Patent No. US10758652 (titled "System and method for collecting plasma") on May 30, 2017. The application was issued on Sep 1, 2020.
’652 is related to the field of blood apheresis and automated plasma collection. Specifically, it addresses the technical challenge of accurately measuring the actual volume of plasma harvested from a donor during a procedure where the collected product is inherently diluted by anticoagulant fluids.
The underlying idea behind ’652 is that the volume of pure plasma in a collection container can be mathematically isolated from the total fluid volume by accounting for the donor's hematocrit and the specific amount of anticoagulant metered into the system. Because anticoagulant does not penetrate red blood cells due to their osmolarity, it remains almost entirely in the plasma fraction, allowing the system to calculate a precise dilution ratio and stop the collection only when a true target volume of plasma is reached.
The claims of ’652 focus on a method and system that dynamically calculate the volume of pure plasma as it is being collected. This is achieved by determining the donor's weight and hematocrit, introducing a controlled amount of anticoagulant into the withdrawn blood, and using a controller to subtract the calculated volume of anticoagulant from the total collected fluid in real-time to ensure the procedure continues until a specific, pure plasma threshold is met.
In practice, the system utilizes a centrifugal bowl to separate whole blood into its constituent parts while sensors monitor the process. The controller tracks the anticoagulant volume by either monitoring the rotations of a metering pump or measuring the weight loss of the anticoagulant source container. Simultaneously, a weight sensor on the plasma collection bag provides the total mass of the mixture, which the system then processes using the donor's hematocrit to determine the exact moment the target yield is achieved.
This approach differs from prior solutions that typically stop collection based on the total volume of the plasma-anticoagulant mixture. By failing to account for the variable dilution caused by different donor hematocrit levels, prior systems often under-collect plasma from donors with high red blood cell counts. The invention optimizes the yield for every donor, ensuring that the maximum allowable pure plasma volume is harvested according to regulatory guidelines without exceeding safety limits.
In the late 2010s when ’652 was filed, automated apheresis systems were standard for separating whole blood into components such as plasma and red blood cells using centrifugal separation. At a time when plasma collection was typically implemented using fixed-volume targets based on the total fluid volume in the collection container, systems commonly relied on gross weight measurements rather than real-time chemical composition analysis. Because the collected product is a mixture of pure plasma and added anticoagulant, hardware and software constraints made the precise, real-time isolation of the pure plasma volume non-trivial, often leading to the termination of collection cycles based on total fluid limits to ensure regulatory compliance, even if the actual volume of biological plasma remained below permissible thresholds.
The disclosed invention represents a technical advancement through the integration of real-time anticoagulant tracking and donor-specific hematocrit data to dynamically calculate the volume of pure plasma within a collection container. By shifting from a gross volume measurement to a calculated component-specific volume, the architecture overcomes the technical constraint of fluid dilution in apheresis products. This is achieved by a controller that monitors anticoagulant pump rotations, source weight changes, and priming volumes to determine the exact percentage of anticoagulant present in the plasma container. This capability enables the system to maximize the yield of biological plasma for each donor while maintaining strict adherence to safety regulations, effectively decoupling the collection limit from the total fluid volume and basing it instead on the actual biological component collected.
This patent contains 20 total claims, with claims 1 and 11 serving as the independent claims. The independent claims focus on a method and a system for collecting plasma that utilize donor weight and hematocrit data to calculate the specific volume of anticoagulant present in the collected plasma, thereby determining the volume of pure plasma collected to reach a precise target amount. The dependent claims serve to provide specific technical implementations for these calculations, such as using weight sensors, optical sensors, or pump rotation counts to monitor anticoagulant flow, donor hematocrit levels, and the total volume of components within the collection containers.
Definitions of key terms used in the patent claims.
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