Extra-corporeal dual stage blood processing method and apparatus

• US 6,945,948 B2
• Filed: 04/20/2004
• Issued: 09/20/2005
• 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: Gordon, Timothy M., Bainbridge, Marlene, Butzke, Scott D., Keller, Muriel, McAteer, Michael J.
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): Deak, Leslie R.
• Application Number:
  US10/709,194
• Publication Number:
  US 20040249332A1
• Time in Patent Office: 518 Days
• Field of Search: 604/5.01, 604 601- 605, 604 607- 611, 604 615- 616, 210/752, 210781- 2, 210/645, 210/787, 210739- 41, 490/437, 494/36, 494/37
• 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 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 extracorporeal collection of blood components from a donor/patient comprising:

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

flowing said blood into a dual stage blood processing vessel;

separating plasma from said blood within said blood processing vessel;

collecting at least a portion of said plasma in a plasma collection reservoir separate from said blood processing vessel;

separating red blood cells from said blood within said dual stage blood processing vessel;

collecting at least a portion of Mid separated red blood cells in a red blood cell collection reservoir separate from said blood processing vessel, wherein said plasma separation and collection steps are completed at least partially contemporaneously with said red blood cell separation and collection steps;

returning uncollected blood components of said blood to said donor/patient through said single needle; and

replacing fluid volume in said donor/patient by flowing a replacement fluid to said donor/patient through said single needle.

2. A method as recited in claim 1, whereby the red blood cell collecting step provides for obtaining a double volume of collected red blood cells.

3. A method as recited in claim 2 in which said double volume of collected red blood cells totals substantially about 400 milliliters contained in two substantially separate reservoirs.

4. A method as recited in claim 1, wherein said plasma collection step is completed at least partially separately from said red blood cell collection step.

5. A method as recited in claim 1, wherein prior to said red blood cell collection step, and separate from said plasma collection step, said method further comprises a red blood cell collection set-up phase including:

establishing a hematocrit of at least about 80 within said separated red blood cells within said blood processing vessel and an AC ratio within said blood at about 8.

6. A method as recited in claim 5, further comprising maintaining said hematocrit and AC ratio during said red blood cell separation and collection steps.

7. A method as recited in claim 1 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.

8. A method as recited in claim 7 in which said step of delivering a replacement fluid includes pumping replacement fluid at a rate equal to the total flow rate of collected fluids minus the inlet flow rate of anticoagulant multiplied by the desired fluid balance percentage resulting within the donor/patient.

9. A method as recited in claim 7 in which a replacement fluid is pumped from a source first to an intermediate reservoir prior to ultimate delivery to the donor/patient.

10. A method as recited in claim 7 in which a replacement fluid is delivered to the donor/patient in a bolus.

11. A method as recited in claim 7 in which a replacement fluid is delivered to the donor/patient in a substantially continuous fashion.

12. A method as recited in claim 1 further comprising:

retaining the separated red blood cells in a first stage of the processing vessel;

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

and flowing the red blood cells to red blood cell outlet.

13. A method as recited in claim 12 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.

14. A method as recited in claim 13, wherein said plasma collection step is performed prior to said red blood cell collection step.

15. A method as recited in claim 13, wherein said plasma collection step is performed at least partially alter said red blood cell collection step.

16. A method as recited in claim 13, wherein said red blood cell collection step is performed at least partially after said plasma collection step.

17. A method as recited in claim 11 further comprising

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

18. A method as recited in claim 17 wherein said packing factor is between 11 and 21.

19. A method as recited in claim 18 wherein said packing factor is at least about 13.

20. A method as recited in claim 19 in which the packing factor is about 16.

21. A method as recited in claim 17 which further includes establishing an AC ratio in tho blood processing vessel of between about 6 and about 16.

22. A method as recited in claim 17 in which the packing factor is about 16 during the contemporaneous collection of separated plasma and separated red blood cell 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.

23. A method as recited in claim 1, further comprising a set up step prior to said collecting steps;

said set up step comprising;

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.

24. A method as recited in claim 23, 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.

25. A method as recited in claim 23, wherein said blood processing vessel is rotated at an rpm rate, and wherein said set-up step comprises:

increasing said rpm rate.

26. A method as recited in claim 1, wherein said processing vessel includes 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;

and

wherein during said plasma collection step, said method further comprises;

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; and

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

27. A device for extracorporeal separation and collection of blood components front a donor/patient, comprising:

a centrifugal blood processing channel into which blood from a donor/patient is adapted to be flowed, and in which said blood is separated into at least separated plasma and separated red blood cells;

said centrifugal dual stage blood processing channel including a first stage and a second stage, the second stare 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;

said centrifugal blood processing channel being adapted to be used with;

a removable plasma collection reservoir operably connected to said centrifugal blood processing channel, whereby into which at least a portion of said separated plasma is collected;

a removable red blood cell collection reservoir operably connected to said blood processing channel whereby a portion of said separated red blood cells are collected in said red blood cell collection reservoir, and

a replacement fluid assembly which is operably connectable to the donor/patient;

wherein said replacement fluid assembly is adapted to deliver replacement fluid to the donor/patient.

28. A disposable blood tubing set adapted to be used with a device for extracorporeal separation and collection of blood components from a donor/patient, said disposable blood tubing set comprising:

a disposable centrifugal dual stage blood processing vessel into which blood from a donor/patient is adapted to be flowed, and in which said blood is separated into at least separated plasma and separated red blood cells;

said centrifugal dual stage blood processing vessel including a firs;

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;

a plasma collection reservoir operably connected to said centrifugal blood processing vessel, whereby into which said plasma collection reservoir at least a portion of said separated plasma is collected;

a red blood cell collection reservoir operably connected to said blood processing vessel whereby a portion of said separated red blood cells are collected in said red blood cell collection reservoir; and

a disposable fluid flow cassette assembly operably interconnected to said centrifugal blood processing vessel, said cassette assembly having an intermediate reservoir disposed therein, said intermediate reservoir being adapted to receive separated uncollected blood components from said centrifugal blood processing vessel; and

a replacement fluid assembly which is operably connected to said fluid flow cassette and said intermediate reservoir;

wherein said replacement fluid assembly is adapted to deliver replacement fluid to said intermediate reservoir for subsequent infusion of the replacement fluid into a donor/patient.