Multi-lumen Mitral Valve Delivery System with Dual-guiding Fixation
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Solution Overview
Problem
Current treatments for mitral valve diseases, such as mitral regurgitation, face challenges in the complex physiology and three-dimensional anatomy of the mitral valve, leading to difficulties in surgical repair and replacement procedures, particularly in securing prosthetic valves to prevent dislodgement and leakage.
Innovation Solution
A heart valve leaflet replacement system with a multi-stage, multi-lumen delivery and implantation system that includes a prosthetic mitral valve replacement device with a stent shape and dual-guiding and fixation members to securely attach the device to the native mitral annulus, preventing dislodgement and leakage, and a method to deploy and fixate the valve using a steerable sheath and torque-driving shaft.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If surgical repair and replacement procedures are performed on the mitral valve, then valve function can be restored, but the complex physiology and three-dimensional anatomy of the mitral valve lead to difficulties in securing prosthetic valves, resulting in potential dislodgement and leakage
Solution Approach 1:
The implantation system is divided into multiple functional components: a delivery catheter for minimally invasive access, an expandable stent frame with radial expansion capability for secure anchoring, and separate leaflet replacement components. This segmentation allows each component to perform its specific function optimally while simplifying the overall implantation process.
Solution Approach 2:
The stent frame is delivered in a compressed state through the catheter and then expanded in situ at the target site before leaflet attachment. This preliminary expansion creates the secure anchoring structure first, ensuring the prosthetic valve cannot dislodge, and provides a stable foundation for subsequent leaflet attachment.
2Ease of operation
If traditional surgical approaches are used for mitral valve replacement, then complete valve replacement can be achieved, but patient trauma and procedural complexity increase
Solution Approach 1:
The invention replaces traditional open-chest surgical mechanical approaches with a minimally invasive catheter-based delivery system. The prosthetic valve is delivered through a flexible catheter and deployed using balloon expansion or self-expansion mechanisms, eliminating the need for sternotomy and cardiopulmonary bypass.
Solution Approach 2:
The delivery catheter employs flexible materials that allow navigation through the vascular system to reach the mitral valve position. The catheter's flexibility enables it to conform to the heart's anatomy, providing safe access without rigid mechanical structures that would cause patient trauma.
3Reliability
If the mitral annulus is enlarged due to left ventricle dilation, then functional mitral regurgitation occurs, but simple replacement does not address the underlying annular dilation
Solution Approach 1:
The invention merges two functions into a single device: the stent frame simultaneously serves as both the structural support for the prosthetic leaflets and the annuloplasty ring that addresses annular dilation. This integrated design provides both valve replacement and annular reconstruction in one implantation procedure.
Solution Approach 2:
The stent frame is designed with multi-functionality: it provides structural support for the prosthetic valve, anchors the device to prevent dislodgement, addresses annular dilation through its rigid structure, and provides a framework for leaflet attachment. This universal design eliminates the need for separate annuloplasty procedures.
Data Source
AI summary
A novel multi-stage and multi-lumen (MSML) delivery and implantation system for implanting a prosthetic heart valve for treatment of a diseased heart valve. The MSML delivery system comprises of a docking system, a dual-guiding-and-fixation (DGF) system for implanting a plurality of DGF members in the proximity of the annulus, a valve delivery system for releasing and locking a prosthetic valve, and a prosthetic valve having a crescent shaped stent, a plurality of DGF members, a plurality of leaflets comprising a free edge, two commissure attachment regions, an attachment edge, a coaptation region, a belly region, and at least one prong structure. The docking system, the DGF system, and the valve delivery system are configured cooperatively for advancing to an operative position, and for delivering and implanting a plurality of DGF head members to the operative position, and for guiding, delivering and fixating the prosthetic valve to the operative position.