Cassette with integral separation device

• US 6,471,855 B1
• Filed: 11/22/2000
• Issued: 10/29/2002
• Est. Priority Date: 11/22/2000
• Status: Expired due to Term

• Current Assignee: Baxter International Inc.
• Original Assignee: Baxter International Inc.
• Inventors: Vandlik, Mark R., Westberg, Tom, Odak, Sanjay V.
• Primary Examiner(s): Drodge, Joseph W.
• Application Number:
  US09/718,912
• Time in Patent Office: 706 Days
• Field of Search: 210/97, 210/134, 210/321.68, 210/321.87, 210/512.1, 210/360.1, 210/781, 210/782, 210/787, 210/110, 210/143, 210/258, 210/416.1, 210/646, 604/4.01, 604/5.01, 604/6.01, 604/6.09, 604/118, 604/153
• US Class Current: 210/143
• CPC Class Codes: A61M 1/0218 with filters
• CPC Class Codes: A61M 1/262 rotating
• CPC Class Codes: A61M 1/265 inducing Taylor vortices
• 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 1/362264 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 1/3693 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 1/38 Removing constituents from donor blood and storing or returning remainder to body , e.g. for transfusion
• CPC Class Codes: A61M 2205/125 with incorporated filters
• CPC Class Codes: A61M 2205/126 with incorporated membrane filters
• CPC Class Codes: A61M 2205/128 with incorporated valves
• CPC Class Codes: A61M 2205/6063 Optical identification systems
• CPC Class Codes: A61M 2230/207 hematocrit
• CPC Class Codes: B01D 17/0217 by centrifugal force
• CPC Class Codes: B01D 17/085 with membranes

Abstract

A pneumatic pump manifold disposable system, configured as a cassette, is used for the purpose of red cell and plasma apheresis. The cassette integrates a separation device, manifold system, macro-aggregate filter, and five pumping chambers for the purpose of separating plasma and red cells from the whole blood. The cassette system, with the separation device directly attached without tubing, simplifies the loading of the disposable set into the hardware, and reduces the manufacturing complexity of the set. The system allows for plasma, plasma and red cells, or just red cells to be stored in long term storage containers after a procedure.

Claims

1. A disposable module adapted for cooperative mounting on a reusable module for processing a suspension comprising blood or blood components, said disposable module comprising:

an integral flow control cassette and separator;

said separator comprising a rotor rotatably mounted therein;

said flow control cassette comprising a rigid base and including a suspension inlet for communicating with a suspension source and defining a first closed flow path in said base for direct fluid contact, said first flow path communicating between said suspension inlet and said separator;

said separator and said base being connected to provide a unitary module adapted for mounting onto said reusable module;

said separator including an inlet communicating with said first flow path of said cassette to receive the suspension into said separator;

said separator including an outlet for a separated portion of said suspension; and

said cassette defining a second closed flow path in said base for direct fluid contact communicating with said separator outlet.

2. The disposable module of claim 1 in which said flow control cassette defines a plurality of flow path segments and includes a plurality of valve stations interconnecting two or more flow path segments and operable to open or close communication between interconnected flow path segments, said valve stations being cooperative with said reusable module to define said first and second flow paths by selectively opening or closing communication between flow path segments.

3. The module of claim 1 further comprising at least one pump station defined in said cassette base and communicating with at least one of said first and second flow paths, said pump station being cooperative with the reusable module to move fluid through said flow path.

4. The module of claim 3 in which said flow control cassette comprises a flexible film selectively movable by the reusable module into or out of contact with said base to close or open said valve stations and to pump fluid through said pump station.

5. The module of claim 4 in which said rigid base includes a plurality of upstanding walls cooperative with said flexible film to define said flow path segments, valve stations and pump stations.

6. The module of claim 1 in which said separator comprises a housing and a core within said housing, said core and housing being relatively rotatable, said core having an outer surface and said housing having an inner surface spaced from said outer surface to define a circumferential gap therebetween, a microporous membrane mounted on selected of said outer and inner surfaces, said separator outlet communicating with the side of said membrane opposite said gap.

7. The module of claim 6 in which said housing rotates and said core is stationary.

8. The module of claim 6 in which said core rotates and said housing is stationary.

9. The module of claim 1 in which said rotor defines a centrifuge chamber and said separator inlet and outlet communicate with said centrifuge chamber.

10. A suspension processing system, comprising:

a disposable module having an integral flow control cassette and separator;

said separator comprising a rotor rotatably mounted therewithin;

said flow control cassette comprising a rigid base and including a suspension inlet for communicating with a suspension source and defining a first closed flow path in said base for direct fluid contact communicating between said suspension inlet and said separator;

said separator and said base being connected to provide a unitary module;

said separator including an inlet communicating with said inlet flow path of said cassette to receive the suspension into said separator;

said separator including an outlet for a separated portion of said suspension;

said cassette defining a second closed flow path in said base for direct fluid contact communicating with said separator outlet; and

a reusable module for receiving said disposable module, said reusable module having a plurality of actuators cooperative with said disposable module for controlling flow through said flow paths for the processing of said suspension.

11. The suspension processing system as defined in claim 10 wherein said reusable module is responsive to a control program.

12. The suspension processing system as defined in claim 10 wherein said reusable module is transportable.

13. The suspension processing system as defined in claim 10 wherein said flow control cassette defines a plurality of flow path segments and includes a plurality of valve stations interconnecting two or more flow path segments and operable to open or close communication between interconnected flow path segments, said valve stations being cooperative with said reusable module to define said first and second flow paths by selectively opening or closing communication between flow path segments.

14. The suspension processing system as defined in claim 13 further comprising at least one pump station defined in said cassette base and communicating with at least one of said first and second flow paths, said pump station being cooperative with the reusable module to move fluid through such flow path.

15. The suspension processing system as defined in claim 14 wherein said flow control cassette comprises a flexible film selectively movable by the reusable module into or out of contact with said base to close or open said valve stations and to pump fluid through said pump station.

16. The suspension processing system of claim 15 in wherein said rigid base includes a plurality of upstanding walls cooperative with said flexible film to define said flow path segments, valve stations and pump stations.

17. The suspension processing system as defined in claim 10 wherein said separator comprises a housing and a core within said housing, said core and housing being relatively rotatable, said core having an outer surface and said housing having an inner surface spaced from said outer surface to define a circumferential gap therebetween, a microporous membrane mounted on selected of said outer and inner surfaces, said separator outlet communicating with the side of said membrane opposite said gap.

18. A suspension processing system as defined in claim 17 wherein said housing rotates and said core is stationary.

19. A suspension processing system as defined in claim 17 wherein said core rotates and said housing is stationary.

20. A disposable blood separation set for installation on an actuator device having a plurality of pressure actuators responsive to a control program, the separation set comprising:

a cassette including a rigid base and defining in said rigid base pre-formed pressure actuated pump stations, pre-formed closed fluid flow paths for direct fluid contact and pre-formed pressure actuated valve stations interconnecting two or more fluid flow paths;

a fluid separation device integral with said cassette and in communication with said fluid paths, the separation device and cassette forming a unitary module adapted for installation onto said actuator device; and

a plurality of cassette ports in direct communication with said flow paths to direct the flow of fluids to and from said cassette and said separation device when the pressure actuators selectively change pressure to said valve and pump stations in response to a control program.

21. A disposable blood separation set as defined in claim 20 wherein said separation device includes a membrane-covered spinner.

22. A disposable blood separation set as defined in claim 20 wherein said separation device includes a centrifuge.

23. A disposable blood separation set as defined in claim 20 wherein said pressure comprises positive and negative pneumatic pressure.

24. A fluid processing system as defined in claim 23 wherein the actuator device is programmable by the control program to place designated fluid flow paths in flow communication with designated pump stations to carry out a selected blood or blood component processing procedure.

25. A fluid processing system as defined in claim 24 wherein the actuator device has a first selectable control program to direct the fluid pressure actuators to apply fluid pressure force to the valve and pump stations to perform a first blood separation procedure, the device further having a second selectable control program to direct the fluid pressure actuators to apply fluid pressure force to the valves and pump stations to perform a second blood separation procedure different than the first blood separation procedure, whereby the same disposable cassette can accommodate the different blood processing procedures.

26. A fluid processing system, comprising:

a disposable cassette including a rigid base and defining in said rigid base pre-formed pressure actuated pump stations, pre-formed closed fluid flow paths for direct fluid contact and pre-formed pressure actuated valve stations inter-connecting two or more fluid flow paths;

a fluid separation device integral with said cassette and in communication with said fluid paths, the separation device and cassette forming a unitary module;

an actuator device for receiving said cassette, said actuator device having a plurality of pressure actuators responsive to a control program; and

a plurality of cassette ports in communication with said flow paths to direct the flow of fluids to and from said cassette and said separation device when said pressure actuators selectively apply pressure force to said valve and pump stations in response to said control program.

27. A fluid processing system as defined in claim 26 herein said separation device includes a relatively rotatable housing and core with a fluid receiving gap defined between them.

28. A fluid processing system as defined in claim 26 wherein said separation device includes a centrifuge.

29. A fluid processing system as defined in claim 26 wherein said pressure force comprises positive and negative pneumatic pressure.

30. A fluid processing system as defined in claim 26 wherein at least two of said pump stations pump out of phase with respect to each other.

31. A fluid processing system as defined in claim 26 wherein three fluids can be pumped simultaneously.

32. A disposable blood separation set for installation on an actuator device having a plurality of pressure actuators responsive to a control program, the separation set comprising:

a cassette including a rigid base and defining pre-formed pressure actuated pump stations, pre-formed closed fluid flow paths and pre-formed pressure actuated valve stations;

a fluid separation device integral with said cassette and in communication with said paths, said separation device having a first generally cylindrical member having a hollow interior and an inner surface, a second generally cylindrical member positioned within said first member, said second member having an outer surface spaced apart from said inner surface of said first member to define a fluid-receiving gap therebetween, one of said paths communicating with said gap, a micro-porous filter membrane disposed on one of said surfaces for passing a filtrate therethrough, one of said paths communicating with said filtrate passing through said membrane, rotating means coupled to one of said members for driving the rotating member at a rate selected to establish annular vortices within said gap, the separation device and cassette forming a unitary module adapted for installation onto said actuator device; and

a plurality of cassette ports in communicable with said flow paths to convey the flow of fluids to and from said cassette and said separation device when said pressure actuators selectively apply pressure force to said valve and pump stations in response to the control program.

33. A disposable blood separation set as defined in claim 32 wherein said pressure force comprises positive and negative pneumatic pressure.

34. A disposable blood separation set as defined in claim 32 wherein three fluids can be pumped simultaneously.

35. A disposable blood separation set as defined in claim 32 wherein said rotating means comprises a drive member adapted to be magnetically coupled to actuator device.

36. A fluid processing system, comprising:

a disposable cassette including a rigid base and defining pre-formed pressure actuated pump stations, pre-formed fluid flow paths and pre-formed pressure actuated valve stations;

a fluid separation device integral with said cassette and in communication with said paths, said separation device having a first generally cylindrical member having a hollow interior and an inner surface, a second generally cylindrical member positioned within said first member, said second member having an outer surface spaced apart from said inner surface of said first member to define a fluid-receiving gap therebetween, one of said paths communicating with said gap, a micro porous filter membrane disposed on one of said surfaces for passing a filtrate therethrough, one of said paths communicating with said filtrate passing through said membrane, rotating means coupled to one of said members for driving the rotating member at a rate selected to establish annular vortices within said gap, the separation device and cassette forming a rigid unitary structure;

an actuator device for receiving said cassette, said actuator device having a plurality of pressure actuators responsive to a control program; and

a plurality of cassette ports in communicable with said flow paths to convey the flow of fluids to and from said cassette and said separation device when said pressure actuators selectively apply pressure force to said valve and pump stations in response to said control program.

37. A fluid processing system as defined in claim 36 wherein the actuator device is programmable by the control program to place selected fluid flow paths in flow communication with selected pump stations to carry out a blood processing procedure.

38. A fluid processing system as defined in claim 37 wherein the actuator device has a first selectable control program to direct the fluid pressure actuator to apply fluid pressure force to the valve and pump stations to perform a first blood separation procedure, the device further having a second selectable control program to direct the fluid pressure actuator to apply fluid pressure force to the valves and pump stations to perform a second blood separation procedure different than the first blood separation procedure, whereby the same disposable set can accommodate different blood processing procedures.

39. A fluid processing system as defined in claim 37 wherein three fluids can be pumped simultaneously.

40. A fluid processing system as defined in claim 36 wherein said pressure force comprises positive and negative pneumatic pressure.

41. A fluid processing system as defined in claim 36 wherein at least two of said pump stations pump out of phase with respect to each other.