Control system for driving fluids through an extracorporeal blood circuit

• US 20060222561A1
• Filed: 06/01/2006
• Published: 10/05/2006
• Est. Priority Date: 09/03/2003
• 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, Walters, Tom, Hutchinson, Mchael, Gara, Stephen
• Granted Patent: US 7,465,285 B2
• Time in Patent Office: Days
• US Class Current: 422/44
• 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 1/3606 Arrangements for blood-volume reduction of extra-corporeal circuits
• 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 1/36226 Constructional details of cassettes, e.g. specific details on material or shape
• 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 1/362263 Details of incorporated filters
• CPC Class Codes: A61M 1/362266 Means for adding solutions or substances to the blood
• CPC Class Codes: A61M 1/3627 Degassing devices; Buffer reservoirs; Drip chambers; Blood filters
• CPC Class Codes: A61M 1/3633 Blood component filters, e.g. leukocyte filters
• CPC Class Codes: A61M 1/3681 by irradiation
• CPC Class Codes: A61M 1/3686 by removing photoactive agents after irradiation
• 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 2205/125 with incorporated filters
• CPC Class Codes: A61M 2205/128 with incorporated valves
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/75 with filters
• CPC Class Codes: F04B 43/0081 systems, control, safety measures
• CPC Class Codes: F04B 43/1292 Pumps specially adapted for several tubular flexible members

Abstract

A control deck and system for controlling and driving blood fluids through an extracorporeal blood circuit kit. In one aspect, the invention is a deck having an improved mechanism for securing a cassette in place during treatment operations. The improved deck comprises catches for slidably receiving tabs of the cassette and one or more rotating clamps for locking and securing the cassette in a loaded position. In another aspect the invention is a system for controlling and driving blood fluids having infrared communication abilities to transmit and receive real time data. In still another aspect, the invention is a system for controlling and driving blood fluids having an upright tower design that reduces the footprint of the system. In this embodiment, a centrifuge chamber is positioned in an upper portion of the system while the control deck and photoactivation chamber are located in a base portion of the system.

Claims

1. An apparatus comprising a cassette for controlling movement of blood and separated blood components, the cassette comprising

a rigid plastic housing;

flexible tube loops extending out of the housing;

flexible tubing other than loops extending into, within, and out from of the housing;

at least one section of flexible tube within the housing exposed on one side of the housing so that fluid flow through the exposed section can be prevented when pressure is exerted on the exposed section from the exposed side.

2. The apparatus of claim 1 having a hub within the housing adapted to connect sections of the flexible tubes.

3. The apparatus of claim 1 wherein hub is adapted to connect five sections of flexible tubes.

4. The apparatus of claim 1 wherein the side of the housing where the flexible tube is exposed comprises apertures through which pressure can be exerted, and the housing has an opposing side adapted to resist the exerted pressure so as to close off the section of tubing between the aperture and the opposing side of the housing and thereby prevent fluid flow.

5. The apparatus of claim 1 wherein the housing has an opposing side which comprises at least one molded occluder bar which transverses the exposed section of flexible tube.

6. The apparatus of claim 1 wherein the rigid plastic housing has a top section and a bottom section which together form an internal space, the bottom section comprising at least one aperture for accessing the at least one exposed flexible tube section.

7. The apparatus of claim 1 having five tube loops and six apertures.

8. The apparatus of claim 1 wherein the housing has a top section and a bottom section which together form an internal space, the bottom section comprising at least one aperture for accessing the exposed flexible tube sections, at least one molded occluder bar on the side of the top section facing the internal space and opposed to the aperture, the cassette adapted to allow at least one actuator to selectively close off fluid flow in the exposed section of flexible tubing by pressing the flexible tubing through the aperture and against the molded occluder bar.

9. The apparatus of claim 1 having a filter in fluid communication with at least one flexible tube.

10. The apparatus of claim 1 having six apertures in the bottom section, corresponding molded ridges in the top section opposed to the apertures, and at least one section of flexible tubing between each aperture and each molded ridge;

five tube loops; and

a hub adapted to connect five sections of tube.

11. The apparatus of claim 1 wherein the cassette comprises a recordable smartcard on which are electronically recorded identification data.

12. An apparatus comprising a disposable kit, the kit comprising a cassette according to claim 1;

a saline bag inlet tube;

a treatment bag;

a plasma collection bag having an inlet tube for flowing plasma from the cassette and an outlet tube for flowing plasma to the cassette;

an anticoagulant inlet tube for flowing anticoagulant to the cassette;

an irradiation chamber having an inlet tube for flowing buffy coat from the cassette and an outlet tube for flowing irradiated buffy coat to the cassette;

a separation bowl having one tube for flowing blood to the separation chamber and at least two tubes for flowing separate blood fragments from the separation chamber;

means to withdraw blood from a patient comprising a tube for flowing blood to the cassette and means for connecting a needle; and

means to return blood fractions to the patient comprising a tube from the cassette.

13. An apparatus comprising a disposable kit according to claim 12 and a non-disposable tower, the tower comprising

a controller;

peristaltic pumps having peristaltic pump heads adapted to engage the pump loops of the cassette and to selectively pump fluid through the pump loops at the command of the controller;

a deck adapted to engage the cassette and having means to selectively exert pressure on each section of flexible tube through each aperture of the cassette under command of the controller;

a centrifuge chamber adapted to rotate the separation bowl at the command of the controller; and

a photoactivation cavity for receiving the irradiation chamber, the irradiation cavity having means to irradiate fluid in the irradiation chamber at the command of the controller.

14. The apparatus of claim 12 wherein the UV irradiation cavity is substantially vertical so that the UV chamber, when inserted in the UV irradiation cavity, has an inlet at the top and an outlet at the bottom of the UV chamber.

15. The apparatus of claim 12, the tower having supports for hanging the saline bag, treatment bag, plasma bag, and anticoagulant bag.

16. The apparatus of claim 12 wherein

the cassette has five pump loops and five apertures and five corresponding molded ridges opposed to the apertures;

and

the tower has five corresponding pump heads and five corresponding means to selectively exert pressure through the cassette apertures.

17. The apparatus of claim 12 having flexible tubing for whole blood flow from the patient to a vent means in the cassette, flexible tubing forming loops, the loops comprising 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, and flexible tubing for return of blood fractions and treated buffy coat back to the patient.

18. The apparatus of claim 12 wherein the cassette comprises a recordable, removable smartcard having electronically stored unique identification information and the tower comprises a smartcard reader-writer module, and means for receiving the smartcard in the module, reading the unique identification information to verify compatibility, and means for recording data to the smartcard during a blood treatment or separation session.

19. A photopheresis method comprising:

providing a disposable kit and a non-disposable tower according to claim 12;

withdrawing whole blood from a patient;

adding anticoagulant to form a mixture;

pumping the whole blood-anticoagulant mixture through the cassette to the centrifuge separation bowl;

operating the separation bowl until air in the bowl is displaced into the plasma bag;

collecting separated plasma in the plasma bag while continuing to pump the mixture into the bowl;

mixing plasma with priming fluid;

when a selected amount of plasma is collected, returning plasma to the patient at the same rate as incoming whole blood until red blood cells are detected at a bowl sensor;

withdrawing red cells and pumping at a speed controlled so as to maintain the red cell line at the sensor interface level;

mixing the withdrawn red blood cells with plasma from the plasma collection bag and returning the red blood cells-plasma mixture to the patient;

at a selected time, continuing to pump whole blood into the bowl while discontinuing withdrawing and pumping red blood cells, thereby causing the red blood cells to push buffy coat out of the bowl past the sensor into the buffy coat collection bag until a selected amount is collected;

discontinuing collection of buffy coat when red blood cells have been detected;

injecting photoactivation chemical into the buffy coat in the buffy coat collection bag;

recirculating buffy coat between the collection bag and the irradiation chamber;

irradiating the buffy coat in the irradiation chamber while recirculating;

pumping the irradiated buffy coat from the irradiation chamber;

pumping irradiated buffy coat from the collection bag through a filter in the cassette and then back to the patient;

rinsing the disposable kit with saline and returning the rinse solution to the patient.