Devices, methods, and systems for priming, separating, and collecting blood components

Patent metadata

Field	Value
Publication number	US-12064544-B2
Application number	US-202016906976-A
Country	US
Kind code	B2
Filing date	Jun 19, 2020
Priority date	Jun 19, 2015
Publication date	Aug 20, 2024
Grant date	Aug 20, 2024

Abstract

A photopheresis system ( 200 ) is disclosed, and that may be configured to execute one or more protocols. These protocols include: 1) protocols ( 400; 430; 460 ) for purging air out of a centrifuge bowl ( 210 ) used by the photopheresis system ( 200 ); 2) protocols ( 500; 510 550 ) for assessing the installation/operation of one or more pressure domes ( 330 ) used by the photopheresis system ( 200 ); and 3) protocols ( 580; 600; 660; 700; 740 ) for collecting buffy coat from blood processed by the photopheresis system ( 200 ).

First claim

What is claimed:

1. A method of operating a blood processing system, wherein said blood processing system comprises a centrifuge, and wherein said centrifuge comprises a first port and a second port, said method comprising:
introducing blood into said centrifuge through said first port;
separating said blood into a plasma layer, a buffy coat layer, and a red blood cell layer within said centrifuge and by rotating said centrifuge;
executing a first monitoring step comprising monitoring a location of an interface between said buffy coat layer and said red blood cell layer within said centrifuge;
executing a second monitoring step comprising monitoring for an existence of a first condition and a second condition;
said first condition requiring: 1) an amount of said blood introduced into said centrifuge being both less than a target processed blood volume and within a first predetermined amount of said target processed blood volume; and 2) a determination by said blood processing system that said interface is in a first position from said first monitoring step;
said second condition being said amount of said blood introduced into said centrifuge being larger than said target processed blood volume by at least a second predetermined amount, wherein the second predetermined amount is greater than zero; and
directing a fluid flow out of said second port of said centrifuge and into a first container, wherein said fluid flow comprises buffy coat from said buffy coat layer, wherein said directing a fluid flow step is initiated in response to said blood processing system having identified an existence of either said first condition or said second condition, wherein each of said first monitoring step, said second monitoring step and said directing a fluid flow step are executed by said blood processing system.

2. The method of claim 1 , wherein said first monitoring step is executed using a bowl optic sensor.

3. The method of claim 1 , wherein said first predetermined amount is 75 ml.

4. The method of claim 1 , wherein said first predetermined amount is a fixed amount that is independent of a magnitude of said target processed blood volume.

5. The method of claim 1 , wherein said second predetermined amount is 75 ml.

6. The method of claim 1 , further comprising:
executing a third monitoring step comprising monitoring a hematocrit of an initial portion of said fluid flow from said directing step;
and
assessing said fluid flow for at least part of said directing a fluid flow step, wherein said at part of said directing a fluid flow step is after said initial portion, wherein said third monitoring step, said determining step, and said assessing step are all executed by said blood processing system.

7. The method of claim 6 , wherein said determining step comprises using an output of a hematocrit sensor associated with a fluid line extending between said centrifuge and said first container.

8. The method of claim 6 , wherein said initial portion of said fluid flow comprises introducing a predetermined fluid amount into said first container.

9. The method of claim 8 , wherein said predetermined fluid amount is 10 ml.

10. The method of claim 6 , wherein said assessing step comprises comparing a current hematocrit value of said fluid flow from said directing a fluid flow step to a hematocrit threshold, wherein said hematocrit threshold is an amount corresponding to a predetermined percentage.

11. The method of claim 10 , wherein said predetermined percentage is 5%.

12. The method of claim 10 , further comprising:
suspending said directing a fluid flow step based upon said assessing step, wherein said suspending step is initiated when said current hematocrit value of said fluid flow from said directing step satisfies said hematocrit threshold.

13. The method of claim 12 , wherein satisfaction of said hematocrit threshold comprises said current hematocrit value being equal to or greater than said hematocrit threshold.

14. The method of claim 12 , wherein said directing a fluid flow step is based upon a continued execution of said introducing blood prior to said suspending step, and wherein said directing a fluid flow step is based upon directing a flow of red blood cells into said centrifuge through said third port after said suspending step.

15. The method of claim 1 , further comprising using a disposable kit, wherein said disposable kit comprises said centrifuge and said first container.

16. The method of claim 1 , further comprising:
terminating said directing a fluid flow step; and
subjecting contents of said first container to photo therapy after said terminating step.

17. The method of claim 1 , further comprising:
said blood processing system receiving user input that activates a blood prime function of said blood processing system, wherein said introducing blood step comprises introducing donor blood into said centrifuge, followed by introducing patient blood into said centrifuge, wherein said blood prime operation comprises said introducing donor blood step.

18. The method of claim 17 , wherein said blood processing system comprises a return bag.

19. The method of claim 18 , wherein said blood processing system is configured to preclude transferring contents of said return bag back to a patient at any time during said directing a fluid flow step and when said blood prime function has been activated.

20. The method of claim 18 , further comprising:
photo-activating contents of said first container, wherein said blood processing system is configured to preclude transferring contents of said return bag back to a patient at any time during said photo-activating step and when said blood prime function has been activated.

21. The method of claim 20 , further comprising:
said blood processing system receiving user input on a rinseback volume; and
reinfusing contents of said first container back to a patient, wherein said blood processing system is configured to transfer said rinseback volume from said return bag back to said patient only after a termination of said photo-activating step, only after a completion of an entirety of said reinfusing step, and when said blood prime function has been activated.

22. A blood processing system configured to execute the method of claim 1 .

23. A photopheresis system configured to execute the method of claim 1 , wherein said blood processing system is said photopheresis system.

Assignees

• Mallinckrodt Hospital Products Ip Ltd
• Mallinckrodt Pharmaceuticals Ireland Ltd

Inventors

• Briggs Dennis
• Do Simon
• Rabeno Eric
• Sangare Abdoulaye
• Vandlik Mark
• Fluck Vicki
• Turek Christopher

Classifications

• A61M1/36222

  Details related to the interface between cassette and machine · CPC title

• A61M1/36225

  with blood pumping means or components thereof · CPC title

• A61M1/362264

  the filter being a blood filter · CPC title

• A61M1/362266

  Means for adding solutions or substances to the blood · CPC title

• A61M1/3644

  Mode of operation · CPC title