Plasma Collection with Remote Programming and Hematocrit Adjustment
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Solution Overview
Problem
Current plasmapheresis systems are inefficient in collecting the maximum volume of raw plasma from donors due to the exclusion of donor hematocrit in determining plasma collection volumes, leading to suboptimal plasma collection and potential donor safety issues.
Innovation Solution
A modified nomogram that accounts for the donor's hematocrit to calculate the target plasma volume, adjusting the anticoagulant ratio and recalculating the plasma collection volume before each extraction phase to maximize the raw plasma volume collected while ensuring donor safety and comfort.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If the FDA nomogram is used to determine plasma collection volume without considering donor hematocrit, then the procedure is simple and easy to operate, but the plasma collection efficiency is reduced and maximum raw plasma volume cannot be collected
Solution Approach 1:
The system dynamically changes the plasma collection volume parameter based on the donor's hematocrit value. By incorporating hematocrit into the volume calculation, the system adjusts the collection parameters to optimize plasma extraction while maintaining donor safety, thereby improving collection efficiency without requiring complex manual calculations.
Solution Approach 2:
The plasmapheresis system automatically calculates the optimal plasma collection volume by integrating hematocrit data into its control algorithm. This self-adjusting capability eliminates the need for manual nomogram lookups and calculations by operators, improving efficiency while keeping the procedure straightforward through automated decision-making.
2Measurement precision
If manual calculation and entry of plasma collection parameters is used, then operator control is maintained, but operator errors occur and suboptimal plasma collection results
Solution Approach 1:
The system implements feedback by automatically using the donor's hematocrit value to adjust plasma collection volume calculations. This closed-loop approach ensures that the collection parameters are continuously optimized based on actual donor characteristics, improving measurement precision while eliminating manual calculation errors through automated feedback-driven adjustments.
Solution Approach 2:
The system replaces manual mechanical calculation methods (nomogram lookups and hand calculations) with automated computational algorithms. This substitution eliminates operator errors in volume determination while maintaining full operator control through the ability to review and adjust automated recommendations, thereby improving accuracy without compromising ease of operation.
3Productivity
If a fixed anticoagulant ratio is used for all donors, then the procedure is standardized and easy to perform, but optimal plasma volume cannot be achieved for donors with different hematocrit levels
Solution Approach 1:
The system transitions from a static, fixed anticoagulant ratio to a dynamic ratio that adjusts based on the donor's hematocrit value. This dynamic adaptation allows the system to optimize plasma collection for each individual donor while maintaining procedural standardization through automated control, thereby improving productivity without sacrificing adaptability.
Solution Approach 2:
The system changes the anticoagulant ratio parameter based on measured hematocrit values. By making this parameter adaptive rather than fixed, the system achieves optimal plasma volume collection for donors with varying hematocrit levels while maintaining ease of operation through automated parameter adjustment, resolving the contradiction between productivity and adaptability.
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
This approach allows for the collection of the maximum allowable raw plasma volume, improving plasma collection efficiency and reducing the risk of operator errors by automating the calculation of optimal plasma collection parameters based on donor-specific 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
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.