Prosthetic Valve Leaflet Coaptation Geometry
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Solution Overview
Problem
Prosthetic heart valves face challenges in durability due to high mechanical stresses and the need for substantial elongation of leaflet materials, which can lead to early failure and immunogenic responses in the body.
Innovation Solution
A prosthetic valve design that imposes a geometry allowing coaptation without pulsatile load, using high-strength, low-elongation biocompatible fibers and textile structures, with a convex surface and excess free margin length to reduce stress and tension on commissures, enabling effective closure and reduced regurgitation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If substantial elongation of leaflet material is used to provide coaptation during pulsatile load, then valve closure function is improved, but durability and reliability deteriorate due to high mechanical stresses and early failure
Solution Approach 1:
The leaflet geometry is pre-formed with an imposed configuration that enables coaptation without requiring substantial elongation during pulsatile load. The leaflet is designed with a specific curvature and excess free margin length that allows it to naturally achieve closure position, reducing the mechanical stress and elongation demands on the material during operation.
Solution Approach 2:
The invention changes the geometric parameters of the leaflet by imposing a specific geometry with excess free margin length. This geometric modification allows the leaflet to achieve coaptation with minimal elongation, fundamentally altering how the leaflet achieves closure from the traditional approach that relied on material stretching.
2Strength
If high-strength, low-elongation fibers are used to improve durability, then resistance to mechanical stress is improved, but flexibility and ability to mimic natural valve deteriorates
Solution Approach 1:
The invention uses a thin film or shell structure with imposed geometry that provides the necessary flexibility for valve operation while maintaining high strength through the geometric design rather than material elongation. The leaflet functions as a flexible structure that achieves closure through its pre-formed geometry rather than material stretching.
3Duration of action of stationary object
If leaflet geometry is designed to coapt without pulsatile load, then durability is improved by reducing stretching, but manufacturing precision requirements increase
Solution Approach 1:
The desired coaptation geometry is pre-imposed on the leaflet during manufacturing, ensuring that the leaflet achieves closure without substantial elongation during operation. This preliminary geometric configuration is built into the leaflet structure itself, allowing for controlled manufacturing processes that focus on achieving the specific geometric parameters rather than relying on material properties.
Data Source
Figure 1A~1B
Figure 1C~1D
Figure 1E~1F
AI summary
The invention relates to a prosthetic valve comprising a leaflet assembly having at least one leaflet (3) attached to a supporting element (2), which leaflet has a free margin that can move between a first position wherein the free margin is flexed away from a closure surface (700) to allow body fluid to flow through the valve, and a second position wherein the free margin abuts the closure surface to close the valve, and wherein the leaflet, without pulsatile load on the valve, can form a coaptation height H of more than 0.1 mm along the length of the free margin. Such prosthetic valve provides good performance during prolonged time, and can be made using various materials for the leaflets. The invention also relates to a leaflet assembly for use in a prosthetic valve, and to methods of making the prosthetic valve, including making the leaflet assembly.