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

• US 20040127841A1
• Filed: 09/03/2003
• Published: 07/01/2004
• 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
• Granted Patent: US 7,479,123 B2
• Time in Patent Office: Days
• US Class Current: 604/6.01
• 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 method of collecting a desired blood component comprising:

providing a separator having an inlet, a first outlet, and a second outlet;

drawing whole blood from a source;

adding an anticoagulant fluid to the whole blood in a predetermined ratio to form a mixture of whole blood and anticoagulant fluid;

pumping the mixture of whole blood and anticoagulant fluid into the separator via the inlet at a selected inlet rate;

separating the mixture into blood components of different densities;

withdrawing plasma and red blood cells from the separator while continuing to pump the mixture of whole blood and anticoagulant fluid into the separator, the plasma and red blood cells being withdrawn at rates so as to build up buffy coat in the separator, the plasma being withdrawn via the first outlet and the red blood cells being withdrawn via the second outlet; and

upon a predetermined amount of buffy coat building up in the separator, collecting the buffy coat from the separator.

2. The method of claim 1 wherein the step of collecting the buffy coat from the separator comprises discontinuing the withdrawal of red blood cells from the second outlet, thereby causing the red blood cells to push the buffy coat out of the separator via the first outlet.

3. The method of claim 2 further comprising collecting the withdrawn buffy coat in a treatment bag.

4. The method of claim 2 further comprising discontinuing the collecting of buffy coat when red blood cells are detected in an outlet line fluidly connected to the first outlet.

5. The method of claim 1 wherein the step of withdrawing plasma and red blood cells from the separator comprises:

withdrawing only the plasma from the separator via the first outlet until a predetermined amount of red blood cells are detected in the separator; and

upon the predetermined amount of red blood cells being detected in the separator, withdrawing red blood cells from the separator at a rate so as to maintain the amount of red blood cells present in the separator at approximately the predetermined amount.

6. The method of claim 5 wherein the predetermined amount of red blood cells is detected using a hematocrit sensor.

7. The method of claim 1 further comprising:

collecting the withdrawn plasma in a plasma storage bag;

mixing the withdrawn plasma with a priming fluid; and

upon a selected amount of plasma being collected in the plasma storage bag, returning the mixture of plasma and priming fluid to the source.

8. The method of claim 7 further comprising mixing the withdrawn red blood cells with the plasma and priming fluid mixture from the plasma collection bag and returning the red blood cells-plasma-priming fluid mixture to the source at a rate approximately equal to the inlet rate.

9. The method of claim 1 wherein the step of pumping the mixture into the separator comprises passing the mixture through a cassette for controlling fluid flow before the mixture enters the separator.

10. The method of claim 1 further comprising:

injecting a photoactivation chemical into the collected buffy coat; and

irradiating the collected buffy coat within an irradiation chamber until a predetermined amount of energy has been transferred to the collected buffy coat.

11. The method of claim 10 wherein the step of irradiating the buffy coat comprises recirculating the collected buffy coat between a treatment bag and the irradiation chamber.

12. The method of claim 10 further comprising:

passing the irradiated buffy coat through a filter; and

returning the irradiated buffy coat to the source.

13. The method of claim 12 wherein overall treatment time is less than about 70 minutes.

14. The method of claim 13 wherein the overall treatment time is less than about 45 minutes.

15. The method of claim 12 wherein the filter is within a cassette for controlling fluid flow.

16. The method of claim 1 further comprising collecting the withdraw red blood cells.

17. The method of claim 1 wherein the source is a patient, a whole blood storage bag, or a blood donor, and wherein the separator is a centrifuge bowl.

18. A method of collecting a desired blood component comprising:

withdrawing whole blood from a patient;

combining anticoagulant with the whole blood at a selected ratio of anticoagulant to whole blood;

pumping the combination of whole blood and anticoagulant through a fluid flow controller to a separator;

operating the separator until air is displaced;

continuing to pump the combined whole blood and anticoagulant into the separator and collecting separated plasma until a selected amount of plasma is collected;

mixing plasma with a priming fluid and returning the mixture of plasma and priming fluid to the patient at the same rate as incoming whole blood until red blood cells are detected;

withdrawing red cells and pumping at a speed controlled so as to maintain a red cell line selected level in the separator while collecting buffy coat in the separator;

at a selected time, when a desired amount of buffy coat cells are collected in the separator, continuing to pump whole blood into the separator while discontinuing pumping red blood cells, thereby causing the red blood cells to push buffy coat out of the separator until a desired amount is collected in a buffy coat collector;

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

19. The method of claim 18 further comprising:

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

pumping buffy coat to a treatment bag;

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

pumping the buffy coat and photoactivation chemical mixture from the treatment bag to an irradiation chamber;

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

irradiating the buffy coat in the irradiation chamber while recirculating;

pumping the irradiated buffy coat from the irradiation chamber to the treatment bag;

pumping irradiated buffy coat from the treatment bag through a filter in the controller and then back to the patient.

20. The method of claim 19 wherein the priming fluid is a mixture of anticoagulant and saline.

21. The method of claim 19 wherein the fluid flow controller is a cassette, wherein the separator is a centrifuge bowl, wherein the air is displaced into a plasma bag, wherein red blood cells are detected at a bowl sensor, wherein the red blood cell line is detected at a sensor interface.

22. The method of claim 19 wherein the buffy coat cells are separated and one or more selected components are collected, the components selected from the group consisting of platelets and leukocytes.

23. The method of claim 19 further comprising priming the separator with anticoagulant and saline mixture.

24. The method of claim 19 further including rinsing the separator, treatment bag, and irradiation chamber with saline and returning the resultant rinse solution to the patient.

25. The method of claim 18 wherein the overall treatment time is less than about 70 minutes.

26. The method of claim 25 wherein the overall treatment time is less than about 45 minutes.

27. A method of performing a photopheresis treatment for diseases on a patient comprising:

drawing whole blood from a source;

adding an anticoagulant fluid to the whole blood in a predetermined ratio to form a mixture of whole blood and anticoagulant fluid;

separating the mixture of whole blood and anticoagulant into a plurality of blood components according to density;

mixing a photoactivation chemical with at least one of the blood components to form a mixture of the photoactivation chemical and the at least one blood component;

irradiating the combination of the at least one blood component and photoactivation chemical; and

returning the irradiated combination to a patient;

wherein the entire photopheresis treatment is completed in less than about 70 minutes.

28. The method of claim 27 wherein the entire photopheresis treatment is completed in less than about 45 minutes.

29. The method of claim 27 wherein the at least one blood component is buffy coat, a leukocyte, or platelets.

30. The method of claim 27 wherein the at least one blood component is buffy coat.

31. The method of claim 30 wherein the step of separating the mixture of whole blood and anticoagulant fluid comprises:

providing a separator having an inlet, a first outlet, and a second outlet;

pumping the mixture of whole blood and anticoagulant fluid into the separator via the inlet at a selected inlet rate; and

withdrawing plasma and red blood cells from the separator while continuing to pump the mixture of whole blood and anticoagulant fluid into the separator, the plasma and red blood cells being withdrawn at rates so as to build up buffy coat in the separator, the plasma being withdrawn via the first outlet and the red blood cells being withdrawn via the second outlet; and

upon a predetermined amount of buffy coat building up in the separator, collecting the buffy coat from the separator.

32. The method of claim 31 wherein the step of collecting the buffy coat from the separator comprises discontinuing the withdrawal of red blood cells from the second outlet, thereby causing the red blood cells to push the buffy coat out of the separator via the first outlet;

and discontinuing the collecting of buffy coat when red blood cells are detected in an outlet line fluidly connected to the first outlet.

33. The method of claim 31 wherein the step of withdrawing plasma and red blood cells from the separator comprises:

withdrawing only the plasma from the separator via the first outlet until a predetermined amount of red blood cells are detected in the separator; and

upon the predetermined amount of red blood cells being detected in the separator, withdrawing red blood cells from the separator at a rate so as to maintain the amount of red blood cells present in the separator at approximately the predetermined amount.

34. The method of claim 31 further comprising irradiating the collected buffy coat within an irradiation chamber until a predetermined amount of energy has been transferred to the collected buffy coat, the predetermined amount of energy being sufficient to induce apoptosis.

35. The method of claim 27 wherein the source is the patient, the photopheresis treatment being performed in a closed-loop system.

36. A method of collecting a desired blood component comprising:

providing a separator having an inlet, a first outlet, and a second outlet;

drawing whole blood from a source;

adding an anticoagulant fluid to the whole blood in a predetermined ratio to form a mixture of whole blood and anticoagulant fluid;

pumping the mixture of whole blood and anticoagulant fluid into the separator via the inlet at a selected inlet rate;

separating the mixture into blood components of different densities;

withdrawing plasma and buffy coat from the separator while continuing to pump the mixture of whole blood and anticoagulant fluid into the separator, the plasma and buffy coat being withdrawn at rates so as to build up red blood cells in the separator, the plasma and buffy coat being withdrawn via the first outlet; and

upon a predetermined amount of red blood cells building up in the separator, collecting the red blood cells from the separator via the second outlet.