Automated system and method for processing biological fluid

• US 6,106,727 A
• Filed: 10/14/1997
• Issued: 08/22/2000
• Est. Priority Date: 07/13/1992
• Status: Expired due to Fees

• Current Assignee: Pall Corporation (Danaher Corporation)
• Original Assignee: Pall Corporation (Danaher Corporation)
• Inventors: Bormann, Thomas J., Matkovich, Vlado I., Gsell, Thomas C., Pascale, Frank R., Krasnoff, Eric J.
• Primary Examiner(s): KIM, SUN U
• Application Number:
  US08/949,817
• Time in Patent Office: 1,043 Days
• Field of Search: 210/85, 210/86, 210/87, 210/94, 210/97, 210/109, 210/134, 210/143, 210/198.1, 210/200, 210/203, 210/206, 210/219, 210/244, 210/245, 210/252, 210/256, 210/257.1, 210/258 , 210/295, 210/319, 210/388, 210/398, 210/416.1, 210/418, 210/435, 210/436, 210/472, 210/739, 210/741, 210/745, 210/767, 210/782, 210/787, 210/411, 210/513, 604/4, 604/5, 604/119, 604/65, 604/67, 604/146, 604/406, 604/408, 604/409, 604/410, 222/52, 222/96, 222/103, 222/214
• US Class Current: 210/739
• CPC Class Codes: A61M 1/02 Blood transfusion apparatus blood infusion by syringes A61M5/14
• CPC Class Codes: A61M 1/0227 and means for securing the filter against damage, e.g. during centrifugation
• 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 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 2202/0429 Red blood cells; Erythrocytes
• CPC Class Codes: A61M 2202/0439 White blood cells; Leucocytes
• CPC Class Codes: A61M 5/1486 the bags being substantially completely surrounded by fluid
• CPC Class Codes: B01D 2321/04 Backflushing
• CPC Class Codes: B01D 2321/2066 Pulsated flow
• CPC Class Codes: B01D 61/20 Accessories; Auxiliary operations
• CPC Class Codes: B01D 61/22 Controlling or regulating
• CPC Class Codes: B01D 65/08 Prevention of membrane fouling or of concentration polarisation

Abstract

An automated system for processing biological fluid includes a pressure differential generator, a biological fluid processing assembly, and an automated control arrangement coupled to at least one of the pressure differential generator and the biological fluid processing assembly. The automated system may include a porous medium, such as a red cell barrier medium, a leukocyte depletion medium, or a combination red cell barrier/leukocyte depletion medium. The automated system may also include a sensor producing a signal reflecting a parameter of fluid flow.

Claims

1. An automated biological fluid processing system comprising:

a pressure differential generator;

a biological fluid processing assembly including;

a first container operatively associated with the pressure differential generator, at least one satellite container in fluid communication with the first container, and

a porous medium comprising a red cell barrier medium or a combined leukocyte depletion/red cell barrier medium interposed between the first container and the satellite container;

a sensor for sensing at least one fluid flow parameter, said sensor providing a signal reflecting a parameter of fluid flow through the porous medium; and

an automated control arrangement coupled to the sensor to receive the signal from the sensor, and coupled to at least one of the pressure differential generator and the biological fluid processing assembly to control flow between the first container and the satellite container.

2. The system according to claim 1, further comprising a separation medium downstream of the satellite container.

3. The system according to claim 1, further comprising a second satellite container, and a leukocyte depletion medium interposed between the first container and the second satellite container.

4. The system according to claim 3, wherein the automated control arrangement controls flow between the first container and the second satellite container.

5. The system according to claim 1, wherein the pressure differential generator includes an arrangement to move fluid within the first container.

6. The system according to claim 1, wherein the pressure differential generator includes an enclosed housing and the first container positioned in the housing, wherein the housing is in fluid communication with a pressure regulating mechanism suitable for controlling the fluid pressure applied to the outside of the first container.

7. The system according to claim 1, wherein the pressure differential generator includes a housing defining an enclosed chamber in fluid communication with a pressure regulating mechanism suitable for controlling the fluid pressure applied to the outside of the first container positioned in the chamber, and wherein the first container comprises a variable-volume container.

33. The system of claim 1 wherein the sensor senses the fluid flow rate.

34. The system of claim 1 wherein the sensor senses the fluid back pressure.

37. The system of claim 1 wherein the sensor comprises a flow meter and the signal comprises a flow rate signal indicative of the fluid flow rate through the porous medium.

8. An automated biological fluid processing system comprising:

an expressor for varying the amount of fluid in a variable-volume container connected to at least one conduit, said expresser comprising a housing defining an enclosed chamber for accommodating the container, the housing having at least one opening through which the conduit can extend;

a pressure regulating mechanism coupled to the housing to vary the pressure of fluid in the chamber and thereby vary the volume of the container; and

an arrangement for moving fluid within the container, the arrangement including at least one of a) a drive mechanism for moving the housing and b) apparatus for pressing against a first portion of the container;

an automated control arrangement coupled to the expressor;

at least one satellite container in fluid communication with the variable-volume container;

a porous medium comprising a red cell barrier medium, or a combined leukocyte depletion/red cell barrier medium, interposed between the variable-volume container and the satellite container; and

a sensor for sensing at least one fluid flow parameter, said sensor being coupled to the automated control arrangement and providing a signal reflecting a parameter of fluid flow through the porous medium;

wherein the automated control arrangement receives the signal from the sensor.

10. The system according to claim 8, wherein the expresser comprises:

a casing; and

an oscillating mechanism disposed within the casing and coupled to the housing via a shaft, the oscillating mechanism oscillating the housing circumferentially about the shaft, wherein the fluid in the container is agitated.

11. The system according to claim 10, wherein the shaft is hollow and includes a passage and wherein the pressure regulating mechanism is coupled to the chamber through the passage.

27. The system of claim 8, wherein the arrangement for moving fluid within the container comprises a drive mechanism for moving the housing.

28. The system of claim 8, wherein the arrangement for moving fluid within the container comprises an apparatus for pressing against a first portion of the container.

29. The system of claim 8 further comprising a gas inlet including a porous medium that allows gas to pass therethrough.

30. The system of claim 8 further comprising a gas outlet including a porous medium that allows gas to pass therethrough.

38. The system of claim 8 wherein the sensor comprises a flow meter and the signal comprises a flow rate signal indicative of the fluid flow rate through the porous medium.

9. An automated biological fluid processing system comprising:

a biological fluid processing assembly including;

a first container and at least one satellite container in fluid communication with the first container;

a porous medium comprising a red cell barrier medium, or a combined leukocyte depletion/red cell barrier medium, interposed between the first container and the satellite container;

a pressure differential generator operatively associated with said first container, said generator including a housing defining an enclosed chamber suitable for accommodating the first container, said chamber including at least one mechanism for securing the container within the housing;

a sensor for sensing at least one fluid flow parameter, said sensor providing a signal reflecting a parameter of fluid flow through the porous medium; and

an automated control arrangement coupled to the sensor to receive the signal from the sensor, said automated control arrangement coupled to at least one of the pressure differential generator and the biological fluid processing assembly to control flow between the first container and the satellite container.

39. The system of claim 9 wherein the sensor comprises a flow meter and the signal comprises a flow rate signal indicative of the fluid flow rate through the porous medium.

12. A method for automatically processing a biological fluid comprising:

(a) placing a variable-volume container having a sediment layer of the biological fluid and a supernatant layer of the biological fluid into an enclosed chamber of a pressure differential generator;

said variable-volume container being part of a biological fluid processing assembly wherein said assembly also includes;

a first satellite container, and

a porous medium comprising a red cell barrier medium, or a combined leukocyte depletion/red cell barrier medium, wherein said medium is interposed between the variable-volume container and the first satellite container;

(b) providing a signal from a sensor sensing at least one fluid flow parameter, said signal reflecting a parameter of fluid flow through the porous medium,

(c) passing the signal from the sensor to an automated control arrangement;

(d) supplying a signal from an automated control arrangement to the pressure differential generator; and

(e) in response to the signal, varying pressure within the chamber to establish flow of the supernatant layer of the biological fluid out of the variable-volume container through the porous medium into the first satellite container.

15. The method according to claim 12, further comprising venting gas.

16. The method according to claim 12, comprising moving biological fluid within the container in response to a signal from the automated control arrangement.

18. The method according to claim 12, further comprising establishing fluid flow of the sediment layer of the biological fluid through a leukocyte depletion medium into a second satellite container.

19. The method according to claim 18, including varying the pressure within the chamber to establish the flow of an additive fluid from the second satellite container into the variable-volume container through the leukocyte depletion medium interposed between the variable-volume container and the second satellite container.

25. The method of claim 12 further comprising:

agitating the fluid in the variable-volume container by moving the chamber back and forth in an oscillatory fashion.

26. The method according to claim 12, wherein varying the pressure also includes establishing a flow of the sediment layer of the biological fluid out of the variable-volume container and into a second satellite container, and establishing fluid flow into the variable-volume container from the second satellite container.

31. The method of claim 12, wherein venting gas includes passing gas through a gas inlet including a porous medium.

32. The method of claim 12, wherein venting gas includes passing gas through a gas outlet including a porous medium.

40. The method of claim 12 wherein providing a signal from a sensor comprises:

providing a signal indicative of the fluid flow rate through the porous medium.

13. A method for processing a biological fluid comprising:

separating a biological fluid in a first container into a first supernatant layer and a second sediment layer and passing the supernatant layer through a porous medium comprising a red cell barrier medium, or a combined leukocyte depletion/red cell barrier medium, wherein said passing includes initiating, monitoring, and terminating flow of the portions by an automated control arrangement and wherein said automated control arrangement is coupled to, and receives a signal from, a sensor that senses at least one fluid flow parameter, said signal reflecting a parameter of fluid flow through the porous medium.

14. The method according to claim 13, further comprising passing the sediment layer through a porous medium comprising a leukocyte depletion medium.

17. The method according to claim 13, comprising moving biological fluid within the container in response to a signal from the automated control arrangement.

20. The method according to claim 13, further comprising agitating the biological fluid within the variable-volume container by pressing against a first portion of the container with a bladder.

21. A method for automatically processing a biological fluid comprising:

obtaining a container having a first portion of biological fluid and a second portion of biological fluid therein;

generating a signal from an automated control arrangement to establish flow of the first portion of a biological fluid along a first fluid flow path through at least one of a leukocyte depletion porous medium, a red cell barrier medium, or a combined leukocyte depletion/red cell barrier medium;

generating a signal indicative of the separation of the first portion of the biological fluid and the second portion of the biological fluid, and supplying the signal to the automated control arrangement;

in response to the signal, terminating flow along the first fluid flow path; and

generating a signal from the automated control arrangement to establish flow of the second portion of a biological fluid along a second fluid flow path through a leukocyte depletion porous medium.

22. The method according to claim 21, comprising ceasing fluid flow of the first portion of the biological fluid in response to a signal from an optical reader.

23. The method according to claim 21, wherein generating the signal indicative of the separation of the first portion of the biological fluid and the second portion of the biological fluid includes generating a signal indicative of at least one of a predetermined position of the second portion, a predetermined back pressure in the first fluid flow path, and a predetermined flow rate through the first fluid flow path.

24. The method according to claim 21, further comprising:

(a) in response to a signal from the automated control arrangement, establishing flow of a physiologically acceptable fluid along the second fluid flow path;

(b) generating a termination signal for terminating the flow of the physiologically acceptable fluid, and supplying the termination signal to the automated control arrangement; and

(c) establishing flow of the second portion of the biological fluid along the second fluid flow path in response to the termination signal.

35. An automated biological fluid processing system comprising:

a biological fluid processing assembly including;

a first container and at least one satellite container in fluid communication with the first container;

a porous medium comprising a leukocyte depletion medium, interposed between the first container and the satellite container;

a pressure differential generator operatively associated with said first container, said generator including a housing defining an enclosed chamber suitable for accommodating the first container;

a sensor for sensing at least one fluid flow parameter, said sensor providing a signal reflecting a parameter of fluid flow through the porous medium; and

an automated control arrangement coupled to the sensor to receive the signal from the sensor, said automated control arrangement coupled to at least one of the pressure differential generator and the biological fluid processing assembly to control flow between the first container and the satellite container.

36. The system of claim 35 wherein the porous medium comprises a fibrous medium.

41. The system of claim 35 wherein the sensor comprises a flow meter and the signal comprises a flow rate signal indicative of the fluid flow rate through the porous medium.

42. An automated biological fluid processing system comprising:

a pressure differential generator;

a biological fluid processing assembly including;

a source container operatively associated with the pressure differential generator, at least one first satellite container in fluid communication with the source container, and

a first porous medium comprising a first leukocyte depletion medium interposed between the source container and the first satellite container;

a first sensor upstream of the first porous medium, the first sensor for sensing the presence of red blood cells near an upstream side of the first porous medium, and providing a signal reflecting the presence of red blood cells near the upstream side of the first porous medium; and

an automated control arrangement coupled to the first sensor to receive the signal from the first sensor, and coupled to at least one of the pressure differential generator and the biological fluid processing assembly to control flow between the source container and the first satellite container.

44. The system of claim 42 wherein the biological fluid processing assembly comprises:

a second satellite container in fluid communication with the source container;

a second porous medium comprising a second leukocyte depletion medium interposed between the source container and the second satellite container; and

a second sensor downstream of the second leukocyte depletion medium for sensing the presence of red blood cells downstream of the second leukocyte depletion medium, and providing a signal reflecting the presence of red blood cells downstream of the second leukocyte depletion medium, wherein the automated control arrangement is coupled to the second sensor.

45. The system of claim 42 wherein the biological fluid processing assembly comprises:

a second satellite container in fluid communication the source container;

a second porous medium comprising a second leukocyte depletion medium interposed between the source container and the second satellite container; and

a second sensor upstream of the second leukocyte depletion medium for sensing the presence of red blood cells upstream of the second leukocyte depletion medium, and providing a signal reflecting the presence of red blood cells upstream of the second leukocyte depletion medium, wherein the automated control arrangement is coupled to the second sensor.

46. The system of claim 42 wherein the biological fluid processing assembly comprises a second sensor operatively associated with the first satellite container for sensing at least one fluid flow parameter, the second sensor providing a signal reflecting a parameter of fluid flow through the first porous medium.

43. An automated biological fluid processing system comprising:

a pressure differential generator;

a biological fluid processing assembly including;

a source container operatively associated with the pressure differential generator, at least one first satellite container in fluid communication with the source container, and

a first porous medium comprising a first leukocyte depletion medium interposed between the source container and the first satellite container;

a first sensor upstream of the first porous medium, the first sensor for sensing the presence of red blood cells upstream of the first porous medium, and providing a signal reflecting the presence of red blood cells upstream of the first porous medium; and

an automated control arrangement coupled to the first sensor to receive the signal from the first sensor, and coupled to at least one of the pressure differential generator and the biological fluid processing assembly to control flow between the source container and the first satellite container.

47. The system of claim 43 wherein the biological fluid processing assembly comprises:

a second satellite container in fluid communication with the source container;

a second porous medium comprising a second leukocyte depletion medium interposed between the source container and the second satellite container; and

a second sensor downstream of the second leukocyte depletion medium for sensing the presence of red blood cells downstream of the second leukocyte depletion medium, and providing a signal reflecting the presence of red blood cells downstream of the second leukocyte depletion medium, wherein the automated control arrangement is coupled to the second sensor.

48. The system of claim 43 wherein the biological fluid processing assembly comprises:

a second satellite container in fluid communication with the source container;

a second porous medium comprising a second leukocyte depletion medium interposed between the source container and the second satellite container; and

a second sensor upstream of the second leukocyte depletion medium for sensing the presence of red blood cells upstream of the second leukocyte depletion medium, and providing a signal reflecting the presence of red blood cells upstream of the second leukocyte depletion medium, wherein the automated control arrangement is coupled to the second sensor.

49. The system of claim 43 wherein the biological fluid processing assembly comprises a second sensor operatively associated with the first satellite container for sensing at least one fluid flow parameter, the second sensor providing a signal reflecting a parameter of fluid flow through the first porous medium.

50. An automated biological fluid processing system comprising:

a pressure differential generator;

a source container operatively associated with the pressure differential generator;

a first satellite container;

a first conduit providing fluid communication between the source container and the first satellite container;

a first porous medium comprising a first leukocyte depletion medium interposed in the first conduit between the source container and the first satellite container;

a first sensor operatively associated with the first conduit, the first sensor for sensing the presence of red blood cells in the first conduit, and providing a signal reflecting the presence of red blood cells in the first conduit;

a second satellite container;

a second conduit providing fluid communication between the source container and the second satellite container;

a second porous medium comprising a second leukocyte depletion medium interposed in the second conduit between the source container and the second satellite container;

a second sensor operatively associated with the second conduit, the second sensor for sensing the presence of red blood cells in the second conduit and providing a signal reflecting the presence of red blood cells in the second conduit; and

an automated control arrangement coupled to the first and second sensors to receive the signals from the first and second sensors, and coupled to at least one of the pressure differential generator and the biological fluid processing assembly to control flow between the source container and the first and second satellite containers.

51. The system of claim 50 comprising a third sensor operatively associated with at least one of the first and second satellite containers, the third sensor sensing at least one fluid flow parameter and providing a signal reflecting fluid flow through at least one of the first porous medium and the second porous medium.