Systems and methods for collecting mononuclear cells

Patent metadata

Field	Value
Publication number	US-12370296-B2
Application number	US-202217672910-A
Country	US
Kind code	B2
Filing date	Feb 16, 2022
Priority date	Mar 7, 2017
Publication date	Jul 29, 2025
Grant date	Jul 29, 2025

Abstract

Fluid processing assemblies and methods are provided for mononuclear cell collection. Mononuclear cells are separated from red blood cells in a blood separation chamber, with the mononuclear cells and then the red blood cells exiting the chamber via an outlet port. The mononuclear cells and then the red blood cells enter an outlet flow path that is in fluid communication with a mononuclear cell collection container. The outlet flow path includes a visual indicium, which an operator may use to determine the position of the red blood cells within the outlet flow path and when to end mononuclear cell collection by preventing fluid communication between the outlet flow path and the mononuclear cell collection container.

First claim

The invention claimed is:

1. A fluid processing assembly configured for use in combination with a fluid processing system for separating mononuclear cells from red blood cells, comprising:
a blood separation chamber configured to separate mononuclear cells from red blood cells and including an outlet port configured to accommodate the flow of mononuclear cells and then red blood cells exiting the blood separation chamber;
a mononuclear cell collection container; and
an outlet flow path extending between the outlet port and the mononuclear cell collection container, wherein the outlet flow path includes a visual indicium upstream of the mononuclear cell collection container, with the visual indicium being visible to an operator and configured to be moved with respect to the outlet flow path, with a location to be identified by the visual indicium depending at least in part upon a flow rate of fluid through the outlet flow path.

2. The fluid processing assembly of claim 1 , wherein the outlet flow path is defined by
a rigid cassette,
an upstream flexible tubing extending between the outlet port and the cassette, and
a downstream flexible tubing extending between the cassette and the mononuclear cell collection container, with the visual indicium identifying a location within the upstream flexible tubing.

3. The fluid processing assembly of claim 1 , wherein the outlet flow path is defined by
a rigid cassette,
an upstream flexible tubing extending between the outlet port and the cassette, and
a downstream flexible tubing extending between the cassette and the mononuclear cell collection container, with the visual indicium identifying a location within the cassette.

4. The fluid processing assembly of claim 1 , wherein the outlet flow path is defined by
a rigid cassette,
an upstream flexible tubing extending between the outlet port and the cassette, and
a downstream flexible tubing extending between the cassette and the mononuclear cell collection container, with the visual indicium identifying a location within the downstream flexible tubing.

5. A method for collecting mononuclear cells, comprising:
separating mononuclear cells from red blood cells in a blood separation chamber;
flowing at least a portion of said mononuclear cells out of the blood separation chamber via an outlet port, through an outlet flow path in fluid communication with the outlet port, and into a mononuclear cell collection container;
flowing at least a portion of said red blood cells out of the blood separation chamber via the outlet port and into the outlet flow path; and
preventing fluid communication between the outlet flow path and the mononuclear cell collection container when said at least a portion of said red blood cells flowing through the outlet flow path reaches a location identified by a visual indicium associated with the outlet flow path, wherein the visual indicium is visible to an operator and the method includes moving the visual indicium to the location based at least in part on a flow rate of fluid through the outlet flow path.

6. The method of claim 5 , wherein the outlet flow path is defined by
a rigid cassette,
an upstream flexible tubing extending between the outlet port and the cassette, and
a downstream flexible tubing extending between the cassette and the mononuclear cell collection container, with the visual indicium identifying a location within the upstream flexible tubing.

7. The method of claim 5 , wherein the outlet flow path is defined by
a rigid cassette,
an upstream flexible tubing extending between the outlet port and the cassette, and
a downstream flexible tubing extending between the cassette and the mononuclear cell collection container, with the visual indicium identifying a location within the cassette.

8. The method of claim 5 , wherein the outlet flow path is defined by
a rigid cassette,
an upstream flexible tubing extending between the outlet port and the cassette, and
a downstream flexible tubing extending between the cassette and the mononuclear cell collection container, with the visual indicium identifying a location within the downstream flexible tubing.

9. The method of claim 5 , wherein said separating mononuclear cells from red blood cells in the blood separation chamber includes separating a plasma constituent from the mononuclear cells and the red blood cells in the blood separation chamber, and further comprising:
flowing at least a portion of said plasma constituent out of the blood separation chamber at a current plasma flow rate,
calculating an ideal plasma flow rate for said at least a portion of the plasma constituent flowing out of the blood separation chamber,
comparing the ideal plasma flow rate to the current plasma flow rate for said at least a portion of the plasma constituent flowing out of the blood separation chamber,
determining that said at least a portion of the plasma constituent has decreased clarity when the percent difference between the ideal plasma flow rate and the current plasma flow rate is greater than a threshold value, and
determining that said at least a portion of the plasma constituent does not have decreased clarity when the percent difference between the ideal plasma flow rate and the current plasma flow rate is less than the threshold value.

10. The method of claim 9 , wherein the threshold value is in a range of approximately 25% to approximately 30%.

11. The method of claim 9 , wherein the threshold value is approximately 20%.

12. The method of claim 9 , further comprising, upon determining that the plasma constituent has decreased clarity, automatically increasing the current plasma flow rate.

13. The method of claim 9 , further comprising, upon determining that the plasma constituent has decreased clarity, enabling the operator to selectively increase the current plasma flow rate.

14. The method of claim 11 , wherein said enabling the operator to selectively increase the current plasma flow rate includes limiting the amount that the operator may increase the current plasma flow rate.

15. The method of claim 5 , wherein the outlet flow path includes a flexible tubing, and further comprising reversing the direction of flow of said at least a portion of said red blood cells through the flexible tubing to minimize the amount of red blood cells reaching the mononuclear cell collection container.

16. The method of claim 15 , wherein said reversing the direction of flow of said at least a portion of said red blood cells through the flexible tubing includes automatically initiating the reversal of the direction of flow.

17. The method of claim 15 , wherein said reversing the direction of flow of said at least a portion of said red blood cells through the flexible tubing includes manually commanding a system controller of a fluid processing system to execute the reversal of the direction of flow.

18. The method of claim 5 , wherein said separating mononuclear cells from red blood cells in the blood separation chamber includes separating a plasma constituent from the mononuclear cells and the red blood cells in the blood separation chamber, and further comprising:
flowing at least a portion of said plasma constituent out of the blood separation chamber,
determining whether the plasma constituent has decreased clarity,
flowing at least a portion of said mononuclear cells out of the blood separation chamber and into the mononuclear cell collection container, and
irradiating said at least a portion of said mononuclear cells in the mononuclear cell collection co

Assignees

• Fenwal Inc

Inventors

• Nguyen Lan T
• Prendergast Jonathan W
• Ali Zahra R
• Abedin Tanima J
• Erickson Molly
• Hershenhouse Korri

Classifications

• G01N2035/00495

  Centrifuges · CPC title

• G01N35/0092

  Scheduling · CPC title

• G01N33/491

  by separating the blood components (G01N15/05 takes precedence) · CPC title

• B01L2400/06

  Valves, specific forms thereof · CPC title

• B01L2300/123

  Flexible; Elastomeric · CPC title