IP Library Granted Patent US 12,064,544
Granted Patent B2
US 12,064,544 · App. 16/906,976 · Granted Aug 20, 2024

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

Inventors: Dennis Briggs (West Chester, PA); Simon Do (Pottstown, PA); Eric Rabeno (Lincoln University, PA); Abdoulaye Sangare (Thorndale, PA); Mark Vandlik (West Chester, PA); Vicki Fluck (Quakertown, PA); Christopher Turek (West Chester, PA)
Assignee: Mallinckrodt Pharmaceuticals Ireland Limited
A61M1/3696A61M1/0209A61M1/3609A61M1/36222A61M1/36225A61M1/362264A61M1/362266A61M1/3643A61M1/3644A61M1/3646A61M1/3652A61M1/3683A61M2202/0439A61M2205/051A61M2205/053A61M2205/3331A61M2205/3334A61M2205/6018A61M2230/207G01M3/26
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Quick Facts
Patent No.
US 12,064,544
App. No.
16/906,976
Granted
Aug 20, 2024
Kind
B2
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 ).

Claims (40)

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.

Assignments (12)
RELEASE OF SECURITY INTEREST Recorded Aug 14, 2025
From: ACQUIOM AGENCY SERVICES LLC
To: MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; OCERA THERAPEUTICS LLC; SPECGX LLC; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC
Reel/Frame 072324/0740 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 25, 2025
From: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
To: THERAKOS DEVELOPMENT LIMITED
Reel/Frame 070623/0621 →
RELEASE OF SECURITY INTERESTS Recorded Dec 3, 2024
From: ACQUIOM AGENCY SERVICES, LLC, AS COLLATERAL AGENT
To: MALLINCKRODT PHARMA IP TRADING LIMITED; STRATATECH CORPORATION; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
Reel/Frame 069476/0103 →
PATENT SECURITY AGREEMENT Recorded Dec 3, 2024
From: SOLARIS IPCO LIMITED
To: NOMURA CORPORATION FUNDING AMERICAS, LLC, AS ADMINISTRATIVE AGENT AND COLLATERAL AGENT
Reel/Frame 069476/0380 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 17, 2024
From: MALLINCKRODT HOSPITAL PRODUCTS IP UNLIMITED COMPANY
To: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
Reel/Frame 067454/0773 →
CHANGE OF NAME Recorded May 17, 2024
From: MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED
To: MALLINCKRODT HOSPITAL PRODUCTS IP UNLIMITED COMPANY
Reel/Frame 067456/0823 →
RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 060434, FRAME 0536 Recorded Nov 16, 2023
From: DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT
To: MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; SPECGX LLC; OCERA THERAPEUTICS, INC.; STRATATECH CORPORATION; VTESSE LLC; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; SUCAMPO PHARMA AMERICAS LLC
Reel/Frame 065601/0347 →
RELEASE OF SECURITY INTERESTS IN PATENTS AT REEL 060389/FRAME 0913 Recorded Nov 15, 2023
From: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS SECOND LIEN COLLATERAL AGENT
To: OCERA THERAPEUTICS LLC (F/K/A OCERA THERAPEUTICS, INC.); MALLINCKRODT LLC; MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY; SPECGX LLC; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
Reel/Frame 065583/0465 →
SECURITY INTEREST Recorded Nov 15, 2023
From: MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; OCERA THERAPEUTICS LLC; SPECGX LLC; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC
To: ACQUIOM AGENCY SERVICES LLC
Reel/Frame 065595/0376 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 10, 2023
From: BRIGGS, DENNIS; DO, SIMON; RABENO, ERIC; SANGARE, ABDOULAYE; VANDLIK, MARK; FLUCK, VICKI; TUREK, CHRISTOPHER
To: MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED
Reel/Frame 063592/0502 →
NOTICE OF GRANT OF SECURITY INTEREST IN INTELLECTUAL PROPERTY Recorded Jun 22, 2022
From: MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; SPECGX LLC; OCERA THERAPEUTICS, INC.; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY
To: DEUTSCHE BANK AG NEW YORK BRANCH
Reel/Frame 060434/0536 →
SECURITY INTEREST Recorded Jun 17, 2022
From: MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; SPECGX LLC; OCERA THERAPEUTICS, INC.; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
To: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS SECOND LIEN COLLATERAL AGENT
Reel/Frame 060389/0913 →