Asymmetric Mitral Valve Frame with Collapsible Extension
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Solution Overview
Problem
Current prosthetic heart valve devices face challenges in percutaneously replacing native mitral valves due to the mitral valve's non-circular, complex, and variable anatomy, leading to issues like backflow, distortion, and inadequate radial support, which are not addressed by existing aortic valve replacement technologies.
Innovation Solution
The development of prosthetic heart valve devices with anchoring members and extension members that can navigate through the heart's anatomy to the mitral valve annulus, utilizing a catheter-delivered approach with adjustable fixation structures and flexible sealing members to ensure proper fit and function, and incorporating a collapsible extension member for improved maneuverability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If aortic valve replacement technology is applied to mitral valve replacement, then the procedure can be performed percutaneously with less invasiveness, but the device cannot properly accommodate the non-circular, complex mitral valve anatomy leading to backflow and distortion
Solution Approach 1:
The patent applies asymmetry by transitioning from the symmetric, circular frame design used in aortic valve replacement to an asymmetric, non-circular frame configuration that matches the D-shaped or kidney-shaped mitral valve annulus. This asymmetric frame geometry allows proper adaptation to the complex mitral valve anatomy while maintaining percutaneous access benefits, preventing both backflow and distortion that occur with circular designs.
Solution Approach 2:
The patent implements local quality by providing different frame characteristics at different locations around the mitral valve annulus. The frame includes varying curvature, diameter, and structural properties at different segments to match the locally varying anatomy of the mitral valve, rather than using a uniform circular design. This allows each portion of the frame to optimize sealing and support at its specific location.
2Stability of the object's composition
If a circular symmetric expandable frame is used, then tri-leaflet prosthetic valves can coapt properly, but the device cannot fit the non-uniform, non-symmetric mitral valve anatomy
Solution Approach 1:
The patent resolves this contradiction by designing an asymmetric frame that abandons the circular symmetry required for tri-leaflet coaptation in aortic valves. Instead, the frame is shaped to match the non-circular mitral valve annulus, and the prosthetic valve is configured with相应的 leaflet arrangements that achieve coaptation in the asymmetric mitral geometry rather than relying on circular symmetry.
Solution Approach 2:
The patent applies dynamics by designing a flexible, expandable frame that can transition from a compressed delivery state to an expanded deployed state. The frame includes elements that can flex and adapt their shape during deployment to conform to the varying anatomy of the mitral valve, allowing the valve to achieve proper fit and leaflet coaptation through dynamic shape adjustment rather than static geometric matching.
3Reliability
If rigid fixation structures are used to stabilize the prosthetic valve, then proper positioning can be achieved, but the device cannot navigate through tortuous vasculature to reach the mitral valve
Solution Approach 1:
The patent resolves this contradiction by designing a dynamic, phase-changeable frame structure. During delivery, the frame is in a compressed, flexible state that allows it to navigate tortuous vasculature and reach the mitral valve through catheter delivery. Upon deployment, the frame transitions to an expanded, rigid state that provides stable positioning and proper valve support, thus achieving both maneuverability during delivery and stability during operation.
Solution Approach 2:
The patent applies segmentation by dividing the frame into multiple segments or struts that can flex relative to each other during navigation. These segmented elements allow the frame to bend and conform to the tortuous path of the vasculature while maintaining structural integrity. Once deployed, the segments lock into a stable configuration that provides rigid support for proper valve positioning.
Data Source
AI summary
The present technology is a prosthetic heart valve device, and related systems and methods, for treating a native valve of a human heart having a native annulus and native leaflets. One embodiment comprises a valve support, a prosthetic valve assembly within the valve support, and an anchoring member. The device further includes an extension member coupled to the anchoring member and having an annular first portion coupled to the anchoring member and a second portion coupled to the first portion. The extension member is folded in a delivery configuration such that the first portion overlaps the second portion. When released from the a delivery catheter, the extension member unfolds such that the first portion extends radially outwardly from the anchoring member and the second portion extends radially outwardly from the first portion.