Plasma Collection Control Using Donor Extracellular Fluid Estimates
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Solution Overview
Problem
Existing plasmapheresis systems fail to optimize the volume of plasma collected from donors, adhering to FDA guidelines, which limits the overall plasma volume available for pooling.
Innovation Solution
A system and method that calculates a target plasma volume based on donor-specific parameters, such as weight and hematocrit, using a control circuit to adjust the plasmapheresis process to maximize the collection of plasma while ensuring donor safety and comfort, incorporating a reusable component with a control circuit and disposable kit for precise separation and reinfusion of blood components.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If the plasma collection volume is increased to maximize pooled plasma volume, then the total plasma volume available for pooling is improved, but the donor safety and comfort may be compromised
Solution Approach 1:
The system dynamically adjusts the plasma collection volume based on donor-specific parameters such as weight, height, age, and hematocrit. By changing the collection parameters according to individual donor characteristics, the system maximizes plasma volume collection while maintaining donor safety within FDA-guided limits.
Solution Approach 2:
The control circuit receives real-time donor parameters and adjusts the target plasma volume calculation accordingly. This feedback mechanism ensures that the collection process adapts to donor conditions, optimizing plasma yield while preventing excessive collection that could harm donor safety.
2Reliability
If a fixed plasma volume limit is applied to all donors according to FDA guidelines, then donor safety is maintained, but the plasma collection efficiency is reduced
Solution Approach 1:
Instead of applying a uniform plasma volume limit to all donors, the system implements localized quality control by calculating individualized target volumes based on each donor's specific characteristics. This allows optimal plasma collection efficiency for each donor while maintaining safety standards.
Solution Approach 2:
The system transitions from a static fixed volume limit to a dynamic calculation that adjusts the target plasma volume based on donor parameters. This dynamic approach enables the collection efficiency to vary appropriately with each donor's characteristics while ensuring safety is maintained through FDA-guided constraints.
3Ease of operation
If the plasma collection process is simplified using standard FDA nomograms, then ease of operation is improved, but the plasma volume optimization is lost
Solution Approach 1:
The control circuit automatically performs the complex calculations of target plasma volume based on donor parameters, eliminating the need for manual nomogram lookups and calculations. The system serves itself by integrating the optimization logic into the automated control process, maintaining simplicity for the operator while achieving volume optimization.
Solution Approach 2:
The manual process of using FDA nomograms is replaced with an automated electronic calculation system. The control circuit computes the target plasma volume based on donor parameters, substituting the mechanical nomogram method with an automated computational approach that maintains ease of operation while improving plasma volume optimization.
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 adjusting the process to account for individual donor characteristics, allowing for the collection of the maximum allowable plasma volume within FDA limits, thereby increasing the total pooled plasma volume.
Implementation Method 1
The separation of the plasma from the cellular components may be accomplished in an automated procedure by centrifugation or membrane filtration
Data Source
AI summary
A system and method for collecting plasma comprises a control circuit configured to control operation of the system, the control circuit configured to receive one or more donor parameters. The control circuit estimates a physiological fluid amount of the donor based at least in part on the one or more donor parameters and calculates a target amount of plasma product comprising raw plasma and anticoagulant by multiplying a prestored constant by the estimated physiological fluid amount. The control circuit controls the system to operate draw and return phases to process whole blood into plasma product until a measured amount of plasma product in the collection container meets the target amount of plasma product.