Plasmapheresis Anticoagulation Control for Higher Plasma Yield
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing plasmapheresis methods face challenges in maximizing the collection of plasma, particularly Immunoglobulin G (IgG), while balancing the need for sufficient anticoagulation to prevent coagulation and flocculation, and the inefficiency of fixed anticoagulant ratios leading to excess anticoagulant in the collected plasma.
Innovation Solution
A method involving selective addition and adjustment of anticoagulant volume and concentration, combined with real-time monitoring of IgG levels using a refractometer, to optimize plasma collection and maximize IgG yield.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a fixed ratio of anticoagulant to whole blood is used, then sufficient anticoagulation is achieved, but excess anticoagulant contaminates the collected plasma reducing its purity and yield
Solution Approach 1:
The patent applies dynamic adjustment of anticoagulant addition by monitoring activated clotting time (ACT) in real-time during plasmapheresis. The anticoagulant flow rate is continuously adjusted based on ACT measurements rather than using a fixed ratio, allowing the system to adapt to varying blood flow rates and donor characteristics. This dynamic approach prevents both under-anticoagulation and excessive anticoagulant contamination of plasma.
Solution Approach 2:
The system implements feedback control by measuring ACT of the blood-anticoagulant mixture and using this information to adjust anticoagulant addition. The ACT monitor provides continuous feedback on coagulation status, and the controller modifies anticoagulant flow accordingly. This closed-loop feedback system ensures optimal anticoagulation while minimizing plasma contamination.
2Stability of the object's composition
If more anticoagulant is added to prevent coagulation and flocculation, then blood components remain stable, but the volume of useful plasma collected decreases
Solution Approach 1:
The patent applies partial action by adding anticoagulant only to the extent necessary for preventing coagulation, as determined by ACT monitoring. Rather than using excessive anticoagulant to ensure stability, the system adds the minimum required amount dynamically adjusted to maintain just-sufficient anticoagulation. This prevents over-anticoagulation while maintaining blood component stability throughout the procedure.
Solution Approach 2:
The system changes the parameter of anticoagulant concentration and flow rate dynamically during plasmapheresis based on ACT measurements. By adjusting these parameters in real-time rather than maintaining a constant high level, the system maintains blood stability while minimizing the total amount of anticoagulant that contaminates collected plasma.
3Ease of operation
If anticoagulant is added at a fixed ratio at the beginning of the procedure, then the process is simple, but it cannot adapt to variations in donor blood characteristics and flow rates
Solution Approach 1:
The system applies self-service by using the donor's own blood characteristics (monitored via ACT) to automatically determine the appropriate anticoagulant dosage. The ACT monitor and controller work together to self-adjust anticoagulant flow based on real-time blood coagulation status, eliminating the need for manual calculation and adjustment by the operator while adapting to each donor's unique characteristics.
Solution Approach 2:
The patent replaces manual judgment and mechanical adjustment with an automated electronic control system. The ACT monitor electronically measures coagulation status, and the controller automatically adjusts anticoagulant pump flow rates based on these measurements. This substitution of manual operation with automated sensing and control maintains simplicity of use while dramatically improving adaptability to donor variations.
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
Enhances plasma collection efficiency by reducing excess anticoagulant volume and tailoring the procedure to individual donor IgG levels, thereby increasing the amount of IgG collected within regulatory limits.
Implementation Method 1
measuring the total plasma protein level in a donor
Implementation Method 2
separating the anticoagulated blood into plasma and red cells
Data Source
AI summary
Methods and systems for the automated collection of plasma from a donor are disclosed. The methods and systems deliver anticoagulant to whole blood and/or to selected and separated components at selected times to provide a sufficient amount of anticoagulant to the selected components to prevent coagulation and/or flocculation. The methods and systems limit the amount of anticoagulant returned to the donor and maximize the amount of collected plasma. Methods and systems for maximize the collection of IgG based on a measured level of total plasma protein are also disclosed.