Aseptic Tissue Processing Kit with Segmented Modules
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Solution Overview
Problem
Current solid tissue processing methods are labor-intensive, require skilled personnel, and pose risks of contamination due to the need for manual handling in non-aseptic conditions, making them unsuitable for efficient and safe processing of cells for therapeutic and research purposes.
Innovation Solution
A semi-automatic aseptic kit and device system that includes a disaggregation module, an enrichment module, and a stabilization module, with flexible containers and conduits for aseptic processing, allowing for closed-system processing and reduced operator exposure, using radio frequency identification tags for automated processing protocols.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual handling methods are used for solid tissue processing, then flexibility and adaptability are maintained, but contamination risk increases and operator safety deteriorates
Solution Approach 1:
The patent introduces an automated processing system as an intermediary between the operator and the tissue sample. The system includes automated disaggregation, enrichment, and stabilization modules that handle the tissue without direct operator contact, thereby preventing contamination while maintaining processing effectiveness.
Solution Approach 2:
The patent replaces manual mechanical handling with automated mechanical systems. The automated device performs tissue disaggregation, cell enrichment, and sample stabilization through programmed mechanical actions, eliminating the need for operators to manually manipulate potentially contaminated materials.
2Ease of operation
If automated processing systems are implemented, then contamination risk is reduced, but device complexity and initial operational difficulty increase
Solution Approach 1:
The automated processing system is divided into distinct functional modules: disaggregation module, enrichment module, and stabilization module. Each module performs a specific function and can be independently controlled, making the overall complex system manageable through modular design.
Solution Approach 2:
The automated processing device is designed to perform multiple functions within a single integrated system. It can handle disaggregation, enrichment, and stabilization of various tissue types, making it a universal platform that reduces the need for multiple separate devices.
3Reliability
If closed-system processing is used, then aseptic conditions are maintained, but processing time and system complexity increase
Solution Approach 1:
The closed-system processing allows continuous operation without interruption for sterilization or contamination control. The system maintains aseptic conditions throughout the entire processing sequence, enabling uninterrupted disaggregation, enrichment, and stabilization operations.
Solution Approach 2:
The system performs preliminary sterilization and preparation of all components before processing begins. The closed system is pre-sterilized and maintained in an aseptic state throughout operation, eliminating the need for repeated sterilization cycles during processing.
Data Source
AI summary
This present invention concerns a single use aseptic kit comprising: a disaggregation module for receipt and processing of material comprising solid mammalian tissue; and a stabilization module for storing disaggregated product material, wherein each of said modules comprises one or more flexible containers connected by one or more conduits adapted to enable flow of the tissue material there between; and wherein each of said modules comprises one or more ports to permit aseptic input of media and/or reagents into the one or more flexible containers. The invention further relates to an automated device for semi-automated aseptic disaggregation and/or enrichment and/or stabilisation of cells or cell aggregates from mammalian solid tissue comprising a programmable processor and the single use aseptic kit. The invention further relates to a semi-automatic aseptic tissue processing method.