EP-4735074-A1 - SYSTEMS AND METHODS FOR MONITORING PLASMA OVERCOLLECTION

Abstract

A method for using an automated blood collection system to collect blood components from a subject includes separating plasma from whole blood as received from the subject; initiating an alert when a predicted accumulated volume loss is greater than a configured removal level, the predicted accumulated volume loss depending on an accumulated volume that includes the separated volume of plasma and the configured removal level being defined by a hypovolemic level or the pre-selected maximum for the subject; and in response to the alert and feedback from an operator of the automated blood collection system, ending the collection process, continuing the collection, or initiating platelet and red blood cell separation.

Inventors

• BAINBRIDGE, MARLENE
• FENDER, LOGAN

Assignees

• Terumo BCT, Inc.

Dates

Publication Date

20260506

Application Date

20240404

Claims (20)

1. 1. A method for using an automated blood collection system to collect blood components from a subject, the method comprising: separating plasma from whole blood as received from the subject; initiating an alert when a predicted accumulated volume loss is greater than a configured removal level, the predicted accumulated volume loss depending on an accumulated volume that includes the separated volume of plasma and the configured removal level being defined by a hypovolemic level or the pre-selected maximum for the subject; and in response to the alert and feedback from an operator of the automated blood collection system, ending the collection process, continuing the collection, or initiating platelet and red blood cell separation.
2. 2. The method of claim 1, wherein the method further includes determining the predicted accumulated volume loss by summing a current predicted platelet volume less than a volume of anticoagulants predicted in the platelet, a current predicted plasma volume less than a volume of anticoagulants predicted in the plasma, a current predicted red blood cell volume less than a volume of anticoagulants predicted in the red blood cell production, and an accumulated volume detected by a reservoir monitor.
3. 3. The method of claim 1, wherein the method further includes determining the configured removal level by multiplying the hypovolemic level or the pre-selected maximum for the subject by a volume accuracy offset value.
4. 4. The method of claim 3, wherein the volume accuracy offset value is greater than or equal to about 1.02 to less than or equal to about 1.1.
5. 5. The method of claim 4, wherein the volume accuracy offset value is 1.06.
6. 6. The method of claim 1, wherein the ending of the collection includes initiating rinseback.
7. 7. The method of claim 1, wherein the continuing of the collection includes continuing to separate plasma from the whole blood as received from the subject.
8. 8. The method of claim 7, wherein during the plasma separation, the method further includes comparing a sum of an actual plasma volume collected and a current predicted platelet volume and a current predicted red blood cell volume to a total blood volume limit.
9. 9. The method of claim 8, wherein when the sum of the actual plasma volume collected and the current predicted platelet volume and the current predicted red blood cell volume is greater than the total blood volume limit, the method further includes initiating platelet and red blood cell separation.
10. 10. The method of claim 8, wherein when the sum of the actual plasma volume collected and the current predicted platelet volume and the current predicted red blood cell volume is less than the total blood volume limit, the method further includes continuing to separate plasma from the whole blood as received from the subject.
11. 11. The method of claim 8, wherein the total blood volume limit is 15 % of a total blood volume as calculated for the individual subject.
12. 12. The method of claim 8, wherein the total blood volume limit is multiplied by a volume accuracy offset value before being compared to the sum of the actual plasma volume collected and the current predicted platelet volume and the current predicted red blood cell volume.
13. 13. The method of claim 12, wherein the volume accuracy offset value is greater than or equal to about 1.02 to less than or equal to about 1.1.
14. 14. The method of claim 1, wherein after the initiation of the platelet and red blood cell collection, the method further includes initiating rinseback.
15. 15. A method for using an automated blood collection system to collect blood components from a subject, the method comprising: separating plasma from whole blood as received from the subject; comparing a predicted accumulated volume loss to a configured removal level, the predicted accumulated volume loss depending on an accumulated volume that includes the separated volume of plasma and the configured removal level being defined by a hypovolemic level or the pre-selected maximum for the subject; and if the predicted accumulated volume loss is greater than the configured removal level, generating an alert that includes at least three prompts for a user of the automated blood collection system, a first prompt of the at least three prompts including ending the collection process in response to the alert, a second prompt of the at least three prompts including continuing the separation of the plasma from the whole blood bypassing the alert, and a third prompt of the at least three prompts including ending a plasma collection phase and initiating a platelet collection phase, a red blood cell collection phase, or a combination of the platelet collection phase and the red blood cell collection phase.
16. 16. The method of claim 15, wherein the method further includes: determining the predicted accumulated volume loss by summing a current predicted platelet volume less than a volume of anticoagulants predicted in the platelet, a current predicted plasma volume less than a volume of anticoagulants predicted in the plasma, a current predicted red blood cell volume less than a volume of anticoagulants predicted in the red blood cell production, and an accumulated volume detected by a reservoir monitor; and determining the configured removal level by multiplying the hypovolemic level or the preselected maximum for the subject by a volume accuracy offset value.
17. 17. The method of claim 15, wherein when the alert is bypassed, the method further includes comparing a sum of an actual plasma volume collected and a current predicted platelet volume and a current predicted red blood cell volume to a total blood volume limit.
18. 18. The method of claim 17, wherein when the sum of the actual plasma volume collected and the current predicted platelet volume and the current predicted red blood cell volume is greater than the total blood volume limit, the platelet and red blood cell collection is initiated, and when the sum of the actual plasma volume collected and the current predicted platelet volume and the current predicted red blood cell volume is less than the total blood volume limit, the method further includes continuing the separation of the plasma from the whole blood.
19. 19. The method of claim 17, wherein the total blood volume limit is 15 % of a total blood volume as calculated for the individual subject.
20. 20. The method of claim 17, wherein the total blood volume limit is multiplied by a volume accuracy offset value before being compared to the sum of the actual plasma volume collected and the current predicted platelet volume and the current predicted red blood cell volume.

Description

SYSTEMS AND METHODS FOR MONITORING PLASMA OVERCOLLECTION CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims priority to U.S. Patent Application No. 18/217,151, filed June 30, 2023. The entire disclosure of the above application is incorporated herein by reference. FIELD [0002] The present disclosure relates to systems and methods for monitoring overcollection during blood component collection. BACKGROUND [0003] This section provides background information related to the present disclosure which is not necessarily prior art. [0004] Blood collection systems for collecting blood from healthy donors for later emergency and/or medical treatment and/or therapeutic uses generally fall into two broad categories: manual blood collection systems and automated blood collection systems. Manual blood collection systems are those commonly seen and used, for example, in community blood drives, where blood from healthy donors is collected by gravity flow into one or more blood collection containers and later separated (using, for example, centrifuge systems) into one or more components, such as red blood cells, plasma, and/or platelets, which are then used for the emergency and/or medical treatment and/or therapeutic uses. Automated blood collection systems, however, use a specialized machine to separate the collected blood into the one or more components as it is collected from the donor. In certain variations, the automated blood collection systems may push back to the donor the unselected components of the one or more components. [0005] Often, automated blood collection systems include prediction function software or programs that use information received and/or collected about the donor to determine appropriate flow rates and volumes that should result in final products that are within the limits of volumes, concentration, and ending cells counts for the individual donor as determined by government and/or blood center regulations and guidelines. Automated blood collection systems are also often configured to continuously monitor and tune and the collection process using the real time data to maintain accepted donation levels (usually referred to as the hypovolemic limit). For example, when one or more pumps (and in particular, the plasma pump(s)) are not appropriately loaded, and because of the positive pressure from the centrifuge(s), more volume can enter a collection bag than the particular automated blood collection system believes it has pump. In response to such situations, automated blood collection systems are often configured to monitor the draw and return volumes in a return reservoir and accumulates discrepancies overtime, applying the accumulated volume to the preselected levels (e.g. , a hypovolemic limit) as set, for example, by governmental and/or blood center regulations and guidelines and alerting an alarm (and in certain instances, terminating the donation) to ensure that the failure mode does not lead to unsafe conditions for the donor. Using this configuration, however, false alarms can occur — that is, when the one or more pumps are examined, the pump(s) are actually properly loaded. Accordingly, it may be desirable to develop systems and methods of using the same that can more accurately monitor the real-time volumes. SUMMARY [0006] This section provides a general summary of the disclosure and is not a comprehensive disclosure of its full scope or all of its features. [0007] In at least one example embodiment, the present disclosure provides a method for using an automated blood collection system to collect blood components from a subject. The method may include separating plasma from whole blood as received from the subject; initiating an alert when a predicted accumulated volume loss is greater than a configured removal level, the predicted accumulated volume loss depending on an accumulated volume that includes the separated volume of plasma and the configured removal level being defined by a hypovolemic level or the pre-selected maximum for the subject; and in response to the alert and feedback from an operator of the automated blood collection system, ending the collection process, continuing the collection, or initiating platelet and red blood cell separation. [0008] In at least one example embodiment, the method may further include determining the predicted accumulated volume loss. The predicted accumulated volume loss may be determined by summing a current predicted platelet volume less than a volume of anticoagulants predicted in the platelet, a current predicted plasma volume less than a volume of anticoagulants predicted in the plasma, a current predicted red blood cell volume less than a volume of anticoagulants predicted in the red blood cell production, and an accumulated volume detected by a reservoir monitor. [0009] In at least one example embodiment, the method may further include determining the configured removal level by multiplying the hypovolemic level o