Prosthetic Valve Leaflet Stapling for Reduced Assembly Time
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Solution Overview
Problem
The labor-intensive process of suturing leaflets to the frame of prosthetic valves, either directly to the struts or via an intermediate inner skirt member, results in increased assembly time and cost.
Innovation Solution
The use of stapling members with spines and legs to couple leaflets to the frame, compressible inserts to secure leaflets within recessed struts, and gripping tubes to wrap around cusp end portions for attachment, reducing the need for suturing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If suturing leaflets to the frame is used, then reliable attachment is achieved, but assembly time and labor intensity increase
Solution Approach 1:
The patent replaces the manual suturing mechanical system with automated stapling members that use a different mechanical mechanism. The stapling members consist of a spine with stapling portions that have legs piercing and bending around the frame struts, creating a mechanical interlocking attachment that is faster than manual suturing while maintaining reliable leaflet-to-frame connection.
2Reliability
If suturing leaflets to the frame is used, then secure attachment is achieved, but assembly complexity and cost increase
Solution Approach 1:
The patent replaces the complex manual suturing process with a simplified automated stapling system. The stapling members are pre-formed components that insert into recesses in the frame struts, eliminating the need for complex suturing maneuvers and reducing assembly complexity while maintaining secure attachment.
Solution Approach 2:
The stapling members are designed to be self-aligning and self-securing. When inserted into the recesses in the frame struts, the legs automatically pierce through the leaflets and bend around the struts to create the attachment, eliminating the need for complex manual manipulation and reducing assembly complexity.
3Reliability
If compressible inserts are used to secure leaflets, then attachment reliability is improved, but device complexity increases
Solution Approach 1:
The patent divides the frame struts into segments with recesses positioned at specific locations. These recesses accommodate the stapling members or compressible inserts, allowing the attachment mechanism to be integrated into the frame structure without requiring complete redesign of the entire frame. This segmented approach maintains reliability while limiting the increase in overall device complexity.
Data Source
AI summary
The present disclosure relates to prosthetic valve that include leaflets coupled to a frame by clamping members, optionally in a sutureless manner. In an example, a prosthetic valve can include at least one stapling member coupling at least one leaflet of a plurality of leaflets to the frame, wherein the clamping member comprises a plurality of stapling portions separated from each other along a spine of the clamping member. Each stapling member can include a pair of legs extending from opposite ends of a backspan, wherein the legs extend through the leaflet and are bent around a corresponding strut of the frame, thereby coupling the leaflet to the frame.