Prosthetic Heart Valve Commissure Assembly for Precise Leaflet Alignment
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Solution Overview
Problem
Conventional methods for attaching leaflets to the frame of prosthetic heart valves to form commissures are difficult and time-consuming, and there is a need for improved devices and methods to secure leaflets together and to frames to minimize the diameter of the prosthetic valve in the collapsed state.
Innovation Solution
The prosthetic heart valve includes a commissure attachment assembly with a support member and reinforcement members, secured by sutures or flexible materials, that form commissures by pairing commissure tab portions of leaflets and attaching them to post members on the frame, allowing for secure alignment and minimization of the valve's collapsed diameter.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If conventional methods are used to attach leaflets to the frame to form commissures, then the attachment is secure, but the assembly process is difficult and time-consuming
Solution Approach 1:
The commissure attachment assembly is pre-assembled with the support member, reinforcement members, and sutures configured before implantation. This preliminary preparation allows for rapid deployment during the procedure, eliminating the need for complex intra-procedural assembly and significantly reducing assembly time while maintaining secure attachment.
Solution Approach 2:
The commissure attachment assembly is divided into distinct functional components: a support member for structural foundation, reinforcement members for added strength, and sutures for securing. This segmentation allows each component to be optimized independently and facilitates streamlined assembly through modular integration.
2Manufacturing precision
If the commissure attachment assembly includes support members and reinforcement members, then leaflet alignment precision is improved, but the device complexity increases
Solution Approach 1:
The support member and reinforcement members are integrated into a single commissure attachment assembly unit that is pre-configured with sutures. This merging of multiple functional elements into one cohesive assembly maintains precise alignment capabilities while simplifying the overall implantation process, as the entire alignment system is deployed as a single unit rather than multiple separate components.
3Ease of operation
If the prosthetic valve is designed to be radially collapsible, then the minimally invasive implantation is enabled, but the structural stability during operation may be compromised
Solution Approach 1:
The frame is designed with dynamic characteristics, being radially collapsible for delivery through minimally invasive catheter-based approaches, and radially expandable to a stable configuration upon deployment. This dynamic design allows the frame to transition from a compressed delivery state to an expanded functional state, providing both ease of implantation and operational stability.
Solution Approach 2:
The commissure attachment assembly, including support members and reinforcement members, is pre-configured to maintain structural stability once the frame is expanded. The sutures and reinforcement elements are positioned in advance to ensure that when the frame transitions to its expanded stable configuration, the leaflets are securely attached and the commissures are properly formed, maintaining structural integrity during operation.
Data Source
AI summary
A prosthetic heart valve includes an annular frame that is radially collapsible and radially expandable, a plurality of leaflets situated within the frame, each leaflet having opposing commissure tab portions on opposite sides of the leaflet, each commissure tab portion paired with an adjacent commissure tab portion of an adjacent leaflet to form at least one commissure, and a plurality of post members mounted on an interior surface of the frame. The at least one commissure includes a commissure attachment assembly including a support member disposed at least partially around the commissure tab portions and the commissure tab portions are folded around the support member. The commissure attachment assembly is secured to a first post member of the plurality of post members such that the commissure tab portions are positioned between the first post member and the support member.


