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Publication Number
US-12324873-B2
Publication Date
2025-06-10
Expiration Date
Abstract
A method for collecting plasma includes determining the weight and hematocrit of a donor, and inserting a venous-access device into the donor. The method then withdraws blood from the donor through a draw line connected to a blood component separation device, and introduces anticoagulant into the withdrawn blood. The blood component separation device separates the blood into a plasma component and a second blood component, and the plasma component is collected from the blood component separation device and into a plasma collection container. The method may then calculate (1) a percentage of anticoagulant in the collected plasma component, and (2) a volume of pure plasma collected within the plasma collection container. The volume of pure plasma may be based, at least in part, on the calculated percentage of anticoagulant. The method may continue until a target volume of pure plasma is collected within the plasma collection container.
Core Innovation
The invention relates to plasma-apheresis systems and methods that collect plasma and determine a volume of pure plasma collected in a plasma collection container. The method inserts a venous-access device into a donor, withdraws whole blood through a draw line, introduces anticoagulant through an anticoagulant line, and separates the withdrawn blood into a plasma component and at least a second blood component using a blood component separation device. The plasma component is collected into the plasma collection container.
A core feature is calculating the volume of pure plasma within the plasma collection container based, at least in part, on the volume of plasma component collected within the plasma collection container, a ratio of anticoagulant added to the withdrawn whole blood, and a hematocrit of the donor. Additional calculations include calculating an anticoagulant percentage in the collected plasma component and using that calculated percentage to determine a volume of pure plasma.
The disclosed system architecture includes a controller that controls operation of the blood component separation device and a blood draw pump and calculates pure plasma volume. The disclosed monitoring concept includes donor hematocrit determination and container or source weight and volume change monitoring, including an anticoagulant source weight sensor and a plasma collection container weight sensor, along with possible optical sensing related to hematocrit or residual anticoagulant.
Claims Coverage
The partial content contains three independent claims covering plasma collection methods and systems. Across the independent claims, the core coverage centers on calculating a volume of pure plasma, or a volume to be collected, in a plasma collection container using collected plasma component volume, an anticoagulant-to-whole-blood ratio, and donor or subject hematocrit, while controlling blood drawing and separation using a venous-access device, a draw line, an anticoagulant line, and a blood component separation device.
Calculating pure plasma volume from plasma component volume, anticoagulant ratio, and donor hematocrit
A method for collecting plasma that separates withdrawn whole blood into a plasma component and at least a second blood component, collects the plasma component into a plasma collection container, and calculates a volume of pure plasma collected within the plasma collection container based, at least in part, on a volume of plasma component collected within the plasma collection container, a ratio of anticoagulant added to the withdrawn whole blood, and a hematocrit of the donor.
Controller-based system to calculate pure plasma volume in a plasma collection container
A system for collecting plasma that includes a venous-access device, a blood component separation device configured to convey the plasma component to a plasma collection container, a blood draw line controlled by a blood draw pump, an anticoagulant line configured to introduce anticoagulant into withdrawn whole blood, and a controller that calculates a volume of pure plasma collected within the plasma collection container based, at least in part, on a volume of plasma component collected within the plasma collection container, a ratio of anticoagulant added to the withdrawn whole blood, and a hematocrit of the subject.
Calculating a target volume of pure plasma to be collected using anticoagulant ratio and hematocrit
A system for collecting plasma that includes a venous-access device, a blood component separation device configured to convey a plasma component to a plasma collection container, a blood draw line controlled by a blood draw pump, an anticoagulant line configured to introduce anticoagulant, and a controller configured to calculate a volume of pure plasma to be collected within the plasma collection container based, at least in part, on a volume of plasma component to be collected within the plasma collection container, a ratio of anticoagulant to be added to the withdrawn whole blood, and a hematocrit of the subject.
Overall, the independent claim set is directed to plasma collection using venous-access and separation components, combined with controller calculations that determine or target the volume of pure plasma in a plasma collection container using plasma component volume, an anticoagulant-to-whole-blood ratio, and donor or subject hematocrit. Dependent refinements further cover calculating anticoagulant percentage or volume and using sensing or monitoring such as weight sensors.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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