Plasma Collection Programming Using Hematocrit-Based Volume Control
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Solution Overview
Problem
Existing plasmapheresis devices inefficiently collect plasma due to the exclusion of donor hematocrit in determining collection volume, leading to suboptimal plasma collection and potential safety risks, despite FDA guidelines for maximum collection volumes.
Innovation Solution
A modified nomogram that accounts for donor hematocrit to calculate the maximum allowable plasma volume, adjusting the target volume based on hematocrit and anticoagulant ratio, and recalculating before each extraction phase to ensure safe and efficient 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 alone, then donor safety is ensured, but plasma collection efficiency is reduced due to exclusion of hematocrit considerations
Solution Approach 1:
The invention changes the parameters used for determining collection volume from weight-only to a combination of weight and hematocrit. The system dynamically adjusts the collection volume parameter based on the donor's hematocrit level, allowing higher volumes for donors with lower hematocrit and lower volumes for those with higher hematocrit, thereby optimizing plasma collection efficiency while maintaining safety margins.
Solution Approach 2:
The invention implements a dynamic collection volume determination process where the target volume is not fixed but adjusts based on real-time donor characteristics. The system recalculates the appropriate collection volume during the procedure based on measured hematocrit values, enabling adaptive optimization of plasma collection while ensuring donor safety throughout the procedure.
2Ease of operation
If a fixed anticoagulant ratio of 1:16 is used as per FDA guidelines, then procedure standardization is achieved, but plasma collection volume is suboptimal for donors with varying hematocrit levels
Solution Approach 1:
The invention modifies the anticoagulant ratio parameter from a fixed 1:16 ratio to a variable ratio that adjusts based on the donor's hematocrit level. The system calculates an optimized anticoagulant-to-blood ratio that accounts for the donor's specific hematocrit, allowing for more efficient plasma collection while maintaining adequate anticoagulation to prevent clotting throughout the procedure.
3Adaptability or versatility
If manual programming of collection parameters is performed, then flexibility in adjusting for individual donor characteristics is possible, but operator error increases leading to safety risks
Solution Approach 1:
The invention enables the system to automatically determine and program the appropriate collection parameters based on donor characteristics. The system self-calculates the optimal collection volume and anticoagulant ratio by inputting the donor's weight and hematocrit, eliminating the need for manual parameter programming by operators while maintaining the flexibility to account for individual donor variations.
Solution Approach 2:
The invention implements a feedback mechanism where the system automatically measures the donor's hematocrit during the procedure and uses this information to adjust the collection parameters. This closed-loop approach ensures that the collection volume and anticoagulant ratio are continuously optimized based on actual donor characteristics rather than relying on manual estimates or fixed protocols.
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
Maximizes the collection of raw plasma within FDA limits, reducing operator errors and enhancing plasma collection efficiency by accurately adjusting for individual donor characteristics.
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
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 system and method for collecting plasma includes drawing whole blood from a donor, combining anticoagulant with the whole blood from the donor, separating the whole blood into a plasma product and a second blood component and sending the plasma product to a collection container. A controller receives parameters over a network from a remote computer, receives a user input to confirm the a parameter and/or procedure, determines a target volume for plasma product and/or raw plasma based on the parameters and, in response to confirming the donor, controls the system to collect the plasma using draw and return phases.