Mitral Annular Ring Platform for Percutaneous Valve Anchoring
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Solution Overview
Problem
Current percutaneous mitral valve replacement technologies face challenges in securely anchoring and sealing due to the mitral valve's non-uniform, non-planar, and dynamic anatomy, with existing methods being difficult to master, inefficient, or risky, particularly for patients with ischemic mitral regurgitation (IMR).
Innovation Solution
A mitral annular platform is designed for percutaneous and/or transapical deployment in multiple stages, featuring anchoring mechanisms such as helical coils, magnetic rings, or petal-shaped wire rings to create a stable 'landing zone' for subsequent implantation of valved-stent devices, ensuring secure anchoring and perivalvular sealing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If percutaneous catheter-based aortic valve replacement technology is directly applied to mitral valve replacement, then the procedure can be performed minimally invasively, but the anchoring and sealing are insufficient due to the mitral valve's non-uniform, non-planar, and dynamic anatomy
Solution Approach 1:
The mitral valve replacement system is divided into multiple components: a delivery catheter, an expandable frame with radial support elements, anchoring elements, and a valve prosthesis. This segmentation allows each component to be optimized for its specific function while enabling percutaneous delivery through a catheter-based approach.
Solution Approach 2:
The invention transitions from the planar geometry of aortic valve annuluses to a three-dimensional, non-planar configuration that conforms to the mitral valve annulus. The expandable frame includes radial support elements that extend in multiple dimensions to engage the non-uniform mitral annular geometry, providing stable anchoring and sealing in this complex anatomical environment.
2Reliability
If existing anchoring mechanisms are used in the mitral valve position, then the device can be anchored, but the anchoring is insecure due to the dynamic and non-uniform anatomy of the mitral valve
Solution Approach 1:
The expandable frame is designed with radial support elements that can dynamically adapt to the mitral valve annulus geometry. The frame expands from a compressed state during delivery to a deployed state where the radial support elements engage the annulus, providing secure anchoring that accommodates the dynamic nature of the mitral valve during cardiac cycles.
Solution Approach 2:
The invention changes the geometric parameters of the anchoring structure to match the mitral valve annulus characteristics. The expandable frame includes radial support elements with specific angles and dimensions that are optimized to engage the non-uniform, non-planar mitral annulus, providing secure anchoring that is adapted to this specific anatomical geometry.
3Ease of operation
If a percutaneous approach is used for mitral valve replacement, then large incisions and cardiopulmonary bypass are avoided, but secure anchoring and sealing are difficult to achieve
Solution Approach 1:
The valve prosthesis is nested within the expandable frame, which itself is nested within the delivery catheter. This nested configuration allows the entire valve replacement system to be delivered percutaneously through a femoral vein approach, avoiding large incisions and cardiopulmonary bypass while maintaining the capability for secure anchoring and sealing through the expandable frame structure.
Solution Approach 2:
The expandable frame acts as an intermediary structure between the delivery catheter and the valve prosthesis. It provides the necessary radial support and anchoring function while facilitating the percutaneous delivery of the valve prosthesis, enabling secure anchoring and sealing without requiring large incisions or cardiopulmonary bypass.
4Device complexity
If the mitral valve annulus geometry is not properly accounted for, then the device can be simplified, but the anchoring and sealing fail due to the non-uniform and non-planar nature of the mitral valve
Solution Approach 1:
The expandable frame is designed with asymmetric radial support elements that correspond to the asymmetric geometry of the mitral valve annulus. The radial support elements are positioned and dimensioned to engage the non-uniform annular geometry, providing secure anchoring and sealing while accounting for the inherent asymmetry of the mitral valve structure.
Solution Approach 2:
Different portions of the expandable frame have different local properties optimized for their specific functions. The radial support elements have varying angles, lengths, and positions to engage different regions of the mitral annulus, providing localized anchoring and sealing that accounts for the non-uniform geometry of the mitral valve at different locations.
Data Source
Figure 1A~1C
Figure 2A~2F
Figure 3A~3D
AI summary
A mitral valve prosthesis is percutaneously and/or transapically deployed in at least two stages. In a first stage, a mitral annular ring platform adapted for percutaneous delivery is delivered to and anchored in the mitral valve annulus, where the mitral annular ring platform includes a plurality of wires preformed into separate but contiguous helices. At least one of the helices is adapted to serve as an anchor on the atrial side of the mitral annulus, and at least one of the helices is adapted to serve as an anchor on the ventricular side of the mitral annulus. At least one of the helices traverses the mitral annulus, connecting the atrial and mitral helices to each other. In the second stage, a valved-stent mitral valve prosthetic device adapted for percutaneously delivery is delivered to the mitral valve annulus for mounting in the mitral annular ring platform. This approach provides a consistent platform for accepting valved-stent mitral valve prosthetic devices from different vendors to be used.