Prosthetic Valve Slanted Leaflet Design for Thrombosis Reduction
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Solution Overview
Problem
Current medical devices for treating venous insufficiency face issues with post-implantation thrombosis and platelet deposition, leading to occlusion and reduced functionality of prosthetic valves due to stagnation and thickening of valve leaflets, which compromises the unidirectional flow mechanism.
Innovation Solution
A prosthetic valve design featuring a combination of semi-rigid and flexible leaflets, where the flexible leaflet moves between open and closed positions to regulate fluid flow, with a configuration that minimizes stagnation and thrombus formation, including curved or tapered leaflets and controlled retrograde flow passages to prevent occlusion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a prosthetic valve is implanted to treat venous insufficiency, then valve functionality is improved, but post-implantation thrombosis and platelet deposition occur leading to occlusion
Solution Approach 1:
The patent applies curvature to the leaflet edges, specifically rounded or curved free edges on both the rigid and flexible leaflets. This curvature design eliminates sharp corners where blood flow separation and stagnation would occur, thereby reducing platelet deposition and thrombus formation while maintaining effective valve closure functionality
Solution Approach 2:
The patent incorporates a flexible leaflet that dynamically adapts its position based on flow conditions. The flexible leaflet moves with the flow during forward flow and closes during retrograde flow, creating dynamic flow patterns that prevent stagnation and reduce thrombosis risk while maintaining valve functionality
2Reliability
If blood stagnation occurs around implanted prosthetic valves, then thrombosis and platelet deposition increase, but valve leaflet functionality is reduced due to stiffening and thickening
Solution Approach 1:
The curved free edges of the leaflets promote smooth blood flow separation and reduce areas of stagnation. This curvature design prevents blood pooling that would otherwise lead to platelet deposition and thrombus formation on the leaflet surfaces, thereby maintaining leaflet flexibility and functionality over time
Solution Approach 2:
The patent design preliminarily addresses the thrombosis risk by incorporating anti-thrombogenic features into the leaflet geometry before implantation. The curved edges and flow-directed design pre-establish flow patterns that minimize stagnation, preventing thrombus formation before it can compromise leaflet functionality
3Reliability
If the flexible leaflet moves between open and closed positions to regulate flow, then unidirectional flow control is improved, but retrograde flow may cause thrombus formation
Solution Approach 1:
The flexible leaflet dynamically responds to flow direction by moving into a closed position during retrograde flow. This dynamic action, combined with the curved edge geometry, directs retrograde flow smoothly along the leaflet surface rather than creating stagnation zones, thereby preventing thrombus formation while maintaining unidirectional flow control
Solution Approach 2:
The patent applies different properties to different parts of the valve structure. The curved free edges are specifically designed to handle retrograde flow, while the main body of the leaflets maintains their closure function. This localized quality differentiation allows the valve to control unidirectional flow while specifically addressing retrograde flow-induced thrombosis risk
Data Source
AI summary
The invention relates to a prosthetic valve for regulating fluid flow through a body lumen. The valve includes a frame and a valve member comprising at least one semi-rigid leaflet and at least one flexible leaflet. The at least one semi-rigid leaflet comprises a first portion and a second portion, the first portion attached to the frame and the second portion free of the frame. The at least one semi-rigid leaflet is slanted in a retrograde direction from the second portion to the first portion. The at least one flexible leaflet comprises a first portion and a second portion, the first portion attached to the frame and the second portion free of the frame. The at least one flexible leaflet is slanted in a retrograde direction from the first portion to the second portion when at rest.