CN116400014A - Anticoagulation test system and test method for extracorporeal circulation dialysis pipeline - Google Patents
Anticoagulation test system and test method for extracorporeal circulation dialysis pipeline Download PDFInfo
- Publication number
- CN116400014A CN116400014A CN202310259463.9A CN202310259463A CN116400014A CN 116400014 A CN116400014 A CN 116400014A CN 202310259463 A CN202310259463 A CN 202310259463A CN 116400014 A CN116400014 A CN 116400014A
- Authority
- CN
- China
- Prior art keywords
- dialysis
- assembly
- circulation
- blood
- fluid
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 238000000502 dialysis Methods 0.000 title claims abstract description 150
- 230000004087 circulation Effects 0.000 title claims abstract description 117
- 238000012360 testing method Methods 0.000 title claims abstract description 105
- 230000010100 anticoagulation Effects 0.000 title claims abstract description 72
- 238000010998 test method Methods 0.000 title claims description 8
- 239000012530 fluid Substances 0.000 claims abstract description 141
- 210000004369 blood Anatomy 0.000 claims abstract description 107
- 239000008280 blood Substances 0.000 claims abstract description 107
- 230000017531 blood circulation Effects 0.000 claims abstract description 55
- 238000004088 simulation Methods 0.000 claims abstract description 49
- 238000005070 sampling Methods 0.000 claims abstract description 32
- 238000000034 method Methods 0.000 claims abstract description 18
- 238000003860 storage Methods 0.000 claims abstract description 13
- 238000005086 pumping Methods 0.000 claims abstract description 10
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 claims description 49
- 229910052760 oxygen Inorganic materials 0.000 claims description 49
- 239000001301 oxygen Substances 0.000 claims description 49
- 238000001914 filtration Methods 0.000 claims description 33
- 238000001514 detection method Methods 0.000 claims description 24
- 239000012528 membrane Substances 0.000 claims description 17
- 230000015271 coagulation Effects 0.000 claims description 15
- 238000005345 coagulation Methods 0.000 claims description 15
- 230000008569 process Effects 0.000 claims description 12
- 239000007789 gas Substances 0.000 claims description 11
- 238000004891 communication Methods 0.000 claims description 9
- 238000002156 mixing Methods 0.000 claims description 9
- 229920000669 heparin Polymers 0.000 claims description 6
- HTTJABKRGRZYRN-UHFFFAOYSA-N Heparin Chemical compound OC1C(NC(=O)C)C(O)OC(COS(O)(=O)=O)C1OC1C(OS(O)(=O)=O)C(O)C(OC2C(C(OS(O)(=O)=O)C(OC3C(C(O)C(O)C(O3)C(O)=O)OS(O)(=O)=O)C(CO)O2)NS(O)(=O)=O)C(C(O)=O)O1 HTTJABKRGRZYRN-UHFFFAOYSA-N 0.000 claims description 5
- 229960002897 heparin Drugs 0.000 claims description 5
- 238000004140 cleaning Methods 0.000 claims description 3
- 238000013022 venting Methods 0.000 claims description 2
- 230000000694 effects Effects 0.000 description 13
- 108010049003 Fibrinogen Proteins 0.000 description 10
- 102000008946 Fibrinogen Human genes 0.000 description 10
- 229940012952 fibrinogen Drugs 0.000 description 10
- 239000007788 liquid Substances 0.000 description 8
- PGOHTUIFYSHAQG-LJSDBVFPSA-N (2S)-6-amino-2-[[(2S)-5-amino-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-4-amino-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-5-amino-2-[[(2S)-5-amino-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S,3R)-2-[[(2S)-5-amino-2-[[(2S)-2-[[(2S)-2-[[(2S,3R)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-5-amino-2-[[(2S)-1-[(2S,3R)-2-[[(2S)-2-[[(2S)-2-[[(2R)-2-[[(2S)-2-[[(2S)-2-[[2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-1-[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-amino-4-methylsulfanylbutanoyl]amino]-3-(1H-indol-3-yl)propanoyl]amino]-5-carbamimidamidopentanoyl]amino]propanoyl]pyrrolidine-2-carbonyl]amino]-3-methylbutanoyl]amino]-4-methylpentanoyl]amino]-4-methylpentanoyl]amino]acetyl]amino]-3-hydroxypropanoyl]amino]-4-methylpentanoyl]amino]-3-sulfanylpropanoyl]amino]-4-methylsulfanylbutanoyl]amino]-5-carbamimidamidopentanoyl]amino]-3-hydroxybutanoyl]pyrrolidine-2-carbonyl]amino]-5-oxopentanoyl]amino]-3-hydroxypropanoyl]amino]-3-hydroxypropanoyl]amino]-3-(1H-imidazol-5-yl)propanoyl]amino]-4-methylpentanoyl]amino]-3-hydroxybutanoyl]amino]-3-(1H-indol-3-yl)propanoyl]amino]-5-carbamimidamidopentanoyl]amino]-5-oxopentanoyl]amino]-3-hydroxybutanoyl]amino]-3-hydroxypropanoyl]amino]-3-carboxypropanoyl]amino]-3-hydroxypropanoyl]amino]-5-oxopentanoyl]amino]-5-oxopentanoyl]amino]-3-phenylpropanoyl]amino]-5-carbamimidamidopentanoyl]amino]-3-methylbutanoyl]amino]-4-methylpentanoyl]amino]-4-oxobutanoyl]amino]-5-carbamimidamidopentanoyl]amino]-3-(1H-indol-3-yl)propanoyl]amino]-4-carboxybutanoyl]amino]-5-oxopentanoyl]amino]hexanoic acid Chemical compound CSCC[C@H](N)C(=O)N[C@@H](Cc1c[nH]c2ccccc12)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](C)C(=O)N1CCC[C@H]1C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(C)C)C(=O)NCC(=O)N[C@@H](CO)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CS)C(=O)N[C@@H](CCSC)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H]([C@@H](C)O)C(=O)N1CCC[C@H]1C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CO)C(=O)N[C@@H](CO)C(=O)N[C@@H](Cc1cnc[nH]1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](Cc1c[nH]c2ccccc12)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CO)C(=O)N[C@@H](CC(O)=O)C(=O)N[C@@H](CO)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](Cc1ccccc1)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](Cc1c[nH]c2ccccc12)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CCCCN)C(O)=O PGOHTUIFYSHAQG-LJSDBVFPSA-N 0.000 description 5
- 108010094028 Prothrombin Proteins 0.000 description 5
- 102100027378 Prothrombin Human genes 0.000 description 5
- 108090000190 Thrombin Proteins 0.000 description 5
- 108010000499 Thromboplastin Proteins 0.000 description 5
- 102000002262 Thromboplastin Human genes 0.000 description 5
- 239000002245 particle Substances 0.000 description 5
- 229940039716 prothrombin Drugs 0.000 description 5
- 230000001105 regulatory effect Effects 0.000 description 5
- 229960004072 thrombin Drugs 0.000 description 5
- CURLTUGMZLYLDI-UHFFFAOYSA-N Carbon dioxide Chemical compound O=C=O CURLTUGMZLYLDI-UHFFFAOYSA-N 0.000 description 4
- 230000002439 hemostatic effect Effects 0.000 description 3
- 238000012546 transfer Methods 0.000 description 3
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 description 2
- 208000007536 Thrombosis Diseases 0.000 description 2
- 239000002585 base Substances 0.000 description 2
- 210000001772 blood platelet Anatomy 0.000 description 2
- 239000001569 carbon dioxide Substances 0.000 description 2
- 229910002092 carbon dioxide Inorganic materials 0.000 description 2
- 230000006866 deterioration Effects 0.000 description 2
- 238000010586 diagram Methods 0.000 description 2
- 238000004090 dissolution Methods 0.000 description 2
- 210000003743 erythrocyte Anatomy 0.000 description 2
- 239000012535 impurity Substances 0.000 description 2
- 210000000265 leukocyte Anatomy 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 230000000087 stabilizing effect Effects 0.000 description 2
- 102000015081 Blood Coagulation Factors Human genes 0.000 description 1
- 108010039209 Blood Coagulation Factors Proteins 0.000 description 1
- MYMOFIZGZYHOMD-UHFFFAOYSA-N Dioxygen Chemical compound O=O MYMOFIZGZYHOMD-UHFFFAOYSA-N 0.000 description 1
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 1
- 238000009825 accumulation Methods 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 230000006978 adaptation Effects 0.000 description 1
- 239000003513 alkali Substances 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 description 1
- 239000003114 blood coagulation factor Substances 0.000 description 1
- 210000004027 cell Anatomy 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 238000007599 discharging Methods 0.000 description 1
- 238000009826 distribution Methods 0.000 description 1
- 239000003792 electrolyte Substances 0.000 description 1
- 230000004907 flux Effects 0.000 description 1
- 239000008103 glucose Substances 0.000 description 1
- 238000001631 haemodialysis Methods 0.000 description 1
- 230000000322 hemodialysis Effects 0.000 description 1
- ZFGMDIBRIDKWMY-PASTXAENSA-N heparin Chemical compound CC(O)=N[C@@H]1[C@@H](O)[C@H](O)[C@@H](COS(O)(=O)=O)O[C@@H]1O[C@@H]1[C@@H](C(O)=O)O[C@@H](O[C@H]2[C@@H]([C@@H](OS(O)(=O)=O)[C@@H](O[C@@H]3[C@@H](OC(O)[C@H](OS(O)(=O)=O)[C@H]3O)C(O)=O)O[C@@H]2O)CS(O)(=O)=O)[C@H](O)[C@H]1O ZFGMDIBRIDKWMY-PASTXAENSA-N 0.000 description 1
- 229960001008 heparin sodium Drugs 0.000 description 1
- 239000012510 hollow fiber Substances 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 230000003993 interaction Effects 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 230000007246 mechanism Effects 0.000 description 1
- 239000002207 metabolite Substances 0.000 description 1
- 229910052751 metal Inorganic materials 0.000 description 1
- 239000002184 metal Substances 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000011056 performance test Methods 0.000 description 1
- 230000002093 peripheral effect Effects 0.000 description 1
- 239000002504 physiological saline solution Substances 0.000 description 1
- 238000000746 purification Methods 0.000 description 1
- 238000005096 rolling process Methods 0.000 description 1
- 235000017557 sodium bicarbonate Nutrition 0.000 description 1
- 229910000030 sodium bicarbonate Inorganic materials 0.000 description 1
- 230000003068 static effect Effects 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 238000000108 ultra-filtration Methods 0.000 description 1
- 238000005406 washing Methods 0.000 description 1
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
- A61M1/1621—Constructional aspects thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
- A61M1/1621—Constructional aspects thereof
- A61M1/165—Constructional aspects thereof with a dialyser bypass on the dialysis fluid line
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
- A61M1/3621—Extra-corporeal blood circuits
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
- A61M1/3672—Means preventing coagulation
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01M—TESTING STATIC OR DYNAMIC BALANCE OF MACHINES OR STRUCTURES; TESTING OF STRUCTURES OR APPARATUS, NOT OTHERWISE PROVIDED FOR
- G01M13/00—Testing of machine parts
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/86—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood coagulating time or factors, or their receptors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3327—Measuring
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Engineering & Computer Science (AREA)
- Hematology (AREA)
- Vascular Medicine (AREA)
- Biomedical Technology (AREA)
- Urology & Nephrology (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Anesthesiology (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- General Physics & Mathematics (AREA)
- Physics & Mathematics (AREA)
- Immunology (AREA)
- Emergency Medicine (AREA)
- Medicinal Chemistry (AREA)
- Analytical Chemistry (AREA)
- Biochemistry (AREA)
- Cardiology (AREA)
- Food Science & Technology (AREA)
- Pathology (AREA)
- Molecular Biology (AREA)
- Biotechnology (AREA)
- Cell Biology (AREA)
- Microbiology (AREA)
- External Artificial Organs (AREA)
Abstract
The invention relates to an anticoagulation test system and method for an extracorporeal circulation dialysis pipeline. The anticoagulation test system comprises: the dialysis test pipeline device comprises a dialysis circulation pipeline assembly and a sampling pipeline assembly, wherein the sampling pipeline assembly is used for collecting fluid circulating in the dialysis circulation pipeline assembly. The blood circulation simulation device comprises a pumping pressure component, a heat exchanger device and an oxygenator device, wherein the blood storage device comprises a first input port, a second input port and a flow dividing piece, the dialysis circulation pipeline component is connected with the first input port and the flow dividing piece, the oxygenator device is connected with the second input port, the pumping pressure component is connected to the flow dividing piece, and fluid flowing in the dialysis circulation pipeline component and fluid flowing in the blood circulation simulation device are mixed in the blood storage device. The blood circulation simulation device can simulate the circulation of human blood so as to keep the test conditions of the extracorporeal circulation dialysis pipeline anticoagulation test system to accord with the clinical use state.
Description
Technical Field
The invention relates to the technical field of testing, in particular to an anticoagulation testing system and an anticoagulation testing method for an extracorporeal circulation dialysis pipeline.
Background
The extracorporeal circulation dialysis pipeline is used for filtering and purifying blood, eliminating or reducing metabolites and harmful substances carried in the blood, maintaining the balance of electrolyte and acid and alkali so that various indexes of the blood accord with normal human body demand parameters, and the purified blood is returned to the human body to meet the normal circulation demands of the human body.
Chinese patent CN109498874a relates to an extracorporeal circulation pipeline for venous hemodialysis, including dialysis joint, pressure sensor, venous drip room, second hemostatic clip, puncture needle tube way attach fitting, third hose, fifth hose and female needle base branch pipeline, dialysis joint's liquid outlet with pressure sensor's inlet is connected, pressure sensor's liquid outlet with venous drip room's inlet passes through third hose connection, venous drip room's liquid outlet passes through fifth hose with puncture needle tube way attach fitting connection, venous drip room's upper end is equipped with first branch pipe interface, female needle base branch pipeline's liquid outlet end with first branch pipe interface connection, second hemostatic clip set up in on the fifth hose.
In the development process, the extracorporeal circulation dialysis pipeline needs to be tested for various indexes, for example, the extracorporeal circulation dialysis pipeline needs to be tested for anticoagulation. The existing test blood circulates along the extracorporeal circulation dialysis pipeline for a plurality of times to complete the anticoagulation test. However, even if the extracorporeal circulation dialysis pipeline is tested under the set temperature condition, the blood storage mechanism for the extracorporeal circulation dialysis pipeline is of a static structure, the internal circulation of a human body cannot be simulated, and the actual clinical use state of the extracorporeal circulation dialysis pipeline is not consistent in index parameters after the blood circulation for the extracorporeal circulation, and the anticoagulation detection of the extracorporeal circulation dialysis pipeline is inaccurate, so that improvement is needed.
Disclosure of Invention
In order to overcome the problems in the related art, the embodiment of the invention provides an anticoagulation test system and a anticoagulation test method for an extracorporeal circulation dialysis pipeline.
According to an embodiment of the invention, an anticoagulation test system for an extracorporeal circulation dialysis pipeline comprises:
the dialysis test pipeline device comprises a dialysis circulation pipeline assembly and a sampling pipeline assembly connected to the dialysis circulation pipeline assembly, wherein the sampling pipeline assembly is used for collecting fluid circulating in the dialysis circulation pipeline assembly;
the blood circulation simulation device comprises a pumping pressure assembly, a heat exchanger device and an oxygenator device which are connected through a conduit, wherein the heat exchanger device is used for adjusting the temperature of the flowing fluid in the blood circulation simulation device, and the oxygenator device is used for adjusting the oxygen content of the flowing fluid in the blood circulation simulation device;
the blood storage device comprises a first input port, a second input port and a flow dividing piece, the dialysis circulation pipeline assembly is connected with the first input port and the flow dividing piece, the oxygenator device is connected with the second input port, the pumping pressure assembly is connected to the flow dividing piece, and fluid circulating in the dialysis circulation pipeline assembly and fluid circulating in the blood circulation simulation device are mixed in the blood storage device.
In one embodiment, the blood reservoir device comprises a housing, a filter assembly mounted in the housing, a blood reservoir is formed between the housing and the filter assembly, the first input port and the second input port are in communication with the filter assembly, and the shunt is in communication with the blood reservoir.
In an embodiment, the filter assembly comprises at least one filter membrane bag for filtering fluid input from the first input port or the second input port.
In an embodiment, the dialysis test pipeline assembly comprises a joint pipe assembly, a dialysis pump pressure assembly, an exhaust assembly and a test pipe group which are sequentially connected through pipelines, wherein the joint pipe assembly is communicated with the blood reservoir device, the sampling pipeline assembly is connected with the joint pipe assembly, the dialysis pump pressure assembly drives fluid in the dialysis test pipeline device to circulate according to a preset pump pressure value, and the exhaust assembly exhausts gas of the fluid in the circulation process of the dialysis test pipeline device.
In one embodiment, the exhaust assembly includes a drip chamber and an exhaust fitting connected to the drip chamber, the dialysis pump pressure assembly line is connected to the drip chamber, and the exhaust fitting controls the fluid level within the drip chamber based on venting gas above the fluid level of the drip chamber.
In an embodiment, the blood circulation simulation device further comprises a blood oxygen detection branch, and the blood oxygen detection branch is arranged at the output end pipeline of the oxygenator device.
In one embodiment, the apparatus further comprises an oxygen content regulator connected to the oxygenator device, the oxygen content regulator regulating the oxygen concentration based on the detection value of the blood oxygen detection branch.
The invention also discloses a test method for anticoagulation of the extracorporeal circulation dialysis pipeline, which uses the extracorporeal circulation dialysis pipeline anticoagulation test system, and comprises the following steps:
the fluid circulating circulation is guided through a dialysis circulating pipeline assembly, and the fluid circulating in the dialysis circulating pipeline assembly is collected through the sampling pipeline assembly;
delivering a fluid of a preset pressure value to the heat exchanger device and the oxygenator device through a pumping assembly;
delivering the fluid flowing through the dialysis circulation pipeline assembly and the blood circulation simulation device to a blood storage device for filtering and mixing;
the filtered and mixed fluid flows into a dialysis circulation pipeline assembly and the blood circulation simulation device respectively;
the above steps are sequentially circulated.
In one embodiment, the method comprises the steps of:
collecting fluid circulating in the dialysis circulation pipeline assembly through the sampling pipeline assembly at fixed time;
and (5) performing coagulation index detection.
In one embodiment, the method comprises the steps of: and pre-cleaning the dialysis test pipeline device by heparin fluid before the extracorporeal circulation dialysis pipeline anticoagulation test system is operated.
The technical scheme provided by the embodiment of the invention can comprise the following beneficial effects: the blood circulation simulation device can simulate the circulation of human blood so as to keep the test conditions of the extracorporeal circulation dialysis pipeline anticoagulation test system to accord with the clinical use state, and can accurately acquire anticoagulation test parameters of the dialysis test pipeline device, and has good simulation effect. The extracorporeal circulation dialysis pipeline anticoagulation test system collects fluid circulated in the system through the sampling pipeline assembly, and then detects various parameters in a fluid sample through the detection instrument, so that various coagulation index parameters are obtained, and the detection accuracy is high. The fluid circulated in the dialysis test pipeline device and the blood circulation simulation device is mixed in the blood storage device, so that mixed fluid is formed, the human body dialysis process is simulated, and the simulation effect is good.
It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention as claimed.
Drawings
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments consistent with the invention and together with the description, serve to explain the principles of the invention.
Fig. 1 is a schematic diagram of an anticoagulation test system according to an exemplary embodiment.
Fig. 2 is a schematic fluid flow diagram of an anticoagulation test system according to an exemplary embodiment.
Fig. 3 is a schematic cross-sectional structural view of a blood reservoir device according to an exemplary embodiment.
Fig. 4 is a schematic cross-sectional view of a blood reservoir device with a fluid guiding rack according to an exemplary embodiment.
Fig. 5 is a schematic transverse cross-sectional view of a blood reservoir device according to an exemplary embodiment.
Fig. 6 is a schematic cross-sectional structural view of another blood reservoir device, according to an exemplary embodiment.
Fig. 7 is a schematic cross-sectional view of a heat exchanger device according to an exemplary embodiment.
In the drawings, a dialysis test line set 10; a dialysis circuit assembly 11; a joint pipe assembly 111; a multi-path junction 1111; a dialysis pump assembly 112; an exhaust assembly 113; a test tube set 114; a sampling line assembly 12; a delivery tube 121; a sampling seal assembly 122; a blood reservoir device 20; a first input port 21; a second input port 22; a flow divider 23; a main channel 231; a filter assembly 24; a first filter bag 241; a second filter bag 242; a housing 25; a blood reservoir 251; spiral guide groove 252; a guide frame 26; a diversion curved surface 261; cylindrical extension 262; a diversion gap 263; a draft tube 264; spiral groove 265; a filtering membrane 27; a blood circulation simulator 30; a pump assembly 31; a heat exchanger device 32; a flow directing assembly 321; a fluid input channel 3211; a fluid output channel 3212; a diversion aperture 3213; a baffle 3214; a thermally conductive assembly 322; a heat conduction pipe 3221; a heat exchange shell 323; an oxygenator device 33; an oxygen content regulator 34; blood oxygen detection branch 35.
Detailed Description
Wherein the drawings are for illustrative purposes only and are shown in schematic, non-physical, and not intended to be limiting of the present patent; for the purpose of better illustrating embodiments of the invention, certain elements of the drawings may be omitted, enlarged or reduced and do not represent the size of the actual product; it will be appreciated by those skilled in the art that certain well-known structures in the drawings and descriptions thereof may be omitted.
The same or similar reference numbers in the drawings of embodiments of the invention correspond to the same or similar components; in the description of the present invention, it should be understood that, if the terms "upper", "lower", "left", "right", "inner", "outer", etc. indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, only for convenience in describing the present invention and simplifying the description, rather than indicating or implying that the apparatus or elements being referred to must have a specific orientation, be constructed and operated in a specific orientation, so that the terms describing the positional relationships in the drawings are merely for exemplary illustration and should not be construed as limiting the present patent, and that the specific meaning of the terms described above may be understood by those of ordinary skill in the art according to specific circumstances.
In the description of the present invention, unless explicitly stated and limited otherwise, the term "coupled" or the like should be interpreted broadly, as it may be fixedly coupled, detachably coupled, or integrally formed, as indicating the relationship of components; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be communication between the two parts or interaction relationship between the two parts. The specific meaning of the above terms in the present invention will be understood in specific cases by those of ordinary skill in the art.
As shown in fig. 1 to 5, the invention provides an anticoagulation test system for an extracorporeal circulation dialysis pipeline, which is used for simulating anticoagulation parameter test of the extracorporeal circulation dialysis pipeline in a clinical state so as to obtain accurate anticoagulation indexes of the extracorporeal circulation dialysis pipeline.
The anticoagulation test system includes a dialysis test line set 10, a blood circulation simulation device 30, and a blood reservoir device 20 connecting the dialysis test line set 10 and the blood circulation simulation device 30. Wherein the dialysis test tubing set 10 is used for simulating an extracorporeal blood circulation dialysis tubing, the blood circulation simulation device 30 is used for simulating an internal blood circulation, and the blood reservoir device 20 forms a blood mixing hub function connecting the extracorporeal circulation and the internal blood circulation.
The blood reservoir device 20 is a container structure having filtering and mixing functions. The blood reservoir device 20 includes a first input port 21, a second input port 22, and a shunt 23, wherein the first input port 21 is used for connecting with the dialysis test line device 10 to guide the fluid flowing in the dialysis test line device 10 into the blood reservoir device 20, and the second input port 22 is used for connecting with the blood circulation simulation device 30 to guide the fluid flowing in the blood circulation simulation device 30 into the blood reservoir device 20. The fluids are mixed within the reservoir device 20 to form a fluid of balanced parameters. The shunt is used to direct a mixed balanced fluid output within the reservoir unit 20 for output to the dialysis test tubing set 10 and the blood circulation simulator 30, respectively.
The dialysis test line set 10 comprises a dialysis circuit line assembly 11 and a sampling line assembly 12 connected to the dialysis circuit line assembly 11, the sampling line assembly 12 being adapted to collect fluid circulated within the dialysis circuit line assembly 11. The dialysis circuit assembly 11 is connected at one end to a branch of the split and at the other end to the first inlet 21. The blood reservoir device 20 and the dialysis circulation line assembly 11 form a first circulation line, the sampling line assembly 12 is connected to the dialysis circulation line assembly 11, and a fluid sample flowing in the dialysis circulation line assembly 11 can be extracted and detected according to a preset frequency, so that anticoagulation parameters of the fluid flowing in the dialysis circulation line assembly 11 are obtained. For example, the fluid is a prepared test fluid prepared by preparing whole blood, and adding glucose, heparin sodium, and sodium bicarbonate to the whole blood to adjust blood. The adjusted test fluid is passed through a cell analyzer to determine the index such as the counts of platelets, WBCs, and RBCs, and if the index meets the requirements, the index is injected into the reservoir device 20. If the index is not satisfactory, the counts of platelets, WBC and RBC are adjusted to within the index range with physiological saline.
The blood circulation simulation device 30 and the blood reservoir device 20 form a second circulation line of the anticoagulation test system, wherein the blood circulation simulation device 30 comprises a pump assembly 31, a heat exchanger device 32 and an oxygenator device 33 which are connected by a conduit, the heat exchanger device 32 is used for adjusting the temperature of the fluid flowing in the blood circulation simulation device 30, and the oxygenator device 33 is used for adjusting the oxygen content of the fluid flowing in the blood circulation simulation device 30. The oxygenator device 33 is connected to the second input port 22 and the pump assembly 31 is connected to the shunt 23, wherein the fluid circulated within the dialysis circuit assembly 11 and the fluid circulated within the blood circulation simulation device 30 are mixed within the reservoir device 20.
The first circulation line and the second circulation line operate independently, and fluid mixing is achieved at the blood reservoir device 20, so that the clinical process of human body dialysis is simulated, and anticoagulation test parameters of the dialysis circulation line assembly 11 can be effectively obtained. The blood circulation simulation device 30 can simulate the circulation of human blood so as to keep the test conditions of the extracorporeal circulation dialysis circuit anticoagulation test system to be in line with the clinical use state, and can accurately acquire the anticoagulation test parameters of the dialysis test circuit device 10, so that the simulation effect is good. The extracorporeal circulation dialysis pipeline anticoagulation test system collects fluid circulated in the system through the sampling pipeline assembly 12, and then detects various parameters in a fluid sample through a detection instrument, so that various coagulation index parameters are obtained, and the detection accuracy is high. The fluid circulating in the dialysis test line set 10 and the blood circulation simulation device 30 is mixed in the blood reservoir device 20, thereby forming a mixed fluid, simulating the human body dialysis process, and having a good simulation effect.
In one embodiment, the reservoir device 20 is a component that mixes fluids in the first and second circulation lines of the anticoagulation test system, which not only enables the two fluids to be directed and mixed, but also requires filtration and purification of the fluids.
The blood reservoir device 20 includes a housing 25, a filter assembly 24 mounted within the housing 25, a blood reservoir 251 defined between the housing 25 and the filter assembly 24, a first input port 21 and a second input port 22 in communication with the filter assembly 24, and a shunt 23 in communication with the blood reservoir 251. The housing 25 is a hollow container structure, and fluid is introduced only through the first input port 21 and the second input port 22. The flow dividing member 23 is provided with a main channel 231 and two or more branch channels connected to the main channel 231, and fluid in the blood storage cavity 251 enters from the main channel 231 and enters into the first circulation pipeline and the second circulation pipeline from the branch channels respectively, so that unified distribution of the fluid is realized, and the fluid parameters of the fluid in the first circulation pipeline and the fluid parameters in the second circulation pipeline are basically consistent. Preferably, the first input port 21 and the second input port 22 are disposed at the top of the housing 25, and the flow divider 23 is disposed at the bottom of the housing 25 to form a self-weight flow, thereby improving the smoothness of the fluid. Preferably, the bottom of the housing 25 is configured to have a conical or curved surface so that the flow divider 23 is positioned at the lowest level of the liquid at the bottom of the housing 25, with the greatest fluid pressure at the inlet of the flow divider 23 and directing the fluid completely out.
Example 1
As shown in fig. 1 to 5, the filtering component 24 filters the fluid input from the dialysis circulation line component 11 and the blood circulation simulation device 30 to remove blood clots, coagulated particles and other large particulate matters generated in the fluid circulation process, so as to keep the smoothness of fluid circulation and meet clinical requirements.
In an alternative embodiment, filter assembly 24 includes at least one filter membrane bag that corresponds to filtering fluid input from either first input port 21 or second input port 22. The filtering membrane bag is provided with a plurality of filtering holes such as meshes or membrane holes, the filtering holes can pass through particles which are smaller than or equal to the size of the filtering holes in the fluid, and large particles with the size of the ultrafiltration holes are blocked in the filtering membrane bag.
Preferably, two filter membrane bags are provided, namely a first filter bag 241 and a second filter bag 242, the first filter bag 241 and the second filter bag 242 being located in the housing 25, the first input port 21 being connected to the first filter bag 241, and the second input port 22 being connected to the second filter bag 242. Preferably, the filter assembly 24 includes a guide member introduced into the filtering membrane bag, the guide member including a guide tube 264 and a guide frame 26 extending from the guide tube 264 to the periphery, the guide frame 26 being provided with a guide curved surface 261. The guide curved surface 261 extends from the guide frame 26 to the edge direction of the filtering membrane bag so as to smoothly guide the fluid into the filtering membrane bag and avoid the phenomenon of forming excessive bubbles and the like. Alternatively, the curved flow guiding surface 261 is configured as a convex spherical surface, and the flow guiding tube 264 is connected to the first input port 21 or the second input port 22 to guide the fluid to uniformly diffuse to the curved flow guiding surface 261. Preferably, the end of the flow guiding curved surface 261 forms a flow guiding gap 263 with the edge of the filtering membrane bag for fluid communication. Preferably, the end of the diversion curved surface 261 is provided with a cylindrical extension surface 262, a plurality of concave spiral grooves 265 are distributed on the surface of the cylindrical extension surface 262, a guide groove is formed between the spiral grooves 265 and the inner wall surface of the filtering membrane bag, and the circulation direction and the circulation flux of fluid are dispersed to form a uniform filtering structure. And, the guide groove communicates with the guide gap 263 to jointly construct a guide space for the fluid.
Example two
As shown in fig. 1, 2 and 6, unlike the bag-like or column-like filter bag structure of the first embodiment, the filter assembly 24 is fixed to the housing 25 and divides the housing 25 into different filter spaces for corresponding filtration and mixing.
Optionally, the filtering component 24 is at least one layer of filtering membrane 27 traversing the housing 25, and the filtering membrane 27 separates the housing 25 to form at least two cavities, wherein the cavity communicating with the splitter 23 forms a blood storage cavity 251, and the cavity communicating with the first input port 21 or the second input port 22 is a filtering cavity. The filtering membrane 27 separates the space in the housing 25 in a flattened posture, so that not only the filtering area is clearly divided, but also the first input port 21 or the second input port 22 can be communicated to the same filtering cavity to realize the mixing and filtering in the filtering cavity, and then flows into the blood storage cavity 251 for secondary mixing, so as to realize the balanced mixing effect.
Optionally, the filter assembly 24 includes a cylindrical hollow mounting frame detachably mounted on the housing 25, and the filter membrane 27 is tensioned on an outer peripheral wall of the mounting frame to form a container structure. The first input port 21 or the second input port 22 communicates with the inside of the mounting frame, and the outer casing surrounds the outside to constitute an inner and outer ring structure. Optionally, a spiral guide groove 252 is disposed in a tangential direction of the mounting frame, the spiral guide groove 252 extends beyond or is formed on an inner side wall of the mounting frame, and the first input port 21 or the second input port 22 flows into the corresponding spiral guide groove 252 along the tangential direction of the mounting frame to form a smooth flow.
The splitter 23 has a multi-branched structure from the total to the partial to constitute a multi-channel output. Preferably, the main channel 231 and the branch channels in the flow dividing member 23 form a channel structure similar to a Y shape, wherein the ratio of the cross-sectional area of the main channel 231 to the cross-sectional area of one branch channel is 1-3, specifically, the ratio of the cross-sectional area of the main channel 231 to the cross-sectional area of one branch channel is set to be 1, 1.5, 2, 2.5, 3, etc., and the difference is formed between the main channel and the branch channel to form a pressure difference, thereby improving the fluid circulation speed.
Example III
As shown in fig. 1 to 7, the dialysis test line assembly includes a junction tube assembly 111, a dialysis pump pressure assembly 112, an exhaust assembly 113, and a test tube set 114, which are sequentially connected through lines, the junction tube assembly 111 communicates with the blood reservoir device 20, and the sampling line assembly 12 is connected to the junction tube assembly 111. The dialysis pump pressure assembly 112 drives the fluid within the dialysis test tubing set 10 through a predetermined pump pressure, and the vent assembly 113 vents the fluid during circulation of the dialysis test tubing set 10.
The joint tube assembly 111 is a piping structure connecting the dialysis pump assembly 112 and the blood reservoir device 20, and an auxiliary structure such as a stopper is provided on the joint tube assembly 111. The sampling line assembly 12 is connected to the connector tube assembly 111, and the connection portion is located between the dialysis pump assembly 112 and the blood reservoir device 20, so that the fluid sample input into the dialysis test line device 10 by the blood reservoir device 20 can be accurately collected, the fluid sample of the sampling line assembly 12 can be periodically or randomly extracted, and then the coagulation index can be measured by the coagulation analyzer, for example, the coagulation analyzer detects the coagulation 4: prothrombin Time (PT), activated Partial Thromboplastin Time (APTT), thrombin Time (TT), fibrinogen (FIB).
Alternatively, the joint pipe assembly 111 is provided with a multi-way joint 1111, for example, the multi-way joint 1111 may be provided as a three-way joint, a four-way joint, or the like. The sampling tube assembly 12 comprises a delivery tube 121 connected to the multichannel joint 1111, a sampling seal assembly 122 located at the end of the delivery tube 121, and a hemostatic clip mounted on the delivery tube 121, wherein the sampling seal assembly 122 is used for needlepunching or discharging a fluid sample to be delivered, and the fluid sample is placed into a coagulation analyzer to realize coagulation item detection.
Optionally, the dialysis pump assembly 112 is configured as a blood pump in the form of a roll pump or other pump, and the dialysis test line set 10 is driven in fluid communication within the dialysis test line set 10 by the dialysis pump assembly 112 as a drive source.
The exhaust assembly 113 is disposed at an output end of the dialysis pump pressure assembly 112, wherein the exhaust assembly 113 comprises a drip chamber and an exhaust pipe connected to the drip chamber, a pipeline of the dialysis pump pressure assembly 112 is connected to the drip chamber, and the exhaust pipe controls the liquid level in the drip chamber based on the gas above the liquid level of the discharge drip chamber. The cross-sectional shape of the dropping funnel is far greater than the size of the conduit in the pipeline, the fluid entering the dropping funnel from the conduit forms accumulation in the dropping funnel, an air space is arranged between the liquid level in the dropping funnel and the input port of the conduit, and the exhaust pipe fitting is connected with the dropping funnel and communicated with the air space, so that the gas quantity in the air space is controlled. Preferably, the exhaust pipe fitting is a one-way conduction piece so as to keep the gas content in the dropping funnel stable. Preferably, the exhaust pipe is a check valve.
The test tube set 114 connects the drip chamber and the blood reservoir device 20, and optionally, the ratio of the conducting length of the test tube set 114 for fluid circulation to the conducting length of the joint tube assembly 111 for fluid circulation is 2-8, so that the test tube set has good fluidity, and the anticoagulation performance of the test tube can be fully reflected, and the accuracy of the anticoagulation performance detection of the tube can be improved. For example, the ratio of the on-lengths is a length ratio of 2, 3, 4, 5, 6, 8, etc.
Example IV
As shown in fig. 1, 2 and 7, the blood circulation simulation device 30 comprises a pumping assembly 31, a heat exchanger device 32 and an oxygenator device 33 connected by a conduit, the heat exchanger device 32 is used for regulating the temperature of the fluid flowing through the blood circulation simulation device 30, and the oxygenator device 33 is used for regulating the oxygen content of the fluid flowing through the blood circulation simulation device 30. The pump assembly 31 is configured as a rolling pump or other pumping type blood pump, and the blood circulation simulation device 30 drives the circulation of fluid in the blood circulation simulation device 30 by using the pump assembly 31 as a driving source.
The heat exchanger device 32 is used for stabilizing the temperature of the fluid by heat exchange with a medium with high temperature in the fluid circulation process. Optionally, the heat exchanger device 32 includes a heat exchange shell 323, a flow guiding assembly 321 and a heat conducting assembly 322, wherein the flow guiding assembly 321 is provided with a fluid input channel 3211 and a fluid output channel 3212, and the heat conducting assembly 322 is provided with a medium input channel and a medium output channel, and the heat conducting assembly 322 is made of a material with high heat conductivity so as to improve heat exchange efficiency. For example, the heat conductive member 322 is made of a material having high heat conductivity such as a metal pipe or a hollow fiber pipe. The heat transfer medium circulates along the heat transfer component 322, and heat exchange is achieved through the contact surface of the heat transfer component 322 and the fluid. Preferably, the heat conducting component 322 is configured as a plurality of tubular heat conducting pipes 3221, and the heat conducting pipes 3221 are distributed in the flow guiding component 321 in a shuttling manner, so as to enlarge the contact area between the fluid in the flow guiding component 321 and the heat conducting pipes 3221, and improve the heat conducting efficiency. Preferably, the heat conductive pipe 3221 has a parallel pipe structure. Preferably, the thermally conductive assembly 322 is interwoven in a mesh structure. Wherein the heat conducting medium may be provided as an aqueous fluid or as a gas.
Preferably, the diversion assembly 321 is provided as a hollow tubular structure, and the fluid input channel 3211 and the fluid output channel 3212 are respectively connected with two ends of the diversion assembly 321. A flow guiding hole 3213 is arranged on the pipe wall of the flow guiding component 321, and the flow guiding hole 3213 communicates the inner side and the outer side of the flow guiding component 321. The heat conducting component 322 is disposed around the diversion component 321 and exchanges heat with the fluid flowing out of the diversion aperture 3213. Optionally, an inclined baffle plate 3214 is disposed in the diversion assembly 321, and the baffle plate 3214 faces to one side of the diversion hole 3213, so that fluid smoothly flows out of the diversion hole 3213. Further, the hole wall of the flow guiding hole 3213 is provided with an inclined plane, and the inclined plane guides the fluid to tangentially flow out of the flow guiding assembly 321, so as to reduce the impact of the fluid, and prolong the flow path of the fluid in the flow guiding assembly 321 in the smaller heat exchange shell 323, thereby improving the heat exchange effect.
The fluid output from the flow guide component 321 enters the oxygenator device 33, and the oxygen content of the blood fluid is regulated at the oxygenator device 33, so that the problems of blood dissolution, deterioration and the like caused by higher carbon dioxide content in the blood are avoided.
Further, the blood circulation simulation device 30 further includes a blood oxygen detection branch 35, and the blood oxygen detection branch 35 is disposed in the output pipeline of the oxygenator device 33. The blood oxygen detecting branch 35 is disposed on the output pipeline of the oxygenator device 33, and the blood oxygen detecting branch 35 is used for detecting the oxygen content in the blood output from the oxygenator device 33 so as to ensure that the output blood meets the blood oxygen parameter index of normal blood. Optionally, the blood oxygen detecting branch 35 is provided with a blood oxygen detecting sensor to output the blood oxygen content in real time, and the oxygen device can adjust the blood oxygen content in real time. For example, when the blood oxygen level detected by the blood oxygen detecting branch 35 meets the set range, the oxygen device is operated normally. When the blood oxygen detecting branch 35 detects that the blood oxygen content is smaller than the normal value, the oxygen device increases the blood oxygen content.
Further, the anticoagulation test system further comprises an oxygen content adjuster 34 connected to the oxygenator device 33, wherein the oxygen content adjuster 34 adjusts the oxygen concentration based on the detection value of the blood oxygen detection branch 35. The oxygen content regulator 34 is used to deliver high concentration oxygen to the oxygenator device 33, which may be provided as pure oxygen or as a gas of different concentrations of oxygen mixed in different gas ratios. When the blood oxygen detecting branch 35 detects that the blood oxygen content in the blood is lower than the preset value, the oxygen content adjuster 34 increases the oxygen concentration or increases the gas supply amount to increase the blood oxygen concentration.
Example five
The anticoagulation performance of the extracorporeal circulation dialysis pipeline is detected by using the extracorporeal circulation dialysis pipeline anticoagulation test system disclosed in the embodiment. In one embodiment, the test method comprises the steps of:
in step S101, the fluid circulation is guided by the dialysis circulation line assembly 11, and the fluid circulating in the dialysis circulation line assembly 11 is collected by the sampling line assembly 12. The pump assembly 31 in the dialysis circuit assembly 11 directs the circulation of fluid in the reservoir unit 20, and the circulation of the dialysis circuit assembly 11 and the blood circulation simulator 30 is performed simultaneously, with the blood in the first and second circuit being mixed at the reservoir unit 20 to form a fluid of uniform parameters. The sampling tube assembly 12 is arranged to collect a blood sample of the first circulation tube at a predetermined time or frequency, so as to obtain an anticoagulation parameter of blood circulating in the whole anticoagulation test system. For example, sampling line assembly 12 draws blood samples during the 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 5.5h, 6h, etc. period of time that the anticoagulation test system is started to operate, and the collected blood samples are coagulated 4 items with a coagulation analyzer: prothrombin Time (PT), activated Partial Thromboplastin Time (APTT), thrombin Time (TT), fibrinogen (FIB). Wherein, in order to control the variability, the range of coagulation factor measurement results is controlled as follows:
activated Partial Thromboplastin Time (APTT): the second is 25-60.
Prothrombin Time (PT): the number of seconds is 11-30.
Fibrinogen (FIB): 2-4g/L.
Thrombin Time (TT): the number of seconds is 12-30.
Judging 4 coagulation items of the anticoagulation pipeline and the non-anticoagulation pipeline by using T test and F test: whether the difference in Prothrombin Time (PT), activated Partial Thromboplastin Time (APTT), thrombin Time (TT), fibrinogen (FIB) is significant; if the difference is significant and the anticoagulation effect of the anticoagulation pipeline is better than that of the non-anticoagulation pipeline, the pipeline is considered to have the anticoagulation effect.
In step S102, a fluid of a predetermined pressure value is supplied to the heat exchanger device 32 and the oxygenator device 33 by the pump assembly 31. The blood circulates through the blood circulation simulator 30, and specifically, the blood circulation simulator 30 drives the circulation of the fluid in the blood circulation simulator 30 by using the pump assembly 31 as a driving source. The heat exchanger device 32 is used for stabilizing the temperature of the fluid by heat exchange with a medium with high temperature in the fluid circulation process. The fluid output from the heat exchanger device 32 enters the oxygenator device 33, and the oxygen content of the blood fluid is regulated at the oxygenator device 33, so that the problems of blood dissolution, deterioration and the like caused by higher carbon dioxide content in the blood are avoided.
In step S103, the fluid flowing through the dialysis circuit module 11 and the blood circulation simulator 30 is fed to the blood reservoir device 20, filtered, and mixed. The blood reservoir device 20 filters the fluid input by the dialysis circulation line assembly 11 and the blood circulation simulation device 30 to remove blood clots, coagulated particles and other large particulate matters generated in the fluid circulation process, so as to keep the smoothness of fluid circulation and meet clinical requirements.
In step S104, the filtered and mixed fluid flows into the dialysis circuit assembly 11 and the blood circulation simulator 30, respectively.
Step S105, the steps are sequentially circulated.
The dialysis test line device 10, the blood circulation simulation device 30 and the blood reservoir device 20 constitute a first circulation line and a second circulation line which run synchronously and independently, thereby simulating the clinical process of human body dialysis and effectively acquiring anticoagulation test parameters of the dialysis circulation line assembly 11. The blood circulation simulation device 30 can simulate the circulation of human blood so as to keep the test conditions of the extracorporeal circulation dialysis circuit anticoagulation test system to be in line with the clinical use state, and can accurately acquire the anticoagulation test parameters of the dialysis test circuit device 10, so that the simulation effect is good. The extracorporeal circulation dialysis pipeline anticoagulation test system collects fluid circulated in the system through the sampling pipeline assembly 12, and then detects various parameters in a fluid sample through a detection instrument, so that various coagulation index parameters are obtained, and the detection accuracy is high. The fluid circulating in the dialysis test line set 10 and the blood circulation simulation device 30 is mixed in the blood reservoir device 20, thereby forming a mixed fluid, simulating the human body dialysis process, and having a good simulation effect.
In step S101, the method further includes the steps of:
in step S201, the fluid circulating in the dialysis circulation line assembly 11 is collected by the sampling line assembly 12 at regular time.
The sampling line assembly 12 periodically collects the fluid circulated in the dialysis circulation line assembly 11 to obtain anticoagulation performance tests of blood after the dialysis circulation line assembly 11 is used for different periods of time, thereby obtaining a blood sample of the dialysis circulation line assembly 11.
Step S202, performing coagulation index detection. The blood sample collected by the sampling pipeline assembly 12 is subjected to T test and F test, and 4 coagulation items of an anticoagulation pipeline and a non-anticoagulation pipeline are judged: whether the difference in Prothrombin Time (PT), activated Partial Thromboplastin Time (APTT), thrombin Time (TT), fibrinogen (FIB) is significant; if the difference is significant and the anticoagulation effect of the anticoagulation pipeline is better than that of the non-anticoagulation pipeline, the pipeline is considered to have the anticoagulation effect.
In one embodiment, the test method comprises: the dialysis test line set 10 is pre-cleaned by heparin fluid prior to operation of the extracorporeal circulation dialysis line anticoagulation test system. Heparin fluid pre-washes dialysis test pipeline device 10, can wash dialysis test pipeline device 10 once, and whether the impurity such as check dialysis test pipeline device 10 has weeping point and washing particle remains dialysis test pipeline device 10's clean and tidy nature, can set up the one deck anticoagulation layer at dialysis test pipeline device 10 again, improves whole anticoagulation effect.
Further, the testing method includes pre-cleaning the blood circulation simulation device 30 with heparin fluid before the extracorporeal circulation dialysis circuit anticoagulation testing system is run, to clean impurities in the circuit and form an anticoagulation layer.
Other embodiments of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the disclosure disclosed herein. This application is intended to cover any variations, uses, or adaptations of the invention following, in general, the principles of the invention and including such departures from the present disclosure as come within known or customary practice within the art to which the invention pertains. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims.
It is to be understood that the invention is not limited to the precise arrangements and instrumentalities shown in the drawings, which have been described above, and that various modifications and changes may be effected without departing from the scope thereof. The scope of the invention is limited only by the appended claims.
Claims (10)
1. An extracorporeal circulation dialysis circuit anticoagulation test system, comprising:
the dialysis test pipeline device comprises a dialysis circulation pipeline assembly and a sampling pipeline assembly connected to the dialysis circulation pipeline assembly, wherein the sampling pipeline assembly is used for collecting fluid circulating in the dialysis circulation pipeline assembly;
the blood circulation simulation device comprises a pumping pressure assembly, a heat exchanger device and an oxygenator device which are connected through a conduit, wherein the heat exchanger device is used for adjusting the temperature of the flowing fluid in the blood circulation simulation device, and the oxygenator device is used for adjusting the oxygen content of the flowing fluid in the blood circulation simulation device;
the blood storage device comprises a first input port, a second input port and a flow dividing piece, the dialysis circulation pipeline assembly is connected with the first input port and the flow dividing piece, the oxygenator device is connected with the second input port, the pumping pressure assembly is connected to the flow dividing piece, and fluid circulating in the dialysis circulation pipeline assembly and fluid circulating in the blood circulation simulation device are mixed in the blood storage device.
2. The extracorporeal circulation dialysis circuit anticoagulation test system according to claim 1, wherein the blood reservoir device comprises a housing, a filter assembly mounted in the housing, a blood reservoir is formed between the housing and the filter assembly, the first input port and the second input port are in communication with the filter assembly, and the shunt is in communication with the blood reservoir.
3. The extracorporeal circulation dialysis circuit anticoagulation test system of claim 2, wherein the filtration assembly comprises at least one filtration membrane bag that corresponds to filtering fluid input from the first input port or the second input port.
4. The extracorporeal circulation dialysis tubing anticoagulation test system according to claim 1, wherein the dialysis test tubing assembly comprises a connector tube assembly, a dialysis pump pressure assembly, an exhaust assembly and a test tube set which are sequentially connected through tubing, wherein the connector tube assembly is communicated with the blood reservoir device, the sampling tubing assembly is connected to the connector tube assembly, the dialysis pump pressure assembly drives fluid in the dialysis test tubing device to circulate according to a preset pump pressure value, and the exhaust assembly exhausts gas of the fluid in the circulation process of the dialysis test tubing device.
5. The extracorporeal circulation dialysis tubing anticoagulation test system of claim 4, wherein the vent assembly comprises a drip chamber and a vent tube connected to the drip chamber, the tubing of the dialysis pump pressure assembly being connected to the drip chamber, the vent tube controlling the fluid level within the drip chamber based on venting gas above the fluid level of the drip chamber.
6. The extracorporeal circulation dialysis tubing anticoagulation test system according to claim 1, wherein the blood circulation simulation device further comprises a blood oxygen detection branch, which is provided to the output tubing of the oxygenator device.
7. The extracorporeal circulation dialysis circuit anticoagulation test system of claim 6, further comprising an oxygen content adjuster connected to the oxygenator device, wherein the oxygen content adjuster adjusts the oxygen concentration based on the detection value of the blood oxygen detection branch.
8. A method for testing anticoagulation of extracorporeal circulation dialysis tubing, characterized in that the extracorporeal circulation dialysis tubing anticoagulation test system according to any one of claims 1 to 7 is used, said method comprising the steps of:
the fluid circulating circulation is guided through a dialysis circulating pipeline assembly, and the fluid circulating in the dialysis circulating pipeline assembly is collected through the sampling pipeline assembly;
delivering a fluid of a preset pressure value to the heat exchanger device and the oxygenator device through a pumping assembly;
delivering the fluid flowing through the dialysis circulation pipeline assembly and the blood circulation simulation device to a blood storage device for filtering and mixing;
the filtered and mixed fluid flows into a dialysis circulation pipeline assembly and the blood circulation simulation device respectively;
the above steps are sequentially circulated.
9. The test method according to claim 8, comprising:
collecting fluid circulating in the dialysis circulation pipeline assembly through the sampling pipeline assembly at fixed time;
and (5) performing coagulation index detection.
10. The test method according to claim 8, comprising: and pre-cleaning the dialysis test pipeline device by heparin fluid before the extracorporeal circulation dialysis pipeline anticoagulation test system is operated.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202310259463.9A CN116400014A (en) | 2023-03-13 | 2023-03-13 | Anticoagulation test system and test method for extracorporeal circulation dialysis pipeline |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202310259463.9A CN116400014A (en) | 2023-03-13 | 2023-03-13 | Anticoagulation test system and test method for extracorporeal circulation dialysis pipeline |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN116400014A true CN116400014A (en) | 2023-07-07 |
Family
ID=87013406
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202310259463.9A Pending CN116400014A (en) | 2023-03-13 | 2023-03-13 | Anticoagulation test system and test method for extracorporeal circulation dialysis pipeline |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN116400014A (en) |
-
2023
- 2023-03-13 CN CN202310259463.9A patent/CN116400014A/en active Pending
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| US8795591B2 (en) | Dual outlet oxygenator for treating blood in an extracorporeal blood circuit | |
| US6331252B1 (en) | Methods for priming a blood compartment of a hemodialyzer | |
| KR101278429B1 (en) | Metabolic detoxification system and method | |
| TW200413040A (en) | The blood purifier | |
| WO1981001793A1 (en) | Blood circuit and bubble traps | |
| JPS618057A (en) | Blood dialytic apparatus | |
| US11940459B2 (en) | Diluent preparation module | |
| CN116400014A (en) | Anticoagulation test system and test method for extracorporeal circulation dialysis pipeline | |
| CN212308926U (en) | Platelet-rich plasma preparation device | |
| JP4078460B2 (en) | Plasma separation filter, plasma separation method and plasma separation apparatus using the same | |
| CN116256528A (en) | Sample analyzer | |
| CN115656489A (en) | Multi-connected coagulation time detection instrument and reagent card | |
| CN207429440U (en) | A kind of Solute removal monitoring system of blood cleaning equipment | |
| CN217006884U (en) | Plasma leakage testing device of membrane oxygenator | |
| CN208350585U (en) | Simulate blood dialysis ultrafiltration dosing accuracy detection device | |
| CN220207385U (en) | Blood cell analyzer | |
| CN116256292A (en) | Membrane oxygenator plasma leakage testing device and testing method thereof | |
| EP4273260A1 (en) | Sampling method | |
| CN116162680A (en) | Method for quantitatively evaluating thrombus degree of blood purification device | |
| CN113694280A (en) | Method for monitoring toxin content distribution in-vitro dialyzer in real time | |
| JP5861342B2 (en) | Hollow fiber oxygenator | |
| JP2022118378A (en) | sampling system | |
| CN113970642A (en) | Automatic protein screening coefficient testing device and testing method thereof | |
| CN116519565A (en) | Method and device for detecting ultrafiltration coefficient of dialyzer | |
| CN111939599A (en) | Method and device for preparing platelet-rich plasma |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination |