System and method for collecting plasma

Patent metadata

Field	Value
Publication number	US-11738124-B2
Application number	US-202217943410-A
Country	US
Kind code	B2
Filing date	Sep 13, 2022
Priority date	May 30, 2017
Publication date	Aug 29, 2023
Grant date	Aug 29, 2023

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the donor through a draw line connected to a blood component separation device, and introduces anticoagulant into the withdrawn blood.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.

First claim

What is claimed is:

1. A method for collecting plasma comprising:
(a) determining a weight of a donor;
(b) determining a hematocrit of the donor;
(c) inserting a venous-access device into the donor;
(d) withdrawing whole blood from the donor through the venous-access device and a draw line, the draw line connected to a blood component separation device;
(e) introducing anticoagulant into the withdrawn whole blood through an anticoagulant line;
(f) separating the withdrawn whole blood into a plasma component and at least a second blood component using the blood component separation device;
(g) collecting the plasma component from the blood component separation device and into a plasma collection container;
(h) calculating a volume of anticoagulant in the collected plasma component based, at least in part, upon the hematocrit of the donor;
(i) calculating a volume of pure plasma collected within the plasma collection container based, at least in part, on the calculated volume of anticoagulant in the collected plasma component; and
(j) continuing steps (d) through (i) until a target volume of pure plasma is collected within the plasma collection container.

2. A method according to claim 1 , further comprising:
determining a change in volume within an anticoagulant container, the calculated volume of anticoagulant in the collected plasma component being based, at least in part, on the change in volume within the anticoagulant container.

3. A method according to claim 1 , further comprising:
determining a volume of anticoagulant introduced into the whole blood based on a number of rotations of an anticoagulant pump, the calculated volume of anticoagulant in the collected plasma component being based, at least in part, on the number of rotations of the anticoagulant pump.

4. A method according to claim 1 , further comprising:
determining a volume of anticoagulant within the blood component separation device, the calculated volume of anticoagulant in the collected plasma component being based, at least in part, on the volume of anticoagulant within the blood component separation device.

5. A method according to claim 1 , further comprising:
monitoring a volume of plasma component collected within the plasma collection container, the calculated volume of pure plasma collected within the plasma collection container based, at least in part, on the monitored volume of collected plasma component.

6. A method according to claim 1 , further comprising:
monitoring a weight of plasma component collected within the plasma collection container, the calculated volume of pure plasma collected within the plasma collection container based, at least in part, on the monitored weight of collected plasma component.

7. A method according to claim 1 , wherein step (b) includes monitoring a volume of red blood cells collected within the blood component separation device, the determined hematocrit of the donor based, at least in part, on the monitored volume of red blood cells collected within the blood component separation device and a volume of whole blood withdrawn from the donor.

8. A method according to claim 1 , wherein the target volume of pure plasma is based, at least in part, on the weight of the donor.

9. A method according to claim 1 , wherein the volume of anticoagulant in the collected plasma component includes at least a portion of the anticoagulant introduced into the withdrawn blood and at least a portion of a volume of anticoagulant added during a priming step.

10. A method according to claim 1 , further comprising:
returning, after collecting at least a portion of the target volume of pure plasma, the second blood component to the donor through a return line.

11. A system for collecting plasma comprising:
a venous-access device for drawing whole blood from a subject and returning blood components to the subject;
a blood component separation device for separating the drawn blood into a plasma component and a second blood component, the blood component separation device having an outlet and being configured to send the plasma component to a plasma container;
a blood draw line fluidly connected to the venous-access device and configured to transport drawn whole blood to the blood component separation device, the flow through the blood draw line being controlled by a blood draw pump;
an anticoagulant line connected to an anticoagulant source, the anticoagulant line configured to introduce anticoagulant into the drawn whole blood; and
a controller configured to control the operation of the blood component separation device and the blood draw pump, the controller configured to calculate (1) a volume of anticoagulant in the collected plasma component based, at least in part, upon the hematocrit of the subject, and (2) a volume of pure plasma collected within the plasma container based, at least in part, upon the volume of anticoagulant in the collected plasma component, the controller configured to stop the blood draw pump when a target volume of pure plasma is collected within the plasma container.

12. A system according to claim 11 , wherein the volume of anticoagulant in the collected plasma component is based, at least in part, on a volume of anticoagulant added to the drawn whole blood.

13. A system according to claim 11 , further comprising:
an anticoagulant source weight sensor configured to measure the weight of the anticoagulant source, the controller further configured to monitor a change in volume within the anticoagulant source based on the measured weight of the anticoagulant source, the calculated volume of anticoagulant in the collected plasma component being based, at least in part, on the change in volume within the anticoagulant source.

14. A system according to claim 11 , wherein the controller is configured to monitor a number of rotations of an anticoagulant pump to determine a volume of anticoagulant introduced into the whole blood, the calculated volume of anticoagulant in the collected plasma component being based, at least in part, on the number of rotations of the anticoagulant pump.

15. A system according to claim 11 , further comprising:
an optical sensor located on the blood component separation device and configured to monitor the contents of the blood component separation device and determine if a volume of anticoagulant remains within the blood component separation device, the calculated volume of anticoagulant in the collected plasma component being based, at least in part, on the volume of anticoagulant within the blood component separation device.

16. A system according to claim 11 , further comprising:
a plasma container weight sensor configured to monitor a volume of plasma component collected within the plasma container, the calculated volume of pure plasma collected within the plasma container based, at least in part, on the monitored volume of collected plasma component.

17. A system according to claim 11 , further comprising:
a plasma container weight sensor configured to monitor a weight of plasma component collected within the plasma container, the calculated volume of pure plasma collected within the plasma container based, at least in part, on the monitored weight of collected plasma component.

18. A system according to claim 11 , further comprising:
an optical sensor located on the blood component separation device and configured to monitor a volume of red blood cells collected within the blood component separation device, the controller configured to determine the subject's hematocrit based, at

Assignees

• Haemonetics Corp

Inventors

• Ragusa Michael

Classifications

• A61M1/3693

  using separation based on different densities of components, e.g. centrifuging · CPC title

• A61M1/024 Primary

  Means for controlling the quantity of transfused blood, e.g. by weighing the container and automatic stopping of the transfusion after reaching a determined amount · CPC title

• A61M1/029

  Separating blood components present in distinct layers in a container, not otherwise provided for (containers for storing blood or blood components A61J1/05; sampling or analysing blood by separating blood components G01N33/491) · CPC title

• A61M1/3672

  Means preventing coagulation · CPC title

• A61M1/38 Primary

  Removing constituents from donor blood and {storing or} returning remainder to body {, e.g. for transfusion} · CPC title