Prosthetic Valve Delivery Packaging Tray for Sterile Crimping
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Solution Overview
Problem
Existing prosthetic heart valve delivery systems face challenges in maintaining sterility and standardization during preparation procedures, leading to inconsistencies and potential loss of components during crimping and assembly.
Innovation Solution
A packaging tray is designed to retain the delivery apparatus and crimping device in a specified orientation, allowing for sterile and standardized preparation of the prosthetic valve within the tray, with components like a crimping device positioned in the middle and a 180-degree bend shaft alignment, ensuring components remain in place during crimping.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If components are packaged separately for shipping and storage, then device complexity is reduced and logistics are simplified, but preparation time increases and sterility maintenance becomes more difficult
Solution Approach 1:
The patent combines multiple separate packaging components (delivery apparatus packaging, prosthetic valve packaging, crimping device packaging) into a single integrated packaging system. The tray structure consolidates all components into one standardized container, eliminating the need to handle multiple separate packages during preparation, thus reducing preparation time while maintaining organizational structure.
Solution Approach 2:
The packaging tray serves multiple functions: it acts as a shipping container, a storage container, and a preparation tray. The standardized tray design with specific recesses and positioning features enables all preparation steps (soaking, crimping, assembly) to be performed within the same container, eliminating the need to transfer components between different containers and maintaining sterility throughout the preparation process.
2Reliability
If multiple separate packages are used for delivery system components, then component protection during shipping is improved, but preparation procedure standardization deteriorates
Solution Approach 1:
The packaging tray incorporates specific localized features for each component: recesses for the delivery apparatus, positioning features for the crimping device, and designated areas for the prosthetic valve. Each component has its own optimized space within the standardized tray, ensuring proper protection during shipping while maintaining consistent preparation procedures across all uses.
3Ease of operation
If components are prepared outside a standardized tray, then ease of operation during preparation is improved, but sterility maintenance and component organization deteriorate
Solution Approach 1:
The packaging tray is designed to be self-contained for the entire preparation process. All necessary components (delivery apparatus, prosthetic valve, crimping device, soaking solution) are included within the tray, eliminating the need to introduce external objects or surfaces during preparation. The tray itself serves as the preparation environment, maintaining sterility while providing all necessary functions.
Data Source
AI summary
Packaging assemblies for a prosthetic valve delivery apparatus are described herein. As an example, an assembly can include a packaging tray comprising a plurality of recesses configured to receive components of a prosthetic valve delivery system, the tray having a first end portion, a second end portion, and a middle portion extending from the first end portion to the second end portion. The assembly includes a delivery apparatus disposed within a set of one or more first recesses of the tray such that a shaft of the delivery apparatus has a curved section forming a 180-degree bend along a distal half of the shaft, the curved section positioned within the first end portion, and a crimping device configured to be received within a second recess of the tray that is positioned within the middle portion, where a valve mounting portion of the delivery apparatus is adjacent the crimping device.