Disposable set for separations of blood into its components

• US 20060226088A1
• 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:
  US11/386,441
• Publication Number:
  US 20060226088A1
• 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 continuous-flow centrifuge (CFC) which may be embodied in an automated system for collecting and separating whole blood into its components. The collection and separation system includes a console and a disposable set. Various blood processing procedures which produce specific blood products may be implemented by using a specific disposable set for each process. 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. The manifold and CFC disk may be included in a cassette that mounts onto the front panel of the console. The console may contain valve actuators, pressure transducers, ultrasonic sensors, a roller pump assembly, a CFC drive system, optical sensors, electronics, software, user interface components, a bar code reader and data acquisition components.

Claims

1. A disposable set for a blood separations system comprising:

a needle adapted to draw blood from a donor;

a 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 the separation channel,

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

a second outlet port to remove plasma from the separation channel, and wherein the inner surface and the outer surface of the separation channel are each independently configured at a non-zero angle relative to a spin axis;

a manifold including;

a housing with a back cover and a front cover;

fluid pathways inside the housing;

one or more elastomer diaphragms at least partially inside the housing in fluid communication with one or more of the fluid pathways;

one or more valves in fluid communication with one or more of the fluid pathways, adapted to be deformed, wherein the deforming of the one or more valves closes one or more fluid pathways; and

one or more sets of tubing segments in fluid communication with one or more of the fluid pathways, wherein the tubing segments are adapted to be depressed to move fluid through one or more of the tubing segments;

one or more product bags adapted to hold blood components separated in the continuous-flow centrifuge; and

tubing connecting the continuous-flow centrifuge to the needle, to the manifold, and to the one or more product bags.

2. The disposable set of claim 1, further including a safety guard for covering the needle.

3. The disposable set of claim 1, wherein the continuous-flow centrifuge disk further comprises a plasma shelf to facilitate movement of the plasma into the second outlet port.

4. The disposable set of claim 1, wherein the first outlet port is positioned at a first radial distance from a center of the continuous-flow centrifuge disk, the inlet port is positioned at a second radial distance from the center of the continuous-flow centrifuge disk, and the first radial distance is greater than the second radial distance.

5. The disposable set of claim 1, wherein the second outlet port is positioned at a third radial distance from the center of the continuous-flow centrifuge disk, and the first radial distance is greater than the third radial distance.

6. The disposable set of claim 3, wherein the continuous-flow centrifuge disk further comprises a plasma shelf to facilitate movement of the plasma into the second outlet port, wherein the plasma shelf further includes a lip configured at a fourth radial distance from the center of the continuous-flow centrifuge disk, the fourth radial distance being less than the first radial distance.

7. The disposable set of claim 1, wherein the separation channel is located at or near an outer circumference of the continuous-flow centrifuge disk.

8. The disposable set of claim 1, wherein the non-zero angle is about three degrees with respect to both the inner surface and the outer surface of the separation channel, relative to the spin axis.

9. The disposable set of claim 1, wherein the inlet port is positioned about 180°

opposite the first outlet port.

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

11. The disposable set of claim 10, wherein the seal assembly further comprises:

a center channel to transport red blood cells,

a first circumferential channel to transport whole blood,

a second circumferential channel to transport plasma, and

a third circumferential channel to transport storage solution, wherein the center, first circumferential, second circumferential, and third circumferential channels are adapted to be in fluid communication with components of a blood processing apparatus by virtue of center, first, second, and third couplings that correspond to the channels and that are configured upon the stationary seal.

12. The disposable set of claim 11, wherein the continuous-flow centrifuge disk further comprises:

a first passage to transport whole blood from the first circumferential channel, and an inlet tube to transport whole blood from the first passage to the inlet port;

a first outlet tube to transport red blood cells from the first outlet port, and a second passage to transport red blood cells from the first outlet tube to the center channel;

a third passage to transport storage solution from the third circumferential channel, a storage solution tube to transport storage solution from the third passage to the first outlet tube, and a connector to connect the storage solution tube to the first outlet tube; and

a fourth passage to transport plasma from the plasma shelf to the second circumferential channel.

13. The disposable set of claim 1, wherein the continuous-flow centrifuge disk further comprises at least one orientation hole adapted to interact with an orientation pin to rotationally orient the continuous-flow centrifuge disk in a centrifugal disk drive cup.

14. The disposable set of claim 1, wherein the continuous-flow centrifuge disk comprises two orientation holes configured about 180°

opposite one another.

15. The disposable set of claim 1, wherein the continuous-flow centrifuge disk further comprises a red blood cell interface optical detector pathway configured axially through the continuous-flow centrifuge disk, and a plasma interface optical detector pathway configured axially through the continuous-flow centrifuge disk.

16. The disposable set of claim 10, wherein the rotating seal and the stationary seal are each constructed of ceramic.

17. The disposable set of claim 10, wherein the continuous-flow centrifuge disk further comprises a stationary seal housing to maintain mechanical contact between the stationary seal and the rotating seal.

18. The disposable set of claim 17, wherein the stationary seal housing permits rotational movement of the stationary seal with respect to the rotating seal only when sufficient axial force is applied to the stationary seal housing to move the stationary seal housing an axial distance toward the continuous-flow centrifuge disk.

19. The disposable set of claim 1, wherein the manifold further includes a clip to secure the one or more sets of tubing segments in place.

20. The disposable set of claim 1, wherein the manifold further includes pressure sensors to measure fluid pressure in the fluid pathways and wherein the one or more elastomer diaphragms are adapted to interact with pressure sensors.

21. The disposable set of claim 1, wherein at least one of the one or more sets of tubing segments is parallel to another set of tubing segment.

22. The disposable set of claim 1, further comprising a storage solution bag to hold storage solution, the storage solution bag being fluidly connected to the continuous-flow centrifuge disk by one or more lengths of tubing.

23. The disposable set of claim 22, further comprising a bacterial filter on at least one of the one or more lengths of tubing connecting the storage solution bag to the continuous-flow centrifuge disk.

24. The disposable set of claim 1, further comprising an anticoagulant bag to hold anticoagulant, the anticoagulant bag being fluidly connected to the continuous-flow centrifuge disk by one or more lengths of tubing.

25. The disposable set of claim 24, further comprising a bacterial filter on at least one of the one or more lengths of tubing connecting the anticoagulant bag to the continuous-flow centrifuge disk.

26. The disposable set of claim 1, further comprising an air bag fluidly connected to the continuous-flow centrifuge disk by one or more lengths of tubing.

27. The disposable set of claim 1, further comprising a leukofilter fluidly connected to the continuous-flow centrifuge disk by a first set of one or more lengths of tubing and wherein one of the one or more product bags is a red blood cell product bag fluidly connected to the leukofilter by a second set of one or more lengths of tubing.

28. A method for separating blood using the disposable set of claim 1, comprising:

collecting whole blood from a donor;

processing the whole blood through a continuous-flow centrifuge disk comprising;

an inner disk wall;

an outer disk wall; and

a separation channel therebetween, comprising;

an inner surface,

an outer surface,

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

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

a second outlet port to remove plasma from the separation channel, and wherein the inner surface and the outer surface of the separation channel are each independently configured at a non-zero angle relative to a spin axis;

collecting a volume of red blood cells from the continuous-flow centrifuge disk; and

collecting a volume of plasma from the continuous-flow centrifuge disk.

29. The method of claim 28, wherein the continuous-flow centrifuge disk further comprises a plasma shelf to facilitate movement of the plasma into the second outlet port.

30. The method of claim 28, further comprising adding storage solution to the red blood cells.

31. The method of claim 28, further comprising adding anticoagulant to the whole blood.

32. The method of claim 28, wherein the disk further includes a seal assembly located at or near an axial center region of the disk, the seal assembly comprising a stationary seal and a rotating seal, the method further comprising configuring the continuous-flow centrifuge disk in a disk drive cup to permit rotational movement of the stationary seal with respect to the rotating seal.