Custom Cell Processing Protocols for Flexible Apheresis Phases
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Solution Overview
Problem
Existing apheresis and cell processing systems have limited flexibility, as they follow pre-defined protocols, restricting their application beyond their original use and not allowing users to customize processing phases and parameters according to specific needs.
Innovation Solution
A method and system that enable users to create custom cell processing protocols by selecting and modifying processing phases and parameters, including flow direction, centrifuge speed, pump speed, and end point criteria, using a display interface, and generating a custom protocol algorithm based on these selections and modifications, which can be validated and optimized for specific applications.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If pre-defined protocols are used in apheresis and cell processing systems, then system reliability and ease of operation are improved, but adaptability and versatility deteriorate
Solution Approach 1:
The system transitions from static pre-defined protocols to dynamic customizable protocols. Users can modify processing phases, parameters, and sequences according to specific application requirements while the system maintains automated control. This allows the system to adapt to different cell processing needs (e.g., academic research, cell therapy) without sacrificing operational reliability through automation.
Solution Approach 2:
The system enables parameter changes within processing phases while maintaining overall protocol structure. Users can adjust specific parameters such as processing speed, wash volume, starting volume, and other phase-specific parameters to optimize performance for different applications, thereby improving adaptability while preserving system reliability through controlled modification capabilities.
2Ease of operation
If pre-defined protocols are used in apheresis and cell processing systems, then ease of operation is improved, but adaptability deteriorates
Solution Approach 1:
The protocol is segmented into discrete processing phases that can be independently selected and modified. Each phase contains specific parameters that can be customized without affecting the entire protocol structure. This segmentation allows users to easily operate the system by selecting from predefined phase templates while adapting specific phases to meet diverse application requirements.
Solution Approach 2:
The system creates a universal protocol framework that can serve multiple functions across different applications. By allowing customization of processing phases and parameters within a standardized structure, the system becomes versatile enough to handle various cell processing needs (academic research, clinical cell therapy, different blood product preparations) while maintaining ease of operation through a unified interface.
3Adaptability or versatility
If custom protocols are created by allowing users to select and modify processing phases and parameters, then adaptability and versatility are improved, but device complexity increases
Solution Approach 1:
The system provides pre-configured processing phases with default parameters that users can select without extensive configuration. These preliminary setups reduce the complexity of creating custom protocols, as users only need to modify specific parameters rather than building protocols from scratch. This maintains versatility while managing device complexity through pre-established templates.
Solution Approach 2:
The system allows users to copy existing processing phases and protocols as templates for customization. Instead of creating entirely new protocols, users can replicate proven configurations and make targeted modifications, thereby achieving versatility across different applications without increasing operational complexity. The copying function preserves successful protocol structures while enabling adaptation to new requirements.
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 approach allows for tailored protocols that enhance the flexibility and applicability of apheresis and cell processing systems, enabling them to be used in various applications, including academic and cell therapy settings, by reducing variability and improving automation, while ensuring safety through validation and pre-set application modes.
Implementation Method 1
blood component separation device
Data Source
AI summary
A method for creating a custom cell processing protocol includes providing a cell processing device having a display, a blood component separation device, and a pump. The method may then select, using the display, a first and second processing phase. The first processing phase has a plurality of first processing phase parameters and the second processing phase has a plurality of second processing phase parameters. The method may then modify the first and second processing phase parameters using the display, and create a custom protocol algorithm. The algorithm may be based, at least in part, on the selected first and second processing phases and the modified first and second processing phase parameters