Integrated automatic blood collection and processing unit

• US 6,890,291 B2
• Filed: 06/24/2002
• Issued: 05/10/2005
• Est. Priority Date: 06/25/2001
• Status: Expired due to Fees

• Current Assignee: Terumo Medical Corporation (Terumo Corporation)
• Original Assignee: Mission Medical, Inc. (Terumo Corporation)
• Inventors: Robinson, Thomas P., Robinson, Thomas C., D'Elia, Richard, Sahines, Thomas, Eibe, Paul
• Primary Examiner(s): Cooley, Charles E.
• Application Number:
  US10/179,920
• Publication Number:
  US 20030199803A1
• Time in Patent Office: 1,051 Days
• Field of Search: 494/1, 494/10, 494/18, 494/42, 494/45, 494/56, 210/781, 210/782, 210/787
• US Class Current: 494/42
• CPC Class Codes: A61M 1/0218 with filters
• 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 1/36224 with sensing 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 1/362265 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 1/3693 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 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• 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 2205/6072 Bar codes
• CPC Class Codes: B04B 2005/045 having annular separation channels
• CPC Class Codes: B04B 5/0442 with means for adding or withdrawing liquid substances during the centrifugation, e.g. continuous centrifugation

Abstract

A system for automatically collecting and separating whole blood into its components is described. The system includes a console, which contains all motors, pumps, sensors, valves and control circuitry, and a unique disposable set that includes a cassette supporting a centrifuge with an improved design, pump interfaces with an improved design, component and solution bags, and tubing. Various processes are implemented using a specific disposable set for each process which allows automatic identification of the process to be performed the console.

Claims

1. A cassette adapted for mounting on a console, wherein the console includes a first motor and pump rotors driven by a second motor, comprising:

a frame;

a continuous flow centrifuge supported on the frame, said continuous flow centrifuge comprising;

a housing,

a rotor rotably supported in the housing, adapted to be driven by the first motor when the cassette is mounted on the console, and

a disk mounted to the rotor,

wherein the rotor is supported in a horizontal position relative to the console when the cassette is mounted on the console, said continuous flow centrifuge having an input port adapted to receive and hold a first length of flexible tubing for delivering fluid to the disk and an output port adapted to receive and hold a second length of flexible tubing for removing fluid from the disk; and

a manifold supported on the frame, said manifold comprising;

a first tube receptacle, a second tube receptacle, a third tube receptacle and a fourth tube receptacle, each of the tube receptacles adapted to receive and hold a length of flexible tubing,

a first pump tube segment defining a first end and a second end;

a second pump tube segment defining a first end and a second end, and

a first fluid pathway, a second fluid pathway, a third fluid pathway and a fourth fluid pathway, wherein the pump tube segments, the lengths of flexible tubing and the fluid pathways are adapted to contain fluid,

wherein the first tube receptacle is connected to the first end of the first pump tube segment by a first fluid pathway, the second end of the first pump tube segment is connected to the second tube receptacle by a second fluid pathway, the third tube receptacle is connected to the first end of the second pump tube segment by a third fluid pathway, and the second end of the second pump tube segment is connected to the fourth tube receptacle by a fourth fluid pathway,

wherein the first length of flexible tubing connects the input port of the continuous flow centrifuge to the second tube receptacle, and the second length of flexible tubing connects the output port of the continuous flow centrifuge to the third tube receptacle, and each of the pump tube segments is adapted for interface with a separate pump rotor chosen from among the pump rotors driven by the second motor when the cassette is mounted on the console, whereby fluid in each of the pump tube segments may be forced from each of the pump tube segments to a selected one of the respective fluid pathways to which the pump tube segments are connected.

2. The cassette of claim 1 wherein at least one of the fluid pathways further includes a valve interface adapted for interaction with a valve contained in the console when the cassette is mounted on the console, whereby the valve may selectively cause the at least one pathway to be blocked.

3. The cassette of claim 2 wherein the valve interface comprises a flexible diaphragm sealed to the manifold and forming a fluid inlet and a fluid outlet, and further adapted to be selectively compressed by the valve.

4. The cassette of claim 2 wherein at least one of the fluid pathways further includes a pressure sensor interface, adapted to respond to a change in pressure in the fluid in the at least one pathway, and further adapted for interaction with a pressure sensor contained in the console when the cassette is mounted on the console, whereby an electronic signal may be generated by the pressure sensor in response to the change in pressure.

5. The cassette of claim 4 wherein the console further includes a bar code reader for generating electronic signals corresponding to bar codes and a controller for controlling the valve in response to an electronic signal generated by the pressure sensor and the bar code reader, wherein the cassette further includes a bar code adapted to be read by the bar code reader.

6. The cassette of claim 1 wherein at least one of the fluid pathways further includes a pressure sensor interface, adapted to respond to a change in pressure in the fluid in the at least one pathway, and further adapted for interaction with a pressure sensor contained in the console when the cassette is mounted on the console, whereby an electronic signal may be produced by the pressure sensor in response to the change in pressure.

7. The cassette of claim 6 wherein the pressure sensor interface comprises a flexible diaphragm sealed to the manifold and forming a fluid inlet and a fluid outlet, and wherein the flexible diaphragm is adapted to expand when fluid pressure in the fluid pathway is increased and contract when fluid pressure in the fluid pathway is decreased.

8. The cassette of claim 1 wherein the cassette forms at least one hole, adapted, when the cassette is mounted on the console, to align with an ultrasonic sensor contained in the console, and a portion of the first length of flexible tubing is held in a fixed position to lie across the hole.

9. The cassette of claim 1 further comprising a bag for containing fluid connected to the first tube receptacle by a third length of flexible tubing.

10. The cassette of claim 1, wherein the disk comprises a substantially circular separation channel comprising an inner wall and an outer wall.

11. The cassette of claim 10, wherein the input port is adapted for introducing whole blood into the separation channel, and the output port is adapted for removing concentrated red blood cells from the separation channel.

12. The cassette of claim 10, wherein the continuous flow centrifuge further includes a second output port adapted for removing plasma from the separation channel.

13. The cassette of claim 10, wherein the separation channel includes a portion where the outer wall is at or near a maximum radial distance from a central axis of the continuous flow centrifuge, and the output port is positioned in the portion.

14. An integrated system for simultaneously collecting and separating whole blood comprising:

a console comprising a first motor and pump rotors driven by a second motor;

a cassette adapted for mounting on the console, said cassette comprising;

a frame,

a continuous flow centrifuge supported on the frame, said continuous flow centrifuge comprising;

a housing,

a rotor rotably supported in the housing, adapted to be driven by the first motor when the cassette is mounted on the console, and

a disk, mounted to the rotor,

wherein the rotor is supported in a horizontal position relative to the console when the cassette is mounted on the console, said continuous flow centrifuge having an input port adapted to receive and hold a first length of flexible tubing for delivering fluid to the disk and an output port adapted to receive and hold a second length of flexible tubing for removing fluid from the disk; and

a manifold supported on the frame, said manifold comprising;

a first tube receptacle, a second tube receptacle, a third tube receptacle and a fourth tube receptacle, each of the tube receptacles adapted to receive and hold a length of flexible tubing,

a first pump tube segment defining a first end and a second end, a second pump tube segment defining a first end and a second end, and

a first fluid pathway, a second fluid pathway, a third fluid pathway and a fourth fluid pathway, wherein the pump tube segments, the lengths of flexible tubing and the fluid pathways are adapted to contain fluid,

wherein the first tube receptacle is connected to the first end of the first pump tube segment by a first fluid pathway, the second end of the first pump tube segment is connected to the second tube receptacle by a second fluid pathway, and the third tube receptacle is connected to the first end of the second pump tube segment by a third fluid pathway, and the second end of the second tube segment is connected to the fourth tube receptacle by a fourth fluid pathway,

and wherein the first length of flexible tubing connects the input port of the continuous flow centrifuge to the second tube receptacle, and the second length of flexible tubing connects the output port of the continuous flow centrifuge to the third tube receptacle, and each of the pump tube segments is adapted for interface with a separate pump rotor chosen from among the pump rotors driven by the second motor when the cassette is mounted on the console, whereby fluid in each of the pump tube segments may be forced from each of the pump tube segments to a selected one of the respective fluid pathways to which the pump tube segments are connected.

15. The system of claim 14, wherein the disk comprises a substantially circular separation channel comprising an inner wall and an outer wall.

16. The system of claim 15, wherein the input port is adapted for introducing whole blood into the separation channel, and the output port is adapted for removing concentrated red blood cells from the separation channel.

17. The system of claim 15, wherein the continuous flow centrifuge further includes a second output port adapted for removing plasma from the separation channel.

18. The system of claim 15, wherein the separation channel includes a portion where the outer wall is at or near a maximum radial distance from a central axis of the continuous flow centrifuge, and the output port is positioned in the portion.