Mitral Valve Anchoring Structure for Recapturable Prosthetic Fit
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Solution Overview
Problem
Existing prosthetic heart valve devices are unsuitable for percutaneous replacement of mitral valves due to the mitral valve's non-circular, D-shaped, and non-symmetric anatomy, which leads to improper fitting, potential gaps for backflow, and distortion of the prosthetic leaflets, and lack of sufficient radial support, making current aortic valve replacements inadequate.
Innovation Solution
A prosthetic heart valve device with a recapturable design that can be partially deployed and repositioned, featuring a flexible anchoring member that conforms to the mitral valve's complex anatomy, includes a fixation structure with flexible arms and sealing members to secure the device while allowing recapture, and is delivered via minimally invasive methods.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a circular expandable frame is used for mitral valve replacement, then the valve structure is simple and symmetric, but it does not conform to the non-circular, kidney-like mitral valve anatomy, leading to poor fit and increased backflow
Solution Approach 1:
The patent applies asymmetry by designing the expandable frame with a non-circular, kidney-like shape that matches the native mitral valve anatomy. The frame includes a first portion with a first curvature and a second portion with a second curvature, creating an asymmetric structure that conforms to the irregular mitral valve geometry, thereby improving fit and reducing backflow compared to symmetric circular designs
Solution Approach 2:
The patent implements dynamics through self-expanding arms that can adapt their configuration upon deployment. The arms are designed to automatically expand to engage with the mitral valve annulus, allowing the device to dynamically adjust to the native anatomy without requiring complex manual adjustment mechanisms
2Object-affected harmful factors
If a percutaneous approach is used for mitral valve replacement, then the procedure is less invasive with lower morbidity, but the device must withstand dynamic heart conditions and complex anatomy, increasing the risk of malfunction
Solution Approach 1:
The patent employs flexible materials in the frame construction, allowing the expandable arms to bend and conform to the native mitral valve anatomy during deployment. This flexibility enables the device to adapt to dynamic heart movements and complex anatomy while maintaining structural integrity, reducing the risk of malfunction under dynamic conditions
Solution Approach 2:
The patent incorporates a sealing member that engages with the mitral valve leaflets before full deployment to provide initial sealing and stabilization. This preliminary engagement cushions against potential malfunctions by ensuring proper positioning and sealing before the full expandable frame is deployed, thereby improving reliability during the complex percutaneous procedure
3Ease of manufacture
If existing prosthetic valves are used for mitral replacement, then the devices are designed for aortic valve anatomy, but they cause poor fit and backflow in mitral valves, requiring invasive procedures
Solution Approach 1:
The patent applies local quality by designing different portions of the frame with different curvatures and engagement characteristics. The first portion has a first curvature optimized for engagement with the mitral valve annulus, while the second portion has a second curvature for different anatomical features. This localized optimization ensures precise fit at each critical location, improving overall manufacturing precision for the mitral valve application
Data Source
AI summary
A prosthetic heart valve device includes a valve support, a prosthetic valve assembly disposed within the valve support, and an anchoring member. The anchoring member includes a base attached to a first region of the valve support, a plurality of arm units projecting laterally outward from the base and inclined in a direction away from the first region in a deployed state, and a fixation structure extending from the arm units. Each arm unit includes a first portion coupled to the base and a second portion coupled to the fixation structure. The fixation structure includes a plurality of struts that define an annular engagement surface configured to press outwardly against a native annulus of a native heart valve. The first portion of each arm unit has a first flexibility greater that a second flexibility of the second portion of each arm unit.