WO2022143932A1 - 一种用于体外诊断装置的可移除试剂包及其控制方法 - Google Patents

一种用于体外诊断装置的可移除试剂包及其控制方法 Download PDF

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Publication number
WO2022143932A1
WO2022143932A1 PCT/CN2021/143218 CN2021143218W WO2022143932A1 WO 2022143932 A1 WO2022143932 A1 WO 2022143932A1 CN 2021143218 W CN2021143218 W CN 2021143218W WO 2022143932 A1 WO2022143932 A1 WO 2022143932A1
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WIPO (PCT)
Prior art keywords
reagent pack
stage
removable
pipeline
host
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PCT/CN2021/143218
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English (en)
French (fr)
Inventor
黄高祥
周川川
赵志翔
Original Assignee
深圳市理邦精密仪器股份有限公司
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Application filed by 深圳市理邦精密仪器股份有限公司 filed Critical 深圳市理邦精密仪器股份有限公司
Priority to EP21914662.8A priority Critical patent/EP4273553A4/en
Publication of WO2022143932A1 publication Critical patent/WO2022143932A1/zh
Priority to US18/343,724 priority patent/US20230349930A1/en

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    • 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
    • G01N33/72—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood pigments, e.g. haemoglobin, bilirubin or other porphyrins; involving occult blood
    • G01N33/721—Haemoglobin
    • 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
    • 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
    • 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
    • G01N33/72—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood pigments, e.g. haemoglobin, bilirubin or other porphyrins; involving occult blood
    • G01N33/721—Haemoglobin
    • G01N33/726—Devices
    • 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
    • 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
    • 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
    • B01L2200/16—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
    • B01L2300/0627—Sensor or part of a sensor is integrated
    • 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
    • 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
    • G01N2035/00306—Housings, cabinets, control panels (details)

Definitions

  • the present invention relates to the field of in vitro technology, and in particular to a removable reagent pack for an in vitro diagnostic device.
  • the determination of gas components in blood is important in various scientific researches and practical applications. In the rescue of critically ill patients in clinical medicine, rapid and continuous determination of blood carbon dioxide partial pressure is crucial. Especially for mechanically ventilated patients, the partial pressure of carbon dioxide in blood is a very key indicator to determine the breathing state of the patient.
  • the parameters of the ventilator are mainly set according to the partial pressure of carbon dioxide in the patient's blood.
  • the most widely used blood gas component detector in medicine is a blood gas analyzer.
  • conventional blood gas analyzers have defects such as the need to collect a large number of blood samples, discontinuity, and lag in test results.
  • the reagent pack for in vitro diagnosis is usually placed inside the test card or the host of the in vitro diagnosis system, which is not convenient for operators to replace, and is prone to waste. Therefore, it is very necessary to provide a A removable reagent pack of an in vitro diagnostic device, the removable reagent pack can be independently transported and stored independently of the test card and the in vitro diagnostic system, and can be combined with the test card to realize the blood gas detection operation.
  • a removable reagent pack for an in vitro diagnostic device characterized in that the reagent pack comprises a housing, at least one external outlet, at least one liquid storage device and its output line, at least one delivery control device, said The delivery control device is capable of controlling at least the direction of flow in the inner tubing of the reagent pack, and at least one positioning mechanism that enables the delivery control device to be actuated.
  • the delivery control device is a pump.
  • the pump is capable of forward and/or reverse rotation.
  • the pump is a peristaltic pump.
  • the reagent pack further includes at least one pipeline switching device.
  • the reagent pack includes at least three pipelines, wherein the output pipeline of the liquid storage device is a first pipeline, a second pipeline that communicates with the outside world, and a second pipeline that communicates with the external interface of the reagent package.
  • the third pipeline, the pipeline switching device makes one of the first pipeline and the second pipeline communicate with the third pipeline.
  • the delivery control device is located on at least the third pipeline.
  • the reagent pack has at least one external interface for outputting liquid, output gas and/or input gas in the reagent pack.
  • the external interface is at least partially surrounded by a seal.
  • the liquid is a calibration liquid.
  • the positioning mechanism is a groove, and/or the pipeline switching device is a three-way valve.
  • the reagent pack has a readable device for recording status information, and the status information includes the liquid type, use temperature, capacity, the type of the adapted sensor, the historical use status of the reagent pack and the current capacity status information. one or more types of information.
  • a control method for a removable reagent pack characterized in that:
  • the delivery control device is configured to cause the reagent pack to output a quantitative calibration solution to the outside;
  • the delivery control device is configured to cause the reagent pack to output a quantitative gas to the outside;
  • the delivery control device is configured to externally input a quantitative gas to the reagent pack
  • the delivery control device is configured to cause the reagent pack to output a metered amount of gas to the outside.
  • the first stage is a stage in which the detection card or the host of the blood gas analyzer calibrates the sensor.
  • the second stage is the stage of emptying the calibration solution after the calibration is completed.
  • the third stage is the stage of injecting the sample to be detected in the detection card to perform blood gas detection.
  • the fourth stage is the stage in which the sample to be detected in the detection card is transferred from the hemoglobin detection area to hemoglobin and its derivatives.
  • the blood gas detection and the detection of hemoglobin and its derivatives are respectively completed.
  • the delivery control device in the first, second and fourth stages, is configured to receive a positive driving force output by the host of the in vitro diagnostic device, and in the third stage, the delivery control device is configured to receive back-drive force output from the host computer of the in vitro diagnostic device.
  • the pipeline switching device in the reagent pack is configured to communicate the output pipeline of the liquid storage device with the external outlet, and in the second to fourth stages, the pipeline The circuit switching device is configured to communicate the air source with the external outlet.
  • the beneficial effect of the present invention is that the removable reagent pack of the in vitro diagnostic device can exist completely independently of the host and the test card of the in vitro diagnostic system, and is suitable for independent transportation and storage.
  • the pump and valve parts provided in the removable reagent pack enable the reagent pack to fit well with the test card of the in vitro diagnostic device to complete the pumping of the calibration solution, emptying the calibration solution, and drawing fluid samples into the test card. To complete the detection of blood gas, hemoglobin and its derivatives and other biochemical parameters.
  • the reagent pack can be reused many times because it has a readable device with factory information and use status, which is convenient for the operator to know the status of the reagent pack in time, which can prevent the waste of calibration solution to a large extent, and reduce the amount of calibration solution reagents.
  • the cost of using the package assisting the operator to better cope with in vitro diagnostics.
  • Figure 1 is a schematic diagram of the external structure of the in vitro medical diagnosis system
  • Fig. 2 is the side schematic diagram of in vitro medical diagnosis system
  • Fig. 3 is the combined schematic diagram of each component of the in vitro diagnostic system
  • FIG. 4 is a schematic half-section view of a removable test card
  • FIG. 5 is a schematic half-section view of a removable test card
  • FIG. 6 is a schematic half-section view of a removable test card
  • Fig. 7 is the connection schematic diagram of removable test card and valve control device
  • Fig. 8 is the control schematic diagram of the valve control device
  • FIG. 9 is a schematic cross-sectional view of a removable reagent pack
  • Figure 10 is a schematic diagram of the external structure of a removable reagent pack
  • FIG. 11 is a schematic structural diagram of a removable reagent pack body and a decorative cover
  • FIG. 12 is a schematic diagram of the structure of the excitation light source of the in vitro medical diagnosis system
  • the exemplary embodiment of the present invention adopts an in vitro medical diagnosis system, as shown in FIGS. 1-3 , including a host 1 , a removable test card 2 , and a removable reagent pack 3 .
  • the host includes a housing, and processing circuits, power supply circuits and optical elements located in the housing.
  • the housing further comprises a first area 1a configured to at least partially receive the removable test card, and a second area 1b configured to at least partially receive the removable reagent pack.
  • the removable test card 2 is engaged with the host 1 and the removable reagent pack 3 through the first area 1a and the second area 1b, respectively, so that the removable test card 2 and the host 1 are separated from each other. There is no fluid communication therebetween, and there is no fluid communication between the removable reagent pack 3 and the host 1 .
  • the inside of the removable test card includes an external interface, a detection area, a waste liquid area, a liquid circuit control area and an internal liquid circuit, among which,
  • the external interface refers to the first interface for receiving fluid samples, the second interface for air pumping/extraction, and the third interface for injecting calibration liquid, which are provided on the four sides, upper top surface or lower bottom surface of the test card.
  • a fluid sample inlet is provided on the first side of the test card, and the fluid sample inlet is used to receive a fluid sample, such as a whole blood blood sample without hemolysis, and a calibration solution inlet and a drain are provided on the second side of the test card.
  • the calibration fluid inlet is configured to receive calibration fluid from the outside (such as a removable reagent pack) so as to calibrate each photochemical sensor inside the test card
  • the exhaust port is configured to communicate with the outside atmosphere to maintain Air pressure balance in the test card to ensure that the calibrator or fluid sample flows into the test card
  • Detection area refers to the area where electrical, optical, chemical sensors required for the detection of various blood gas parameters and/or cavities that do not contain sensors are placed, and the detection of blood gas, hemoglobin, electrolytes and other biochemical parameters is completed in this area;
  • Waste area refers to the area used to store the fluid samples that have been tested
  • the internal liquid path refers to the pipeline path inside the test card for the flow of fluid samples or calibration liquid.
  • the pipeline path has multiple interconnected liquid path paths, and the detection area, waste liquid area, and liquid path control area are respectively located in on different sections of the liquid path;
  • the liquid circuit control area means that several on-off control devices are set in this area, and the on-off control devices are used to control the on-off of the internal liquid circuit, so as to realize the switching of the liquid circuit and make the calibration under different test stages.
  • the liquid and fluid samples flow into the detection area and the waste liquid area through different paths. The detailed switching operation will be described in detail later.
  • the detection area, the waste liquid area and the liquid path control area are usually located between the first side and the second side of the test card.
  • test card Each functional area and internal liquid circuit of the test card have various implementations, and one of the preferred implementations is provided below:
  • the removable test card 2 includes a card body that is at least partially transparent.
  • the card body can be made of molded plastic, another material, or a kit of materials.
  • the fluid sample to be detected is a blood sample, preferably a whole blood blood sample without hemolysis, the detection area includes a blood gas detection area 7, a hemoglobin and its derivative detection area 8; the waste liquid area 11 is used to store the blood samples that have been detected;
  • the internal liquid path 9 is divided into a main liquid path and three controllable liquid paths, wherein the main liquid path is connected to the calibration liquid inlet, the blood gas detection area and the liquid path control area 10.
  • the blood gas detection area 7 is located at the calibration liquid inlet 6 and the liquid path control area 10; the first section of the controllable liquid path is used to control the on-off of the liquid path between the sample inlet 4 and the main liquid path; the second section of the controllable liquid path controls the main liquid path and hemoglobin and its derivatives
  • the liquid path between the inlets of the substance detection area 8 is connected and disconnected, and the outlet of the hemoglobin and its derivatives detection area 8 is connected to the waste liquid area 11; the third controllable liquid path is used for the communication between the waste liquid area 11 and the main liquid path.
  • the waste liquid area 11 is communicated with the exhaust port 5, wherein several position monitoring points are arranged in the blood gas control area and the second-stage controllable liquid circuit; the liquid circuit control area 10 is provided with three valves 10a for controlling the on-off of the internal liquid circuit -10c, respectively used to control the first, second and third sections of the controllable liquid circuit, and the control method will be described in detail later.
  • the blood gas detection area has 12 sensor cavities 7A-7L, and the cavities are arranged in order and arranged on the main liquid circuit.
  • the cavities can be of various shapes, and the shapes of the cavities can be the same or different, but In the flow direction of the liquid path, the width of the sensor cavity is wider than the width of the liquid path.
  • Various types of sensors can be placed in the cavity.
  • the distance from the calibration liquid inlet in the direction of the flow path The distances are arranged in order from far to near, and are sequentially numbered 7A-7L.
  • the first 11 sensor cavities 7A-7K are sequentially placed with different photochemical sensors, and the 12th sensor cavity 7L is used as a backup for future detection. parameter expansion.
  • the hemoglobin and its derivative detection area 8 is only a cavity, and no sensor is provided.
  • the photochemical sensors in the first ten sensor cavities 7A-7J are respectively configured to detect blood gas parameters such as CO 2 , O 2 , pH, Na+, Mg++ and the like in the blood fluid sample;
  • the fluid sample may be a whole blood blood sample, a urine sample or other types of human body fluid samples, in this case, the sensor in the detection card detects the corresponding biochemical parameter index.
  • test card The control mode of the test card is described in detail below.
  • the test card 2 Before detecting the blood sample, it is necessary to calibrate all the sensors in the test card 2, that is, inject calibration liquid into the sensors, and empty all the calibration liquid in the test card 2 after the calibration is completed. Then inject the fluid sample to be detected, preferably a blood sample without hemolysis, complete the detection in the detection area, read the corresponding parameters through the host of the in vitro medical diagnosis system, and display the corresponding parameters and diagnosis on the host screen after the diagnostic analysis is completed. The results, so that the medical staff can be informed of the corresponding situation in time.
  • inject the fluid sample to be detected preferably a blood sample without hemolysis
  • Step 1 Put the test card 2 into the first area 1a;
  • Step 2 pump the calibration solution into the detection area in the test card 2;
  • Step 3 after the calibration is completed, transfer the calibration solution in the test card 2 to the waste liquid area 11 in the test card;
  • Step 4 inject the blood sample into the detection area, and complete at least the detection of hemoglobin and blood gas in the detection area;
  • Step 5 Transfer the blood sample in the detection area to the waste liquid area 11 in the test card 2, and the detection is completed.
  • the step 1 is specifically, before the test card 2 is connected with the reagent pack 3 and the host 1, the inside of the test card 2 is dry and there is no calibration solution, and the calibration solution is stored in the reagent pack 3 and separated from the test card 2,
  • the detection position is the first area 1a in the host 1. After the test card is placed in this area, the fluid sample inside the test card 2 is detected. As shown in FIG. 3, the test There are at least six position detection points 11a-11f in the card 2, which can receive the light intensity emitted by the detection light source after passing through the test card 2 to detect and determine whether there is liquid at the position detection points 11a-11f.
  • the third section of the controllable liquid path is connected, the first and second sections of the controllable liquid path are controllable and closed, and the host 1 controls the peristaltic pump 16 and the three-way valve 17 in the reagent pack 3. , switch the three-way valve 17 to the calibration solution pipeline 19, and pump the calibration solution in the reagent pack 15 (that is, the standard sample liquid with known composition and concentration) through the connector 20 inserted into the calibration solution inlet of the test card.
  • the host 1 controls the peristaltic pump 16 in the reagent pack 3 to stop moving. 1.
  • Use to start calibrating each sensor that is, reading the reading of the sensor to measure the standard sample liquid sensor
  • the host 1 reads the detected value of each sensor and ends the calibration.
  • the third section of the controllable liquid circuit is kept connected, the first and second sections of the controllable liquid circuit are kept closed, and the host 1 controls the three-way valve 17 in the reagent pack 3 to switch to air. channel, and control the peristaltic pump 16 to pump the air into the test card 2 through the connector 20 inserted into the calibration liquid inlet of the test card 2, because the waste liquid area 11 of the test card 2 is connected to the outside air through the exhaust port 5. The connection is maintained. Therefore, with the pumping of air, the calibration liquid continues to move toward the waste liquid area 11 in the first and third liquid paths until all the calibration liquid enters the waste liquid area 11 .
  • the step 4 is divided into two stages,
  • the controllable liquid path of the first section is connected, and the controllable liquid path of the second and third sections is closed.
  • the host 1 controls the peristaltic pump 16 to reverse, draws out the air inside the test card 2, and generates negative pressure in the test card 2 to suck the blood at the blood sample inlet 4 into the inside of the test card 2,
  • the sensor cavities 4A-4L After determining that the blood sample to be detected completely enters the sensor cavities 4A-4L through the position monitoring points 12a-12f, stop injecting the blood sample to be detected into the test card 2, or the host 1 controls the peristaltic pump 16 to stop pumping air,
  • the preferred method is that a photochemical sensor is arranged in the sensor cavities 4A-4K, and the sensor cavity 4L is used as a backup or other types of sensors are placed.
  • the principle is that the photochemical method uses organic dyes to emit fluorescence with different wavelengths from the irradiated light under the influence of O 2 , CO 2 concentration and pH under the illumination of a specific wavelength, and transmits the fluorescence signal to the detector for detection and quantification. By analyzing, O 2 , CO 2 , and pH values can be detected.
  • the second stage is entered, that is, the detection of hemoglobin and its derivatives is carried out.
  • the peristaltic pump 16 is controlled to rotate forward, and the air is pumped into the test card 2, so that the blood in the blood gas detection area is sent to the hemoglobin and its derivative detection area 8 through the second controllable liquid path, and then the host 1 controls the peristaltic pump 16. Stop pumping air into the test card 2, use the light emitted by the first light source to illuminate the hemoglobin and its derivatives detection area 8 from one side, and receive transmitted light on the other side of the hemoglobin and its derivatives detection area 8, according to colorimetry The detection principle of the method is used to detect the presence of hemoglobin and its derivatives in blood samples.
  • the specific content of the step 5 is that after the detection of hemoglobin and its derivatives is completed, the first and third sections of the controllable liquid circuit are kept off and the second section of the controllable liquid circuit is turned on, and the host 1 controls the peristaltic pump. 16 rotates forward, and the air is pumped into the test card 2, thereby pushing the blood sample in the hemoglobin and its derivative detection area 8 into the waste liquid area 11. After the blood sample enters the waste liquid area 11, the host 1 controls the peristaltic pump. 16 Stop turning and the test is over.
  • the liquid circuit control area 10 has three valves 10a-10c, wherein the valves 10a-10c are respectively used to control the on-off of the first, second and third controllable liquid circuits, and the on-off of the valves 10a-10c. They are respectively driven by the control mechanisms 13A-13C in the valve control device 13. When one of the control mechanisms 13A-13C moves downward, a valve corresponding to the valves 10a-10c will be opened, and the controllable liquid path of the corresponding section will be turned on. , on the contrary, when one of the control mechanisms 13A-13C moves upward to the end.
  • valves 10a-10c are all in the off state, and the positions of each control mechanism are shown in Figure 8a, that is, the first, second and third sections of the controllable liquid circuit are all disconnected;
  • valves 10a-10c are in the off state, the valve 10c is in the on state, the positions of each control mechanism are shown in Figure 8b, and the main liquid path is communicated with the waste liquid area, so that the test card can be sent to the test card.
  • the calibration solution is pumped into 2, and after the calibration is completed, air is pumped into the test card 2, so that the calibration solution enters the waste liquid area 11;
  • valve 10a In the first stage of the step 4, the valve 10a is controlled to be turned on, and the valves 10b-10c are in the off state. A blood sample is injected into the card 2, so that the sample blood reaches the blood gas detection area 7 for blood gas detection;
  • the positions of each control mechanism are shown in Fig. 8d.
  • the derivative detection area 8 is connected, so that the blood sample can enter the hemoglobin and its derivative detection area 8 to realize the detection of hemoglobin and its derivatives.
  • the blood sample is sent to the waste area.
  • valves 10a-10c are all in the shut-off sequence, which can be set as a fixed sequence, and can also be customized and controlled by logic programming according to the needs of the operator.
  • the widths of the first, second and third liquid paths may be set to be different, and a preferred manner is that the width of the second liquid path is greater than the width of the first liquid path.
  • the thickness of the sensor cavity of the test card 2 in the blood gas detection area 7 is different from the cavity thickness of the hemoglobin and its derivatives detection area 8, so as to adapt to the blood gas photochemical detection of whole blood blood samples and the different detection methods of hemoglobin and its derivatives. requirements.
  • test card 2 is configured to be discarded after use.
  • test card 2 may be configured to be recycled to test more than one fluid sample.
  • electrochemical sensors can also be used in the test card 2 to detect blood gas, hemoglobin and their derivatives. Since the electrochemical detection technology is relatively mature, it is not repeated here.
  • FIG. 9 is a cross-sectional view of the reagent pack 3 , and the reagent pack 3 can be both disposable and removable.
  • the reagent package includes a housing 14, and a calibration solution package 15, a peristaltic pump 16, a three-way valve 17, an air pipeline 18 and a calibration solution pipeline 19 located in the housing, which are calibrated with the test card.
  • the calibration solution pack 15 is configured to store calibration solution and is configured to be connected to the three-way valve 17 through the calibration solution line 19 .
  • the housing of the reagent pack is made of plastic, but may also be made of another material or set of materials.
  • the reagent pack may also include a reagent pack cover. As shown in FIG. 6 , the reagent pack trim cover 23 is attached to the front portion of the reagent pack housing 14 .
  • the reagent pack cover 23 can protect the reagent pack housing 14 when the reagent pack is not in use (ie, not engaged with the host).
  • the calibration solution bag 15 may be an unused soft elastic fluid bag filled with calibration solution.
  • the inside of the test card 2 is dry and has no calibration solution, and the calibration solution is all stored in the reagent pack 3 and separated from the test card 2 .
  • the connector 20 on the reagent pack 3 is inserted into the calibration liquid inlet 6 of the test card 2.
  • the connector 20 is a tubular steel needle, and the The circumference of the tubular steel needle is provided with a sealing ring, such as a rubber sealing ring, to ensure the sealing performance of the insertion point between the tubular steel needle and the calibration solution inlet 6 of the test card 2. After pumping the calibration solution into the test card 2 After that, the calibration solution will not leak from the calibration solution inlet 6 .
  • the controller inside the host 1 controls the output power of the rotating shaft of the stepping motor, and controls the peristaltic pump 16 in the reagent pack 3 to rotate forward or reverse through the pump interface 21, so that the test card 2 can complete the calibration and fluid sample detection,
  • the specific working principle will be described in detail below.
  • the working principle of the reagent pack 3 is as follows:
  • the three-way valve 17 in the reagent pack 3 is switched to the calibration solution pipeline 19 and the calibration solution.
  • the connecting piece 20 is connected, and the peristaltic pump 16 is in a forward rotation state, so that the reagent pack 3 can output the calibration solution, and after the calibration solution enters the test card 2, the photochemical sensor in the test card 2 is calibrated;
  • the calibration solution and the detected blood sample are transferred to the waste liquid area 11 of the test card 2, for example, in the aforementioned step 4.
  • the second stage that is, when the blood sample is transferred to the hemoglobin and its derivatives detection area 8 after the blood gas detection is completed, the three-way valve 17 in the reagent pack 3 is switched to the air pipeline 18 to communicate with the connector 20 , the peristaltic pump 16 is in a forward rotation state, so that the reagent pack 3 can pump air into the test card 2, so that the blood sample inside the test card 2 can be pumped in with the air, and the conduction in the test card 2. flow in the liquid path;
  • the three-way valve 17 in the reagent pack 3 is closed.
  • the air line 18 is switched to communicate with the connector 20, and the peristaltic pump 16 is in a reversed state, so that the air in the test card 2 is inhaled in the reagent pack 3, and the blood sample enters the test card under the action of air pressure 2 to perform blood gas testing.
  • the host 1 includes a housing, and processing circuits, power supply circuits and optical elements located in the housing.
  • the housing can be plastic or any other material suitable for this application.
  • the housing further comprises a first area 1 a configured to at least partially receive the removable test card 2 , and a second area 1 b configured to at least partially receive the removable reagent pack 3 .
  • the removable test card 2 is connected to the host 1 and the removable reagent pack 3 through the first area 1a and the second area 1b, respectively, to perform blood gas detection, detection of hemoglobin and its derivatives, or detection of other biochemical parameters, the test card 2. There is only mechanical transmission contact with the host 1, and there is no liquid path connection.
  • the reagent pack 3 and the host 1 have only mechanical power transmission connection, but no liquid path connection.
  • the test card 2 is connected to the reagent pack. 3 are connected through the calibration liquid inlet 6 to realize the flow of the calibration liquid/air.
  • the above design method makes the host 1 do not have a liquid circuit system, and there is no need for liquid flow with the test card 2 and the reagent pack 3.
  • the first area 1a of the housing includes a test slot for accommodating a test card.
  • a syringe containing a fluid sample such as a blood sample, is configured to communicate with the sample inlet 4 of the test card 2 .
  • the host 1 is configured to test the fluid sample and report the results to the user via the output.
  • the host 1 may include a display serving as an output.
  • the diagnostic results may also or alternatively be reported to the user by other outputs, including audio outputs, data communication outputs, or print outputs, among others.
  • the test card 2 may be removed from the host 1 once the fluid sample is tested.
  • the host 1 may include an eject button that the user can depress to eject the test card 2 from the test slot once the test is completed.
  • the host 1 can also be configured to automatically eject the test card when the test cycle is complete.
  • the host 1 may be portable.
  • the diagnostic results are displayed on the display.
  • the processing circuit of the host computer 1 can cause the display to display information related to a specific application.
  • the display may be a one-way screen configured to display output to the user, or alternatively, may be a touch screen configured to receive and respond to touch input from the user.
  • the diagnostic apparatus further includes a print slot configured to receive paper output by a printer housed in the host 1 .
  • the second area 1b of the main body 1 includes a reagent pack door.
  • the reagent pack door is configured to open from the side of the main unit 1 .
  • the reagent pack door and the opening behind the reagent pack door are sized to receive reagent packs.
  • the reagent pack door can be opened by a latch, but can also be opened by other mechanisms in other exemplary embodiments, and the reagent pack door can also be located in other locations, such as the reagent pack door can be located on the sides, back, front, or top of the host .
  • the latch is positioned adjacent to the reagent pack door.
  • the reagent pack 3 and the host 1 may be joined in the following manner.
  • the connector 20 of the reagent pack 3 is connected to the main unit injection port on one side of the main unit 1, and the main unit injection port is further communicated with the calibration solution inlet 6 of the test card 2, so as to ensure that the calibration solution can flow into the test card.
  • the calibration solution pack 15 of the reagent pack 3 includes a bayonet groove configured to snap onto the reagent pack 3 fixing device on one side of the host 1 , so as to fix the reagent pack 3 in the second area 1 b of the host 1 .
  • the valve connector 22 of the reagent pack 3 is connected to the on-off valve control device of the reagent pack on the side of the host 1 , so as to realize the on-off control of the three-way valve 17 of the reagent pack by the host 1 .
  • the pump interface 21 of the reagent pack 3 is connected with the peristaltic pump control device on the side of the host 1, such as the output shaft of the stepping motor, so that the host 1 can control the peristaltic pump in the reagent pack 3.
  • host 1 may include one or more ports.
  • the port is configured to receive a cable or other connection mechanism.
  • Ports may be configured to connect host 1 to other pieces of the system (eg, via a communication network) or may be configured to upload or download information to host 1 .
  • the host 1 may also be configured to exchange data wirelessly, including via Wi-Fi (Wireless Internet Technology), via an additional wireless Internet connection, or via any other wireless exchange of information.
  • the host 1 may also include a speaker configured to communicate noise or acoustic responses to the user.
  • the host 1 may also include a handle configured to hold the host 1 . The handle rotates between two positions depending on whether it is being used or not.
  • the main unit 1 may also include support legs configured to allow the main unit 1 to rest on a table top or other surface.
  • the host 1 may further include a barcode scanner installed in the side of the host 1 .
  • the barcode scanner is configured to scan barcodes on test cards, calibrator packs or any other items with scannable barcodes and for use with the host 1 .
  • the barcode scanner may also be configured to scan barcode labels representing patient or operator identity.
  • the barcode scanner emits a light beam that covers the barcode. If the barcode is successfully scanned, the host 1 beeps and the beam is automatically turned off.
  • the barcode scanner is a one-dimensional barcode scanner. In other embodiments, the barcode scanner is a two-dimensional scanner.
  • the processing circuit of the host computer 1 includes an analog-to-digital converter and an analog control board.
  • the analog-to-digital converter is configured to process the analog signal from the photochemical sensor and pass the processed digital signal to the analog control board.
  • an analog control board is referred to herein and in the drawings as an "analog control board,” it should be understood that the analog control board may include digital processing. Further, the analog control board may utilize a digital-to-analog converter to convert the digital output (on/off modulated signal) to an analog signal (eg, for a photochemical sensor).
  • the processing circuit and power supply circuit in the host 1 may be used as separate printed circuit boards (PCBs), may be integrated on the same PCB, or otherwise integrated and distributed in combination.
  • the processing circuit and the power supply circuit may include discrete components and/or integrated circuits.
  • the power supply circuit may include all discrete electronic components.
  • the processing circuit may include one or more processors.
  • a processor may variously operate as a general purpose processor, an application specific integrated circuit (ASIC), one or more field programmable gate arrays (FPGA), a set of processing elements or other suitable electronic processing elements, etc.
  • the processing circuit may also One or more memories are included.
  • the memory can be one or more devices for storing data and/or computer codes.
  • the memory can be or include non-transitory volatile memory and/or non-volatile memory.
  • the memory can include Database components, object code components, script components, or any other type of information structure used to support various activities and information structures described herein.
  • Memory may be communicably connected to the processor and include functions for executing one or more of the information structures described herein. computer code modules of the described program.
  • optical elements of the host 1 will now be described in detail.
  • blood gas parameters in blood samples are measured by photochemical sensors, and hemoglobin and its derivatives are detected by optical methods, such as colorimetry without photochemical sensors. Therefore, optical elements are required to provide light sources, excite photochemical sensors, transmit optical signals, and the like.
  • the optical element of the host 1 includes two parts.
  • the first part is configured in the host 1 and includes a first light source for detecting hemoglobin and its derivatives and a second light source for detecting the fluid position of the test card 2, with different emission
  • the detection beams are respectively used to detect hemoglobin and its derivatives in the blood sample and whether there is fluid at each position monitoring point in the test card.
  • the host 1 is provided with a light source 24 for optical detection of blood gas components in the blood sample, as shown in FIG. 12 , specifically, the light source is an excitation light source 24 configured to emit an excitation beam to excite the test card 2
  • the photochemical sensor in and the excitation light source is arranged in the host 1, and the height is lower than the first area 1a.
  • the diagnostic device includes a valve control mechanism configured to control a valve component of the test card.
  • the present diagnostic apparatus is generally shown to include processing circuitry including memory.
  • the processing circuitry may include a processor that operates as a general purpose processor, an application specific integrated circuit (ASIC), one or more field programmable gate arrays ((FPGA), a set of processing elements, or other suitable electronic processing elements
  • a memory is one or more devices (eg, RAM, ROM, flash memory, hard disk storage, etc.) used to store data and/or computer code for carrying out and/or implementing the various programs described herein.
  • Memory can be or include non-transitory volatile memory and/or non-volatile memory.
  • Memory can include database components, object code components, script components, or any other type of information structure for supporting various activities and described herein The information structure.
  • the memory can be communicatively connected to the processor and includes a computer code module for executing one or more programs described herein.

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Abstract

本发明提供了一种用于体外诊断装置的可移除试剂包，该可移除试剂包内部包括定标液包及定标液输出管路，阀门部件，泵和空气管路，其中，所述定标液输出管路与所述阀门部件的第一端连接，空气管路与所述阀门部件的第二端连接，所述阀门部件的第三端通过泵与试剂包外部接口连接，所述可移除试剂包适用于独立的运输和存储，并且所述试剂包由于具有出厂信息和使用状态的可读取器件，故可以多次重复使用，便于操作人员及时获知试剂包状态，能够较大程度地防止定标液浪费，降低定标液试剂包的使用成本，辅助操作人员更好地应对体外诊断。

Description

一种用于体外诊断装置的可移除试剂包及其控制方法 技术领域
本发明涉及体外技术领域，并且特别地涉及一种用于体外诊断装置的可移除试剂包。
背景技术
血液中气体成分的测定在各类科学研究和实际应用中是很重要的。在临床医学危重病人的抢救中，血液二氧化碳分压的快速和连续测定至关重要。尤其是机械通气病人，血液二氧化碳分压是判定患者呼吸状态的非常关键的指标，呼吸机的各项参数主要根据患者血液的二氧化碳分压来设定。目前医学上使用最广泛的血液中气体成分检测仪是血气分析仪，但常规的血气分析仪存在需要采集大量血样、非连续、检测结果滞后等缺陷。
而传统的体外血气检测是在大型的装备良好的测试中心执行，尽管这些传统的测试中心可以提供大体积流体样本的有效且准确的测试，但是不能够提供直接结果。执业医师必须收集流体样本，将其运送到实验室，然后由实验室处理，最后，将结果传送给患者。这种传统的检测手段使得血气检测周期耗时长，环节多，使得患者无法即时获知诊断结果，非常不利于医护人员对患者的及时诊断，也无法给患者带来良好的就诊体验。
此外，传统的体外诊断测试需要培训实验室技术人员以便执行测试，从而保证测试的准确性和可靠性。但是，由处理样本的人员导致的使用错误可能导致表面污染、样本溢出或造成修理和维护成本增加的诊断装置的损坏。
与此同时，在现有技术中，体外诊断的试剂包通常置于测试卡或者体外诊断系统的主机内部，既不便于操作人员更换，也容易造成浪费，因此，非常有必要设置一种用于体外诊断装置的可移除试剂包，该可移除试剂包能够独立于测试卡和体外诊断系统，进行独立的运输和存储，并配合测试卡一并实现血气检测操作。
发明内容
鉴于以上，本发明的目的提供了一种用于体外诊断装置的可移除试剂包，其能够至少部分地缓解或消除现有技术中的至少一个缺陷。
一种用于体外诊断装置的可移除试剂包，其特征在于，所述试剂包包括壳体，至少一个外部出口，至少一个液体存储装置及其输出管路，至少一个输送控制装置，所述输送控制装置至少能够控制所述试剂包内部管路中的流动方向，以及至少一个定位机构，所述定位机构使得所述输送控制装置能够被驱动。
优选地，所述输送控制装置为泵。
优选地，所述泵能够正转和/或反转。
优选地，所述泵为蠕动泵。
优选地，所述试剂包还包括至少一个管路切换装置。
优选地，所述试剂包至少包括三段管路，其中，所述液体存储装置的输出管路为第一管路，与外界连通的第二管路，与所述试剂包的外部接口连通的第三管路，所述管路切换装置使得第一、第二管路之一与第三管路相连通。
优选地，所述输送控制装置至少位于第三管路上。
优选地，所述试剂包具有至少一个外部接口，该接口用于输出试剂包内的液体、输出气体和/或输入气体。
优选地，所述外部接口至少部分包裹有密封件。
优选地，所述液体为定标液。
优选地，所述定位机构是凹槽，和/或所述管路切换装置是三通阀。
优选地，所述试剂包具有记录状态信息的可读取器件，所述状态信息包括所述液体类型、使用温度、容量、适配的传感器类型、试剂包历史使用状态及当前容量状态信息中的一种或者多种信息。
一种可移除试剂包的控制方法，其特征在于：
第一阶段，输送控制装置被配置为使得所述试剂包向外输出定量定标液；
第二阶段，输送控制装置被配置为使得所述试剂包向外输出定量气体；
第三阶段，输送控制装置被配置为使得外部向试剂包输入定量气体；
第四阶段，输送控制装置被配置为使得所述试剂包向外输出定量气体。
优选地：所述第一阶段为，检测卡或者血气分析仪主机对传感器进行定标的阶段。
优选地：所述第二阶段为，定标结束后排空定标液的阶段。
优选地：所述第三阶段为，在检测卡中注入待检测样本进行血气检测的阶段。
优选地：所述第四阶段为，检测卡中待检测样本从血红蛋白检测区转移至血红蛋白及其衍生物的阶段。
优选地：基于检测卡内的同一份待检测样本，在所述第三和第四阶段中，分别完成血气检测及血红蛋白及其衍生物的检测。
优选地：所述第一、第二和第四阶段中，所述输送控制装置被配置为接受体外诊断装置的主机输出的正向驱动力，所述第三阶段中，所述输送控制装置被配置为接受体外诊断装置的主机输出的反向驱动力。
优选地：所述第一阶段中，所述试剂包内的管路切换装置被配置为连通液体存储装置的输出管路与所述外部出口，所述第二至第四阶段中，所述管路切换装置被配置连通气源与所述外部出口。
本发明的有益效果在于，所述体外诊断装置的可移除试剂包能够完全独立于体外诊断系统的主机和测试卡而存在，适用于独立的运输和存储。同时，可移除试剂包设置的泵和阀门部件使得所述试剂包能够很好地配体外诊断装置的测试卡完成定标液泵入、排空定标液、抽取流体样本至测试卡内部以完成血气、血红蛋白及其衍生物和其他生化参数的检测。并且所述试剂包由于具有出厂信息和使用状态的可读取器件，故可以多次重复使用，便于操作人员及时获知试剂包状态，能够较大程度地防止定标液浪费，降低定标液试剂包的使用成本，辅助操作人员更好地应对体外诊断。
附图说明：
图1为体外医疗诊断系统的外形结构示意图
图2为体外医疗诊断系统的侧面示意图；
图3为体外诊断系统各部件的组合示意图；
图4为可移除测试卡的半剖面示意图；
图5为可移除测试卡的半剖面示意图；
图6为可移除测试卡的半剖面示意图；
图7为可移除测试卡与阀门控制装置的连接示意图；
图8为阀门控制装置的控制示意图；
图9为可移除试剂包的剖面示意图；
图10为可移除试剂包的外形结构示意图；
图11为可移除试剂包主体及饰盖的结构示意图；
图12为体外医疗诊断系统的激发光源结构示意图；
具体实施例：
下面结合附图和具体实施例对本发明作进一步说明。
在转向详细地图示示例性实施例的附图之前，应该理解，本申请并不限于在说明书中所示出的或在附图中所图示的细节或方法。其专业术语目的仅仅用于说明而不应限制对本产品及相应方法的理解。
本发明的示例性实施例通过了一种体外医疗诊断系统，如图1-3所示，包括主机1，可移除测试卡2、可移除试剂包3。所述主机包括壳体，以及位于壳体中的处理电路、供电电路和光学元件。所述壳体进一步包括配置成至少部分地接纳所述可移除测试卡的第一区域1a，以及配置成至少部分地接纳所述可移除试剂包的第二区域1b。所述可移除测试卡2分别通过第一区域1a和第二区域1b与所述主机1和所述可移除试剂包3接合，使得从所述可移除测试卡2与所述主机1之间不存在流体互通，并且，从所述可移除试剂包3与所述主机1之间也不存在流体互通。
可移除测试卡
可移除测试卡内部包括外部接口、检测区、废液区、液路控制区以及内部液路，其中，
外部接口，是指所述测试卡四周侧面、上顶面或者下底面上设置的用于接受流体样本的第一接口、空气泵入/抽出的第二接口及注入定标液的第三接口。具体而言，在所述测试卡第一侧具有流体样本入口，流体样本入口用于接收流体样本，比如无需溶血的全血血液样本，在所述测试卡第二侧具有定标液入口和排气口，其中，定标液入口配置从外部(比如可移除试剂包)接收定标液，以便对所述测试卡内部的各光化学传感器进行定标，排气口配置成与外界大气相通保持测试卡中的气压平衡，以便确保定标液或者流体样本流入测试卡；
检测区，是指放置有各类血气参数检测所需的电学、光学、化学传感器和/或不包含传感器的空腔的区域，在该区域内完成血气、血红蛋白、电解质以及其他生化参数的检测；
废液区，是指用于存放已完成检测的流体样本的区域；
内部液路，是指所述测试卡内部用于流体样本或定标液流动的管道通路，所述管道通路具有相互连通的多段液路路径，检测区、废液区、液路控制区分别位于不同段的液路路径上；
液路控制区，是指该区域内设置有若干通断控制装置，所述通断控制装置用于控制所述内部液路的通断，从而实现液路切换，使得不同测试阶段下的定标液、流体样本通过不同的路径流入检测区、废液区，详细的切换操作会在后续详细描述。
需要指出的是，所述检测区、废液区和液路控制区通常位于测试卡第一侧和第二侧之间。
所述测试卡的各功能区及内部液路均有多种实现方式，下面提供的是其中一种优选实现方式：
具体地，如图4-6所示，可移除测试卡2包括卡体，卡体至少部分透明。卡体可以由模制塑料、另外材料或成套材料制成。为了更好的体现卡体透明外壳和内部功能区域的划分，我们在图4-图6中采用半剖面图的方式来展示测试卡的外壳和内部功能区域。
待检测的流体样本为血液样本，优选为无需溶血的全血血液样本，检测区包括血气检测区7、血红蛋白及其衍生物检测区8；废液区11用于存储已完成检测的血液样本；内部液路9分为主液路和三段可控液路，其中主液路连通定标液入口、血气检测区和液路控制区10，优选地， 血气检测区7位于定标液入口6和液路控制区10之间；第一段可控液路用于控制样本入口4和主液路之间的液路通断；第二段可控液路控制主液路与血红蛋白及其衍生物检测区8入口之间的液路通断，血红蛋白及其衍生物检测区8出口连通至废液区11；第三段可控液路用于废液区11与主液路之间的通断，废液区11与排气口5连通，其中血气控制区和第二段可控液路上布置有若干个位置监测点；液路控制区10设置有三个控制内部液路通断的阀门10a-10c，分别用于控制第一、第二和第三段可控液路，其控制方式会在后续详细描述。
血气检测区具有12个传感器空腔7A-7L，各空腔之间按顺序依次排布并布置在主液路上，空腔可以是各种形状，且各空腔形状可以相同也可以不同，但在液路流动的方向上，传感器空腔的宽度宽于液路宽度，所述空腔内可放置各类型的传感器，所述12个传感器空腔中，按照流动路径方向上距离定标液入口的距离从远到近依次排列，依次编号为7A-7L，其中，前11个传感器空腔7A-7K依次放置有不同的光化学传感器，而第12个传感器空腔7L作为备用，以备未来检测参数的扩展。而血红蛋白及其衍生物检测区8仅为空腔，并不设置传感器。
优选地，前10个传感器空腔7A-7J中的光化学传感器分别配置成检测血液流体样本中的CO 2、O 2、pH、Na+、Mg++等血气参数；
优选地，所述流体样本可以是全血血液样本、也可以是尿液样本以及其他类型的人体体液样本，此情况下，所述检测卡中传感器检测的是相应生化参数指标。
以下对于测试卡的控制方式进行详细描述。
在针对血液样本检测之前，需要先对所述测试卡2内的所有传感器进行定标，即向传感器内注入定标液，定标结束后排空所述测试卡2内的所有定标液，然后注入待检测的流体样本，优选为无需溶血的血液样本，在检测区完成检测，通过体外医疗诊断系统的主机读取相应的参数，完成诊断分析后在主机屏幕上显示出相应的参数和诊断结果，以便于医护人员及时获知相应情况。
具体操作步骤如下：
步骤1：将测试卡2放入第一区域1a；
步骤2：向所述测试卡2内的检测区泵入定标液；
步骤3：定标结束后，将所述测试卡2内的所述定标液转移至所述测试卡内的废液区11；
步骤4：注入血液样本至所述检测区，在检测区至少完成血红蛋白和血气的检测；
步骤5：将所述检测区的血液样本转移至所述测试卡2内的废液区11，检测完毕。
所述步骤1，具体为，在测试卡2与试剂包3和主机1接合之前，测试卡2内部干燥且无定标液，而定标液存储在试剂包3中，与测试卡2分离，所述检测位置为所述主机1中的所述第一区域1a，当所述测试卡放入该区域后，对所述测试卡2内部流体样本进行检测，如图3所示，所述测试卡2内有至少六个位置检测点11a-11f，能够接收检测光源发出的透过测试卡2后的光强，以此检测判断所述位置检测点11a-11f处是否存在液体。
所述步骤2，具体为，所述第三段可控液路连通，所述第一、二段可控液路可控关闭，主机1控制试剂包3内的蠕动泵16以及三通阀17，将三通阀17切换至定标液管路19，将试剂包15中的定标液(即成分、浓度均已知的标准样本液体)通过插入测试卡定标液入口的连接件20泵入所述测试卡2中，当位置监测点11a检测到有液体时，主机1控制试剂包3内的蠕动泵16停止运动，此时，各传感器空腔4A-4K内充满定标液，主机1利用开始对各传感器进行定标(即读取传感器测量标准样本液体传感器的读数)，主机1读取各传感器检测数值后定标结束。
所述步骤3，具体为，所述第三段可控液路保持连通，所述第一、第二段可控液路保持关闭，主机1控制试剂包3内的三通阀17切换至空气通道，并控制蠕动泵16将空气通过插入测试卡2定标液入口的连接件20泵入所述测试卡2中，由于所述测试卡2的废液区11经排气口5与外界空气保持连通，因此，随着空气的泵入，定标液在第一、第三段液路中持续向废液区11移动，直至全部定标液进入废液区11。
所述步骤4分为两个阶段，
第一阶段进行血气检测，具体为，第一段可控液路连通，第二、第三段可控液路关闭，在此情况下进行血气检测，从所述测试卡2的样本入口4注入血液样本，无需溶血，或者由主机1控制蠕动泵16反转，抽出所述测试卡2内部的空气，在测试卡2内产生负压从而将血液样本入口4处的血液吸入测试卡2内部，使得通过位置监测点12a-12f确定待检测的血液样本完全进入传感器空腔4A-4L后，停止向所述测试卡2注入待检测的血液样本，或者主机1控制蠕动泵16停止泵入空气，利用传感器空腔4A-4L完成对血液样本的检测，优选方式是在传感器空腔4A-4K内设置有光化学传感器，传感器空腔4L作为备用或者放置其他类型的传感 器，所述光化学传感器的基本检测原理是光化学方法是利用有机染料在特定波长的光照下，受O 2、CO 2浓度和pH等物质的影响，发射出与照射光波长不同的荧光，传输至探测器检测其荧光信号并进行定量分析，进而能够检测出O 2、CO 2、pH值。
待完成血气检测之后进入第二阶段，即进行血红蛋白及其衍生物的检测，保持第一段可控液路连通和第三段可控液路关闭，打开第二段可控液路，主机1控制蠕动泵16正转，将空气泵入所述测试卡2，从而将血气检测区的血液通过第二段可控液路送入血红蛋白及其衍生物检测区8，之后主机1控制蠕动泵16停止向测试卡2泵入空气，利用第一光源的发出光从一侧照射血红蛋白及其衍生物检测区8，并在血红蛋白及其衍生物检测区8的另一侧接收透射光，根据比色法的检测原理来检测血液样本中是否存在血红蛋白及其衍生物。
所述步骤5，具体内容为，完成血红蛋白及其衍生物的检测后，保持第一、第三段可控液路的关断和第二段可控液路的导通，主机1控制蠕动泵16正转，将空气泵入所述测试卡2中，从而将血红蛋白及其衍生物检测区8的血液样本推入废液区11，待血液样本进入废液区11之后，主机1控制蠕动泵16停止转动，测试结束。
上述各步骤中，第一、第二、第三段可控液路的控制，具体实现方式如图7-图8所示：
所述液路控制区10内部具有三个阀门10a-10c，其中阀门10a-10c分别用于控制第一、第二和第三段可控液路的通断，而阀门10a-10c的通断分别由阀门控制装置13中的控制机构13A-13C来驱动，当控制机构13A-13C之一向下运动时，则阀门10a-10c对应的一个阀门将被打开，相应段的可控液路导通，反之，控制机构13A-13C之一向上运动到尽头时，。
具体来说，
在前述步骤1中，阀门10a-10c均处于关断状态，各控制机构位置如图8a所示，即第一、第二和第三段可控液路均断开；
在前述步骤2-3中，阀门10a-10c处于关断状态，阀门10c出于导通状态，各控制机构位置如图8b所示，主液路与废液区连通，从而能够实现向测试卡2中泵入定标液，定标结束后，通过向测试卡2泵入空气，使得定标液进入废液区11；
所述步骤4的第一阶段，控制所述阀门10a导通，阀门10b-10c处于关断状态，各控制机构位置如图8c所示，主液路与样本入口4连通，从而能够实现向测试卡2中注入血液样本，使 得样本血液达到血气检测区7进行血气检测；
所述步骤4的第二阶段，即血气检测结束之后，所述控制所述阀门10b导通，阀门10a、10c处于关断状态，各控制机构位置如图8d所示，主液路与血红蛋白及其衍生物检测区8连通，使得血液样本能够进入血红蛋白及其衍生物检测区8，实现血红蛋白及其衍生物的检测。
检测完毕后，将血液样本送入废液区。
所述阀门10a-10c均处于关断顺序可以设定为固定时序，也可以根据操作人员的需求进行定制和逻辑编程控制。
在示例性实施例中，第一、第二和第三段液路的宽度可以设置为不同，优选的方式是第二段液路宽度大于第一段液路的宽度。并且测试卡2在血气检测区7的传感器空腔厚度和血红蛋白及其衍生物检测区8处的空腔厚度不同，以便适应针对全血血液样本的血气光化学检测和血红蛋白及其衍生物不同检测方法的要求。
在示例性实施例中，测试卡2配置成用完即丢弃。可替换地，测试卡2可以配置成循环使用，以测试超过一份的流体样本。
进一步地，测试卡2中也可以采用电化学传感器来检测血气和血红蛋白及其衍生物，由于电化学检测技术较为成熟，故，在此不再赘述。
试剂包
如图9所示，图9为试剂包3的剖视图，试剂包3既可以是一次性使用的和可移除的。具体地，试剂包包括壳体14，以及位于壳体中的定标液包15、蠕动泵16、三通阀17、空气管路18和定标液管路19，与所述测试卡定标液入口6插接的连接件20，与所述主机上步进电机转轴连接的泵接口21，所述步进电机通过泵接口21驱动试剂包上的蠕动泵正转或者反转，以及阀门连接件22，所述主机通过阀门连接件22控制试剂包上的三通阀17进行切换，将泵接口21与空气管路18或者定标液管路19连通。定标液包15配置成存储定标液，并且配置成与通过定标液管路19与三通阀17连接。
在示例性实施例中，试剂包的壳体由塑料制成，但是也可以由另外的材料或成套材料制成。试剂包也可以包括试剂包盖。如图6所示，试剂包饰盖23被连接到试剂包壳体14的前部分。当试剂包未被使用(即未与所述主机接合)时，试剂包饰盖23可以保护试剂包壳体14。定 标液包15可以是被未使用的充满定标液的软的弹性流体袋。
在测试卡2、试剂包3分别和主机接合之前，测试卡2内部干燥且无定标液，而定标液全部存储在试剂包3中，且与测试卡2分离。
当所述测试卡2放入第一区域1a之后，试剂包3上的连接件20插接至所述测试卡2定标液入口6，优选地，连接件20为管状钢针，且所述管状钢针的圆周设置有密封圈，比如橡胶密封圈，以确保所述管状钢针与所述测试卡2定标液入口6插接处的密封性能，在将定标液泵入测试卡2后，定标液不会从所述定标液入口6处泄露。主机1内部的控制器控制步进电机的转轴输出动力，通过泵接口21控制试剂包3中的蠕动泵16正转或者反转，以使得所述测试卡2能够完成定标和流体样本检测，具体工作原理在以下会有详细描述。
当测试卡2和试剂包3分别安置于主机1的第一区域1a和第二区域1b后，试剂包3的工作原理如下：
当需要输出试剂包3内的定标液时，比如前述步骤2中测试卡2的定标阶段，试剂包3内的所述三通阀17被切换至所述定标液管路19与所述连接件20连通，所述蠕动泵16处于正转状态，使得试剂包3能够向外输出定标液，定标液进入测试卡2后，对测试卡2中的光化学传感器进行定标；
当需要向外界泵出空气时，比如前述步骤3和步骤5中将定标液和检测完毕的血液样本转移至所述测试卡2所述废液区11时，又比如前述步骤4中的第二阶段，即血气检测完毕后将血液样本转移至血红蛋白及其衍生物检测区8时，试剂包3内的所述三通阀17被切换至所述空气管路18与所述连接件20连通，所述蠕动泵16处于正转状态，使得试剂包3能够向测试卡2泵入空气，使得测试卡2内部的血液样本能够随着空气的泵入，在所述测试卡2内导通的液路中进行流动；
当需要向试剂包3内吸入空气时，比如前述步骤4中第一阶段，即将血液样本吸入至所述测试卡2中的血气检测区7时，试剂包3内的所述三通阀17被切换至所述空气管路18与所述连接件20连通，所述蠕动泵16处于反转状态，使得试剂包3内吸入测试卡2中的空气，在气压的作用下，血液样本进入测试卡2中的液路，从而进行血气检测。
主机
如前所述，主机1包括壳体，以及位于壳体中的处理电路、供电电路和光学元件。壳体可以是塑料或适用于本应用的任何其他材料。壳体进一步包括配置成至少部分地接纳可移除测试卡2的第一区域1a，以及配置成至少部分地接纳可移除试剂包3的第二区域1b。可移除测试卡2分别通过第一区域1a和第二区域1b与主机1和可移除试剂包3接合，进行血气检测、血红蛋白及其衍生物的检测或者其他生化参数检测，所述测试卡2与主机1之间仅有机械传动接触，并无液路连接，所述试剂包3与主机1之间仅有机械动力传动连接，而并无液路连接，所述测试卡2与试剂包3之间通过定标液入口6相连接，实现定标液/空气的流动，上述设计方式使得主机1内部不存在液路系统，亦无需与测试卡2、试剂包3进行液路流动。
在示例性实施例中，壳体的第一区域1a包括用于容纳测试卡的测试槽。装有流体样本，比如血液样本，的注射器配置成与测试卡2的样本入口4连通。主机1配置成测试流体样本并且经由输出部将结果报告给用户。例如，主机1可以包括充当输出部的显示器。然而，在该实施例或其他实施例中，诊断结果还可以或替代地可以由其他输出部报告给用户，包括音频输出部，数据通信输出部，或者打印输出部，等等。
在示例性实施例中，一旦流体样本被测试，测试卡2就可以从主机1中被移除。主机1可以包括弹射按钮，一旦测试完成，用户就可以下压所述弹射按钮，以便将测试卡2从测试槽中弹射。当测试循环完成时，主机1还可以被配置成自动地弹射测试卡。特别地，主机1可以是便携式的。
在示例性实施例中，诊断结果被显示在显示器上。主机1的处理电路可以使显示器显示与特定应用有关的信息。显示器可以是被配置成将输出显示给用户的单向视幕，或者可替换地，可以是被配置成接收和响应用户的接触输入的触摸屏。在示例性实施例中，诊断装置还包括打印槽，所述打印槽被配置成接收由容纳在该主机1内的打印机输出的纸张。
在示例性实施例中，如图3所示，主机1的第二区域1b包括试剂包门。试剂包门配置成从主机1侧面打开。试剂包门和在所述试剂包门后的开口的尺寸被配置成以便接纳试剂包。试剂包门可以通过门闩打开，但是也可以由在另外示例性实施例中的其他机构打开，试剂包门亦可位于其他位置，比如试剂包门可以位于主机的两侧、背面、正面或者顶面。门闩邻近于试剂包门定位。试剂包外部向泵供给电力的供电接口，以及向阀门部件供给电力的供电接口。 在示例性实施例中，除了试剂包连接件20直接与测试卡2的定标液入口6连接以外，试剂包3和主机1还可以通过以下方式接合。试剂包3的连接件20与主机1一侧上方的主机进样口连接，而所述主机进样口进一步与测试卡2的定标液入口6连通，从而确保定标液能够流入测试卡。试剂包3的定标液包15包括卡口凹槽，其配置成卡接主机1一侧的试剂包3固定装置，以便在主机1的第二区域1b中固定试剂包3。试剂包3的阀门连接件22与主机1一侧的试剂包通断阀门控制装置连接，从而实现主机1对试剂包的三通阀17的通断控制。另外，试剂包3的泵接口21与主机1一侧的蠕动泵控制装置，比如步进电机输出轴，连接，从而实现主机1对试剂包3内蠕动泵的控制。
在示例性实施例中，主机1可以包括一个或多个端口。端口被配置成接纳缆绳或其他连接机构。端口可以配置成将主机1连接到系统的其他片件(例如，经由通信网络)或者可以配置成上传信息或下载信息到主机1。主机1还可以被配置成无线地交换数据，包括通过Wi-Fi(无线上网技术)、通过另外的无线因特网连接或通过任何其他无线信息交换。主机1还可以包括扬声器，该扬声器配置成将噪声或声响反应传递给用户。主机1还可以包括手柄，该手柄配置成把持主机1。手柄取决于其是否被使用而在两个位置之间旋转。在示例性实施例中，主机1还可以包括支撑腿，该支撑腿被配置成允许主机1停靠在桌面或其他表面上。在示例性实施例中，主机1还可以包括条码扫描仪，该条码扫描仪被安装在主机1的侧面中。条形码扫描仪被配置成扫描在测试卡上的条形码、定标液包或者具有可扫描条形码和使用于该主机1的任何其他条目。条形码扫描仪也可以被配置成扫描表示患者身份或操作者身份的条形码标签。在示例性实施例中，条形码扫描仪发射覆盖条形码的光束。如果条形码被成功地扫描，则主机1发出蜂鸣声，光束就自动地关闭。如果条形码没有被成功地扫描，则主机1将通过发出噪音或通过某一其他输出部在显示器上提醒用户。在示例性实施例中，条形码扫描仪是一维的条形码扫描仪。在其他实施例中，条形码扫描仪是二维的扫描仪。
根据示例性实施例体，主机1的处理电路包括模数转换器和模拟控制板。该模数转换器配置成处理来自光化学传感器的模拟信号，并且将处理后的数字信号传递给模拟控制板。当这里和附图中的模拟控制板被命名为“模拟控制板”时，应当理解的是，模拟控制板可以包括数字处理。进一步地，模拟控制板可以利用数模转换器将数字输出(打开/关闭已调信号)转换成模拟信号(例如，用于光化学传感器)。
主机1中的处理电路和供电电路可以当做独立的印刷电路板(PCB)使用、可以在相同的PCB上集成或者另外地集成和分配相结合来使用。处理电路和供电电路可以包括分立部件和/或集 成电路。例如，供电电路可以包括所有的分立电子部件。处理电路可以包括一个或多个处理器。处理器可以作为通用处理器、专用集成电路(ASIC)、一个或多个现场可编程门阵列((FPGA)、一组处理部件或其他适合电子处理部件等被多方面地操作。处理电路还可以包括一个或多个存储器。存储器可以是一个或多个用于存储数据和/或计算机代码的装置。存储器可以是或包括非瞬态易失性存储器和/或非易失性存储器。存储器可以包括数据库部件、目标代码部件、脚本部件或任何其他类型的用于支持各种活动的信息结构和本文所描述的信息结构。存储器可以可传播地连接到处理器并且包括用于执行一个或多个本文所描述的程序的计算机代码模块。
现在详细介绍主机1的光学元件。如前所述，在本发明的实施例中，通过光化学传感器对血液样本中的血气参数进行测量，并且采用光学方法，比如无需光化学传感器的比色法，检测血红蛋白及其衍生物。因此，需要光学元件来提供光源、激发光化学传感器、传输光信号等。
具体地，主机1的光学元件包括两个部分，第一部分配置在主机1中，包括用于血红蛋白及其衍生物检测的第一光源和用于测试卡2流体位置检测的第二光源，发射不同的检测光束分别用一检测血液样本中的血红蛋白及其衍生物和测试卡中各位置监测点处是否存在流体。而第二部分配置主机1内部设置有针对血液样本中血气成分光学检测的光源24，如图12所示，具体地，光源为激发光源24，该激发光源配置成发射激发光束以激发测试卡2中的光化学传感器，且激发光源设置于主机1内，且高度低于第一区域1a。
在示例性实施例中，诊断装置包括阀门控制机构，其配置成控制测试卡的阀门部件。
如这里所利用的，术语“大致地”、“大约”、“基本上”和类似术语意图具有与本领域技术人员所认可的普遍且可接受用法一致的广泛含义，本公开的主体属于所述普遍且可接受用法。查看本公开的本领域技术人员应该理解的是，这些术语意图允许对所描述的和要求优选权的某些特点进行说明，而不将这些特点的范围限制到所设置的精确数值范围内。因此，这些术语应被解释为，所描述的和所要求优先权的主体的非实质或不连贯的修正或修改应被视为在本发明的范围内，并由附属权利要求说明。应该注意的是，本文所使用的用于描述不同实施例的术语“示例性的”意图指的是，这种实施例是可能的实例、代表和/或可能实施例的图示(这种术语并不意图暗示这种实施例一定是非同寻常的实例或最高级的实例)。本文所使用的术语“耦合的”和“连接的”及其类似物指的是两个构件直接地或间接地被彼此结合。这种结合可以是静态的(例如，恒久性)或可移动的(例如，可移除的或可释放的)。通过 两个构件或彼此整合地形成单整体主体的所述两个构件和任何附加中间构件，或者，通过所述两个构件或彼此附接的所述两个构件与任何附加的中间构件，可以获得这种结合。仅仅图示该系统的构造和布置以及用于提供如在各种示例性实施例中所示出的体外医疗诊断装置的方法。
虽然，仅仅在本公开中详细地描述本发明的一些实施例，但是查阅本公开的本领域的技术人员应容易地了解，可以有许多的修正(例如，各种元件的大小、尺寸、结构、形状和比例的改变，参数值、安装布置、材料的使用、颜色、和定向的改变，等等)，而不实质地脱离本文所公开的主题的新颖教导和优点。例如，如整体地形成而示出的元件可以由多零件或元件构成，元件的位置可以倒转或另外地改变，以及，可以改变或变化分立元件的性质、数量或位置。因此，所有的这些修正都意图被包括在如附属权利要求中所定义的本发明的范围内。任何过程或方法步骤的次序或顺序都可以根据替代性实施例被改变或被再次排序。各种示例性实施例的设计、操作条件和布置都可以做出其他替换、修正、改变和省略，而不脱离本发明的范围。
本诊断装置通常地被显示成包括包含存储器的处理电路。处理电路可以包括处理器，所述处理器做为通用处理器、专用集成电路(ASIC)、一个或多个现场可编程门阵列((FPGA)、一组处理部件或其他适合电子处理部件被操作。存储器是一个或多个用于存储数据和/或计算机代码的装置(例如，RAM，ROM，闪存，硬盘存储器，等等)，用于完成和/或实现本文所描述的各种程序。存储器可以是或包括非瞬态易失性存储器和/或非易失性存储器。存储器可以包括数据库部件、目标代码部件、脚本部件或任何其他类型的用于支持各种活动的信息结构和本文所描述的信息结构。存储器可以可传播地连接到处理器并且包括用于执行一个或多个本文所描述的程序的计算机代码模块。以上所述仅为本发明的较佳实施例而已，并不用以限制本发明，凡在本发明的精神和原则之内所作的任何修改、等同替换和改进等，均应包含在本发明的保护范围之内。

Claims (20)

  1. 一种用于体外诊断装置的可移除试剂包，其特征在于，所述试剂包包括壳体，至少一个外部出口，至少一个液体存储装置及其输出管路，至少一个输送控制装置，所述输送控制装置至少能够控制所述试剂包内部管路中的流动方向，以及至少一个定位机构，所述定位机构使得所述输送控制装置能够被驱动。
  2. 根据权利要求1所述的可移除试剂包，其特征还在于，所述输送控制装置为泵。
  3. 根据权利要求2所述的可移除试剂包，其特征还在于，所述泵能够正转和/或反转。
  4. 根据权利要求2所述的可移除试剂包，其特征还在于，所述泵为蠕动泵。
  5. 根据权利要求1所述的可移除试剂包，其特征还在于，所述试剂包还包括至少一个管路切换装置。
  6. 根据权利要求5所述的可移除试剂包，其特征还在于，所述试剂包至少包括三段管路，其中，所述液体存储装置的输出管路为第一管路，与外界连通的第二管路，与所述试剂包的外部接口连通的第三管路，所述管路切换装置使得第一、第二管路之一与第三管路相连通。
  7. 根据权利要求1所述的可移除试剂包，其特征还在于，所述输送控制装置至少位于第三管路上。
  8. 根据权利要求1所述的可移除试剂包，其特征还在于，所述试剂包具有至少一个外部接口，该接口用于输出试剂包内的液体、输出气体和/或输入气体。
  9. 根据权利要求1所述的可移除试剂包，其特征还在于，所述外部接口至少部分包裹有密封件。
  10. 根据权利要求1所述的可移除试剂包，其特征还在于，所述液体为定标液。
  11. 根据权利要求5所述的可移除试剂包，其特征还在于，所述定位机构是凹槽，和/或所述管路切换装置是三通阀。
  12. 根据权利要求1所述的可移除试剂包，其特征还在于，所述试剂包具有记录状态信息的可读取器件，所述状态信息包括所述液体类型、使用温度、容量、适配的传感器类型、试 剂包历史使用状态及当前容量状态信息中的一种或者多种信息。
  13. 一种可移除试剂包的控制方法，其特征在于：
    第一阶段，输送控制装置被配置为使得所述试剂包向外输出定量定标液；
    第二阶段，输送控制装置被配置为使得所述试剂包向外输出定量气体；
    第三阶段，输送控制装置被配置为使得外部向试剂包输入定量气体；
    第四阶段，输送控制装置被配置为使得所述试剂包向外输出定量气体。
  14. 根据权利要求13所述的控制方法，其特征在于：所述第一阶段为，检测卡或者血气分析仪主机对传感器进行定标的阶段。
  15. 根据权利要求13所述的控制方法，其特征在于：所述第二阶段为，定标结束后排空定标液的阶段。
  16. 根据权利要求13所述的控制方法，其特征在于：所述第三阶段为，在检测卡中注入待检测样本进行血气检测的阶段。
  17. 根据权利要求14所述的控制方法，其特征在于：所述第四阶段为，检测卡中待检测样本从血红蛋白检测区转移至血红蛋白及其衍生物的阶段。
  18. 根据权利要求13所述的控制方法，其特征在于：基于检测卡内的同一份待检测样本，在所述第三和第四阶段中，分别完成血气检测及血红蛋白及其衍生物的检测。
  19. 根据权利要求13所述的控制方法，其特征在于：所述第一、第二和第四阶段中，所述输送控制装置被配置为接受体外诊断装置的主机输出的正向驱动力，所述第三阶段中，所述输送控制装置被配置为接受体外诊断装置的主机输出的反向驱动力。
  20. 根据权利要求13所述的控制方法，其特征在于：所述第一阶段中，所述试剂包内的管路切换装置被配置为连通液体存储装置的输出管路与所述外部出口，所述第二至第四阶段中，所述管路切换装置被配置连通气源与所述外部出口。
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