Plasmapheresis Collection Volume Optimization Using Donor Hematocrit
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Solution Overview
Problem
Existing plasmapheresis systems are inefficient in maximizing plasma collection from donors due to the exclusion of donor hematocrit in determining collection volume, leading to suboptimal plasma volume collection that could be safely achieved, thereby reducing the overall efficiency of plasma collection centers.
Innovation Solution
An automated system and method that accounts for donor-specific characteristics, particularly hematocrit, to adjust and recalibrate the plasma collection volume during the procedure, ensuring the maximum safe plasma volume is collected by using a modified nomogram and real-time hematocrit monitoring, thereby optimizing plasma collection.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the FDA nomogram is used to determine plasma collection volume based on donor weight only, then donor safety is ensured, but plasma collection efficiency is reduced
Solution Approach 1:
The system changes the parameters used for volume determination from weight-only (FDA nomogram) to a comprehensive model incorporating weight, height, sex, age, and hematocrit. This allows the collection volume to be optimized for each donor's physiological characteristics, maximizing plasma yield while maintaining safety margins through validated physiological relationships.
Solution Approach 2:
The system performs preliminary calculations of total blood volume and plasma volume before the procedure based on donor demographics and hematocrit. This pre-determination of optimized collection volumes allows the system to plan and execute maximum safe collection from the outset, avoiding under-collection while ensuring donor safety through validated physiological models.
2Ease of operation
If collection volume is limited by FDA nomogram without considering hematocrit, then procedure simplicity is maintained, but plasma volume collected is suboptimal
Solution Approach 1:
The system automatically calculates optimized collection volumes using the integrated physiological model and donor characteristics. The processor autonomously determines total blood volume, plasma volume, and maximum safe collection limits without requiring manual nomogram lookup or complex calculations by operators, maintaining procedural simplicity while achieving optimized plasma collection.
Solution Approach 2:
The system incorporates hematocrit as an additional parameter beyond the traditional weight-based nomogram. By integrating hematocrit into the volume calculation model, the system adjusts collection targets to reflect the actual plasma content of donor blood, thereby increasing plasma volume collected without complicating the operational workflow.
3Reliability
If higher hematocrit donors are collected using FDA nomogram limits, then donor safety is maintained, but plasma yield is reduced
Solution Approach 1:
The system explicitly incorporates hematocrit as a key parameter in volume determination. For high hematocrit donors, the model calculates their actual plasma volume based on the relationship between hematocrit, total blood volume, and plasma fraction. This allows the system to set collection limits that reflect the true plasma availability in high hematocrit donors, maximizing plasma yield while maintaining safety through physiologically-based calculations.
Solution Approach 2:
The system performs preliminary assessment of donor hematocrit and uses it to pre-calculate the actual plasma volume available for collection. This pre-planning based on hematocrit allows the system to optimize collection targets for high hematocrit donors before the procedure begins, ensuring maximum plasma recovery while maintaining donor safety through validated physiological relationships.
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
The system enhances plasma collection efficiency by ensuring that the maximum allowable plasma volume is collected from each donor, improving the overall yield of plasma proteins while maintaining donor safety and comfort.
Implementation Method 1
The separation of the plasma from the cellular components is typically accomplished in an automated procedure by centrifugation or membrane filtration
Data Source
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AI summary
A plasmapheresis system and a method for operating a plasmapheresis system are provided by which the volume/weight of anticoagulated plasma that is collected is optimized. In one example, a nomogram is provided that utilizes the donor's hematocrit to calculate the volume/weight of raw plasma within a plasma product having the maximum volume permitted by the FDA nomogram. In a plasmapheresis procedure having multiple collection phases followed by a reinfusion cycle in which concentrated red blood cells are returned to the donor, the volume of plasma product to be collected is calculated prior to the start of each collection cycle to account for the donor's increasing hematocrit, thus resulting in a greater total volume of plasma product to be collected during the plasmapheresis procedure.