Systems and methods which obtain a uniform targeted volume of concentrated red blood cells in diverse donor populations

• US 6,251,284 B1
• Filed: 11/26/1997
• Issued: 06/26/2001
• Est. Priority Date: 08/09/1995
• Status: Expired due to Term

• Current Assignee: Fenwal Incorporated (Fresenius SE & Co. KGaA)
• Original Assignee: Baxter International Inc.
• Inventors: Goldhaber, Richard P, Likens, Matthew E, Duff, Daniel H, Deniega, Jose C, Bischof, Daniel F
• Primary Examiner(s): Kim, John
• Application Number:
  US08/979,160
• Time in Patent Office: 1,308 Days
• Field of Search: 210/85, 210/86, 210/90, 210/97, 210/109, 210/134, 210/143, 210/321.67, 210/321.68, 210/321.78, 210/739, 210/782, 210/787, 210/789, 604/4, 604/5, 604/6, 604/65, 604/67, 604/4.01, 604/5.01, 604/6.01, 604/6.02, 604/6.04, 604/6.05, 604/6.03, 494/37, 494/43, 494/45
• US Class Current: 210/739
• CPC Class Codes: A61M 1/265 inducing Taylor vortices
• 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 1/306 Pressure control, e.g. using substantially rigid closed or gas buffered or elastic reservoirs
• 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 1/309 with trans-membrane pressure [TMP] increasing substantially continuously during arterial phase
• CPC Class Codes: A61M 1/34 Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
• CPC Class Codes: A61M 1/3403 Regulation parameters
• CPC Class Codes: A61M 1/341 by measuring the filtrate rate or volume
• CPC Class Codes: A61M 1/3496 Plasmapheresis; Leucopheresis; Lymphopheresis A61M1/3472 takes precedence
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3393 by weighing the reservoir
• CPC Class Codes: A61M 2209/082 Mounting brackets, arm supports for equipment
• CPC Class Codes: B01D 17/0217 by centrifugal force
• CPC Class Codes: B01D 17/085 with membranes
• CPC Class Codes: B01D 21/0012 Settling tanks making use of filters, e.g. by floating layers of particulate material
• CPC Class Codes: B01D 21/2405 Feed mechanisms for settling tanks
• CPC Class Codes: B01D 21/26 Separation of sediment aided by centrifugal force or centripetal forcecentrifuges B04B; cyclones B04C
• CPC Class Codes: B01D 2221/10 Separation devices for use in medical, pharmaceutical or laboratory applications, e.g. separating amalgam from dental treatment residues apparatus for dental treatment A61C17/065

Abstract

Blood separation systems and methods draw whole blood from a blood donor selected from a population of blood donors. The whole blood of the selected blood donor has a known hematocrit value that varies within the population of blood donors according to morphology of the selected blood donor. The systems and methods operate a pump in the inlet line to convey a volume of whole blood from the donor at a commanded flow rate for processing into plasma constituent and concentrated red blood cells. The systems and methods set the commanded flow rate to vary the volume of whole blood conveyed over time as a function of the known hematocrit value of the selected donor. The systems and methods obtain, after processing the whole blood volume, a targeted volume of concentrated red blood cells, which is substantially constant for the population of blood donors despite variances in known hematocrit values among the donors.

Claims

1. A blood separation system comprising

an inlet line to draw whole blood from a blood donor selected from a population of blood donors, the whole blood of the selected blood donor having a known hematocrit value that varies within the population of blood donors according to morphology of the selected blood donor, the inlet line including a collection container to collect a volume of the whole blood for processing, after severing the inlet line, in an off-line centrifuge into a plasma constituent and a volume of concentrated red blood cells,

a first input for receiving the known hematocrit value of the selected blood donor,

a second input for receiving a targeted collection time value,

a third input for receiving a targeted volume value for the concentrated red blood cells,

an inlet pump in the inlet line to convey a volume of whole blood from the donor at a commanded flow rate into the collection container, and

control means coupled to the input for setting the commanded flow rate to vary the volume of whole blood conveyed over time as a function of the known hematocrit value of the selected donor, the targeted collection time value, and the targeted volume value for the concentrated red blood cells to obtain, after off-line centrifugal processing, a targeted volume of concentrated red blood cells for any donor in the population of blood donors, despite variances in known hematocrit values among the donors.

2. A system according to claim 1 further including at least one transfer container coupled to the blood collection container to receive the plasma constituent after centrifugal processing.

3. A system according to claim 1 wherein the inlet line includes a device to separate leukocytes from the volume of whole blood.

4. A system according to claim 1 wherein the inlet line includes a source of anticoagulant for mixing with the volume of whole blood.

5. A system according to claim 4 and further including a pump for mixing anticoagulant with the whole blood at a set anticoagulant-to-whole blood ratio.

6. A blood separation method comprising the steps of

drawing whole blood from a blood donor through an inlet line into a blood collection container, the blood donor being selected from a population of blood donors, the whole blood of the selected blood donor having a known hematocrit value that varies within the population of blood donors according to morphology of the selected blood donor,

recording the known hematocrit value of the selected blood donor,

recording a targeted collection time,

recording a targeted volume of concentrated red blood cells,

operating a pump in the inlet line to convey a volume of whole blood from the donor into the blood collection container at a commanded flow rate

setting the commanded flow rate to vary the volume of whole blood conveyed into the blood collection container over time as a function of the known hematocrit value of the selected donor, the targeted collection time, and the targeted volume of concentrated red blood cells,

severing the inlet line to terminate collection of whole blood in the blood collection container, and

centrifugally separating the volume of whole blood in the collection container to obtain a plasma constituent and the targeted volume of concentrated red blood cells for any donor in the population of blood donors, despite variances in known hematocrit values among the donors.

7. A method according to claim 6

wherein the pump operating step conveys the volume of whole blood through a device to separate leukocytes from the volume of whole blood.

8. A method according to claim 6

wherein the blood drawing step includes mixing anticoagulant with the volume of whole blood.

9. A method according to claim 6 further including the step of conveying the plasma constituent from the blood collection container into a transfer container.