Segmented Aortic Valve Frame for Coronary Access and PVL Sealing
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Solution Overview
Problem
Current aortic valve designs face challenges with coronary access due to densely-packed cells, limited retrievability upon partial deployment, and perivalvular leak (PVL) issues, which hinder effective replacement and functionality.
Innovation Solution
A heart valve assembly with a frame that transitions from a compressed to an expanded configuration, featuring an inflow section with radial legs, a connecting section with varying flexibility, and a leaflet and skirt assembly that forms a soft cuff upon expansion to seal gaps, allowing for up to two-thirds retrievability and minimizing PVL.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Force
If densely-packed cells are used in the frame to achieve required expansion force, then expansion force is improved, but coronary access becomes difficult
Solution Approach 1:
The frame is divided into multiple sections with different cell structures. The first section has densely-packed cells for strong expansion force, while the second section has larger, less densely-packed cells that facilitate coronary catheter access. This segmentation allows each section to fulfill its specific function without compromising the other.
Solution Approach 2:
Different regions of the frame are given different structural qualities. The first section maintains condensed cell packing for maximum expansion force where needed, while the second section uses larger cells with more open spacing specifically where coronary access is required, creating local variations in structural properties.
2Stability of the object's composition
If the valve assembly is made non-retrievable upon partial deployment to ensure stability, then stability is improved, but retrievability is lost
Solution Approach 1:
The frame is segmented into a first section that expands with high force for stability and a second section with lower expansion force that allows controlled collapse for retrieval. This segmentation enables the valve to achieve stable deployment when needed while maintaining retrievability through selective section behavior.
Solution Approach 2:
The frame's expansion and collapse characteristics are made dynamic through its segmented structure. The first section provides strong expansion for stable deployment, while the second section's lower expansion force allows it to collapse more easily when retrieval is required, enabling the system to transition between stable and retrievable states.
3Reliability
If a separate cuff component is added to address perivalvular leak, then PVL sealing is improved, but the profile when crimped increases
Solution Approach 1:
The cuff function is merged with the frame structure itself rather than being a separate component. The frame's second section is designed to form a cuff that seals against the annulus, integrating the sealing function into the existing frame structure and avoiding the need for additional components that would increase the crimped profile.
Solution Approach 2:
The second section of the frame serves multiple functions: it provides structural support, facilitates coronary access with its larger cells, and forms a sealing cuff against the annulus. This multi-functionality eliminates the need for separate dedicated components for each function, maintaining a compact overall profile.
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 solution enhances coronary access, facilitates easy resheathing of the valve assembly, and reduces PVL by providing a flexible and expandable design that maintains a low profile during deployment and seals effectively against the annulus.
Implementation Method 1
the frame is made of a shape memory material
Data Source
Figure 1A~1B
Figure 2~3
Figure 4~5
AI summary
A heart valve assembly has a frame comprising an inflow section, an outflow section, and a connecting section that is located between the inflow section and the outflow section. The inflow section has a plurality of legs that extend radially outwardly, and the connecting section has a greater flexibility than the inner section. The assembly also includes a plurality of leaflets coupled to the connecting section, a valve skirt extending from the leaflets towards the inflow section of the frame, and a cuff section, with the legs and the cuff section together defining a cuff for engagement with a native annulus.