Microfluidic Cell Separation Cassette for Closed Sterile Processing
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Solution Overview
Problem
Current systems for separating target cells from patient samples face challenges such as the need for human intervention, which compromises sterility, and they often have moving parts that can cause contamination and reduce throughput.
Innovation Solution
A closed-end system using microfluidic cartridges and cassettes with integrated channels and recirculating pathways for continuous processing, eliminating the need for human intervention and ensuring sterility, while using peristaltic pumps and sensors to manage fluid flow and prevent contamination.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If human intervention is used during sample processing, then operational flexibility is improved, but sterility of the environment and product solution deteriorates
Solution Approach 1:
The system enables self-service operation through automated fluid handling, recirculation, and separation processes. The microfluidic device automatically processes samples without requiring manual intervention during the separation phase, maintaining sterility while achieving operational goals through self-contained automation.
Solution Approach 2:
The patent replaces manual mechanical operations with automated microfluidic systems. The microfluidic device uses integrated pumps, valves, and separation channels to automate the separation process, eliminating the need for human hands to manipulate sterile samples and thereby maintaining sterility.
2Ease of operation
If moving parts are used throughout the separation process, then operational control is improved, but the possibility of failure and contamination increases
Solution Approach 1:
The patent extracts moving parts from the sterile separation environment. The microfluidic device isolates mechanical components (pumps, valves) in non-sterile zones and uses only fixed, sterile structures within the separation chamber, eliminating contamination risks from moving parts while maintaining operational control through external actuation.
Solution Approach 2:
The system uses an intermediary sterile barrier (the microfluidic membrane or channel structure) that separates the sterile separation zone from the non-sterile control zone. Moving parts operate externally to this barrier, controlling the process without physically present in the sterile environment, thus preventing contamination.
3Productivity
If traditional separation systems are used, then processing capability is achieved, but throughput of the sample solution decreases
Solution Approach 1:
The patent merges multiple functions (fluid delivery, mixing, separation, collection) into a single integrated microfluidic device. This consolidation eliminates the need for multiple separate processing steps and equipment, thereby increasing throughput while managing complexity through functional integration rather than multiplication of components.
Solution Approach 2:
The microfluidic device transitions from traditional bulk-phase separation to micro-scale channel flow, utilizing a different dimensional approach (microfluidics vs. macrofluidics). This dimensional change enables continuous flow processing with higher throughput by processing samples in parallel micro-channels rather than sequential bulk operations.
4Quantity of substance
If recirculation is used to concentrate target particles, then concentration is improved, but processing time increases
Solution Approach 1:
The system implements continuous recirculation flow where target particles continuously pass through the separation zone multiple times. This continuous action concentrates particles efficiently by repeatedly exposing the same fluid volume to the separation mechanism, achieving high concentration without the need for batch processing interruptions.
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 achieves high-throughput, sterile separation of target cells with enhanced recovery and viability, reducing inflammatory cytokine release and improving the quality of therapeutic immune cell populations.
Implementation Method 1
the at least one embedded channel comprising a plurality of obstacles
Implementation Method 2
using peristaltic pumps and sensors to manage fluid flow
Data Source
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AI summary
Described herein are systems and methods for generating a product enriched in one or more target particles, comprising a cassette to which the one or more microfluidic cartridges are releasably coupled and supported, the cassette comprising (i) a plurality of input containers releasably and fluidically coupled thereto, wherein at least one of the plurality of input containers comprises an incoming sample, (ii) a plurality of outlets having a plurality of output containers releasably and fluidically coupled thereto, (iii) one or more microfluidic cartridges for separating one or more target particles from the sample, and (iv) a plurality of fluidic channels extending between the plurality of inlets, the plurality of outlets, and the one or more microfluidic cartridges, wherein the cassette having the plurality of input containers, the plurality of output containers, and the one or more microfluidic cartridges coupled thereto, collectively provides a closed end-to-end sterile environment that enables inline continuous processing of the incoming sample without external manual handling or intervention, so as to generate a product that is enriched in one or more target particles and free of contamination.