Blood processing systems and methods with sensors to detect contamination due to presence of cellular components or dilution due to presence of plasma

• US 6,348,156 B1
• Filed: 09/03/1999
• Issued: 02/19/2002
• 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, Joie, Michel L. F., Muller, Matthew R., Smith, Kelly B, Vishnoi, Rohit, Vandlik, Mark R
• Primary Examiner(s): KIM, SUN U
• Application Number:
  US09/390,492
• Time in Patent Office: 900 Days
• Field of Search: 210/85, 210/87, 210/94, 210/97, 210/103, 210/109, 210/143, 210/232, 210/739, 210/745, 210/782, 210/787, 210/789, 494/1, 494/2, 494/3, 494/5, 494/10, 494/37, 494/43, 494/45
• US Class Current: 210/739
• CPC Class Codes: A61M 1/0236 with sampling means, e.g. sample bag or sampling port
• CPC Class Codes: A61M 1/3496 Plasmapheresis; Leucopheresis; Lymphopheresis A61M1/3472 takes precedence
• 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 1/362262 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 1/3646 Expelling the residual body fluid after use, e.g. back to the body
• 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 2202/0415 Plasma
• CPC Class Codes: A61M 2202/0429 Red blood cells; Erythrocytes
• CPC Class Codes: A61M 2205/125 with incorporated filters
• 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: B01D 17/0217 by centrifugal force
• CPC Class Codes: B01D 21/2444 : Discharge mechanisms for the classified liquid
• CPC Class Codes: B01D 21/245 : Discharge mechanisms for the sediments
• CPC Class Codes: B01D 21/26 : Separation of sediment aided by centrifugal force or centripetal forcecentrifuges B04B; cyclones B04C
• CPC Class Codes: B01D 21/262 : by using a centrifuge
• CPC Class Codes: B01D 21/302 : Active control mechanisms with external energy, e.g. with solenoid valve
• CPC Class Codes: B01D 21/34 : Controlling the feed distribution; Controlling the liquid level ; Control of process parameters
• CPC Class Codes: B01D 2221/08 : Mobile separation devices
• CPC Class Codes: B01D 2221/10 : Separation devices for use in medical, pharmaceutical or laboratory applications, e.g. separating amalgam from dental treatment residues

Abstract

Blood processing systems and methods employ two sensors, one to detect a condition of plasma exiting a separation device and another sensor to detect a condition of a cellular component exiting the separation device. The first sensor detects, e.g., contamination of the plasma due to presence of unwanted cellular components. The second sensor detects, e.g., dilution of the cellular component due to presence of plasma. Blood processing parameters are carried out based, at least in part, by conditions detected by one or both of the sensors.

Claims

1. A blood separation system comprising

a device which, in use, operates to separate whole blood into red blood cells and plasma,

a whole blood inlet line to convey a flow of whole blood into the device,

a plasma collection line outside the device to convey a flow of plasma from the device,

a red blood cell collection line outside the device to convey a flow of red blood cells from the device,

a first sensing assembly including a first sensor in the plasma collection line operating to detect presence of at least one species of cellular blood component in the flow of plasma and generating a first output,

a second sensing assembly including a second sensor in the red blood cell collection line operating to detect red blood cell hematocrit in the flow of red blood cells and generating a second output, and

a controller operating to control flows in the plasma collection line and the red blood cell collection line based upon the first and second outputs.

2. A system according to claim 1 wherein the plasma collection line includes a plasma pump operable to provide variable flow rates, and

wherein the controller operates the plasma pump based upon the first and second outputs.

3. A system according to claim 1

wherein the whole blood inlet line includes a whole blood pump operable to provide variable flow rates, and

wherein the controller operates the whole blood pump based upon the first and second outputs.

4. A system according to claim 1

wherein the first sensor operates to detect platelets in the flow of plasma.

5. A system according to claim 1

wherein the first sensor operates to detect red blood cells in the flow of plasma.

6. A system according to claim 1

wherein, during separation of the whole blood, a buffy coat layer forms between the plasma and the red blood cells, and

wherein the first sensor operates to detect an interface between the buffy coat layer and the plasma.

7. A system according to claim 1

wherein, during separation of the whole blood, a buffy coat layer forms between the plasma and the red blood cells, and

wherein the first sensor operates to detect an interface between the buffy coat layer and the red blood cells.

8. A system according to claim 1

wherein the first sensor assembly operates the first sensor to differentiate between platelets and red blood cells in the flow of plasma.

9. A system according to claim 1

wherein the controller includes an input for selecting either a first blood collection protocol to collect plasma or a second blood collection protocol to collect red blood cells, and

wherein the first sensor assembly operates the first sensor to detect platelets in the flow of plasma when the first blood collection protocol is selected and operates the first sensor to detect red blood cells in the flow of plasma when the second blood collection protocol is selected.

10. A system according to claim 1

wherein, during separation of the whole blood, a buffy coat layer forms between the plasma and the red blood cells,

wherein the controller includes an input for selecting a blood collection protocol to collect the buffy coat layer, and

wherein, when the first blood collection protocol is selected, the first sensor assembly operates the first sensor to detect an interface between the buffy coat layer and the plasma and an interface between the buffy coat layer and the red blood cells.

11. A system according to claim 1

wherein the device includes a separation chamber constructed and arranged for rotation about an axis and includes a low-G wall spaced from the axis and toward which the plasma flows during rotation, and a high-G wall spaced from the axis a greater distance than the low-G wall and toward which the red blood cells flow during rotation,

wherein the plasma collection line collects plasma along the low-G wall, and

wherein the red blood cell collection line collects red blood cells along the high-G wall.

12. A system according to claim 11

wherein the plasma collection line includes a plasma pump operable to provide variable flow rates, and

wherein the controller operates the plasma pump based upon the first and second outputs.

13. A system according to claim 1

wherein the controller includes an input for selecting different blood collection protocols, and

wherein the first sensor assembly operates the first sensor to detect different cellular blood components according to the blood collection protocol selected.

14. A blood separation method comprising the steps of

separating blood into red blood cells and plasma in a device,

conveying a flow of plasma from the device while sensing to detect a specified cellular blood component in the flow of plasma,

conveying a flow of red blood cells from the device while sensing to detect red blood cell hematocrit in the flow of red blood cells,

controlling flows in a plasma collection line and a red blood cell collection line based upon the sensing.