Mitral Valve Docking Station Anchoring
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Solution Overview
Problem
Current anchoring devices face challenges in securely positioning replacement mitral valves due to the thinner, wider mitral valve annulus, which makes it difficult to anchor prosthetic valves without obstructing the left ventricular outflow tract or requiring larger delivery systems, and existing solutions have not been widely adopted by surgeons.
Innovation Solution
A low-profile docking station that can be implanted in the native mitral valve to support expandable prosthetic valves without interfering with native leaflets, allowing for simple installation with reduced imaging requirements and preventing obstruction, and is designed to be universal for various types of prosthetic valves.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If current percutaneously delivered valves are used for mitral valve replacement, then the delivery profile remains small for easy navigation, but the valves cannot be securely anchored in the wider mitral valve annulus
Solution Approach 1:
The anchoring device is divided into multiple components: a delivery catheter, an expandable frame, and anchoring elements. The frame segments into radial struts that can independently engage with the annulus, allowing secure anchoring while maintaining a compact delivery profile.
Solution Approach 2:
The anchoring mechanism transitions from a low-profile collapsed state to a three-dimensional expanded configuration within the annulus. The radial struts extend perpendicular to the annulus plane, creating anchoring points in multiple spatial dimensions that secure the valve without requiring a large delivery profile.
2Reliability
If self-expanding stents are used to anchor the valve, then the valve becomes securely anchored to the annulus, but the stent may occlude the left ventricle outflow tract
Solution Approach 1:
The anchoring struts are designed with varying characteristics: some struts have barbs or hooks for anchoring, while others remain smooth to avoid obstruction. The anchoring elements are localized to specific regions of the annulus that do not interfere with the outflow tract, providing secure fixation without harmful occlusion.
Solution Approach 2:
Instead of using a continuous self-expanding stent that could occlude the outflow tract, the invention uses discrete anchoring points that engage the annulus from the inside. The anchoring direction is inverted - rather than expanding outward to anchor, the struts engage inwardly with the annulus tissue, securing the valve without blocking the outflow path.
3Reliability
If a larger expanded configuration is used to securely anchor the valve in the mitral annulus, then anchoring improves, but the delivery system diameter increases making endovascular delivery more dangerous
Solution Approach 1:
The expandable frame and anchoring struts are nested within a compact delivery catheter in a collapsed configuration. The frame segments fold or compress within the catheter lumen, allowing the entire anchoring system to be delivered through a small-bore catheter that can navigate the vasculature safely, then expand to a larger configuration for secure anchoring at the target site.
4Manufacturing precision
If the mitral valve annulus is used as the anchoring site, then the valve can be positioned in the correct location, but the thinner, wider annulus makes it difficult to properly seat the replacement valve
Solution Approach 1:
The anchoring struts are designed with adjustable engagement parameters - the depth, angle, and radial position of strut insertion into the annulus can be modified to match the thinner, wider mitral annulus geometry. The struts can be configured to engage at optimal points on the annulus that provide sufficient purchase despite the reduced thickness, ensuring proper seating of the replacement valve.
Data Source
AI summary
An anchoring device that can be positioned within a native valve, such as the native mitral valve, to secure a replacement prosthetic valve in place. The anchoring device can comprise a docking station formed of a super elastic wire-like member defining a continuous, closed shape. The docking station can have an upper or atrial ring with at least two ring portions or half rings that are spaced apart across gaps. Descending bends from the ends of the two ring portions lead to a pair of anchors. The anchors can include oppositely-directed rounded V-shaped arms that extend generally parallel to the upper ring. When installed by a delivery device, the anchors can be located in the subvalvular space or the region/vicinity of the native leaflets and pinch the leaflets and the annulus against the upper ring which is located on the other side of the annulus.