CN106994193B - A kind of full-automatic time-sharing multiplex protein A immunoadsorbent system of single-column - Google Patents

A kind of full-automatic time-sharing multiplex protein A immunoadsorbent system of single-column Download PDF

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Publication number
CN106994193B
CN106994193B CN201710201722.7A CN201710201722A CN106994193B CN 106994193 B CN106994193 B CN 106994193B CN 201710201722 A CN201710201722 A CN 201710201722A CN 106994193 B CN106994193 B CN 106994193B
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pipeline
blood
choked flow
pump
plasma separator
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CN201710201722.7A
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CN106994193A (en
Inventor
杨建龙
刘仲德
蒋俊杰
唐乾基
邱光
陈杰
李武明
邹志强
杨高强
陈校园
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Guangzhou Kangsheng Biotechnology Co., Ltd
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GUANGZHOU KANG HUAI BIOLOGY SCIENCE AND TECHNOLOGY Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3679Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits by absorption
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D15/00Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08Selective adsorption, e.g. chromatography
    • B01D15/10Selective adsorption, e.g. chromatography characterised by constructional or operational features
    • B01D15/16Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to the conditioning of the fluid carrier
    • B01D15/163Pressure or speed conditioning
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D15/00Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08Selective adsorption, e.g. chromatography
    • B01D15/26Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/38Selective adsorption, e.g. chromatography characterised by the separation mechanism involving specific interaction not covered by one or more of groups B01D15/265 - B01D15/36
    • B01D15/3804Affinity chromatography
    • B01D15/3809Affinity chromatography of the antigen-antibody type, e.g. protein A, G, L chromatography
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00Special media to be introduced, removed or treated
    • A61M2202/04Liquids
    • A61M2202/0413Blood
    • A61M2202/0415Plasma

Abstract

A kind of full-automatic time-sharing multiplex protein A immunoadsorbent system of single-column, including one end of the first pipeline are connect with patient, and the other end is sequentially connected one end of access plasma separator after heparin pump, blood pump;The plasma separator is terminated with the second pipeline away from the one of the first pipeline, and second pipeline is connect after being sequentially connected plasma separator, liquid level detector, air-foam detector, choked flow folder K1 with patient;Third pipeline is connected on the outside of the plasma separator, the 4th pipeline accesses the liquid level detector after being sequentially connected absorber, waste fluid container, choked flow folder K6, and the waste fluid container presss from both sides K7 and the third piping connection by choked flow.Advantage is the system of independent completion;All treatments are completed using single-column;Greatly reduce the adsorption column use cost of patient.

Description

A kind of full-automatic time-sharing multiplex protein A immunoadsorbent system of single-column
Technical field
The present invention relates to medical instruments fields, and in particular to a kind of full-automatic time-sharing multiplex albumin A of single-column is immune to be inhaled Attached system.
Background technology
Immuno absorbence is emerging a kind of blood purification method in recent ten years, it is sent out on the basis of plasma exchange Exhibition, clinically for treating autoimmune disease and some conventional methods immune mediating disease hard to work Disease.
The basic principle of immuno absorbence be using antigen, antibody or certain substances with specific physical chemistry affinity as Aglucon is combined with carrier, and immunosorbent is made, and utilizes its specific adsorption performance, selectivity or specifically removing patient's blood Virulence factor in liquid, to achieve the purpose that purify blood, alleviate the state of an illness.
There are many existing immunosorbent type, according to the action principle between adsorbent and absorbate, can be divided into life Object affinity adsorbent and physical chemistry affinity adsorbent.The former specificity is high, but preparation, sterilizing and storage request are high;The latter is special It is anisotropic poor, but preparation is convenient, activity stabilized.
And existing adsorbent is also many with sill, but be actually used in clinical and few.The confession developed at present The immunosorbent of Clinical practice is most widely used with sill with staphylococcal protein A.
Staphylococcal protein A is a kind of protein ingredient of certain staphylococcus aureus strains cell walls, is single chain polypeptide Structure is made of 7-10 kind amino acid, and molecular mass is 42000 dalton, it has now been found that albumin A amino terminal has 4 height Similar Fc sections combined area, can be special with the Fc sections of immunoglobulin (mainly IgG) molecule and CIC ELISA (CIC) Property combine, and carboxyl terminal is then connected with cell wall.It, can be by urea, thiocyanic acid after albumin A is combined with IgG and CIC The separation such as salt, acid or guanine hydrochlorate.Using albumin A it is this not only can with IgG specifically bind again can by Cucumber dissociation Feature can remove the pathogenic immune globulin or immune complex of patient's body, to achieve the purpose that the certain diseases for the treatment of.
But at present temporarily without independent special equipment in global range, it is both needed to combine auxiliary operation, nothing by other equipment Method realizes that therapeutic process is not necessarily to human assistance (intervention), and treatment much needs the index monitored not monitor simultaneously, safety Cause anxiety.Example:The CITEM10 needs of Excorim companies of Sweden are used cooperatively with PEM10, and are Double-pillar.Domestic typical usage: 1. hemo system accommodation uses 2 absorption of needs using 2. hemo systems+blood pump or perfusion machine+blood pump or CRRT machines, wherein twin columns machine Column, since adsorption column cost is very high, the financial burden of making patients.
Invention content
The purpose of the present invention is overcoming the above-mentioned prior art, the albumin A for providing a dedicated independent completion is exempted from Epidemic disease adsorption system need to rely on the cooperation of the ancillary equipments such as hemo system, CRRT machines, blood pump when other systems being avoided to work.This system With perfect monitoring, it is ensured that use the safety of process.The present invention also by single suction adnexa be automatically performed including treatment, elution, The working cycles such as balance, preliminary filling are not necessarily to any manual intervention.Reduce the adsorption column use cost of patient.
The present invention is achieved through the following technical solutions:A kind of full-automatic time-sharing multiplex Protein A immunoadsorption of single-column System, including one end of the first pipeline are connect with patient, and the other end accesses plasma separator after being sequentially connected heparin pump, blood pump One end;The plasma separator is terminated with the second pipeline away from the one of the first pipeline, and second pipeline is sequentially connected blood It is connect with patient after slurry separator, liquid level detector, air-foam detector, choked flow folder K1;It is connect on the outside of the plasma separator Have a third pipeline, the third pipeline be sequentially connected choked flow folder K2, physiological saline container, balance liquid container, eluate container, Absorber is accessed after blood plasma pump, the physiological saline container presss from both sides K3 and the third piping connection by choked flow, described Balance liquid container and K4 and the third piping connection pressed from both sides by choked flow, the eluate container by choked flow press from both sides K5 with it is described Third piping connection;The absorber is terminated with the 4th pipeline, the described the 4th pipe away from the one of the third pipeline The liquid level detector is accessed in road after being sequentially connected absorber, waste fluid container, choked flow folder K6, and the waste fluid container passes through resistance Stream folder K7 and the 4th piping connection.
As an improvement, first pipeline is equipped with pressure gauge P1, the pressure gauge P1 be located at the blood pump and Between plasma separator.
As an improvement, second pipeline, which is equipped with pressure gauge P2, the pressure gauge P2, is located at the liquid level inspection It surveys between device and plasma separator.
As an improvement, the third pipeline is equipped with pressure gauge P3, pressure gauge P4, the pressure gauge P3 are located at described Eluate container and blood plasma pump between;The pressure gauge P4 is between the blood plasma pump and absorber.
As an improvement, the rotating speed of the blood plasma pump is the 25%-35% of blood pump.
The invention has the advantages that:
1. the system of independent completion does not depend on other equipment independent operating, perfect safety precautions, while including blood Starch separator column pressure, plasma separator transmembrane pressure, blood circuit vein pressure, absorber column pressure, bloody path side liquid level, bubble detection, Anti-coagulants sky liquid and occlusion detection.
2. completing all treatments using single-column;Greatly reduce the adsorption column use cost of patient.And therapeutic process is whole Automation, mitigates the labor intensity of operating personnel, the human accident for avoiding the error due to operating personnel from causing.
3. blood pump and the locking of blood plasma pump rotating speed ratio, synchronous adjustable function in adsorption process.It avoids due to individually adjusting blood Plasma separator transmembrane pressure exceeds tolerance band caused by pump or blood plasma pump, improves the reliability of system.
Description of the drawings
Fig. 1 is a kind of structure principle chart of the full-automatic time-sharing multiplex protein A immunoadsorbent system of single-column of the present invention.
Specific implementation mode
Embodiment
As shown in Figure 1, a kind of full-automatic time-sharing multiplex protein A immunoadsorbent system of single-column, includes one end of the first pipeline 1 It is connect with patient, the other end is sequentially connected one end of access plasma separator 4 after heparin pump 2, blood pump 3;The blood plasma separation Device 4 is terminated with the second pipeline 5 away from the one of the first pipeline 1, and second pipeline 5 is sequentially connected plasma separator 4, liquid level inspection It is connect with patient after surveying device 6, air-foam detector 7, choked flow folder K1;The outside of the plasma separator 4 is connected to third pipeline 8, The third pipeline 8 is sequentially connected choked flow folder K2, physiological saline container 9, balance liquid container 10, eluate container 11, blood plasma Absorber 13 is accessed after pump 12, the physiological saline container 9 presss from both sides K3 by choked flow and connect with the third pipeline 8, described Balance liquid container 10 by choked flow press from both sides K4 connect with the third pipeline 8, the eluate container 11 is pressed from both sides by choked flow K5 is connect with the third pipeline 8;The absorber 13 is terminated with the 4th pipeline away from the one of the third pipeline 8 14, the 4th pipeline 14 accesses the liquid level detector after being sequentially connected absorber 13, waste fluid container 15, choked flow folder K6 6, the waste fluid container 15 presss from both sides K7 by choked flow and is connect with the 4th pipeline 14.First pipeline 1 is equipped with pressure Power table P1, the pressure gauge P1 is between the blood pump 3 and plasma separator 4.Second pipeline 5 is equipped with pressure Power table P2, the pressure gauge P2 is between the liquid level detector 6 and plasma separator 4.On the third pipeline 8 Equipped with pressure gauge P3, pressure gauge P4, the pressure gauge P3 is between the eluate container 11 and blood plasma pump 12;It is described Pressure gauge P4 between the blood plasma pump 12 and absorber 13.The rotating speed of the blood plasma pump 12 is the 25%- of blood pump 3 35%.
Operation principle:Blood lateral body external circulation line:Blood is drawn through the first pipeline 1 by patient's body, is added through heparin pump 2 After adding anti-coagulants, it is pumped to plasma separator 4 through blood pump 3, is examined by liquid level through the second pipeline 5 by the blood of plasma separator 4 Device 6, air-foam detector 7 are surveyed, defeated time patient's body of K1 is pressed from both sides in choked flow.The blood of blood side is drawn will not with defeated time entire therapeutic process Stop.3 pump speed of blood pump can adjust in a certain range at any time, to adapt to the opportunity situation of patient.It is normal in all detection devices In the case of, K1 openings are pressed from both sides in choked flow, so that blood smoothly flows back, after detection device sends out alarm or exception information, close resistance Stream folder K1 and blood pump 3, the anti-unexpected reflux of Hemostatic Oral Liquid ensure the treatment safety of patient.
The power of blood plasma side be blood plasma pump 12, entire therapeutic process be divided into according to timeslice samsara draw slurry absorption overfall wash It is de- to balance six periods of preliminary filling again,
Draw the slurry stage:Ensure blood side normal operation, open choked flow and press from both sides K7, K2, closes choked flow and press from both sides K6, K3, K4, K5, it will The blood plasma that plasma separator 4 is isolated is full of pipeline C, absorber 13, the 4th pipeline 14, the preparation stage preliminary filling in discharge line Physiological saline, prepare for next adsorbing therapy.
Absorption phase:Ensure blood side normal operation, open choked flow and press from both sides K6, K2, closes choked flow and press from both sides K7, K3, K4, K5, it will The blood plasma that plasma separator 4 is isolated full of pipeline C, absorber 13,13 purified blood plasma of absorber via the 4th pipeline 14, Choked flow folder K6 is back to the second pipeline 5 and converges rear defeated time patient's body with blood.
The overfall stage:Ensure blood side normal operation, open choked flow and press from both sides K6, K3, closes choked flow and press from both sides K7, K2, K4, K5, it will Physiological saline in physiological saline container 9 is gradually filled with pipeline C, absorber 13, the 4th pipeline 14, by pipeline C, the 4th pipeline 14 Interior blood plasma is back to blood lateral vein pot via choked flow folder K6 and converges rear defeated time patient's body with blood.
Elution stage:Ensure blood side normal operation, open choked flow and press from both sides K7, K5, closes choked flow and press from both sides K6, K2, K3, K4, it will Eluent in eluate container 11 is gradually filled with pipeline C, absorber 13, the 4th pipeline 14, is emitted into via choked flow folder K7 useless Liquid container 15.
Equilibrium stage:Ensure blood side normal operation, open choked flow and press from both sides K7, K4, closes choked flow and press from both sides K6, K2, K3, K5, it will Equilibrium liquid in balance liquid container 10 is gradually filled with pipeline C, absorber 13, the 4th pipeline 14, is emitted into via choked flow folder K7 useless Liquid container 15.
Charging stage again:Ensure blood side normal operation, open choked flow and press from both sides K7, K3, closes choked flow and press from both sides K6, K2, K4, K5, Physiological saline in physiological saline container 9 is gradually filled with the 4th pipeline 14 of pipeline C absorbers 13, is emitted into via choked flow folder K7 Waste fluid container 15.
The above treatment circulation is repeated until equipment completes preset absorption number, the entire treatment of completion.
Above-listed detailed description is illustrating for possible embodiments of the present invention, which is not to limit this hair Bright the scope of the claims, all equivalence enforcements or change without departing from carried out by the present invention are intended to be limited solely by the scope of the claims of this case.

Claims (1)

1. a kind of full-automatic time-sharing multiplex protein A immunoadsorbent system of single-column, it is saturating that the system independent operating does not depend on blood Analysis machine, CRRT machines, therapeutic process are full-automatic, which is characterized in that one end of the first pipeline is connect with patient, and the other end connects successively Connect one end that plasma separator is accessed after heparin pump, blood pump;The plasma separator is terminated with the away from the one of the first pipeline Two pipelines, second pipeline be sequentially connected plasma separator, liquid level detector, air-foam detector, choked flow folder K1 after with trouble Person connects;Third pipeline is connected on the outside of the plasma separator, the third pipeline is sequentially connected choked flow folder K2, physiology Absorber is accessed after saline container, balance liquid container, eluate container, blood plasma pump, the physiological saline container passes through choked flow K3 and the third piping connection are pressed from both sides, the balance liquid container presss from both sides K4 and the third piping connection, institute by choked flow The eluate container stated presss from both sides K5 and the third piping connection by choked flow;The absorber deviates from the third pipeline One be terminated with the 4th pipeline, the 4th pipeline be sequentially connected access after absorber, waste fluid container, choked flow folder K6 it is described Liquid level detector, the waste fluid container press from both sides K7 and the 4th piping connection by choked flow;It is set on first pipeline There is pressure gauge P1, the pressure gauge P1 is between the blood pump and plasma separator;Second pipeline is equipped with Pressure gauge P2, the pressure gauge P2 is between the liquid level detector and plasma separator;On the third pipeline Equipped with pressure gauge P3, pressure gauge P4, the pressure gauge P3 is between the eluate container and blood plasma pump;The pressure Power table P4 is between the blood plasma pump and absorber;
The system includes plasma separator column pressure, plasma separator transmembrane pressure, blood circuit vein pressure and absorber column pressure Detection, including the detection of bloody path side liquid level, bubble, anti-coagulants sky liquid and occlusion detection;
The rotating speed of the blood plasma pump is the 25%-35% of blood pump, the blood pump described in adsorption process and blood plasma pump rotating ratio Example locking synchronizes adjustable, and blood pump rotating speed can be adapted to status of patient in a certain range at any time.
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CN110624150A (en) * 2019-10-24 2019-12-31 常州市第一人民医院 Plasma separation protein A immunoadsorption device

Citations (2)

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Publication number Priority date Publication date Assignee Title
CN2822644Y (en) * 2005-07-13 2006-10-04 缪志俊 Protein A immunoadsorbent system
CN104721897A (en) * 2013-12-18 2015-06-24 甘布罗伦迪亚股份公司 An Apparatus For Extracorporeal Blood Treatment And A Control Method Therefor

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DE3927633C1 (en) * 1989-08-22 1990-10-04 Fresenius Ag, 6380 Bad Homburg, De
DE102005007372A1 (en) * 2005-02-17 2006-08-24 Fresenius Medical Care Deutschland Gmbh Device for eliminating substances from liquids, in particular blood

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN2822644Y (en) * 2005-07-13 2006-10-04 缪志俊 Protein A immunoadsorbent system
CN104721897A (en) * 2013-12-18 2015-06-24 甘布罗伦迪亚股份公司 An Apparatus For Extracorporeal Blood Treatment And A Control Method Therefor

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Address after: 510530 No. 8 Shenzhou street, Science City, Guangzhou hi tech Industrial Development Zone, Guangdong, Guangzhou

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