Integrated Fluid Circuit for Platelet Pathogen Inactivation
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Solution Overview
Problem
Current pathogen inactivation kits require cumbersome and time-consuming sterilization and assembly processes due to the need for different sterilization methods for 'wet' and 'dry' components, which complicates the integration of platelet collection and inactivation components.
Innovation Solution
An integrated fluid processing system with a reusable hardware unit, pre-programmed controller, and disposable fluid circuit that allows for steam sterilization of all 'wet' components and radiation sterilization of 'dry' components, eliminating the need for separate connections by incorporating a rotating centrifuge, fluid processing cassettes, and a light-transmitting illumination/collection container, along with a method for combining photoactive agents and additive solutions within the system.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If different sterilization methods are used for wet and dry components, then sterilization effectiveness is improved, but assembly complexity and time increase
Solution Approach 1:
The system is divided into wet side components (flexible circuit, fluid pathways) and dry side components (electronic controls, housing), each sterilized by appropriate methods independently before final assembly, resolving the contradiction between sterilization effectiveness and assembly complexity
Solution Approach 2:
All sterilization processes are completed before final assembly of wet and dry sides. The wet side undergoes steam sterilization and the dry side undergoes radiation sterilization in advance, eliminating the need for complex post-assembly sterilization procedures
2Reliability
If separate connection of wet and dry sides is performed, then sterilization requirements are met, but processing time increases
Solution Approach 1:
The wet side and dry side are sterilized separately in advance using their respective optimal methods (steam for wet, radiation for dry), and then quickly connected through a sterile barrier breach mechanism, minimizing the time required for the connection process while maintaining sterilization compliance
Solution Approach 2:
A sterile barrier serves as an intermediary that allows the wet and dry sides to be prepared and sterilized separately, then connected through a controlled breach of the barrier, enabling parallel processing and reducing overall assembly time
3Ease of operation
If integrated fluid circuit is used, then assembly simplicity is improved, but manufacturing complexity increases
Solution Approach 1:
The fluid circuit is manufactured as an integrated unit with fluid pathways, filtration components, and connection interfaces pre-assembled and sterilized together, simplifying final system assembly while allowing modular manufacturing and quality control
Solution Approach 2:
The integrated fluid circuit serves multiple functions simultaneously: fluid transport, filtration, sterilization containment, and connection to both wet and dry sides, reducing the number of separate components needed and simplifying assembly
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
This solution streamlines the sterilization and assembly process, enabling efficient and integrated pathogen inactivation by allowing all 'wet' components to be steam sterilized and 'dry' components to be radiation sterilized, thereby simplifying the integration of platelet collection and inactivation components, reducing time and complexity.
Implementation Method 1
a processing chamber mounted on a rotor/spool of said centrifuge and having a sub-chamber, where blood or blood components can be separated under the influence of centrifugal force
Implementation Method 2
an illumination/collection container made of a material able to transmit light of a selected wavelength
Data Source
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AI summary
An integrated blood component collection and pathogen inactivation fluid circuit is disclosed.