Closed Bedside Cell Reinfusion Circuit Without Apheresis Disconnects
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Solution Overview
Problem
Existing blood processing systems require apheresis and involve complex fluid circuits that necessitate disconnection and reconnection of components, which complicates the processing and reinfusion of target cells to patients.
Innovation Solution
A bedside cell processing system with a continuous, pre-defined fluid circuit that processes whole blood without apheresis, allowing for direct connection and reinfusion of treated target cells to patients without disconnecting any part of the circuit, using a cell processing device and reinfusion system with integrated fluid pathways.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If apheresis-based systems are used to separate and process target cells, then target cell collection is achieved, but the fluid circuit requires disconnection and reconnection which increases system complexity and processing time
Solution Approach 1:
The patent applies preliminary action by pre-defining the fluid pathway and establishing a continuous closed circuit before processing begins. The reinfusion system is pre-configured with sterile connections that remain intact throughout the entire process, eliminating the need for mid-process disconnections and reconnections that would compromise sterility or increase complexity
Solution Approach 2:
The patent merges the collection and reinfusion functions into a single integrated continuous circuit. Instead of separate apheresis and reinfusion systems requiring disconnection, the fluid pathway is combined into one continuous loop that allows blood to flow from collection through processing directly to reinfusion without breaking the sterile barrier
2Productivity
If apheresis-based systems with disconnection are used, then target cell processing is completed, but the disconnection and reconnection process increases contamination risk and processing time
Solution Approach 1:
The patent implements continuity of useful action by maintaining an unbroken fluid circuit throughout the entire cell processing workflow. The pre-defined fluid pathway ensures continuous flow from blood collection through cell separation and processing directly to reinfusion, eliminating idle time during disconnection and reconnection operations while maintaining constant sterile conditions
3Reliability
If apheresis-based systems are used, then target cell separation is achieved, but the integrated apheresis and reinfusion flow paths increase system complexity
Solution Approach 1:
The patent applies segmentation by dividing the continuous fluid pathway into distinct functional modules (collection module, processing module, reinfusion module) that are pre-configured and connected in a predetermined sequence. This modular segmentation allows each component to be optimized independently while maintaining overall system simplicity through standardized pre-defined connections
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
Facilitates a sterile, continuous, and efficient processing and reinfusion of target cells, such as CAR-T cells, directly to patients, reducing the complexity and risk of contamination while maintaining sterility.
Implementation Method 1
separates and collects particular target cells... separates target cells from the whole blood
Data Source
AI summary
Systems and method for separating, collecting, treating target cells and infusing the treated target cells to a patient are disclosed. The closed system includes a pre-defined fluid pathway providing flow communication between a whole blood source and said patient.