Mitral Valve Prosthesis Docking Station for Stable Annular Anchoring
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Solution Overview
Problem
Existing anchoring devices for replacing mitral valves face challenges due to the thinner, wider mitral valve annulus, making it difficult to securely implant replacement valves, and current solutions like self-expanding stents risk occluding the left ventricle outflow tract or requiring larger delivery systems, increasing procedural risk.
Innovation Solution
A docking device with a hypotube featuring varying cuts and pitches along its length, allowing for biasing and maneuverability, combined with an actuating wire and interlocking disconnect system, to securely anchor prosthetic valves at the mitral annulus, preventing paravalvular leakage and ensuring stable implantation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If self-expanding stents are used to anchor the valve, then the valve can be secured to the annulus, but the stent may occlude the left ventricle outflow tract
Solution Approach 1:
The docking device features a non-uniform coil structure with varying pitch and diameter along its length. The distal portion has a smaller diameter and tighter pitch to engage the annulus securely, while the proximal portion has a larger diameter and wider pitch to prevent outflow tract occlusion. This local differentiation of structural properties allows the single device to simultaneously achieve anchoring stability and avoid harmful occlusion.
2Ease of operation
If larger delivery systems are used to deploy replacement valves, then the valves can be delivered to the mitral position, but the procedural risk increases
Solution Approach 1:
The docking device is designed with a nested structure where the coil engages within the mitral annulus plane, and the prosthetic valve is contained within the docking device structure. This nesting allows the valve to be delivered through a smaller profile catheter compared to traditional self-expanding stent approaches, reducing vascular access risks and improving procedural safety while maintaining delivery capability.
3Adaptability or versatility
If current replacement valves are used in the mitral position, then valve replacement can be performed, but secure implantation is difficult due to the thinner, wider mitral valve annulus
Solution Approach 1:
The docking device utilizes controlled changes in geometric parameters along its length, specifically varying the coil pitch, diameter, and spacing. The distal coils have smaller diameter and tighter pitch for secure annular engagement, while proximal coils have larger diameter and wider pitch for stability and seal formation. This parameter variation allows the device to adapt to the thinner, wider mitral annulus geometry and achieve secure implantation.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The docking device provides a stable anchoring site, reducing paravalvular leakage and ensuring long-term stability by securely implanting prosthetic valves at the mitral annulus, avoiding complications associated with larger delivery systems and anatomical obstructions.
Implementation Method 1
The hypotube includes a plurality of cuts to allow biasing of the hypotube
Data Source
Figure 1
Figure 2A~2D
Figure 2E~2F
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 an elastic tube-like member defining a generally coiled shape. The docking station can have an atrial or stabilization turn, a leading or encircling turn, and a central region. In many embodiments, the docking device possess a plurality of cuts on opposing sides of the tube-like member to allow biasing of the member.