Color-Coded Bioprosthetic Valve System for Mitral Implantation
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Solution Overview
Problem
Current bioprosthetic heart valve systems are complex and difficult to use, particularly in the mitral position, where commissure posts can become entangled with pre-installed anchoring sutures, potentially damaging the annulus or tissue valve during delivery, and there is a need for enhancements to ease the implantation process for operating room staff and surgeons.
Innovation Solution
A color-coded bioprosthetic valve system with a valve holder system that includes a holder, post, and adapter with distinct colors to facilitate training and correct identification of components, ensuring proper deployment and reducing the risk of entanglement, featuring a flex handle with a matching color to the adapter, and an annulus sizer with a grip in the same color to indicate the correct valve size, along with a jar clip with movement indicators to aid in storage and deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a bioprosthetic valve system uses a holder with post and adapter components for mitral valve implantation, then the valve can be securely held and deployed, but the commissure posts can become entangled with pre-installed anchoring sutures, potentially damaging the annulus or tissue valve during delivery
Solution Approach 1:
The patent applies preliminary action by pre-assembling the holder, post, and adapter components in a specific configuration before valve implantation. The holder is sutured to the valve ring, the post is operatively connected to the holder, and the adapter is sutured to the post in advance, creating a pre-configured assembly that reduces the risk of entanglement during the actual implantation procedure.
2Reliability
If a bioprosthetic valve system uses multiple components (holder, post, adapter) for secure deployment, then the valve can be properly positioned, but the system becomes complex and difficult to use for operating room staff and surgeons
Solution Approach 1:
The patent applies color coding to the holder, post, and adapter components to facilitate easy identification and correct assembly. Each component is assigned a specific color or color combination, allowing operating room staff and surgeons to quickly verify they are using the correct components together without needing to memorize complex assembly instructions, thereby reducing operational complexity while maintaining proper positioning.
3Reliability
If a bioprosthetic valve system uses bracketing structures to prevent damage during storage, then the valve is protected from striking the inside of the jar, but the system requires additional components (clip and tubular sleeve) that increase complexity
Solution Approach 1:
The patent merges the holder, post, and adapter components into an integrated assembly that serves both the protective bracketing function during storage and the deployment function during implantation. The holder is sutured to the valve ring and the clip is attached to the holder, creating a unified structure that eliminates the need for separate tubular sleeve components while maintaining protection against damage during storage and transport.
Data Source
AI summary
A color-coded bioprosthetic valve system having a valve with an annular sewing ring, and a valve holder system with a holder sutured to the ring of the valve, a post operatively connected to the holder, and an adapter sutured to the post and having a color associated with the valve model and/or size. For example, the adapter may be blue to indicate that the valve of the system is a mitral valve of a particular type and/or size. The system may also include a flex handle that is configured to engage with the adapter. The handle has a color associated with the adapter such that a user is able to visually determine that the handle color matches the valve model. For example, the handle may have a grip that is colored blue to match the blue color of the adapter. Accordingly, the color-coded system enables users to confirm easily that the correct accessories such as the sizer or flex handle are being used with the correct valve.