Two-Component Mitral Valve Prosthesis for Precise Sealing
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Solution Overview
Problem
Existing heart valve replacement technologies, particularly for mitral valves, face challenges due to unpredictable and non-uniform valve annulus geometries, difficulty in precise placement, potential for fatal complications like mitral regurgitation, and limitations of stent-based prostheses, which are not suitable for percutaneous delivery and often result in paravalvular leaks.
Innovation Solution
A two-component heart valve prosthesis comprising a housing component and a valve component, designed for percutaneous delivery and expansion within the native valve orifice, with flexible elements and anchoring mechanisms to secure the prosthesis to heart structures, allowing for precise placement and minimizing leaks.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If stent-based valve prostheses are used for mitral valve replacement, then the valve can be replaced, but the thin vessel wall cannot withstand significant radial forces and may collapse the aortic outflow tract
Solution Approach 1:
The prosthesis is divided into two separate components: a housing component that provides structural support and anchoring, and a valve component that performs the valve function. This segmentation allows the housing to bear the radial forces while the valve component remains protected, resolving the contradiction between effective valve replacement and protection of the thin vessel wall from harmful radial forces.
Solution Approach 2:
The housing component acts as an intermediary between the valve component and the vessel wall. It provides a protective framework that distributes and reduces the radial forces transmitted to the thin vessel wall, preventing collapse of the aortic outflow tract while still enabling effective valve replacement.
2Adaptability or versatility
If the mitral valve annulus is highly distorted with unpredictable geometry, then anatomical variability exists, but precise placement of pre-constructed prostheses becomes difficult
Solution Approach 1:
The housing component is designed with dynamic characteristics that allow it to adapt to the distorted and unpredictable geometry of the mitral valve annulus. The housing can deform and conform to the irregular annular shape during implantation, enabling precise placement while accommodating anatomical variability.
Solution Approach 2:
The prosthesis design allows for parameter changes in the housing component to match the specific geometric parameters of the patient's mitral valve annulus. This enables the housing to conform to highly distorted geometries with unpredictable shapes, ensuring precise placement despite anatomical variability.
3Reliability
If native valve removal is performed prior to replacement, then the failed valve is eliminated, but profound mitral regurgitation may occur that is not adequately addressed by subsequent replacement
Solution Approach 1:
The housing component is designed to provide immediate structural support and prevent mitral regurgitation from the outset, rather than waiting for potential complications after valve removal. The housing is pre-configured to maintain proper valve function and prevent regurgitation, addressing the issue before it can develop into a harmful complication.
4Reliability
If stent-based aortic valves are used, then valve replacement is achieved, but they are not repositionable and precise placement is difficult
Solution Approach 1:
The housing component is designed with dynamic characteristics that allow for repositioning during the implantation process. The housing can be adjusted and repositioned to achieve precise placement, unlike traditional stent-based valves that are fixed once deployed. This dynamic design enables correction of placement errors and optimization of valve position.
Data Source
AI summary
A heart valve prosthesis for replacing a native atrioventricular valve of the heart. The prosthesis includes a housing component that is configured to be radially expandable and compressible between a radially compressed state and a radially expanded state to engage structure of the native atrioventricular valve to fix the housing component relative to the native atrioventricular valve. The housing component includes a housing body and an annular sealing element connected to an atrial end of the housing body. The annular sealing element is made of polyester and is reinforced with wire. A valve component is configured to be radially expandable and compressible between a radially compressed state and a radially expanded state within the housing component. The valve component includes a valve body having a valve passage extending therethrough and three leaflets made from pericardium secured to the valve body.