Multi-frame Prosthetic Heart Valve with Film Coupling
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Solution Overview
Problem
Bioprosthetic and synthetic leaflet valves face durability issues due to calcification, cusp tears, and mechanical failure under repetitive loading, particularly at the mounting edge, leading to premature failure and the need for reoperation.
Innovation Solution
A prosthetic valve design featuring a multi-part support member with a leaflet frame and outer frame coupled by a film, where the leaflet frame is nested within the outer frame to prevent relative movement and contact, providing structural support and preventing peeling or delamination of the leaflet material.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If a single rigid frame is used to support the leaflet, then the leaflet is securely mounted, but stress concentrations occur at the mounting edge leading to mechanical failure
Solution Approach 1:
The single rigid frame is divided into two separate frames: an inner frame that provides leaflet support and an outer frame that provides structural stability. This segmentation distributes the mechanical loads away from the mounting edge, reducing stress concentrations and preventing material failure while maintaining secure leaflet mounting.
2Stability of the object's composition
If the leaflet frame is made rigid to provide support, then dimensional stability is achieved, but the valve cannot be compressed for transcatheter delivery
Solution Approach 1:
The frame structure is designed with dynamic characteristics, allowing it to transition between a compressed state for delivery and an expanded stable state for operation. The two-frame configuration with film coupling enables the structure to maintain dimensional stability when deployed while being compressible during delivery through a catheter.
3Device complexity
If the leaflet is directly attached to the frame, then the structure is simple, but the leaflet material peels or delaminates under repetitive loading
Solution Approach 1:
A film material is introduced as an intermediary between the inner and outer frames, preventing direct contact between the frames while providing a coupling mechanism. This film layer distributes loads evenly across the leaflet attachment area, preventing stress concentrations that cause peeling or delamination under repetitive loading conditions.
4Ease of operation
If a bioprosthetic valve is used to mimic native valve function, then excellent hemodynamic performance is achieved, but calcification and cusp tears occur leading to premature failure
Solution Approach 1:
The valve combines bioprosthetic leaflet material with a synthetic two-frame structure. The bioprosthetic material maintains excellent hemodynamic performance and flexibility, while the durable synthetic frame provides structural support and prevents calcification and mechanical failure, creating a composite structure that leverages the advantages of both material types.
Data Source
AI summary
Described embodiments are directed toward prosthetic valves and systems and methods of making prosthetic valves. In accordance with an embodiment, a prosthetic valve comprises and leaflet frame, and outer frame and a film. The leaflet frame has a generally tubular shape defining a plurality of leaflet windows. The outer frame has a generally tubular shape. The leaflet frame is coaxially disposed at least partially within the outer frame. The leaflet frame and outer frame is coupled at least in part by a contiguous portion of the film. At least a portion of the contiguous portion of the film is contained between and coupling the leaflet frame and outer frame operable to prevent relative movement and contact therebetween. The film defines a leaflet extending from each of the leaflet windows.