Prosthetic Heart Valve Leaflet Assembly With Sutureless Wedge Fixation
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Solution Overview
Problem
Existing methods for assembling prosthetic heart valve leaflet assemblies are complex, time-consuming, and prone to wear due to numerous stitches, which can lead to instability of the commissure tab assembly during handling, crimping, or valve expansion.
Innovation Solution
The proposed solution involves a leaflet assembly with commissure tab assemblies that are inserted into commissure windows of an expandable annular frame, with wedge members used to restrain radial motion and secure the assembly without the need for sutures through dynamic portions of the leaflets.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If commissure tab assemblies are attached to commissure posts using numerous stitches, then the leaflet assembly can be secured to the frame, but wear along the stitches occurs leading to instability during handling, crimping, or valve expansion
Solution Approach 1:
The patent removes the harmful stitching elements from the dynamic portions of the leaflets. Instead of using numerous stitches that cause wear, the invention uses a sutureless attachment method where commissure tab assemblies are secured to commissure posts through a different mechanism that eliminates the wear-prone stitch locations entirely.
Solution Approach 2:
The patent introduces an intermediary attachment mechanism between the commissure tab assemblies and commissure posts. This intermediary system replaces the direct stitch connection with a different fastening method that avoids wear on the leaflet material while maintaining secure attachment during handling, crimping, and expansion.
2Reliability
If traditional suture-based methods are used to attach leaflet assemblies to frames, then attachment can be achieved, but the process becomes complex and time-consuming
Solution Approach 1:
The patent extracts and removes the complex suture-based attachment process entirely. By eliminating the need for numerous stitches and suture threading operations, the invention simplifies the assembly process while maintaining reliable attachment of the leaflet assembly to the frame.
Solution Approach 2:
The patent implements a self-service attachment mechanism where the commissure tab assemblies can be secured to the commissure posts through a simplified process that does not require complex suturing techniques. The design allows for easier, more straightforward attachment that reduces both complexity and assembly time.
3Strength
If numerous stitches are used to secure commissure tab assemblies, then attachment strength can be achieved, but the risk of leaflet tearing increases
Solution Approach 1:
The patent removes the harmful stitches from the dynamic portions of the leaflets where they would concentrate stress and create tear risks. By eliminating these penetration points, the invention maintains attachment strength through alternative means while removing the source of potential leaflet tearing.
Solution Approach 2:
The patent utilizes the flexibility and integrity of the leaflet material itself in a sutureless design, where the leaflet structure is configured to work with the attachment mechanism without requiring penetrating stitches. This approach preserves the continuous integrity of the leaflet film, preventing stress concentration and tear propagation.
Data Source
AI summary
Assembly methods for installing a leaflet assembly to an expandable frame of a prosthetic heart valve are described. The leaflet assembly comprises a plurality of leaflets coupled together at adjacent tabs, which form respective commissure tab assemblies. The commissure tab assemblies are inserted into corresponding windows of support members of the expandable frame. One or more wedge members are inserted into the commissure tab assembly, e.g., between the adjacent tabs or with the adjacent tabs therebetween, to restrain radial motion of the commissure tab assembly with respect to the window. The window can be a closed window, and the wedge member insertion can be after the commissure tab assembly is inserted into the window. Alternatively, the window can be an open window or channel, and the wedge member insertion can be before the commissure tab assembly is installed in the window.