Helical Valve Docking Coil With Clasp for Mitral THV Anchoring
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Solution Overview
Problem
Existing transcatheter heart valves (THVs) face challenges in securely anchoring to native heart valves, particularly the mitral valve, leading to issues like paravalvular leakage and valve malfunction due to inadequate structural support.
Innovation Solution
A docking device with a helical coil and a clasp member is used to secure the THV, which includes a movable first end portion that can be opened or closed to grasp native tissue, providing a stable anchoring site for the prosthetic valve.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a transcatheter heart valve is implanted without a docking device, then the implantation procedure is simpler, but the valve cannot be securely anchored to the native tissue leading to paravalvular leakage and valve malfunction
Solution Approach 1:
The docking device is divided into distinct functional components: a coil body providing structural support and a clasp member for tissue engagement. This segmentation allows each component to perform its specific function optimally while maintaining overall device manageability during implantation
Solution Approach 2:
The docking device is designed to be nested within the prosthetic valve assembly during delivery, with the coil and clasp member contained within the valve housing. This nesting approach consolidates multiple functions into a single implantable unit, improving reliability without proportionally increasing operational complexity
2Reliability
If the native tissue structure is insufficient, then the prosthetic valve cannot be secured in place, but adding a docking device increases the complexity of the implantation system
Solution Approach 1:
The docking device provides localized structural reinforcement at the implantation site through the coil body, which creates a stable anchor point in tissues that would otherwise be insufficient. The clasp member further enhances local engagement with native tissue, allowing secure fixation without requiring the entire implantation system to be overly complex
Solution Approach 2:
The docking device is deployed first to prepare the implantation site by creating a stable anchor structure in the native tissue. This preliminary action establishes a secure foundation before the prosthetic valve is released, ensuring reliable anchoring without requiring complex real-time adjustments during valve deployment
Data Source
AI summary
A docking device for securing a prosthetic valve at a native valve includes a coil having a plurality of helical turns when deployed at the native valve and a clasp member attached to the coil. The clasp member includes a first end portion and a second end portion. The second end portion is fixed relative to the coil and the first end portion is movable between an open position and a closed position. When in the closed position, the first end portion of the clasp member is adjacent to the coil so that the clasp member extends substantially parallel to a segment of the coil. When in the open position, the first end portion is spaced away from the coil so that the clasp member extends angularly relative to the segment of the coil.