Prosthetic Heart Valve Leaflet Attachment Geometry
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Solution Overview
Problem
Synthetic leaflet prosthetic heart valves suffer from premature failure due to suboptimal design and lack of durable synthetic materials, leading to mechanical failure under repetitive loads, calcification, and cusp tears, which limits their effectiveness as a valid heart valve replacement option.
Innovation Solution
A prosthetic heart valve design featuring a leaflet frame with a tubular shape and attached film, where the leaflet attachment zones are shaped as isosceles trapezoids or triangles, minimizing stress and preventing peeling or delamination, and a telescoping structure with a contiguous film to prevent leakage and enhance durability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of stationary object
If synthetic materials are used for leaflet fabrication, then durability is improved, but mechanical failure under repetitive loads occurs due to suboptimal design
Solution Approach 1:
The patent changes the geometric parameters of the leaflet attachment zone from conventional designs to an isosceles trapezoid shape with specific angle ranges (30-60 degrees for the base angles). This parameter optimization redistributes stress patterns during leaflet cycling, preventing fatigue failure while maintaining durability of the synthetic material.
Solution Approach 2:
The attachment zone employs an isosceles trapezoid geometry rather than a symmetric shape, creating asymmetric stress distribution that favors load dispersion across the mounting edge. The diverging sides at specific angles prevent stress concentration at the leaflet frame interface, resolving the mechanical failure issue while preserving synthetic material durability.
2Stress or pressure
If the leaflet base is made flat, then stress distribution is improved, but bending stress concentration occurs at the mounting edge
Solution Approach 1:
The patent introduces curvature through the isosceles trapezoid geometry with diverging sides, replacing a flat base design. The curved/angled transitions at the mounting edge eliminate sharp corners and stress concentration points, distributing bending stresses more evenly across the leaflet frame interface while maintaining overall stress distribution improvements.
3Productivity
If small radius bends are present in the leaflet, then hemodynamic performance is improved, but high stress zones cause holes and tears under repetitive loading
Solution Approach 1:
The patent optimizes the radius parameter of leaflet bends by specifying minimum radius thresholds in the geometric design. The isosceles trapezoid attachment zone geometry inherently creates larger bend radii at critical stress areas compared to sharp-angled designs, reducing stress concentration while preserving hemodynamic performance through controlled curvature.
4Ease of manufacture
If the leaflet attachment zone uses conventional shapes, then ease of manufacture is improved, but delamination and peeling occur under repetitive loading
Solution Approach 1:
The patent specifies precise geometric parameters for the attachment zone including isosceles trapezoid shape with defined angle ranges (30-60 degrees) and aspect ratios. These parameter optimizations create favorable stress distributions that prevent delamination while maintaining manufacturability through standard fabrication processes capable of achieving the required geometric tolerances.
Data Source
AI summary
Described embodiments are directed toward prosthetic heart valve leaflets of particular shapes that control bending character. In accordance with an embodiment, a prosthetic heart valve comprises a leaflet frame having a generally tubular shape with attached film. The leaflet frame defines a plurality of leaflet windows. The film defines at least one leaflet extending from each of the leaflet windows. Each leaflet attachment zone on the leaflet frame has substantially the shape of an isosceles trapezoid having two leaflet sides, a leaflet base and a leaflet free edge opposite the leaflet base. The two leaflet sides diverge from the leaflet base, wherein the leaflet base is substantially flat.