Pre-constricted Prosthetic Heart Valve Holder
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Solution Overview
Problem
Existing methods for implanting prosthetic heart valves face challenges due to suture looping around commissure posts, which can lead to complications such as leaflet tearing and increased risk of mortality.
Innovation Solution
A holder and packaging system that pre-constricts and/or pre-shields the commissure posts of prosthetic heart valves, preventing suture looping and easing implantation. The system includes solid legs that directly contact and constrict the commissure posts or flexible members that shield the post tips during implantation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If commissure posts are left unconstricted during delivery, then the valve structure remains simple and easy to manufacture, but suture looping occurs around the posts causing implantation complications
Solution Approach 1:
The holder is designed to automatically constrict the commissure posts when the valve is loaded into the delivery system, before implantation begins. This preliminary constriction action prevents suture looping during the parachuting process while maintaining structural simplicity for manufacturing.
2Reliability
If commissure posts are constricted inwardly during delivery, then suture looping is prevented, but the device complexity increases due to additional constriction mechanisms
Solution Approach 1:
The holder utilizes the natural geometry of the commissure posts and the elastic recovery properties of the valve structure to achieve constriction automatically during loading. The design requires no additional actuators, motors, or complex mechanical systems - the constriction happens self-service through the loading process itself.
3Ease of operation
If the holder is attached to the inflow end for mitral valves, then the delivery approach is standardized, but the surgeon cannot visually monitor the commissure posts on the blind side during implantation
Solution Approach 1:
The holder automatically constricts the commissure posts before delivery, creating a compressed configuration that prevents suture looping. This preliminary protective action eliminates the need for visual monitoring during the blind-side parachuting process, as the constriction mechanism proactively prevents the harmful suture looping condition.
4Reliability
If sutures are used to constrict commissure posts, then the constriction can be applied, but suture creep over time during storage causes the posts to return to their original position
Solution Approach 1:
The holder employs a disposable, single-use design where the constriction mechanism is integrated into the delivery system itself. After implantation, the holder is removed, and the valve maintains its constrained configuration through the implanted structure rather than relying on reusable sutures that creep over time.
Data Source
AI summary
An improved holder and storage system for prosthetic heart valves that pre-shields or pre-constricts the commissure posts of the valve to prevent suture looping. Pre-shielding and pre-constriction mean at the time of manufacture, so that the valves are stored with the commissure posts shielded and/or constricted. The holders may have solid legs that directly contact and constrict and hold the commissure posts without the use of sutures in tension that might creep over the time in storage. The holder may have a base in contact with the inflow end and a shaft portion that projects through the valve leaflets and cooperates with movable legs on the outflow end of the valve in contact with the commissure posts. The holders may, alternatively, have flexible leg members that extend through the valve and have distal end portions configured to extend over and shield the tips of commissure posts.