Blood processing method and apparatus with disposable cassette

• US 5,311,908 A
• Filed: 12/17/1992
• Issued: 05/17/1994
• Est. Priority Date: 07/09/1991
• Status: Expired due to Term

• Current Assignee: Haemonetics Corporation
• Original Assignee: Haemonetics Corporation
• Inventors: Barone, David, Plante, Joseph R., Medberry, Joseph M., Volpini, Paul M., Herrig, Russell
• Primary Examiner(s): JENKINS, ROBERT
• Application Number:
  US07/992,057
• Time in Patent Office: 516 Days
• Field of Search: 494/37, 494/1, 494/2, 494/5, 494/7, 494/10, 137/881, 137/883, 251/7, 73/863.01, 73/865.9, 73/597, 340/603, 340/606, 340/621, 604/408, 604/409, 604/410
• US Class Current: 137/881
• 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 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. A flat surface is provided on the manifold to couple sonic radiation into the manifold and sense the presence of fluids therein.

Claims

1. A blood-processing apparatus for providing failsafe control of fluid transfer between a primary tube and a plurality of secondary tubes with which the primary tube is in fluid communication, the apparatus comprising:

a cassette to which the secondary tubes are mounted, each secondary tube being mounted adjacent a closing surface;

a working surface to which the cassette is removably secured; and

a plurality of pinch valves each of which controls occlusion of one of the secondary tubes, the pinch valves being biased in a normally-closed position such that absent electrical power to the apparatus and with the cassette secured to the working surface, each pinch valve compresses a secondary tube against a closing surface to restrict fluid flow therethrough.

2. An apparatus according to claim 1 wherein the pinch valves protrude through the working surface.

3. An apparatus according to claim 1 further comprising a securing mechanism by which the cassette is removably secured to the working surface, the securing mechanism being linked to motion of the pinch valves such that with the cassette located adjacent the working surface, operation of the securing mechanism to secure the cassette to the working surface causes the pinch valves to extend toward the cassette to engage the secondary tubes and the primary tube being coupled at one end to a manifold having a transparent surface to permit detection of fluid in the manifold by a fluid sensor.

4. A blood-processing apparatus for providing failsafe control of fluid transfer between a primary tube and a plurality of secondary tubes with which the primary tube is in fluid communication, the apparatus comprising:

a cassette to which the secondary tubes are mounted, a first manifold coupling each secondary tube to the primary tube and a second manifold coupling another tube to the primary tube, each secondary tube being mounted adjacent a closing surface;

a working surface to which the cassette is removably secured;

a plurality of pinch valves each of which controls occlusion of one of the secondary tubes, the pinch valves being biased in a normally-closed position such that with the cassette secured to the working surface, each pinch valve compresses a secondary tube against a closing surface to restrict fluid flow therethrough;

a movable handle which, when closed, causes the cassette to be secured to the working surface;

a base plate to which the pinch valves are mounted;

a lifting mechanism linking motion of the base plate in a direction perpendicular to the plane of the working surface to motion of the handle, closing of the handle moving the base plate closer to the working surface such that the pinch valves extend through spaces in the working surface to engage the secondary tubes of the cassette mounted to the working surface; and

a locking mechanism which, if locked when the handle is in a closed position, restricts the motion of the handle and the lifting mechanism to prevent motion of the handle away from the closed position while the blood-processing apparatus is being operated; and

a fluid sensor for monitoring the presence of fluid in the second manifold.

5. An apparatus according to claim 4 wherein the lifting mechanism comprises a cam which rotates with rotation of the handle and a cam rod secured to the base plate, the cam rod having a surface which contacts a surface of the cam such that rotation of the cam causes said cam surface to move relative to said cam rod surface to change the vertical position of the cam rod and the base plate relative to the working surface.

6. Apparatus for processing of blood fluids comprising:

a) a first flexible fluid communication tube coupled between first and second rigid fluid manifolds;

b) said first manifold having an external flat sonic coupling surface for coupling radiation from an external transducer into and out of the manifold for sensing the presence of fluid in the manifold.

7. The apparatus of claim 6 wherein the manifold is generally tubular in shape except where the flat surface is located.

8. The apparatus of claim 7 wherein the flat coupling surface is formed opposite three flat reflective surfaces formed respectively on the exterior, far interior and near interior surfaces of the manifold.

9. The apparatus of claim 6 wherein the radiation is sound radiation.

10. The apparatus of claim 9 wherein the sound radiation is in the ultrasonic range.

11. A disposable assembly for use with an apparatus which regulates the flow of biological fluids, the assembly comprising:

a first tube;

a plurality of secondary tubes;

an interconnection manifold for providing fluid communication between the first tube and the secondary tubes;

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

a flat radiation coupling surface formed on the exterior of the manifold for coupling radiation from an external transducer into the interior of the manifold to sense the presence of fluids therein.

12. An assembly according to claim 11 further including three flat reflective surfaces formed in said manifold opposite the coupling surface.

13. An assembly according to claim 11 wherein the manifold is an injection-molded structure.

14. An assembly according to claim 11 wherein the manifold is comprised of a generally tubular rigid member coupled at one end to the first tube and at another end to a secondary tube.

15. The assembly of claim 11 wherein the radiation is sound radiation.

16. The assembly of claim 15 in which the sound radiation is in the ultrasonic range.

17. Apparatus for a disposable cassette in which a rigid fluid manifold is provided for interconnecting a first flexible conduit to a second flexible conduit comprising:

a) a planar deck for supporting said cassette in a horizontal position;

b) a base plate depending from the deck and adapted for vertical movement from a lower plane position to an upper plane position parallel to said planar deck; and

c) a fluid detector affixed to said base plate opposite an opening in said deck adjacent said manifold;

such that when said base plate is in said upper plane position the detector is in intimate contact with a surface of the manifold.

18. The apparatus of claim 17 including mechanical base means disposed between the detector and the base plate for controlling the coupling force between the detector and the manifold surface.

19. The apparatus of claim 17 wherein the sensor is a sonic sensor which detects the presence of fluid in the manifold by detecting the difference in time of travel of a sonic signal in air versus in fluid.

20. The apparatus of claim 17 further including pinch valves mounted on the base plate for controlling the flow of fluid through the flexible conduits.

21. The apparatus of claim 20 wherein the pinch valves are biased in a normally closed position such that each pinch valve compresses a respective conduit against a surface via openings provided in the deck.

22. A blood processing system comprising:

a) a first flexible fluid communication tube coupled on one side to a rigid fluid manifold and on another side to a blood processing centrifuge in which blood fluid is separated into constituent component fluids, some of which are coupled by said tube to said manifold;

b) said manifold having an external flat sonic coupling surface; and

c) an external transducer for coupling sonic radiation into and out of the manifold through the coupling surface for sensing the presence of fluid in the manifold.

23. The system of claim 22 in which the manifold is mounted on a fixed deck and the transducer on a translatable base plate such that the transducer may be moved into and out of contact with the coupling surface.