IP Library Granted Patent US 10,434,239
Granted Patent B1
US 10,434,239 · App. 15/261,968 · Granted Oct 8, 2019

Centrifuge system and method with component tracking

Inventors: Dennis Briggs (West Chester, PA); Simon Do (Pottstown, PA); Mark Vandlik (West Chester, PA); Kevin Murphy (Media, PA)
Assignee: Mallinckrodt Hospital Products IP Limited
A61M1/3683A61K31/37A61K35/15A61K41/0066A61M1/0209A61M1/3693B04B5/0442B04B13/00G06Q30/018G16B50/00A61M2205/52A61M2205/70
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Quick Facts
Patent No.
US 10,434,239
App. No.
15/261,968
Granted
Oct 8, 2019
Kind
B1
Abstract

Devices, methods, and systems are provided for priming, separating, and collecting blood components. At least one disposable component may be utilized, and a determination may be made as to whether such a disposable component is authentic, is new/unused or used, or both.

Claims (35)

1. A method of operating an extracorporeal photopheresis system, said extracorporeal photopheresis system comprising a disposable photopheresis kit, a plurality of pumps, a photoactivation module, and a drug container comprising a drug that is used in the execution of an extracorporeal photopheresis procedure by said extracorporeal photopheresis system, said method comprising:

reading data from each of said disposable photopheresis kit and said drug container for said extracorporeal photopheresis system to determine if a matched condition exists between said disposable photopheresis kit and said drug container;

executing a first acquiring step comprising acquiring data on said disposable photopheresis kit, said disposable photopheresis kit comprising a centrifuge bowl, a plasma bag, a treatment bag, an irradiation bag, and tubing, wherein said first acquiring step is executed by said extracorporeal photopheresis system;

interconnecting each pump of said plurality of pumps with a different portion of said tubing of said disposable photopheresis kit;

interconnecting said drug container with said treatment bag;

disposing said irradiation bag of said disposable photopheresis kit in said photoactivation module;

executing a first determining step comprising determining if said disposable photopheresis kit is of a first unused condition from said first acquiring step, wherein said first determining step is executed by said extracorporeal photopheresis system;

allowing said extracorporeal photopheresis system to conduct said extracorporeal photopheresis procedure if said extracorporeal photopheresis system determines that at least each of the following is satisfied: 1) that said matched condition exists between said disposable photopheresis kit and said drug container; and 2) that said disposable photopheresis kit is of said first unused condition using said first acquiring step; and

precluding said extracorporeal photopheresis system from conducting said extracorporeal photopheresis procedure if said extracorporeal photopheresis system determines that at least one of the following applies: 1) that said matched condition fails to exist between said disposable photopheresis kit and said drug container; and 2) that said disposable photopheresis kit is of a first used condition using said first acquiring step.

2. The method of claim 1 , wherein said first determining step comprises comparing said data from said first acquiring step to a database.

3. The method of claim 2 , further comprising:

said extracorporeal photopheresis system determining if said disposable photopheresis kit is either authentic or counterfeit from said comparing step;

wherein said allowing step further comprises allowing said extracorporeal photopheresis system to conduct said extracorporeal photopheresis procedure if said extracorporeal photopheresis system determines that at least each of the following is satisfied: 1) that said matched condition exists between said disposable photopheresis kit and said drug container; 2) that said disposable photopheresis kit is of said first unused condition using said first acquiring step; and 3) that said disposable photopheresis kit is authentic; and

wherein said precluding step further comprises precluding said extracorporeal photopheresis system from conducting said extracorporeal photopheresis procedure if said extracorporeal photopheresis system determines that at least one of the following applies: 1) that said matched condition fails to exist between said disposable photopheresis kit and said drug container; 2) that said disposable photopheresis kit is of said first used condition using said first acquiring step; and 3) that said disposable photopheresis kit is counterfeit.

4. The method of claim 3 , wherein said database comprises a plurality of authentic disposable photopheresis kits, and wherein each authentic said disposable photopheresis kit in said database also has an associated use status.

5. The method of claim 1 , further comprising:

said extracorporeal photopheresis system determining if said disposable photopheresis kit is either authentic or counterfeit using said data from said first acquiring step;

wherein said allowing step further comprises allowing said extracorporeal photopheresis system to conduct said extracorporeal photopheresis procedure if said extracorporeal photopheresis system determines that at least each of the following is satisfied: 1) that said matched condition exists between said disposable photopheresis kit and said drug container; 2) that said disposable photopheresis kit is of said first unused condition using said first acquiring step; and 3) that said disposable photopheresis kit is authentic; and

wherein said precluding step further comprises precluding said extracorporeal photopheresis system from conducting said extracorporeal photopheresis procedure if said extracorporeal photopheresis system determines that at least one of the following applies: 1) that said matched condition fails to exist between said disposable photopheresis kit and said drug container; 2) that said disposable photopheresis kit is of said first used condition using said first acquiring step; and 3) that said disposable photopheresis kit is counterfeit.

6. The method of claim 1 , further comprising:

executing a second acquiring step comprising acquiring data on said drug container;

executing a second determining step comprising determining if said drug container is of a second unused condition from said second acquiring step, wherein said second determining step is executed by said extracorporeal photopheresis system;

wherein said allowing step further comprises allowing said extracorporeal photopheresis system to conduct said extracorporeal photopheresis procedure if said extracorporeal photopheresis system determines that at least each of the following is satisfied: 1) that said matched condition exists between said disposable photopheresis kit and said drug container; 2) that said disposable photopheresis kit is of said first unused condition using said first acquiring step; and 3) that said drug container is of said second unused condition using said second acquiring step; and

wherein said precluding step further comprises precluding said extracorporeal photopheresis system from conducting said extracorporeal photopheresis procedure if said extracorporeal photopheresis system determines that at least one of the following applies: 1) that said matched condition fails to exist between said disposable photopheresis kit and said drug container; 2) that said disposable photopheresis kit is of said first used condition using said first acquiring step; and 3) that said drug container is of a second used condition using said second acquiring step.

7. The method of claim 6 , further comprising:

said extracorporeal photopheresis system determining if said drug container is either authentic or counterfeit using said data from said second acquiring step;

wherein said allowing step further comprises allowing said extracorporeal photopheresis system to conduct said extracorporeal photopheresis procedure if said extracorporeal photopheresis system determines that at least each of the following is satisfied: 1) that said matched condition exists between said disposable photopheresis kit and said drug container; 2) that said disposable photopheresis kit is of said first unused condition using said first acquiring step; 3) that said drug container is of said second unused condition using said second acquiring step; and 4) that said drug container is authentic; and

wherein said precluding step further comprises precluding said extracorporeal photopheresis system from conducting said extracorporeal photopheresis procedure if said extracorporeal photopheresis system determines that at least one of the following applies: 1) that said that said matched condition fails to exist between said disposable photopheresis kit and said drug container; 2) that said disposable photopheresis kit is of said first used condition using said first acquiring step; 3) that said drug container is of said second used condition using said first acquiring step; and 4) that said drug container is counterfeit.

8. The method of claim 6 , further comprising:

said extracorporeal photopheresis system determining if said disposable photopheresis kit is either authentic or counterfeit using said data from said first acquiring step;

said extracorporeal photopheresis system determining if said drug container is either authentic or counterfeit using said data from said second acquiring step;

wherein said allowing step further comprises allowing said extracorporeal photopheresis system to conduct said extracorporeal photopheresis procedure if said extracorporeal photopheresis system determines that at least each of the following is satisfied: 1) that said matched condition exists between said disposable photopheresis kit and said drug container; 2) that said disposable photopheresis kit is of said first unused condition using said first acquiring step; 3) that said disposable photopheresis kit is authentic; 4) that said drug container is of said second unused condition using said second acquiring step; and 5) that said drug container is authentic; and

wherein said precluding step further comprises precluding said extracorporeal photopheresis system from conducting said extracorporeal photopheresis procedure if said extracorporeal photopheresis system determines that at least one of the following applies: 1) that said that said matched condition fails to exist between said disposable photopheresis kit and said drug container; 2) that said disposable photopheresis kit is of said first used condition using said first acquiring step; 3) that said disposable photopheresis kit is counterfeit; 4) that said drug container is of said second used condition using said second acquiring step; and 5) that said drug container is counterfeit.

9. The method of claim 8 , wherein said first determining step comprises comparing said data from said first acquiring step to a database, and wherein said second determining step comprises comparing said data from said second acquiring step to said database.

10. The method of claim 9 , wherein said database comprises a plurality of authentic disposable photopheresis kits and a plurality of authentic drug containers, and wherein each authentic said disposable photopheresis kit and each authentic said drug container in said database also has an associated use status.

Assignments (26)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 10, 2026
From: MALLINCKRODT HOSPITAL PRODUCTS IP UNLIMITED COMPANY
To: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED COMPANY
Reel/Frame 075393/0921 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 23, 2026
From: THERAKOS DEVELOPMENT LIMITED
To: THERAKOS HOLDINGS USA, LLC
Reel/Frame 075227/0886 →
RELEASE OF PATENT SECURITY INTEREST RECORDED AT REEL 69476, FRAME 0380 Recorded Mar 17, 2026
From: NOMURA CORPORATE FUNDING AMERICAS, LLC, AS ADMINISTRATIVE AGENT AND COLLATERAL AGENT
To: THERAKOS DEVELOPMENT LIMITED
Reel/Frame 075101/0970 →
PATENT SECURITY AGREEMENT Recorded Mar 17, 2026
From: THERAKOS HOLDINGS USA, LLC
To: NOMURA CORPORATE FUNDING AMERICAS, LLC, AS ADMINISTRATIVE AGENT AND COLLATERAL AGENT
Reel/Frame 075102/0334 →
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 070623/0274 →
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 043601, FRAME 0025 Recorded Nov 16, 2023
From: DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT
To: MALLINCKRODT INTERNATIONAL FINANCE S.A.; MALLINCKRODT CB LLC; MALLINCKRODT FINANCE GMBH; MALLINCKRODT US HOLDINGS LLC (F/K/A MALLINCKRODT US HOLDINGS INC.); MALLINCKRODT CARRIBEAN, INC.; MALLINCKRODT US POOL LLC; MNK 2011 LLC (F/K/A MALLINCKRODT INC.); LUDLOW LLC (F/K/A LUDLOW CORPORATION); CNS THERAPEUTICS, INC.; MALLINCKRODT ENTERPRISES HOLDINGS LLC (F/K/A MALLINCKRODT ENTERPRISES HOLDINGS, INC.); MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; LAFAYETTE PHARMACEUTICALS LLC; LIEBEL-FLARSHEIM COMPANY LLC; MALLINCKRODT BRAND PHARMACEUTICALS LLC (F/K/A MALLINCKRODT BRAND PHARMACEUTICALS, INC.); MALLINCKRODT VETERINARY, INC.; MALLINCKRODT US HOLDINGS LLC; IMC EXPLORATION COMPANY; MEH, INC.; MALLINCKRODT HOSPITAL PRODUCTS IP UNLIMITED COMPANY (F/K/A MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED); MALLINCKRODT ARD IP UNLIMITED COMPANY (F/K/A MALLINCKRODT ARD IP LIMITED); OCERA THERAPEUTICS LLC (F/K/A OCERA THERAPEUTICS, INC.); SPECGX LLC; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC (F/K/A VTESSE INC.); MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY (F/K/A MALLINCKRODT PHARMA IP TRADING D.A.C.); INFACARE PHARMACEUTICAL CORPORATION; ST SHARED SERVICES LLC; THERAKOS, INC.; IKARIA THERAPEUTICS LLC; INO THERAPEUTICS LLC
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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
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RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 049822, FRAME 0674 Recorded Nov 16, 2023
From: DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT
To: MALLINCKRODT INTERNATIONAL FINANCE S.A.; MALLINCKRODT CB LLC; MALLINCKRODT FINANCE GMBH; MALLINCKRODT US HOLDINGS LLC (F/K/A MALLINCKRODT US HOLDINGS INC.); MALLINCKRODT CARRIBEAN, INC.; MALLINCKRODT US POOL LLC; MNK 2011 LLC (F/K/A MALLINCKRODT INC.); LUDLOW LLC (F/K/A LUDLOW CORPORATION); CNS THERAPEUTICS, INC.; MALLINCKRODT ENTERPRISES HOLDINGS LLC (F/K/A MALLINCKRODT ENTERPRISES HOLDINGS, INC.); MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; LAFAYETTE PHARMACEUTICALS LLC; LIEBEL-FLARSHEIM COMPANY LLC; MALLINCKRODT BRAND PHARMACEUTICALS LLC (F/K/A MALLINCKRODT BRAND PHARMACEUTICALS, INC.); MALLINCKRODT VETERINARY, INC.; MALLINCKRODT US HOLDINGS LLC; IMC EXPLORATION COMPANY; MEH, INC.; MALLINCKRODT HOSPITAL PRODUCTS IP UNLIMITED COMPANY (F/K/A MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED); MALLINCKRODT ARD IP UNLIMITED COMPANY (F/K/A MALLINCKRODT ARD IP LIMITED); OCERA THERAPEUTICS LLC (F/K/A OCERA THERAPEUTICS, INC.); SPECGX LLC; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC (F/K/A VTESSE INC.); MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY (F/K/A MALLINCKRODT PHARMA IP TRADING D.A.C.); INFACARE PHARMACEUTICAL CORPORATION; ST SHARED SERVICES LLC; THERAKOS, INC.; IKARIA THERAPEUTICS LLC; INO THERAPEUTICS LLC
Reel/Frame 065609/0454 →
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 →
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 →
RELEASE OF SECURITY INTEREST Recorded Jun 17, 2022
From: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS SECOND LIEN COLLATERAL AGENT
To: OCERA THERAPEUTICS, INC.; MALLINCKRODT LLC; MALLINCKRODT ARD IP UNLIMITED COMPANY (F/K/A MALLINCKRODT ARD IP LIMITED); MALLINCKRODT HOSPITAL PRODUCTS IP UNLIMITED COMPANY (F/K/A MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED); MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY (F/K/A MALLINCKRODT PHARMA IP TRADING DESIGNATED ACTIVITY COMPANY); SPECGX LLC; STRATATECH CORPORATION; VTESSE LLC (F/K/A VTESSE INC.)
Reel/Frame 060389/0839 →
SECURITY INTEREST Recorded Dec 10, 2019
From: MALLINCKRODT ARD IP LIMITED; MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED; SPECGX LLC; OCERA THERAPEUTICS, INC.; MALLINCKRODT PHARMA IP TRADING DESIGNATED ACTIVITY COMPANY; STRATATECH CORPORATION; VTESSE INC.; MALLINCKRODT LLC
To: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS SECOND LIEN COLLATERAL AGENT
Reel/Frame 051256/0829 →
NUNC PRO TUNC ASSIGNMENT Recorded Aug 15, 2019
From: THERAKOS, INC
To: MALLINCKRODT CRITICAL CARE FINANCE INC.
Reel/Frame 050061/0371 →
NUNC PRO TUNC ASSIGNMENT Recorded Aug 15, 2019
From: MALLINCKRODT PHARMA IP TRADING D.A.C.
To: MALLINCKRODT IP
Reel/Frame 050061/0498 →
NUNC PRO TUNC ASSIGNMENT Recorded Aug 15, 2019
From: MALLINCKRODT IP
To: MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED
Reel/Frame 050061/0605 →
NUNC PRO TUNC ASSIGNMENT Recorded Aug 15, 2019
From: MALLINCKRODT CRITICAL CARE FINANCE INC
To: MALLINCKRODT PHARMA IP TRADING D.A.C.
Reel/Frame 050061/0438 →
NOTICE OF GRANT OF SECURITY INTEREST IN INTELLECTUAL PROPERTY Recorded Jul 22, 2019
From: MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED
To: DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT
Reel/Frame 049822/0674 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 6, 2018
From: BRIGGS, DENNIS; DO, SIMON; VANDLIK, MARK; MURPHY, KEVIN
To: MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED
Reel/Frame 046280/0436 →
NOTICE OF GRANT OF SECURITY INTEREST IN PATENTS Recorded Aug 18, 2017
From: MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED
To: DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT
Reel/Frame 043601/0025 →