Blood component processing systems and methods using fluid-actuated pumping elements that are integrity tested prior to use

• US 6,846,161 B2
• Filed: 10/24/2002
• Issued: 01/25/2005
• Est. Priority Date: 10/24/2002
• Status: Expired due to Term

• Current Assignee: Fenwal Incorporated (Fresenius SE & Co. KGaA)
• Original Assignee: Baxter International Inc.
• Inventors: Nayak, Abinash, Ingo, Carson, Bedard, Peter, Scheidt, Robert, Kline, Tiffany, Boniquit, Christopher
• Primary Examiner(s): FREAY, CHARLES GRANT
• Application Number:
  US10/280,108
• Publication Number:
  US 20040223857A1
• Time in Patent Office: 824 Days
• Field of Search: 417/46, 417/53, 417/63, 417/394, 417/395, 604/29, 604/30, 73/407
• US Class Current: 417/46
• CPC Class Codes: A61M 1/0218 with filters
• CPC Class Codes: A61M 1/36222 Details related to the interface between cassette and machine
• 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 1/362263 Details of incorporated filters
• 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 1/3652 using gas, e.g. air
• CPC Class Codes: A61M 1/3663 Flow rate transducers; Flow integrators
• 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 2205/705 Testing of filters for leaks blood in dialysate A61M1/1692
• CPC Class Codes: A61M 2209/084 Supporting bases, stands for equipment
• CPC Class Codes: F04B 43/009 : leakage control; pump systems with two flexible members; between the actuating element and the pumped fluid
• CPC Class Codes: F04B 43/06 : Pumps having fluid drive

Abstract

Blood component processing systems and methods are coupled to a blood component processing device. The systems and methods include a fluid circuit that comprises at least one fluid pressure actuated pump station, at least one fluid flow path communicating with the pump station, and at least one valve in the fluid flow path. A control module is sized and configured to interact with the fluid circuit. The control module includes an actuator to selectively apply fluid pressure to the pump station in concert with operation of the valve to pump fluid through the fluid flow path in response to a control program. A controller coupled to the control module includes the control program and a fluid circuit integrity test function. The fluid circuit integrity test function commands the control module to selectively apply fluid pressure to the pump station in concert with operation of the valve to introduce a fluid within a region of the fluid circuit and to confine the fluid within the region while applying fluid pressure to the pump chamber. The fluid circuit integrity test function generates an integrity output in response to sensing leakage of fluid from the region.

Claims

1. A blood component processing system coupled to a blood component processing device comprising

a fluid circuit comprising at least one fluid pressure actuated pump station, at least one fluid flow path communicating with the pump station, and at least one valve in the fluid flow path,

a control module sized and configured to interact with the fluid circuit including an actuator to selectively apply fluid pressure to the pump station in concert with operation of the valve to pump fluid through the fluid flow path in response to a control program, and

a controller coupled to the control module including the control program and a fluid circuit integrity test function that commands the control module to selectively apply fluid pressure to the pump station in concert with operation of the valve to introduce a fluid within a region of the fluid circuit and to confine the fluid within the region while applying fluid pressure to the pump chamber, the fluid circuit integrity test function generating an integrity output in response to sensing leakage of fluid from the region.

2. A system according to claim 1

wherein the fluid circuit integrity test function includes assessing variation in the fluid pressure applied over time to sense leakage of fluid from the region.

3. A system according to claim 1

wherein the fluid circuit integrity test function includes assessing variation in volume of the fluid within the pump chamber over time to sense leakage of fluid from the region.

4. A system according to claim 1

wherein the fluid circuit integrity test function includes using a capacitive sensor to assess variation in volume of the fluid within the pump chamber over time to sense leakage of fluid from the region.

5. A system according to claim 1

wherein the pumped fluid is air.

6. A system according to claim 5

wherein the fluid circuit integrity test function includes assessing variation in the fluid pressure applied over time to sense leakage of air from the region.

7. A system according to claim 1

wherein the pumped fluid is a liquid.

8. A system according to claim 7

wherein the fluid circuit integrity test function includes assessing variation in volume of the fluid within the pump chamber over time to sense leakage of the liquid from the region.

9. A system according to claim 7

wherein the fluid circuit integrity test function includes using a capacitive sensor to assess variation in volume of the liquid within the pump chamber over time to sense leakage of the liquid from the region.

10. A system according to claim 1

wherein the valve comprises a fluid pressure actuated valve.

11. A system according to claim 1

wherein the fluid circuit comprises a preformed cassette that includes the fluid pressure actuated pump station, at least a portion of the fluid flow path, and the valve, the valve also being fluid pressure actuated by the actuator in concert with the pump station.

12. A system according to claim 1

wherein the fluid flow path includes a donor tube intended to be coupled to a donor, wherein the valve comprises a donor valve that opens and closes the donor tube, and

wherein the fluid circuit integrity test function generates an integrity output in response to sensing leakage of fluid through the donor tube when the donor valve is closed.

13. A system according to claim 12

wherein the pumped fluid is air.

14. A system according to claim 13

wherein the fluid circuit integrity test function includes assessing variation in the pneumatic pressure applied over time to sense leakage of air through the donor tube.

15. A system according to claim 1

wherein the fluid flow path includes an anticoagulant conveying tube joined to a donor tube intended to be coupled to a donor,

wherein the valve comprises a donor valve that opens and closes communication between the anticoagulant conveying tube and the donor tube, and

wherein the fluid circuit integrity test function generates an integrity output in response to sensing leakage of fluid through the anticoagulant conveying tube when the donor valve is closed.

16. A system according to claim 15

wherein the pumped fluid is air.

17. A system according to claim 16

wherein the fluid circuit integrity test function includes assessing variation in the fluid pressure applied over time to sense leakage of air through the anticoagulant conveying tube when the donor valve is closed.

18. A system according to claim 1

wherein the fluid circuit comprises a preformed cassette that includes an array of fluid pressure actuated pump stations, an array of fluid flow paths, and an array of fluid pressure actuated valves actuated by the actuator in concert with the pump stations to convey fluid through selected fluid flow paths according to the control program, and

wherein the fluid circuit integrity test function commands the control module to selectively apply fluid pressure to one or more selected pump stations in concert with operation of one or more selected valves to introduce a fluid within one or more fluid flow paths defining a test region within the cassette and to confine the fluid within the test region while applying fluid pressure to one of the selected pump chambers, the fluid circuit integrity test function generating an integrity output in response to sensing leakage of fluid from the test region into another region of the cassette.

19. A system according to claim 18

wherein the pumped fluid is a liquid.

20. A system according to claim 19

wherein the fluid circuit integrity test function includes assessing variation in volume of the fluid within the one selected pump chamber over time to sense leakage of the liquid from the test region into another region of the cassette.

21. A system according to claim 19

wherein the fluid circuit integrity test function includes using a capacitive sensor to assess variation in volume of the liquid within the one selected pump chamber over time to sense leakage of the liquid from the test region into another region of the cassette.

22. A system according to claim 18

wherein the fluid circuit integrity test function includes successively defining more than one test region and, for each defined test region, generating an integrity output in response to sensing leakage of the liquid from each defined test region into another region of the cassette.

23. A method of carrying out an integrity test function for a fluid circuit for blood component processing, the fluid circuit comprising at least one preformed, fluid pressure actuated pump station, at least one fluid flow path communicating with the pump station, and at least one valve in the fluid flow path, the fluid circuit being configured for interaction with a control module including an actuator to selectively apply fluid pressure to the pump station in concert with operation of the valve to pump fluid through the fluid flow path in response to a control program, the integrity test function comprising the steps of

operating the control module to selectively apply pneumatic pressure to the pump station in concert with operation of the valve to introduce a fluid within a region of the fluid circuit,

operating the control module to confine the fluid within the region while applying fluid pressure to the pump chamber, and

generating an integrity output in response to sensing leakage of fluid from the region.

24. A method according to claim 23

wherein the integrity test function includes the step of assessing variation in the fluid pressure applied over time to sense leakage of fluid from the region.

25. A method according to claim 23

wherein the integrity test function includes assessing variation in volume of the fluid within the pump chamber over time to sense leakage of fluid from the region.

26. A method according to claim 23

wherein the integrity test function includes using a capacitive sensor to assess variation in volume of the fluid within the pump chamber over time to sense leakage of fluid from the region.

27. A method according to claim 23

wherein the pumped fluid is air.

28. A method according to claim 27

wherein the integrity test function includes assessing variation in the pneumatic pressure applied over time to sense leakage of air from the region.

29. A method according to claim 23

wherein the pumped fluid is a liquid.

30. A method according to claim 29

wherein the integrity test function includes assessing variation in volume of the fluid within the pump chamber over time to sense leakage of the liquid from the region.

31. A method according to claim 29

wherein the integrity test function includes using a capacitive sensor to assess variation in volume of the liquid within the pump chamber over time to sense leakage of the liquid from the region.

32. A method according to claim 23 wherein the fluid circuit comprises a preformed cassette that includes an array of fluid pressure actuated pump stations, an array of fluid flow paths, and an array of fluid pressure actuated valves actuated by the actuator in concert with the pump stations to convey fluid through selected fluid flow paths according to the control program, and wherein the integrity test function includes the steps of

operating the control module to selectively apply fluid pressure to one or more selected pump stations in concert with operation of one or more selected valves to introduce a fluid within one or more fluid flow paths defining a test region within the cassette,

operating the control module to confine the fluid within the test region while applying fluid pressure to one of the selected pump chambers, and

generating an integrity output in response to sensing leakage of fluid from the test region into another region of the cassette.

33. A method according to claim 32

wherein the pumped fluid is a liquid.

34. A method according to claim 33

wherein the integrity test function includes assessing variation in volume of the fluid within the one selected pump chamber over time to sense leakage of the liquid from the test region into another region of the cassette.

35. A method according to claim 33

wherein the integrity test function includes using a capacitive sensor to assess variation in volume of the liquid within the one selected pump chamber over time to sense leakage of the liquid from the test region into another region of the cassette.

36. A method according to claim 32

wherein the integrity test function includes successively defining more than one test region and, for each defined test region, generating an integrity output in response to sensing leakage of the liquid from each defined test region into another region of the cassette.