WO2021147352A1 - 体外诊断分析仪、试剂卡及安装结构 - Google Patents

体外诊断分析仪、试剂卡及安装结构 Download PDF

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Publication number
WO2021147352A1
WO2021147352A1 PCT/CN2020/115468 CN2020115468W WO2021147352A1 WO 2021147352 A1 WO2021147352 A1 WO 2021147352A1 CN 2020115468 W CN2020115468 W CN 2020115468W WO 2021147352 A1 WO2021147352 A1 WO 2021147352A1
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WIPO (PCT)
Prior art keywords
reagent card
calibration fluid
sealing
sample tube
calibration
Prior art date
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PCT/CN2020/115468
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English (en)
French (fr)
Inventor
黄郁荣
王继华
Original Assignee
广州万孚生物技术股份有限公司
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Filing date
Publication date
Application filed by 广州万孚生物技术股份有限公司 filed Critical 广州万孚生物技术股份有限公司
Priority to EP20915043.2A priority Critical patent/EP4095530A4/en
Priority to US17/795,009 priority patent/US20230078497A1/en
Publication of WO2021147352A1 publication Critical patent/WO2021147352A1/zh

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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5027—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip
    • B01L3/502715—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/10—Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices
    • G01N35/1009—Characterised by arrangements for controlling the aspiration or dispense of liquids
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584—Control arrangements for automatic analysers
    • G01N35/00594—Quality control, including calibration or testing of components of the analyser
    • G01N35/00693—Calibration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150503—Single-ended needles
    • 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
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00029—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor provided with flat sample substrates, e.g. slides
    • G01N35/00069—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor provided with flat sample substrates, e.g. slides whereby the sample substrate is of the bio-disk type, i.e. having the format of an optical disk
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/10—Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/02—Adapting objects or devices to another
    • B01L2200/025—Align devices or objects to ensure defined positions relative to each other
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/02—Adapting objects or devices to another
    • B01L2200/026—Fluid interfacing between devices or objects, e.g. connectors, inlet details
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/02—Adapting objects or devices to another
    • B01L2200/026—Fluid interfacing between devices or objects, e.g. connectors, inlet details
    • B01L2200/027—Fluid interfacing between devices or objects, e.g. connectors, inlet details for microfluidic devices
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/06—Fluid handling related problems
    • B01L2200/0684—Venting, avoiding backpressure, avoid gas bubbles
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/10—Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/16—Reagents, handling or storing thereof
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/06—Auxiliary integrated devices, integrated components
    • B01L2300/0672—Integrated piercing tool
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/08—Geometry, shape and general structure
    • B01L2300/0809—Geometry, shape and general structure rectangular shaped
    • B01L2300/0816—Cards, e.g. flat sample carriers usually with flow in two horizontal directions
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/08—Geometry, shape and general structure
    • B01L2300/0832—Geometry, shape and general structure cylindrical, tube shaped
    • B01L2300/0838—Capillaries
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00—Moving or stopping fluids
    • B01L2400/04—Moving fluids with specific forces or mechanical means
    • B01L2400/0475—Moving fluids with specific forces or mechanical means specific mechanical means and fluid pressure
    • B01L2400/0481—Moving fluids with specific forces or mechanical means specific mechanical means and fluid pressure squeezing of channels or chambers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00—Moving or stopping fluids
    • B01L2400/04—Moving fluids with specific forces or mechanical means
    • B01L2400/0475—Moving fluids with specific forces or mechanical means specific mechanical means and fluid pressure
    • B01L2400/0487—Moving fluids with specific forces or mechanical means specific mechanical means and fluid pressure fluid pressure, pneumatics
    • B01L2400/049—Moving fluids with specific forces or mechanical means specific mechanical means and fluid pressure fluid pressure, pneumatics vacuum
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00—Moving or stopping fluids
    • B01L2400/06—Valves, specific forms thereof
    • B01L2400/0677—Valves, specific forms thereof phase change valves; Meltable, freezing, dissolvable plugs; Destructible barriers
    • B01L2400/0683—Valves, specific forms thereof phase change valves; Meltable, freezing, dissolvable plugs; Destructible barriers mechanically breaking a wall or membrane within a channel or chamber
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00—Moving or stopping fluids
    • B01L2400/06—Valves, specific forms thereof
    • B01L2400/0694—Valves, specific forms thereof vents used to stop and induce flow, backpressure valves
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00029—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor provided with flat sample substrates, e.g. slides
    • G01N2035/00099—Characterised by type of test elements
    • G01N2035/00148—Test cards, e.g. Biomerieux or McDonnel multiwell test cards
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N2035/00178—Special arrangements of analysers

Definitions

  • This application relates to the technical field of medical devices, such as an in vitro diagnostic analyzer and a reagent card.
  • Reagent cards also called test cards, test cards
  • the reagent cards integrate biochemical detection electrodes, are calibrated by a calibration solution, and then perform sample fluid (blood, tissue fluid, etc.) testing.
  • the reagent card in the related art usually realizes the on-off control of the sample liquid by squeezing the closing and opening of the sample injection channel. But its problems are as follows:
  • the application provides an in vitro diagnostic analyzer, a reagent card and an installation structure.
  • the installation structure can install the sample tube, and can realize the on-off control of the sample liquid, which solves the above-mentioned hidden dangers of sample liquid leakage and inability to extract.
  • the reagent card integrates the above-mentioned installation structure and adopts a new on-off control scheme of the sample liquid, which can solve the hidden dangers of the above-mentioned sample liquid leakage and inability to extract.
  • the on-off control of the sample liquid is reliable, which is beneficial to improve the reliability of the detection.
  • the embodiment of the present application provides a mounting structure, including a mounting body, the mounting body includes a mounting hole for socketing a sample tube, a hollow needle arranged in the mounting hole, a sealing portion arranged in the mounting hole, and an air inlet channel , One end of the hollow needle can be inserted into the sample tube, and the sealing part is in a sealing fit with the outer wall of the sample tube.
  • the air inlet channel includes an air outlet and an air inlet provided on the surface of the mounting body. The air outlet is used to be installed on the mounting hole The sample tube is connected.
  • the sample tube can be inserted into the installation hole. During this process, the hollow needle will be inserted into the sample tube. After the installation of the sample tube is completed, the sealing part will be sealed and matched with the sample tube. At this time, when the inlet hole is opened, gas (such as air) can enter the sample tube through the inlet channel, that is, the liquid in the sample tube can be sucked away through the hollow needle; when the inlet hole is closed, the gas ( For example, air cannot enter the sample tube through the air inlet channel, and the sample tube is sealed by the sealing part, so that the sample tube cannot communicate with outside air, making it difficult for the liquid in the sample tube to be sucked out through the hollow needle.
  • gas such as air
  • the installation structure can realize the installation of the sample tube.
  • the sealing portion is provided with a sealing hole for sealingly fitting with the sample outlet end of the sample tube, one end of the hollow needle is arranged in the sealing hole, and the air outlet hole communicates with the sealing hole.
  • the outer edge of the air inlet hole is provided with a sealing layer.
  • the sealing layer includes an elastic layer and an adhesive layer arranged on the elastic layer, and the elastic layer is arranged outward.
  • the embodiment of the present application also provides a reagent card, including the installation structure in any of the above embodiments, and further includes a reagent card body, the reagent card body is fixed to the installation structure, and the reagent card body includes a reagent card body communicating with the outlet end of the hollow needle
  • the sampling channel, the detection cavity, and the gas connection end, and the sampling channel and the gas connection end are in communication with the detection cavity.
  • the sample tube can be inserted into the mounting hole of the mounting body. During this process, the hollow needle will be inserted into the sample tube. After the sample tube is installed, the sealing part will be sealed and matched with the sample tube.
  • gas such as air
  • the air connection end is connected to the negative pressure generator to generate suction, so that the liquid in the sample tube can be inhaled through the hollow needle Inject the sample channel and flow into the detection chamber for detection and analysis;
  • gas such as air
  • the sample tube is sealed by the sealing part, making the sample tube unable to communicate with the outside world.
  • the gas connection makes it difficult for the liquid in the sample tube to be sucked out through the hollow needle.
  • the reagent card does not need to be squeezed to deform the injection channel to close or rely on the self-reset of the injection channel to realize the opening of the injection channel when the on-off control of the sample liquid is performed. It only needs to open or close the inlet through the telescopic valve.
  • the air holes are used to realize the on-off control of the sample liquid, which can solve the hidden dangers of the above-mentioned sample liquid leakage and inability to extract.
  • the mounting body and the reagent card body are integrally formed.
  • the reagent card body further includes a calibration fluid channel, and the calibration fluid channel is in communication with the detection cavity.
  • the reagent card body further includes a waste liquid storage cavity communicating with the liquid outlet end of the detection cavity, and the liquid outlet end of the waste liquid storage cavity is communicated with the gas connection end.
  • the reagent card body further includes a first calibration fluid bag and a valve core
  • the first calibration fluid bag is fixed on the reagent card body
  • the first calibration fluid bag is provided with a calibration fluid channel
  • the valve core is arranged in the calibration fluid channel or the first calibration fluid bag
  • the valve core is provided with a spike part for piercing the mating part.
  • the embodiment of the present application also provides an in vitro diagnostic analyzer, which includes the reagent card in any of the above embodiments, and also includes a negative pressure generator, a sample tube, a first retractor, a detection device and a controller, and a negative pressure generator Butt with the air connection end, the sample tube is provided with a sample outlet end that is matched with the hollow needle, the first expansion device is provided with a sealing end for sealing the air inlet, the controller and the negative pressure generator, the first expansion device and the detection device Communication connection, the detection end of the detection device is arranged in the detection cavity.
  • the sample tube can be inserted into the mounting hole of the installation body. During this process, the hollow needle will be inserted into the sample tube. After the sample tube is installed, the sealing part will be sealed and matched with the sample tube, and then the reagent card Install to the preset position of the in vitro diagnostic analyzer.
  • the first controller controls the action of the first retractor to make the sealed end leave the air inlet hole, that is, when the air inlet hole is opened, gas (such as air) can enter the sample tube through the air inlet channel, that is, the air connection end is docked at this time
  • gas such as air
  • the negative pressure generator generates suction so that the liquid in the sample tube can be sucked into the sampling channel through the hollow needle and flowed into the detection chamber for detection and analysis; and when the controller controls the action of the first retractor, the sealing end and the air inlet hole are sealed and matched , That is, when the inlet hole is closed, gas (such as air) cannot enter the sample tube through the inlet channel, and the sample tube is sealed by the sealing part, making the sample tube unable to communicate with the outside gas, making it difficult for the liquid in the sample tube to pass through the hollow The needle is sucked out.
  • the in vitro diagnostic analyzer is used, the on-off control of the sample liquid is reliable, which is beneficial to improve the reliability of the
  • the sealing end is provided with a protruding sealing ring, and the sealing ring can be sealingly arranged on the outer edge of the air inlet hole.
  • the reagent card body further includes a calibration fluid channel communicating with the detection cavity, a first calibration fluid bag, and a valve core
  • the first calibration fluid bag is fixed on the reagent card body
  • the first calibration fluid bag is fixed on the reagent card body
  • the first calibration fluid bag is fixed on the reagent card body
  • the first calibration fluid bag is fixed on the reagent card body.
  • the standard fluid bag is provided with a matching part that is butted with the calibration fluid channel
  • the valve core is arranged in the calibration fluid channel or in the first calibration fluid bag
  • the valve core is provided with a spiked part for piercing the matching part
  • the diagnostic diagnostic analyzer also includes a second retractor that is communicatively connected with the controller. The retractable end of the second retractor can press the calibration fluid channel or the first calibration fluid bag in a preset direction, so that the spiked part punctures and fits. Department.
  • the in vitro diagnostic analyzer further includes a calibration fluid channel communicating with the detection chamber, and a second calibration fluid bag, and the second calibration fluid bag communicates with the calibration fluid channel through an on-off valve.
  • Fig. 1 is a schematic structural diagram of an in vitro diagnostic analyzer shown in an embodiment
  • FIG. 2 is a schematic diagram of the structure of the in vitro diagnostic analyzer shown in an embodiment
  • FIG. 3 is a schematic diagram of the structure of the reagent card shown in FIG. 2;
  • FIG. 4 is a partial enlarged schematic diagram of A shown in FIG. 3;
  • Fig. 5 is a schematic diagram of the test card shown in Fig. 3 sucking a calibration solution
  • Fig. 6 is a schematic diagram of the reagent card shown in Fig. 3 after calibration analysis is completed;
  • Fig. 7 is a schematic diagram of the state of the air inlet in the state of the reagent card shown in Fig. 5 or Fig. 6;
  • Fig. 8 is a schematic diagram of the reagent card shown in Fig. 3 sucking sample liquid;
  • FIG. 9 is a partial enlarged schematic diagram of B shown in FIG. 8.
  • Fig. 10 shows the state of the air inlet in the state of the reagent card shown in Fig. 8;
  • FIG. 11 is a schematic diagram of the structure of the reagent card shown in FIG. 1;
  • FIG. 12 is a schematic diagram of the structure of the second calibration solution and the valve core of the reagent card shown in FIG. 11.
  • Reagent card 100. Reagent card body; 110, sampling channel; 120, detection chamber; 130, gas terminal; 140, calibration fluid channel; 150, first calibration fluid bag; 160, matching part; 170 , Spool; 172, spiked part; 180, waste liquid storage cavity; 200, mounting structure; 210, mounting body; 212, mounting hole; 220, hollow needle; 230, air inlet channel; 232, air inlet; 234 , Vent hole; 240, sealing part; 242, sealing hole; 250, sealing layer; 252, elastic layer; 254, adhesive layer; 20, negative pressure generator; 40, first retractor; 42, sealing end; 44 , Sealing ring; 50, the second retractor; 60, the controller; 70, the sample tube; 80, the second calibration fluid bag.
  • an element when an element is referred to as being “fixed to”, “installed on”, “fixed on” or “installed on” another element, it can be directly on the other element or there may also be a centered element. .
  • an element When an element is considered to be “connected” to another element, it can be directly connected to the other element or an intermediate element may be present at the same time.
  • the two when one element is considered to be “connected” to another element, the two can be fixed by detachable connection or non-detachable connection, such as socketing, clamping, integral fixing, welding, etc. It can be implemented in related technologies, so it will not be redundant here.
  • the present application also provides an in vitro diagnostic analyzer, which includes a reagent card 10, a negative pressure generator, a sample tube 70, a first retractor 40, a detection device and a controller 60.
  • an in vitro diagnostic analyzer which includes a reagent card 10, a negative pressure generator, a sample tube 70, a first retractor 40, a detection device and a controller 60.
  • the reagent card 10 includes a reagent card body 100 and a mounting structure 200 fixed on the detection body.
  • the reagent card body 100 includes a sampling channel 110, a detection cavity 120, and a connection
  • the gas end 130, the sampling channel 110 and the gas connection end 130 are in communication with the detection cavity 120.
  • the mounting structure 200 includes a mounting body 210, which includes a mounting hole 212 for socketing the sample tube 70, a hollow needle 220 arranged in the mounting hole 212, a sealing portion 240 arranged in the mounting hole 212, and an air inlet In the channel 230, one end of the hollow needle 220 can be inserted into the sample tube 70, and the other end is inserted into the sample injection channel 110.
  • the sealing portion 240 is sealed to the outer wall of the sample tube 70.
  • the air inlet channel 230 includes an air outlet 234 and is arranged on the mounting body The air inlet hole 232 and the air outlet hole 234 on the surface of 210 are used to communicate with the sample tube 70 installed on the mounting hole 212.
  • the negative pressure generator is connected to the gas receiving end 130
  • the sample tube 70 is provided with a sample outlet end that is clearance fit with the hollow needle 220
  • the first retractor 40 is provided with a sealing end 42 for sealing the air inlet 232
  • the controller 60 It is communicatively connected with the negative pressure generator 20, the first retractor 40 and the detection device, and the detection end of the detection device is arranged in the detection cavity 120.
  • the sample tube 70 can be inserted into the mounting hole 212 of the mounting body 210. During this process, the hollow needle 220 will be inserted into the sample tube 70. After the sample tube 70 is installed, the sealing part 240 will contact the sample. The tube 70 is sealed and fitted, and then the reagent card 10 is installed to the preset position of the in vitro diagnostic analyzer.
  • the first controller 60 controls the action of the first retractor 40 so that the sealed end 42 leaves the air inlet 232, that is, when the air inlet 232 is opened (as shown in FIGS.
  • gas such as air
  • the air inlet channel 230 that is, if the air connection end 130 is connected to the negative pressure generator 20 to generate suction, the liquid in the sample tube 70 can be sucked into the sampling channel 110 through the hollow needle 220 and flow into
  • the detection chamber 120 is detected and analyzed by the detection device; and when the controller 60 controls the first retractor 40 to move, so that the sealed end 42 and the air inlet hole 232 are sealed and matched, that is, when the air inlet hole 232 is closed (as shown in FIG.
  • gas such as air
  • the sample tube 70 is sealed by the sealing part 240, so that the sample tube 70 cannot communicate with the outside gas, making the liquid in the sample tube 70 difficult It is sucked out through the hollow needle 220.
  • the on-off control of the sample liquid is reliable, which is beneficial to improve the reliability of the detection.
  • the "negative pressure generator 20" may be any related liquid suction equipment that meets the requirements of the present application, such as a suction pump and a vacuum pump.
  • controller 60 includes but is not limited to a programmable controller 60, a motion control card, a computer, and the like.
  • the “sealing portion 240” includes but is not limited to structures such as a sealing ring, a sealing sleeve, and a sealing layer, as long as the sample tube 70 can be sealed and fixed in the mounting hole 212.
  • sample tube 70 includes structures such as a syringe and a test tube.
  • an end of the hollow needle 220 can be inserted into the sample tube” can be understood as an end of the hollow needle 220 protruding from the bottom of the mounting hole 212 to form an interface.
  • the "bottom of the mounting hole 212" can be understood as the bottom wall corresponding to the sample outlet end of the sample tube 70 after the sample tube 70 is inserted, including but not limited to as shown in FIG. 1, and also includes other equivalent solutions after deformation.
  • the reagent card body 100 further includes a calibration fluid channel 140, and the calibration fluid channel 140 is in communication with the detection cavity 120.
  • the reagent card 10 can introduce the calibration solution into the detection cavity 120 through the calibration solution channel 140 for calibration, and then the sample solution is detected.
  • the reagent card body 100 further includes a first calibration fluid bag 150 and a valve core 170, and the first calibration fluid bag 150 is fixed on On the reagent card body 100, the first calibration fluid bag 150 is provided with a matching portion 160 that is butted with the calibration fluid channel 140, and the valve core 170 is arranged in the calibration fluid channel 140 or in the first calibration fluid bag 150 , The valve core 170 is provided with a spiked portion 172 for piercing the matching portion 160; the in vitro diagnostic analyzer also includes a second retractor 50 communicatively connected with the controller 60, and the retractable end of the second retractor 50 can be preset The direction presses the calibration fluid channel 140 or the first calibration fluid bag 150 so that the spike portion 172 pierces the matching portion 160.
  • the calibration solution can be integrated into the reagent card body 100.
  • the sample tube 70 can be inserted into the mounting hole 212 of the mounting body 210.
  • the hollow needle 220 will be inserted into the sample tube 70.
  • the sealing part 240 will be sealed and matched with the sample tube 70, and then the reagent card 10 will be installed in the preset position of the in vitro diagnostic analyzer, and the controller 60 will control the action of the first retractor 40 so that the sealed end 42 and the air inlet 232 are sealed and matched , That is, the air inlet 232 is closed. Then perform calibration analysis.
  • the controller 60 controls the telescopic end of the second retractor 50 to press the calibration fluid channel 140 or the first calibration fluid bag 150 in a preset direction, and drives the spike portion 172 of the valve core 170 to pierce the fit. Part 160, so that the calibration fluid in the first calibration fluid bag 150 flows into the calibration fluid channel 140.
  • the controller 60 then controls the action of the negative pressure generator 20, sends the calibration solution into the detection chamber 120 for calibration, and then uses the detection device to analyze the calibration solution to complete the calibration analysis. After the calibration analysis is completed, the negative pressure generator 20 continues to work, so that the calibration fluid is drawn out of the detection cavity 120.
  • the first retractor 40 is controlled to act, so that the air inlet 232 is opened.
  • the negative pressure generator 20 continues to operate, and an appropriate amount of sample liquid (such as blood) can be sucked into the detection chamber 120, and then the detection device is used to The detection liquid is analyzed, and an analysis report of the sample liquid is obtained.
  • sample liquid such as blood
  • the blood gas analyzer it can precisely control the extraction volume of the calibration solution, ensure that the calibration solution completely covers the detection end of the detection device, accurately complete the calibration analysis, and obtain precise calibration parameters.
  • the on-off control of the air inlet 232 is reliable, the sample liquid will not interfere with the calibration analysis, and when the sample liquid is analyzed, the suction is smooth, which is beneficial to the smooth progress of the sample liquid detection and improves the reliability.
  • the in-vitro diagnostic analyzer further includes a second calibration fluid bag 80, and the second calibration fluid bag 80 communicates with the calibration fluid channel 140 through an on-off valve (not labeled).
  • the second calibration fluid bag 80 can be externally placed outside the reagent card body 100, and docking can be achieved by using pipes and on-off valves, and the calibration fluid can be stored in the in vitro diagnostic analyzer.
  • the on-off valve is used to realize the on-off between the second calibration fluid bag 80 and the calibration fluid channel 140.
  • the controller 60 controls the action of the first retractor 40 so that the sealed end 42 and the air inlet hole 232 are sealed and matched, that is, the air inlet hole 232 is closed. Then, the calibration analysis is performed, and the on-off valve is opened, so that the calibration fluid in the second calibration fluid bag 80 flows into the calibration fluid channel 140.
  • the controller 60 then controls the action of the negative pressure generator 20, sends an appropriate amount of calibration solution into the detection chamber 120 for calibration, and then uses the detection device to analyze the calibration solution to complete the calibration analysis, close the on-off valve, and avoid the second
  • the liquid in the calibration liquid bag 80 interferes with subsequent detection, and can supply liquid for the next reagent card 10.
  • the negative pressure generator 20 continues to work, so that the calibration fluid is drawn out of the detection cavity 120.
  • the first retractor 40 is controlled to act so that the air inlet 232 is opened.
  • the negative pressure generator 20 continues to operate, and an appropriate amount of sample liquid (such as blood) can be sucked into the detection chamber 120, and then the detection device is used to The test solution is tested, and the test result of the sample solution is obtained.
  • the on-off valve is an electromagnetic on-off valve, which is connected to the controller 60 in communication.
  • the on-off valve includes, but is not limited to, a rotary valve or a linear sliding valve.
  • the reagent card body 100 further includes a waste liquid storage cavity 180 communicating with the liquid outlet end of the detection cavity 120, and the waste liquid storage cavity The liquid outlet end of 180 is in communication with the gas connection end 130.
  • the sample liquid can also be stored to avoid exposure of the sample to be tested (for example, blood outflow, contamination of the instrument).
  • the "detection cavity 120" includes but is not limited to being formed by a pipe or formed by a cavity.
  • the “waste liquid storage cavity 180" includes but is not limited to being formed by a pipe or formed by a cavity.
  • the sealing portion 240 is provided with a sealing hole 242 for sealingly fitting with the sample outlet end of the sample tube 70, and one end of the hollow needle 220 It is arranged in the sealing hole 242, and the air outlet hole 234 communicates with the sealing hole 242.
  • the inner side wall of the sealed hole 242 is used to stick to the outer side wall of the sample outlet end of the sample tube 70, so that the sample tube 70 can be sealed and reliably installed on the mounting body 210, avoiding air leakage and affecting the detection result.
  • the gas outlet 234 is arranged in the sealing hole 242, so that the gas inlet channel 230 can better provide gas for the sample tube 70.
  • the outer edge of the air inlet 232 is provided with a sealing layer 250.
  • the sealing layer 250 can be used to better fit the sealing end 42 and the sealing effect is better.
  • the sealing layer 250 includes an elastic layer 252 and an adhesive layer 254 disposed on the elastic layer, and the elastic layer 252 is disposed facing outward.
  • the elastic layer 252 can be adhesively fixed to the outer surface of the mounting body 210 by using the adhesive layer 254, which is easy to implement.
  • the sealing end 42 is provided with a protruding sealing ring 44, and the sealing ring 44 can be sealed and arranged outside the air inlet 232 edge. In this way, the air inlet 232 can be sealed better by using the sealing ring 44.
  • Cooperating with the elastic layer 525 of the foregoing embodiment is beneficial to improve the sealing effect.
  • the material of the sealing ring is an elastic material.
  • the "installation body 210 and the reagent card body 100" include, but are not limited to, detachable connection fixation, such as socket connection, plug-in connection; or non-detachable connection fixation, such as thermal welding, adhesive bonding, and the like.
  • the mounting body 210 and the reagent card body 100 are integrally formed and manufactured.
  • the "installation structure 200" includes but is not limited to being provided on the reagent card 10, and can also be provided on other structures.

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Abstract

一种体外诊断分析仪、试剂卡(10)及安装结构(200)，安装结构(200)包括安装本体(210)，安装本体(210)包括用于套接样品管(70)的安装孔(212)、设置于安装孔(212)内的空心针(220)、设置于安装孔(212)内的密封部(240)以及进气通道(230)，空心针(220)的一端能够插入样品管(70)内，密封部(240)与样品管(70)的外壁密封配合，进气通道(230)包括出气孔(234)、以及设置于安装本体(210)的表面的进气孔(232)，出气孔(234)用于与安设于安装孔(212)上的样品管(70)连通；试剂卡(10)集成了安装结构(200)，体外诊断分析仪集成了试剂卡(10)，通过打开或关闭进气孔(232)实现了样品液的通断控制，解决了样品液泄露及无法抽取的问题。

Description

体外诊断分析仪、试剂卡及安装结构
本申请要求申请日为2020年1月23日、申请号为202010076460.8的中国专利申请的优先权，该申请的全部内容通过引用结合在本申请中。
技术领域
本申请涉及医疗器械技术领域，例如涉及一种体外诊断分析仪及试剂卡。
背景技术
试剂卡(也称测试卡、检测卡)广泛用于医疗行业，该试剂卡集成生化检测电极，通过定标液定标，然后进行样品液(血液、组织液等)检测。
相关技术中的试剂卡通常通过挤压进样通道的关闭及打开来实现样品液的通断控制。但其存在问题如下：
1、存在样品液沿管道泄漏的隐患：当试剂卡插入不到位或仪器装配件尺寸有偏差时，抵压件容易压偏，造成进样通道无法压紧而无法关闭。如此在进行定标分析时，该样品液会意外流入试剂卡内，导致定标分析失真。
2、存在样品液无法抽取的隐患：当仪器所在环境温度过低或试剂卡内负压偏大时，会出现进样通道的弹性体回弹不良或甚至无法回弹的现象，造成样品液无法流入试剂卡内。
发明内容
本申请提供了一种体外诊断分析仪、试剂卡及安装结构。该安装结构能够安装样品管，且能够实现样品液的通断控制，解决了上述样品液泄露及无法抽取的隐患。该试剂卡集成了上述安装结构，采用了一种新的样品液的通断控制方案，能够解决上述样品液泄露及无法抽取的隐患。该体外诊断分析仪使用时，样品液的通断控制可靠，有利于提高检测的可靠性。
本申请实施例提供一种安装结构，包括安装本体，安装本体包括用于套接样品管的安装孔、设置于安装孔内的空心针、设置于所述安装孔内的密封部以及进气通道，空心针的一端能够插入样品管内，密封部与样品管的外壁密封配合，进气通道包括出气孔、以及设置于安装本体的表面的进气孔，出气孔用于与安设于安装孔上的样品管连通。
上述安装结构使用时，样品管可以插入安装孔内，此过程中，空心针会插入到样品管中，完成样品管安装后，密封部会与样品管密封配合。此时，当进气孔被打开时，气体(如空气)能够通过进气通道进入样品管内，即此时样品管内的液体能够通过空心针被吸走；当进气孔被封闭时，气体(如空气)无法通过进气通道进入样品管内，而样品管又被密封部密封，使得样品管无法与外界的气体连通，使得样品管内的液体难以通过空心针被吸出。该安装结构能实现样品管的安装，在进行样品液的通断控制时，无需进行挤压使进样通道的变形来关闭或依赖进样通道的自复位来实现进样通道打开，只需通过打开或关闭进气孔来实现样品液的通断控制，有利于解决了上述样品液泄露及无法抽取的隐患。
在其中一个实施例中，密封部设有用于与样品管的出样端密封配合的密封孔，空心针的一端设置于密封孔内，且出气孔与密封孔连通。
在其中一个实施例中，进气孔的外边缘设有密封层。
在其中一个实施例中，密封层包括弹性层及设置于弹性层上的粘接层，弹性层朝外设置。
本申请实施例还提供了一种试剂卡，包括上述任一实施例中的安装结构，还包括试剂卡本体，试剂卡本体与安装结构固定，试剂卡本体包括与空心针的出液端相通的进样通道、检测腔、以及接气端，进样通道及接气端与检测腔连通。
上述试剂卡使用时，样品管可以插入安装本体的安装孔内，此过程中，空心针会插入到样品管中，完成样品管安装后，密封部会与样品管密封配合。此时，当进气孔被打开时，气体(如空气)能够通过进气通道进入样品管内，即此时接气端对接负压发生器，产生吸力，使得样品管内的液体能够通过空心针吸入进样通道，并流入检测腔进行检测分析；当进气孔被封闭时，气体(如空气)无法通过进气通道进入样品管内，而样品管又被密封部密封，使得样品管无法与外界的气体连通，使得样品管内的液体难以通过空心针被吸出。该试剂卡在进行样品液的通断控制时，无需进行挤压使进样通道的变形来关闭或依赖进样通道的自复位来实现进样通道打开，只需通过伸缩阀来打开或关闭进气孔来实现样品液的通断控制，能解决了上述样品液泄露及无法抽取的隐患。
在其中一个实施例中，安装本体与试剂卡本体一体成型制造。
在其中一个实施例中，试剂卡本体还包括定标液通道，定标液通道与检测 腔连通。
在其中一个实施例中，试剂卡本体还包括与检测腔的出液端相通的废液存储腔，废液存储腔的出液端与接气端连通。
在其中一个实施例中，试剂卡本体还包括第一定标液袋及阀芯，第一定标液袋固设于试剂卡本体上，且第一定标液袋设有与定标液通道对接的配合部，阀芯设置于定标液通道内或设置于第一定标液袋内，阀芯设有用于刺破配合部的尖刺部。
本申请实施例还提供了一种体外诊断分析仪，包括上述任一实施例中的试剂卡，还包括负压发生器、样品管、第一伸缩器、检测装置及控制器，负压发生器与接气端对接，样品管设有与空心针间隙配合的出样端，第一伸缩器设有用于密封进气孔的密封端，控制器与负压发生器、第一伸缩器及检测装置通信连接，检测装置的检测端设置于检测腔内。
上述体外诊断分析仪使用时，样品管可以插入安装本体的安装孔内，此过程中，空心针会插入到样品管中，完成样品管安装后，密封部会与样品管密封配合，然后将试剂卡安装到体外诊断分析仪的预设位置。当第一控制器控制第一伸缩器动作使得密封端离开进气孔，即该进气孔被打开时，气体(如空气)才能够通过进气通道进入样品管内，即此时接气端对接负压发生器，产生吸力，使得样品管内的液体能够通过空心针吸入进样通道，并流入检测腔进行检测分析；而当控制器控制第一伸缩器动作，使得密封端与进气孔密封配合，即进气孔被封闭时，气体(如空气)无法通过进气通道进入样品管内，而样品管又被密封部密封，使得样品管无法与外界的气体连通，使得样品管内的液体难以通过空心针被吸出。该体外诊断分析仪使用时，样品液的通断控制可靠，有利于提高检测的可靠性。
在其中一个实施例中，密封端设有凸出设置的密封环，密封环能够密封设置于进气孔的外边缘。
在其中一个实施例中，试剂卡本体还包括与检测腔连通的定标液通道、第一定标液袋及阀芯，第一定标液袋固设于试剂卡本体上，且第一定标液袋设有与定标液通道对接的配合部，阀芯设置于定标液通道内或设置于第一定标液袋内，阀芯设有用于刺破配合部的尖刺部；体外诊断诊断分析仪还包括与控制器通信连接的第二伸缩器，第二伸缩器的伸缩端能够按预设方向抵压定标液通道或第一定标液袋，使得尖刺部刺破配合部。
在其中一个实施例中，体外诊断分析仪还包括与检测腔连通的定标液通道、以及第二定标液袋，第二定标液袋与定标液通道之间通过开关阀连通。
附图说明
图1为一实施例中的所示的体外诊断分析仪的结构示意图；
图2为一实施例中的所示的体外诊断分析仪的结构示意图；
图3为图2所示的试剂卡的结构示意图；
图4为图3所示的A的局部放大示意图；
图5为图3所示的测试卡吸入定标液的示意图；
图6为图3所示的试剂卡完成定标分析后的示意图；
图7为图5或图6所示的试剂卡状态下进气孔的状态示意；
图8为图3所示的试剂卡吸入样品液的示意图；
图9为图8所示的B的局部放大示意图；
图10图8所示的试剂卡状态下进气孔的状态示意；
图11为图1所示的试剂卡的结构示意图；
图12为图11所示的试剂卡的第二定标液与阀芯的结构示意图。
附图标记说明：
10、试剂卡；100、试剂卡本体；110、进样通道；120、检测腔；130、接气端；140、定标液通道；150、第一定标液袋；160、配合部；170、阀芯；172、尖刺部；180、废液存储腔；200、安装结构；210、安装本体；212、安装孔；220、空心针；230、进气通道；232、进气孔；234、出气孔；240、密封部；242、密封孔；250、密封层；252、弹性层；254、粘接层；20、负压发生器；40、第一伸缩器；42、密封端；44、密封环；50、第二伸缩器；60、控制器；70、样品管；80、第二定标液袋。
具体实施方式
需要说明的是，当元件被称为“固定于”、“设置于”、“固设于”或“安设于”另一个元件，它可以直接在另一个元件上或者也可以存在居中的元件。当一个元件被认为是“连接”另一个元件，它可以是直接连接到另一个元件或者可能同时存在居中元件。进一步地，当一个元件被认为是“连接”另一个元件，二者可以是可拆卸连接方式的固定，也可以不可拆卸连接的固定，如套接、卡 接、一体成型固定、焊接等，在相关技术中可以实现，在此不再累赘。当元件与另一个元件相互垂直或近似垂直是指二者的理想状态是垂直，但是因制造及装配的影响，可以存在一定的垂直误差。本文所使用的术语“垂直的”、“水平的”、“左”、“右”以及类似的表述只是为了说明的目的，并不表示是唯一的实施方式。
除非另有定义，本文所使用的所有的技术和科学术语与属于本申请的技术领域的技术人员通常理解的含义相同。本文中在本申请的说明书中所使用的术语只是为了描述具体的实施方式的目的，不是旨在于限制本申请。本文所使用的术语“及/或”包括一个或多个相关的所列项目的任意的和所有的组合。
本申请中涉及的“第一”、“第二”不代表具体的数量及顺序，仅仅是用于名称的区分。
如图1及图2所示，本申请还提供了一种体外诊断分析仪，包括试剂卡10、负压发生器、样品管70、第一伸缩器40、检测装置及控制器60。
其中，如图3、图4及图7所示，试剂卡10包括试剂卡本体100以及固设于检测本体上的安装结构200，试剂卡本体100包括进样通道110、检测腔120、以及接气端130，进样通道110及接气端130与检测腔120连通。安装结构200包括安装本体210，安装本体210包括用于套接样品管70的安装孔212、设置于安装孔212内的空心针220、设置于所述安装孔212内的密封部240以及进气通道230，空心针220的一端能够插入样品管70内，另一端插入进样通道110内，密封部240与样品管70的外壁密封配合，进气通道230包括出气孔234、以及设置于安装本体210的表面的进气孔232，出气孔234用于与安设于安装孔212上的样品管70连通。
其中，负压发生器与接气端130对接，样品管70设有与空心针220间隙配合的出样端，第一伸缩器40设有用于密封进气孔232的密封端42，控制器60与负压发生器20、第一伸缩器40及检测装置通信连接，检测装置的检测端设置于检测腔120内。
上述体外诊断分析仪使用时，样品管70可以插入安装本体210的安装孔212内，此过程中，空心针220会插入到样品管70中，完成样品管70安装后，密封部240会与样品管70密封配合，然后将试剂卡10安装到体外诊断分析仪的预设位置。当第一控制器60控制第一伸缩器40动作使得密封端42离开进气孔232，即该进气孔232被打开时(如图9及图10所示)，气体(如空气)才能够 通过进气通道230进入样品管70内，即此时若接气端130对接负压发生器20，产生吸力，可使得样品管70内的液体能够通过空心针220吸入进样通道110，并流入检测腔120，并利用检测装置进行检测分析；而当控制器60控制第一伸缩器40动作，使得密封端42与进气孔232密封配合，即进气孔232被封闭时(如图7所示)，气体(如空气)无法通过进气通道230进入样品管70内，而样品管70又被密封部240密封，使得样品管70无法与外界的气体连通，使得样品管70内的液体难以通过空心针220被吸出。该体外诊断分析仪使用时，样品液的通断控制可靠，有利于提高检测的可靠性。
可选地，“负压发生器20”可为抽吸泵、真空泵等任意一种满足本申请要求的相关液体抽吸设备。
可选地，“控制器60”包括但不仅限于可编程控制器60、运动控制卡、电脑等。
可选地，“密封部240”包括但不仅限于密封环、密封套、密封层等结构，只要能够实现将样品管70密封固定于安装孔212内即可。
可选地，“样品管70”包括注射器、试管等结构。
可选地，“空心针220的一端能够插入所述样品管内”，可以理解为空心针220的一端凸出安装孔212的底部设置形成接口。
而“安装孔212的底部”可以理解为插入样品管70后，与样品管70的出样端相对应的底壁，包括但不仅限于如图1所示，还包括其他变形后等同的方案。
在上述实施例的基础上，如图3或图11所示，一实施例中，试剂卡本体100还包括定标液通道140，定标液通道140与检测腔120连通。如此，该试剂卡10能够通过定标液通道140将定标液导入检测腔120中进行定标，然后在进行样品液的检测。
在上述实施例的基础上，如图11至图12所示，一实施例中，试剂卡本体100还包括第一定标液袋150及阀芯170，第一定标液袋150固设于试剂卡本体100上，且第一定标液袋150设有与定标液通道140对接的配合部160，阀芯170设置于定标液通道140内或设置于第一定标液袋150内，阀芯170设有用于刺破配合部160的尖刺部172；体外诊断诊断分析仪还包括与控制器60通信连接的第二伸缩器50，第二伸缩器50的伸缩端能够按预设方向抵压定标液通道140或第一定标液袋150，使得尖刺部172刺破配合部160。
此时，该定标液可以集成到试剂卡本体100上。参考图1及图5至图9所示，使用时，样品管70可以插入安装本体210的安装孔212内，此过程中，空心针220会插入到样品管70中，完成样品管70安装后，密封部240会与样品管70密封配合，然后将试剂卡10安装到体外诊断分析仪的预设位置，控制器60控制第一伸缩器40动作，使得密封端42与进气孔232密封配合，即进气孔232被封闭。然后进行定标分析，控制器60控制第二伸缩器50的伸缩端按预设方向抵压定标液通道140或第一定标液袋150，带动阀芯170的尖刺部172刺破配合部160，从而使第一定标液袋150的定标液流入定标液通道140中。控制器60再控制负压发生器20动作，将定标液送入检测腔120进行定标，然后利用检测装置对定标液进行分析，完成定标分析。完成定标分析后，负压发生器20继续工作，使得定标液抽离检测腔120。此时控制第一伸缩器40动作，使得进气孔232被打开，此时负压发生器20继续动作，可以将适量的样品液(如血液)吸入检测腔120内，然后再利用检测装置对检测液进行分析，获得样品液的分析报告。该血气分析仪在进行定标工作时，能够精确控制定标液的抽取量，保证定标液完全覆盖检测装置的检测端，精准地将完成定标分析，获得精确的定标参数。此过程中，进气孔232的通断控制可靠，样品液不会干扰定标分析，而进行样品液分析时，抽吸顺利，有利于样品液检测的顺利进行，提高可靠性。
另一实施例中，如图2所示，体外诊断分析仪还包括第二定标液袋80，第二定标液袋80与定标液通道140之间通过开关阀(未标注)连通。等同的，此时该第二定标液袋80可以外置于试剂卡本体100的外面，利用管道及开关阀实现对接，可以将定标液存储在体外诊断分析仪内。利用开关阀来实现第二定标液袋80与定标液通道140之间的通断。
示例性地，如图5至图9所示，控制器60控制第一伸缩器40动作，使得密封端42与进气孔232密封配合，即进气孔232被封闭。然后进行定标分析，打开开关阀，从而使第二定标液袋80的定标液流入定标液通道140中。控制器60再控制负压发生器20动作，将适量的定标液送入检测腔120进行定标，然后利用检测装置对定标液进行分析，完成定标分析，关闭开关阀，避免第二定标液袋80的液体干扰后续检测，可以为下一张试剂卡10供液。完成定标分析后，负压发生器20继续工作，使得定标液抽离检测腔120。此时控制第一伸缩器40动作，使得进气孔232被打开，此时负压发生器20继续动作，可以将适量的样品液(如血液)吸入检测腔120内，然后再利用检测装置对检测液进行检测， 获得样品液的检测结果。
可选地，该开关阀为电磁开关阀，与控制器60通信连接。
此外，该开关阀包括但不仅限于旋转阀或直线滑动阀。
在前述两个实施例的基础上，如图3或图11所示，一实施例中，试剂卡本体100还包括与检测腔120的出液端相通的废液存储腔180，废液存储腔180的出液端与接气端130连通。如此，完成定标分析后的定标液可以推入或吸入废液存储腔180中，既可以避免定标液外露，也可以防止定标液的存留影响测试液的分析结果。此外，也可以存储样品液，避免待测样品外露(例如血液外流，污染仪器)。
可选地，“检测腔120”包括但不仅限于由一条管道形成或由一个空腔形成。同理，“废液存储腔180”包括但不仅限于由一条管道形成或由一个空腔形成。
在上述任一实施例的基础上，如图4及图9所示，一实施例中，密封部240设有用于与样品管70的出样端密封配合的密封孔242，空心针220的一端设置于密封孔242内，且出气孔234与密封孔242连通。如此，利用密封孔242的内侧壁进贴样品管70的出样端的外侧壁，使得样品管70可以密封可靠地安装到安装本体210上，避免出现漏气而影响检测结果。同时出气孔234设置于密封孔242内，使得进气通道230可更好地为样品管70提供气体。
在上述任一实施例的基础上，如图7及图10所示，一实施例中，进气孔232的外边缘设有密封层250。如此，利用密封层250可以更好地与密封端42配合，密封效果更佳。
示例性地，如图7所示，一实施例中，密封层250包括弹性层252及设置于弹性层上的粘接层254，弹性层252朝外设置。如此，可以利用粘接层254将弹性层252粘接固定于安装本体210的外表面，易于实施。
在上述任一实施例的基础上，如图7或图10所示，一实施例中，密封端42设有凸出设置的密封环44，密封环44能够密封设置于进气孔232的外边缘。如此，利用密封环44可以更好地密封进气孔232。与前述实施例的弹性层525相配合，有利于提高密封效果。
可选地，该密封环的材质为弹性材料。
可选地，“安装本体210与试剂卡本体100”包括但不仅限于可拆卸连接的固定，如套接，插接；或不可拆卸连接的固定，如热焊接、粘接剂粘接等。
本实施例中，安装本体210与试剂卡本体100一体成型制造。
可选地，“安装结构200”包括但不仅限于设置于试剂卡10上，还可以设置于其他结构上。
以上实施例的各技术特征可以进行任意的组合，为使描述简洁，未对上述实施例中的各个技术特征所有可能的组合都进行描述，然而，只要这些技术特征的组合不存在矛盾，都应当认为是本说明书记载的范围。

Claims (13)

  1. 一种安装结构，包括安装本体，所述安装本体包括用于套接样品管的安装孔、设置于所述安装孔内的空心针、设置于所述安装孔内的密封部、以及进气通道，所述空心针的一端能够插入所述样品管内，所述密封部与所述样品管的外壁密封配合，所述进气通道包括出气孔、以及设置于所述安装本体的表面的进气孔，所述出气孔用于与安设于所述安装孔上的所述样品管连通。
  2. 根据权利要求1所述的安装结构，其中，所述密封部设有用于与所述样品管的出样端密封配合的密封孔，所述空心针的一端设置于所述密封孔内，且所述出气孔与所述密封孔连通。
  3. 根据权利要求1或2所述的安装结构，其中，所述进气孔的外边缘设有密封层。
  4. 根据权利要求3所述的安装结构，其中，所述密封层包括弹性层及设置于所述弹性层上的粘接层，所述弹性层朝外设置。
  5. 一种试剂卡，包括如权利要求1至4任一项所述的安装结构，还包括试剂卡本体，所述试剂卡本体与所述安装结构固定，所述试剂卡本体包括与所述空心针的出液端相通的进样通道、检测腔、以及接气端，所述进样通道及所述接气端与所述检测腔连通。
  6. 根据权利要求5所述的试剂卡，其中，所述安装本体与所述试剂卡本体一体成型制造。
  7. 根据权利要求5或6所述的试剂卡，其中，所述试剂卡本体还包括定标液通道，所述定标液通道与所述检测腔连通。
  8. 根据权利要求7所述的试剂卡，其中，所述试剂卡本体还包括与所述检测腔的出液端相通的废液存储腔，所述废液存储腔的出液端与接气端连通。
  9. 根据权利要求7所述的试剂卡，其中，所述试剂卡本体还包括第一定标液袋及阀芯，所述第一定标液袋固设于所述试剂卡本体上，且所述第一定标液袋设有与所述定标液通道对接的配合部，所述阀芯设置于所述定标液通道内或设置于所述第一定标液袋内，所述阀芯设有用于刺破所述配合部的尖刺部。
  10. 一种体外诊断分析仪，包括如权利要求5至8任一项所述的试剂卡，还包括负压发生器、样品管、第一伸缩器、检测装置及控制器，所述负压发生器与所述接气端对接，所述样品管设有与所述空心针间隙配合的出样端，所述第一伸缩器设有用于密封所述进气孔的密封端，所述控制器与所述负压发生器、第一伸缩器及检测装置通信连接，所述检测装置的检测端设置于所述检测腔内。
  11. 根据权利要求10所述的体外诊断分析仪，其中，所述密封端设有凸出设置的密封环，所述密封环能够密封设置于所述进气孔的外边缘。
  12. 根据权利要求10或11所述的体外诊断分析仪，其中，所述试剂卡本体还包括与所述检测腔连通的定标液通道、第一定标液袋及阀芯，所述第一定标液袋固设于所述试剂卡本体上，且所述第一定标液袋设有与所述定标液通道对接的配合部，所述阀芯设置于所述定标液通道内或设置于所述第一定标液袋内，所述阀芯设有用于刺破所述配合部的尖刺部；所述体外诊断诊断分析仪还包括与所述控制器通信连接的第二伸缩器，所述第二伸缩器的伸缩端能够按预设方向抵压所述定标液通道或所述第一定标液袋，使得所述尖刺部刺破所述配合部。
  13. 根据权利要求10或11所述的体外诊断分析仪，还包括与所述检测腔连通的定标液通道、以及第二定标液袋，所述第二定标液袋与所述定标液通道之间通过开关阀连通。
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