# US 2025/0082829 A1 · System and method for collecting plasma

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- Number: US 2025/0082829 A1
- Document ID: US20250082829A1
- Status: Published application
- Kind: A1
- Application number: 18/955,269
- Filed: 2024-11-21
- Published: 2025-03-13
- Earliest claimed: 2017-05-30
- Assignees: Haemonetics Corporation
- Applicants: Haemonetics Corporation
- Inventors: Michael Ragusa
- Web page: https://patentgrep.com/patent/US20250082829A1

## CPC

- A61M 1/024: {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}
- A61M 1/029: {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)}
- A61M 1/3672: {Means preventing coagulation}
- A61M 1/38: Removing constituents from donor blood and {storing or} returning remainder to body {, e.g. for transfusion}
- A61M 1/3693: {using separation based on different densities of components, e.g. centrifuging}
- A61M 2202/0415: Plasma
- A61M 2230/207: hematocrit
- G01N 15/042: {by centrifuging and investigating centrifugates (centrifuges per se B04B)}
- G01N 15/05: in blood
- G01N 2015/055: {for hematocrite determination}
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## 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.

## Claims

### Claim 1

A method for collecting plasma comprising:
(a) inserting a venous-access device into a donor;
(b) withdrawing whole blood from the donor through the venous-access device and a draw line, the draw line fluidly coupled to a blood component separation device;
(c) introducing anticoagulant into the withdrawn whole blood through an anticoagulant line;
(d) separating the withdrawn whole blood into a plasma component and at least a second blood component using the blood component separation device;
(e) collecting the plasma component from the blood component separation device and into a plasma collection container; and
(f) calculating 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.

### Claim 2 (depends on 1)

A method according to claim 1, further comprising calculating a percentage of anticoagulant in the collected plasma component.

### Claim 3 (depends on 2)

A method according to claim 2, wherein the calculated percentage of anticoagulant in the collected plasma component is based, at least in part, on the ratio of anticoagulant added to the withdrawn whole blood, and the hematocrit of the donor.

### Claim 4 (depends on 2)

A method according to claim 2, wherein the calculated volume of pure plasma collected within the plasma collection container is based, at least in part, on the calculated percentage of anticoagulant in the collected plasma component.

### Claim 5 (depends on 1)

A method according to claim 1, further comprising:
calculating a volume of anticoagulant in the collected plasma component based, at least in part, upon the hematocrit of the donor, the calculated 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.

### Claim 6 (depends on 5)

A method according to claim 5, 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.

### Claim 7 (depends on 1)

A method according to claim 1, further comprising:
monitoring the volume of plasma component collected within the plasma collection container.

### Claim 8 (depends on 1)

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.

### Claim 9 (depends on 1)

A method according to claim 1, further comprising:
monitoring a volume of red blood cells collected within the blood component separation device, the hematocrit of the donor being determined 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.

### Claim 10 (depends on 1)

A method according to claim 1, further comprising:
continuing steps (b) through (f) to collect a target volume of pure plasma and/or a target volume of plasma component within the plasma collection container.

### Claim 11 (depends on 10)

A method according to claim 10, wherein the target volume of pure plasma and/or the target volume of plasma component is based, at least in part, on a weight of the donor.

### Claim 12 (depends on 10)

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

### Claim 13

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 withdrawn blood into a plasma component and a second blood component, the blood component separation device having an outlet and being configured to convey the plasma component to a plasma collection container;
a blood draw line fluidly coupled to the venous-access device and configured to transport withdrawn 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 fluidly coupled to an anticoagulant source, the anticoagulant line configured to introduce anticoagulant into the withdrawn 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 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.

### Claim 14 (depends on 13)

A system according to claim 13, wherein the controller is further configured to calculate a percentage of anticoagulant in the collected plasma component.

### Claim 15 (depends on 14)

A system according to claim 14, wherein the calculated percentage of anticoagulant in the collected plasma component is based, at least in part, upon the ratio of anticoagulant added to the withdrawn whole blood, and the hematocrit of the donor.

### Claim 16 (depends on 14)

A system according to claim 14, wherein the calculated volume of pure plasma collected within the plasma collection container is based, at least in part, on the calculated percentage of anticoagulant in the collected plasma component.

### Claim 17 (depends on 13)

A system according to claim 13, wherein the controller is further configured to calculate a volume of anticoagulant in the collected plasma component based, at least in part, upon the hematocrit of the subject, the volume of pure plasma collected within the plasma collection container based, at least in part, upon the volume of anticoagulant in the collected plasma component.

### Claim 18 (depends on 17)

A system according to claim 17, further comprising:
an anticoagulant source weight sensor configured to measure a 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.

### Claim 19 (depends on 13)

A system according to claim 13, wherein the controller is configured to monitor the operation of an anticoagulant pump to determine a total volume of anticoagulant introduced into the system.

### Claim 20 (depends on 13)

A system according to claim 13, further comprising:
a plasma collection container weight sensor configured to monitor the volume of plasma component collected within the plasma collection container.

### Claim 21 (depends on 13)

A system according to claim 13, further comprising:
a plasma collection container weight sensor configured to monitor 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.

### Claim 22 (depends on 13)

A system according to claim 13, wherein the controller is configured control the plasma collection process to collect a target volume of pure plasma and/or a target volume of plasma component within the plasma collection container.

### Claim 23 (depends on 22)

A system according to claim 22, wherein the target volume of pure plasma and/or the target volume of plasma component is based, at least in part, on a weight of the subject.

### Claim 24

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 withdrawn whole blood into a plasma component and a second blood component, the blood component separation device having an outlet and being configured to convey the plasma component to a plasma collection container;
a blood draw line fluidly coupled to the venous-access device and configured to transport withdrawn 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 fluidly coupled to an anticoagulant source, the anticoagulant line configured to introduce anticoagulant into the withdrawn 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 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.

### Claim 25 (depends on 24)

A system according to claim 24, wherein the controller is configured to control the plasma collection process to collect a target volume of pure plasma and/or target volume of plasma component.

### Claim 26 (depends on 25)

A system according to claim 25, wherein the target volume of pure plasma and/or target volume of plasma component is based, at least in part, on a weight of the subject.

### Claim 27 (depends on 24)

A system according to claim 24, wherein the controller is configured to calculate a percentage of anticoagulant to be collected in the plasma component.

### Claim 28 (depends on 27)

A system according to claim 27, wherein the calculated percentage of anticoagulant to be collected in the plasma component is based, at least in part, upon the ratio of anticoagulant to be added to the withdrawn whole blood and the hematocrit of the donor.

### Claim 29 (depends on 27)

A system according to claim 27, wherein the calculated volume of pure plasma to be collected within the plasma collection container is based, at least in part, on the calculated percentage of anticoagulant to be collected in the plasma component.

### Claim 30 (depends on 24)

A system according to claim 24, wherein the controller is further configured to calculate a volume of anticoagulant to be collected in the collected plasma component based, at least in part, upon the hematocrit of the subject, the volume of pure plasma to be collected within the plasma collection container based, at least in part, upon the volume of anticoagulant to be collected in the collected plasma component.
