Method and system for fractionating a quantity of blood into the components thereof

• US 4,187,979 A
• Filed: 09/21/1978
• Issued: 02/12/1980
• Est. Priority Date: 09/21/1978
• Status: Expired due to Term

• Current Assignee: Baxter Travenol Laboratories Incorporated
• Original Assignee: Baxter Travenol Laboratories Incorporated
• Inventors: Cullis, Herbert M., De Vries, James H., Dorsey, Evelyn E.
• Primary Examiner(s): Krizmanich, George H.
• Application Number:
  US05/944,640
• Time in Patent Office: 509 Days
• Field of Search: 233/14 R, 233/14 A, 233/19 R, 233/19 A, 233/27, 233/26, 233/21, 233/22, 128/214 R, 128/2 F, 128/214 D
• US Class Current: 494/1
• CPC Class Codes: A61M 1/3603 in the same direction
• CPC Class Codes: A61M 1/3616 Batch-type treatment
• CPC Class Codes: A61M 1/3692 Washing or rinsing blood or blood constituents
• 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 2205/3306 Optical measuring means
• CPC Class Codes: B04B 5/0442 with means for adding or withdrawing liquid substances during the centrifugation, e.g. continuous centrifugation

Abstract

The method, and system for carrying out the steps of the method, are utilized in taking whole blood from a supply of blood withdrawn from a donor or from a previously banked supply of whole blood in a container, centrifuging the blood in a centrifuge device to separate the whole blood into its components, and then collecting the components, namely red blood cells, white blood cells, platelets and plasma. The fractionation of the whole blood in the centrifuge device takes place in first, second and third separation chambers. The first chamber has a square shape and is positioned in the centrifuge device in a diamond position. Each corner of the first separation chamber has an opening. Whole blood is pumped into one side corner opening and red blood cells are withdrawn from the other side corner opening and returned to the container for recirculation through the first chamber. White blood cells, platelets and plasma are withdrawn from the upper corner opening and passed through the second chamber wherein white blood cells are separated by centrifugal force. The plasma and platelets are then withdrawn from the second chamber and passed through the third chamber wherein the platelets are separated from the plasma by centrifugal force. The plasma exiting from the third separation chamber is passed back into the bottom corner of the first chamber to cause a flow of plasma across the flow of whole blood and red blood cells to elute white blood cells and plateletstherefrom and to wash the red blood cells. By appropriate operation of electromechanically controlled clamps associated with tubing carrying the various blood components, plasma can be siphoned off into a plasma collection receptacle located outside the centrifuge device. After the red blood cells have been recirculated several times through the first separation chamber, the red blood cells then can be directed to a red blood cell collection receptacle by operation of other electromechanically controlled clamps.

Claims

1. A method for fractionating a given amount of whole blood into several of its components, including the steps of:

separating the whole blood in a chamber, such as by centrifugation, into at least one cellular portion and a primarily fluid portion;

withdrawing the primarily fluid portion from the chamber;

passing the primarily fluid portion back through the one separated cellular portion in the chamber at least once; and

then removing the primarily fluid portion from the chamber thereby to effect a more complete separation of the primarily fluid portion from the one cellular portion of the blood.

2. The method according to claim 1 wherein said one cellular portion is comprised of red blood cells.

3. The method according to claim 1 wherein the fluid of said primarily fluid portion is comprised of plasma.

4. The method according to claim 1 wherein said primarily fluid portion is recirculated back through said one separated cellular portion by withdrawing said fluid portion from the top of the chamber containing said one cellular portion and introducing said fluid portion back into the bottom of the chamber.

5. The method according to claim 1 wherein said one cellular portion is comprised of red blood cells and said primarily fluid portion is comprised of plasma.

6. The method according to claim 1 wherein said one cellular portion is comprised of red blood cells and said primarily fluid portion is comprised of plasma and platelets.

7. The method according to claim 1 wherein said one cellular portion is comprised of red blood cells and said primarily fluid portion is comprised of plasma containing platelets and white blood cells.

8. The method according to claim 1 wherein said one cellular portion is comprised of red blood cells and wherein said method further includes the steps of:

collecting the primarily fluid portion after passing it through the one cellular portion several times;

passing a wash solution through the red blood cells;

collecting the wash solution; and

, then collecting the red blood cells.

9. The method according to claim 8 wherein some of said primarily fluid portion is added back to the red blood cells when collecting them.

10. The method according to claim 9 wherein said primarily fluid portion is comprised of plasma.

11. The method according to claim 8 wherein a storage medium containing nutrients is added to the red blood cells when collecting them.

12. The method according to claim 1 wherein said one cellular portion is comprised of red blood cells and said primarily fluid portion is comprised of plasma containing platelets and white blood cells and wherein said method further includes the steps of recirculating the primarily fluid portion through the red blood cells a predetermined number of times, collecting the primarily fluid component;

and collecting the red blood cells.

13. The method according to claim 12 including the further steps of passing a wash solution through the red blood cells prior to collecting the red blood cells.

14. The method according to claim 13 including the step of adding a storage medium containing a nutrient to the red blood cells when collecting the red blood cells.

15. The method according to claim 1 wherein said one cellular portion is comprised of red blood cells and said primarily fluid portion is comprised of plasma containing platelets and white blood cells and wherein said method further includes the steps of:

separating platelets from the primarily fluid portion, such as by passing the one fluid portion through a separation chamber undergoing centrifugation, prior to passing the primarily fluid portion back through the red blood cells;

passing the platelet-poor primarily fluid portion through the red blood cells a predetermined number of times;

collecting the plasma with some white blood cells;

collecting the platelets with some white blood cells; and

collecting the red blood cells with some white blood cells.

16. A method for fractionating a given amount of whole blood into components thereof and for collecting at least one cellular component, comprising the steps of supplying the whole blood to a first separation chamber mounted in a centrifuge device, centrifuging the whole blood in the first separation chamber to cause fractionation of the whole blood into components thereof and to cause the components to congregate at different zones in the first separation chamber during centrifugation, withdrawing a first cellular component of the blood from the separation chamber and recirculating that first component back through the first separation chamber with the whole blood until only the first component is being recirculated, withdrawing blood fluid containing plasma, and passing that blood fluid back into the first separation chamber in a direction which traverses the flow path of whole blood into, and withdrawal of the first component from the first separation chamber a predetermined number of times thereby to elute blood components other than the first cellular component from the whole blood and first component with the blood fluid and to wash the first component with the blood fluid.

17. The method according to claim 16 wherein the given amount of whole blood is contained in a closed container and said method is performed in a completely closed environment.

18. The method according to claim 16 wherein said given quantity of blood is initially taken from a donor and banked in a sealed air-tight bag from which it is supplied to the first separation chamber.

19. The method according to claim 18 including the step of collecting the first component comprised of red blood cells in the blood bag.

20. The method according to claim 18 including the step of collecting the first component comprised of red blood cells in a receptacle.

21. The method according to claim 20 including the step of recirculating the first blood component back through the whole blood bag for a predetermined period of time to ensure that all of the whole blood has been processed in and through the first separation chamber followed by collecting the first blood component comprised of red blood cells in the receptacle.

22. The method according to claim 16 including the steps of monitoring the compoistion of the blood fluid being withdrawn from the first separation chamber and adjusting the rate of supplying whole blood from a whole blood source in response to the composition sensed.

23. The method according to claim 16 including the steps of passing the blood fluid through a second separation chamber undergoing centrifugation to separate a second cellular blood component from the blood fluid prior to passing the blood fluid back through the first separation chamber;

withdrawing the remaining blood fluid from the second separation chamber; and

, then passing that blood fluid back into the first separation chamber.

24. The method according to claim 23 including the steps of monitoring the composition of the blood fluid being withdrawn from the first separation chamber and adjusting the rate of supplying whole blood from a whole blood source in response to the composition sensed.

25. The method according to claim 23 wherein the step of monitoring the composition of the blood fluid being withdrawn from the first separation chamber is for the purpose of sensing red blood cells mixed with the blood fluid and includes the steps of:

stopping and then reversing for a predetermined time period the flow of blood fluid from the first separation chamber when red blood cells are sensed in the blood fluid thereby to return the mixture of blood fluid and red blood cells to the first separation chamber for reseparation of the blood components therein;

adjusting the rate of supplying whole blood to the first separation chamber and the rate of withdrawal of blood fluid from the first separation chamber in response to the sensing of red blood cells in the blood fluid; and

reversing the flow of blood fluid so that it is again withdrawn from the first separation chamber to continue the processing of the whole blood.

26. The method according to claim 25 wherein the sensing of the composition of blood fluid being withdrawn from the first separation chamber is performed outside of the centrifuge device.

27. The method according to claim 25 wherein the ratio of the rate of supplying whole blood to the first separation chamber is maintained at a given ratio.

28. The method according to claim 27 wherein the ratio of the rate of supplying whole blood to the first separation chamber to the rate of withdrawal of blood fluid from the first separation chamber is approximately 3:

1.

29. The method according to claim 23 wherein said second cellular component is comprised of platelets.

30. The method according to claim 23 wherein said second cellular component is comprised of white blood cells.

31. The method according to claim 23 including the step of coupling a third separation chamber between the outlet from the second separation chamber and the inlet to the first separation chamber and wherein the first blood component separated from the whole blood in the first separation chamber constitutes red blood cells, the second component separated in the second separation chamber by centrifugation and sedimentation constitutes white blood cells and a third component which is separated by centrifugation and sedimentation in the third separation chamber constitutes platelets.

32. The method according to claim 31 including the step of collecting plasma in a plasma collection receptacle after the blood fluid containing plasma has been passed through the separation chambers for a predetermined period of time.

33. The method according to claim 32 including the step of passing the blood fluid exiting from the third separation chamber through a bubble trap prior to its re-entry into the first separation chamber.

34. The method according to claim 31 including the steps of:

blocking the flow of blood fluid to the second separation chamber and the flow of blood fluid from the third separation chamber into the first separation chamber;

coupling the outlet and inlet for the blood fluid from and into the first separation chamber to a source of wash solution;

recirculating the first blood component back through the first separation chamber;

passing the wash solution through the first separation chamber for a predetermined period of time to wash the first blood component constituting red blood cells and then collecting the red blood cells in a receptacle.

35. The method according to claim 34 including the step of adding some of the plasma to the red blood cells when collecting them.

36. The method according to claim 34 including the step of adding a storage medium to the red blood cells when collecting them.

37. The method according to claim 16 wherein the fluid path for the blood fluid has a given volume and 3 to 8 of such given volumes of blood fluid are circulated through the first separation chamber during the processing of the given amount of whole blood.

38. The method according to claim 37 wherein approximately 5 given volumes of blood fluid are passed through the first separation chamber during processing of the given amount of whole blood.

39. The method according to claim 16 wherein at least 3 given volumes of whole blood are passed through the first separation chamber during the processing of the given amount of whole blood.

40. A system for automatically fractionating a given quantity of whole blood into components thereof and for collecting at least one component comprising:

a centrifuge device, a first separation chamber mounted in said centrifuge device and having first and second inlets and first and second outlets, means for withdrawing whole blood from a source thereof and for supplying same to said first inlet of said first separation chamber, first conduit means for coupling said first outlet of said first separation chamber to the source of recirculation, fluid coupling means for coupling said second outlet of said first separation chamber to said second inlet of said first separation chamber and means for causing blood fluid to flow from said second outlet to said second inlet and through said first separation chamber, and said inlets and outlets of said first separation chamber being arranged so that blood fluid flowing in said first separation chamber from said second inlet to said second outlet traverses the flow path of whole blood entering said first inlet and the blood component exiting from said first outlet such that the flowing blood fluid elutes blood components from the whole blood while at the same time the flowing blood fluid washes the one component.

41. The system according to claim 40 wherein said source of whole blood is a closed container and said system processes blood in a completely closed system.

42. The system according to claim 40 wherein said source of whole blood is a donor.

43. The system according to claim 40 wherein said source of whole blood is a container for whole blood and said system includes an inlet and an outlet connected to said container.

44. The system according to claim 43 wherein said container has another inlet for bleeding blood into said container from a donor after which the said another inlet is sealed.

45. The system according to claim 43 including a receptacle for collecting red blood cells, second conduit means for coupling a junction in said first conduit means to said receptacle, said outlet from said container being coupled to said first inlet of said first separation chamber, first valve means associated with a portion of said first conduit means between said junction and said container for controlling fluid flow in said first conduit means and second valve means associated with said second conduit means for controlling fluid flow in said second conduit means whereby the first blood component constituting red blood cells exiting from the first outlet of said first separation chamber first can, by operation of said first and second valve means, be caused to flow back through said container and back into said first separation chamber and subsequently can, by further operation of said first and second valve means, by delivered directly to said red blood cell collection receptacle.

46. The system according to claim 45 wherein said first and second conduit means are flexible tubings and said first and second valve means are electromechanically controlled clamps associated with said respective flexible tubings.

47. The system according to claim 40 including means associated with said fluid coupling means for monitoring and sensing the composition of the blood fluid being withdrawn from said first separation chamber and for causing a predetermined quantity of blood fluid to be returned to the first separation chamber when red blood cells mixed with the blood fluid are sensed.

49. The system according to claim 40 including a second separation chamber situated in said centrifuge device and having an inlet and an outlet and wherein said fluid coupling means includes second conduit means for coupling said second outlet of said first separation chamber to said inlet of said second separation chamber and third conduit means for coupling said outlet of said second separation chamber to said second inlet of said first separation chamber.

50. The system according to claim 49 including a third separation chamber coupled into said third conduit means in series with and between said outlet of said second separation chamber and said second inlet of said first separation chamber.

51. The system according to claim 50 wherein said third separation chamber is a platelet separation bag which has a curved, generally rectangular shape and which is positioned in said centrifugal device on a cylindrical envelope coaxial with the axis of rotation of said centrifuge device.

52. The system according to claim 49 including a bubble trap coupled into said third conduit means in series with and between said second separation chamber and said second inlet to said first separation chamber.

53. The system according to claim 49 including a plasma collection receptacle, fourth conduit means for coupling a junction in said second conduit means to said plasma collection receptacle, first valve means associated with said fourth conduit means between said junction and said plasma collection receptacle for controlling fluid flow in said fourth conduit means, and second valve means associated with said second conduit means for controlling fluid flow in said second conduit means and said second inlet to said second separation chamber, said second valve means being operable to block flow of plasma from said second outlet of said first separation chamber to said inlet of said second separation chamber and the connection of said fourth conduit means and the opening of said first valve means then permitting flow of plasma to said plasma collection receptacle.

54. The system according to claim 53 wherein said source of whole blood, said red blood cell collection receptacle and said plasma collection receptacle are situated outside said centrifuge device and said first, second and third conduit means comprise flexible tubings which extend from said centrifuge device and are rotated at a speed different than the speed of rotation of said centrifuge device to prevent twisting of the tubings thereby to provide a closed fluid system.

55. The system according to claim 53 wherein said conduit means comprise flexible tubings and each of said valve means comprises an electromechanically controlled clamp associated with one of said tubings.

56. The system according to claim 40 including a source of wash solution, second conduit means for coupling said source of wash solution to said fluid coupling means, first valve means associated with said fluid coupling means for blocking flow of blood fluid through said fluid coupling means and through said first chamber and second valve means associated with said second conduit means for permitting flow of wash solution through said second conduit means to said fluid coupling means and through said first separation chamber.

57. The system according to claim 56 including a source of storage medium, third conduit means for coupling said source of storage medium to said fluid coupling means and third valve means associated with said third conduit means to permit flow of storage medium through said third conduit means to said first separation chamber.

58. The system according to claim 57 wherein said conduit means and said fluid coupling means are comprised of flexible tubings and each of said valve means comprises an electromechanically controlled clamp associated with one of said tubings.

59. The system according to claim 49 including first valve means associated with said third conduit means between said second separation chamber and said inlet to said first separation chamber for controlling fluid flow in said third conduit means, a source of wash solution having a first fluid connection to said third conduit means between said first valve means and said second inlet to said first separation chamber and having a second fluid connection to said second conduit means, second valve means associated with said first fluid connection for controlling fluid flow through said first fluid connection, third valve means associated with said second fluid connection for controlling fluid flow therethrough, and fourth valve means associated with said second conduit means for controlling fluid flow therethrough and connected between said second fluid connection to said second conduit means and said inlet to said second separation chamber.

60. The system according to claim 59 including a source of storage medium, fourth conduit means for coupling said storage medium source to said third conduit means and fifth valve means associated with said fourth conduit means for controlling flow of storage medium through said fourth conduit means to said first separation chamber.

61. The system according to claim 60 wherein said conduit means and said fluid connections comprise flexible tubings and each of said valve means comprises an electromechanically controlled clamp associated with one of said tubings.

62. The system according to claim 49 wherein said second and third conduit means each have a portion thereof situated outside said centrifuge device and said blood fluid flow causing means includes first and second peristaltic pumps operated synchronously in tandem, said first pump being associated with and including said portion of said second conduit means and said second pump being associated with an including said portion of said third conduit means.

63. The system according to claim 62 wherein said conduit means comprises flexible tubings which extend out of said centrifuge device and which are rotated at a different speed of rotation than said centrifuge device to prevent twisting thereby to provide a closed fluid system.

64. The system according to claim 49 wherein said second separation chamber is a curved, generally rectangular, white blood cell collection bag which is located in said centrifuge device on a cylindrical envelope coaxial with the axis of rotation of said centrifuge device.

65. The system according to claim 40 wherein said first separation chamber has four corners and is arranged in a diamond position within said centrifuge device so as to have an upper corner, a lower corner, a first side corner, and a second side corner, said upper corner having said second outlet for blood fluid, said lower corner having said second inlet for re-entry of blood fluid into said first separation chamber, said first side corner having said first inlet for whole blood and said second side corner having said first outlet for the one blood component.

66. The system according to claim 65 wherein said first separation chamber has spaced sidewalls which extend to each of said corners and has edges between said corners.

67. The system according to claim 66 wherein said first separation chamber is positioned in said centrifuge device with the radius from the axis of rotation of the centrifuge device to said upper corner being shorter than the radius from the axis of rotation of said centrifuge device to said lower corner.

68. The system according to claim 67 wherein said two side corners are each positioned respectively substantially the same radial distance from the axis of rotation of said centrifuge device.

69. The system according to claim 66 wherein said first separation chamber is positioned in the centrifuge device so that a plane extending between said upper and lower corners and including tangents at said corners is at an angle of between 0+ and 5 degrees to the vertical.

70. The system according to claim 69 wherein said angle is approximately 1 degree.

71. The system according to claim 65 wherein said first separation chamber has a generally square configuration.

72. The system according to claim 65 wherein said first separation chamber has a generally diamond configuration.

73. The system according to claim 65 wherein said first separation chamber has a general shape of a kite with said two side corners being closer to said upper corner than to said lower corner.

74. The system according to claim 73 wherein said edges of said first separation chamber extending between said corners thereof are concave.

75. The system according to claim 74 wherein said concave edges of said first separation chamber follow generally parabolic curves which are related to the parabolic flow paths of the blood components as they are being centrifuged in said first separation chamber.

48. The system according to claim 48 wherein a light transmitting portion of said fluid coupling means is situated outside said centrifuge device and said means for monitoring and sensing the composition of the blood fluid withdrawn from said first separation chamber includes a light source and a photodetector associated with said light transmitting portion of said fluid coupling means.

76. For use in a blood fractionating system wherein whole blood is passed into and through a separation chamber in a centrifuge device for fractionating the whole blood into components thereof, an improved separation chamber having four corners and adapted to be positioned in a diamond position so that the four corners define an upper corner, a lower corner, a first side corner and a second side corner, said upper corner having an outlet for blood fluid containing components being fractionated in said separation chamber, said lower corner having a re-entry inlet for blood fluid withdrawn from said upper corner, said first side corner having an inlet for the whole blood and said second side corner having an outlet for a blood component.

77. The separation chamber according to claim 76 having spaced sidewalls which extend to each of said corners and edges between said corners.

78. The separation chamber according to claim 77 being adapted to be positioned in the centrifuge device with the radius from the axis of rotation of the centrifuge device to said upper corner being shorter than the radius from the axis of rotation of the centrifuge device to said lower corner.

79. The separation chamber according to claim 78 wherein said other two corners are each adapted to be positioned, respectively, at substantially the same radial distance from the axis of rotation of the centrifuge device.

80. The separation chamber according to claim 79 wherein said chamber is adapted to be positioned in the centrifuge device so that a plane extending between said upper and lower corners and including tangents at said corners is at an angle of between 0+ and 5 degrees to the vertical.

81. The separation chamber according to claim 80 wherein said angle is approximately 1 degree.

82. The separation chamber according to claim 76 having a generally square configuration.

83. The separation chamber according to claim 76 having a generally diamond configuration.

84. The separation chamber according to claim 76 having the general shape of a kite with said side two corners being closer to said upper corner than to said lower corner.

85. The separation chamber according to claim 84 wherein said edges of said separation chamber extending between said corners thereof are concave.

86. The separation chamber according to claim 85 wherein said concave edges of said chamber follow generally parabolic curves which are related to the parabolic flow paths of the blood components as they are being centrifuged in said chamber.