W-Shaped Prosthetic Valve Leaflets for Better Coaptation
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Solution Overview
Problem
Heart valve malfunction, such as regurgitation, can occur due to improper functioning of heart valves, leading to impaired heart function and blood leakage, which current minimally invasive treatments like TAVR face challenges in effectively addressing.
Innovation Solution
The development of prosthetic valve leaflets with a 'W'-like shape, featuring a central peak and valleys, and specific thickness and curvature profiles, enhancing coaptation and durability, facilitating easier assembly and reducing leakage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional flat valve leaflets are used, then manufacturing is simpler, but coaptation performance is insufficient leading to regurgitation
Solution Approach 1:
The patent applies local quality by creating a W-shaped edge profile with specific geometric features (peaks and valleys) at the free edge of the leaflet. The thickness is varied locally to create a convex portion at the peak and concave portions at the valleys, allowing different regions of the leaflet to perform different functions - the convex portion enhances coaptation while the concave portions maintain flexibility and prevent tissue folding.
Solution Approach 2:
The patent utilizes curvature by forming a W-shaped edge profile with specific radii of curvature at the peaks and valleys. The convex portion at the peak has a specific radius of curvature that creates a rounded transition, while the concave portions at the valleys have radii that prevent sharp angles. This curvature design improves coaptation by allowing smoother tissue interaction and reduces stress concentrations.
2Reliability
If leaflet thickness is increased at the peak, then coaptation is improved, but manufacturing precision requirements increase
Solution Approach 1:
The patent applies parameter changes by systematically varying the thickness parameter across the leaflet edge. The thickness is increased at the peak (convex portion) to enhance coaptation and decreased at the valleys (concave portions) to maintain flexibility. Specific thickness ranges are provided (e.g., 0.3-0.4mm at peak, 0.2-0.3mm at valleys) to control the coaptation performance while managing manufacturing complexity.
3Reliability
If the distance between peak and valleys is reduced, then coaptation surface area is increased, but structural integrity may be compromised
Solution Approach 1:
The patent applies local quality by creating a W-shaped edge profile with specific geometric features (peaks and valleys) at the free edge of the leaflet. The thickness is varied locally to create a convex portion at the peak and concave portions at the valleys, allowing different regions of the leaflet to perform different functions - the convex portion enhances coaptation while the concave portions maintain flexibility and prevent tissue folding.
Data Source
AI summary
Embodiments include a valve leaflet for an implantable valve device comprising a leaflet body. The leaflet body comprising a free edge configured for coaptation with free edges of one or more other valve leaflets; and a root edge disposed opposite the free edge. The free edge defining an edge profile comprising a peak and valleys disposed on opposite sides of the peak. Other embodiments are also included herein.