This application claims priority to Chinese Patent Application No. 202010076460.8 filed on Jan. 23, 2020, which is incorporated herein by reference in its entirety.
This application relates to the technical field of medical devices, for example, to an in-vitro diagnostic analyzer and a reagent card.
Reagent cards (also known as test cards or detection cards) are widely used in the medical industry. The reagent card integrates biochemical detection electrodes. Calibration is conducted by the calibration liquid, and then the sample solution (blood, tissue fluid, etc.) is detected.
The reagent card in the related art usually realizes the on-off control of the sample solution by closing and opening the sample inlet channel through extrusion. However, it has the following problems:
1. There is a hidden danger that the sample solution leaks along the tubing: when the reagent card is not inserted in place or the size of the instrument assembly is deviated, the pressing part is easy to be deviated, such that the sample inlet channel cannot be compressed and closed. In this way, during calibration analysis, the sample solution will accidentally flow into the reagent card, resulting in distortion of the calibration analysis.
2. There is a hidden danger that the sample solution cannot be extracted: when the ambient temperature of the instrument is too low or the negative pressure in the reagent card is too large, the elastic body of the sample inlet channel will rebound poorly or even fail to rebound, such that the sample solution fails to flow into the reagent card.
This 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 on-off control of a sample solution, so as to solve the above-mentioned hidden dangers that the sample solution leaks and cannot be extracted. The reagent card is integrated with the above-mentioned installation structure, and adopts a new on-off control scheme for the sample solution, which can solve the above-mentioned hidden dangers that the sample solution leaks and cannot be extracted. When the in-vitro diagnostic analyzer is used, the on-off control of the sample solution is reliable, which is beneficial to improve the reliability of detection.
The embodiments of the present disclosure provide an installation structure, including an installation body. The installation body includes an installation hole configured to sleeve a sample tube, a hollow needle provided in the installation hole, a sealing portion provided in the installation hole, and an air inlet channel. One end of the hollow needle is capable of being inserted into the sample tube. The sealing portion is in sealing fit with an outer wall of the sample tube. The air inlet channel includes an air outlet hole and an air inlet hole. The air inlet hole is provided on a surface of the installation body. The air outlet hole is configured for communication with the sample tube provided on the installation hole.
When the above installation structure is used, the sample tube can be inserted into the installation hole. In this process, the hollow needle will be inserted into the sample tube. After the sample tube is installed, the sealing portion will be in sealing fit with the sample tube. At this time, when the air inlet hole is opened, gas (such as air) can enter the sample tube through the air inlet channel, that is, liquid in the sample tube can be sucked away through the hollow needle at this time. When the air inlet hole is closed, gas (such as air) cannot enter the sample tube through the air inlet channel, and the sample tube is sealed by the sealing portion, such that the sample tube cannot communicate with the external gas, making it difficult for the liquid in the sample tube to be sucked out through the hollow needle. The installation structure can realize the installation of the sample tube. During the on-off control of the sample solution, there is no need to deform the sample inlet channel through extrusion, so as to close or rely on the self-reset of the sample inlet channel to open the sample inlet channel. It is only necessary to open or close the air inlet hole to realize the on-off control of the sample solution, which is beneficial to solve the above-mentioned hidden dangers that the sample solution leaks and cannot be extracted.
In some embodiments, the sealing portion may be provided with a sealing hole in sealing fit with a sample outlet end of the sample tube. One end of the hollow needle may be arranged in the sealing hole. The air outlet hole may communicate with the sealing hole.
In some embodiments, an outer edge of the air inlet hole may be provided with a sealing layer.
In some embodiments, the sealing layer may include an elastic layer and an adhesive layer arranged on the elastic layer, and the elastic layer may be arranged facing outward.
The embodiments of the present disclosure further provide a reagent card, including the installation structure in any of the above embodiments, and further including a reagent card body. The reagent card body is fixed to the installation structure. The reagent card body includes a sample inlet channel communicating with a liquid outlet end of the hollow needle, a detection chamber, and an air receiving end. The sample inlet channel and the air receiving end communicate with the detection chamber.
When the above reagent card is used, the sample tube can be inserted into the installation hole in the installation body. In this process, the hollow needle will be inserted into the sample tube. After the sample tube is installed, the sealing portion will be in sealing fit with the sample tube. At this time, 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 receiving end is in connection with a negative pressure generator at this time to generate suction, such that liquid in the sample tube can be sucked into the sample inlet channel through the hollow needle, and flow into the detection chamber for detection and analysis. When the air inlet hole is closed, gas (such as air) cannot enter the sample tube through the air inlet channel, and the sample tube is sealed by the sealing portion, such that the sample tube cannot communicate with the external gas, making it difficult for the liquid in the sample tube to be sucked out through the hollow needle. During the on-off control of the sample solution by the reagent card, there is no need to deform the sample inlet channel through extrusion, so as to close or rely on the self-reset of the sample inlet channel to open the sample inlet channel. It is only necessary to open or close the air inlet hole through a telescopic valve to realize the on-off control of the sample solution, which can solve the above-mentioned hidden dangers that the sample solution leaks and cannot be extracted.
In some embodiments, the installation body and the reagent card body may be integrally formed.
In some embodiments, the reagent card body may further include a calibration liquid channel, and the calibration liquid channel may communicate with the detection chamber.
In some embodiments, the reagent card body may further include a waste liquid storage chamber communicating with a liquid outlet end of the detection chamber, and a liquid outlet end of the waste liquid storage chamber may communicate with the air receiving end.
In some embodiments, the reagent card body may further include a first calibration liquid bag and a valve core. The first calibration liquid bag may be fixed on the reagent card body. The first calibration liquid bag may be provided with a matching portion in connection with the calibration liquid channel. The valve core may be arranged in the calibration liquid channel or in the first calibration liquid bag. The valve core may be provided with a spiked portion configured to pierce the matching portion.
The embodiments of the present disclosure further provide an in-vitro diagnostic analyzer, including the reagent card in any of the above embodiments, and further including a negative pressure generator, a sample tube, a first retractor, a detection device, and a controller. The negative pressure generator is in connection with the air receiving end. The sample tube is provided with a sample outlet end in clearance fit with the hollow needle. The first retractor is provided with a sealing end configured to seal the air inlet hole. The controller telecommunicates with the negative pressure generator, the first retractor, and the detection device. A detection end of the detection device is arranged in the detection chamber.
When the above in-vitro diagnostic analyzer is used, the sample tube can be inserted into the installation hole in the installation body. In this process, the hollow needle will be inserted into the sample tube. After the sample tube is installed, the sealing portion will be in sealing fit with the sample tube. Then the reagent card is installed at a preset position of the in-vitro diagnostic analyzer. When the first controller controls the action of the first retractor to make the sealing end leave the air inlet hole, that is, the air inlet hole is opened, gas (such as air) can enter the sample tube through the air inlet channel, that is, the air receiving end is in connection with the negative pressure generator at this time to generate suction, such that liquid in the sample tube can be sucked into the sample inlet channel through the hollow needle, and flow into the detection chamber for detection and analysis. When the controller controls the action of the first retractor to make the sealing end be in sealing fit the air inlet hole, that is, the air inlet hole is closed, gas (such as air) cannot enter the sample tube through the air inlet channel, and the sample tube is sealed by the sealing portion, such that the sample tube cannot communicate with the external gas, making it difficult for the liquid in the sample tube to be sucked out through the hollow needle. When the in-vitro diagnostic analyzer is used, the on-off control of the sample solution is reliable, which is beneficial to improve the reliability of detection.
In some embodiments, the sealing end may be provided with a protruding sealing ring, and the sealing ring can be hermetically arranged at an outer edge of the air inlet hole.
In some embodiments, the reagent card body may further include a calibration liquid channel communicating with the detection chamber, a first calibration liquid bag, and a valve core. The first calibration liquid bag may be fixed on the reagent card body. The first calibration liquid bag may be provided with the matching portion in connection with the calibration liquid channel. The valve core may be arranged in the calibration liquid channel or in the first calibration liquid bag. The valve core may be provided with a spiked portion configured to pierce the matching portion. The in-vitro diagnostic analyzer may further include a second retractor that telecommunicates with the controller. A telescopic end of the second retractor is capable of pressing the calibration liquid channel or the first calibration liquid bag in a preset direction, such that the spiked portion may pierce the matching portion.
In some embodiments, the in-vitro diagnostic analyzer may further include the calibration liquid channel that communicates with the detection chamber, and a second calibration liquid bag. The second calibration liquid bag may communicate with the calibration liquid channel through an on-off valve.
10, reagent card; 100, reagent card body; 110, sample inlet channel; 120, detection chamber; 130, air receiving end; 140, calibration liquid channel; 150, first calibration liquid bag; 160, matching portion; 170, valve core; 172, spiked portion; 180, waste liquid storage chamber; 200, installation structure; 210, installation body; 212, installation hole; 220, hollow needle; 230, air inlet channel; 232, air inlet hole; 234, air outlet hole; 240, sealing portion; 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, second retractor; 60, controller; 70, sample tube; and 80, second calibration liquid bag.
It should be noted that when a component is “fixed”, “provided”, “fixed on”, or “provided on” another component, the component may be fixed on the other component directly or via an intermediate component. When a component is connected with the other component, the component may be connected with the other component directly or via an intermediate component. Further, when an element is considered to be “connected” with another element, the two can be fixed by detachable connection, or can be fixed by non-detachable connection, such as sleeve connection, snap connection, integral molding fixing, and welding, which can be implemented in the related art, and is not redundant here. When one component and another component are perpendicular or approximately perpendicular to each other, it means that the ideal state of the two is vertical, but due to the influence of manufacturing and assembly, there may be a certain vertical error. The terms “vertical”, “horizontal”, “left”, and “right” and similar expressions used herein are just for illustrative purposes, and do not mean sole implementations.
Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the technical field of this application. The terms used herein in the specification of this application are merely for the purpose of describing specific embodiments, and are not intended to limit this application. The term “and/or” used herein includes any and all combinations of one or more of the associated listed items.
The “first” and “second” mentioned in this application do not represent the specific quantity and order, and they are merely used to distinguish the name.
As shown in
As shown in
The negative pressure generator is in connection with the air receiving end 130. The sample tube 70 is provided with a sample outlet end in clearance fit with the hollow needle 220. The first retractor 40 is provided with a sealing end 42 configured to seal the air inlet hole 232. The controller 60 telecommunicates with the negative pressure generator 20, the first retractor 40, and the detection device. A detection end of the detection device is arranged in the detection chamber 120.
When the above in-vitro diagnostic analyzer is used, the sample tube 70 can be inserted into the installation hole 212 in the installation body 210. In this process, the hollow needle 220 will be inserted into the sample tube 70. After the sample tube 70 is installed, the sealing portion 240 will be in sealing fit with the sample tube 70. Then the reagent card 10 is installed at a preset position of the in-vitro diagnostic analyzer. When the first controller 60 controls the action of the first retractor 40 to make the sealing end 42 leave the air inlet hole 232, that is, the air inlet hole 232 is opened (as shown in
Optionally, the “negative pressure generator 20” can be any related liquid suction equipment such as a suction pump and a vacuum pump that meets the requirements of this application.
Optionally, the “controller 60” includes, but is not limited to, a programmable controller 60, a motion control card, and a computer.
Optionally, 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 installation hole 212.
Optionally, the “sample tube 70” includes structures such as a syringe and a test tube.
Optionally, the expression that “one end of the hollow needle 220 is capable of being inserted into the sample tube” can be understood as one end of the hollow needle 220 protruding from the bottom of the installation hole 212 to form an interface.
The “bottom of the installation 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 those shown in
On the basis of the above embodiment, as shown in
On the basis of the above embodiment, as shown in
At this time, the calibration liquid can be integrated into the reagent card body 100. With reference to
In another embodiment, as shown in
Exemplarily, as shown in
Optionally, the on-off valve is an electromagnetic on-off valve, which telecommunicates with the controller 60.
In addition, the on-off valve includes, but is not limited to, a rotary valve or a linear slide valve.
On the basis of the foregoing two embodiments, as shown in
Optionally, the “detection chamber 120” is formed by, including but not limited to, a tubing or a cavity. Similarly, the “waste liquid storage chamber 180” is formed by, including but not limited to, a tubing or a cavity.
On the basis of any of the above embodiments, as shown in
On the basis of any of the above embodiments, as shown in
Exemplarily, as shown in
On the basis of any of the above embodiments, as shown in
Optionally, the sealing ring is made of an elastic material.
Optionally, connection between “installation body 210 and reagent card body 100” includes, but is not limited to, detachable connection, such as sleeve connection and plug connection; or non-detachable connection, such as heat welding and adhesive bonding.
In the present embodiment, the installation body 210 and the reagent card body 100 are integrally formed.
Optionally, the “installation structure 200” is arranged on, including but not limited to, the reagent card 10, and may also be arranged on other structures.
The technical characteristics of the above embodiments can be arbitrarily combined. To simplify the description, all possible combinations of all the technical characteristics of the above embodiments may not be described; however, these combinations of the technical characteristics should be construed as falling within the scope defined by the specification as long as no contradiction occurs.
Number | Date | Country | Kind |
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202010076460.8 | Jan 2020 | CN | national |
Filing Document | Filing Date | Country | Kind |
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PCT/CN2020/115468 | 9/16/2020 | WO |