Dry Heart Valve Packaging with Dual Sterile Oxidation Barriers
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Solution Overview
Problem
Existing packaging methods for dry bioprosthetic heart valves suffer from oxidation and structural damage during sterilization and storage, leading to decreased mechanical and biochemical functionality.
Innovation Solution
A double sterile barrier packaging system that stabilizes dry bioprosthetic heart valves using gas-permeable and gas-impermeable containers to prevent oxidation during long-term storage, allowing for efficient gas sterilization without liquid preservatives.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If dry bioprosthetic heart valves are sterilized using traditional methods (ethylene oxide, gamma irradiation, or electron beam irradiation), then sterilization is achieved, but oxidation damage occurs leading to decreased mechanical and biochemical functionality
Solution Approach 1:
The patent employs an inert atmosphere packaging system where the heart valve is sealed in a container filled with inert gas (such as nitrogen or argon) after sterilization. This inert environment prevents oxidation by excluding oxygen from contact with the sterilized valve, thereby preserving its mechanical and biochemical functionality while maintaining sterilization effectiveness.
Solution Approach 2:
The patent extracts the harmful oxygen from the packaging environment by replacing air with inert gas. This removal of the oxidizing agent (oxygen) eliminates the source of oxidation damage while preserving the sterilized state of the heart valve, resolving the contradiction between sterilization and prevention of oxidation damage.
2Reliability
If liquid preservatives (such as glutaraldehyde) are used during storage, then preservation is achieved, but toxicity and calcification effects occur
Solution Approach 1:
The patent completely removes liquid preservatives from the storage system. Instead of using glutaraldehyde or other chemical preservatives that cause toxicity and calcification, the invention relies on the inert gas atmosphere and sterile packaging to preserve the heart valve, eliminating harmful chemical substances while maintaining preservation effectiveness.
Solution Approach 2:
The patent employs a disposable sterile packaging system with inert gas that provides preservation without requiring long-term chemical preservatives. The packaging itself serves as a short-term protective barrier that maintains sterility and prevents oxidation during storage and transport, replacing the need for toxic liquid preservatives.
3Device complexity
If a single sterile barrier packaging is used, then packaging simplicity is maintained, but protection against oxidation and contamination during long-term storage is insufficient
Solution Approach 1:
The patent employs a nested packaging structure where the heart valve is first sealed in an inner sterile container, which is then placed within an outer container filled with inert gas. This nested arrangement provides multiple protective barriers: the inner container maintains initial sterility while the outer inert gas environment prevents oxidation during long-term storage, enhancing protection effectiveness without excessive complexity.
Solution Approach 2:
The packaging system is segmented into distinct functional layers: an inner sterile barrier layer that prevents contamination and an outer inert gas layer that prevents oxidation. This segmentation allows each layer to perform its specific protective function optimally, providing comprehensive protection while maintaining reasonable packaging simplicity.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The packaging system effectively prevents oxidation and maintains the structural integrity of dry bioprosthetic heart valves, ensuring their mechanical and biochemical functionality during storage and transit.
Implementation Method 1
gas-permeable and gas-impermeable containers to prevent oxidation during long-term storage, allowing for efficient gas sterilization
Implementation Method 2
prevents oxidation of the implant during long-term storage
Data Source
AI summary
Packaging for prosthetic heart valves including an assembly for stabilizing dry prosthetic tissue implants such as heart valves during storage. The packaging assembly includes a primary sterile barrier that permits gas sterilization of the tissue implant, and a secondary sterile barrier that also prevents oxidation of the implant during long-term storage. Tissue heart valves may be placed or suspended within a cavity of an inner rigid tray with a gas-permeable lid sealed thereon, and a cap placed over the cavity to limit movement of the valve therein. The inner tray is placed within an outer sterile barrier, such as another rigid tray or a flexible pouch, and the assembly is then sterilized. The outer sterile barrier may include a double seal so that a first gas-permeable seal can be closed for sterilization, after which a second gas-impermeable seal can be closed to seal out any further oxygen contact with the tissue implant. Alternatively, the inner tray may be placed within a sterile pouch and the assembly gas-sterilized, and then the entire assembly is placed within another pouch that provides an impermeable barrier to the surrounding atmosphere to prevent oxidation of the tissue implant.