Modular Valve Retainer for Prosthetic Heart Valve Storage
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Solution Overview
Problem
Existing packaging systems for prosthetic heart valves are inflexible and require multiple containers for different valve designs and sizes, making inventory management inefficient and complicating the sterile handling and preparation of valves during surgery.
Innovation Solution
A modular valve retainer system that includes a cylindrical body with a shelf and cap, allowing for customizable valve pockets within a sterile liquid container, facilitating easy opening and minimizing exposure to non-sterile surfaces, and enabling quick removal and rinsing of the valve without direct contact.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If multiple containers are used for different valve designs and sizes, then valve storage flexibility is improved, but inventory management complexity increases
Solution Approach 1:
The retainer is designed with a universal body structure that can accommodate multiple valve types and sizes through interchangeable shelves. The shelf insertion/removal mechanism allows a single retainer body to serve multiple storage configurations, eliminating the need for separate containers for each valve design while maintaining inventory management simplicity.
2Reliability
If traditional packaging systems are used, then valve protection is maintained, but handling time during surgery increases
Solution Approach 1:
The retainer is divided into separable components: a body, interchangeable shelves, and a cap. This segmentation allows the retainer to be quickly disassembled and reconfigured during surgery to match different valve types without requiring complete container replacement, reducing handling time while maintaining protection through the sealed design.
Solution Approach 2:
The retainer transitions from a static sealed container to a dynamic system where shelves can be easily inserted and removed. This dynamic capability allows surgical personnel to quickly adapt the retainer to different valve configurations during procedures, reducing preparation time while maintaining the protective sealed environment.
3Reliability
If valves are stored in sealed containers, then sterility is maintained, but ease of access during surgery decreases
Solution Approach 1:
The sealed container is segmented into a body and a removable cap, allowing sterile access by simply removing the cap rather than opening the entire container. This maintains sterility by minimizing exposure of the internal valve environment while providing easy access for surgical personnel to retrieve and exchange valves during procedures.
4Stability of the object's composition
If fixed position retainers are used, then valve stability during storage is improved, but adaptability to different valve configurations decreases
Solution Approach 1:
The retainer body is segmented from the shelf component, allowing the shelf to be removed and replaced with different configurations. This maintains stable valve positioning during storage through the fixed body structure while enabling adaptability to different valve types by simply changing the shelf insertion.
Solution Approach 2:
The retainer transitions from a fixed configuration to a dynamic system where shelves can be easily changed. The body maintains structural stability for secure valve holding, while the interchangeable shelf mechanism provides adaptability to accommodate various valve configurations without compromising the stable storage environment.
Data Source
AI summary
This invention relates to a system and apparatus for retaining a prosthetic valve in a valve pocket suspended in a sealed container to protect from damage and contamination during shipment, handling and storage. The apparatus is an easy to open container having remote fill ports for adding a sterile liquid after enclosing the valve inside. A tamper evident seal is provided having a novel configuration to detect prior opening of the container. The apparatus includes an assembly having a shelf that is provided in a variety of configurations. The shelf has a mitral valve configuration and an aortic valve configuration. The shelf is selected based on the valve configurations and size. The system is easily assembled having a single variable component to adapt to a particular prosthetic valve to be stored. The present invention provides an apparatus for eliminating the need for direct attachment of the valve serial tag to the valve.