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

• US 7,476,209 B2
• Filed: 12/15/2005
• Issued: 01/13/2009
• Est. Priority Date: 12/21/2004
• 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: Hutchinson, Michael, Star, Cynthia, Gara, Stephen, Briggs, Dennis, Watters, Tom
• Primary Examiner(s): Deak; Leslie R
• Application Number:
  US11/304,092
• Publication Number:
  US 20060155236A1
• Time in Patent Office: 1,125 Days
• Field of Search: 604/4.01, 604/5.01, 604/6.01, 604/6.1, 604/6.11, 210/90, 422/44, 137/628, 417/477.2, 417/477.9, 417/477.13
• US Class Current: 604/6.01
• CPC Class Codes: A61M 1/0231 with gas separating means, e.g. air outlet through microporous membrane or gas bag
• CPC Class Codes: A61M 1/3603 in the same direction
• CPC Class Codes: A61M 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30
• CPC Class Codes: A61M 1/362227 the interface providing means for actuating on functional elements of the cassette, e.g. plungers
• 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 1/362261 at least one cassette surface or portion thereof being flexible, e.g. the cassette having a rigid base portion with preformed channels and being covered with a foil
• CPC Class Codes: A61M 1/362264 the filter being a blood filter
• CPC Class Codes: A61M 1/362265 Details of valves
• CPC Class Codes: A61M 1/362266 Means for adding solutions or substances to the blood
• CPC Class Codes: A61M 1/3633 Blood component filters, e.g. leukocyte filters
• CPC Class Codes: A61M 1/3679 by absorption A61M1/3675 takes precedence
• 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 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 2205/502 : User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/75 : with filters
• CPC Class Codes: Y10T 137/86919 : Sequentially closing and opening alternately seating flow controllers
• CPC Class Codes: Y10T 137/86928 : Sequentially progressive opening or closing of plural valves

Abstract

Methods and apparatus for collecting and treating blood component. An apparatus and methods for improvement of an extracorporeal photopheresis treatment is described. A cassette having flexible tubes inside its housing and on the bottom surface outside the cassette housing for ease of manufacturing is operated with a centrifuge bowl having an inlet and two outlets, pressure domes for measuring pressures in tubes, an improved irradiation plate, and a dual chamber bag in an extracorporeal photopheresis treatment.

Claims

1. An apparatus comprising a cassette for controlling movement of blood and separated blood components, the cassette comprising a housing formed by joining a rigid plastic cover and a rigid plastic base;

said rigid plastic cover having a top surface, a bottom surface, and a wall having a plurality of openings;

said rigid plastic base having a top surface, a bottom surface, and a plurality of apertures through the top and bottom surfaces, and a wall having a plurality of openings adapted to overlap with the openings of the wall of the cover;

said top surface of the base comprises a first upper level and a first lower level, wherein the first lower level has a plurality of first flexible tubings, secured by raceways, for one or more of a) connecting to other tubings through multitube connectors, b) extending out of or entering the housing, or c) forming first flexible tube loops having one end extending out of the housing and one end entering the housing;

said plurality of apertures are located on the first lower level and expose at least one section of the first flexible tubing inside the housing so that fluid flow through the exposed section can be prevented when an actuator exerts pressure on the exposed section through the apertures against a first occluder bar located above the first lower level surface;

said bottom surface of the base comprises a second upper level and a second lower level, wherein the second lower level has a plurality of second flexible tubings outside of the housing and secured by raceways on said second lower level for one or more of extending through or entering the openings of the wall of the base or forming second flexible tube loops having one end extending out of the wall and one end entering the wall of the base; and

wherein fluid flowing through the second flexible tubing can be prevented when another actuator exerts pressure on the tubing against a second occluder bar located on the second lower level of the bottom surface of the base.

2. The apparatus of claim 1 further comprises a filter in fluid communication with one first flexible tubing and one second flexible tubing, and a recordable smartcard on which are electronically recorded identification data.

3. The apparatus of claim 1 wherein the cassette has three first tube loops extend from inside the housing, two second tube loops extends from the lower level of the bottom surface of the base and five apertures on the base.

4. The apparatus of claim 1 wherein the apparatus further comprises a pressure dome that is connected in series between the cassette and a centrifuge bowl for measuring a pressure of a fluid inside a flexible tubing connecting the cassette to the centrifuge bowl, and a pressure dome which is configured to be connected in series between a blood donor or patient and the cassette for measuring a pressure of a blood or blood component in a flexible tubing configured to connect the patient to the cassette;

and said flexible tubings having fluid communications with said pressure domes.

5. An apparatus according to claim 1 further comprises a centrifuge bowl for separating the components of a fluid, and flexible tubes fluidly connecting between the bowl and the cassette, the bowl comprising

an outer housing having a housing outlet, said outer housing adapted for rotation about a center axis;

said outer housing containing a core providing a separation volume between said core and said outer housing;

said core has a core end and is connected with said outer housing for rotation therewith, said core end having a lumen connector;

a first lumen for providing fluid communication from the housing outlet through the lumen connector and then radially outward through the core to the fluid separation volume;

a second lumen providing fluid communications from the housing outlet extending axially along center axis to housing floor;

a connection sleeve which forms with the lumen connector a chamber and provide fluid communications between the housing outlet and the separation volume; and

the flexible tubes comprising a first flexible tube for inflowing of the fluid from the cassette to the first bowl channel;

a second flexible tube for removing a the first separated fluid component of the second bowl channel; and

a third flexible tube for removing a second separated fluid component from the bowl chamber to the cassette.

6. An apparatus according to claim 5 wherein the connection sleeve is adapted to be secured to the centrifuge bowl near said housing outlet of said outer housing for rotation therewith, said connection sleeve adapted to fluidly connect a first bowl channel, a second bowl channel, and a bowl chamber.

7. The apparatus of claim 6 wherein the first separated fluid component comprises red blood cells.

8. The apparatus of claim 6 wherein the second separated fluid component comprises buffy coat.

9. The apparatus of claim 1 further comprising an irradiation chamber having

a first port connected to a flexible tube for carrying buffy coat from the cassette to the irradiation chamber;

a second port connected to a flexible tube for carrying irradiated buffy coat from the irradiation chamber to the cassette;

the irradiation chamber having a rigid first plate having a first surface and a second surface the second surface having a groove boundary formed by two ridges surrounding a plurality of groove partitions formed by two ridges;

a rigid second plate having a first surface and a second surface, the second surface having a ridge boundary surrounding a plurality of ridge partitions;

wherein the groove boundary and groove partitions of the second surface of the rigid first plate is contacted with the ridge boundary and ridge partitions of the second surface of the rigid second plate thereby forming a chamber;

the chamber defined by a boundary formed by the joining of the groove boundary and the ridge boundary surrounding the plurality of partitions formed by the joining of the groove partitions and the ridge partition wherein a plurality of channels are formed by the partitions providing fluid communication with the first port and second port.

10. The apparatus of claim 1 wherein the first and second flexible tube loops of the cassette comprise an anticoagulant pump loop, a whole blood pump loop, a return to patient pump loop, a red blood pump loop, and a buffy coat recirculation pump loop.

11. The apparatus of claim 10 wherein the cassette comprises a recordable, removable smartcard having electronically stored unique identification information.