Systems and methods for on line collection of cellular blood components that assure donor comfort

• US 6,007,725 A
• Filed: 11/21/1997
• Issued: 12/28/1999
• Est. Priority Date: 12/23/1991
• Status: Expired due to Term

• Current Assignee: Fenwal Incorporated (Fresenius SE & Co. KGaA)
• Original Assignee: Baxter International Inc.
• Inventors: Brown, Richard I.
• Primary Examiner(s): Kim, John
• Application Number:
  US08/975,694
• Time in Patent Office: 767 Days
• Field of Search: 210/85, 210/97, 210/134, 210/143, 210/195.1, 210/252, 210/254, 210/257.1, 210/259, 210/645, 210/739, 210/767, 210/782, 210/805, 210/806, 494/37, 604/4, 604/5, 604/6, 604/65, 604/67
• US Class Current: 210/739
• 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• CPC Class Codes: A61M 1/302 having a reservoir for withdrawn untreated blood
• 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 1/3693 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
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: B01D 21/2405 Feed mechanisms for settling tanks
• CPC Class Codes: B01D 21/245 Discharge mechanisms for the sediments
• CPC Class Codes: B01D 21/26 Separation of sediment aided by centrifugal force or centripetal forcecentrifuges B04B; cyclones B04C
• CPC Class Codes: B04B 13/00 Control arrangements specially designed for centrifuges; Programme control of centrifuges control arrangements for feed, charge, or discharge B04B11/00
• CPC Class Codes: B04B 2005/045 having annular separation channels
• CPC Class Codes: B04B 5/0442 with means for adding or withdrawing liquid substances during the centrifugation, e.g. continuous centrifugation

Abstract

Systems and methods convey anticoagulated blood suspension from a donor into a separation device for component separation. One or more components are retained for therapeutic use, while one or more are returned to the donor. The systems and methods monitor the rate at which anticoagulant carried in the returned components is being returned. The rate, expressed in terms of milligram (mg) of anticoagulant per kilogram (kg) of donor body weight per unit of time of blood processing, is compared to a nominal rate that is correlated with donor comfort.

Claims

1. A blood processing system comprising

a separation device,

an inlet path to convey whole blood from an individual donor into the separation device for separation into red blood cells and a plasma constituent,

an anticoagulant including a citrate concentration added to the whole blood,

a return path communicating with the separation device to convey plasma constituent to the individual donor at a plasma return rate, the plasma constituent carrying a citrate concentration due to the anticoagulant added to the whole blood, and

a controller coupled to the return path including a first processing element to derive an infusion rate at which citrate concentration in the plasma constituent is conveyed to the individual donor in the return path, expressed in terms of units of citrate per units of body weight of the individual donor per units of processing time, a second processing element to compare the derived infusion rate to a physiological infusion rate, which is also expressed in terms of units of citrate per units of body weight of the individual donor Per units of processing time, which is empirically selected based upon citrate reactions in a population of donors, and which remains constant among a population of different individual donors, and to generate an output based upon the comparison, and a third processing element that governs the plasma return rate in response to the output.

2. A system according to claim 1

wherein the third processing element decreases the plasma return rate when the output indicates that the derived infusion rate exceeds the physiological infusion rate.

3. A system according to claim 1

wherein the separation device centrifugally separates whole blood into red blood cells and plasma constituent.

4. A system according to claim 1

and further including a second separation device to remove leukocytes from the plasma constituent.

5. A system according to claim 4

wherein the second separation device comprises a filter.

6. A system according to claim 5

wherein the first defined separation device centrifugally separates whole blood into red blood cells and plasma constituent.

13. A system according to claim 1

wherein the physiological infusion rate is about 1.2 mg/kg/min.

7. A blood processing method comprising the steps of

conveying whole blood from an individual donor,

adding an anticoagulant including a citrate concentration to the whole blood,

separating the whole blood into red blood cells and a plasma constituent, the plasma constituent carrying a citrate concentration due to the anticoagulant added to the whole blood,

conveying plasma constituent to the individual donor at a plasma return rate,

deriving an infusion rate at which citrate concentration in the plasma constituent is conveyed to the individual donor expressed in terms of units of citrate per units of body weight of the individual donor per units of processing time,

comparing the derived infusion rate to a physiological infusion rate, which is also expressed in terms of units of citrate per units of body weight of the individual donor per units of processing time, which is empirically selected based upon citrate reactions in a population of donors, and which remains constant among a population of different individual donors,

generating an output based upon the comparing step, and

governing the plasma return rate in response to the output.

8. A method according to claim 7

wherein the governing step decreases the plasma return rate when the output indicates that the derived infusion rate exceeds the physiological infusion rate.

9. A method according to claim 7

wherein the separating step centrifugally separates whole blood into red blood cells and plasma constituent.

10. A method according to claim 7

and further including a second separating step to remove leukocytes from the plasma constituent.

11. A method according to claim 10

wherein the second separating step comprises filtration.

12. A method according to claim 11

wherein the first defined separating step centrifugally separates whole blood into red blood cells and plasma constituent.

14. A method according to claim 7

wherein the physiological infusion rate is about 1.2 mg/kg/min.