Method and apparatus for blood separations

• US 20060226090A1
• Filed: 03/22/2006
• Published: 10/12/2006
• Est. Priority Date: 04/08/2005
• Status: Abandoned Application

• Current Assignee: Terumo Medical Corporation (Terumo Corporation)
• Original Assignee: Mission Medical, Inc. (Terumo Corporation)
• Inventors: D'Elia, Richard R., Sahines, Thomas P., Fernandez, Robert K., Briones, Victor A., Nier, David M., Zamora, Salvador M., McNamara, Thomas Noland, Lewis, Brian D., Robinson, Thomas Charles
• Application Number:
  US11/387,018
• Publication Number:
  US 20060226090A1
• Time in Patent Office: Days
• US Class Current: 210/787
• CPC Class Codes: A61M 1/0218 with filters
• CPC Class Codes: A61M 1/0231 with gas separating means, e.g. air outlet through microporous membrane or gas bag
• CPC Class Codes: A61M 1/0236 with sampling means, e.g. sample bag or sampling port
• CPC Class Codes: A61M 1/362223 the interface being evacuated interfaces to enhance contact
• 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 1/36225 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 1/362261 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 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/505 Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 2209/082 Mounting brackets, arm supports for equipment
• CPC Class Codes: A61M 2209/084 Supporting bases, stands for equipment
• CPC Class Codes: B04B 5/0442 with means for adding or withdrawing liquid substances during the centrifugation, e.g. continuous centrifugation

Abstract

Described herein is a method and apparatus for collecting and separating whole blood into its components, including collecting an amount of plasma and red blood cells. The collection and separation system includes a console and a disposable set. The method may include processing the blood through the centrifuge, collecting plasma, collecting red blood cells and returning red blood cells until a desired plasma volume is reached. Then a final volume of red blood cells and plasma may be collected. The disposable set may include a manifold, a CFC, and various components attached by tubing. These components may include one or more solution bags, blood product bags, bacterial filters, leukofilters, and a donor blood collection tube with access needle.

Claims

1. A method for separating blood comprising:

drawing a first volume of whole blood from a source;

processing said first volume of whole blood through a continuous-flow centrifuge disk, the continuous-flow centrifuge disk including

an inner disk wall;

an outer disk wall; and

a separation channel therebetween, including;

an inner surface,

an outer surface,

an inlet port to introduce whole blood into said separation channel,

a first outlet port to remove concentrated red blood cells from said separation channel,

a second outlet port to remove plasma from said separation channel, and

wherein said inner surface and said outer surface of said separation channel are each independently configured at an angle relative to a spin axis;

collecting a first volume of red blood cells;

collecting a first volume of plasma;

returning at least a portion of the first volume of red blood cells to the source;

drawing a final volume of whole blood from the source;

processing said final volume of whole blood through the continuous-flow centrifuge disk; and

collecting a final volume of red blood cells; and

collecting a final volume of plasma.

2. The method of claim 1, wherein the continuous-flow centrifuge disk further includes a plasma shelf to facilitate movement of said plasma into said outlet port.

3. The method of claim 1, wherein said first outlet port is positioned at a first radial distance from a center of said disk, said inlet port is positioned at a second radial distance from said center of said disk, and said first radial distance is greater than said second radial distance.

4. The method of claim 3, wherein said second outlet port is positioned at a third radial distance from said center of said disk, and said radial distance is greater than said third radial distance.

5. The method of claim 1, wherein said inner surface is configured at an angle of about three degrees relative to the spin axis and said outer surface is configured at an angle of about three degrees relative to the spin axis.

6. The method of claim 1, wherein said inlet port is positioned about 180°

opposite said first outlet port.

7. The method of claim 1, wherein the continuous-flow centrifuge disk further includes a seal assembly located at or near a center region of said disk, said seal assembly comprising a stationary seal and a rotating seal, wherein, upon rotational movement of said disk, said rotating seal does not move substantially relative to said separation channel and said stationary seal is free to move substantially relative to said separation channel.

8. The method of claim 1, further comprising adding saline to the first volume of red blood cells before returning the first volume of red blood cells to the source.

9. The method of claim 1, further comprising:

drawing a second volume of whole blood from the source prior to the drawing the final volume of whole blood from the source;

processing said second volume of whole blood through the continuous-flow centrifuge disk;

collecting a second volume of red blood cells;

returning at least a portion of the second volume of red blood cells to the source; and

collecting a second volume of plasma.

10. The method of claim 1, further comprising ending the drawing a final volume of whole blood cells when a predetermined volume of red blood cells and a predetermined volume of plasma have been collected.

11. The method of claim 10, further comprising:

weighing all red blood cells collected up to and during the collecting the final volume of red blood cells;

weighing all plasma collected up to and during the collecting the final volume of plasma; and

ceasing the collecting the final volume of red blood cells when a predetermined weight of red blood cells and a predetermined weight of plasma have been collected.

12. The method of claim 1, further comprising:

after collecting the final volume of red blood cells and the final volume of plasma, collecting all red blood cells remaining in the continuous-flow centrifuge disk.

13. The method of claim 1, further comprising passing the red blood cells through a leukofilter prior to collecting the red blood cells.

14. A method for separating whole blood into its constituent parts, comprising:

collecting whole blood from a source;

processing said whole blood through a continuous-flow centrifuge disk;

collecting a first volume of red blood cells;

collecting a first volume of plasma;

returning at least a portion of the first volume of red blood cells to the source;

collecting a second volume of red blood cells;

collecting a second volume of plasma; and

repeating the returning of red blood cells, the collecting of plasma and the collecting of red blood cells until a desired total volume of plasma has been collected.

15. The method of claim 14, further comprising inserting a needle into the source for collection of whole blood from the source and returning blood components to the source, wherein the collecting a first volume of red blood cells and the returning at least a portion of the first volume of red blood cells to the source are performed while the needle is connected to the source.

16. An apparatus for separating blood into its components comprising:

a needle to draw whole blood from a source,

a continuous-flow centrifuge disk to process the whole blood, the continuous-flow centrifuge disk including

an inner disk wall;

an outer disk wall; and

a separation channel therebetween, including;

an inner surface,

an outer surface,

an inlet port to introduce whole blood into said separation channel,

a first outlet port to remove concentrated red blood cells from said separation channel,

a second outlet port to remove plasma from said separation channel,

wherein said inner surface and said outer surface of said separation channel are each independently configured at an angle relative to a spin axis;

a first collection reservoir to collect a first volume of red blood cells and a final volume of red blood cells;

a second collection reservoir to collect a first volume of plasma and a final volume of plasma;

tubing fluidly connecting the needle, the first collection reservoir, and the second collection reservoir to the continuous-flow centrifuge disk;

a pump on tubing between the first collection reservoir and the continuous-flow centrifuge disk to return the first volume of red blood cells to the source.

17. The apparatus of claim 16, wherein the continuous-flow centrifuge disk further includes a plasma shelf to facilitate movement of said plasma into said outlet port.

18. The apparatus of claim 16, wherein said first outlet port is positioned at a first radial distance from a center of said disk, said inlet port is positioned at a second radial distance from said center of said disk, and said first radial distance is greater than said second radial distance.

19. The apparatus of claim 16, wherein said second outlet port is positioned at a third radial distance from said center of said disk, and said radial distance is greater than said third radial distance.

20. The apparatus of claim 16, wherein said inner surface is configured at an angle of about three degrees relative to the spin axis and said outer surface is configured at an angle of about three degrees relative to the spin axis.

21. The apparatus of claim 16, wherein said inlet port is positioned about 180°

opposite said first outlet port.

22. The apparatus of claim 16, wherein the continuous-flow centrifuge disk further includes a seal assembly located at or near a center region of said disk, said seal assembly comprising a stationary seal and a rotating seal, wherein, upon rotational movement of said disk, said rotating seal does not move substantially relative to said separation channel and said stationary seal is free to move substantially relative to said separation channel.

23. The apparatus of claim 16, further comprising a saline storage reservoir to add saline to the first volume of red blood cells before the first volume of red blood cells is returned to the source.

24. The apparatus of claim 16, further comprising a scale to measure collected volumes of red blood cells.

25. The apparatus of claim 16, further comprising a scale to measure collected volumes of plasma.

26. The apparatus of claim 16, further comprising a leukofilter to filter red blood cells that exit the continuous-flow centrifuge disk before the collecting of red blood cells, wherein the leukofilter is fluidly connected to the first collection reservoir and to the continuous-flow centrifuge disk by tubing.