Multiple Bag System for Sterile Blood Component Preparation
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current methods for preparing blood components are prone to microbial contamination, time-consuming, and lack effective traceability, making them unsuitable for large-scale production and therapeutic applications.
Innovation Solution
A system of multiple sterile bags connected via sterile connections allows for the preparation, storage, and traceability of blood components, maintaining sterility throughout the process and enabling easy assembly and disassembly without contamination, using a kit comprising bags for red blood cell separation, platelet-rich plasma, and platelet-poor plasma, with a traceability system and facilitated opening mechanism.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If multiple handling steps are used to prepare blood components in sterile bags, then the blood components can be separated and stored, but the risk of microbial contamination increases and the process becomes time-consuming
Solution Approach 1:
The system divides the blood component preparation process into multiple separate sterile bags, each dedicated to a specific function (collection, separation, storage). This segmentation allows parallel processing of different blood components while maintaining sterility in each isolated unit, reducing overall preparation time without compromising reliability.
Solution Approach 2:
The patent introduces sterile connections as intermediary elements that enable fluid transfer between bags while maintaining the sterile barrier. These connections act as mediators that allow necessary interactions between components without breaking sterility, thus reducing preparation time without increasing contamination risk.
2Productivity
If multiple handling steps are used to prepare blood components, then separation and storage are achieved, but the risk of microbial contamination increases
Solution Approach 1:
The system maintains a sterile, inert environment within each sealed bag throughout the preparation process. By creating isolated sterile compartments for each handling step, the patent enables efficient blood component separation while preventing microbial contamination from the external environment.
Solution Approach 2:
The patent employs disposable sterile bags and connections that are used once and then discarded. This approach allows for efficient, repeated blood component preparation without the need to sterilize equipment between uses, maintaining high productivity while eliminating cross-contamination risks between different preparation cycles.
3Reliability
If traditional sterile bags are used without opening mechanisms, then sterility is maintained, but the bags cannot be opened for product removal
Solution Approach 1:
The system incorporates pre-assembled sterile connections and opening mechanisms that are prepared in advance within the sterile packaging. These preliminary preparations allow the bags to be opened easily for product removal without compromising sterility, as the opening capability is built into the sealed sterile system before use.
4Adaptability or versatility
If assembly and disassembly of bags is required, then flexibility is improved, but contamination risk increases
Solution Approach 1:
The patent uses sterile connections as intermediary elements that enable flexible assembly and disassembly of the bag system while maintaining sterility. These specialized connectors allow bags to be joined or separated without breaking the sterile barrier, providing adaptability without compromising reliability.
Data Source
Figure 1
Figure 2
Figure 3
AI summary
The present invention relates to a biomedical device for the production, storage, traceability and administration of blood components.