D-Shaped Mitral Valve Prosthesis for Paravalvular Leak Reduction
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Solution Overview
Problem
Current transcatheter mitral valve replacement (TMVR) devices do not accommodate the unique anatomy of the mitral valve, leading to higher incidents of paravalvular regurgitation and ventricular outflow tract obstruction due to their circular shape and mal-alignment with the natural D-shaped mitral valve orifice.
Innovation Solution
A D-shaped mitral valve prosthesis with a U-shaped anchor and multiple mounds on its surface, designed to conform to the natural morphology of the mitral valve, is implanted using a system of two guide wires to ensure proper orientation and reduce paravalvular leaks, along with an elliptical ring for anchoring adjacent aortic valve replacements.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If a circular-shaped mitral valve prosthesis is used, then the device structure is simple and easy to manufacture, but it causes mal-alignment with the natural D-shaped mitral valve orifice leading to paravalvular regurgitation
Solution Approach 1:
The patent applies asymmetry by changing the valve prosthesis from a circular shape to a D-shaped configuration that matches the natural anatomy of the mitral valve orifice. The D-shaped stent frame and valve leaflets are specifically designed with a flat side to align with the flat portion of the mitral annulus adjacent to the aortic valve, thereby eliminating mal-alignment and preventing paravalvular regurgitation while maintaining manufacturability
2Device complexity
If a circular-shaped mitral valve prosthesis is used, then the device structure is simple, but it causes ventricular outflow tract obstruction due to protrusion into cardiac tissue
Solution Approach 1:
The D-shaped configuration with a flat side is designed to conform to the flat portion of the mitral annulus, preventing the valve from protruding into the ventricular outflow tract. This asymmetric geometry ensures that the valve sits flush against the native anatomy, eliminating obstruction while maintaining structural simplicity
3Ease of operation
If rotational positioning is required for implantation, then the valve can be oriented, but it requires advanced imaging and manipulation increasing procedural complexity
Solution Approach 1:
The patent incorporates preliminary action by pre-configuring the D-shaped stent frame with asymmetric features including a flat side and curvature that naturally correspond to the mitral annulus anatomy. This pre-shaping allows the valve to self-align during implantation without requiring rotational positioning, advanced imaging, or complex manipulation, thereby simplifying the procedure while ensuring proper orientation
4Device complexity
If a flat surface valve is used, then the valve structure is simple, but it does not conform to the natural contours of the mitral valve orifice causing leakage
Solution Approach 1:
The patent applies local quality by incorporating mounds or surface topography features on specific portions of the valve stent frame, particularly on the curved side of the D-shape. These localized three-dimensional features conform to the natural contours of the mitral valve orifice and surrounding cardiac tissue, creating a secure seal that prevents paravalvular regurgitation while maintaining overall structural simplicity
Data Source
AI summary
Described herein is a mitral valve and systems and methods for implanting the same. The mitral valve device is designed to easily orient to and conform to the mitral orifice natural morphology. This mitral valve system may be implanted using a system of 2 guide wires that facilitate orientation of the flat portion of the stent properly with the flat portion of the mitral valve that is adjacent to the aortic valve. Additionally, the disclosed valve may have multiple mounds distributed across the outer surface of the valve/stent complex so as to prevent or reduce paravalvular leak after implantation.