Pathogen Inactivation of Whole Blood

• US 20080299538A1
• Filed: 07/30/2008
• Published: 12/04/2008
• Est. Priority Date: 02/28/2003
• Status: Abandoned Application

• Current Assignee: Terumo BCT Biotechnologies, LLC (Terumo Corporation)
• Original Assignee: Caridianbct Biotechnologies LLC (Baxter International Inc.)
• Inventors: GOODRICH, Raymond P., HLAVINKA, Dennis J., REDDY, Heather L.
• Application Number:
  US12/182,280
• Publication Number:
  US 20080299538A1
• Time in Patent Office: Days
• US Class Current: 435/2
• CPC Class Codes: A61K 41/17 by ultraviolet [UV] or infrared [IR] light, X-rays or gamma rays
• CPC Class Codes: A61L 2/0011 using physical methods
• CPC Class Codes: A61L 2/0082 using chemical substances
• CPC Class Codes: A61L 2/0088 Liquid substances
• CPC Class Codes: A61M 1/0213 with isolated sections of the tube used as additive reservoirs
• CPC Class Codes: A61M 1/029 Separating blood components present in distinct layers in a container, not otherwise provided for containers for storing blood or blood components A61J1/05; sampling or analysing blood by separating blood components G01N33/491
• CPC Class Codes: A61M 1/3681 by irradiation
• CPC Class Codes: A61M 1/3683 using photoactive agents
• 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 1/3698 Expressing processed fluid out from the turning rotor using another fluid compressing the treatment chamber; Variable volume rotors
• CPC Class Codes: A61M 2205/123 with incorporated reservoirs
• CPC Class Codes: A61P 7/08 Plasma substitutes; Perfusion solutions; Dialytics or haemodialytics; Drugs for electrolytic or acid-base disorders, e.g. hypovolemic shock artificial tears A61P27/04

Abstract

This invention is directed toward a method of pathogen inactivating whole blood. The steps include collecting whole blood from a donor into a bag; illuminating the whole blood with light at a sufficient energy so that an alloxazine photosensitizer present in the whole blood may be photolyzed to inactivate any pathogens which may be present in the whole blood; and storing the pathogen inactivated whole blood. The invention also includes a method of separating the pathogen inactivated whole blood into components.

Claims

1. A method of pathogen inactivating whole blood comprising the steps of:

collecting whole blood from a donor into a bag;

illuminating the whole blood with light at a sufficient energy so that an alloxazine photosensitizer present in the whole blood may be photolyzed to inactivate any pathogens which may be present in the whole blood; and

storing the pathogen inactivated whole blood.

2. The method of claim 1 further comprising adding the alloxazine photosensitizer to the bag before the whole blood is collected.

3. The method of claim 1 further comprising adding the alloxazine photosensitizer to the bag after the whole blood is collected.

4. The method of claim 1 wherein the alloxazine photosensitizer is riboflavin.

5. The method of claim 1 wherein the energy sufficient to photolyze the alloxazine photosensitizer in the whole blood is between about 22-110 J/mL_RBC.

6. The method of claim 1 wherein the whole blood is illuminated in the collection bag.

7. The method of claim 1 wherein the whole blood is illuminated in a bag separate from the collection bag.

8. The method of claim 1 further comprising a step of separating the stored pathogen inactivated whole blood into separated blood components.

9. The method of claim 8 wherein the whole blood is separated into components in the collection bag.

10. The method of claim 8 wherein the whole blood is separated into components in a bag separate from the collection bag.

11. The method of claim 8 wherein the separated blood components further comprise red blood cells.

12. The method of claim 8 wherein the separated blood components further comprise platelets.

13. The method of claim 8 wherein the separated blood components further comprise plasma.

14. A method of collecting, pathogen inactivating and separating whole blood into at least one pathogen reduced blood component comprising the steps of:

collecting whole blood in a bag;

illuminating the whole blood and an alloxazine photosensitizer for a time sufficient to inactivate any pathogens which may be present in the whole blood to create pathogen inactivated whole blood;

separating the pathogen inactivated whole blood into at least one blood component and

expressing the at least one blood component.

15. The method of claim 14 wherein the alloxazine photosensitizer is riboflavin.

16. The method of claim 14 wherein the at least one blood component is red blood cells.

17. The method of claim 14 wherein the at least one blood component is platelets.

18. The method of claim 14 wherein the at least one blood component is plasma.

19. The method of claim 14 wherein the photosensitizer is added to the bag before the whole blood is collected.

20. The method of claim 14 wherein the photosensitizer is added to the bag after the whole blood is collected.

21. The method of claim 14 wherein the separation step is a centrifugation step.

22. The method of claim 14 wherein the collecting, illuminating, separating and expressing steps occur in the same bag.

23. The method of claim 14 wherein the collecting, illuminating, separating and expressing steps occur in separate bags.

24. The method of claim 16 wherein the red blood cells are not leukoreduced prior to administering them to a patient.

25. A method for separating pathogen inactivated whole blood into components comprising the steps of:

loading a bag containing pathogen inactivated whole blood onto a rotor;

spinning the rotor to separate the pathogen inactivated whole blood into at least a first component and a second component; and

squeezing the bag to transfer the first component into a first satellite bag.

26. The method of claim 25 further comprising the step of squeezing the bag to transfer the second component into a second satellite bag.

27. The method of claim 25 wherein the second component remains in the bag.

28. The method of claim 25 further comprising the step of spinning the rotor to further separate the pathogen inactivated whole blood into a third component.

29. The method of claim 25 wherein the step of squeezing the bag occurs on the rotor.

31. The pre-connected bag and collection set of claim 28 further comprising a photosensitizer bag containing photosensitizer pre-connected via transfer tubing to the illumination bag.

30. A pre-connected bag and solution set comprising:

a collection bag for collecting whole blood;

an illumination bag pre-connected via transfer tubing to the collection bag; and

a storage bag pre-connected via transfer tubing to the illumination bag.