Systems for separating high hematocrit red blood cell concentrations

• US 5,762,791 A
• Filed: 08/09/1995
• Issued: 06/09/1998
• Est. Priority Date: 08/09/1995
• Status: Expired due to Fees

• Current Assignee: Baxter International Inc.
• Original Assignee: Baxter International Inc.
• Inventors: Duff, Daniel H., Deniega, Jose C.
• Primary Examiner(s): Kim, John
• Application Number:
  US08/512,807
• Time in Patent Office: 1,035 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, 210/321.87, 604/4, 604/5, 604/6, 604/65, 604/67
• US Class Current: 210/321.67
• 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 2205/3393 by weighing the reservoir
• CPC Class Codes: A61M 2209/082 Mounting brackets, arm supports for equipment

Abstract

Blood separation systems and methods utilize a membrane separation device comprising a gap between a microporous membrane and a surface facing the microporous membrane, one of the microporous membrane and the surface being rotatable relative to the other to cause separation of whole blood in the gap into plasma and concentrated red blood cells. The systems and methods include an inlet pump element coupled to the membrane separation device to convey whole blood having a known beginning hematocrit value into the gap for separation. The systems and methods also include a drive element coupled to the membrane separation device to cause rotation of the rotatable one of the microporous membrane and the facing surface. The systems and methods command the inlet pump element and the drive element as a function of the known beginning hematocrit value. This command technique obtains concentrated red blood cells having a high end hematocrit value that remains substantially constant despite variances in the known beginning hematocrit value, and, in particular, when the known beginning hematocrit value is low.

Claims

1. A blood separation system comprising

a membrane separation device comprising a gap between a microporous membrane and a surface facing the microporous membrane, one of the microporous membrane and the surface being rotatable relative to the other to cause separation of whole blood in the gap into plasma and concentrated red blood cells,

an inlet pump element coupled to the membrane separation device to convey into the gap for separating whole blood from a blood donor selected from a population of blood donors, the whole blood of the selected blood donor having a known beginning hematocrit value that varies within the population of blood donors according to morphology of the selected blood donor,

a drive element coupled to the membrane separation device to cause rotation of the rotatable one of the microporous membrane and the facing surface, and

control means including an input for receiving the known beginning hematocrit value of the selected blood donor, the control means being operative for commanding the inlet pump element and the drive element as a function of the known beginning hematocrit value to obtain concentrated red blood cells having an end hematocrit value that remains substantially constant for the population of blood donors despite variances in the known beginning hematocrit value according to morphology of the selected blood donor.

2. A system according to claim 1

and further including a container having a characteristic beneficial for storing concentrated red blood cells for at least twenty-four hours to receive concentrated red blood cells from the membrane separation device.

3. A system according to claim 1

wherein the control means includes means for commanding the drive element to vary relative rotation between the membrane and the surface as a function of the known beginning hematocrit value.

4. A system according to claim 1 or 3

wherein the control means includes means for commanding the inlet pump element to vary conveyance of whole blood as a function of the known beginning hematocrit value.

5. A system according to claim 2 and further including

an outlet pump element coupled to the membrane separation device and the container to convey concentrated red blood cells from the membrane separation device into the container,

a weight sensor for sensing changes in weight of the container as the outlet pump element conveys concentrated red blood cells into the container, and

wherein the control means includes

a first element that commands the outlet pump element to convey concentrated red blood cells from the membrane separation device into the container at a command flow rate,

a second element that monitors changes in weight sensed by the weight sensor over time and derives therefrom an actual rate at which concentrated red blood cells are being conveyed into the container, and

a third element that compares the actual rate to the command flow rate and generates an output based upon the comparison.

6. A blood separation system comprising

a membrane separation device comprising a gap between a microporous membrane and a surface facing the microporous membrane, one of the microporous membrane and the surface being rotatable relative to the other to cause separation of whole blood in the gap into plasma and concentrated red blood cells,

an inlet pump element coupled to the membrane separation device to convey whole blood having a known beginning hematocrit value into the gap for separation,

a drive element coupled to the membrane separation device to cause rotation of the rotatable one of the microporous membrane and the facing surface, and

a control means coupled to the inlet pump element and the drive element including

an input for receiving the known beginning hematocrit value,

a processing element to generate an inlet pump command signal as a first function of the known beginning hematocrit value and a rotation command signal as a second function of the known beginning hematocrit value, and

an output transmitting the inlet pump command signal to the inlet pump element and the rotation command signal to the drive element.

7. A system according to claim 6 and further including a red blood cell container having a characteristic beneficial to storage of red blood cells for at least twenty-four hours, the red blood cell container communicating with the membrane separation device to receive concentrated red blood cells conveyed from the separation device.

8. A system according to claim 7

wherein the concentrated red blood cells received in the red blood cell container contain a population of leukocytes, and

further including an element to reduce the leukocyte population in the concentrated red blood cells received in the red blood cell container.

9. A system according to claim 6 or 7 or 8 or 9 or 10 and further including a plasma container having a characteristic beneficial to storage of plasma communicating with the membrane separation device to receive plasma from the membrane separation device.

10. A system according to claim 7 and further including

an outlet pump element coupled to the membrane separation device and the red blood cell container to convey concentrated red blood cells from the membrane separation device into the red blood cell container,

a weight sensor for sensing changes in weight of the red blood cell container as the outlet pump element conveys concentrated red blood cells into the red blood cell container, and

wherein the control means includes

a first element that commands the outlet pump element to convey concentrated red blood cells from the membrane separation device into the red blood cell container at a command flow rate,

a second element that monitors changes in weight sensed by the weight sensor over time and derives therefrom an actual rate at which concentrated red blood cells are being conveyed into the red blood cell container, and

a third element that compares the actual rate to the command flow rate and generates an output based upon the comparison.

11. A system according to claims 5 or 10

wherein the control means further includes a fourth element that generates a rate adjustment command to the outlet pump element based upon the output.

12. A system according to claim 11

wherein the fourth element generates the rate adjustment command until the actual rate corresponds to the command flow rate.

13. A blood separation system comprising

a membrane separation device comprising a gap between a microporous membrane and a surface facing the microporous membrane, one of the microporous membrane and the surface being rotatable relative to the other to cause separation of whole blood in the gap into plasma and concentrated red blood cells,

an inlet pump element coupled to the membrane separation device to convey whole blood having a known beginning hematocrit value into the gap for separation subject to a transmembrane pressure,

a sensor for sensing the transmembrane pressure,

a drive element coupled to the membrane separation device to cause rotation of the rotatable one of the microporous membrane and the facing surface,

an outlet pump element coupled to the membrane separation device to convey concentrated red blood cells from the membrane separation device, and

a control element coupled to the inlet pump element, the drive element, the outlet pump element, and the sensor including

an input for receiving the known beginning hematocrit value,

a processing element to generate an inlet pump command signal as a first function of the known beginning hematocrit value received by the input, a rotation command signal as a second function of the known beginning hematocrit value received by the input, and an outlet pump command signal as a third function of transmembrane pressure sensed by the sensor,

an output transmitting the inlet pump command signal to the inlet pump element, the rotation command signal to the drive element, and the outlet pump command signal to the outlet pump element, and

a red blood cell container having a characteristic beneficial to storage of red blood cells for at least twenty-four hours, the red blood cell container communicating with the outlet pump element to receive concentrated red blood cells conveyed from the separation device, the concentrated red blood cells having as a result of the first, second, and third functions an end hematocrit value that remains substantially constant despite variances in the known beginning hematocrit value received by the input.

14. A system according to claim 13

wherein the concentrated red blood cells conveyed from the separation device contain a population leukocytes, and

further including an element to reduce the leukocyte population in the concentrated red blood cells received in the red blood cell container.

15. A system according to claim 13 and further including

a weight sensor for sensing changes in weight of the red blood cell container as the outlet pump element conveys concentrated red blood cells into the red blood cell container in response to the outlet pump command signal, and

wherein the control element includes

an element that monitors changes in weight sensed by the weight sensor over time and derives therefrom an actual rate at which concentrated red blood cells are being conveyed into the red blood cell container, and

an element that compares the actual rate to the outlet pump command signal and generates an output adjusting the outlet pump command signal based upon the comparison.

16. A blood separation system comprising

a membrane separation device comprising a gap between a microporous membrane and a surface facing the microporous membrane, one of the microporous membrane and the surface being rotatable relative to the other to cause separation of whole blood in the gap into plasma and concentrated red blood cells,

a first pump operable at a variable command pumping rate, RATE₁, to convey anticoagulated whole blood into the gap, the anticoagulated whole blood having a hematocrit HCT_WB when entering the gap,

a driver coupled to the membrane separation device to rotate the rotatable one of the membrane and surface at a variable command rate of rotation, ROTOR, to separate whole blood in the gap into plasma, which is passes from the gap through the membrane subject to a transmembrane pressure, and red blood cells, which remain in the gap,

a sensor for sensing the transmembrane pressure, TMP_SENSED,

a second pump operable at a variable command pumping rate, RATE₂, to convey red blood cells from the gap at a hematocrit HCT_RBC,

a controller coupled to the first pump, the second pump, the driver, and the sensor including

an element for inputting HCT_WB, and

a processing element to operate the first pump, the second pump, and the driver to maintain HCT_RBC at a desired value comprising

an element that derives ROTOR according to a first function of HCT_WB that increases ROTOR as HCT_WB decreases,

an element that derives RATE₁ according to a second function of HCT_WB that increases RATE₁ as HCT_WB increases,

an element that derives a control value for transmembrane pressure, TMP_set, according to a third function of HCT_WB ;

ROTOR; and

RATE₁, and

an element that commands the driver to rotate the membrane at ROTOR while commanding the first pump to operate at RATE₁ while commanding the second pump to operate at RATE₂ to maintain TMP_SENSED ≈

TMP_set.

17. A system according to claim 16

and further including a sensor for sensing whole blood pressure P_WB upstream of the first pump, and

wherein the element that commands the first pump includes means for varying RATE₁ to maintain P_WB below a set value.

20. A system according to claim 16 or 18

wherein the first function is expressed as follows:

##EQU5## where;

AHCT_MAX is a set maximum anticoagulated hematocrit of whole blood that will be processed, derives as follows;

space="preserve" listing-type="equation">AHCT.sub.MAX =HCT.sub.MAX (1-AC)

where;

HCT_MAX is a set maximum donor whole blood hematocrit that will be processed; and

AC is a selected anticoagulant ratio;

AHCT_MIN is a set minimum anticoagulated hematocrit of whole blood that will be processed, derived as follows;

space="preserve" listing-type="equation">AHCT.sub.MAX =HCT.sub.MIN (1-AC)

where;

HCT_MIN is a set minimum donor whole blood hematocrit that will be processed;

AHCT_WB is anticoagulated hematocrit of the donor'"'"'s whole blood entering the gap, derived as follows;

space="preserve" listing-type="equation">AHCT.sub.WB =HCT.sub.WB (1-AC)

where;

HCT_WB is hematocrit of the donor'"'"'s whole blood entering the gap;

and

ROTOR_MAX and ROTOR_MIN are, respectively, set maximum and minimum values for ROTOR taking into account AHCT_MIN and AHCT_MIN.

21. A system according to claim 16 or 18

wherein the second function is expressed as follows:

##EQU6## where;

AHCT_MAX is a set maximum anticoagulated hematocrit of whole blood that will be processed, derives as follows;

space="preserve" listing-type="equation">AHCT.sub.MAX =HCT.sub.MAX (1-AC)

where;

HCT_MAX is a set maximum donor whole blood hematocrit that will be processed; and

AC is a selected anticoagulant ratio;

AHCT_MIN is a set minimum anticoagulated hematocrit of whole blood that will be processed, derived as follows;

space="preserve" listing-type="equation">AHCT.sub.MAX =HCT.sub.MIN (1-AC)

where;

HCT_MIN is a set minimum donor whole blood hematocrit that will be processed;

AHCT_WB is anticoagulated hematocrit of the donor'"'"'s whole blood entering the gap, derived as follows;

space="preserve" listing-type="equation">AHCT.sub.WB =HCT.sub.WB (1-AC)

where;

HCT_WB is hematocrit of the donor'"'"'s whole blood entering the gap;

and

RATE_MAX and RATE_MIN are, respectively, maximum and minimum values for RATE₁, taking into account AHCT_MAX and AHCT_MIN.

22. A blood separation system according to claim 16 or 18

and further including a filter for reducing leukocyte populations in red blood cells separated in the device.

23. A blood separation system according to claim 16 or 18

and further including a container for collecting red blood cells conveyed from the gap, the container having characteristics adapted for storing red blood cells for at least twenty-four hours after separation in the gap.

24. A blood separation system according to claim 23

and further including a filter for reducing leukocyte populations in red blood cells stored in the container.

25. A blood separation system according to claim 23 and further including

a weight sensor for sensing changes in weight of the container as the second pump conveys red blood cells into the container at RATE₂, and

wherein the controller includes

an element that monitors changes in weight sensed by the weight sensor over time and derives therefrom an actual rate at which red blood cells are being conveyed into the container, and

an element that compares the actual rate to RATE₂ and generates an output adjusting RATE₂ based upon the comparison.

18. A blood separation system comprising

a membrane separation device comprising a gap between a microporous membrane and a surface facing the microporous membrane, one of the microporous membrane and the surface being rotatable relative to the other to cause separation of whole blood in the gap into plasma and concentrated red blood cells,

a first pump operable at a variable command pumping rate, RATE₁, to convey anticoagulated whole blood into the gap, the anticoagulated whole blood having a hematocrit HCT_WB when entering the gap,

a driver coupled to the membrane separation device to rotate the rotatable one of the membrane and the surface at a variable command rate of rotation, ROTOR, to separate whole blood in the gap into plasma, which is passes from the gap through the membrane subject to a transmembrane pressure, and red blood cells, which remain in the gap,

a sensor for sensing the transmembrane pressure, TMP_SENSED,

a second pump operable at a variable command pumping rate, RATE₂, to convey red blood cells from the gap at a hematocrit HCT_RBC,

a controller coupled to the first pump, the second pump, the driver and the sensor including

an element for inputting HCT_WB, and

a processing element to operate the first pump, the second pump, and the driver to maintain HCT_RBC at a desired value according to processing steps comprising

deriving ROTOR according to a first function of HCT_WB that increases ROTOR as HCT_WB decreases,

deriving RATE₁ according to a second function of HCT_WB that increases RATE₁ as HCT_WB increases,

deriving a control value for transmembrane pressure, TMP_set, according to a third function of HCT_WB ;

ROTOR; and

RATE₁, and

commanding the driver to rotate the membrane at ROTOR while commanding the first pump to operate at RATE₁ while commanding the second pump to operate at RATE₂ to maintain TMP_SENSED ≈

TMP_set.

19. A system according to claim 18

and further including a sensor for sensing whole blood pressure P_WB upstream of the first pump, and

wherein the processing steps by which the processing element controls the first pump includes varying RATE₁ to maintain P_WB below a set value.