System and method for processing biological fluid

• US 5,616,254 A
• Filed: 05/26/1995
• Issued: 04/01/1997
• Est. Priority Date: 11/06/1990
• Status: Expired due to Term

• Current Assignee: Pall Corporation (Danaher Corporation)
• Original Assignee: Pall Corporation (Danaher Corporation)
• Inventors: Bormann, Thomas, Matkovich, Vlado I., Gsell, Thomas C., Pall, David B.
• Primary Examiner(s): Kim, John
• Application Number:
  US08/451,494
• Time in Patent Office: 676 Days
• Field of Search: 210/188, 210/252, 210/257.1, 210/295, 210/323.1, 210/435, 210/436, 210/472, 210/483, 210/496, 210/503, 210/505, 210/508, 210/446, 210/782, 210/767, 210/789, 210/806, 422/101, 494/37, 604/4, 604/5, 604/6, 604/406, 604/408, 604/410
• US Class Current: 210/806
• CPC Class Codes: A61J 1/05 for collecting, storing or administering blood, plasma or medical fluids multiple bags systems for separating or storing blood components A61M1/0209; Infusion or perfusion containers
• CPC Class Codes: A61J 1/10 Bag-type containers
• CPC Class Codes: A61M 1/02 Blood transfusion apparatus blood infusion by syringes A61M5/14
• CPC Class Codes: A61M 1/0209 Multiple bag systems for separating or storing blood components
• CPC Class Codes: A61M 1/0218 with filters
• CPC Class Codes: A61M 1/0227 and means for securing the filter against damage, e.g. during centrifugation
• CPC Class Codes: A61M 1/0231 with gas separating means, e.g. air outlet through microporous membrane or gas bag
• CPC Class Codes: A61M 1/025 Means for agitating or shaking blood containers A61M1/0245 takes precedence; shaking in general B01F31/00
• 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 1/3472 with treatment of the filtrate
• CPC Class Codes: A61M 1/3633 Blood component filters, e.g. leukocyte filters
• CPC Class Codes: A61M 1/3646 Expelling the residual body fluid after use, e.g. back to the body
• CPC Class Codes: A61M 1/3652 using gas, e.g. air
• CPC Class Codes: A61M 1/3693 using separation based on different densities of components, e.g. centrifuging
• CPC Class Codes: A61M 2202/0035 fluid leaving the cross-flow filter without having passed through the filtering element
• CPC Class Codes: A61M 2202/0042 filtrate, i.e. the fluid passing through the filter
• CPC Class Codes: A61M 2202/005 residue retained by the filter due to size
• CPC Class Codes: A61M 2202/0092 starting product created by centrifuging
• CPC Class Codes: A61M 2202/0413 Blood
• CPC Class Codes: A61M 2202/0415 Plasma
• CPC Class Codes: A61M 2202/0427 : Platelets; Thrombocytes
• CPC Class Codes: A61M 2202/0429 : Red blood cells; Erythrocytes
• CPC Class Codes: A61M 2202/0439 : White blood cells; Leucocytes
• CPC Class Codes: A61M 2206/12 : the flow being spirally in a plane, e.g. against a plane side of a membrane filter element
• CPC Class Codes: A61M 5/1486 : the bags being substantially completely surrounded by fluid
• CPC Class Codes: B01D 2321/2083 : By reversing the flow
• CPC Class Codes: B01D 61/145 : Ultrafiltration
• CPC Class Codes: B01D 61/147 : Microfiltration
• CPC Class Codes: B01D 61/16 : Feed pretreatment
• CPC Class Codes: B01D 61/20 : Accessories; Auxiliary operations
• CPC Class Codes: B01D 61/22 : Controlling or regulating
• CPC Class Codes: B01D 63/087 : Single membrane modules
• CPC Class Codes: B01D 65/08 : Prevention of membrane fouling or of concentration polarisation

Abstract

A system for collecting and processing donated blood comprises a first porous medium interposed between a blood collection bag and a satellite bag and a second porous medium interposed between the blood collection bag and another satellite bag. The porous media are leucocyte depletion media. The system may also include one or more of the following: a red cell barrier medium, a separation medium, a gas inlet, and a gas outlet. The system can be used to centrifuge whole blood into one or more components, and includes a means for protecting the system during centrifugation.

Claims

1. A biological fluid processing system comprising

a first container;

a second container in fluid communication with the first container;

a third container in fluid communication with the first container;

a first porous medium suitable for passing biological fluid therethrough interposed between the first container and the second container comprising at least one of a leucocyte depletion medium, a red cell barrier medium, and a combined leucocyte depletion red cell barrier medium;

a second porous medium suitable for passing biological fluid therethrough interposed between the first container and the third container and comprising a leucocyte depletion medium; and

,

a first gas inlet comprising at least one porous medium for passing gas therethrough, interposed between the first container and the first porous medium, or interposed between the first container and the second porous medium.

2. The system of claim 1, further comprising a second gas inlet, said first gas inlet interposed between the first container and the first porous medium for passing biological fluid therethrough;

and said second gas inlet interposed between the first container and the second porous medium for passing biological fluid therethrough.

3. The system of claim 1 further comprising an additional container in fluid communication with the second container.

4. The system of claim 1 comprising a closed sterile system.

5. The system of claim 1 wherein the gas inlet includes at least one porous medium that allows gas to pass therethrough but prevents the passage of bacteria therethrough.

6. The system of claim 5 wherein the gas inlet includes a porous medium having a pore rating of about 0.2 micrometers or less.

7. The system of claim 1 wherein the first porous medium has a CWST of greater than about 70 dynes/cm.

8. The system of claim 7 wherein the first porous medium has a CWST of greater than about 90 dynes/cm.

9. The system of claim 1 wherein the second porous medium has a CWST of greater than about 53 dynes/cm.

10. The system of claim 9 wherein the second porous medium has a CWST of greater than about 60 dynes/cm.

11. The system of claim 1 wherein the first porous medium and the second porous medium are both fibrous porous media.

12. The system of claim 1 wherein the first porous medium and the second porous medium are each capable of depleting the biological fluid of greater than 99.9% of the leukocytes in the biological fluid.

13. The system of claim 1 wherein the gas inlet includes a liquophobic membrane.

14. The system of claim 1 wherein at least one of the first porous medium and the second porous medium has a negative zeta potential.

15. The system of claim 1, further comprising a first gas outlet comprising a porous medium for passing gas therethrough, said gas outlet interposed between the first porous medium and the second container, or interposed between the second porous medium and the third container.

16. The system of claim 15, wherein the first gas outlet includes a liquophilic membrane and a liquophobic membrane.

17. A biological fluid processing system comprising

a first container;

a second container in fluid communication with the first container;

a third container in fluid communication with the first container;

a first porous medium suitable for passing biological fluid therethrough interposed between the first container and the second container comprising at least one of a leucocyte depletion medium, a red cell barrier medium, and a combined leucocyte depletion red cell barrier medium;

a second porous medium suitable for passing biological fluid therethrough interposed between the first container and the third container and comprising a leucocyte depletion medium; and

,

a first gas outlet comprising a porous medium for passing gas therethrough, interposed between the first porous medium and the second container, or interposed between the second porous medium and the third container.

18. The system of claim 17, further comprising a second gas outlet, said first gas outlet interposed between the first porous medium for passing biological fluid therethrough and the second container;

and said second gas outlet interposed between the second porous medium for passing biological fluid therethrough and the third container.

19. The system of claim 18 comprising a closed sterile system.

20. The system of claim 17 further comprising an additional container in fluid communication with the second container.

21. The system of claim 17 wherein the gas outlet includes at least one porous medium that allows gas to pass therethrough but prevents the passage of bacteria therethrough.

22. The system of claim 21 wherein the gas outlet includes a porous medium having a pore rating of about 0.2 micrometers or less.

23. The system of claim 17 wherein the first porous medium has a CWST of greater than about 70 dynes/cm.

24. The system of claim 23 wherein the first porous medium has a CWST of greater than about 90 dynes/cm.

25. The system of claim 17 wherein the second porous medium has a CWST of greater than about 53 dynes/cm.

26. The system of claim 25 wherein the second porous medium has a CWST of greater than about 60 dynes/cm.

27. The system of claim 17 wherein the first porous medium and the second porous medium are both fibrous porous media.

28. The system of claim 17 wherein the first porous medium and the second porous medium are each capable of depleting the biological fluid of greater than 99.9% of the leukocytes in the biological fluid.

29. The system of claim 17 wherein the gas outlet includes a liquophobic membrane.

30. The system of claim 29 wherein the gas outlet further comprises a liquophilic membrane.

31. The system of claim 17 wherein at least one of the first porous medium and the second porous medium has a negative zeta potential.

32. A biological fluid processing system comprising

a first container;

a second container in fluid communication with the first container;

a third container in fluid communication with the first container;

a first porous fibrous medium suitable for passing biological fluid therethrough interposed between the first container and the second container comprising at least one of a leucocyte depletion medium, a red cell barrier medium, and a combined leucocyte depletion red cell barrier medium; and

a second porous fibrous medium suitable for passing biological fluid therethrough interposed between the first container and the third container and comprising a leucocyte depletion medium;

the first porous fibrous medium and the second porous fibrous medium each having fibers which have an average fiber diameter of about 1 to about 4 micrometers;

wherein the system comprises a closed sterile system.

33. The system of claim 32 wherein the first porous fibrous medium and the second porous fibrous medium are each capable of depleting the biological fluid of greater than 99.9% of the leukocytes present in the biological fluid.

34. The system of claim 33 wherein the first porous fibrous medium has a CWST of greater than about 70 dynes/cm, and wherein the second porous fibrous medium has a CWST of greater than about 53 dynes/cm.

35. The system of claim 34 wherein the first porous fibrous medium has a CWST of greater than about 90 dynes/cm, and wherein the second fibrous porous medium has a CWST of greater than about 60 dynes/cm.

36. The system of claim 32 wherein the first and second porous fibrous media comprise synthetic fibers.

37. The system of claim 36 wherein the synthetic fibers comprise melt-blown fibers.

38. A method for processing blood comprising:

collecting human whole blood in a container; and

, within about 8 hours of collecting the blood;

centrifuging the whole blood to form a supernatant layer and a sediment layer;

passing the supernatant layer of the centrifuged blood through a first porous medium, the first porous medium comprising at least one of a leucocyte depletion medium, a red cell barrier medium, and a combined leucocyte depletion red cell barrier medium; and

passing the sediment layer of the centrifuged blood through a second porous medium, the second porous medium comprising a leucocyte depletion medium.

39. The method of claim 38 wherein centrifuging the whole blood includes separating the whole blood into a supernatant layer that includes platelets and a sediment layer that includes red blood cells;

and,

wherein passing the supernatant layer through the first porous medium comprises passing the centrifuged blood, supernatant layer first, through the red cell barrier medium or the combined leucocyte depletion red cell barrier medium until the first porous medium is blocked.

40. The method of claim 38 wherein passing the supernatant layer through the first porous medium depletes the supernatant layer of greater than about 99.9% of the leukocytes present in the supernatant layer.

41. The method of claim 40 wherein passing the sediment layer through the second porous medium depletes the sediment layer of greater than about 99.9% of the leukocytes present in the sediment layer.

42. The method of claim 38 wherein passing the sediment layer through the second porous medium depletes the sediment layer of greater than about 99.9% of the leukocytes present in the sediment layer.

43. The method of claim 38 wherein the method is carried out in a closed sterile blood processing system.

44. The method of claim 43 wherein passing supernatant layer through the first porous medium displaces gas, the method further comprising passing the displaced gas through a liquophobic membrane that allows the displaced gas, but not supernatant layer, to pass therethrough.

45. The method of claim 44 wherein passing gas through the liquophobic membrane includes separating gas from the blood processing system through a gas outlet.

46. The method of claim 43 wherein passing sediment layer through the second porous medium displaces gas, the method further comprising passing the displaced gas through a liquophobic membrane that allows the displaced gas, but not sediment layer, to pass therethrough.

47. The method of claim 46 wherein passing gas through the liquophobic membrane includes separating gas from the blood processing system through a gas outlet.

48. A biological fluid collection and processing system comprising

a first container;

a second container in fluid communication with the first container;

a third container in fluid communication with the first container;

a first porous medium suitable for passing first biological fluid therethrough interposed between the first container and the second container comprising at least one of a leucocyte depletion medium, a red cell barrier medium, and a combined leucocyte depletion red cell barrier medium;

a second porous medium suitable for passing a second biological fluid therethrough interposed between the first container and the third container and comprising a leucocyte depletion medium; and

,

at least one porous medium for passing gas therethrough, that allows gas to be separated from at least one of the first biological fluid and the second biological fluid.

49. The system of claim 48 comprising a closed sterile system.

50. The system of claim 48 wherein the porous medium for passing gas therethrough comprises a liquophobic membrane.

51. A method for processing biological fluid comprising:

collecting biological fluid in a first container;

forming a supernatant layer and a sediment layer of the biological fluid;

passing the supernatant layer of the biological fluid from the first container through a first porous medium to a second container, the first porous medium comprising at least one of a leucocyte depletion medium, a red cell barrier medium, and a combined leucocyte depletion red cell barrier medium;

passing the sediment layer of the biological fluid from the first container through a second porous medium to a third container, the second porous medium comprising a leucocyte depletion medium;

the method further comprising passing gas through a gas inlet comprising a porous medium for passing gas therethrough, said gas inlet interposed between the first container and the first porous medium, or interposed between the first container and the second porous medium.

52. The method of claim 51 wherein the gas inlet is interposed between the first container and the first porous medium, the method further comprising passing gas through the gas inlet, and collecting the supernatant layer displaced by the gas into the second container.

53. The method of claim 52 comprising collecting the supernatant layer in a closed sterile system.

54. The method of claim 52 wherein an additional gas inlet comprising a porous medium for passing gas therethrough is interposed between the first container and the second porous medium, the method further comprising passing gas through the additional gas inlet, and collecting the sediment layer displaced by the gas into the third container.

55. The method of claim 52 further comprising a gas outlet comprising a porous medium for passing gas therethrough interposed between the first porous medium and the second container, the method further comprising passing gas through the gas outlet.

56. The method of claim 51 wherein the gas inlet is interposed between the first container and the second porous medium, the method further comprising passing gas through the gas inlet, and collecting the sediment layer displaced by the gas into the third container.

57. The method of claim 56 comprising collecting the sediment layer in a closed sterile system.

58. The method of claim 56 further comprising a gas outlet comprising a porous medium for passing gas therethrough interposed between the second porous medium and the third container, the method further comprising passing gas through the gas outlet.

59. A method for processing biological fluid comprising:

collecting biological fluid in a first container;

forming a supernatant layer and a sediment layer of the biological fluid;

passing the supernatant layer of the biological fluid from the first container through a first porous medium to a second container, the first porous medium comprising at least one of a leucocyte depletion medium, a red cell barrier medium, and a combined leucocyte depletion red cell barrier medium;

passing the sediment layer of the biological fluid from the first container through a second porous medium to a third container, the second porous medium comprising a leucocyte depletion medium;

the method further comprising passing gas through a gas outlet comprising a porous medium for passing gas therethrough, said gas outlet interposed between the first porous medium and the second container, or interposed between the second porous medium and the third container.

60. The method of claim 59 wherein the gas outlet is interposed between the first porous medium and the second container, the method further comprising passing gas through the gas outlet, and then collecting the supernatant layer in the second container.

61. The method of claim 60 comprising collecting the supernatant layer in a closed sterile system.

62. The method of claim 60 wherein an additional gas outlet comprising a porous medium for passing gas therethrough is interposed between the second porous medium and the third container, the method further comprising passing gas through the additional gas outlet, and then collecting the sediment layer in the third container.

63. The method of claim 59 wherein the gas outlet is interposed between the second porous medium and the third container, the method further comprising passing gas through the gas outlet, and then collecting the sediment layer in the third container.

64. The method of claim 63 comprising collecting the sediment layer in a closed sterile system.