Mitral Valve Replacement Assembly With Leaflet Anchoring and Sealing
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Solution Overview
Problem
Existing prosthetic valves for the mitral valve face challenges due to the distinct anatomy and complex subvalvular apparatus of the mitral valve, requiring difficult and accurate placement, which can lead to unsuccessful or undesirable implantation, especially in elderly and frail patients.
Innovation Solution
Prosthetic heart valves with a radially expandable and compressible support structure and projections that engage the native heart valve leaflets for secure placement, featuring a frame with projections to penetrate and anchor the valve, and a sealing member to reduce paravalvular leakage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If transvascular techniques are used for mitral valve replacement, then invasiveness is reduced and patient eligibility increases, but placement accuracy and reliability become more challenging
Solution Approach 1:
The delivery system is pre-configured with the prosthetic valve in a compressed state within a delivery catheter, allowing precise navigation to the implantation site through the vasculature before deployment. The delivery system includes positioning features and guidance mechanisms that ensure accurate placement at the mitral valve annulus prior to valve expansion
Solution Approach 2:
A delivery catheter and positioning system serve as intermediaries between the operator and the prosthetic valve, enabling precise control and accurate placement of the valve at the mitral annulus. The delivery system includes guide catheters, positioning wires, and deployment mechanisms that mediate the implantation process to ensure reliable positioning
2Reliability
If the prosthetic valve is designed to engage native leaflets for secure placement, then anchoring reliability improves, but device complexity increases
Solution Approach 1:
The prosthetic valve assembly is divided into distinct functional components: a frame structure with engagement projections, a valve component, and a delivery system. The engagement projections are separate elements on the frame that specifically interact with native leaflets, allowing the anchoring function to be isolated and optimized without complicating the entire device
Solution Approach 2:
Instead of trying to anchor the valve to the annulus directly, the design inverts the approach by having the valve frame engage the native leaflets themselves. The projections on the frame capture and hold the leaflet tissue, creating a secure anchor point that leverages the natural valve structure rather than opposing it
3Object-generated harmful factors
If a sealing member is added to reduce paravalvular leakage, then sealing performance improves, but device complexity and manufacturing difficulty increase
Solution Approach 1:
The sealing function is merged with the existing frame structure by integrating a sealing member that extends from the frame into the valve annulus. The sealing member is combined with the frame and leaflet engagement mechanism, creating a unified structure that provides both anchoring and sealing functions without requiring separate independent components
Solution Approach 2:
The sealing member serves multiple functions: it provides a seal against the valve annulus to prevent paravalvular leakage, structures the valve opening, and works in conjunction with the engagement projections to secure the valve in place. This multi-functional design reduces the need for additional separate components
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 provides secure and minimally invasive implantation, reducing migration and leakage, and effectively restores native heart valve functionality.
Implementation Method 1
a radially expandable and compressible support structure, the support structure comprising an annular frame
Implementation Method 2
projections that engage the native heart valve leaflets for secure placement, featuring a frame with projections to penetrate and anchor the valve
Implementation Method 3
a sealing member to reduce paravalvular leakage
Data Source
Figure 1~2
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Figure 5~6
AI summary
In one representative embodiment, a prosthetic valve assembly for replacing a native heart valve comprises a radially expandable and compressible support structure, the support structure comprising an annular frame having a lumen extending from an inflow end to an outflow end, the support structure further comprising an annular sealing member extending radially inwardly into the lumen of the frame and having an inner peripheral portion defining an orifice, and a radially expandable and compressible valve component, the valve component comprising an annular frame and a valve structure supported inside of the frame for permitting the flow blood through the valve component in one direction and blocking the flow of blood in the opposite direction, wherein the valve component is configured to expand within the orifice of the sealing member and engage the inner peripheral portion of the sealing member when radially expanded.