Prosthetic Valve Packaging Tray for Pre-Assembled Delivery
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Solution Overview
Problem
The preparation and assembly of transcatheter heart valves and their delivery systems are complicated, time-consuming, and prone to human error, especially in the operating room, where multiple personnel are involved across sterile and non-sterile fields.
Innovation Solution
A packaging system that securely stores and transports a prosthetic valve and its delivery system, allowing for efficient handling and assembly by reducing steps and personnel, ensuring the correct sequence, and maintaining the valve in a compressed state without a liquid preservative solution, using a tray with a valve cover and engaging surfaces to stabilize the system.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If traditional separate packaging and preparation methods are used for prosthetic valves and delivery systems, then the assembly process requires multiple personnel and extensive steps, but this increases operating room time, complexity, and potential for human error
Solution Approach 1:
The patent combines the prosthetic valve and delivery system into a single integrated packaged unit. The delivery system is pre-assembled with the prosthetic valve in a compressed state within a sterile sealed pouch, eliminating the need for separate packaging and manual assembly steps in the operating room. This merging of components directly addresses the contradiction by improving assembly efficiency while reducing procedure complexity.
Solution Approach 2:
The delivery system and prosthetic valve are pre-assembled and pre-sterilized together in a controlled manufacturing environment before delivery to the operating room. The prosthetic valve is pre-compressed onto the delivery system in the correct configuration, and the entire assembly is sealed in a sterile pouch. This preliminary action eliminates time-consuming assembly steps during the procedure and reduces the risk of human error.
2Reliability
If the prosthetic valve is stored in a liquid preservative solution, then the valve remains hydrated and functional, but this increases packaging volume and complicates the preparation process
Solution Approach 1:
The patent changes the storage parameter from liquid immersion to compressed dry storage. The prosthetic valve is maintained in a compressed state within a sterile sealed pouch without liquid preservative solution. The valve's biological components are preserved through sterilization and sealing in a controlled atmosphere, eliminating the need for liquid storage while maintaining functionality.
Solution Approach 2:
The patent extracts the liquid preservative solution from the packaging system. Instead of storing the prosthetic valve in a liquid environment, the valve is stored in a dry compressed state within a sterile sealed pouch. This extraction of the liquid component reduces packaging volume and simplifies the preparation process while maintaining valve reliability through alternative preservation methods.
3Ease of manufacture
If multiple personnel are involved in the assembly process across sterile and non-sterile fields, then complex assembly tasks can be performed, but this increases the risk of human error and extends operating room time
Solution Approach 1:
The complex assembly of the prosthetic valve onto the delivery system is performed in advance during manufacturing, not during the surgical procedure. The pre-assembled unit is sterilized and packaged together as a single integrated component. This eliminates the need for multiple personnel to perform complex assembly maneuvers in the operating room, reducing human error while maintaining assembly quality.
Solution Approach 2:
The packaged system is designed to be self-contained and ready-to-use, requiring minimal manipulation during the procedure. The sterile sealed pouch maintains sterility without requiring complex transfer procedures between sterile and non-sterile fields. The system serves itself by maintaining its own sterility and configuration, reducing the need for multiple personnel and minimizing opportunities for human error.
Data Source
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AI summary
A packaging system for storing a prosthetic valve and an elongated delivery system in a non-fluid environment. The packaging system comprises a tray for securing both a prosthetic valve and an elongated delivery system. The tray includes a cavity sized and shaped to house a valve cover containing the prosthetic valve and at least part of the distal portion of the elongated delivery system. A mounting surface removably couples the valve cover to the cavity floor and to prevent the valve cover from moving. An engaging surface is disposed peripherally of the cavity and is elevated above the cavity floor. A ramp extends downwardly from the engaging surface and into the cavity through an opening defined in the peripheral side wall and adjacent the floor of the cavity. The engaging surface and ramp are configured to secure at least part of the elongated delivery system externally of the cavity.