Blood Component Separation Control With Pre-Process Evaluation
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Solution Overview
Problem
Existing biological fluid processing systems rely on empirical assumptions that may not accurately reflect the conditions of the actual processing, leading to potential inefficiencies and unsafe operations due to lack of precise data and operator experience.
Innovation Solution
A blood processing system with reusable hardware and disposable fluid circuits, equipped with a controller that performs pre-process calculations and checks, providing real-time feedback and warnings to ensure accurate volume collection and safe operation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If pre-process calculations and real-time monitoring are implemented, then processing accuracy and safety are improved, but device complexity increases
Solution Approach 1:
The system performs pre-process calculations before the actual separation process to determine expected volumes, times, and conditions. This allows the system to prepare monitoring parameters and safety thresholds in advance, improving accuracy without adding real-time computational complexity during the actual process.
Solution Approach 2:
The system continuously monitors actual process parameters (volume, time, pressure) and compares them against pre-calculated expectations and preset ranges. When deviations are detected, the system provides feedback to the operator through warnings and alerts, enabling corrective action while maintaining automated monitoring.
2Reliability
If multiple sensors and monitoring systems are added, then operational safety is improved, but device complexity increases
Solution Approach 1:
The control unit serves multiple functions: it controls the separation process, monitors sensor data, performs pre-process calculations, stores process parameters, and interfaces with the operator. This multi-functionality reduces the need for separate dedicated components for each function, improving safety without proportionally increasing complexity.
Solution Approach 2:
The system automatically monitors itself through integrated sensors that track process parameters without requiring external monitoring equipment. The control unit self-diagnoses and provides warnings when parameters deviate from expected ranges, enabling the system to monitor its own safety without additional complex external systems.
3Manufacturing precision
If real-time monitoring and warnings are implemented, then process control is improved, but loss of time increases
Solution Approach 1:
The system provides real-time feedback through warnings and alerts when process parameters approach unsafe ranges or deviate from expected values. This allows the operator to take corrective action proactively, preventing process failures and interruptions before they occur, thereby maintaining precision while minimizing actual process downtime.
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
Ensures uniform and safe processing by preventing damage to materials and producing products that meet specifications, while alerting operators to deviations during operation.
Implementation Method 1
Separation devices may separate the biological fluid based on centrifugal separation
Implementation Method 2
Separation devices may separate the biological fluid based on centrifugal separation and/or, as described below, membrane separation
Implementation Method 3
a weight scale configured to weigh the product container
Implementation Method 4
check the air detector sensor for a fluid/air interface
Data Source
AI summary
A cell processing system includes a processor connectable to a source container filled with a biological fluid, the processor including a separator configured to separate the biological fluid from the source container into at least two streams according to a process including at least one process parameter, and a controller coupled to the processor and an input. The controller is configured to receive the at least one process parameter, to evaluate the process using the at least one process parameter before performing the process, and to carry out one or more actions based on the evaluation, such as providing an output estimate to the operator, preventing the process from being performed according to a comparison between a calculated condition and a control, or providing an error indication to the operator according to the calculated condition and a measured in-process condition.