Plasma Collection Control Using Donor-Specific Pure Volume Targets
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Solution Overview
Problem
Existing plasma collection systems fail to accurately determine the total volume of plasma collected, leading to variations in the percentage of plasma collected from different donors, as they rely on total collection volume rather than individual-specific parameters, violating regulatory limits and resulting in inconsistent plasma collection.
Innovation Solution
A method and system that calculates the volume of pure plasma by determining the donor's weight and hematocrit, using anticoagulant percentage and volume to tailor plasma collection, ensuring compliance with regulatory limits by stopping the process when a target volume of pure plasma is reached.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If prior art plasma collection systems collect based on total collection volume, then the collection process is simple to operate, but the accuracy of plasma volume measurement deteriorates leading to regulatory compliance issues
Solution Approach 1:
The system continuously monitors multiple parameters (total volume, anticoagulant volume, hematocrit) and uses this feedback to dynamically calculate and adjust the plasma volume measurement in real-time, ensuring both operational simplicity and measurement accuracy
Solution Approach 2:
The patent replaces direct mechanical measurement of plasma volume with a computational approach, using sensors to measure physical quantities (volumes, concentrations) and mathematical models to derive the plasma volume, thereby achieving high precision without complex mechanical measurement devices
2Device complexity
If prior art systems use fixed collection volume limits, then the system is easy to control, but the consistency of plasma collection percentage across different donors deteriorates
Solution Approach 1:
The system transitions from static fixed volume limits to dynamic adaptive collection targets, where the target plasma volume is calculated based on individual donor characteristics (weight, hematocrit, plasma volume estimates), allowing each donor to receive a personalized collection plan while maintaining overall system control
Solution Approach 2:
The patent changes the control parameter from fixed volume to variable percentage of plasma volume, using donor-specific parameters (weight, hematocrit, estimated plasma volume) to dynamically determine the collection target, thereby achieving consistency across different donors
3Measurement precision
If the system calculates pure plasma volume using multiple parameters, then the measurement precision improves, but the device complexity increases
Solution Approach 1:
The system segments the measurement process into distinct functional modules: volume measurement module, concentration measurement module, calculation module, and control module. Each module performs a specific function, making the overall complex system manageable and maintainable while achieving high measurement precision
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 consistent and compliant plasma collection by accurately measuring pure plasma volume, allowing for greater plasma collection within regulatory limits, reducing variability among donors.
Implementation Method 1
separate, using the blood component separation device, the withdrawn whole blood into a plasma component and at least a second blood component
Data Source
AI summary
A method for collecting plasma includes determining the weight, height, and hematocrit of a donor, and calculating a donor plasma volume and a target plasma collection volume. The target plasma collection volume is based on the donor plasma volume and a target percentage of plasma. The method then withdraws blood from the donor through a line connected to a blood component separation device, and introduces anticoagulant into the withdrawn blood. The blood component separation device separates the blood into a plasma component and a second blood component, and the plasma component is collected from the blood component separation device and into a plasma collection container. The method may then calculate the volume of pure plasma collected within the plasma collection container, and continue processing/collecting until the calculated volume of pure plasma equals the target plasma collection volume.


