Catheter-Delivered Mitral Valve Leaflet Replacement With Annular Anchoring
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Solution Overview
Problem
Conventional mitral valve replacement devices face challenges such as operative delivery difficulties, positioning and fixation issues, seal and paravalvular leakage, and hemodynamic function obstructions, particularly due to the large size and dynamic nature of the mitral valve.
Innovation Solution
A heart valve leaflet replacement system with a stent-shaped prosthetic mitral valve featuring an upper flared atrial portion and lower ventricular portion, anchored by fixation members and secured using tethers and locking devices, allowing for precise deployment and attachment to the native mitral annulus, minimizing leakage and dilation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If conventional mitral valve replacement devices are used, then valve replacement can be achieved, but operative delivery difficulties arise due to the large size and dynamic nature of the mitral valve
Solution Approach 1:
The prosthetic mitral valve is designed to be deliverable within a catheter through a nested configuration where the valve is compressed into a small delivery profile and then deployed at the target location. The valve structure allows it to be contained within the catheter lumen during delivery and then expanded to its functional size at the mitral annulus.
Solution Approach 2:
The delivery system employs dynamic characteristics including a deflectable tip that can be steered through the catheter to reach the mitral annulus, and a self-expanding or balloon-expandable valve mechanism that transitions from a compressed delivery state to an expanded functional state at the target location.
2Manufacturing precision
If conventional mitral valve replacement devices are used, then valve replacement can be achieved, but positioning and fixation issues occur
Solution Approach 1:
The system first positions a guide wire through the catheter to the mitral annulus to establish the exact location for valve deployment. The prosthetic valve is then deployed over the guide wire, ensuring accurate positioning. Following deployment, the valve is expanded to engage with the annulus and is secured using sutures or other fixation mechanisms to prevent dislodgment.
3Reliability
If conventional mitral valve replacement devices are used, then valve replacement can be achieved, but seal and paravalvular leakage occur
Solution Approach 1:
The prosthetic valve incorporates a flexible sealing skirt or annular seal that can conform to the shape of the native mitral annulus. This flexible membrane structure creates a tight seal between the prosthetic valve and the annulus, preventing blood leakage through the paravalvular space while accommodating anatomical variations.
4Reliability
If conventional mitral valve replacement devices are used, then valve replacement can be achieved, but hemodynamic function obstructions occur
Solution Approach 1:
The prosthetic valve is designed with differentiated zones: a ventricular portion with a smaller outer diameter to avoid obstructing the left ventricular outflow tract, and an atrial portion with a larger diameter to provide adequate sealing at the mitral annulus. This local variation in dimensions ensures proper hemodynamic function while preventing obstruction of critical structures.
Data Source
AI summary
A prosthetic heart valve for treatment of a diseased heart valve having native anterior and posterior leaflets that move between an open configuration and a closed position to regulate blood flow through the heart valve during a cardiac cycle of a heart. The prosthetic heart valve having a crescent shaped stent, at least one prosthetic leaflet mounted on an inner surface of the stent, and at least one prong structure coupling a portion of the at least one prosthetic leaflet to a lower ventricular portion of the stent frame. The prosthetic heart valve further having systems for anchoring the upper flared portion of the stent to a posterior portion of the native valve annulus.