoring. This local quality differentiation enables the device to simultaneously achieve reliable occlusion and conform to irregular gap shapes.
Solution Approach 2:
The adjustment mechanism allows the device to dynamically change its configuration to match the specific geometry of the leakage region. The compliant waist region can flex and adapt to various shapes and sizes of gaps, ensuring proper conformance while maintaining secure anchoring through the flanged ends.
3Adaptability or versatility
If the device structure is made complex to adjust to gap geometry, then adaptability improves, but device complexity increases
Solution Approach 1:
The device utilizes a compliant waist region that functions as a flexible element to adapt to gap geometry. This flexible region can be implemented as a thin-film or mesh structure that naturally conforms to the target area without requiring complex active adjustment mechanisms, thereby achieving adaptability while minimizing overall device complexity.
Solution Approach 2:
The adjustment mechanism is designed to be minimally complex, utilizing elastic deformation and passive spring-like elements that automatically adapt to gap geometry without requiring active control systems. This dynamic adaptation through simple mechanical means achieves versatility while keeping the device structure relatively simple.
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 occludes the gap, restoring normal blood flow and preventing complications by ensuring a secure seal, adaptable to varying gap sizes and shapes.
Implementation Method 1
a heart valve is described which utilizes an expansile material, such as hydrogel and/or foam, which expands at the treatment site in order to seal the heart valve against the blood vessel
Implementation Method 2
The adjustment mechanism can comprise, for example, a spring, tether, wire, and/or shaped braid
Data Source
AI summary
Heart valve replacement often involves complications associated with paravalvular leaks. Vascular plug and occlusive devices, as well as heart valves particularly beneficial in treating the phenomenon of paravalvular leaks are described to address this issue.