D-Shaped Prosthetic Heart Valve Mitral Annulus Sealing
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Solution Overview
Problem
Current prosthetic mitral valves face challenges such as paravalvular leakage due to gaps between the prosthesis and native tissues, especially at the mitral position, where higher transvalvular pressure differences exacerbate issues, and existing transcatheter valve replacements are not well-suited for the unique geometry and loading conditions of the mitral valve.
Innovation Solution
A self-expanding prosthetic heart valve with a D-shaped cross-section support framework and a saddle-shaped frame structure, featuring petal-shaped and crown-structures that clamp securely at the mitral annulus, along with a cuff and skirt for enhanced sealing, designed to minimize leakage and conform to the native valve anatomy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If transcatheter valves are expanded into the diseased valve leaflets, then less invasive therapeutic approaches are achieved, but gaps between the prosthesis and surrounding native tissues occur leading to paravalvular leakage
Solution Approach 1:
The patent employs a flexible sealing skirt or cuff that extends radially outward from the support framework to contact and seal against the native mitral annulus and surrounding tissues. This flexible membrane structure adapts to the anatomical geometry while maintaining continuous contact to prevent paravalvular leakage, resolving the contradiction between minimally invasive expansion and sealing reliability.
2Reliability
If standard prosthetic valves are sutured onto the aortic annulus, then secure anchoring is achieved, but open heart surgery and dissection of native leaflets are required
Solution Approach 1:
The support framework is designed to be self-expanding and self-anchoring within the mitral annulus without requiring external suturing or surgical dissection. The radial expansion force and anatomical interlocking mechanism enable the prosthesis to secure itself autonomously, eliminating the need for open heart surgery while maintaining reliable anchoring.
3Reliability
If the prosthetic valve is expanded into the mitral position, then valve replacement is achieved, but higher transvalvular pressure difference exacerbates paravalvular leakage
Solution Approach 1:
The flexible sealing skirt is designed to dynamically adapt to pressure changes across the mitral valve. The membrane material and structural configuration allow it to maintain continuous contact with the native annulus under varying pressure conditions, preventing leakage even when high transvalvular pressure differences occur during cardiac function.
4Ease of manufacture
If a circular cross-section framework is used, then manufacturing simplicity is maintained, but conformance to native mitral valve geometry is poor
Solution Approach 1:
The support framework employs an asymmetric cross-sectional geometry (such as D-shaped or kidney-shaped) that mirrors the natural geometry of the mitral annulus. This asymmetric configuration provides superior anatomical conformance and sealing contact area while remaining manufacturable through conventional forming processes, resolving the contradiction between manufacturing simplicity and geometric conformance.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The solution effectively reduces paravalvular leakage and improves fit by securely anchoring the valve at the mitral annulus, maintaining unidirectional blood flow while minimizing pressure on adjacent structures, thus addressing the specific anatomical and loading challenges of the mitral valve position.
Implementation Method 1
a support framework (10) which is reversibly transformable between a collapsed configuration and an expanded configuration
Implementation Method 2
The support structure can be collapsed by pulling on the apexes of the framework
Data Source
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AI summary
A prosthetic heart valve (1) for implantation at the mitral annulus of a heart, the prosthetic heart valve comprising: a support framework (10) reversibly transformable between a collapsed configuration and an expanded configuration; and one or more leaflets connected to the framework; wherein, in the expanded configuration: the support framework defines a fluid pathway through the prosthetic heart valve, the fluid pathway having a portion with a D-shaped cross section for engaging the mitral annulus; and the one or more leaflets allow fluid to pass through the fluid pathway in a first direction but prevent fluid from flowing in the opposite direction.