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

• US 5,690,835 A
• Filed: 09/24/1996
• Issued: 11/25/1997
• Est. Priority Date: 12/23/1991
• Status: Expired due to Fees

• Current Assignee: Baxter International Inc.
• Original Assignee: Baxter International Inc.
• Inventors: Brown, Richard I.
• Primary Examiner(s): Kim, John
• Application Number:
  US08/719,312
• Time in Patent Office: 427 Days
• Field of Search: 210/85, 210/97, 210/109, 210/134, 210/143, 210/145, 210/147, 210/195.1, 210/198.1, 210/205, 210/252, 210/254, 210/257.1, 210/259, 210/295, 210/323.1, 210/324 , 210/360.1, 210/739, 210/435, 210/446, 210/512.1, 210/767, 210/780, 210/782, 210/787, 210/789, 210/805, 210/806, 604/4, 604/5, 604/6, 604/65, 604/67, 604/408, 604/410, 494/7, 494/10, 494/37, 364/413.01, 364/413.02, 364/413.07
• US Class Current: 210/739
• CPC Class Codes: A61M 1/0218 with filters
• CPC Class Codes: A61M 1/025 Means for agitating or shaking blood containers A61M1/0245 takes precedence; shaking in general B01F31/00
• 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• CPC Class Codes: A61M 1/302 having a reservoir for withdrawn untreated blood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 1/3603 in the same direction
• CPC Class Codes: A61M 1/3624 Level detectors; Level control
• CPC Class Codes: A61M 1/3672 Means preventing coagulation
• 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 2202/0071 product to be retained or harvested, e.g. by pheresis
• CPC Class Codes: A61M 2202/0427 Platelets; Thrombocytes
• CPC Class Codes: A61M 2205/331 used as turbidity change detectors, e.g. for priming-blood or plasma-hemoglubine-interface detection
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2205/3351 Controlling upstream pump pressure
• CPC Class Codes: A61M 2205/3355 Controlling downstream pump pressure
• CPC Class Codes: A61M 2205/3393 by weighing the reservoir
• CPC Class Codes: B01D 17/0217 by centrifugal force
• 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: B01D 21/262 : by using a centrifuge
• CPC Class Codes: B01D 21/34 : Controlling the feed distribution; Controlling the liquid level ; Control of process parameters
• CPC Class Codes: B01D 2221/08 : Mobile separation devices
• CPC Class Codes: B01D 2221/10 : Separation devices for use in medical, pharmaceutical or laboratory applications, e.g. separating amalgam from dental treatment residues
• 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
• CPC Class Codes: B04B 7/08 : Rotary bowls centrifugal casting machines B22D

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 for obtaining during a processing period a cellular-rich concentrate from an anticoagulated cellular suspension conveyed from donor, while returning a cellular-poor component containing anticoagulant to the donor, without significant adverse anticoagulant-related donor reactions, comprising

a supply path including a supply pump to convey a cellular blood suspension including plasma from the donor,

a source of anticoagulant,

a branch path communicating with the supply path and the source of anticoagulant to add anticoagulant to the cellular blood suspension conveyed by the supply path in an added anticoagulant-to-cellular suspension volume ratio,

a separation device communicating with the supply path to receive the anticoagulant-containing cellular blood suspension and to separate the anticoagulant-containing cellular blood suspension into a cellular-rich concentrate having a first plasma and anticoagulant volume and a cellular-poor component having a second plasma and anticoagulant volume, the second plasma and anticoagulant volume being greater than the first plasma and anticoagulant volume,

a return path communicating with the separation device, including a return pump to convey the cellular-poor component from the separation device to the donor,

a collection container,

a collection path communicating with the return path and the collection container, including a retention pump to divert a portion of the cellular-poor component away from the donor for retention in the collection container while a remaining portion of cellular-poor component is conveyed to the donor in the return path, and

a processing controller including

an input for receiving operating parameters including a portion of cellular-poor component to be diverted by the retention pump during the processing period, a volume of cellular-rich component to be collected during the processing period, and the added anticoagulant-to-cellular suspension volume ratio,

an input for receiving physiological parameters of the donor including donor body weight, volume of cellular component present per unit volume of cellular blood suspension conveyed from the donor, and a physiological infusion rate of anticoagulant physiologically tolerated by the donor without significant adverse reactions, taking donor body weight into account,

a processor that (i) derives an operative anticoagulant infusion rate based upon the operating parameters and the physiological parameters, (ii) compares the operative infusion rate to the physiological infusion rate, and (iii) generates a first control signal when the operative infusion rate is equal to or less than the physiological infusion rate and a second control signal when the operative infusion rate exceeds the physiological infusion rate, and

an output coupled to the supply pump, the return pump, and the retention pump and being responsive to the first control signal to operate the supply, return, or retention pumps to achieve the operating parameters and being responsive to the second control signal to adjust at least one of the operating parameters, except the added anticoagulant-to-cellular suspension volume ratio, to lower the operative anticoagulant infusion rate to be equal to or below the physiological infusion rate.

2. A system according to claim 1

wherein the operative anticoagulant infusion rate and the physiological anticoagulant infusion rate are expressed in terms of the volume of anticoagulant in the cellular-poor component returned by the return pump to the donor per unit of time per unit of donor body weight.

3. A blood processing system for obtaining during a processing period a platelet concentrate from anticoagulated whole blood conveyed from donor, while returning a platelet-poor plasma component containing anticoagulant to the donor, without significant adverse anticoagulant-related donor reactions, comprising

a supply path including a supply pump to convey whole blood from the donor,

a source of anticoagulant,

a branch path communicating with the supply path and the source of anticoagulant to add anticoagulant to the whole blood conveyed by the supply path in an added anticoagulant-to-whole blood volume ratio,

a first separation device communicating with the supply path to receive the anticoagulated whole blood and to separate the anticoagulated whole blood into red blood cells having a first anticoagulant volume and a platelet-rich plasma component having a second anticoagulant volume, the second anticoagulant volume being greater than the first anticoagulant volume,

an intermediate path communicating with the first separation device, including a transfer pump to convey the platelet-rich plasma component from the first separation device,

a second separation device communicating with the intermediate path to receive the platelet-rich plasma component and to separate the platelet-rich plasma component into a platelet concentrate and a platelet-poor plasma component having a third anticoagulant volume generally equal to the second anticoagulant volume,

a return path communicating with the second separation device, including a return pump to convey the platelet-poor plasma component and third anticoagulant volume from the second separation device to the donor,

a collection container,

a collection path communicating with the return path and the collection container, including a retention pump to divert a portion of the platelet-poor plasma component and the third anticoagulant volume away from the donor for retention in the collection container while a remaining portion of platelet-poor plasma component and the third anticoagulant volume are conveyed to the donor in the return path, and

a processing controller including

an input for receiving operating parameters including a portion of platelet-poor plasma component to be diverted by the retention pump during the processing period, a volume of platelets to be collected as platelet concentrate during the processing period, and the added anticoagulant-to-whole blood volume ratio,

an input for receiving physiological parameters of the donor including donor body weight, volume of red blood cells and platelet components present per unit volume of whole blood conveyed from the donor, and a physiological infusion rate of anticoagulant physiologically tolerated by the donor without significant adverse reactions, taking donor body weight into account,

a processor that (I) derives an operative anticoagulant infusion rate based upon the operating parameters and the physiological parameters, (ii) compares the operative infusion rate to the physiological infusion rate, and (iii) generates a first control signal when the operative infusion rate is equal to or less than the physiological infusion rate and a second control signal when the operative infusion rate exceeds the physiological infusion rate, and

an output coupled to the supply pump, the return pump, and the retention pump and being responsive to the first control signal to operate the supply, return, or retention pumps to achieve the operating parameters and being responsive to the second control signal to adjust at least one of the operating parameters, except the added anticoagulant-to-whole blood volume ratio, to lower the operative anticoagulant infusion rate to be equal to or below the physiological infusion rate.

4. A system according to claim 3

wherein the operative anticoagulant infusion rate and the physiological anticoagulant infusion rate are expressed in terms of the volume of anticoagulant in the platelet-poor plasma component returned by the return pump to the donor per unit of time per unit of donor body weight.

5. A blood processing method for obtaining during a processing period a cellular-rich concentrate from an anticoagulated cellular suspension conveyed from donor, while returning a cellular-poor component containing anticoagulant to the donor, without significant adverse anticoagulant-related donor reactions, comprising the steps of

(a) conveying into a separation device a cellular blood suspension including plasma from the donor, while adding anticoagulant to the cellular blood suspension in an added anticoagulant-to-cellular suspension volume ratio,

(b) separating the anticoagulant-containing cellular blood suspension in the separation device into a cellular-rich concentrate having a first plasma and anticoagulant volume and a cellular-poor component having a second plasma and anticoagulant volume, the second plasma and anticoagulant volume being greater than the first plasma and anticoagulant volume,

(c) conveying the cellular-poor component from the separation device to the donor, while diverting a portion of the cellular-poor component away from the donor for retention in a collection container,

(d) deriving an operative anticoagulant infusion rate based upon operating parameters and physiological parameters of the donor, the operating parameters including a portion of cellular-poor component to be diverted into the collection container during the processing period, a volume of cellular-rich component to be collected during the processing period, and the added anticoagulant-to-cellular suspension volume ratio, the physiological parameters of the donor including donor body weight, volume of cellular component present per unit volume of cellular blood suspension conveyed from the donor, and a physiological infusion rate of anticoagulant physiologically tolerated by the donor without significant adverse reactions, taking donor body weight into account,

(e) comparing the operative infusion rate to the physiological infusion rate,

(f) generating a first control signal when the operative infusion rate is equal to or less than the physiological infusion rate and a second control signal when the operative infusion rate exceeds the physiological infusion rate, and either

(g) in response to the first control signal, carrying out steps (a), (b), and (c) to achieve the operating parameters, or

(h) in response to the second control signal, carrying out steps (a), (b), and (c) while adjusting at least one of the operating parameters, except the added anticoagulant-to-cellular suspension volume ratio, to lower the operative anticoagulant infusion rate to be equal to or below the physiological infusion rate.

6. A method according to claim 5

wherein the operative anticoagulant infusion rate and the physiological anticoagulant infusion rate are expressed in terms of the volume of anticoagulant in the cellular-poor component returned by the return pump to the donor per unit of time per unit of donor body weight.