Extra-corporeal blood processing method and apparatus based on donor characteristics

• US 7,354,415 B2
• Filed: 04/20/2004
• Issued: 04/08/2008
• Est. Priority Date: 03/09/2000
• Status: Expired due to Term

• Current Assignee: Terumo BCT, Inc. (Terumo Corporation)
• Original Assignee: Gambro BCT, Inc. (Terumo Corporation)
• Inventors: Bainbridge, Marlene, Butzke, Scott D., Keller, Muriel, Gordon, Timothy M., McAteer, Michael J.
• Primary Examiner(s): Deak; Leslie R.
• Application Number:
  US10/709,196
• Publication Number:
  US 20040230152A1
• Time in Patent Office: 1,449 Days
• Field of Search: 604/4.01, 604/5.01, 604/6.01, 604/6.02, 604/6.04, 604/6.05, 604/6.06, 604/6.1, 604/6.11, 604/6.15, 604/6.16, 604/403, 422 44- 48, 702/19, 702/21, 494/1, 494/7, 494/35, 210/600, 210/634, 210/645, 210/739, 210/781, 210/782, 210/805, 210/252
• US Class Current: 604/6.01
• CPC Class Codes: A61M 1/30 Single needle dialysis ; Reciprocating systems, alternately withdrawing blood from and returning it to the patient, e.g. single-lumen-needle dialysis or single needle systems for hemofiltration or pheresis
• CPC Class Codes: A61M 1/303 having a reservoir for treated blood to be returned
• CPC Class Codes: A61M 1/308 Volume control, e.g. with open or flexible containers, by counting the number of pump revolutions, weighing
• CPC Class Codes: A61M 1/3603 in the same direction
• 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 1/362262 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 1/3692 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

Abstract

Methods and apparatus particularly involving the separation of blood into blood components and the collection of such components are disclosed. In one aspect, an extra-corporeal method for the collection of plasma and red blood cells is provided, wherein the collection of plasma and red blood cells may occur simultaneously or subsequently utilizing the same dual stage blood processing vessel. The flow of blood to the blood processing vessel and return of uncollected blood components may be provided via a single needle, wherein blood is removed from and returned to a donor/patient during alternating blood removal and blood return submodes. Platelet separation and collection options are also described. In either case, prior to red blood cell collection, a set-up phase may be carried out to set a predetermined hematocrit and AC ratio. Replacement fluid delivery may optionally also be provided either substantially continuously during any collection phase(s) and/or in a bolus mode.

Claims

1. A method for extra-corporeal collection of a blood component from a donor/patient, comprising:

using an extra-corporeal blood processing system having an extra-corporeal blood processing machine, wherein said machine generates a list of component collection options;

using a plurality of donor/patient characteristics to determine blood components capable of being collected from said donor/patient according to different procedures wherein said donor/patient characteristic includes the hematocrit of the donor/patient;

generating a list having a plurality of blood component collection procedures;

using the list in selecting a blood component collection procedure;

establishing a pre-determined packing factor for separated red blood cells within a centrifugal blood processing vessel;

removing blood from a donor/patient;

flowing the blood into said centrifugal blood processing vessel;

separating the blood into separated blood components within said centrifugal blood processing vessel, said separated blood components including at least separated plasma and separated red blood cells;

collecting at least a portion of at least one of said blood components from said centrifugal blood processing vessel in a blood component collection reservoir separate from said centrifugal blood processing vessel;

returning at least a portion of the uncollected separated blood components from said blood processing vessel to said donor/patient.

2. A method for extra-corporeal collection of a blood component from a donor/patient according to claim 1 in which said method uses an extra-corporeal blood processing system having an extra-corporeal blood processing machine and a plurality of tubing and bag set options available for use with said machine, said method further comprising loading an appropriate tubing and bag set on said machine after a blood component collection procedure has been selected from said list.

3. A method as recited in claim 2, wherein said plasma collection step is performed at least partially after said red blood cell collection step.

4. A method as recited in claim 2, wherein said red blood cell collection step is performed at least partially after said plasma collection step.

5. A method according to claim 1 wherein said donor/patient characteristics are input into said machine, and said machine uses said donor/patient characteristics to generate said list.

6. A method according to claim 1 wherein said donor/patient characteristic includes the height and weight of the donor/patient.

7. A method according to claim 1 wherein said packing factor is between 11 and 21.

8. A method according to claim 1 comprising establishing a packing factor of at least about 13 for the separated red blood cells within said blood processing vessel.

9. A method according to claim 8 in which the packing factor is about 16.

10. A method according to claim 1 which further includes establishing an AC ratio in the blood processing vessel of between about 6 and about 16.

11. A method according to claim 1 wherein said donor/patient characteristic includes the platelet count of the donor/patient.

12. A method according to claim 1 wherein said list of blood component options includes at least one option selected from the group consisting essentially of platelets, red blood cells, and plasma.

13. A method according to claim 1 wherein said list of blood component options includes at least one option selected from the group consisting essentially of single platelets, double platelets, triple platelets, red blood cells, double red blood cells, and plasma.

14. A method according to claim 1 wherein said list of blood component options includes at least two options as a combination of collectible products selected from the group consisting essentially of single platelets, double platelets, triple platelets, red blood cells, double red blood cells, and plasma.

15. A method as recited in claim 1 wherein said step of generating said list of procedures further comprises listing other procedures with indications that certain further products might be qualified for said donor/patient if certain process variable were changed.

16. A method as recited in claim 15 further comprising changing variable information and regenerating said list of procedures.

17. A method as recited in claim 16 in which said method uses an extra-corporeal blood processing system having an extra-corporeal blood processing machine and a plurality of tubing and bag set options available for use with said machine, said method further comprising loading an appropriate tubing and bag set on said machine after a blood component collection procedure has been selected from said list.

18. A method for extra-corporeal collection of a blood component from a donor/patient, comprising:

using a donor/patient characteristic to determine a blood component capable of being collected, said donor/patient characteristic including the hematocrit of the donor/patient;

generating a list having at least one blood component collection option;

using the list in selecting a blood component to be collected;

removing blood from a donor/patient;

flowing the blood into a centrifugal blood processing vessel;

separating the blood into separated blood components within said centrifugal blood processing vessel, said separated blood components including at least separated plasma and separated red blood cells;

collecting at least a portion of at least one of said blood components from said centrifugal blood processing vessel in a blood component collection reservoir separate from said centrifugal blood processing vessel;

returning at least a portion of the uncollected separated blood components from said blood processing vessel to said donor/patient,

wherein said method uses an extra-corporeal blood processing system having an extra-corporeal blood processing machine, whereby said machine generates said list of at least one component collection option, and

establishing a pre-determined packing factor for the separated red blood cells within said blood processing vessel, in which the packing factor is about 16 during the contemporaneous collection of separated plasma and separated red blood cells and the packing factor is then reduced to about 13 during the at least partial step of collecting separated red blood cells after the performance of the collection of separated plasma.

19. A method for extra-corporeal collection of a blood component from a donor/patient, comprising:

using a donor/patient characteristic to determine a blood component capable of being collected;

generating a list having at least one blood component collection option;

using the list in selecting a blood component to be collected;

removing blood from a donor/patient;

flowing the blood into a centrifugal blood processing vessel;

separating the blood into separated blood components within said centrifugal blood processing vessel, said separated blood components including at least separated plasma and separated red blood cells;

adding anticoagulant to the blood flowing into the centrifugal blood processing vessel;

collecting at least a portion of at least one of said blood components from said centrifugal blood processing vessel in a blood component collection reservoir separate from said centrifugal blood processing vessel;

delivering a replacement fluid including flowing replacement fluid at a rate equal to the total flow rate of collected blood components minus the flow rate of anticoagulant multiplied by the desired fluid balance percentage in the donor/patient; and

returning at least a portion of the uncollected separated blood components from said blood processing vessel to said donor/patient.

20. A method according to claim 19 in which a replacement fluid is flowed from a source first to an intermediate reservoir prior to ultimate delivery to the donor/patient.

21. A method for extra-corporeal collection of a blood component from a donor/patient, comprising:

using a plurality of donor/patient characteristics to determine blood components capable of being collected from said donor/patient according to different procedures;

generating a list having a plurality of blood component collection procedures;

using the list in selecting a blood component collection procedure;

removing blood from a donor/patient;

flowing the blood into a centrifugal blood processing vessel;

separating the blood into separated blood components within said centrifugal blood processing vessel, said separated blood components including at least separated plasma and separated red blood cells;

collecting at least a portion of at least one of said blood components from said centrifugal blood processing vessel in a blood component collection reservoir separate from said centrifugal blood processing vessel;

recirculating a portion of the uncollected separated blood components into said blood processing vessel; and

returning substantially all of the uncollected separated blood components to said donor/patient.

22. A blood-processing machine according to claim 21 in which said extra-corporeal blood processing machine is adapted to use a plurality of tubing and bag set options.

23. A blood-processing machine according to claim 21 wherein said donor/patient characteristic includes the height and weight of the donor/patient.

24. A blood-processing machine according to claim 21 wherein said donor/patient characteristic includes the hematocrit of the donor/patient.

25. A blood-processing machine according to claim 21 wherein said donor/patient characteristic includes the platelet count of the donor/patient.

26. A blood-processing machine according to claim 21 wherein said list of blood component options includes at least one option selected from the group consisting essentially of platelets, red blood cells, and plasma.

27. A blood-processing machine according to claim 21 wherein said list of blood component options includes at least one option selected from the group consisting essentially of single platelets, double platelets, triple platelets, red blood cells, double red blood cells, and plasma.

28. A blood-processing machine according to claim 21 wherein said list of blood component options includes at least two options as a combination of collectible products selected from the group consisting essentially of single platelets, double platelets, triple platelets, red blood cells, double red blood cells, and plasma.