Blood separation systems and methods using a multiple function pump station to perform different on-line processing tasks

• US 7,041,076 B1
• Filed: 09/03/1999
• Issued: 05/09/2006
• Est. Priority Date: 09/03/1999
• Status: Expired due to Term

• Current Assignee: Fenwal Incorporated (Fresenius SE & Co. KGaA)
• Original Assignee: Baxter International Inc.
• Inventors: Westberg, Tom, Vishnoi, Rohit, Vandlik, Mark R
• Primary Examiner(s): Bianco, Patricia
• Application Number:
  US09/389,504
• Time in Patent Office: 2,440 Days
• Field of Search: 604/6.01, 604/5.01, 604/4.01, 604 602- 605, 604/6.07, 604/6.09, 604/6.1, 604/6.11, 604/6.15, 604/6.16, 210/739, 210/741, 210744- 45, 210/767, 210/787, 210781- 82, 210/790, 210/90, 210/85, 210 87- 8, 210/98, 210/103, 210/143, 210/257, 210252- 56, 210258- 62, 210/282, 494/35, 494/43, 494/45, 494 60- 63
• US Class Current: 604/6.01
• CPC Class Codes: A61M 1/0218 with filters
• CPC Class Codes: A61M 1/30 Single needle dialysis ; Reciprocating systems, alternately withdrawing blood from and returning it to the patient, e.g. single-lumen-needle dialysis or single needle systems for hemofiltration or pheresis
• CPC Class Codes: A61M 1/302 having a reservoir for withdrawn untreated blood
• CPC Class Codes: A61M 1/303 having a reservoir for treated blood to be returned
• CPC Class Codes: A61M 1/308 Volume control, e.g. with open or flexible containers, by counting the number of pump revolutions, weighing
• CPC Class Codes: A61M 1/362223 the interface being evacuated interfaces to enhance contact
• CPC Class Codes: A61M 1/362227 the interface providing means for actuating on functional elements of the cassette, e.g. plungers
• CPC Class Codes: A61M 1/36225 with blood pumping means or components thereof
• CPC Class Codes: A61M 1/362261 at least one cassette surface or portion thereof being flexible, e.g. the cassette having a rigid base portion with preformed channels and being covered with a foil
• CPC Class Codes: A61M 1/362262 Details of incorporated reservoirs
• CPC Class Codes: A61M 1/362264 the filter being a blood filter
• CPC Class Codes: A61M 1/362265 Details of valves
• CPC Class Codes: A61M 1/362266 Means for adding solutions or substances to the blood
• CPC Class Codes: A61M 1/3633 Blood component filters, e.g. leukocyte filters
• CPC Class Codes: A61M 1/3636 having a flexible housing
• 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 2205/128 with incorporated valves
• CPC Class Codes: A61M 2205/331 used as turbidity change detectors, e.g. for priming-blood or plasma-hemoglubine-interface detection
• CPC Class Codes: A61M 2205/3393 by weighing the reservoir
• CPC Class Codes: A61M 60/113 : in other functional devices, e.g. dialysers or heart-lung machines
• CPC Class Codes: A61M 60/279 : Peristaltic pumps, e.g. roller pumps
• CPC Class Codes: A61M 60/30 : Medical purposes thereof other than the enhancement of the cardiac output
• CPC Class Codes: A61M 60/427 : the force acting on the blood contacting member being hydraulic or pneumatic
• CPC Class Codes: A61M 60/43 : using vacuum at the blood pump, e.g. to accelerate filling
• CPC Class Codes: A61M 60/523 : using blood flow data, e.g. from blood flow transducers
• CPC Class Codes: A61M 60/546 : of blood flow, e.g. by adapting rotor speed

Abstract

A multiple function pump station performs different on-line processing tasks. The pump station can be operated in one mode to draw blood from a donor can, in another mode, be operated to return blood to the donor. The pump station used to draw blood from a donor can also be used to perform subsequent blood processing tasks, such as mixing processing or additive fluids with the blood, or transfering a harvested blood component to a storage container, or finishing the processing of a harvested blood component, e.g., by passage through a filter to remove leukocytes.

Claims

1. A blood processing system comprising

a donor flow channel to convey fluid to and from a donor,

a blood processing flow channel including a blood separation chamber to separate a blood component from donor blood,

a blood component collection flow channel including a blood component collection container,

a pump station communicating with the donor flow channel, the blood processing flow channel, and the blood component collection flow channel,

a controller to operate the pump station in multiple modes, including a processing mode, during which the pump station is operated to convey blood in the donor flow channel into the blood processing flow channel for separation of the blood component in the blood separation chamber, and a collection mode, during which the pump station is operated to convey at least some of the blood component in the blood processing flow channel into the blood component collection flow channel for collection in the blood component collection container, and a blood component return mode, during which the pump station is operated to convey at least some of the blood component in the blood processing flow channel into the donor flow channel for return to the donor, and

a utility flow channel including a processing fluid container,

the pump station communicating with the utility flow channel, and

the controller configured to operate the pump station during the blood component return mode to convey processing fluid in the utility flow channel into the donor flow channel for mixing with the blood component returned to the donor.

3. A system according to claim 1 or 2

wherein the blood component collection flow channel includes a filter to remove undesired materials from the blood component before entering the blood component collection container.

4. A system according to claim 3

wherein the filter removes leukocytes.

5. A system according to claim 1 or 2

wherein the pump station, the donor flow channel, the blood processing flow channel, and the blood component collection flow channel communicate within a cassette.

6. A system according to claim 5

further including an actuator to receive the cassette and operate the pump station, and

wherein the controller is coupled to the actuator.

7. A system according to claim 1 or 2

wherein the blood processing flow channel includes a blood component holding container to hold the blood component, and

wherein, in the collection mode, the pump station is operated to convey at least some of the blood component in the blood component holding container into the blood component collection flow channel.

8. A system according to claim 7

wherein the controller operates the pump station in a blood component return mode, during which the pump station is operated to convey at least some of the blood component in the blood component holding container into the donor flow channel for return to the donor.

9. A system according to claim 1 or 2

wherein the blood processing flow channel includes a donor blood holding container to hold donor blood prior to separation in the blood separation chamber, and

wherein, in the processing mode, the pump station is operated to convey blood in the donor flow channel into the donor blood holding container.

10. A system according to claim 9

further including a second pump station, independent of the first defined pump station, communicating with the donor blood holding container and the blood separation chamber and operating to convey donor blood from the donor blood holding container in the blood separation chamber for separation in the blood component.

11. A system according to claim 1 or 2

wherein the pump station comprises first and second fluid pressure actuated pump stations, and a fluid pressure actuator operating to selectively apply fluid pressure pump strokes in tandem to the first and second pump stations to convey fluid from a source to a destination,

wherein, during at least one of the multiple modes, the controller switches between a first flow state, in which the pump strokes draw a fluid volume into the first pump station from the source and expel a fluid volume from the second pump station to the destination, and a second flow state, in which the pump strokes draw a fluid volume into the second pump station from the source and expel a fluid volume from the first pump station to the destination, the control function operating to synchronize the pump strokes so that fluid flow from the source is essentially continuous while fluid flow to the destination is pulsatile.

12. A system according to claim 1 or 2

wherein the blood component comprises red blood cells.

13. A system according to claim 1 or 2

wherein the blood component comprises plasma.

14. A system according to claim 1 or 2

wherein the pump station includes a fluid pressure actuated pump and an actuator to apply fluid pressure to the pump, and

wherein the controller is coupled to the actuator.

15. A system according to claim 1

wherein the processing fluid includes saline.

2. A blood processing system comprising

a donor flow channel to convey fluid to and from a donor,

a blood processing flow channel including a blood separation chamber to separate a blood component from donor blood,

a blood component collection flow channel including a blood component collection container,

a pump station communicating with the donor flow channel, the blood processing flow channel, and the blood component collection flow channel,

a controller to operate the pump station in multiple modes, including a processing mode, during which the pump station is operated to convey blood in the donor flow channel into the blood processing flow channel for separation of the blood component in the blood separation chamber, and a collection mode, during which the pump station is operated to convey at least some of the blood component in the blood processing flow channel into the blood component collection flow channel for collection in the blood component collection container, and

a utility flow channel including a processing fluid container,

the pump station communicating with the utility flow channel, and

the controller configured to operate the pump station in a processing fluid transfer mode, during which the pump station is operated to convey processing fluid in the utility flow channel into the blood processing flow channel or the blood component collection flow channel for mixing with the blood component.

16. A system according to claim 2

wherein the processing fluid includes a blood component additive.

17. A blood processing system comprising

a donor flow channel to convey fluid to and from a donor,

a blood processing flow channel including a blood separation chamber to separate red blood cells from donor whole blood,

a blood component collection flow channel including a red blood cell collection container and an in-line filter to remove leukocytes from the red blood cells before entering the red blood cell collection container,

a pump station communicating with the donor flow channel, the blood processing flow channel, and the blood component collection flow channel,

a controller to operate the pump station in multiple modes, including a processing mode, during which the pump station is operated to convey whole blood in the donor flow channel into the blood processing flow channel for separation of the red blood cells in the blood separation chamber, and a collection mode, during which the pump station is operated to convey at least some of the red blood cells in the blood processing flow channel into the blood component collection flow channel for on-line removal of leukocytes and collection in the red blood cell collection container, and a blood component return mode, during which the pump station is operated to convey at least some of the red blood cells in the blood processing flow channel into the donor flow channel for return to the donor, and

a utility flow channel including a processing fluid container,

the pump station communicating with the utility flow channel, and

the controller configured to operate the pump station during the blood component return mode to convey processing fluid in the utility flow channel into the donor flow channel for mixing with the red blood cells returned to the donor.

18. A system according to claim 17

wherein the pump station, the donor flow channel, the blood processing flow channel, and the blood component collection flow channel communicate within a cassette.

19. A system according to claim 18

further including an actuator to receive the cassette and operate the pump station, and

wherein the controller is coupled to the actuator.

20. A system according to claim 17

wherein the processing fluid includes saline.

21. A system according to claim 17

wherein the pump station includes a fluid pressure actuated pump and an actuator to apply fluid pressure to the pump, and

wherein the controller is coupled to the actuator.

22. A blood processing system comprising

a donor flow channel to convey fluid to and from a donor,

a blood processing flow channel including a blood separation chamber to separate red blood cells from donor whole blood,

a blood component collection flow channel including a red blood cell collection container and an in-line filter to remove leukocytes from the red blood cells before entering the red blood cell collection container,

a pump station communicating with the donor flow channel, the blood processing flow channel, and the blood component collection flow channel,

a controller to operate the pump station in multiple modes, including a processing mode, during which the pump station is operated to convey whole blood in the donor flow channel into the blood processing flow channel for separation of the red blood cells in the blood separation chamber, and a collection mode, during which the pump station is operated to convey at least some of the red blood cells in the blood processing flow channel into the blood component collection flow channel for on-line removal of leukocytes and collection in the red blood cell collection container, and

a utility flow channel including a processing fluid container,

the pump station communicating with the utility flow channel, and

the controller configured to operate the pump station in a processing fluid transfer mode, during which the pump station is operated to convey processing fluid in the utility flow channel into the blood processing flow channel or the blood component collection flow channel for mixing with the red blood cells.

23. A system according to claim 22

wherein the processing fluid includes a red blood cell additive.

24. A blood processing system comprising

a donor flow channel to convey fluid to and from a donor,

a blood processing flow channel including a blood separation chamber to separate red blood cells from donor whole blood,

a blood component collection flow channel including a red blood cell collection container and an in-line filter to remove leukocytes from the red blood cells before entering the red blood cell collection container,

a pump station communicating with the donor flow channel, the blood processing flow channel, and the blood component collection flow channel, and

a controller to operate the pump station in multiple modes, including a processing mode, during which the pump station is operated to convey whole blood in the donor flow channel into the blood processing flow channel for separation of the red blood cells in the blood separation chamber, and a collection mode, during which the pump station is operated to convey at least some of the red blood cells in the blood processing flow channel into the blood component collection flow channel for on-line removal of leukocytes and collection in the red blood cell collection container,

the pump station comprising first and second fluid pressure actuated pump stations, and a fluid pressure actuator operating to selectively apply fluid pressure pump strokes in tandem to the first and second pump stations to convey fluid from a source to a destination,

wherein, during at least one of the multiple modes, the controller switches between a first flow state, in which the pump strokes draw a fluid volume into the first pump station from the source and expel a fluid volume from the second pump station to the destination, and a second flow state, in which the pump strokes draw a fluid volume into the second pump station from the source and expel a fluid volume from the first pump station to the destination, the control function operating to synchronize the pump strokes so that fluid flow from the source is essentially continuous while fluid flow to the destination is pulsatile.

25. A blood processing method comprising the steps of

coupling a multi-function pump station to a donor flow channel to convey fluid to and from a donor, a blood processing flow channel including a blood separation chamber to separate a blood component from donor blood, and a blood component collection flow channel including a blood component collection container,

operating the pump station in multiple modes, including a processing mode, during which the pump station is operated to convey blood in the donor flow channel into the blood processing flow channel for separation of the blood component in the blood separation chamber, and a collection mode, during which the pump station is operated to convey at least some of the blood component in the blood processing flow channel into the blood component collection flow channel for collection in the blood component collection container,

coupling the pump station to a utility flow channel including a processing fluid container, and

operating the pump station in a processing fluid transfer mode, during which the pump station is operated to convey a processing fluid in the utility flow channel into the blood processing flow channel or the blood component collection flow channel for mixing with the blood component.

26. A method according to claim 25

wherein, in operating the pump station in the collection mode, the blood component is passed through an in-line filter in the blood component collection flow channel to remove undesired materials from the blood component before entering the blood component collection container.

27. A method according to claim 26

wherein the filter removes leukocytes.

28. A method according to claim 25

further including operating the pump station in a blood component return mode, during which the pump station is operated to convey at least some of the blood component in the blood processing flow channel into the donor flow channel for return to the donor.

29. A method according to claim 25

further including operating the pump station during the blood component return mode to convey a processing fluid in the utility flow channel into the donor flow channel for mixing with the blood component returned to the donor.

30. A method according to claim 29

wherein the processing fluid includes saline.

31. A method according to claim 25

wherein the processing fluid includes a blood component additive.

32. A method according to claim 25

wherein the blood component comprises red blood cells.

33. A method according to claim 25

wherein the blood component comprises plasma.

34. A method according to claim 25

wherein the pump station comprises first and second fluid pressure actuated pump stations, and a fluid pressure actuator operating to selectively apply fluid pressure pump strokes in tandem to the first and second pump stations to convey fluid from a source to a destination,

wherein, during at least one of the multiple modes, operation of the pump station is switched between a first flow state, in which the pump strokes draw a fluid volume into the first pump station from the source and expel a fluid volume from the second pump station to the destination, and a second flow state, in which the pump strokes draw a fluid volume into the second pump station from the source and expel a fluid volume from the first pump station to the destination, the control function operating to synchronize the pump strokes so that fluid flow from the source is essentially continuous while fluid flow to the destination is pulsatile.

35. A red blood cell processing method comprising the steps of

coupling a multi-function pump station to a donor flow channel to convey fluid to and from a donor, a blood processing flow channel including a blood separation chamber to separate red blood cells from donor whole blood, and a blood component collection flow channel including a red blood cell collection container and an in-line filter to remove leukocytes from the red blood cells before entering the red blood cell collection container,

operating the pump station in multiple modes, including a processing mode, during which the pump station is operated to convey whole blood in the donor flow channel into the blood processing flow channel for separation of the red blood cells in the blood separation chamber, and a collection mode, during which the pump station is operated to convey at least some of the red blood cells in the blood processing flow channel into the blood component collection flow channel for on-line removal of leukocytes and collection in the red blood cell collection container, and a blood component return mode, during which the pump station is operated to convey at least some of the red blood cells in the blood processing flow channel into the donor flow channel for return to the donor,

coupling the pump station to utility flow channel including a processing fluid container, and

operating the pump station during the blood component return mode to convey a processing fluid in the utility flow channel into the donor flow channel for mixing with the red blood cells returned to the donor.

36. A method according to claim 35

further including operating the pump station in a processing fluid transfer mode, during which the pump station is operated to convey a processing fluid in the utility flow channel into the blood processing flow channel or the blood component collection flow channel for mixing with the red blood cells.

37. A method according to claim 36

wherein the processing fluid includes a red blood cell additive.

38. A method according to claim 35

wherein the processing fluid includes saline.

39. A method according to claim 35

wherein the pump station comprises first and second fluid pressure actuated pump stations, and a fluid pressure actuator operating to selectively apply fluid pressure pump strokes in tandem to the first and second pump stations to convey fluid from a source to a destination, and

wherein, during at least one of the multiple modes, operation of the pump station is switched between a first flow state, in which the pump strokes draw a fluid volume into the first pump station from the source and expel a fluid volume from the second pump station to the destination, and a second flow state, in which the pump strokes draw a fluid volume into the second pump station from the source and expel a fluid volume from the first pump station to the destination, the control function operating to synchronize the pump strokes so that fluid flow from the source is essentially continuous while fluid flow to the destination is pulsatile.