Leaflet Connector Structure for Prosthetic Valve Coaptation
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Solution Overview
Problem
Ischemic heart disease causes regurgitation of heart valves due to papillary muscle dysfunction and ventricular dilation, leading to incomplete valve coaptation and increased stroke volume, which weakens the heart over time.
Innovation Solution
A prosthetic valve implant with a tubular portion, upstream support portion, and flanges, assembled from concentric frames, is percutaneously delivered and expanded to secure native valve tissue between the support and flanges, using a flexible sheet with connectors to secure leaflets, ensuring proper coaptation and reducing regurgitation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional prosthetic valves are used, then valve replacement is achieved, but regurgitation persists due to incomplete leaflet coaptation
Solution Approach 1:
The prosthetic valve is divided into separate functional components: a frame structure and distinct leaflet connectors that attach to each commissure. This segmentation allows independent optimization of each connector to ensure proper leaflet alignment and coaptation, directly addressing the regurgitation problem through precise localized attachment rather than generic fixation.
Solution Approach 2:
Leaflet connectors serve as intermediary elements between the frame and the leaflets. These connectors mediate the attachment process by providing dedicated structures that engage with the leaflet commissures, ensuring proper positioning and coaptation. The connectors act as intermediaries that translate frame expansion into precise leaflet alignment, eliminating the harmful regurgitation effect.
2Ease of operation
If percutaneous delivery method is used, then minimally invasive implantation is achieved, but precise positioning and secure attachment of leaflets become more difficult
Solution Approach 1:
The leaflet connectors are pre-formed with specific geometries designed to engage leaflet commissures at predetermined locations. The frame is also pre-configured with attachment features that guide connector placement. This preliminary preparation ensures that when the implant is deployed percutaneously, the leaflets are automatically positioned with high precision without requiring complex manual adjustment during the minimally invasive procedure.
Solution Approach 2:
The implant system incorporates dynamic elements that allow for self-adjustment during deployment. The frame expands from a compressed to an expanded state, and the leaflet connectors are designed to engage leaflets at different stages of this expansion. This dynamic behavior enables precise positioning to be achieved automatically during the percutaneous delivery process, reconciling the ease of minimally invasive implantation with the precision of leaflet attachment.
Data Source
AI summary
A unitary flexible sheet is folded to defines a panel, and first and second tabs. Each of the tabs has an inner layer and an outer layer. First and second prosthetic leaflets are coupled to a tubular frame via the sheet. Each of the leaflets has a respective commissural portion. For each of the commissural portions, a first region of the commissural portion is sandwiched between inner layers of the first and second tabs, and a second region of the commissural portion is disposed flat against the panel. Other embodiments are also described.