Elliptical Aortic Valve Devices for Leaflet Alignment
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Solution Overview
Problem
Current devices and methods for aortic valve repair or replacement, particularly those with circular or supra- or infra-annular rings, are not effective for long-term improvement and often require complex surgical procedures, failing to adequately address the geometric complexities of the aortic valve.
Innovation Solution
The development of elliptical-shaped aortic valve devices and implants with commissure-support regions that flare outward from a vertical plane, featuring an elliptical cross-sectional geometry to correctly orient and align valve leaflets, which can be constructed from various materials including biopolymers and metals, and designed for surgical implantation or percutaneous delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If circular or supra- or infra-annular rings are used for aortic valve repair, then the surgical procedure can be performed, but the geometric complexities of the aortic valve are not adequately addressed, leading to poor long-term effectiveness
Solution Approach 1:
The patent applies asymmetry by transitioning from circular to elliptical ring geometry to match the natural elliptical shape of the aortic valve annulus. This asymmetric design better conforms to the anatomical structure, improving long-term effectiveness by adequately addressing the geometric complexities of the aortic valve while maintaining reasonable device complexity.
Solution Approach 2:
The patent implements local quality by creating commissure-support regions with outward flaring from a vertical plane in specific locations around the elliptical ring. These localized structural variations provide enhanced support at critical commissure areas while maintaining the overall elliptical geometry, thus improving reliability without uniformly increasing device complexity throughout the entire structure.
2Reliability
If commissural annuloplasty is performed to decrease annular circumference, then mild-to-moderate secondary aortic insufficiency can be treated, but the entire annulus is not fixed, allowing potential for further dilatation and recurrent aortic insufficiency
Solution Approach 1:
The patent applies universality by designing an elliptical ring structure that provides comprehensive fixation of the entire aortic annulus rather than localized commissural support only. This multi-functional device simultaneously decreases annular circumference, fixes the entire annulus to prevent further dilatation, and addresses geometric complexities, thereby improving reliability for preventing recurrent aortic insufficiency without proportionally increasing device complexity.
3Reliability
If elliptical-shaped devices with commissure-support regions are used, then coaptation angles and long-term functionality are improved, but the device structure becomes more complex compared to circular rings
Solution Approach 1:
The patent applies asymmetry by using an elliptical ring geometry with commissure-support regions that flare outward at specific locations, which improves coaptation angle alignment by matching the natural elliptical anatomy of the aortic valve. This asymmetric design enhances reliability for leaflet alignment while keeping structural complexity manageable through purposeful rather than arbitrary complexity.
Data Source
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AI summary
The present disclosure provides aortic valve prosthetic devices (10) that are constructed in an elliptical shape, or are expandable to an elliptical shape for improved results in the repair of defective aortic valves. The devices can be surgically implanted, or they can be implanted percutaneously through an insertion catheter. The expandable devices can be self - expanding or expanded by an inflatable balloon to an elliptical cross section geometry.