CN100478038C - Blood treating system - Google Patents

Abstract

Blood processing systems and methods separate blood drawn from a donor into red blood cells and platelets. The systems and methods operate in a first mode to collect platelets while returning red blood cells to the donor. The systems and methods operate in a second mode to concurrently collect both platelets and red blood cells without returning platelets or red blood cells to the donor.

Description

Blood processing system

Invention field

The present invention relates to centrifugal blood processing system and equipment.

Background of invention

Some treatment needs a large amount of blood constitutent of input, and for example, some experience chemotherapeutic patient needs a large amount of platelet of input regularly.So a large amount of hematoblastic effective ways are a kind ofly gathered from each donor by manual blood pack system.

Use a large amount of platelet of online blood separation system collection to address that need at present.On-line system is carried out essential separating step, when the donor is on the scene, by continuous processing, isolates PC from whole blood.On-line system is set up the whole blood stream from the donor, isolates required platelet from blood pathway, and remaining erythrocyte and blood plasma are returned to the donor, and all these is in the circulation of a continuous-flow.

Use on-line system can handle a large amount of whole blood (for example, 2.0 liters).Owing to handled a large amount of whole bloods, can gather a large amount of Platelet Concentrate (for example, 4 * 10 ¹¹Platelet suspension is in the 200ml fluid).Yet, still need so that use the mode of blood constitutent in a large number, further improve the system and method for under online blood collection condition, from blood constitutent, gathering rich cell concentration liquid, thereby realize cellular blood component such as the platelet and the erythrocytic high yield of urgent need.

Summary of the invention

The invention provides blood separation protoerythrocyte and hematoblastic blood processing system and the method that to extract out from the donor.This system and method is worked under first and second patterns.

In first mode of operation, system and method is handled whole blood and is gathered platelet.In first pattern, do not gather erythrocyte simultaneously, but it is turned back to the donor.

In second mode of operation, system and method is handled whole blood and is gathered erythrocyte simultaneously and the platelet of relevant extra quantity.In second pattern, there is not blood constitutent to turn back to the donor.

In one embodiment, system and method is also with three-mode work.In the 3rd mode of operation, system and method is carried out final blood volume debugging functions.In the volume debugging functions, the erythrocyte that a part is gathered turns back to the donor.The volume debugging functions guarantee that the blood constitutent volume of actual acquisition is no more than the target acquired volume.

Under the condition that does not depart from spirit of the present invention and inner characteristic, the present invention has multiple imbody form.Scope of the present invention is defined by the appended claims, rather than is limited by following detailed description.Therefore, all fall into embodiment in the meaning of claim and the equivalency range all in the claim restricted portion.Detailed design of part that the present invention provides in being not limited to the following describes or shown in the drawings and arrangement.The present invention can be implemented by other embodiment and various other method.Term and words and phrases only are to be used for explanation, and should not be regarded as restriction.

Brief description of drawings

Fig. 1 is the sketch map of online blood processing system;

Fig. 2 is the sketch map of the controller of control blood processing system work shown in Figure 1;

Fig. 3 is the blood processing system by Fig. 1 of controller control, carries out blood drawing circulation sketch map in non-while drainage pattern;

Fig. 4 is the blood processing system by Fig. 1 of controller control, carries out in non-while drainage pattern and returns the circulation sketch map;

Fig. 5 is the blood processing system by Fig. 1 of controller control, carries out the sketch map of drainage pattern simultaneously;

Fig. 6 is by the blood processing system of Fig. 1 of controller control, carries out the blood volume debugging functions;

Fig. 7 is the front view of blood collection device, and it is used to receive the erythrocyte of system acquisition shown in Figure 1, before storing it is for further processing.

Detailed description of the preferred embodiment

Fig. 1 shows online blood processing system 10 with diagrammatic form, and it can carry out the automatic blood capture program.

As shown in the figure, system 10 comprises single needle blood collection net, but also can use the crosspointer net.

I. system survey

System 10 comprises a series of durable hardware components, and their work is by processing controller 18 controls.Hardware components comprises centrifuge 12, and donor's whole blood (WB) is separated into platelet, blood plasma and erythrocyte at this.Operable typical centrifuge is shown in people's such as Brown the United States Patent (USP) 5690602, and this patent at this as a reference.

Hardware components also comprises various pumps, normally peristaltic pump (being labeled as P1 to P7); And various online clamps and valve (being labeled as V1) to V7.Certainly, also can comprise the hardware components of other type that Fig. 1 does not illustrate usually, as solenoid, pressure monitor or the like.

System 10 also comprises the disposable fluid treating device 14 that some link to each other with hardware components usually.In illustrated embodiment, device 14 comprises process chamber 16, and it has two stages 24 and 32.During use, centrifuge 12 makes process chamber 16 rotations with centrifugalize blood constitutent.

The structure of two phase process chambers 16 can change.For example, can adopt two pocket types, as illustrated in people's such as Cullis the United States Patent (USP) 4146172 and the process chamber of describing, this patent at this as a reference.Perhaps, process chamber 16 can adopt the form of integrated bag of two stages of lengthening, and as illustrated in the United States Patent (USP) 5,632,893 of Brown and describe, this patent at this as a reference.

In illustrated blood processing system 10, blood processor 14 also comprises the one group of flexible pipe that constitutes fluid circuit.Fluid circuit is transported to process chamber 16 or output liquid therefrom with liquid.Pump P1-P7 and valve V1-V7 are connected in the pipeline and flow by the mode of setting with the control fluid.Fluid circuit also comprises some containers (being labeled as C1 to C5), distributes in processing procedure and reception liquid.

The work of the various hardware components of controller 18 controls, operative installations 14 is carried out one or more Processing tasks.Controller 18 is also carried out assessment of real-time treatment conditions and output information, helps the operator farthest to separate and gathers blood constitutent.

Can tectonic system 10 to finish polytype blood separation process.The structure of system 10 shown in Figure 1 can be carried out auto-programming, use single needle 22 from a donor gather (i) requirement be suspended in the blood plasma PC (PC) (for example, up to two treatment units), there is not leukocyte fully in the goods that (if necessary) provided; (ii) the erythrocyte concentrated solution (RBC) of requirement (for example, reach 200ml when about 100% hematocrit value, perhaps reach 230ml when about 85% hematocrit value) can not have leukocyte in the goods that (if necessary) provided fully yet; The (iii) platelet poor plasma (PPP) of (if necessary) requirement.

The qualification of suitable regulations according to the blood volume of permission, PC, PPP and the RBC goods of varying number can be gathered by system 10, for example, in the U.S., system's 10 current blood constitutent quantity that can provide comprise: for example one every kind of (i) PC, PPP and RBC treat unit, or (ii) one every kind treatment of PC and RBC unit, or the (iii) PC of two treatment units and the RBC of a unit.

To describe in further detail below to reaching the work of these blood treatment purpose systems 10.

II. system controller

Controller 18 is born above-mentioned all processing controls and the monitoring function of system 10.

(see figure 2) in illustrated and preferred embodiment, controller comprises Main Processor Unit (MPU) 44.In a preferred embodiment, MPU44 comprises the 68030 type microprocessors that Motorola Inc. makes, but also can use the custom microprocessor of other type.

In a preferred embodiment, MPU44 uses conventional real-time multi-task to handle, for Processing tasks distributes the MPU circulation.The timing in cycle interrupt (as, per 5 milliseconds) handle carrying out of task earlier and arrange to be in another task of preparing executing state.If task, the task of then arranging to have in the SBR highest priority are rearranged in request.Otherwise, arrange the next item down task in the SBR tabulation.

A. hardware controls

MPU44 comprises application program control and management device 46.The activation of application program control and management device 46 management controlling application program program libraries 48.Each controlling application program instruction program according to predetermined mode using system hardware (as, centrifuge 12, pump P1-P7 and valve V1-V7) carry out given functional task.In illustrated and preferred embodiment, application program is stored among the EPROM of MPU44 as process software.

Equipment manager 50 also is stored among the EPROM of MPU44 as process software.Be communicated with between equipment manager 50 and the application program control and management device 46.Equipment manager 50 also with between the rudimentary peripheral controllers 52 is communicated with, and these rudimentary peripheral controllers 52 are used for pump, solenoid, valve and other functional hardware of system.

As shown in Figure 2, when activated application program sends application, application program control and management device 46 will send the concrete function instruction to equipment manager 50.Equipment manager 50 identifications are carried out the peripheral controllers or the controller 52 of this function and are compiled into the special instruction of hardware.The special instruction of hardware is carried out in peripheral controllers 52 direct and hardware communications, and hardware is worked by specified mode.Lower layer protocol and communication between communications manager 54 management equipment managers 50 and the peripheral controllers 52.

As shown in Figure 2, equipment manager 50 also will feed back to application program control and management device 46 about the operation of handling procedure and the status data of functional conditions.For example, status data can be expressed as the pressure of for example fluid-flow rate, detection and the fluid volume of detection.

Application program control and management device 46 is shown to the operator with selected status data.Application program control and management device 46 will be worked and functional conditions is sent to application A 1 and carry out monitoring facilities A2.

B. operator interface therewith

In illustrated embodiment, MPU44 also comprises interactive user interface 58.Interface 58 allows operator's observation information relevant with the work of system 10 with understanding.Interface 58 also allows the operator to select to be stored in application program in the application program control and management device 46 and some function and the operative norm of change system 10.

Interface 58 comprise interface screen 60 and, preferred sound device 62.Interface screen 60 shows the information of observing for the operator with alphanumeric style and graph image.Sound device 62 provides auditory tone cues, causes that perhaps the operator notes, perhaps confirms operator's operation.

In illustrated and preferred embodiment, interface screen 60 is also as input equipment.It receives operator's input by conventional touch start mode.Perhaps combine, use mouse and keyboard as input equipment with touching starting.

Be communicated with between interface manager 64 and interface screen 60 and the sound device 62.And interface manager 64 also with between the application program control and management device 46 is communicated with.Interface manager 64 is stored among the EPROM of MPU44 as process software.

People's such as Lyle United States Patent (USP) 5,581,687 discloses the more detailed description at MPU44 and interface 58, and this patent at this as a reference.

C. system control function

(see figure 2) in illustrated embodiment, program library 48 comprise at least one controlling application program A1 of system.That the controlling application program A1 of system comprises several special uses but the utilitarian function that connects each other.Certainly, the quantity of utilitarian function and type can change.

In illustrated embodiment, the platelet yield of utilitarian function F1 derivation system 10 (Yld).Utilitarian function F1 finds out the instantaneous physical condition of the system 10 that represents with separation efficiency and with the donor's that can represent for the circulation platelet counts of gathering instantaneous physiological condition.From these data, utilitarian function F1 is the continuous hematoblastic instant productivity of deriving during handling.

Another utilitarian function F2 produces selected information state value and parameter according to platelet yield (Yld) that calculates and other treatment conditions.These values and parameter are presented on the interface 58, help the operator to set up and keep best executive condition.State value and parameter that utilitarian function F2 derives can change.For example, in illustrated embodiment, utilitarian function F2 report needs residual volume, residue processing time of handling and the volume and the speed of gathering blood constitutent.

Other utilitarian function produces control variable according to ongoing treatment conditions, and application program control and management device 46 uses these variablees to set up and keep optimal treatment condition.For example, a utilitarian function F3 produces control variable, optimizes the platelet separation condition in the phase I 24.Another utilitarian function F4 produces control variable, and the agent of control citrate anticoagulation blood turns back to donor's speed with PPP, with the citrate toxic reaction of avoiding occurring.

The utilitarian function of these and other more than the United States Patent (USP) 5,676,841 of Brown has been described in more detail, this patent at this as a reference.The summary of the various utilitarian functions that relied on is listed in the end of its description.

III. system works

In illustrated embodiment, regulating system 10 is to realize at least three processing intents.First purpose is to gather the PC (PC) that needs quantity.Second purpose is to gather to need the storage medium of the PPP of quantity as collection PC.The 3rd purpose is to gather the erythrocyte (RBC) that needs quantity.Other purpose also can reach, and for example, the PPP that gathers extra quantity stores.

In order to reach above purpose, utilitarian function F1 regulating system 10 is with at least three kinds of different working modes collections and processing blood.

In first mode of operation, regulating system 10 is handled whole blood and is gathered PC and PPP.In first pattern, do not gather RBC simultaneously, but turn back to the donor.The PPP that surpasses required quantity also turns back to the donor.

In second mode of operation, regulating system 10 is handled whole blood and is gathered the PC and the PPP of RBC and extra quantity simultaneously.In second pattern, there is not blood constitutent to turn back to the donor.

In the 3rd mode of operation, regulating system 10 is carried out final blood flow volume and is adjusted function.In blood volume is adjusted function course, the RBC that a part is gathered, the perhaps PPP that gathers of all or a part, perhaps the two turns back to the donor simultaneously.Blood volume adjustment function guarantees that the blood constitutent amount of actual acquisition is no more than the target volume of collection.

When the processing handling procedure began, the operator used the PC output (Yld of the required collection of interface 58 inputs _Goal), the RBC volume (RBC of required collection _Goal), and the PPP volume (PPP of required collection _Goal).

Controller 18 regulating systems 10 are carried out the blood treatment of first mode of operation.Controller 18 changes to second mode of operation and consider two treatment variables when second mode of operation changes to the instruction of the 3rd mode of operation sending from first mode of operation.First treatment variable is to finish the volume of whole blood V that required platelet yield need continue to gather _Brem(unit/ml).Second treatment variable is to finish required erythrocyte volume RBC _GoalThe volume of whole blood Vb that needs processing _RBC

Work as V _Brem=Vb _RBCThe time, controller 18 with first working mode change to second mode of operation.Work as Vb _RemBecome at 0 o'clock, controller 18 is with second working mode change to the, three mode of operations.

(i) calculate Vb _Rem

Utilitarian function F2 depends on the Yld that is calculated by the first utilitarian function F1 and derives and finish Yld _GoalThe volume of whole blood that needs processing.In the blood treatment process, by will remaining residue output that processing procedure need gather average platelet counting divided by expection, and with the modifying factor η that reflects work at present efficient _PltRevise, utilitarian function F2 derives continuously and finishes the volume Vb that required platelet yield is still needed and handled _Rem(unit/ml).

In illustrated embodiment, utilitarian function F2 is according to following formula this value of deriving:

${\mathrm{Vb}}_{\mathrm{rem}}=\frac{200000\×({\mathrm{Yld}}_{\mathrm{Goal}}-{\mathrm{Yld}}_{\mathrm{Current}})}{{\mathrm{\η}}_{\mathrm{Plt}}\×\mathrm{ACDil}\×({\mathrm{Plt}}_{\mathrm{Current}}+{\mathrm{Plt}}_{\mathrm{Post}})}$

In the formula:

Yld _GoalIt is required platelet yield (k/ μ l);

Vb _RemBe to finish Yld _GoalThe volume (ml) of still needing and handling;

Yld _CurrentBe current hematoblastic output (k/ μ l), calculate according to current processing costs (illustrating in the summary hereinafter) by utilitarian function F1;

η _PltBe current (instantaneous) platelets gathering efficient, calculate according to current processing costs (illustrating in the summary hereinafter);

ACDil is anticoagulant dilution gfactor (illustrating in the summary hereinafter);

Plt _CurrentBe current (instantaneous) circulation donor platelet count, calculate (illustrating in the summary hereinafter) according to current processing costs;

Plt _PostBe donor's platelet count of expection after finishing dealing with, also calculate (illustrating in the summary hereinafter) according to total processing costs.

(ii) calculate Vb _RBC

Utilitarian function F2 is according to RBC _GoalDerivation Vb _RBC, and consideration donor's TBH (Hct).Donor's TBH Hct comprises when program begins the value that detects, perhaps the value of online detection program the term of execution.

In illustrated embodiment, directly do not measure or detect Hct.On the contrary, controller 18 depends on the apparent specific volume value H of the whole blood that enters the separation chamber _bController 18 is according to the flox condition and the theoretical Consideration derivation H that detect _bH _bDerivation summary hereinafter in describe in detail.

According to H _b, utilitarian function F2 presses following formula derivation Vb _RBC:

${\mathrm{Vb}}_{\mathrm{RBC}}=\frac{{\mathrm{RBC}}_{\mathrm{Goal}}+\mathrm{Buf}}{H_b}$

In the formula:

Buf is the buffer volumes of setting, as 20ml.

In illustrated embodiment, the Vb of utilitarian function F2 by calculating _RBCValue make progress into to, for example nextly can be provided bigger buffer volumes by 10 maximum integer that divide exactly.

In illustrated embodiment, utilitarian function F2 is also with the Vb that calculates _RBCValue compares with the maximum of setting (as 600ml).If Vb _RBCEqual or exceed the maximum of setting, it is a less setting value that utilitarian function F2 selects this value downwards, as 595ml.

(iii) first mode of operation

First or non-while mode of operation in, system 10 handles whole bloods and gathers PC and PPP is used for storing.In first pattern, RBC and the PPP that does not gather quantity turn back to the donor.

System 10 shown in Figure 1 uses a single-lumen fleams 22.In the pattern of non-while, controller 18 operating systems 10 are in successive extraction and return circulation.In extracting circulation out (Fig. 3), controller 18 is fed to donor's WB in the chamber 16 by pin 22 and handles.In returning circulation (Fig. 4), controller 18 turns back to donor with PPP by identical pin 22 with blood constitutent RBC.

In illustrated embodiment, the structure of system 10 can make blood separate in chamber 16, does not interrupt and can and not return in the cyclic process in successive extraction circulation.Particularly, system 10 comprises extraction storage capsule 66.In extracting circulation (Fig. 3) out, a certain amount of whole blood of donor injects storage capsule 66, and this part whole blood is to exceed the part of delivering to outside the quantity of handling in the chamber 16.System 10 also comprises and returns storage capsule 68.In extracting circulation out, the RBC of some collected and return in the storage capsule 68, be used for turning back to donor's (see figure 4) periodically returning circulation.In returning circulation, WB is transported to chamber 16 from extract storage capsule 66 out, do not interrupt to keep separation.

In the extraction circulation of non-while pattern (Fig. 3), whole blood pump P1 is transported to from pin 22 WB and extracts storage capsule 66 out by the first pipe branch road 20.Simultaneously, auxiliary tube branch road 26 quantitatively is transported to anticoagulant the WB stream from container C1 by anticoagulant pump P3.The type of anticoagulant can change, and illustrated embodiment is used ACDA, and it is a normally used anticoagulant in a kind of blood collection art.

Container C 2 splendid attire saline solutions.Another auxiliary tube branch road 28 is transported to the first pipe branch road 20 by online valve V1 with saline, is used for starting drive 14 and removal air wherein before handling beginning.After processing finishes also with the residual blood component in the normal saline washing device 14, to turn back to the donor.

Processing controller 18 receives process information from balance 70.The WB amount that balance 70 monitorings are gathered in extracting storage capsule 66 out.Extract out when having stored volume required WB in the storage capsules 66 in case balance 70 is indicated, controller 18 instruction whole bloods are handled pump P2 work, continuously WB are transported to the phase I 24 of process chamber 16 by inlet branch road 36 from extraction storage capsule 66.Controller 18 handle whole blood pump P1 with higher speed running (for example, 100ml/min), its speed be higher than whole blood handle the continuous operation speed of pump P2 (as, 50ml/min), therefore the blood collection of a certain amount of interpolation anticoagulant is in storage capsule 66.By using balance 70 its weight of monitoring, controller is handled whole blood inlet pump P1 off and on, to keep the WB that extracts requirement in the storage capsule 66 out.

The WB that adds anticoagulant enters and is full of the phase I 24 of process chamber 16.Here, the centrifugal force of centrifuge 12 rotation generations is separated into erythrocyte (RBC) and plateletrich blood plasma (PRP) with WB.

PRP pump P4 running is extracted PRP out and is entered the second stage 32 of the second pipe branch road 30 to be transported to process chamber 16 from the phase I 24 of process chamber 16.Here, PRP is separated into the blood plasma (PPP) of PC (PC) and anemia platelet.

Controller 18 optical monitorings in the phase I 24 of process chamber 16 RBC and PRP between the position at interface.Controller 18 is handled PRP pump P4, keeps the interface of process chamber in 24 phase I 24 to be positioned at desired location.This will prevent that the most of leukocyte that occupies the interface from entering in the PRP stream.

As selection, also can carry PRP by filter F, before separating, remove leukocyte in second stage 32.Filter F can be used the filter medium of the fiber of type described in the United States Patent (USP) 4,936,998 that contains people such as Nishimura, and this patent at this as a reference.The filter medium that contains these fibers is sold in the filter of commodity SEPACELL by name by Asahi pharmaceuticals.

System 10 comprises recirculation pipe branch road 34 and relevant recirculation pump P5.Processing controller 18 operating pumps P5 turn to the part PRP of 16 phase I 24 of process chamber, and enter the process chamber WB remix of 16 phase I 24.The recirculation of PRP is set up the condition that needs that makes RBC and PRP maximum separation in the inlet region of phase I 24.

RBC branch road 38 is transported to RBC and returns storage capsule 68 (it is by valve V3 control) from phase I 24 of process chamber 16.The PPP volume of gathering in the balance 72 monitoring container C 4.

When PPP pump P7 worked, PPP branch road 40 was with second stage 32 outputs of PPP from process chamber 16.Open valve V5,, all or part PPP can be transported to collection container C4 according to the flowing velocity of pump P7.The PPP volume of gathering in the balance 74 monitoring container C 4.The PPP that gathers does not flow into and returns storage capsule 68, and mixes with RBC therein.

In second mode of operation, (will be described in more detail below), gather more PPP usually and (that is, account for PPP _Goal50%-75%), and do not return the donor.Anticipate this point, the speed of gathering PPP in controller 16 restrictions first pattern.This is avoided gathering excessive PPP when EP (end of program).By limiting the speed of gathering PPP during first mode of operation, controller 18 has reduced the time of blood flow volume debugging functions subsequently, thereby has reduced total processing time.A small amount of excessive PPP can also use the higher flowing velocity of returning during the blood flow volume debugging functions, because turn back to amount (carrying among the PPP) minimizing of donor's anticoagulant during the blood flow volume debugging functions.

Controller 18 receives the process information of balances 72, and the volume of RBC and PPP in the storage capsule 68 is returned in monitoring.When previously selected volume occurring, controller 18 with the work of system 10 from extracting cyclic transformation out to returning circulation.

In returning circulation (Fig. 4), controller 18 stops whole blood front pump P1 and anticoagulant pump P3, starts blood and returns pump P6.Return branch 42 is transported to the donor by RBC and the PPP that pin 22 will return in the storage capsule 68.

Simultaneously, in returning circulation, controller 18 keeps WB to handle the work of pump P2, PRP pump P4 and recirculation pump P5, handles the WB that enters in the extraction storage capsule 66 continuously with phase I 24 and second stage 32 by chamber 16.

When balance 72 indicated the component of returning in the storage capsule 68 to be transported to the donor, controller 18 was transformed into another extraction circulation with the work of system 10.

Controller 18 is in successive extraction and return execution repeatedly between the circulation, up to Vb _Rem=Vb _RBCWork as Vb _Rem=Vb _RBCThe time, controller 18 sends and finally returns the circulation instruction, and the component of returning in the storage capsule 68 is turned back to the donor.After component in returning storage capsule 68 is returned, controller 18 from first working mode change to second mode of operation.

(iv) drainage pattern simultaneously

Second or simultaneously (Fig. 5) in the drainage pattern, controller 18 regulating systems 10 are worked under the extraction circulation that continues, handling whole blood and to gather the RBC of target volume simultaneously, and the PC and the PPP of relevant extra quantity.At the same time in the drainage pattern, controller 18 is not transformed into the work of system 10 and returns circulation.Only there is a lasting extraction circulation at the same time in the drainage pattern, and do not have blood constitutent to turn back to the donor.

In the lasting extraction cyclic process of drainage pattern, controller 18 is avoided a large amount of excessive whole bloods are collected in the extraction storage capsule 66 at the same time.In illustrated embodiment, to compare with the current difference that whole blood inlet pump P1 and whole blood in the extraction of the non-while drainage pattern circulation are handled between the pump P2, controller 18 reaches this purpose more for a short time by keeping this current difference.For example, in illustrated embodiment, whole blood inlet pump P1 handles under the difference of a minimum of pump P2 and works surpassing whole blood, as only being 1ml/min.

In order further to guarantee to extract the whole blood that only keeps a small amount of buffering quantity in the storage capsule 66 out during the lasting extraction of drainage pattern circulates simultaneously, as long as the blood quantity in the storage capsule 66 that balance 70 detects surpasses specified minimal buffering quantity, as 5g, balance 70 just makes whole blood inlet pump P1 and anticoagulant pump P3 cut out.

In the lasting extraction circulation of drainage pattern, erythrocyte is opened (return valve V3 and close, therefore do not gather RBC in returning storage capsule 68) by valve V4 input collection container C4 for reaching this purpose valve V4 at the same time.The weight of balance 108 monitoring collection container C4.

In the second stage 32 of chamber 16, gather the PC of correlated measure, and in collection container C3, gather the PPP (by the work of PPP pump P7 and valve V5, valve V5 opens) of correlated measure.Because valve V3 closes, therefore in returning storage capsule 68, do not gather PPP.

Controller 18 is derivation Vb continuously in the lasting extraction circulation of drainage pattern at the same time _RemWork as Vb _RemBecome at 0 o'clock, controller 18 finishes drainage pattern simultaneously.

(iv) blood quantity debugging functions

(see figure 6) in illustrated embodiment, when drainage pattern finished at the same time, controller 18 utilized balance 108 and 74 to estimate the RBC of collection and the quantity of PPP respectively.

If the RBC quantity of gathering surpasses RBC _Goal, controller 18 instruction systems 10 enter and return circulation, by the online work of returning pump P6, excessive RBC are entered return pipeline 42 (valve V2 closes) from collection container C4 by branch line 43 (valve V6 opens), turn back to the donor.

Equally, if the PPP quantity of gathering surpasses PPP _Goal, controller 18 instruction systems 10 enter and return circulation, by the online work of returning pump P6, excessive PPP are entered return pipeline 42 from collection container C3 by branch line 45 (valve V7 opens, and valve V5 closes), turn back to the donor.

When blood quantity debugging functions finished, the brinish input service again of controller 18 instructions was to turn back to the donor with the blood remaining in the system 10 and the fluid infusion volume of setting.

(the processing after v) gathering

(1)PPP

Behind component separation process N-process, keeping PPP has multiple use.

Keep PPP therapeutic use is arranged in processing procedure.PPP contains most of anticoagulants that are metered among the WB in the component separation process.By keeping a part of PPP rather than all PPP being returned the donor, total anticoagulant quantity that the donor receives in processing procedure reduces.This minimizing is obvious especially when handling a large amount of blood.Keeping PPP in processing procedure also makes the donor keep higher in processing procedure and the platelet count that circulates more uniformly.

The advantage that system 10 can also obtain handling from keep PPP.For example, in a kind of selectable recirculation mode, system 10 can recirculation the PPP that keeps of a part, rather than PRP is used for mixing with the WB that enters first Room 24.Perhaps, if flowing of WB temporarily stops in processing procedure, system 10 can extract the fluid of the PPP conduct of reserve part with " maintenance is open " of anticoagulant out, to keep the opening of fluid circuit.In addition, when separation process finished, system 10 can extract the fluid of the PPP of reserve part as " flushing is gone back " out, the RBC in the phase I chamber 24 is suspended again and clean, turns back to the donor by return branch 42.

(2)PC

After the separation process, also with the pattern work of resuspending, extraction unit is divided the PC in the PPP resuspending second stage 24 that keeps in system 10, is used for carrying and being stored in collection container C5.Can be manual or the resuspending of the online PC of finishing and be transported to collection container C5.

The container C 5 that is preferred for adorning PC is made by have the more infiltrative material of atmospheric than the plastifying pvc material of DEHP-, and this material is of value to hematoblastic storage.For example, can use polyolefine material (as what describe in people's such as Gajewski the United States Patent (USP) 4,140,162) or with the plastifying pvc material of tri trimellitate (2-ethylhexyl) ester (TEHTM).

(2)RBC

(see figure 7) in illustrated embodiment shows disposable harvester 76, and it is handled the RBC that gathers and is used for storing.

Device 76 comprises transfer pipeline 78.Transfer pipeline 78 has the free end 80 of sealing, is connected (see figure 7) with the pipeline section 82 of the sealing on aseptic state and the RBC collection container C4.Can use the known aseptic connecting device (not shown) of describing as the United States Patent (USP) 4,412,835 of Spencer, transfer pipeline 78 is connected with pipeline section 82.These connecting devices form the sealing of fusing between the pipe end, in case after the cooling, form aseptic welding.

Communicate with transfer pipeline 78 by one section probe tube 86 for first bag 84.Contain erythrocyte additive solution S for first bag 84, for example, SAG-M or

Solution (Baxter keep healthy company).With harvester 76 with after RBC collection container C4 is connected, open the online frangible sleeve pipe 106 of the routine in the probe tube 86, erythrocyte additive solution S is transported to collection container C4 from first bag 84, is used for mixing with the RBC that gathers.Then the mixture of additive solution and RBC is carried back first bag 84.

Residual air in first bag 84 is discharged to online air and discharges chamber 88, and it communicates with transfer pipeline 78.Meanwhile, the RBC of the part collection in first bag 84 can enter probe tube 86 fast.

Preferred pipe 86 has identification code 90, it be printed on or with other method yards 90 identical attached on first bag 84.Then 86, the first bag 84 of the Sealing Method sealed tube of fractureing-separate with routine separates with harvester 76, is used to store the RBC of collection.Use conventional seal of tube device, pipe 86 further can be sealed to fragment,, be used for analyzing and cross matching to separate a plurality of RBC samples.

Device 76 also comprises second bag 92, links to each other with transfer pipeline 78 by the downstream of branch line 94 at first bag 84.Branch line 94 comprises pot strainer 96.Pot strainer 96 has filter medium 98, optionally removes leukocyte from erythrocyte.Filter comprises, for example, and R-3000 erythrocyte filter (Asahi pharmaceuticals).

The mixture of erythrocyte and additive solution can be transported to second bag 92 by pot strainer 96 from collection bag C4, walks around first bag 84.In such a way, device 76 produces does not have leukocytic erythrocyte fully, is suitable for long term storage.

Air drain passageway 100 extends to transfer pipeline 78 from second bag 92, walks around pot strainer 96.Conventional smash in 106, the second bag 92 of the sleeve pipe remaining air and can be discharged to online air by path 100 and discharge chamber 88 by opening in the path 100.Check valve 104 in the path 100 allows air and liquid to flow out through path 100 from bag 92, but can not flow along opposite direction.

Simultaneously, the RBC of the part collection in second bag 92 can enter exhaust channel 100 fast.Exhaust channel 100 has identification code 102, it be printed on or with other method yards 102 identical attached on second bag 92.The Sealing Method that fractures-separate with routine can seal exhaust channel 100 and branch line 94, makes second bag 92 and separates with carrier pipe 78.Pipe 100 also can be sealed to fragment, so that a plurality of RBC samples to be provided, is used for analyzing and cross matching.

The motility that harvester 76 provides supply to be suitable for the erythrocyte transfusion of long term storage, it can be to store not reduce or reduced before leukocytic goods.

The summary of IV. various processing utilitarian functions

A. the platelet yield of deriving

Platelet separation efficiency (the η of the continuous computing system 10 of utilitarian function F1 _Plt).Utilitarian function F1 makes platelet separation efficiency η _PltEqual from donor's whole blood the ratio of getable total plasma volume in the isolating plasma volume and whole blood.Therefore, utilitarian function F1 hypothesis each platelet in the isolated blood plasma from donor's whole blood has all been gathered.

Because the dilution of anticoagulant and the minimizing effect of blood plasma in the processing procedure, donor's hematocrit changes, so separation efficiency η _PltCan not remain steady state value, but in the whole procedure process, change.Utilitarian function F1 overcomes these variations relevant with process by the output that monitoring increases gradually.These output are called and remove dilatation (Δ ClrVol), by with current separation efficiency η _PltThe increment with donor's whole blood of anticoagulant dilution that multiply by processing calculates, as shown in the formula:

Δ ClrVol=ACDil * η _Plt* Δ VOL _ProcFormula (1)

In the formula:

Δ Vol _ProcIt is the increment of the volume of whole blood of processing; With

ACDil is the anticoagulant dilution gfactor that is used for the volume of whole blood increment, is calculated as follows:

$\mathrm{ACDil}=\frac{\mathrm{AC}}{\mathrm{AC}+1}$ Formula (2)

In the formula:

AC be the volume of whole blood selected with the ratio of anticoagulant volume (as, 10: 1 or " 10 ").AC can be fixed value in each stage in processing procedure.Perhaps, the stage change of standard that can set in each stage according to processing procedure of AC.

For example, when handling beginning, in one section initial time setting, AC is set at a less ratio, then in the later time section, increases gradually stage by stage.As, setting AC in first minute of processing beginning is 6: 1, then increases to 8: 1 in subsequently 2.5 to 3 minutes, finally increases to 10: 1 processing horizontal.

The inlet pressure of 32 PRP processing stage of entering second by monitoring also can add anticoagulant stage by stage.For example, drop to preset threshold pressure (as 200mmHg～300mHg) before AC is set at 6: 1 up to initial pressure (as 500mmHg).Then AC is progressively increased to 10: 1 processing horizontal, monitoring pressure maintains desired level to guarantee it simultaneously.

Utilitarian function F1 also estimates donor's current circulation platelet count (Plt continuously _Circ), contain 1000 platelet (or k/ μ l) expression with every microlitre (μ l) blood plasma.As η _Plt, Plt _CircIn processing procedure because the dilution and the dilution effect will change.Utilitarian function F1 is also by removing each blood plasma dilatation Δ ClrVol (according to instantaneous calculating η _Plt) multiply by instantaneous circulation platelet count Plt _CirThe increment of estimated value stepping ground monitoring platelet yield.The result is the increment (Δ yld) of platelet yield, is typically expressed as e ⁿPlatelet, wherein e ⁿ=0.5 * 10 ⁿPlatelet (e ¹¹=0.5 * 10 ¹¹Platelet).

At any given time, platelet yield increment Delta yld adds and constitutes current platelet yield Yld _Current, also can be expressed as following formula:

${\mathrm{Yld}}_{\mathrm{Current}}={\mathrm{Yld}}_{\mathrm{Old}}+\frac{\mathrm{\ΔClrVol}\×{\mathrm{Plt}}_{\mathrm{Cur}}}{100000}$ Formula (3)

In the formula:

Yld _OldBe the last Yld that calculates _Current,

$\mathrm{\ΔYld}=\frac{\mathrm{\ΔClrVol}\×{\mathrm{Plt}}_{\mathrm{Current}}}{100000}$ Formula (4)

In the formula:

Plt _CurrentIt is the donor's of current (instantaneous) estimation circulation platelet count.

In the formula (4) with Δ Yld divided by 100,000th, for balancing unit.

Further describe the derivation of utilitarian function F1 below to above-mentioned treatment variable.

(i) derivation total efficiency of separation η _Plt

Overall system efficiency η _PltBe to draw, be shown below by the independent efficient of system's ingredient:

η _Plt=η _1stSep* η _2ndSep* η _AncFormula (5)

In the formula:

η _1stSepBe the efficient of from WB, isolating PRP at first separation phase;

η _2ndSepBe the efficient of from PRP, isolating PC at second separation phase;

η _AncBe the efficient of other aid in treatment step of system;

1. phase I separation efficiency η _1stSep

Utilitarian function F1 is according to that detect and empirical processing costs, derivation η continuously in the entire process process _1stSep, be shown below:

${\mathrm{\η}}_{\mathrm{Sep}}=\frac{Q_p}{(1-H_b)Q_b}$ Formula (6)

In the formula:

Q _bIt is the whole blood flow velocity that detects (unit/ml/min);

Q _pIt is the PRP flow velocity that detects (unit/ml/min);

H _bIt is the apparent specific volume of whole blood that enters the interpolation anticoagulant of phase I separation chamber.H _bIt is the value that utilitarian function is derived according to the flox condition and the theoretic consideration of detection.Therefore utilitarian function F1 does not need online hematocrit sensor, to detect actual WB specific volume.

Utilitarian function F1 is according to following relation derivation H _b:

$H_b=\frac{H_{\mathrm{rbc}}(Q_b-Q_p)}{Q_b}$ Formula (7)

In the formula:

H _RbcBe according to the phase I separation chamber the working condition of detection and the apparent specific volume of the RBC in actual size draws phase I separation chamber.As H _b, utilitarian function F1 does not need actual pick off to determine H _Rbc, but derive according to following relational expression:

$H_{\mathrm{rbc}}=1-{\left(\frac{\mathrm{\β}}{g{\mathrm{A\κS}}_{\mathrm{\γ}}}(q_b-q_p)\right)}^{\frac{1}{k+1}}$ Formula (8)

In the formula:

q _bBe the blood flowing speed (cm of inlet ³/ sec), be a known quantity, when converting ml/min to, be equivalent to the Q in the formula (6) _b

q _pBe the flowing velocity (cm of the PRP of detection ³/ sec), be a known quantity, when converting ml/min to, be equivalent to the Q in the formula (6) _p

β is the shear rate continuous item, S _γBe erythrocyte sedimentation coefficient (sec).Data rule of thumb, formula is inferred β/S in (8) _γ=15.8 * 10 ⁶Sec ^-1

A is the area (cm of separation chamber ²), be a known quantity;

G is centrifugal acceleration (cm/sec ²), the radius (known quantity) that equals first separation chamber multiply by square Ω of rotary speed ²(radian per second ²Rad/sec ²) (another known quantity);

K is a viscosity constant, equals 0.625, and κ is according to k and another viscosity constant α=4.5 viscosity constants that draw:

$\mathrm{\κ}=\frac{k+2}{\mathrm{\α}}{\left(\frac{k+2}{k+1}\right)}^{k+1}=1.272$ Formula (9)

Formula (8) is to derive from the relation of facial (10) expression down:

$H_{\mathrm{rbc}}{(1-H_{\mathrm{rbc}})}^{(k+1)}=\frac{\mathrm{\β}{H}_b{q}_b}{g{\mathrm{A\κS}}_{\mathrm{\γ}}}$ Formula (10)

Following formula is published in Brown's: " physics of continuous flow centrifugation cell separation " (ThePhysics of Continuous Flow Centrifugal Cell Separation) " artificial organ " " Artificial Organs " 1989; 13 (1): 4-20.Formula (8) has solved the H in the formula (10) _Rbc

2. second stage separation efficiency η _2ndSep

Utilitarian function F1 also in the whole procedure process according to the algorithm η that derives continuously _2ndSep, this algorithm is derived from computer model, promptly calculates mark in second separation phase 32 that logarithm-normal state separation platelet of gathering is shared and their size (mean platelet volume, or MPV), flowing velocity (Q _p), (g, the radius of turn that equals second separation chamber multiply by square Ω of rotary speed for the area (A) of separation chamber 32 and centrifugal acceleration ²) function.

This algorithm can be expressed as a function, promptly uses an independent dimensionless parameters gAS _p/ Q _pExpression η _2ndSep, wherein:

S _p=1.8 * 10 ^-9MPV ^2/3(sec); With

MPV is mean platelet volume (millimicro microlitre, fl, or cu), can detect this numerical value the donor's blood sample with routine techniques collection before handling.Because use different enumerators, MPV has variation.Therefore utilitarian function can comprise the standardized question blank of the MPV that function is adopted according to employed counter type.Perhaps, can be according to from clinical platelet estimated amount Plt _PREThe Function Estimation MPV that data derive, these data utilitarian functions can be used.The inventor believes that according to his assessment to these clinical datas, the MPV function can be expressed as:

MPV(f1)≈11.5-0.009Plt _PRE(k/μl)

3. auxiliary separation efficiency η _Anc

η _AncConsider the efficient (platelet loss factor) of processing system other parts.η _AncConsider that platelet (in PRP) is transported to the efficient of second stage chamber from the phase I chamber; Carry the efficient of platelet (also in PRP) by leucocyte removal filter; The efficient of handling back platelet (in PC) resuspending and from the second stage chamber, exporting; And the efficient of in single needle or crosspointer structure, the blood of first pre-treatment being handled again.

The efficient of these aid in treatment steps can be estimated according to the clinical data estimation or according to computer model.According to these considerations, can give η with a predictive value _Anc, formula (5) in whole given program with it as constant.

B. the donor's platelet count of deriving (Plt _Circ)

Utilitarian function F1 is according to the current circulation platelet count of donor Plt in the kinetic model prediction process _CircThis model is estimated the blood volume of donation, then estimates dilution and dilution effect in the processing procedure, according to following relational expression derivation Plt _Circ:

Plt _Circ=[(Dilution) * Plt _PreThe formula of]-(Depletion) (11)

In the formula:

Plt _PreBe to handle beginning donor's circulation platelet count (k/ μ l) before, can detect these data the donor's blood sample that uses routine techniques before handling, to gather.Owing to use different enumerators, Plt _PreChange (referring to, for example, people such as Peoples " influence is used for the multiple spot research of variable of the platelet count of blood constitutent quality control " (A Multi-Site Study ofVariables Affecting Platelet Counting for Blood Component QualityControl), blood transfusion (Transfusion) (supplementary issue of making a summary in detail, 47 annual meetings) the 34th the volume 10S phase, in October, 1994 supplementary issue).Therefore, utilitarian function can comprise a question blank, makes all platelet counts that function uses (Plt for example _PreAnd Plt _Post, explanation hereinafter) and according to institute's usage counter type standardization.

Dilution is because the increase of the apparent blood circulation volume of donor that is caused by the adding of system start-up volume and anticoagulant, thereby makes donor's pretreatment circulation platelet count Plt _PreThe factor that reduces.Dilution has also considered in processing procedure, the factor that kidney is removed fluid from blood vessel continuously.

Depletion is the factor of having considered to make by processing donor's circulation platelet dilution.Depletion has considered also that in processing procedure spleen makes platelet reenter the factor that enumerator is moved.

1. estimate Dilution

Utilitarian function F1 estimates dilution gfactor according to following expression:

$\mathrm{Dilution}=1-\frac{\mathrm{Prime}+\frac{2\mathrm{ACD}}{3}-\mathrm{PPP}}{\mathrm{DonVol}}$ Formula (12)

In the formula:

Prime is the startup volume (ml) of system;

ACD be used anticoagulant volume (current or end point, as to depend on the time of deriving) (ml);

PPP be the PPP that gathers volume (current or target) (ml);

DonVol (ml) is based on donor's blood volume of the model of having considered donor's height, body weight and sex.The use experience data are further simplified these models, drawing the curve of blood volume and donor's body weight, and obtain following linear representation by linear regression:

DonVol=1024+51Wgt (r ²=0.87) formula (13)

In the formula: Wgt is donor's a body weight (kg).

2. estimate Depletion

The continuous acquisition thrombocytopenia available circulation platelet amount.First order model prediction donor platelet yield (Yld) (current or target) has reduced donor's platelet count divided by the quantity of donor's blood circulation amount (DonVol), is shown below:

$\mathrm{Depl}=\frac{100000\mathrm{Yld}}{\mathrm{DonVol}}$ Formula (14)

In the formula: Yld is the platelet yield (k/ μ l) of current instantaneous or target.In formula (14), it is for balancing unit that Yld be multiply by 100000.

Formula (14) does not consider that spleen discharges hematoblastic transfer factor, and this is called spleen and transfers the factor (or Spleen).Spleen represents that the low donor of platelet count still has a large amount of platelet and is stored in the spleen.In processing procedure, along with extract the circulation platelet out from donor's blood, spleen is discharged in the blood the hematoblastic reduction thereby partial offset circulates with the platelet that it stores.The inventor finds that although the excursion of platelet estimated amount is very big among the donor, obtainable platelet counts total among the donor obviously remains constant.Average apparent donor's amount is that 3.10 ± 0.25ml platelet is arranged in every liter of blood.Variation coefficient is 8.1%, only a little more than the variation coefficient of normal donor's hematocrit.

Transferring factor S pleen is to draw by dilution and Depl (formula (14)) contrast with actual detected, with Spleen and Plt _PreFunction construction and linearisation, express Speen (its lower limit is defined as 1) with following equation:

Spleen=[2.25-0.004Plt _Pre] 〉=1 formula (1 5)

Based on formula (14) and formula (15), it is as follows that utilitarian function derives Depletion:

$\mathrm{Depletion}=\frac{100000\mathrm{Yld}}{\mathrm{Spleen}\×\mathrm{DonVol}}$ Formula (16)

C. real-time program correction

The operator always when program begins, do not obtain every donor as thromboblast estimated amount Plt _PreUtilitarian function F1 allows system to start with the value of default parameter or previous program.Utilitarian function F1 also allows the operator to import actual platelet estimated amount Plt in program process _PreUtilitarian function F1 recomputates under certain condition the platelet yield of determining, with the make new advances value of input of reflection.Utilitarian function F1 utilizes current output to calculate and effectively removes volume, then utilizes the new current output of this volume calculation, preserves with spleen and transfers the relevant platelet estimated amount of character.

Utilitarian function F1 utilizes current output to calculate and effectively removes volume, as shown in the formula:

$\mathrm{ClrVol}=\frac{100000\×\mathrm{DonVol}\×{\mathrm{Yld}}_{\mathrm{Current}}}{(\mathrm{DonVol}-\mathrm{Prime}-\frac{\mathrm{ACD}}{3}+\frac{\mathrm{PPP}}{2})\×{\mathrm{Pre}}_{\mathrm{Old}}-\frac{50000\×{\mathrm{Yild}}_{\mathrm{Current}}}{{\mathrm{Spleen}}_{\mathrm{Old}}}}$ Formula (17)

In the formula:

ClrVol is the blood plasma volume of removing;

DonVol is donor's blood circulation volume, calculates by formula (13);

Yld _CurrentBe current platelet yield, calculate based on current treatment conditions by formula (3);

Prime be except that blood startup volume (blood-side priming volume) (ml);

ACD is the volume (ml) of used anticoagulant;

PPP is the volume (ml) of the platelet poor plasma of collection;

Pre _OldIt is the platelet count of handling before the donor who imports before the beginning handles (k/ μ l);

Spleen _OldBe that spleen is transferred the factor, use formula (16) based on Pre _OldCalculate.

Utilitarian function F1 utilizes the ClrVol that calculates by formula (17) to calculate new current output, as shown in the formula:

${\mathrm{Yld}}_{\mathrm{New}}=\left[\frac{\mathrm{DonVol}-\mathrm{Prime}-\frac{\mathrm{ACD}}{3}+\frac{\mathrm{<figure-callout\; id="2"\; label="PPP"\; filenames="C0081436000331.png"\; state="\{\{state\}\}">PPP</figure-callout>}}{2}}{\mathrm{DonVol}+\frac{\mathrm{<figure-callout\; id="2"\; label="ClrVol"\; filenames="C0081436000331.png"\; state="\{\{state\}\}">ClrVol</figure-callout>}}{2\&times;{\mathrm{Spleen}}_{\mathrm{New}}}}\right]\&times;\left[\frac{\mathrm{ClrVol}\&times;{\mathrm{Pre}}_{\mathrm{New}}}{100000}\right]$ Formula (18)

In the formula:

Pre _NewIt is the revised value of importing in the processing procedure of donor's platelet estimated amount (k/ μ l);

Yld _NewBe to have considered revised donor's platelet estimated amount Pre _NewNew platelet yield;

ClrVol is the blood plasma volume of removing, and calculates according to formula (17);

DonVol is donor's a blood circulation volume, calculates by formula (13), and is identical with formula (17);

Prime is the startup volume (ml) except that blood, and is identical with formula (17);

ACD is the volume (ml) of used anticoagulant, and is identical with formula (17);

PPP is the volume (ml) of the platelet poor plasma of collection, and is identical with formula (17);

Spleen _NewBe that spleen is transferred the factor, use formula (15) based on Pre _NewCalculate.

D. remain the processing time

Utilitarian function F2 also can calculate residue acquisition time (t _Rem) (min of unit), as follows:

$t_{\mathrm{rem}}=\frac{{\mathrm{Vb}}_{\mathrm{rem}}}{Q_b}$ Formula (19)

In the formula:

Vb _RemBe the residual volume that needs processing, calculate based on current treatment conditions by formula (19);

Q _bBe the flowing velocity of whole blood, perhaps set, perhaps derive by controller 18 by user.

E. sampled plasma

Utilitarian function F2 adds up each demand of gathering blood plasma, draws sampled plasma volume (PPP _Goal) (unit/ml), be shown below:

PPP _Goal=PPP _PC+ PPP _Source+ PPP _Reinfuse+ PPP _Waste+ PPP _CollChamFormula (20)

In the formula:

PPP _PCBe the platelet poor plasma volume of selecting that is used for the PC goods, its common default value is 250ml, perhaps also can be calculated based on current treatment conditions by controller 18;

PPP _SourceBe to gather being used to of selecting the platelet poor plasma volume of back as source blood plasma;

PPP _WasteBe select be the stand-by platelet poor plasma volumes (default value is 30ml) of various processing purposes deposit;

PPP _CollChamIt is the blood plasma volume (default value is 40ml) of gathering the chamber;

PPP _ReinfuseIt is the platelet poor plasma volume of infusion again in the processing procedure.

F. sampled plasma speed

Utilitarian function F2 is calculated as follows sampled plasma speed (Q _PPP) (unit/ml/min):

$Q_{\mathrm{PPP}}=\frac{{\mathrm{PPP}}_{\mathrm{Goal}}-{\mathrm{PPP}}_{\mathrm{Current}}}{t_{\mathrm{rem}}}$ Formula (21)

In the formula:

PPPGoal is required platelet poor plasma acquired volume (ml);

PPP _CurrentBe the platelet poor plasma gathered when front volume (ml);

t _RemBe the residue acquisition time, calculate according to current treatment conditions with formula (19).

G. the total consumption of Yu Qi AC

Utilitarian function F2 can also be calculated as follows the cumulative volume (ACD of the anticoagulant that expection is used in the processing procedure _End) (unit/ml):

${\mathrm{ACD}}_{\mathrm{End}}={\mathrm{ACD}}_{\mathrm{Current}}+\frac{Q_b\&times;{\mathrm{<figure-callout\; id="1"\; label="t\; rem"\; filenames="C0081436000331.png,C0081436000351.png"\; state="\{\{state\}\}">t</figure-callout>}}_{\mathrm{rem}}}{1+\mathrm{AC}}$ Formula (22)

In the formula:

ACD _CurrentIt is the volume (ml) of the anticoagulant of current use;

AC is the anticoagulant ratio of selecting;

Q _bBe the whole blood flowing velocity, can set, perhaps calculate according to current treatment conditions by controller 18 by user;

t _RemBe the residue acquisition time, calculate according to current treatment conditions with formula (19).

In the various feature instantiation of the present invention in the appended claim.

Claims (11)

1. blood processing system comprises:

Hardware components, it comprises whole blood pump, whole blood processing pump and separation chamber, and described separation chamber isolates erythrocyte and platelet from the blood of taking from the donor, and described separation chamber has inlet;

Controller, it is connected to described hardware components and comprises application program control and management device, gather when it is functionally regulated described hardware components and works under first mode of operation and hematoblasticly simultaneously erythrocyte is turned back to the donor, and gather platelet when regulating described hardware components and under second mode of operation, working and erythrocyte does not turn back to the donor with platelet or erythrocyte simultaneously

Described system comprises the first pipe branch road that is suitable for being connected to described donor, be connected to the described first pipe branch road to receive the extraction storage capsule of blood in the first pipe branch road, described whole blood pump is located at the appointment draw-off pump speed set according to described application program control and management device in the described first pipe branch road will be from described donor's blood transport to described extraction storage capsule, be communicated with the inlet of described separation chamber and the inlet branch road of described extraction storage capsule, described whole blood is handled pump and is located at the inlet that the designated treatment pump rate of setting according to described application program control and management device in the described inlet branch road arrives the blood transport of described extraction storage capsule described separation chamber, described system is not except by being interconnected between the inlet of described first pipe branch road and described separation chamber the described extraction storage capsule, and

Wherein, in first and second patterns, described application program control and management device is regulated described whole blood and is handled the pump continuous operation, and wherein, in described first pattern, described application program control and management device keeps first difference between described appointment draw-off pump speed and the described designated treatment pump rate, thereby being retained in preestablishing in the described extraction storage capsule in the first pattern work process handles the blood of volume and enough maintains at least one blood draw circulation and at least one follow-up blood and return and collect platelet in the cyclic process continuously, return at described blood that erythrocyte returns the donor in the cyclic process, and wherein, in described second pattern, described application program control and management device keeps second difference between described appointment draw-off pump speed and the described designated treatment pump rate to be lower than described first difference, thereby the blood that preestablishes buffer volumes that is retained in the second pattern work process in the described extraction storage capsule is less than the blood that preestablishes the processing volume, and enough maintain in the single blood draw cyclic process and collect platelet and erythrocyte simultaneously, and return circulation without any need for blood.

2. blood processing system as claimed in claim 1, from blood, isolate when it is characterized in that separation chamber's work and be substantially free of hematoblastic blood plasma, and, in first pattern, return at least one follow-up blood and in the cyclic process at least a portion to be substantially free of hematoblastic blood plasma and to turn back to the donor, in second pattern, in described single blood draw cyclic process, gather all and be substantially free of hematoblastic blood plasma.

3. blood processing system as claimed in claim 1 comprises that also a single needle is used for extracting blood out and blood being turned back to the donor from the donor.

4. blood processing system as claimed in claim 1 also comprises and remove leukocytic parts from platelet.

5. blood processing system as claimed in claim 1 also comprises and remove leukocytic parts from erythrocyte.

6. blood processing system as claimed in claim 1 also comprises and the blended blood additive solution of erythrocyte source.

7. blood processing system as claimed in claim 1, wherein said controller are included as the input equipment that is connected with described application program control and management device via interface manager that first and second patterns are set required platelet yield.

8. blood processing system as claimed in claim 1, wherein said controller are included as the input equipment that is connected with described application program control and management device via interface manager that second pattern is set required erythrocyte output.

9. blood processing system as claimed in claim 1, it is characterized in that described application program control and management device regulates described hardware components in three-mode work, the erythrocyte that a part is gathered in second pattern turns back to the donor, to reach required erythrocyte output.

10. blood processor as claimed in claim 1,

Wherein said system comprises the erythrocyte collection container receiving the erythrocyte in second mode process,

The transfer pipeline that is connected with described erythrocyte collection container;

First branch line that is connected with transfer pipeline, it comprise be equipped with for described erythrocyte collection container in first bag of the blended blood additive solution of erythrocyte;

Second branch line that is connected with transfer pipeline, it is in the first branch line downstream and comprise second bag; With

Leucocyte removal filter in second branch line is to remove leukocyte from the erythrocyte of described erythrocyte collection container.

11. blood processor as claimed in claim 10 also comprises and second bag of gas exhaust piping that is connected with transfer pipeline, is used for air from second bag of discharge, gas exhaust piping is connected in the pipeline of walking around leucocyte removal filter.

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