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

• US 9,238,097 B2
• Filed: 06/07/2010
• Issued: 01/19/2016
• Est. Priority Date: 03/04/2002
• Status: Active Grant

• Current Assignee: Mallinckrodt Critical Care Finance Inc (Mallinckrodt plc), Mallinckrodt Pharma Ip Trading DAC (Mallinckrodt plc)
• Original Assignee: Therakos, Inc (Mallinckrodt plc)
• Inventors: Briggs, Dennis
• Primary Examiner(s): DEAK, LESLIE R
• Application Number:
  US12/795,308
• Publication Number:
  US 20100298752A1
• Time in Patent Office: 2,052 Days
• Field of Search: 604/4.01, 604/5.01, 604/6.01, 604/6.06, 604/6.07, 604/6.08, 604/6.11, 604/6.15, 210/645, 422/44
• US Class Current: 1/1
• CPC Class Codes: A61K 41/0066 Psoralene-activated UV-A photochemotherapy (PUVA-therapy), e.g. for treatment of psoriasis or eczema, extracorporeal photopheresis with psoralens or fucocoumarins
• CPC Class Codes: A61M 1/0227 and means for securing the filter against damage, e.g. during centrifugation
• CPC Class Codes: A61M 1/3603 in the same direction
• CPC Class Codes: A61M 1/361 before treatment
• CPC Class Codes: A61M 1/36224 with sensing means or components thereof
• CPC Class Codes: A61M 1/36225 with blood pumping means or components thereof
• CPC Class Codes: A61M 1/362264 the filter being a blood filter
• CPC Class Codes: A61M 1/362266 Means for adding solutions or substances to the blood
• CPC Class Codes: A61M 1/3681 by irradiation
• CPC Class Codes: A61M 1/3683 using photoactive agents
• CPC Class Codes: A61M 1/3686 by removing photoactive agents after irradiation
• CPC Class Codes: A61M 1/3693 using separation based on different densities of components, e.g. centrifuging
• CPC Class Codes: A61M 1/3696 with means for adding or withdrawing liquid substances during the centrifugation, e.g. continuous centrifugation
• CPC Class Codes: A61M 1/72 Cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 1/77 Suction-irrigation systems aspiration tips supplying fluids A61M1/85; specific for negative pressure wound therapy A61M1/92; combined with tracheal tubes A61M16/0463
• CPC Class Codes: A61M 2202/0092 starting product created by centrifuging
• CPC Class Codes: A61M 2202/0427 Platelets; Thrombocytes
• CPC Class Codes: A61M 2205/051 with radiation therapy
• CPC Class Codes: A61M 2205/053 ultraviolet
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/125 : with incorporated filters
• CPC Class Codes: A61M 2205/35 : Communication
• CPC Class Codes: A61M 2205/3569 : sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/52 : with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/60 : with identification means
• CPC Class Codes: A61M 2205/75 : with filters
• CPC Class Codes: A61M 3/0201 : Cassettes therefor
• CPC Class Codes: B04B 2005/0464 : with hollow or massive core in centrifuge bowl
• CPC Class Codes: B04B 2005/0492 : with fluid conveying umbilicus between stationary and rotary centrifuge parts
• CPC Class Codes: B04B 5/0442 : with means for adding or withdrawing liquid substances during the centrifugation, e.g. continuous centrifugation
• CPC Class Codes: F04B 43/1253 : by using two or more rollers as squeezing elements, the rollers moving on an arc of a circle during squeezing
• CPC Class Codes: F28F 2260/02 : having microchannels

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

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.