Extracorporeal blood processing methods and apparatus

• US 6,730,055 B2
• Filed: 03/09/2001
• Issued: 05/04/2004
• Est. Priority Date: 03/09/2000
• Status: Expired due to Term

• Current Assignee: Terumo BCT, Inc. (Terumo Corporation)
• Original Assignee: Gambro, Inc. (DaVita Incorporated)
• Inventors: Bainbridge, Marlene, Butzke, Scott D., Keller, Muriel, Gordon, Timothy M., McAteer, Michael J.
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): DEAK, LESLIE R
• Application Number:
  US09/803,304
• Publication Number:
  US 20020033370A1
• Time in Patent Office: 1,152 Days
• Field of Search: 210/752, 210/787, 490/437, 604/4.01, 604/5.01, 604/6.01, 604/6.04, 604/6.11, 604/6.05
• US Class Current: 604/6.04
• 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 extracorporeal 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 extracorporeal separation and collection of blood components from a donor/patient, comprising:

flowing blood into a centrifugal dual stage blood processing vessel, said processing vessel including a first stage and a second stage, the second stage being separated from said first stage by a dam, a blood inlet for communicating blood into the first stage, a plasma outlet disposed in the second stage and a red blood cell outlet disposed in the first stage;

centrifugally separating the blood into separated blood components including;

separating plasma from said blood within said centrifugal dual stage blood processing vessel to establish separated plasma, whereby a portion of the separated plasma flows over the dam in the processing vessel to the plasma outlet in the second stage of the processing vessel;

separating red blood cells from said blood within said centrifugal dual stage blood processing vessel to establish separated red blood cells whereby the separated red blood cells remain in the first stage of the processing vessel and flow to the red blood cell outlet;

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

collecting at least a portion of at least one separated blood component including;

collecting as a double red blood cell product at least a portion of said separated red blood cells in a red blood cell collection reservoir separate from said blood processing vessel to establish collected red blood cells.

2. A method according to claim 1 in which said collecting step further includes a step for collecting at least a portion of the separated plasma in a plasma collection reservoir separate from said blood processing vessel to establish collected plasma;

and wherein said plasma collection step is performed at least partially contemporaneously with said red blood cell collection step.

3. A method as recited in claim 2, wherein said plasma collection step is performed prior to said red blood cell collection step.

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

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

10. A method according to claim 1 which further comprises the step of delivering a replacement fluid to the donor/patient.

11. A method according to claim 10 in which said step of delivering a replacement fluid includes flowing replacement fluid at a rate equal to the total flow rate of collected blood components multiplied by the desired fluid balance percentage resulting within the donor/patient.

12. A method according to claim 10 which further includes a step of adding anticoagulant to the blood flowing into the centrifugal dual stage blood processing vessel;

and in which said step of delivering a replacement fluid includes 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 resulting in the donor/patient.

13. A method according to claim 10 in which a replacement fluid is flowed from a source first to an intermediate reservoir prior to ultimate delivery to the donor/patient.

14. A method according to claim 10 in which a replacement fluid is delivered to the donor/patient in a substantially continuous fashion.

15. A method according to claim 10 in which a replacement fluid is delivered to the donor/patient in a bolus.

18. A method as recited in claim 1, further comprising:

removing said blood from a donor/patient through a single needle;

returning uncollected separated blood components of said blood to said donor/patient through said single needle.

19. A method as recited in claim 18, wherein said removing and returning steps are alternately and repeatedly performed.

25. A method as recited in claim 1, further comprising:

adding a storage solution to said separated red blood cells collected in said red blood cell collection reservoir.

27. A method as recited in claim 1, further comprising:

leukoreduction filtering of said separated red blood cells collected in said red blood cell collection reservoir.

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

29. A method according to claim 28 wherein said packing factor is at least about 13.

6. A method for extracorporeal separation and collection of blood components from a donor/patient, comprising:

flowing blood into a centrifugal dual stage blood processing vessel, said processing vessel including a first stage and a second stage, the second stage being separated from said first stage by a dam, a blood inlet for communicating blood into the first stage, a plasma outlet disposed in the second stage and a red blood cell outlet disposed in the first stage;

centrifugally separating the blood into separated blood components including;

separating plasma from said blood within said centrifugal dual stage blood processing vessel to establish separated plasma, whereby a portion of the separated plasma flows over the dam in the processing vessel to the plasma outlet in the second stage of the processing vessel;

separating red blood cells from said blood within said centrifugal dual stage blood processing vessel to establish separated red blood cells whereby the separated red blood cells remain in the first stage of the processing vessel and flow to the red blood cell outlet;

establishing a packing factor of at least about 13 for the separated red blood cells within said blood processing vessel;

collecting at least a portion of at least one separated blood component including;

collecting as a double red blood cell product at least a portion of said separated red blood cells in a red blood cell collection reservoir separate from said blood processing vessel to establish collected red blood cells

collecting at least a portion of the separated plasma in a plasma collection reservoir separate from said blood processing vessel to establish collected plasma; and

wherein said plasma collection step is performed at least partially contemporaneously with said red blood cell collection step.

7. A method according to claim 6 in which the packing factor is about 16.

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

9. A method according to claim 6 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.

16. A method for extracorporeal separation and collection of blood components from a donor/patient, comprising:

flowing blood into a centrifugal dual stage blood processing vessel, said processing vessel including a first stage and a second stage, the second stage being separated from said first stage by a dam, a blood inlet for communicating blood into the first stage, a plasma outlet disposed in the second stage and a red blood cell outlet disposed in the first stage;

centrifugally separating the blood into separated blood components including;

separating plasma from said blood within said centrifugal dual stage blood processing vessel to establish separated plasma, whereby a portion of the separated plasma flows over the dam in the processing vessel to the plasma outlet in the second stage of the processing vessel;

separating red blood cells from said blood within said centrifugal dual stage blood processing vessel to establish separated red blood cells whereby the separated red blood cells remain in the first stage of the processing vessel and flow to the red blood cell outlet;

collecting at least a portion of at least one separated blood component including;

collecting as a double red blood cell product at least a portion of said separated red blood cells in a red blood cell collection reservoir separate from said blood processing vessel to establish collected red blood cells in which said double volume of collected red blood cells totals substantially about 400 milliliters contained in two substantially separate reservoirs.

17. A method for extracorporeal separation and collection of blood components from a donor/patient, comprising:

flowing blood into a centrifugal dual stage blood processing vessel, said processing vessel including a first stage and a second stage, the second stage being separated from said first stage by a dam, a blood inlet for communicating blood into the first stage, a plasma outlet disposed in the second stage and a red blood cell outlet disposed in the first stage;

centrifugally separating the blood into separated blood components including;

separating plasma from said blood within said centrifugal dual stage blood processing vessel to establish separated plasma, whereby a portion of the separated plasma flows over the dam in the processing vessel to the plasma outlet in the second stage of the processing vessel;

separating red blood cells from said blood within said centrifugal dual stage blood processing vessel to establish separated red blood cells whereby the separated red blood cells remain in the first stage of the processing vessel and flow to the red blood cell outlet;

flowing the separated blood components out of said blood processing vessel, wherein substantially all of said separated blood components flowing out of the blood processing vessel are accumulated for re-infusion to a donor/patient during the set-up step;

collecting at least a portion of at least one separated blood component including;

collecting as a double red blood cell product at least a portion of said separated red blood cells in a red blood cell collection reservoir separate from said blood processing vessel to establish collected red blood cells.

21. A method as recited in claim 17, wherein said blood is flowed into said blood processing vessel at an inlet flow rate, and said set-up step comprises:

reducing said inlet flow rate.

22. A method as recited in claim 17, wherein said blood processing vessel is rotated at an rpm rate, and wherein said set-up step comprises:

increasing said rpm rate.

23. A method as recited in claim 17, said set-up step including:

maintaining a predetermined anticoagulant infusion rate to said donor/patient.

24. A method as recited in claim 17, said set-up step including:

removing the separated red blood cells and a portion of the separated plasma together through the RBC outlet from said blood processing vessel to establish the interface between the separated RBC, and the separated plasma at the RBC outlet in the first stage of the blood processing vessel.

20. A method for extracorporeal separation and collection of blood components from a donor/patient, comprising:

removing blood from a donor/patient through a single needle;

flowing said blood into a centrifugal dual stage blood processing vessel, said processing vessel including a first stage and a second stage, the second stage being separated from said first stage by a dam, a blood inlet for communicating blood into the first stage, a plasma outlet disposed in the second stage and a red blood cell outlet disposed in the first stage;

centrifugally separating the blood into separated blood components including;

separating plasma from said blood within said centrifugal dual stage blood processing vessel to establish separated plasma, whereby a portion of the separated plasma flows over the dam in the processing vessel to the plasma outlet in the second stage of the processing vessel;

separating red blood cells from said blood within said centrifugal dual stage blood processing vessel to establish separated red blood cells whereby the separated red blood cells remain in the first stage of the processing vessel and flow to the red blood cell outlet;

collecting at least a portion of at least one separated blood component including;

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

collecting as a double red blood cell product at least a portion of said separated red blood cells in a red blood cell collection reservoir separate from said blood processing vessel to establish collected red blood cells;

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

collecting at least a portion of the separated plasma in a plasma collection reservoir separate from said blood processing vessel to establish collected plasma; and

wherein said plasma collection step is performed at least partially contemporaneously with said red blood cell collection step.

26. A method for extracorporeal separation and collection of blood components from a donor/patient, comprising:

flowing blood into a centrifugal dual stage blood processing vessel, said processing vessel including a first stage and a second stage, the second stage being separated from said first stage by a dam, a blood inlet for communicating blood into the first stage, a plasma outlet disposed in the second stage and a red blood cell outlet disposed in the first stage;

centrifugally separating the blood into separated blood components including;

separating plasma from said blood within said centrifugal dual stage blood processing vessel to establish separated plasma, whereby a portion of the separated plasma flows over the dam in the processing vessel to the plasma outlet in the second stage of the processing vessel;

separating red blood cells from said blood within said centrifugal dual stage blood processing vessel to establish separated red blood cells whereby the separated red blood cells remain in the first stage of the processing vessel and flow to the red blood cell outlet;

collecting at least a portion of at least one separated blood component including;

collecting as a double red blood cell product at least a portion of said separated red blood cells in a red blood cell collection reservoir separate from said blood processing vessel to establish collected red blood cells;

adding a storage solution to said separated red blood cells collected in said red blood cell collection reservoir, said storage solution being added through an assembly having a sterile barrier filter.