System and method for collecting plasma
Patent No. US10792416 (titled "System and method for collecting plasma") on Oct 25, 2017. The application was issued on Oct 6, 2020.
What is this patent about?
’416 is related to the field of blood apheresis and automated plasma collection. Specifically, it addresses the technical challenges of accurately measuring collected plasma volumes and tailoring collection limits to individual donor physiology rather than broad weight categories.
The underlying idea behind ’416 is that standard plasma collection metrics are often inaccurate because the collected product is a mixture of plasma and anticoagulant, and the donor's actual plasma volume varies significantly based on height, weight, and hematocrit. By dynamically calculating the anticoagulant dilution within the collection container and determining the donor's specific total plasma volume, the system can collect a precise, optimized amount of pure plasma while maintaining donor safety.
The claims of ’416 focus on a method and system that calculates a target plasma collection volume derived from a donor’s calculated plasma volume and a specific target percentage. The system monitors the collection process in real-time, calculating the volume of anticoagulant present in the collection container to isolate the volume of pure plasma actually harvested, continuing the draw until this pure plasma volume reaches the individualized target.
In practice, the invention utilizes a controller to integrate donor-specific data—such as BMI and hematocrit—to establish a personalized collection goal, typically between 26.5% and 29.5% of the donor's total plasma. The system employs sensors, such as optical sensors on the centrifuge bowl and weight sensors on the containers, to track the movement of red blood cells and the volume of fluids, ensuring the calculation of pure plasma accounts for anticoagulant added during both the priming and draw phases.
This approach differentiates itself from prior art by moving away from fixed FDA weight-class limits, which often result in inconsistent collection percentages across different donors. By focusing on isovolemia, the system can also calculate an intravascular deficit and return a tailored volume of saline to the donor, significantly reducing the risk of adverse reactions like fainting or light-headedness that occur when fluid replacement is not individualized.
How does this patent fit in bigger picture?
Technical Landscape
In the late 2010s when ’416 was filed, blood apheresis procedures were typically implemented using automated centrifugal separators that managed fluid volumes based on coarse donor weight categories and fixed collection limits. At a time when systems commonly relied on total volume measurements of the final collected product—which inherently included both biological plasma and added chemical anticoagulants—rather than isolating the specific volume of the pure biological component, the precision of collection was limited by the inability to differentiate between these fluids in real-time. Furthermore, when hardware and software constraints made the dynamic calculation of a donor's specific intravascular deficit and individualized plasma volume non-trivial, practitioners generally adhered to standardized regulatory ceilings that did not account for physiological variations such as hematocrit levels or precise body mass index.
Prosecution Position
The disclosed invention represents a meaningful technical advancement through the integration of real-time fluid monitoring and physiological modeling to enable high-precision plasma collection. By implementing an architectural shift from total-volume collection to a pure-plasma target, the system utilizes a controller to dynamically calculate the percentage of anticoagulant within the collection container based on pump rotations, weight sensors, and optical monitoring of the separation device. This capability enables the system to overcome the technical constraint of fluid dilution, allowing for the collection of a target volume of pure plasma that is specifically tailored to a donor's calculated plasma volume and hematocrit. Additionally, the system achieves a controlled intravascular deficit by calculating and returning specific volumes of saline and residual blood components, ensuring that the collection process is optimized for both yield and donor safety.
Claims
The patent includes a total of 30 claims, with claims 1 and 17 being the independent claims. These independent claims focus on a method and a system for collecting plasma that utilize donor-specific metrics—specifically weight, height, and hematocrit—to calculate a donor's plasma volume and a target collection volume, while further accounting for the volume of anticoagulant within the collected plasma to determine the precise amount of pure plasma obtained. The dependent claims generally serve to provide specific operational parameters and additional steps, such as calculating body mass index, managing intravascular deficits through saline return, defining target percentage ranges for collection, and utilizing various sensors or pump rotations to monitor anticoagulant and plasma volumes during the procedure.
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US10792416
- Application Number
- US15793339A
- Filing Date
- Oct 25, 2017
- Publication Date
- Oct 6, 2020
- External Links
- Slate, USPTO , Google Patents