Systems and methods for removing viral agents from blood

• US 6,190,855 B1
• Filed: 10/28/1996
• Issued: 02/20/2001
• Est. Priority Date: 10/28/1996
• Status: Expired due to Term

• Current Assignee: Fenwal Incorporated (Fresenius SE & Co. KGaA)
• Original Assignee: Baxter International Inc.
• Inventors: Mayaudon, Veronique, Chapman, John, Sun, Chong-Son, Bischof, Daniel F., de Gheldere, Serge, Mathias, Jean M, Herman, Robert E.
• Primary Examiner(s): Celsa, Bennett
• Assistant Examiner(s): PONNALURI, PADMASHRI
• Application Number:
  US08/742,572
• Time in Patent Office: 1,576 Days
• Field of Search: 435/2, 210/782, 210/749, 424/530, 424/532, 424/534, 604/5, 422/44
• US Class Current: 435/2
• CPC Class Codes: A61K 35/16 Blood plasma; Blood serum umbilical cord blood A61K35/51
• CPC Class Codes: A61L 2/0011 using physical methods
• CPC Class Codes: A61L 2/022 Filtration
• CPC Class Codes: A61L 2/08 Radiation
• CPC Class Codes: Y10S 435/975 Kit

Abstract

System and methods treat plasma carrying contaminants and cellular matter that are capable of entraining contaminants. The systems and methods separate cellular matter from the plasma by filtration, thereby removing contaminants entrained within the cellular matter. The system and methods add to the plasma a photoactive material. The systems and methods emit radiation at a selected wavelength into the plasma to activate the photoactive material and thereby eradicate the contaminant that is free of entrainment by cellular matter.

Claims

1. A system for treating plasma that is essentially free of red blood cells and includes a first cellular blood species, a second cellular blood species and is different than the first cellular blood species, and an extracellular viral agent, the system comprising

tubing adapted to be coupled to a source of the plasma,

a first filtration media coupled to the tubing to separate the first cellular blood species from the plasma conveyed from the source,

a second filtration media coupled to the tubing in series with the first filtration media to separate the second cellular blood species from the plasma conveyed from the source, to thereby produce a filtered plasma that is essential free of red blood cells, the first cellular blood species, and the second cellular blood species,

a transfer container coupled to the tubing to receive the filtered plasma from the first and second filtration media, and

a photoactive material to be mixed with the filtered plasma to bind to the extracellular viral agent and inactivate the extracellular viral agent upon exposure to light energy in a particular spectrum.

2. A system according to claim 1

wherein the photoactive material is contained within the transfer container.

3. A system according to claim 1

wherein the transfer container is made of a material that is transparent to the light energy.

4. A system according to claim 1 further including an overwrap enveloping the transfer container, the overwrap being made of a light filtering material that absorbs the light energy.

5. A system according to claim 4

wherein the overwrap includes a vapor barrier material.

6. A system according to claim 4

wherein the photoactive material comprises methylene blue, and

wherein the light filtering material includes a blue material on the overwrap.

7. A system according to claim 6

wherein the blue material includes phthalocyanine pigments.

8. A system according to claim 1

wherein the transfer container is made of material that accommodates plasma storage.

9. A system according to claim 1

wherein the photoactive material comprises an auxiliary container separate from the transfer container.

10. A system according to claim 9

wherein the auxiliary container is made of a light filtering material that absorbs the light energy.

11. A system according to claim 10

wherein the photoactive material comprises methylene blue, and

wherein the light filtering material includes a blue material.

12. A system according to claim 11

wherein the blue material includes phthalocyanine pigments.

13. A system according to claim 1

wherein the photoactive material includes methylene blue.

14. A system according to claim 1

wherein the first or second filtration media removes leukocytes.

15. A system according to claim 1 wherein the first or second filtration media removes platelets.

16. A system according to claim 1

wherein the first filtration media removes leukocytes, and

wherein the second filtration media removes platelets.

17. A system for treating plasma comprising

tubing adapted to be coupled to a plasma source,

a first filtration media coupled to the tubing to separate a first cellular blood species from the plasma conveyed from the source,

a second filtration media coupled to the tubing in series with the first filtration media to separate a second cellular blood species different than the first cellular blood species from the plasma conveyed from the source, to thereby produce a filtered plasma that is essentially free of the first and second cellular blood species,

a transfer container coupled to the tubing to receive the filtered plasma from the first and second filtration media, the tubing including a path to vent air from the transfer container in a path that bypasses the first and second filtration media, and

a photoactive material to be mixed with the cellular matter-reduced plasma to bind to an extracellular viral agent in the plasma and inactivate the extracellular viral agent upon exposure to light energy in a particular spectrum.

18. A system according to claim 17

wherein the photoactive material includes methylene blue.

19. A system according to claim 17

wherein the first or second filtration media removes leukocytes.

20. A system according to claim 17

wherein the first or second filtration media removes platelets.

21. A system according to claim 17

wherein the first filtration media removes leukocytes, and

wherein the second filtration media removes platelets.

22. A system for treating plasma comprising

tubing adapted to be coupled to a plasma source,

a first filtration media coupled to the tubing to separate a first cellular blood species from the plasma conveyed from the source,

a second filtration media coupled to the tubing in series with the first filtration media to separate a second cellular blood species different than the first cellular blood species from the plasma conveyed from the source, to thereby produce a filtered plasma that is essentially free of the first and second cellular blood species,

a transfer container coupled to the tubing to receive the filtered plasma from the first and second filtration media,

a photoactive material comprising methylene blue to be mixed with the cellular matter-reduced plasma to bind to an extracellular viral agent in the plasma and inactivate the extracellular viral agent upon exposure to light energy in a particular spectrum, and

an overwrap enveloping the transfer container, the overwrap being made of a light filtering material including phthalocyanine pigments to absorb the light energy.

23. A system according to claim 22

wherein the transfer container is made of a material that accommodates plasma storage.

24. A system for treating plasma that is essentially free of red blood cells and includes a first cellular blood species, a second cellular blood species and is different than the first cellular blood species, and an extracellular viral agent, the system comprising

tubing adapted to be coupled to a source of the plasma,

a first filtration media coupled to the tubing to separate the first cellular blood species from the plasma conveyed from the source,

a second filtration media coupled to the tubing in series with the first filtration media to separate the second cellular blood species from the plasma conveyed from the source, to thereby produce a filtered plasma that is essential free of red blood cells, the first cellular blood species, and the second cellular blood species,

a transfer container coupled to the tubing to receive the filtered plasma from the first and second filtration media,

the tubing also including a path to vent air from the transfer container in a path that bypasses the first and second filtration media, and

a photoactive material to be mixed with the filtered plasma to bind to the extracellular viral agent and inactivate the extracellular viral agent upon exposure to light energy in a particular spectrum.

25. A system according to claim 24

wherein the path vents air from the transfer container to the plasma source.

26. A system according to claim 24

wherein the path includes a one way valve that blocks fluid flow in a direction toward the transfer container while permitting fluid flow in a direction away from the transfer container.

27. A system according to claim 24

and further including an air reservoir, and

wherein the path communicates with the air reservoir.

28. A system for treating plasma comprising

tubing adapted to be coupled to a plasma source,

a first filtration media coupled to the tubing to separate a first cellular blood species from the plasma conveyed from the source,

a second filtration media coupled to the tubing in series with the first filtration media to separate a second cellular blood species different than the first cellular blood species from the plasma conveyed from the source, to thereby produce a filtered plasma that is essentially free of the first and second cellular blood species,

a transfer container coupled to the tubing to receive the filtered plasma from the first and second filtration media, the tubing including a path to vent air from the transfer container to the plasma source in a path that bypasses the first and second filtration media, and

a photoactive material to be mixed with the cellular matter-reduced plasma to bind to an extracellular viral agent in the plasma and inactivate the extracellular viral agent upon exposure to light energy in a particular spectrum.

29. A system for treating plasma comprising

tubing adapted to be coupled to a plasma source,

a first filtration media coupled to the tubing to separate a first cellular blood species from the plasma conveyed from the source,

a second filtration media coupled to the tubing in series with the first filtration media to separate a second cellular blood species different than the first cellular blood species from the plasma conveyed from the source, to thereby produce a filtered plasma that is essentially free of the first and second cellular blood species,

a transfer container coupled to the tubing to receive the filtered plasma from the first and second filtration media, the tubing including a path to vent air from the transfer container in a path that bypasses the first and second filtration media, the path including a one way valve that blocks fluid flow in a direction toward the transfer container while permitting fluid flow in a direction away from the transfer container, and

a photoactive material to be mixed with the cellular matter-reduced plasma to bind to an extracellular viral agent in the plasma and inactivate the extracellular viral agent upon exposure to light energy in a particular spectrum.

30. A system for treating plasma comprising

tubing adapted to be coupled to a plasma source,

a first filtration media coupled to the tubing to separate a first cellular blood species from the plasma conveyed from the source,

a second filtration media coupled to the tubing in series with the first filtration media to separate a second cellular blood species different than the first cellular blood species from the plasma conveyed from the source, to thereby produce a filtered plasma that is essentially free of the first and second cellular blood species,

a transfer container coupled to the tubing to receive the filtered plasma from the first and second filtration media, the tubing including a path to vent air from the transfer container in a path that bypasses the first and second filtration media,

an air reservoir communicating with the path, and

a photoactive material to be mixed with the cellular matter-reduced plasma to bind to an extracellular viral agent in the plasma and inactivate the extracellular viral agent upon exposure to light energy in a particular spectrum.

31. A system for treating plasma comprising

tubing adapted to be coupled to a plasma source,

a first filtration media coupled to the tubing to separate a first cellular blood species from the plasma conveyed from the source,

a second filtration media coupled to the tubing in series with the first filtration media to separate a second cellular blood species different than the first cellular blood species from the plasma conveyed from the source, to thereby produce a filtered plasma that is essentially free of the first and second cellular blood species,

a transfer container coupled to the tubing to receive the filtered plasma from the first and second filtration media, the tubing including a path to vent air from the transfer container in a path that bypasses the first and second filtration media, and

a photoactive material contained within the transfer container to be mixed with the cellular matter-reduced plasma to bind to an extracellular viral agent in the plasma and inactivate the extracellular viral agent upon exposure to light energy in a particular spectrum.

32. A system for treating plasma comprising

tubing adapted to be coupled to a plasma source,

a first filtration media coupled to the tubing to separate a first cellular blood species from the plasma conveyed from the source,

a second filtration media coupled to the tubing in series with the first filtration media to separate a second cellular blood species different than the first cellular blood species from the plasma conveyed from the source, to thereby produce a filtered plasma that is essentially free of the first and second cellular blood species,

a transfer container coupled to the tubing to receive the filtered plasma from the first and second filtration media, the tubing including a path to vent air from the transfer container in a path that bypasses the first and second filtration media,

a photoactive material to be mixed with the cellular matter-reduced plasma to bind to an extracellular viral agent in the plasma and inactivate the extracellular viral agent upon exposure to light energy in a particular spectrum and

the transfer container includes a material that is essentially transparent to the light energy.

33. A system for treating plasma comprising

tubing adapted to be coupled to a plasma source,

a first filtration media coupled to the tubing to separate a first cellular blood species from the plasma conveyed from the source,

a second filtration media coupled to the tubing in series with the first filtration media to separate a second cellular blood species different than the first cellular blood species from the plasma conveyed from the source, to thereby produce a filtered plasma that is essentially free of the first and second cellular blood species,

a transfer container coupled to the tubing to receive the filtered plasma from the first and second filtration media, the tubing including a path to vent air from the transfer container in a path that bypasses the first and second filtration media,

a photoactive material to be mixed with the cellular matter-reduced plasma to bind to an extracellular viral agent in the plasma and inactivate the extracellular viral agent upon exposure to light energy in a particular spectrum, and

an overwrap enveloping the transfer container, the overwrap being made of a light filtering material that absorbs the light energy.

34. A system according to claim 33

wherein the overwrap includes a vapor barrier material.

35. A system according to claim 33

wherein the photoactive material comprises methylene blue, and

wherein the light filtering material includes a blue material on the overwrap.

36. A system according to claim 34

wherein the blue material includes phthalocyanine pigments.

37. A system for treating plasma comprising

tubing adapted to be coupled to a plasma source,

a first filtration media coupled to the tubing to separate a first cellular blood species from the plasma conveyed from the source,

a second filtration media coupled to the tubing in series with the first filtration media to separate a second cellular blood species different than the first cellular blood species from the plasma conveyed from the source, to thereby produce a filtered plasma that is essentially free of the first and second cellular blood species,

a transfer container made of a material that accommodates plasma storage, the transfer container being coupled to the tubing to receive the filtered plasma from the first and second filtration media, the tubing including a path to vent air from the transfer container in a path that bypasses the first and second filtration media, and

a photoactive material to be mixed with the cellular matter-reduced plasma to bind to an extracellular viral agent in the plasma and inactivate the extracellular viral agent upon exposure to light energy in a particular spectrum.

38. A system for treating plasma comprising

tubing adapted to be coupled to a plasma source,

a first filtration media coupled to the tubing to separate a first cellular blood species from the plasma conveyed from the source,

a second filtration media coupled to the tubing in series with the first filtration media to separate a second cellular blood species different than the first cellular blood species from the plasma conveyed from the source, to thereby produce a filtered plasma that is essentially free of the first and second cellular blood species,

a transfer container coupled to the tubing to receive the filtered plasma from the first and second filtration media, the tubing including a path to vent air from the transfer container in a path that bypasses the first and second filtration media,

an auxiliary container separate from the transfer container, and

a photoactive material in the auxilary container to be mixed with the cellular matter-reduced plasma to bind to an extracellular viral agent in the plasma and inactivate the extracellular viral agent upon exposure to light energy in a particular spectrum.

39. A system according to claim 38

wherein the auxiliary container is made of a light filtering material that absorbs the light energy.

40. A system according to claim 39

wherein the photoactive material comprises methylene blue, and

wherein the light filtering material includes a blue material.

41. A system according to claim 40

wherein the blue material includes phthalocyanine pigments.

42. A system for treating plasma comprising

tubing adapted to be coupled to a plasma source,

a first filtration media coupled to the tubing to separate a first cellular blood species from the plasma conveyed from the source,

a second filtration media coupled to the tubing in series with the first filtration media to separate a second cellular blood species different than the first cellular blood species from the plasma conveyed from the source, to thereby produce a filtered plasma that is essentially free of the first and second cellular blood species,

a transfer container coupled to the tubing to receive the filtered plasma from the first and second filtration media,

a photoactive material contained within the transfer container comprising methylene blue to be mixed with the cellular matter-reduced plasma to bind to an extracellular viral agent in the plasma and inactivate the extracellular viral agent upon exposure to light energy in a particular spectrum, and

an overwrap enveloping the transfer container, the overwrap being made of a light filtering material including phthalocyanine pigments to absorb the light energy.

43. A system according to claim 42

wherein the transfer container is made of a material that is essentially transparent to the light energy.

44. A system for treating plasma comprising

tubing adapted to be coupled to a plasma source,

a first filtration media coupled to the tubing to separate a first cellular blood species from the plasma conveyed from the source,

a second filtration media coupled to the tubing in series with the first filtration media to separate a second cellular blood species different than the first cellular blood species from the plasma conveyed from the source, to thereby produce a filtered plasma that is essentially free of the first and second cellular blood species,

a transfer container coupled to the tubing to receive the filtered plasma from the first and second filtration media,

an auxiliary container separate from the transfer container,

a photoactive material contained within the auxiliary container comprising methylene blue to be mixed with the cellular matter-reduced plasma to bind to an extracellular viral agent in the plasma and inactivate the extracellular viral agent upon exposure to light energy in a particular spectrum, and

an overwrap enveloping the transfer container, the overwrap being made of a light filtering material including phthalocyanine pigments to absorb the light energy.

45. A system according to claim 44

wherein the auxiliary container is made of a light filtering material that absorbs the light energy.

46. A system for treating plasma comprising

tubing adapted to be coupled to a plasma source,

a first filtration media coupled to the tubing to separate a first cellular blood species from the plasma conveyed from the source,

a second filtration media coupled to the tubing in series with the first filtration media to separate a second cellular blood species different than the first cellular blood species from the plasma conveyed from the source, to thereby produce a filtered plasma that is essentially free of the first and second cellular blood species,

a transfer container coupled to the tubing to receive the filtered plasma from the first and second filtration media,

a photoactive material comprising methylene blue to be mixed with the cellular matter-reduced plasma to bind to an extracellular viral agent in the plasma and inactivate the extracellular viral agent upon exposure to light energy in a particular spectrum, and

an overwrap enveloping the transfer container, the overwrap being made of a light filtering material including phthalocyanine pigments to absorb the light energy, the overwrap also including a vapor barrier material.

47. A system for treating plasma the system comprising

a source container holding plasma that has been centrifugally separated from whole blood and is essentially free of red blood cells, the plasma containing leukocytes, platelets, and an extracellular viral agent,

tubing coupled to the source container,

a first filtration media coupled to the tubing to separate leukocytes from the plasma conveyed from the source container,

a second filtration media coupled to the tubing downstream of the first filtration media to separate leukocytes and platelets from the plasma conveyed from the source, to thereby produce a filtered plasma that is essential free of red blood cells, the leukocytes, and platelets,

a transfer container coupled to the tubing to receive the filtered plasma from the first and second filtration media, and

a photoactive material to be mixed with the filtered plasma to bind to the extracellular viral agent and inactivate the extracellular viral agent upon exposure to light energy in a particular spectrum.

48. A system according to claim 47

wherein the tubing includes a path to vent air from the transfer container in a path that bypasses the first and second filtration media.

49. A system according to claim 47

wherein the source of photoactive material is contained within the transfer container.

50. A system according to claim 47

wherein the transfer container is made, at least in part, of material that is essentially transparent to light that activates the photoactive material.

51. A system according to claim 47

and further including an overwrap enveloping the transfer container, the overwrap being made of a light filtering material that absorbs light that activates the photoactive material.

52. A system according to claim 51

wherein the overwrap includes a vapor barrier material.

53. A system according to claim 51

wherein the photoactive material comprises methylene blue, and

wherein the light filtering material includes a blue material.

54. A system according to claim 53

wherein the blue material includes phthalocyanine pigments.

55. A system according to claim 47

wherein the transfer container is made of material that accommodates plasma storage.

56. A system according to claim 47

further including an auxiliary container separate from the transfer container, and

wherein the photoactive material is contained within the auxiliary container.

57. A system according to claim 56

wherein the auxiliary container is made, at least in part, of light filtering material that absorbs light that activates the photoactive material.

58. A system according to claim 57

wherein the photoactive material comprises methylene blue, and

wherein the light filtering material includes a blue material.

59. A system according to claim 58

wherein the blue material includes phthalocyanine pigments.

60. A system according to claim 48

wherein the path vents air from the transfer container to the plasma source.

61. A system according to claim 48

wherein the path includes a one way valve that blocks fluid flow in a direction toward the transfer container while permitting fluid flow in a direction away from the transfer container.

62. A system according to claim 48

and further including an air reservoir, and

wherein the path communicates with the air reservoir.

63. A system according to claim 48

wherein the photoactive material includes methylene blue.