Programmable, fluid pressure actuated blood processing systems and methods

• US 6,949,079 B1
• Filed: 09/03/1999
• Issued: 09/27/2005
• 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
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): DEAK, LESLIE R
• Application Number:
  US09/390,268
• Time in Patent Office: 2,216 Days
• Field of Search: 604/4.01, 604/5.01, 604/6.01, 604/6.1, 604/6.11, 210/238, 210/646, 210/781, 210/252, 210/258, 210/259, 210/260
• US Class Current: 604/6.11
• 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• CPC Class Codes: A61M 1/302 having a reservoir for withdrawn untreated blood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 1/362227 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 1/3696 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 60/109 incorporated within extracorporeal blood circuits or systems
• CPC Class Codes: A61M 60/113 in other functional devices, e.g. dialysers or heart-lung machines
• CPC Class Codes: A61M 60/36 for specific blood treatment; for specific therapy
• 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 60/546 : of blood flow, e.g. by adapting rotor speed
• CPC Class Codes: A61M 60/847 : arranged in a cassette
• CPC Class Codes: F04B 13/02 : of two or more fluids at the same time
• CPC Class Codes: F04B 2205/09 : Flow through the pump
• CPC Class Codes: F04B 43/026 : each plate-like pumping flexible member working in its own pumping chamber
• CPC Class Codes: F04B 49/065 : and making use of computers

Abstract

Programmable, fluid pressure actuated blood processing systems and methods are used in association a blood separation device. The systems and methods employ a cassette, which contains several preformed, pneumatically actuated pump stations, several preformed fluid flow paths, and several preformed, pneumatically actuated valves in the fluid flow paths. The systems and methods also employ a programmable pneumatic actuator to hold the cassette and selectively apply pneumatic force to the valves and pump stations.

Claims

1. A programmable blood processing system coupled to a blood separation device comprising

a cassette containing first and second preformed, pneumatically actuated pump stations, more than two preformed fluid flow paths, and more than two preformed, pneumatically actuated valves in the fluid flow paths, a first pump station in selective communication with at least two fluid flow paths and a second pump station in selective communication with at least the same two fluid flow paths,

a control program, and

a programmable pneumatic actuator to hold the cassette and selectively apply pneumatic force to the valves and pump stations in response to the control program to direct fluid flow through any selected pump station in either a forward direction between two valves, or a reverse direction between two valves, or an in-out direction through a single valve.

2. A system according to claim 1

wherein the pneumatic actuator selectively applies both positive pressure and negative pressure to the valves and pump stations.

3. A system according to claim 1

wherein the pneumatic actuator selectively applies positive pressure to close the valves and negative pressure to the open the valves.

4. A system according to claim 1

wherein the pneumatic actuator selectively applies positive pressure to expel fluid from the pump stations and negative pressure to draw fluid into the pump stations.

5. A system according to claim 1

wherein at least one of the pump stations includes first and second pump chambers operating in tandem in response to the application of pneumatic force.

6. A programmable blood processing system coupled to a blood separation device comprising

a cassette containing first, second, and third preformed, pneumatically actuated pump stations, more than three preformed fluid flow paths, and more than three preformed, pneumatically actuated valves in the fluid flow paths, and

a programmable pneumatic actuator to hold the cassette and selectively apply pneumatic force to the valves and pump stations in response to a control program to place the first pump station in flow communication with at least three fluid flow paths and the second pump station in flow communication with at least the same three fluid flow paths, the system being configured to simultaneously place two of the pump stations in flow communication with the blood separation device while simultaneously placing the third pump station in flow communication with a venipuncture.

7. A system according to claim 6

wherein a first pump station is placed in communication with an inlet of the blood separation device while a second pump station is placed in simultaneous communication with an outlet of the blood separation device.

8. A system according to claim 6

wherein the program able pneumatic actuator selectively applies pneumatic force to the valves and third pump station to direct fluid flow through the third pump station in either a direction away from the venipuncture or a direction toward the venipuncture.

9. A system according to claim 6

wherein the programmable pneumatic actuator selectively applies pneumatic force to the valves and pump stations to direct fluid flow through any selected pump station in either a forward direction between two valves, or a reverse direction between two valves, or an in_out direction through a single valve.

10. A system according to claim 6

further including a controller having a first selectable control program to direct the pneumatic actuator to apply pneumatic force to the valves and pump stations to perform a first blood separation procedure, the controller having a second selectable control program to direct the pneumatic actuator to apply pneumatic force to the valves and pump stations to perform a second blood separation procedure different than the first blood separation procedure, whereby the preformed pump stations, preformed fluid flow paths, and preformed valves in the cassette can accommodate different blood processing procedures.

11. A system according to claim 6

wherein the pneumatic actuator selectively applies both positive pressure and negative pressure to the valves and pump stations.

12. A system according to claim 6

wherein the pneumatic actuator selectively applies positive pressure to close the valves and negative pressure to the open the valves.

13. A system according to claim 6

wherein the pneumatic actuator selectively applies positive pressure to expel fluid from the pump stations and negative pressure to draw fluid into the pump stations.

14. A system according to claim 6

wherein at least one of the pump stations includes first and second pump chambers operating in tandem in response to the application of pneumatic force.

15. A programmable blood processing system coupled to a blood separation device comprising

a cassette containing first and second and third preformed, pneumatically actuated pump stations, more than three preformed fluid flow paths, and more than three preformed, pneumatically actuated valves in the fluid flow paths, and

a programmable pneumatic actuator to hold the cassette and selectively apply pneumatic force to the valves and pump stations in response to a control program to place the first, second, and third pump stations in selective communication with at least three fluid flow paths, the system being configured to place the first pump station in communication with an inlet of a blood separation device to supply blood to the separation device for separation into components, to place the second pump station in communication with an outlet of the blood separation device to withdraw a blood component from the blood separation device, and to place the third pump station in communication with a venipuncture to supply and return blood to a donor.

16. A system according to claim 15

wherein the programmable pneumatic actuator selectively applies pneumatic force to the valves and first, second and third pump stations to simultaneously supply blood to and withdraw blood from the separation device.

17. A system according to claim 15

wherein the programmable pneumatic actuator selectively applies pneumatic force to the valves and pump stations to supply blood to or withdraw blood from the separation device while blood is supplied from or returned to the donor.

18. A system according to claim 15

wherein the programmable pneumatic actuator selectively applies pneumatic force to the valves and pump stations to place a fourth pump station in communication with a source of anticoagulant for mixing with blood.

19. A system according to claim 15

wherein the programmable pneumatic actuator selectively applies pneumatic force to the valves and third pump station to place the third pump station in communication with a source of fluid for mixing with blood.

20. A system according to claim 15

further including a controller having a first selectable control program to direct the pneumatic actuator to apply pneumatic force to the valves and pump stations to perform a first blood separation procedure, the controller having a second selectable control program to direct the pneumatic actuator to apply pneumatic force to the valves and pump stations to perform a second blood separation procedure different than the first blood separation procedure, whereby the preformed pump stations, preformed fluid flow paths, and preformed valves in the cassette can accommodate different blood processing procedures.

21. A system according to claim 15

wherein the pneumatic actuator selectively applies both positive pressure and negative pressure to the valves and pump stations.

22. A system according to claim 15

wherein the pneumatic actuator selectively applies positive pressure to close the valves and negative pressure to the open the valves.

23. A system according to claim 15

wherein the pneumatic actuator selectively applies positive pressure to expel fluid from the pump stations and negative pressure to draw fluid into the pump stations.

24. A system according to claim 15

wherein at least one of the pump stations includes first and second pump chambers operating in tandem in response to the application of pneumatic force.

25. A blood processing method comprising the steps of

providing a cassette containing first, second, and third preformed, pneumatically actuated pump stations, more than three preformed fluid flow paths, and more than three preformed, pneumatically actuated valves in the fluid flow paths, whereby the first pump station may be placed in flow communication with at least three fluid flow paths and the second pump station may be placed in flow communication with at least the same three fluid flow paths, and the third pump station may be placed in flow communication with a venipuncture, and

placing the cassette in association with a pneumatic actuator to selectively apply pneumatic force to the valves and pump stations,

providing a first selectable control program to operate the pneumatic actuator to perform a first desired blood processing procedure using the cassette including conveying blood from the venipuncture through a separation device for separation into a first component part and a second component part, at least a portion of the first component part is collected, and at least a portion of the second component part is returned through the venipuncture, and

providing a second selectable control program to operate the pneumatic actuator to perform a second desired blood processing procedure different than the first desired blood processing procedure using the cassette including conveying blood from the venipuncture through a separation device for separation into a fist component part and a second component part, at least a portion of the second component part is collected, and at least a portion of the first component part is returned through the venipuncture.

26. A blood processing method according to claim 25

wherein the first component part includes red blood cells.

27. A blood processing method according to claim 25

wherein the second component part includes plasma.

28. A blood processing method according to claim 25

further including the step of providing a third selectable control program to operate the pneumatic actuator to perform a third desired blood processing procedure using the cassette including conveying blood through a separation device for separation into first and second component parts, at least a portion of which are collected.

29. A programmable blood processing system coupled to a blood separation device comprising

a cassette containing first and second preformed, pneumatically actuated pump stations;

a first, second and third preformed fluid flow paths;

a first, second and third preformed, pneumatically actuated valves in the fluid flow paths;

a first pump in selective communication with the first, second and third fluid flow paths;

a second pump in selective communication with the first, second and third fluid flow paths;

a control program, and

a programmable pneumatic actuator to hold the cassette and selectively apply pneumatic force to the valves and pump stations in response to the control program to direct fluid flow through any selected pump station in either a forward direction between two valves, or a reverse direction between two valves, or an in-out direction through a single valve.