Dual-Chamber BAO Packaging for Sterile Nutrient Submersion
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Solution Overview
Problem
Existing packaging systems for bioartificial organs (BAOs) fail to maintain sterility, provide mechanical protection, and facilitate surgical transfer while ensuring continuous submersion in liquid nutrients during storage and transport.
Innovation Solution
A biomedical packaging system with a dual-chamber design, including a liquid nutrient chamber and a gas-free chamber separated by a baffle, featuring a port and closure system for maintaining sterility and enabling surgical transfer, using materials like polycarbonate and polyesters for durability and transparency.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If a single-chamber packaging system is used, then the device complexity is reduced, but the ability to maintain liquid and gas isolation is compromised
Solution Approach 1:
The packaging system is divided into two separate chambers: a first chamber for liquid nutrient media and a second chamber for gas phase storage. This segmentation allows independent control and maintenance of liquid and gas environments, ensuring proper isolation while providing specialized conditions for the BAO during storage and transport.
2Device complexity
If the BAO is packaged without a baffle structure, then the device complexity is reduced, but the ability to maintain proper liquid level and prevent gas intrusion is compromised
Solution Approach 1:
A baffle structure with a controlled port is introduced as an intermediary element between the liquid and gas chambers. The baffle maintains liquid level in the first chamber while the port allows controlled gas exchange. This intermediary structure ensures reliable liquid-gas isolation while enabling necessary gas flow for BAO viability.
3Reliability
If the packaging system includes multiple chambers and sealing components, then the sterility and mechanical protection are improved, but the ease of operation during surgical transfer is reduced
Solution Approach 1:
The packaging system is pre-configured with a removable cap, closure system, and pre-positioned baffle structure before sterilization and BAO placement. This preliminary arrangement ensures that during surgical transfer, the clinician only needs to perform simple sequential actions: remove cap, transfer BAO, and resecure closure, maintaining sterility while simplifying the surgical workflow.
4Strength
If the packaging system uses a secure closure system with multiple sealing components, then the mechanical protection is improved, but the device complexity increases
Solution Approach 1:
The closure system integrates multiple functions into a single removable cap assembly: the cap itself provides sealing against the chamber, incorporates a port closure for gas control, and includes engagement features for secure attachment. This merging of functions maintains strong sealing integrity while reducing the number of separate components and simplifying the overall closure mechanism.
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 system ensures sterility and mechanical protection of BAOs, allowing continuous submersion and facilitating safe surgical transfer by maintaining a sterile environment and providing mechanical support during transport.
Implementation Method 1
a baffle including a port, configured to separate the chambers
Implementation Method 2
the second chamber is sealed with a non-permeable membrane on or over the flange
Implementation Method 3
the baffle can be configured to vent gas during the filling of the first chamber with liquid
Data Source
AI summary
Embodiments of the present disclosure are directed to a biomedical packaging system which may include an assembly/primary packaging having one chamber configured to hold liquid nutrient media, as well as a bio-artificial organ (BAO), and another chamber arranged adjacent to the first compartment configured to be substantially liquid-free. The system can further include a baffle including a port, configured to separate the first chamber from the second chamber, as well as a storage container/secondary packaging.


