System and method for collecting plasma

Inventors

Ragusa, Michael

Assignees

Haemonetics Corp

Abstract

A method for collecting plasma includes determining the weight, height, and hematocrit of a donor, and calculating a donor plasma volume and a target plasma collection volume. The target plasma collection volume is based on the donor plasma volume and a target percentage of plasma. The method then withdraws blood from the donor through a line connected to a blood component separation device, and introduces anticoagulant into the withdrawn blood.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 the volume of pure plasma collected within the plasma collection container, and continue processing/collecting until the calculated volume of pure plasma equals the target plasma collection volume.

Core Innovation

The disclosed invention provides a system for collecting plasma from a donor using a venipuncture needle to draw whole blood and a blood separator to separate the whole blood into a plasma product and a second blood component comprising red blood cells. The separated plasma product is sent via a plasma line to a plasma product collection container, while the second blood component is returned to the donor. The system includes a donor line coupled to the venipuncture needle and controlled by a first pump, and an anticoagulant line coupled to an anticoagulant source and controlled by a second pump to combine anticoagulant with the whole blood.

The system uses a touchscreen and a controller programmed to receive donor information and to control draw and return cycles. The controller is programmed to receive at least a donor's weight and hematocrit, and to determine a target volume for plasma product and/or raw plasma based on the donor's total blood volume and/or the donor's plasma volume. The controller controls operation to withdraw whole blood from the donor and separate it into the plasma product and the second blood component, return the second blood component to the donor, and establish a current value of the donor's hematocrit for determining a new target volume.

The disclosed control approach adapts to donor physiology by taking changing hematocrit into account in calculating a new target volume and by repeating the draw and return cycle accordingly. In further embodiments, the controller determines a target volume prior to withdrawing the whole blood, and operates a plurality of draw and return cycles based on re-determination and defined stopping criteria when measured plasma product volume and/or raw plasma volume in the plasma collection container reaches the target volume. The target volume may be determined using donor parameters including weight, height, sex and hematocrit, and may include raw plasma and anticoagulant as part of the target plasma product volume.

Claims Coverage

The provided portion includes multiple independent claims covering a plasma-collection system controlled via operator input and a controller that determines and updates a target plasma product/raw plasma volume based on donor parameters, and controls repeated draw-and-return cycles with defined stopping conditions.

The independent claims collectively cover systems that combine donor lines, anticoagulant lines, a blood separator with plasma output to a plasma collection container, and a controller that determines target plasma product/raw plasma volumes from donor inputs. The claims further cover iterative draw-and-return cycle control, including updating or pre-determining target volume based on donor physiology parameters and implementing conditional control based on target attainment in the plasma collection container, with anticoagulant included in the target plasma product in at least one independent claim.

Stated Advantages

Documented Applications