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Publication Number
US-11738124-B2
Publication Date
2023-08-29
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the donor through a draw line connected to a blood component separation device, and introduces anticoagulant into the withdrawn blood.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 disclosure describes a plasma collection method that estimates the volume of anticoagulant in collected plasma based, at least in part, on donor hematocrit. It uses that estimate to calculate the volume of pure plasma collected and continues collection until a target volume of pure plasma is reached. The method separates withdrawn whole blood into a plasma component and at least a second blood component.
The identified problem is that stopping collection at a total plasma–anticoagulant mixture volume does not provide the same target pure-plasma volume across donors. The disclosure addresses this by calculating pure-plasma volume rather than relying only on total collected mixture volume. It also describes a system with a controller that performs the volume calculations and stops the blood draw pump when the target pure-plasma volume is collected.
Claims Coverage
The two independent claims cover one plasma collection method and one plasma collection system. Together, they present two main inventive features: estimating collected pure-plasma volume using an anticoagulant-volume calculation informed by hematocrit, and using that calculation to govern collection to a target volume.
Pure-plasma volume calculation and target-based collection
The method determines donor hematocrit, calculates the volume of anticoagulant in the collected plasma component based at least in part on hematocrit, and calculates the volume of pure plasma based at least in part on the calculated anticoagulant volume. Collection continues until a target volume of pure plasma is collected.
Controller-based plasma collection system
The system includes a venous-access device, a blood component separation device, a blood draw line and pump, an anticoagulant line, and a controller. The controller calculates anticoagulant volume in the collected plasma component based at least in part on the subject's hematocrit, calculates pure-plasma volume based at least in part on that anticoagulant volume, and stops the blood draw pump when the target pure-plasma volume is collected.
The claims cover a method and a system that estimate collected pure-plasma volume by accounting for anticoagulant and use the estimate to reach a target pure-plasma volume.
Stated Advantages
More consistent collection of a target pure-plasma volume across donors than stopping at a total plasma–anticoagulant mixture volume.
Documented Applications
Collecting plasma using a blood component separation device, with collection controlled to reach a target volume of pure plasma.
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