A2 Clip Anchoring for Side-Delivered Mitral Valve
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Solution Overview
Problem
Current transcatheter mitral valve replacement technologies face challenges with regurgitation and material durability issues, requiring expensive materials to withstand the mechanical stress of heart function, and often necessitate invasive procedures.
Innovation Solution
A side-delivered transcatheter mitral valve with an A2 clip system that extends to capture native mitral leaflet and chordae tissue, utilizing a self-expanding annular support frame and collapsible flow control component made from Nitinol, allowing for delivery and deployment without an oversized catheter and at a non-acute angle, with features like a distal anchoring tab and A2 clip for secure anchoring.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If traditional transcatheter valve delivery methods are used, then the valve can be delivered through the catheter, but the procedure requires invasive apex perforation and anchoring
Solution Approach 1:
The patent inverts the traditional delivery approach by delivering the valve through the side wall of the heart chamber rather than through apex perforation. The delivery catheter is introduced through a peripheral vein and positioned in the left ventricle, then the valve is deployed through the lateral wall, avoiding the need for apex puncture and reducing invasive procedures.
Solution Approach 2:
The patent uses a delivery catheter as an intermediary device that enables side-wall delivery without direct surgical access. The catheter serves as a conduit to transport the compressed valve to the target location and facilitates deployment through the lateral wall, mediating between the external delivery system and the internal heart chamber.
2Reliability
If large-diameter valves are deployed, then regurgitation is minimized, but material strain and durability issues increase
Solution Approach 1:
The patent changes the delivery parameters by using side-wall access rather than trans-apical or trans-aortic approaches. This allows large-diameter valves to be delivered without requiring oversized catheters or high-pressure deployment, reducing mechanical stress on the valve materials while maintaining the large diameter needed to prevent regurgitation.
Solution Approach 2:
The patent applies different structural characteristics to different parts of the valve system. The valve frame uses a self-expanding structure with radial force distribution, while the delivery catheter has a flexible, collapsible design. This local differentiation allows the valve to maintain structural integrity and durability while achieving large diameter for effective sealing.
3Duration of action of stationary object
If expensive durable materials are used, then valve durability improves, but procedure cost increases
Solution Approach 1:
The patent employs self-expanding valve frames that automatically expand to their functional configuration upon deployment without requiring additional deployment mechanisms or complex actuation systems. The shape memory alloy material provides self-actuating radial expansion, eliminating the need for expensive deployment balloons or complex mechanical systems, thereby reducing manufacturing costs while maintaining durability.
4Ease of operation
If traditional delivery angles are used, then valve deployment is straightforward, but the procedure requires acute angle approach and oversized catheters
Solution Approach 1:
The patent changes the delivery dimension by approaching the target valve from the lateral wall of the heart chamber rather than from the apex or aorta. This side-wall approach allows the delivery catheter to access the left ventricle through peripheral veins and deploy the valve through the lateral wall, avoiding the need for acute angle approaches and oversized catheters required by traditional methods.
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
Enables the deployment of a large-diameter valve with reduced material strain and improved durability, minimizing regurgitation and the need for expensive materials, while allowing for a less invasive outpatient procedure.
Implementation Method 1
a self-expanding annular outer support frame... made from Nitinol
Implementation Method 2
collapsible inner flow control component... made from Nitinol
Data Source
AI summary
The invention relates to an A2 clip for a side-delivered prosthetic mitral valve where the A2 clip is extended using a guide wire to capture native mitral leaflet and/or chordae tissue and withdrawing the guide wire contracts the A2 clip and pins the native tissue against the subannular sidewall of the prosthetic valve.