Mitral Valve Prosthesis Structure for Small Elliptical Annuli
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Solution Overview
Problem
Existing prosthetic heart valve prostheses are unsuitable for patients with smaller native mitral valves due to their oversized design, particularly for those with elliptically-shaped annuli, leading to implantation challenges and potential oversizing issues.
Innovation Solution
A heart valve prosthesis with a valve support having varying diameters and an anchor element that mechanically isolates the upstream segment from the anchor, allowing it to adapt to smaller, elliptically-shaped native mitral valves, featuring a deformable tissue fixation ring and inwardly angled connectors for secure implantation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If known mitral valve prostheses are designed for larger native mitral valves (annulus perimeter 101-119 mm), then they provide adequate coverage and structural stability for the general adult population, but they become oversized and unsuitable for patients with smaller native mitral valves (annulus perimeter 89-101 mm), particularly those with elliptically-shaped annuli
Solution Approach 1:
The valve support is divided into multiple segments or struts that can be independently positioned and configured. This segmentation allows the prosthesis to adapt to different annulus sizes and shapes, particularly accommodating smaller and elliptically-shaped annuli by adjusting the spatial arrangement of individual segments rather than relying on a fixed circular geometry
Solution Approach 2:
The prosthesis incorporates asymmetric design elements including elliptical-shaped valve support structures and non-uniform strut configurations that match the natural elliptical geometry of smaller mitral annuli. This asymmetric design replaces the traditional symmetric circular configuration to better fit the anatomical variations of smaller native valves
2Ease of manufacture
If the valve support has a constant diameter design, then manufacturing is simplified and structural uniformity is maintained, but the prosthesis cannot adapt to the varying dimensions of smaller and elliptically-shaped native mitral valves
Solution Approach 1:
Different portions of the valve support structure have different geometric properties - the upstream segment has a first diameter while the downstream segment has a second diameter that is larger than the first. This local variation in dimensions allows the prosthesis to conform to the natural gradient of mitral valve anatomy, fitting smaller and elliptical annuli better while maintaining manufacturability through modular construction
3Stability of the object's composition
If the anchor element is directly connected to the upstream segment of the valve support, then structural continuity is maintained, but the anchor element cannot independently adapt to the native annulus shape without affecting the valve support positioning
Solution Approach 1:
The connection between the anchor element and the upstream segment of the valve support is removed or extracted. This decoupling allows the anchor element to independently engage the native annulus tissue and adapt to its shape without transmitting mechanical constraints to the valve support, while the valve support maintains its own positioning independent of the anchor element's deformation
Data Source
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AI summary
The devices and methods of this disclosure relate to a heart valve prosthesis that is configured to be implanted within a native heart valve having a smaller perimeter annuli with a generally elliptical shape.