Collapsible Heart Valve Holder Deflector for Suture Loop Prevention
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Solution Overview
Problem
Existing prosthetic heart valve holders are prone to suture looping and other complications during implantation, leading to improper valve operation and potential damage, and existing solutions are often complex, prone to user error, and costly.
Innovation Solution
A prosthetic heart valve holder system with a deflector mechanism that prevents suture looping by deflecting sutures away from commissure posts, featuring a collapsible design that is pre-deployed or automatically actuated, reducing the number of parts and steps, and integrating alignment features to minimize user error and damage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a prosthetic heart valve holder is used during implantation, then the valve can be securely positioned and installed, but suture looping may occur around commissure posts causing improper valve operation and potential damage
Solution Approach 1:
The patent applies preliminary anti-action by pre-deploying a deflector mechanism before suture attachment that actively prevents suture looping around commissure posts. The deflector is positioned in advance to intercept and redirect sutures away from the commissure posts, eliminating the harmful looping effect before it can occur during the implantation process.
Solution Approach 2:
The patent introduces a deflector as an intermediary component between the sutures and the commissure posts. This mediator physically intercepts the sutures and redirects them along a safe path, preventing direct contact between the sutures and commissure posts that would cause looping, while allowing the implantation procedure to continue uninterrupted.
2Reliability
If complex holder mechanisms are used to prevent suture looping, then valve implantation safety may improve, but device complexity and user error risk increase
Solution Approach 1:
The patent applies preliminary action by pre-deploying the deflector mechanism as part of the holder assembly before the implantation procedure begins. The deflector is automatically positioned in place through integrated deployment features, eliminating the need for complex manual assembly or activation steps during surgery, thereby reducing user error risk while maintaining safety.
Solution Approach 2:
The patent merges the deflector mechanism with the holder assembly into an integrated unit. By combining these components, the patent eliminates separate complex mechanisms and reduces the number of parts that need to be assembled or activated, simplifying the overall device while maintaining the suture-looping prevention function.
3Device complexity
If traditional holders without deflectors are used, then device simplicity is maintained, but suture looping and valve damage risk increase
Solution Approach 1:
The patent introduces a deflector as an intermediary component between the sutures and the commissure posts. This mediator physically intercepts the sutures and redirects them along a safe path, preventing direct contact between the sutures and commissure posts that would cause looping, while allowing the implantation procedure to continue uninterrupted.
Solution Approach 2:
The patent applies preliminary anti-action by pre-deploying a deflector mechanism before suture attachment that actively prevents suture looping around commissure posts. The deflector is positioned in advance to intercept and redirect sutures away from the commissure posts, eliminating the harmful looping effect before it can occur during the implantation process.
Data Source
AI summary
A prosthetic heart valve holder system includes a prosthetic heart valve having a base at an inflow end, a plurality of commissure posts extending from the base toward an outflow end, and valve leaflets secured to the commissure posts to permit flow through the heart valve. A deflector is provided at the outflow end having a central hub and a plurality of arms extending from the central hub secured to and covering the tips of respective commissure posts. A valve support body is secured to the base and a post connects the valve support body to the hub of the deflector. The plurality of arms are sufficiently collapsible such that, in a first position, free ends of the arms are located axially between the hub and the valve support body to prevent suture looping during an implant procedure, and in a second position, the hub is located axially between the free ends of the arms and the valve support body to permit removal of the deflector from the outflow side of the valve, through the valve leaflets, to the inflow side of the valve.


