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Publication Number
US-12171916-B2
Publication Date
2024-12-24
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the donor through a draw line connected to a blood component separation device, and introduces anticoagulant into the withdrawn blood.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 a system for collecting plasma that draws whole blood from a donor using a venipuncture needle and separates the whole blood into a plasma product and a second blood component comprising red blood cells using a blood separator. The plasma product is sent via a plasma line to a plasma product collection container, while the red blood cell component is returned to the donor. The system includes a donor line and an anticoagulant line that combine anticoagulant with the whole blood, each flow being controlled by respective pumps, under controller control.
A controller receives at least a donor’s weight and hematocrit, determines a target volume for plasma product and/or raw plasma, and controls draw and return cycles to withdraw whole blood, separate the whole blood into the plasma product and the second blood component, and return the second blood component to the donor. The controller establishes a current value of the donor’s hematocrit and determines a new target volume for subsequent plasma product and/or raw plasma, taking the donor’s changing hematocrit into account in calculating new target volumes.
The disclosed processing continues through draw and return cycles while collecting plasma, including determining and using a target volume of pure plasma to reach a target for compliance with plasma volume limits. The system calculates anticoagulant percentage in collected plasma and derives corresponding pure-plasma volume, using measurements such as anticoagulant container weight, anticoagulant pump rotations, plasma container weight, and optionally optical sensing of separation contents including RBC layers and residual anticoagulant. The controller determines when to initiate final return of the second blood component based on reaching the target volume for plasma product and/or raw plasma, with return of non-collected components to the donor.
Claims Coverage
The independent claims cover controller-based plasma collection with pump-controlled donor and anticoagulant lines, separation into a plasma product and a red blood cell component, and target-volume control using donor weight and hematocrit. The claims collectively emphasize adaptive target-volume calculation based on changing hematocrit, with additional forms that account for anticoagulant in the collected plasma product or determine target volumes from electronically received donor parameters.
Controller updates target volume using changing hematocrit
A controller programmed to receive at least a donor's weight and hematocrit, determine a target volume for plasma product and/or raw plasma, control draw and return cycles to withdraw whole blood and separate the whole blood into the plasma product and the second blood component while returning the second blood component to the donor, establish a current value of the hematocrit of the donor, and determine a new target volume for plasma product and/or raw plasma for a subsequent draw and return cycle, whereby the donor's changing hematocrit is taken into account in calculating the new target volume.
Account for anticoagulant introduced into the plasma collection container separately from plasma product
The controller is further programmed to account for anticoagulant introduced into the plasma collection container separately from the plasma product.
Target volume for plasma product comprising raw plasma and anticoagulant determined prior to withdrawing whole blood using anticoagulant ratio
The controller programmed to receive at least a donor's weight and hematocrit and determine a target volume for plasma product comprising raw plasma and anticoagulant, wherein the target volume for plasma product is determined prior to withdrawing the whole blood from the donor based at least in part on an anticoagulant ratio, the donor's weight and the donor's hematocrit, and to then control the system to operate a plurality of draw and return cycles to withdraw whole blood, separate the whole blood into the plasma product and the second blood component, and return the second blood component to the donor.
Target volume determination using electronically received donor parameters from a control system
A controller programmed to receive donor parameters electronically from a control system, to determine a target volume for plasma product and/or raw plasma based at least in part on the donor parameters, and to control the system to operate draw and return phases to withdraw whole blood from a donor and separate the whole blood into the plasma product and the second blood component and to return the second blood component to the donor.
Across the independent claims, the system’s claim coverage centers on controller-based target-volume control for plasma collection using donor weight and hematocrit, including updating the target volume to account for changing hematocrit during subsequent draw and return cycles. Additional coverage includes separate accounting of anticoagulant introduced into the plasma collection container, calculating a target plasma volume that comprises raw plasma and anticoagulant using an anticoagulant ratio prior to withdrawal, and determining target volumes based on donor parameters received electronically from a control system.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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