IP Library Granted Patent US 9,238,097
Granted Patent B2
US 9,238,097 · App. 12/795,308 · Granted Jan 19, 2016

Method for collecting a desired blood component and performing a photopheresis treatment

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Quick Facts
Patent No.
US 9,238,097
App. No.
12/795,308
Granted
Jan 19, 2016
Kind
B2
Abstract

An improved method for separating whole blood into components and collecting a desired blood component. The method allows a desired blood component to be subjected to centrifugal forces within a separator for prolonged periods of time, yielding a cleaner cut and higher yield of the desired blood component. Whole blood is drawn from a source and pumped into a separator, the undesired blood components are removed from the separator at rates so as to build up the desired blood component in the separator. The desired blood component is only removed after a predetermined amount of the desired blood component has built up in the separator. It is preferred that the desired blood component be buffy coat and that the method be used to perform photopheresis treatments. In another aspect, the invention is a method of performing a full photopheresis treatment to treat diseases in a reduced time, preferably less than about 70 minutes, and more preferably less than about 45 minutes.

Claims (50)

1. A disposable closed-circuit kit for single use in a reusable tower system, the reusable tower system including at least one pump and at least one processor, the at least one processor being operably coupled to the at least one pump and the kit for continuously separating at least one first component from a biological fluid and subjecting the at least one first component to at least one therapeutic application, the kit comprising:

a first needle adapter for obtaining the biological fluid from a subject;

a cassette for operably coupling to the at least one pump to direct a flow of at least one fluid through the kit;

a single centrifuge bowl for operably coupling to the at least one processor, the centrifuge bowl comprising:

an inlet port to control a rate of inflow of the biological fluid into the centrifuge bowl;

a first outlet port to control a first rate of withdrawal of the at least one first component of the biological fluid from the centrifuge bowl; and

a second outlet port to control a second rate of withdrawal of at least one second component of the biological fluid from the centrifuge bowl, such that the at least one first component of the biological fluid is at least one of accumulated in and withdrawn from the centrifuge bowl independently from the at least one second component of the biological fluid, thereby continuously separating the at least one first component from the biological fluid;

a collection bag for receiving the at least one second component from the centrifuge bowl;

a treatment bag for receiving the at least one first component from the centrifuge bowl for subjecting the at least one first component to the at least one therapeutic application;

a second needle adapter for returning at least one treated component of the biological fluid to the subject; and

tubing operably coupled to the cassette for providing a closed circuit of sealed passageways, thereby directing a flow of at least:

saline to the cassette;

anticoagulant to the cassette;

the biological fluid from the first needle adapter and to the cassette;

the at least one second component to the collection bag;

the at least one first component to the treatment bag; and

the at least one treated component to the second needle adapter.

2. The kit of claim 1 , wherein subjecting the at least one first component to the at least one therapeutic application includes exposing the at least one first component to a therapeutic agent.

3. The kit of claim 2 , wherein the cassette and the tubing are further configured for directing a flow of the therapeutic agent to the treatment bag for mixing with the at least one first component.

4. The kit of claim 2 , wherein the therapeutic agent is a photoactive agent.

5. The kit of claim 1 , wherein subjecting the at least one first component to the at least one therapeutic application includes exposing the at least one first component to electromagnetic radiation.

6. The kit of claim 1 , wherein subjecting the at least one first component to the at least one therapeutic application includes performing photopheresis on the at least one first component.

7. The kit of claim 1 , further comprising at least one of an irradiation chamber, a hematocrit sensor, a data card, a filter, and a pressure sensor.

8. The kit of claim 1 , wherein the biological fluid is whole blood and the at least one first component is at least one of buffy coat and red blood cells.

9. A disposable closed-circuit kit for single use in a reusable tower system, the reusable tower system including at least one pump and at least one processor, the at least one processor being operably coupled to the at least one pump and the kit for continuously separating at least one first component from a biological fluid and subjecting the at least one first component to at least one therapeutic application, the kit comprising:

a first needle adapter for obtaining the biological fluid from a subject;

a cassette for operably coupling to the at least one pump to direct a flow of at least one fluid through the kit;

a single centrifuge bowl for operably coupling to the at least one processor, the centrifuge bowl comprising:

an inlet port to control a rate of inflow of the biological fluid into the centrifuge bowl;

a first outlet port to control a first rate of withdrawal of the at least one first component of the biological fluid from the centrifuge bowl; and

a second outlet port to control a second rate of withdrawal of at least one second component of the biological fluid from the centrifuge bowl, such that the at least one first component of the biological fluid is at least one of accumulated in and withdrawn from the centrifuge bowl independently from the at least one second component of the biological fluid, thereby continuously separating the at least one first component from the biological fluid;

a collection bag for receiving the at least one second component from the centrifuge bowl;

a treatment bag for receiving the at least one first component from the centrifuge bowl;

an irradiation chamber comprising two or more fluid channels for receiving and exposing the at least one first component and a photoactive agent to electromagnetic radiation, thereby subjecting the at least one first component to the at least one therapeutic application;

a second needle adapter for returning at least one treated component of the biological fluid to the subject; and

tubing operably coupled to the cassette for providing a closed circuit of sealed passageways, thereby directing a flow of at least:

saline to the cassette;

anticoagulant to the cassette;

the biological fluid from the first needle adapter and to the cassette;

the at least one second component to the collection bag;

the at least one first component to the treatment bag; and

the at least one treated component from the irradiation chamber and to the second needle adapter.

10. The kit of claim 9 , wherein subjecting the at least one first component to the at least one therapeutic application includes performing photopheresis on the at least one first component.

11. The kit of claim 9 , further comprising at least one of a hematocrit sensor, a filter, a pressure sensor, and a data card.

12. The kit of claim 9 , wherein:

the treatment bag is further configured for receiving the photoactive agent; and

the cassette and the tubing are further configured to control and direct a flow of the photoactive agent to the treatment bag for mixing with the at least one first component.

13. The kit of claim 9 , wherein the electromagnetic radiation is ultraviolet light.

14. The kit of claim 9 , wherein the biological fluid is whole blood and the at least one first component is at least one of buffy coat and red blood cells.

15. The kit of claim 9 , wherein prior to withdrawing the biological fluid from a subject, the photoactive agent has been administered to the subject in vivo.

Assignments (15)
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 →
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 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 PATENT SECURITY INTERESTS RECORDED AT REEL 036662, FRAME 0053 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 065610/0503 →
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 →
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 →
NUNC PRO TUNC ASSIGNMENT Recorded Jul 1, 2019
From: THERAKOS, INC.
To: MALLINCKRODT CRITICAL CARE FINANCE INC.
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NUNC PRO TUNC ASSIGNMENT Recorded Jul 1, 2019
From: MALLINCKRODT CRITICAL CARE FINANCE INC.
To: MALLINCKRODT PHARMA IP TRADING D.A.C.
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NUNC PRO TUNC ASSIGNMENT Recorded Jul 1, 2019
From: MALLINCKRODT PHARMA IP TRADING D.A.C.
To: MALLINCKRODT IP
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NUNC PRO TUNC ASSIGNMENT Recorded Jul 1, 2019
From: MALLINCKRODT IP
To: MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED
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