Plasma Anticoagulant Ratio Control for Consistent Plasmapheresis
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Solution Overview
Problem
The variation in plasma anticoagulant percentage during plasmapheresis procedures is influenced by donor characteristics, leading to inconsistencies in plasma quality due to dilution or clotting issues, affecting both plasma and platelet storage.
Innovation Solution
A method and system that utilize a programmable controller to calculate and adjust the anticoagulant-to-whole blood ratio (ACR) based on donor-specific hematocrit values, allowing for consistent plasma anticoagulant percentage through initial and potentially adjusted ACR settings during the procedure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a constant anticoagulant-to-whole blood ratio (ACR) is used during plasmapheresis, then the procedure is simple to operate, but the plasma anticoagulant percentage varies based on donor characteristics
Solution Approach 1:
The system dynamically adjusts the ACR based on real-time monitoring of plasma anticoagulant percentage and donor characteristics. The controller continuously modifies the anticoagulant flow rate to maintain target percentage despite variations in donor hematocrit and plasma flow rate, transforming a static constant-ratio approach into a dynamic adaptive system.
Solution Approach 2:
The system implements feedback control by monitoring the plasma anticoagulant percentage and using this information to adjust the ACR. The controller receives input about actual anticoagulant levels in the plasma product and modifies the anticoagulant-to-whole blood ratio accordingly to maintain the desired target percentage, creating a closed-loop control system.
2Stability of the object's composition
If the ACR is adjusted based on donor characteristics, then the plasma anticoagulant percentage consistency is improved, but the device complexity increases
Solution Approach 1:
The system performs self-adjustment by automatically calculating the optimal ACR based on donor characteristics and real-time plasma anticoagulant percentage measurements. The controller autonomously modifies operational parameters without requiring manual intervention from operators, allowing the system to self-regulate and maintain consistent anticoagulant levels despite donor variability.
Solution Approach 2:
The system changes operational parameters (ACR, anticoagulant flow rate) based on donor-specific characteristics such as hematocrit and plasma flow rate. By dynamically adjusting these parameters rather than using fixed values, the system adapts to individual donor variations while maintaining consistent plasma anticoagulant percentage.
3Reliability
If high anticoagulant percentage is used in plasma product, then clotting prevention is improved, but plasma quality deteriorates due to dilution
Solution Approach 1:
The system replaces fixed mechanical ratio settings with a controlled delivery mechanism that adjusts anticoagulant flow based on plasma flow rate and desired percentage. This substitution allows precise control of anticoagulant addition, ensuring sufficient levels for clotting prevention while minimizing unnecessary dilution that would compromise plasma quality.
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 a stable and consistent plasma anticoagulant percentage, improving plasma and platelet quality by minimizing variability and maintaining optimal storage conditions.
Implementation Method 1
The separation of the plasma from the cellular components is typically accomplished in an automated procedure by centrifugation or membrane filtration.
Implementation Method 2
whole blood is drawn from the donor, mixed at a specified ratio with anticoagulant (ACR)
Data Source
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AI summary
A method for performing plasmapheresis using a blood separating system including a fluid flow circuit, a blood separator, and a controller. The method includes inputting a hematocrit value for a donor, setting a desired plasma anticoagulant percentage for a plasma product, calculating an initial ratio of anticoagulant to whole blood (ACR), and performing a separation with the separation system. A system is also provided comprising a programmable controller having a screen for receiving input from an operator and configured to provide, based on operator input, an initial ACR and operate the system at the initial ACR.