EP-4735075-A1 - METHODS FOR BLOOD COMPONENT COLLECTION

Abstract

A method for collecting blood components includes separating a first amount of plasma from whole blood; separating a total amount of collectable platelets from the whole blood as available after the separation of the first amount of plasma; if a total collected amount is less than a maximum as adjusted by real-time data regarding collection following the separation of the total amount of platelets, separating a second amount of plasma from the whole blood as available after the separation of the total amount of platelets and then separating a total amount of red blood cells from the whole blood as available after the separation of the second amount of plasma; and if the total collected amount is at the maximum as adjusted by real-time data regarding collection, separating the total amount of red blood cells from the whole blood as available after the separation of the total amount of platelets.

Inventors

• BAINBRIDGE, MARLENE
• BUTZKE, SCOTT

Assignees

• Terumo BCT, Inc.

Dates

Publication Date

20260506

Application Date

20240405

Claims (20)

1. 1. A method for using an automated blood collection systems to collect blood components from a subject, the method comprising: separating a first amount of plasma from whole blood received from the subject; following the separation of the first amount of plasma from the whole blood, separating a total amount of collectable platelets from the whole blood as available after the separation of the first amount of plasma; and following the separation of the total amount of platelet, separating a second amount of plasma from the whole blood as available after the separation of the total amount of platelets.
2. 2. The method of claim 1, wherein the first amount of plasma is a total amount of collectable plasma less than greater than or equal to about 8 millimeters to less than or equal to about 25 milliliters, the total amount of collectable plasma being determined by a hypovolemic level or a pre-selected maximum for the subject as adjusted by real-time data regarding collection.
3. 3. The method of claim 2, wherein the method further includes at least one of determining the total amount of collectable plasma and determining the first amount of plasma.
4. 4. The method of claim 1, wherein the first amount of plasma is a total amount of collectable plasma less than about 10 mL, the total amount of collectable plasma being determined by a hypovolemic level or a pre-selected maximum for the subject as adjusted by real-time data regarding collection.
5. 5. The method of claim 1, wherein the second amount of plasma is greater than or equal to about 8 millimeters to less than or equal to about 25 milliliters.
6. 6. The method of claim 1, wherein the method further includes, following the separation of the total amount of platelet and before the separating of the second amount of plasma, determining if a total collected amount has reached a hypovolemic level or a pre-selected maximum for the subject as adjusted by real-time data regarding collection.
7. 7. The method of claim 1, wherein the method further includes determining the second amount of plasma to be separated based on the relationship of a total collected amount to a hypovolemic level or a pre-selected maximum for the subject as adjusted by real-time data regarding collection.
8. 8. The method of claim 1, wherein the method further includes, following the separation of the second amount of plasma, separating a total amount of red blood cells from the whole blood as available after the collection of the second amount of plasma.
9. 9. A method for using an automated blood collection system to collect blood components from a subject, the method comprising: separating a first amount of plasma from whole blood received from the subject; following the separation of the first amount of plasma from the whole blood, separating a total amount of collectable platelets from the whole blood as available after the separation of the first amount of plasma; if a total collected amount is less than a hypovolemic level or a pre-selected maximum for the subject as adjusted by real-time data regarding collection following the separation of the total amount of platelets, separating a second amount of plasma from the whole blood as available after the separation of the total amount of platelets and then separating a total amount of red blood cells from the whole blood as available after the separation of the second amount of plasma; and if the total collected amount is at the hypovolemic level or the pre-selected maximum for the subject as adjusted by real-time data regarding collection, separating the total amount of red blood cells from the whole blood as available after the separation of the total amount of platelets.
10. 10. The method of claim 9, wherein the method further includes determining if the total collected amount is less than or at the hypovolemic level or the pre-selected maximum for the subject as adjusted by real-time data regarding collection.
11. 11. The method of claim 9, wherein the first amount of plasma is a total amount of collectable plasma less than greater than or equal to about 8 millimeters to less than or equal to about 25 milliliters, the total amount of collectable plasma being determined by the hypovolemic level or the pre-selected maximum for the subject as adjusted by real-time data regarding collection.
12. 12. The method of claim 11, wherein the method further includes determining at least one of the total amount of collectable plasma and the first amount of plasma.
13. 13. The method of claim 9, wherein the first amount of plasma is about 10 mL less than a total amount of collectable plasma, the total amount of collectable plasma being determined by the hypovolemic level or the pre-selected maximum for the subject as adjusted by real-time data regarding collection.
14. 14. The method of claim 9, wherein the method further includes determining the second amount of plasma to be separated based on the hypovolemic level or the pre-selected maximum for the subject as adjusted by real-time data regarding collection.
15. 15. A protocol for an automated blood collection system configured to collect blood components from a subject, the protocol comprising: a pre -platelet plasma collection phase that includes separating a first amount of plasma from whole blood received from the subject; a platelet collection phase that includes, following the pre-platelet plasma collection phase, separating a total amount of collectable platelets from the whole blood as available after the separation of the first amount of plasma; and a post-platelet plasma collection phase that includes, following the platelet collection phase, separating a second amount of plasma from the whole blood as available after the separation of the total amount of platelets.
16. 16. The protocol of claim 15, wherein the first amount of plasma is a total amount of collectable plasma less than greater than or equal to about 8 millimeters to less than or equal to about 25 milliliters, the total amount of collectable plasma being determined by a hypovolemic level or a pre-selected maximum for the subject as adjusted by real-time data regarding collection.
17. 17. The protocol of claim 15, wherein the first amount of plasma is a total amount of collectable plasma less than about 10 milliliters, the total amount of collectable plasma being determined by the hypovolemic level or the pre-selected maximum for the subject as adjusted by real-time data regarding collection.
18. 18. The protocol of claim 15, the protocol further includes, following the platelet collection phase and before the post-platelet plasma collection phase, a calculation phase that includes determining if a total collected amount is less than or at a hypovolemic level or a preselected maximum for the subject as adjusted by real-time data regarding collection.
19. 19. The protocol of claim 18, wherein the calculation phase also includes determining the second amount of plasma to be separated based on the hypovolemic level or a pre-selected maximum for the subject as adjusted by real-time data regarding collection.
20. 20. The protocol of claim 15, wherein protocol further includes a red blood cell phase that includes separating a total amount of red blood cells from the whole blood as available after the separation of the second amount of plasma.

Description

METHODS FOR BLOOD COMPONENT COLLECTION CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims priority to U.S. Patent Application No. 18/216,686, filed June 30, 2023. The entire disclosure of the above application is incorporated herein by reference. FIELD [0002] The present disclosure relates to methods for blood component collection using blood collection systems. 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). The calculated volume of red blood cells is often the same as the tuned volume actually collected. However, platelet collection is often limited in real time because plasma collection finishes (i.e., predicted volumes collected) first and triggers hypovolemic limits often causing the automated blood collected systems to end collection and initiate rinseback, which pushes remaining blood components back to the donor. Accordingly, it may be desirable to develop systems and methods of using the same that can prioritize the often more desired platelet collection over plasma collection. 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 systems to collect blood components from a subject. The method may include separating a first amount of plasma from whole blood received from the subject; following the separation of the first amount of plasma from the whole blood, separating a total amount of collectable platelets from the whole blood as available after the separation of the first amount of plasma; and following the separation of the total amount of platelet, separating a second amount of plasma from the whole blood as available after the separation of the total amount of platelets. [0008] In at least one example embodiment, the first amount of plasma may be a total amount of collectable plasma less than greater than or equal to about 8 millimeters to less than or equal to about 25 milliliters. The total amount of collectable plasma may be determined by a hypovolemic level or a pre-selected maximum for the subject as adjusted by real-time data regarding collection. [0009] In at least one example embodiment, the method may further include at least one of determining the total amount of collectable plasma and determining the first amount of plasma. [0010] In at least one example embodiment, the first amount of plasma may be a total amount of collectable plasma less than about 10 milliliters. The total amount of collectable plasma ay be determined by a hypovolemic level or a pre-selected maximum for the subject as adjusted by real-time data regarding collection. [0011] In at least one example embodiment, the second amount of plasma may be greater than or equal to about 8 millimeters to less than or equal to about 25 milliliters. [0012] In at least one example embodiment, the method may further include, following the separation of the total amount of platelet and before the separating of the second amount of plasma, determining if a total collected amount has reached a hypovolemic level or a pre-selected maximum for the subject as adjusted by real-