Blood processing method and apparatus with disposable cassette

• US 5,273,517 A
• Filed: 07/09/1991
• Issued: 12/28/1993
• Est. Priority Date: 07/09/1991
• Status: Expired due to Term

• Current Assignee: Haemonetics Corporqation
• Original Assignee: Haemonetics Corporation
• Inventors: Vandor, Robert, Porreca, Ronald, Stenfors, Alan L., Barone, David, Medberry, Joseph M., Kaleskas, Edward, Volpini, Paul M., Herrig, Russell
• Primary Examiner(s): JENKINS, ROBERT
• Application Number:
  US07/727,663
• Time in Patent Office: 903 Days
• Field of Search: 494/37, 494/35, 494/32, 494/85, 494/16, 494/23, 494/27, 494/29, 494/30, 494/36, 494/45, 417/474, 604/4, 604/5, 604/6, 251/5
• US Class Current: 494/37
• CPC Class Codes: A61M 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30
• CPC Class Codes: A61M 1/36222 Details related to the interface between cassette and machine
• CPC Class Codes: A61M 1/36224 with sensing means or components thereof
• CPC Class Codes: A61M 1/36225 with blood pumping means or components thereof
• CPC Class Codes: A61M 1/36226 Constructional details of cassettes, e.g. specific details on material or shape
• 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 1/3692 Washing or rinsing blood or blood constituents
• 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 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/128 with incorporated valves
• CPC Class Codes: Y10T 137/87861 Spring coaxial with valve

Abstract

A fluid flow apparatus includes a peristaltic pump rotor mounted to a deck module assembly. A disposable software set is provided which includes a cassette which has a primary flexible tube and a pump platen adjacent to which the primary flexible tube resides. Tubing with blood processing bags are coupled to the manifold along with the input port of the rotor of a disposable blood processing centrifuge bowl. The cassette is removably secured to the hardware apparatus such that the flexible tube contacts both the platen of the cassette and the rollers of the pump rotor. The pump rotor is rotated to induce a fluid flow through the primary flexible tube. The software set also includes a three-to-one manifold which connects the primary tube to a plurality of secondary flexible tubes. Fluid flow through the secondary flexible tubes is controlled by a plurality of pinch valves which pinch the secondary tubes closed against closing surfaces on the cassette. A deck module assembly allows a user to properly secure the cassette relative to the pump rotor and the pinch valves.

Claims

1. A disposable assembly for use with an apparatus which regulates the flow of biological fluids with a peristaltic pump having a rotor, the assembly comprising:

a cassette for housing a primary flexible fluid communication tube, the cassette having a platen adjacent which the flexible tube resides, the cassette being securable to said apparatus such that the primary flexible tube is in contact with the platen and a rotor of the peristaltic pump;

a plurality of secondary tubes;

an interconnection manifold secured to the cassette for providing fluid communication between the primary tube and the secondary tubes;

a plurality of fluid containers, each in fluid communication with a separate one of the secondary tubes.

2. An assembly according to claim 1 wherein the cassette is formed of a plastic material.

3. An assembly according to claim 2 wherein the cassette is an injection-molded structure.

4. An assembly according to claim 1 wherein the cassette includes means for reinforcing the platen of the cassette.

5. An assembly according to claim 1 wherein the cassette includes mounting clips which removably secure the secondary tubes to the cassette.

6. An assembly according to claim 1 wherein the cassette includes closing surfaces adjacent the secondary tubes for providing a surface against which the secondary tubes can be pinched closed.

7. An assembly according to claim 1 including an additional manifold removably secured to the cassette for providing one-to-one fluid communication between an additional flexible tube and a side of the primary tube away from the interconnection manifold.

8. An assembly according to claim 1 wherein the fluids comprise blood cells and one side of the primary tube is adapted to be coupled to a cell washing centrifuge.

9. An assembly according to claim 1 wherein the fluid containers include a blood container, a wash solution container, and a blood reinfusion bag.

10. An apparatus for regulating flow of fluids in a blood-washing system, comprising:

a rotor for a peristaltic pump having a plurality of rollers disposed about the circumference of the rotor;

a disposable cassette for housing a flexible tube through which fluid flows, the cassette having a platen adjacent to which the flexible tube resides; and

a securing mechanism for removably securing the cassette to the apparatus such that the flexible tube is in contact with both the platen and rollers of the rotor for inducing fluid flow through the tube by rotating the rotor and wherein the flexible tube is a primary flexible tube and the cassette further comprises a manifold connecting a plurality of secondary flexible tubes to the primary flexible tube to allow fluid flow between the primary flexible tube and each of the secondary flexible tubes.

11. An apparatus according to claim 10, further comprising a plurality of valving elements each controlling the flow of fluid through one of the second flexible tubes.

12. An apparatus according to claim 11, wherein each of the valving elements comprises a pinch valve.

13. An apparatus for regulating flow of fluids in a blood-washing system, comprising:

a rotor for a peristaltic pump having a plurality of rollers disposed about the circumference of the rotor;

a disposable cassette for housing a flexible tube through which fluid flows, the cassette having a platen adjacent to which the flexible tube resides; and

a securing mechanism for removably securing the cassette to the apparatus such that the flexible tube is in contact with both the platen and rollers of the rotor for inducing fluid flow through the tube by rotating the rotor wherein the flexible tube is a primary flexible tube and the cassette further comprises a manifold connecting a plurality of secondary flexible tubes to the primary flexible tube to allow fluid flow between the primary flexible tube and each of the secondary flexible tubes, wherein the securing mechanism comprising a movable handle which, when closed, causes the flexible tube to be secured against the rollers of the rotor;

a drag bar which moves with the handle and contacts the cassette drawing the cassette toward the rotor as the handle is moved toward the closed position; and

a locking mechanism which locks the handle in a closed position.

14. An apparatus according to claim 13, wherein the locking mechanism is a pneumatically operable locking mechanism.

15. An apparatus according to claim 13, further comprising;

a base plate to which said elements protruding through spaces in the working surface are mounted; and

a lifting mechanism linking motion of the base plate in a direction perpendicular to the plane of the working surface to rotational motion of the handle.

16. An apparatus according to claim 15, wherein a rotating of the handle from the closed position to the opened position corresponds to a motion of the base plate away from the working surface such that said elements protruding through spaces in the working surface recede below the level of the working surface.

17. An apparatus according to claim 15, further comprising a switch providing a signal which indicates when the cassette is properly mounted on the working surface.

18. A blood processing apparatus, comprising:

a rotatable rotor for a peristaltic pump having a plurality of rollers disposed about the circumference of the rotor;

a disposable cassette housing a primary flexible tube through which fluid flows, the cassette having a platen against which the primary flexible tube resides, the cassette further comprising a manifold connecting a plurality of secondary flexible tubes to the primary flexible tube to allow fluid to be introduced into the primary flexible tube from a plurality of different fluid sources;

a plurality of pneumatic solenoid controlled pinch valve for individually occluding each of the secondary flexible tubes against a closing surface of the cassette; and

a securing mechanism for removably securing the cassette to the apparatus such that the primary flexible tube is in contact with both the platen and the rollers of the rotor, whereby fluid flow through the primary tube may be induced by rotating the rotor.

19. A cassette for housing a primary flexible tube through which a fluid flow is induced by a peristaltic pump, the cassette comprising;

a platen adjacent which the primary tube resides, the primary tube being compressed between the platen and a rotor of the peristaltic pump;

a secondary tube in fluid communication with the primary tube; and

a closing surface adjacent the secondary tube against which the secondary tube can be pinched to restrict fluid flow through the secondary tube with additional secondary tubes each in fluid communication with the primary tube and additional closing surfaces each located adjacent one of the additional secondary tubes such that each secondary tube can be closed individually.

20. A blood-processing apparatus for securing a primary pumping tube in a peristaltic pumping mechanism, the apparatus comprising:

a cassette to which the primary pumping tube is mounted;

a working surface to which the cassette is removably securable, the cassette being restricted in first and second mutually perpendicular directions when positioned on the working surface;

a peristaltic pump rotor located adjacent the working surface; and

a securing mechanism which responds to manual force in a single direction to bring a restricting member into contact with the cassette located on the working surface, application of said manual force causing the restricting member to move the cassette in a third direction perpendicular to said first and second directions to bring the primary pumping tube of the cassette into engagement with the pump rotor.

21. An apparatus according to claim 20 wherein the cassette comprises a platen adjacent which the primary pumping tube resides, the moving of the cassette in said third direction causing compression of the primary pumping tube between the platen and the peristaltic pump rotor.

22. A method of regulating flow of biological fluids, the method comprising:

providing a rotor for a peristaltic pump having a plurality of rollers disposed about the circumference of the rotor;

providing a disposable cassette housing a flexible tube through which fluid flows, the cassette having a platen against which the flexible tube resides;

securing the cassette to the rotor with a securing mechanism such that the flexible tube is in contact with both the platen and rollers of the rotor; and

rotating the rotor to induce fluid flow through the flexible tube, wherein the flexible tube provided with the disposable cassette is a primary flexible tube and the step of providing a disposable cassette further comprises providing a manifold connecting a plurality of secondary flexible tubes to the primary flexible tube to allow the fluid flow between the primary flexible tube and each of the secondary flexible tubes.

23. A method according to claim 22, further comprising providing a plurality of valving elements and individually occluding the flow of fluid through each of the secondary flexible tubes with one of said valving elements.

24. A method according to claim 23, wherein providing a plurality of valving elements comprises providing a plurality of pneumatic pinch valves.

25. A method according to claim 24, wherein providing a disposable cassette further comprises providing a disposable cassette having a plurality of closing surfaces against which the pinch valves each compress a secondary flexible tube for controlling fluid flow through the tube.

26. A method according to claim 22, wherein securing the cassette to the rotor comprises securing the cassette to the rotor with a handle having a drag bar which is linked to motion of the handle such that the drag bar contacts the cassette and draws the cassette toward the pump rotor as the handle is moved to a closed position.

27. A method according to claim 22, further including a one-to-one manifold coupled to the primary tube and monitoring the presence of fluid in the one-to-one manifold with a fluid detector.

28. A method of regulating flow of biological fluids, the method comprising:

providing a rotor for a peristaltic pump having a plurality of rollers disposed about the circumference of the rotor;

providing a disposable cassette housing a flexible tube through which fluid flows, the cassette having a platen against which the flexible tube resides;

securing the cassette to the rotor with a securing mechanism such that the flexible tube is in contact with both the platen and rollers of the rotor; and

rotating the rotor to induce fluid flow through the flexible tube, wherein the flexible tube provided with the disposable cassette is a primary flexible tube and the step of providing a disposable cassette further comprises providing a manifold connecting a plurality of secondary flexible tubes to the primary flexible tube to allow the fluid flow between the primary flexible tube and each of the secondary flexible tubes, wherein locking the securing mechanism comprises locking the securing mechanism with a pneumatic lock.

29. A method of regulating flow of biological fluids, the method comprising:

providing a rotor for a peristaltic pump having a plurality of rollers disposed about the circumference of the rotor;

providing a disposable cassette housing a flexible tube through which fluid flows, the cassette having a platen against which the flexible tube resides;

securing the cassette to the rotor with a securing mechanism such that the flexible tube is in contact with both the platen and rollers of the rotor; and

rotating the rotor to induce fluid flow through the flexible tube, wherein the flexible tube provided with the disposable cassette is a primary flexible tube and the step of providing a disposable cassette further comprises providing a manifold connecting a plurality of secondary flexible tubes to the primary flexible tube to allow the fluid flow between the primary flexible tube and each of the secondary flexible tubes, further comprising;

providing a working surface on which the cassette resides while secured to the rotor; and

providing a base plate to which elements which interact with the cassette are secured, said elements protruding through spaces in the working surface to interact with the cassette while the cassette is secured to the rotor and lowering the base plate when the cassette is not secured to the rotor such that said elements which interact with the cassette are recessed below the working surface.

30. A method according to claim 29, wherein motion of the base plate is linked to motion of the handle.