KR101298771B1 - Cartridge - Google Patents

Abstract

The present invention is to provide a cartridge of the measuring device that allows the unskilled person to easily proceed with sample preparation.
The present invention penetrates the tube storage unit recessed so that the capillary tube can be temporarily seated, and the capillary tube into which the biomaterial is inserted can be inserted into one opening, and the first solution necessary for the sample preparation work is inserted therein. An upper housing having a filled first storage part, a second storage part penetrated so that the capillary tube can be inserted into one side opening, and a second storage part filled with a second solution necessary for sample preparation work therein; A cover for covering the other openings of the second storage part, and an injection part to be mounted on the upper housing in a state where the other openings of the first storage part and the second storage part are covered; The lower housing is configured to move the positions of the upper housing and the other openings of the first storage part and the second storage part in stepwise with the injection part. This is to overlap.

Description

Cartridge of measuring device {CARTRIDGE}

The present invention relates to a cartridge of a measuring device, and more particularly, to a cartridge usable in a measuring device configured to automatically execute a sample operation.

The cartridge is a measuring device such as glycosylated hemoglobin assay, albumin (Microalbumin, U-Albumin), creatine (Creatinine), C reactive protein (CRP: C-Reactivw protein), D-Dimer (D-Dimer), etc. It is a measuring means used for.

Among these various measuring apparatuses, the present invention will be described taking glycated hemoglobin measuring apparatus and its cartridge as an example.

Glycated or Glycosylated hemoglobin refers to the ratio of hemoglobin (hemoglobin) molecules in red blood cells that carry oxygen to glucose (glucose) in the blood. Since red blood cells turn into new red blood cells after a period of about 120 days, glycated hemoglobin usually shows long-term blood glucose levels for two to three months.

Hemoglobin in adults is composed of HbA (90%), HbA1 (7%), HbA2 (2%), HBF (0.5%), and when HbA1 is further fractionated, HbA1a, HbA1b, HbA1c (90%) Can be divided. Generally, glycated hemoglobin refers to HbA1c (Hemoglobin A1c), and HbA1c refers to the formation of a ketoamine bond with glucose in the N-terminal valine of the hemoglobin β-chain. Say.

Glycated hemoglobin measurement is mainly used to check whether the blood sugar control of diabetics are properly managed. Fasting blood glucose measurements can only be performed on an empty stomach, and measurements may vary depending on other factors, such as pain or infection, but glycated hemoglobin can be done at any time, with or without fasting, and there are few variables that can affect the results of the measurement. none.

Recently, the American Diabetes Association (ADA) issued a new guideline for diagnosing diabetes that recommends measuring glycated hemoglobin for diagnosing diabetes. Although glycated hemoglobin measurement is not new at all, it has not been standardized and has been used only as a follow-up test and not as a diagnosis of diabetes. However, as a result of many clinical studies, the utilization of the measurement result is increasing.

The glycated hemoglobin measurement method includes ion-exchange chromatography, electrophoresis, high-performance liquid chromatography (HPLC), and the like.

However, the above-described conventional techniques are most often measured in a clinical laboratory of a hospital, which is expensive, takes a long time to perform a fraction, and there is a problem that a small temperature change affects a result. Therefore, these conventional technologies are difficult to access by the general public because they have to use a large amount of expensive technology and expensive technology.

Recently, point of care (Poc) technology, which reduces the cost of measuring equipment and unnecessary measuring costs (small size, portable type), and is easy to handle and quickly knows the measurement result, has been in the spotlight. For example, it is referred to as point of care, which enables the diagnosis of clinical pathology in the vicinity of a patient, such as an emergency institution, an outpatient clinic, or a home.

Therefore, the growing interest in the health of modern people is increasing the desire to easily and easily measure their physical condition, glycosylated hemoglobin measurement that can be easily and conveniently checked at any time, anywhere, as well as clinical pathologists There is an urgent need for a description of the device.

However, it is difficult for beginners or the general public to perform sample preparation, such as taking biomaterials into the cartridge, mixing reagents, incubating, injecting washer solutions, and introducing them before using the measuring device. There is this. In addition, during the preparation of the sample, impurities may be introduced into the sample to affect the measured value.

An object of the present invention devised in view of the above point is to provide a cartridge of a measuring device that allows an unskilled person to easily proceed with sample preparation.

Still another object of the present invention is to provide a cartridge of a measuring apparatus which can improve the accuracy of a measured value by preventing foreign substances from being introduced into a sample injecting portion while a sample preparation operation is performed.

Still another object of the present invention is to provide a cartridge of a measuring device that can be automatically performed from a sample preparation operation to a measuring operation when using an automated measuring device.

The cartridge of the measuring device for achieving the object of the present invention as described above penetrated so that the capillary tube is temporarily recessed and the capillary tube into which the biomaterial is inserted can be inserted into one side opening. And a first storage part filled with a first solution required for a sample preparation work therein, and a second storage filled with a second solution required for a sample preparation work therein, through which the capillary tube is inserted into one opening. An upper housing provided with; A cover configured to cover the other openings of the first storage unit and the second storage unit, respectively; And a lower housing including an injection part into which the sample is inserted and movably mounted in the upper housing in a state of covering the other openings of the first storage part and the second storage part. And the position of the upper housing is moved so that the other opening of the second storage part overlaps with the injection part step by step.

In addition, more preferably, the first solution is made of a reagent which is mixed with a biological material and subjected to an incubation process in the first reservoir.

More preferably, the second solution consists of another reagent mixed with the biological material.

Further, more preferably, the upper housing further includes at least one further storage part having the same shape as the first storage part or the second storage part.

Further, more preferably, the second solution is made of a washer solution to inject a washer solution into the injection part.

Further, more preferably, the tube housing, the first reservoir, and the second reservoir are arranged in sequence in the upper housing.

Further, more preferably, the upper housing is provided with a protrusion protruding along the opening of the tube storage portion, the protrusion having an outer diameter smaller than the outer diameter of the head portion of the capillary tube.

Further, more preferably, the upper housing further includes a cover covering one opening of the first storage portion and the second storage portion, and the cover is formed of a thin film to be penetrated by the capillary tube. Is done.

More preferably, the injection portion is provided with a membrane filter layer and a solution absorbing layer.

In addition, more preferably, the upper housing and the lower housing has a cube shape, a guide protrusion and a guide extending along the longitudinal direction to guide the guide protrusion on the contact surface where the upper housing and the lower housing contact; The rails are formed in pairs.

Further, more preferably, the guide protrusion protrudes outwardly from both side portions of the contact surface of the upper housing and extends along the length direction, and the guide rail is provided on both side portions of the contact surface of the lower housing. Concave in shape and extend in the longitudinal direction.

Further, more preferably, the guide protrusion and the guide rail further include a stopper for temporarily fixing the upper housing at a position where the other openings of the first storage unit and the second storage unit are close to the injection unit.

In addition, more preferably, the upper housing and the lower housing is formed in a hexahedral shape, the upper housing and the lower housing is formed by a pair of rotating shaft and the rotating groove, the upper housing is rotated about the rotation axis position Is moved.

The cartridge of the measuring device for achieving the object of the present invention as described above is penetrated so that the capillary tube is temporarily seated and the capillary tube into which the biomaterial is inserted can be inserted into one side opening. An upper housing having at least one reservoir filled with a solution necessary for preparing a sample; The at least one storage including a cover for covering the other opening of the storage unit and a lower housing having a injection part into which the sample is injected, and being mounted to be movable in the upper housing while the other opening of the storage unit is covered; The position of the upper housing is moved so that the other opening of the portion overlaps with the injection portion.

Further, more preferably, the solution to be filled in any one of the reservoirs is made of a reagent that is mixed with the biological material and can be incubated in the reservoir.

Further, more preferably, the solution to be filled in the other one of the reservoirs is made of a wash liquid to enable the injection of the washer solution into the injection portion.

Further, more preferably, the tube housing and the reservoir are geometrically arranged along the movement trajectory when the upper housing and the lower housing move in the upper housing.

Further, more preferably, as at least one of the upper housing and the lower housing is moved, the injection portion is exposed to the outside so that it can be measured by the measuring means.

As described above, the cartridge of the measuring device according to the present invention can easily perform a sample preparation operation even by an unskilled person, thereby improving the usability.

In addition, the cartridge of the present invention is prevented from entering the sample or the sample inlet during the sample preparation operation has the effect of improving the reliability of the measured value.

In addition, the cartridge of the present invention, when using an automated measuring device, can be automatically performed from the sample preparation to the measurement work has the effect of increasing the ease of use.

1 is an exploded perspective view showing a cartridge of a measuring device which is a preferred embodiment of the present invention;
2 is a longitudinal sectional view showing a cartridge of the measuring device;
3 is a cross-sectional view showing the cartridge of the measuring device;
4 is a plan view showing a cartridge of the measuring device;
5 to 7 is a state diagram showing a sample preparation step by step,
5 is a state diagram showing an incubation step,
6 is a state diagram showing a washing solution injection step,
7 is a state diagram showing a measuring step,
8 is a perspective view showing a cartridge of a measuring device according to another embodiment of the present invention;
FIG. 9 is a longitudinal sectional view of the cartridge shown in FIG. 8; FIG.

Referring to the attached drawings of the cartridge of the measuring device which is a preferred embodiment of the present invention in more detail as follows.

1 is an exploded perspective view showing a cartridge of a measuring device which is a preferred embodiment of the present invention, FIG. 2 is a longitudinal sectional view showing a cartridge of the measuring device, FIG. 3 is a cross sectional view showing a cartridge of the measuring device, and FIG. 4 5 is a plan view showing the cartridge of the measuring device, Figure 5 to Figure 7 is a state diagram showing a sample preparation step by step, Figure 5 is a state diagram showing an incubation step, Figure 6 is a state diagram showing a washing solution injection step 7 is a state diagram illustrating a measurement step.

As shown, the cartridge of the measuring device, which is a preferred embodiment of the present invention, includes an upper housing 20, a lower housing 60 mounted to be movable in the upper housing 20, and a tube storage provided in the upper housing 20. It consists of a capillary tube 10 seated on the portion 21. The upper housing 20 is made of a structure that is coupled to the lower housing 60 so as to be movable in position, preferably formed of a structure that is coupled to the guide protrusion 71 and the guide rail 72 to be described later sliding. Do. However, the upper housing 20 and the lower housing 60 is not limited to the structure that slides along the longitudinal direction, and includes all the structures capable of moving in a state where the upper housing 20 is coupled to the lower housing 60. .

The upper housing 20 is preferably formed in a hexahedral shape, and the tube storage part 21, the first storage part 22, and the second storage part 23 penetrated from one upper surface to the other lower surface are sequentially arranged. The order of each storage unit may be changed according to a user's intention, but as shown in the drawing, the tube storage unit 12, the first storage unit 22, and the second storage unit 23 are preferably arranged in a line. Do. In addition, another storage unit may be added beside the second storage unit 23 as needed for measurement. The other storage portion is formed in the same shape as the first storage portion 22 or the second storage portion 23, and both openings are covered by the covers 51 and 52 described later, and a reagent, a washing liquid, and the like are disposed therein. This can optionally be stored. The number can be increased to suit the stage of the sample preparation step. That is, if the sample or step used in the sample preparation step is made in three steps, only one additional storage part is added, and if the sample or step used in the sample preparation step is made in four steps, another storage part is It can be configured as an additional structure, and the present invention includes all these structures. In addition, the tube storage unit 21 in which the capillary tube 10 is stored may be formed in the upper housing 20 according to the change of the sample preparation step.

Covers 52 and 51, such as foils, are attached to the upper and lower surfaces of the upper housing 20, respectively. The covers 51 and 52 cover the openings at both ends of each of the first storage part 22 and the second storage part 23 or the additional storage part to seal the internal space. The first solution 30 made of a reagent that is mixed with a biological material and undergoes an incubation process is injected into the inner space of the first storage unit 22. The second solution 40 made of the washing solution is injected into the inner space of the second storage unit 23 so as to inject the washing solution. At this time, the first solution 30 and the second solution 40 may be changed in type and amount to suit the progress of the sample preparation step. That is, the second solution 40 may be made of another kind of reagent that is mixed with the biological material instead of the washer. Another additional reservoir may be added with the kind of reagent or washer required for the progress of the sample preparation step.

It is mentioned that the measuring device proposed in the present invention can be used not only for glycated hemoglobin, but also for the measurement of albumin, creatine, C-reactive protein, di-dimer, and the like. Reagents injected with substances (e.g. blood, urine, plasma, serous, cerebrospinal fluid, spinal fluid, saliva, etc.), for example, reagents such as boronic acid concanavalin, antibodies, etc. The optical properties (for example, colorimetric method, light emission method, light absorption method, and fluorescence method) corresponding to the measurement object may be different from each other, or according to the reagent and the measurement object.

The cover 51 is preferably made of a thin film such that through holes are formed when the capillary tube 10 is pressed. In addition, the material may be used as long as the through hole is formed by the capillary tube 10 without affecting the reagent or washer solution to be injected.

The upper housing 20 is formed with a protrusion 25 protruding along the tube reservoir tube reservoir. The protrusion 25 has an outer diameter smaller than the outer diameter of the head portion 11 of the capillary tube 10. The protrusion 25 serves to space the upper surface of the upper housing 20 from the head portion 11 of the capillary tube 10 by a predetermined interval. The user can easily hold the capillary tube 10 by the hand or the holder of the measuring device.

Capillary tube 10 is made of a pin shape having a head portion 11 on one side. The other side is formed with a needle 13 protruding sharply. Capillary tube 12 penetrates through the central axis of the needle portion 13 and has a structure in which the biomaterial is introduced through the capillary tube.

The lower housing 60 has a hexahedral shape that is coupled to the lower surface of the upper housing 20. An injection part 61 is formed at one side of the upper surface, which is a contact surface in contact with the upper housing 20. The injection part 61 is provided with a membrane filter layer 61a and a solution absorbing layer 61b. The injection part 61 is provided with various types of filter layers or absorbing layers according to the types of biological materials to be measured. The injection part 61 is formed at a position sequentially matching the openings of the first storage part 22 and the second storage part 23 formed in the upper housing 20 as the lower housing 60 moves.

The guide protrusions 71 and the guide rails 72 are formed in a pair on the contact surface between the upper housing 20 and the lower housing 60. The guide protrusion 71 or the guide rail 72 may be selectively formed on the contact surface of the upper housing 20 or the lower housing 60, respectively. The guide protrusion 71 is installed on the upper housing 20, and the guide rail 72 is preferably installed on the lower housing 60. The guide protrusions 71 protrude to a predetermined height toward both sides of the lower surface of the upper housing 20 in the outward direction and extend along the longitudinal direction. The guide protrusion 71 has been described as an example formed on both sides, but may be partially formed. The guide rail 72 is formed in a structure in which the guide protrusions 71 are introduced into both sides of the upper surface of the lower housing 60, and extend along the longitudinal direction. In addition, the other end of the first storage part 22 and the second storage part 23 is temporarily fixed to the guide protrusion 71 and the guide rail 72 at the position close to the injection part 61. A stopper 73 is provided. The stopper 73 includes a groove 73b formed in the guide rail 72 of the lower housing 60 and a protrusion 73a temporarily inserted into the groove 73b. The protrusion 73a is formed at a position coincident with the center point of the tube storage part 21, the center point of the first storage part 22, and the center point of the second storage part 23, and the groove 73b is formed in the injection part 61. Is formed at a position coinciding with the center point.

The operation of preparing a sample using the cartridge of the measuring device which is a preferred embodiment of the present invention configured as described above is as follows.

As shown in FIG. 3, the capillary tube 10 in which the collection of the biomaterial is completed is placed in the tube reservoir 21.

In this state, as shown in FIG. 5, the position of the upper housing 20 is moved to position the first storage part 22 on the upper part of the injection part 61. The capillary tube 10 is taken out and introduced into the first reservoir 22. At this time, the capillary tube 10 is mixed with the first solution 30 stored in the first storage unit 22 in a state in which the cover 52 of the upper end is placed so as not to damage the lower cover 51. Incubate for about two minutes. When the incubation process is completed, the capillary tube 10 is pressed further to allow the cover 52 to be drilled. As the lower cover 52 is opened, the sample mixed with the first solution 30 is injected into the injection part 61.

When the injection of the sample is completed, as shown in FIG. 6, the capillary tube 10 is taken out and the position of the upper housing 20 is moved to coincide with the second storage part 23 on the upper part of the injection part 61. Position it as possible. And the capillary tube 10 is introduced into the second reservoir 22. At this time, the capillary tube 10 is pressurized to a position to punch the cover 52 and the cover 51 of the upper end. As the hole is formed in the cover 51 at the bottom, the second solution 40 contained in the second storage part 23 is injected into the injection part 61, and the washing step is performed. When the washing is completed in the membrane filter layer 61a of the injection portion 61, the position of the upper housing 20 is moved as shown in FIG. 7 to introduce the injection portion 61 into a measuring means such as an optical portion, thereby measuring Make it happen.

As described above, since the sample preparation operation is performed in a state in which the injection unit 61 is not disclosed to the outside, foreign substances may be blocked from being injected into the injection unit 61 at the source. In addition, the first storage unit 22, the second storage unit 23, and another storage unit are formed in sequence for each step, so that the unskilled person can easily proceed with the sample preparation step.

In particular, when using an automated measuring device, the user simply injects a sample into the capillary tube 10, plugs it into the tube storage unit 21, and mounts the measuring device so that all the other processes can be automatically performed. Will be. As a result, the ease of use can be dramatically improved, and the measurement ease between the unskilled person and the skilled person or the operator of the laboratory or the hospital can be minimized.

Similarly, the cartridge of the measuring device, which is another preferred embodiment of the present invention, has an upper housing 20 and a lower housing 60 having a hexahedral shape, as shown in FIGS. 8 and 9, and the upper housing 20 and the lower housing. The rotation shaft 73 and the rotation groove 74 are formed in the pair 60. When the rotary shaft 73 is formed in the upper housing 20, the rotary groove 74 is formed in the lower housing 60, and when the rotary shaft 73 is formed in the lower housing 20, the rotary groove 74 is the upper housing ( 60). The upper housing 20 is rotated about the rotation shaft 73 and is moved. In this case, the first storage part 22 and the second storage part 23 forming the storage part are geometrically arranged along an arc having the rotational axis 73 as the center point.

In the cartridge of the measuring device configured as described above, the upper housing 20 is rotated about the rotation shaft 73, and the other openings of the first storage part 22 and the second storage part 23 are formed in the housing 60. It is superimposed on the injection port 61 to be.

Other configurations and operating procedures are the same as in the preferred embodiment of the present invention.

It will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the invention as defined in the appended claims and their equivalents. Of course, such modifications are within the scope of the claims.

10 capillary tube 11 head portion
20: upper housing 21: tube storage
22: first storage unit 23: second storage unit
25: protrusion 30: first solution
40: second solution 51, 52: cover
60: lower housing 61: injection portion
71: guide protrusion 72: guide rail
73: rotating shaft 74: rotating groove

Claims (18)

The tube reservoir 21 recessed so that the capillary tube 10 can be temporarily seated, and the capillary tube 10 into which the biomaterial is introduced are inserted into one opening, and the sample preparation work therein. The first reservoir 22 filled with the first solution 30 required for the filling, and the capillary tube 10 penetrates into the opening at one side thereof, and the second solution 40 necessary for the sample preparation work therein. An upper housing 20 provided with the filled second storage part 23;
A cover 51 covering the other openings of the first storage part 22 and the second storage part 23, respectively; And
The injection part 61 is mounted to the upper housing 20 so as to be movable in a state where the other openings of the first storage part 22 and the second storage part 23 are covered, and a sample is inserted therein. Including a lower housing 60;
The cartridge of the measuring device, characterized in that the position of the upper housing (20) is moved so that the other opening of the first reservoir (22) and the second reservoir (23) overlaps with the injection portion in steps. The cartridge of claim 1, wherein the first solution (30) is made of a reagent that is mixed with a biological material and subjected to an incubation process in the first reservoir (22). 3. The cartridge of a measuring device according to claim 2, wherein said second solution (40) consists of another reagent mixed with a biological material. The measuring device of claim 3, wherein the upper housing 20 further includes at least one further storage part having the same shape as the first storage part 22 or the second storage part 23. Cartridge. 3. The cartridge of the measuring device according to claim 2, wherein the second solution (40) is made of a washer solution for injecting a washer solution into the injection part (61). 2. The measurement according to claim 1, wherein the upper housing (20) is arranged so that the tube storage part (21), the first storage part (22) and the second storage part (23) are arranged in sequence. Cartridge of the device. According to claim 6, wherein the upper housing 20 is formed with a protrusion 25 protruding along the tube storage tube storage portion, the protrusion 25 is the head portion of the capillary tube (10) A cartridge of a measuring device having an outer diameter smaller than that of 11). The upper housing 20 further includes a cover 52 covering one opening of the first storage part 22 and the second storage part 23, wherein the cover 51, 52 is a cartridge of the measuring device, characterized in that made of a thin film to be penetrated by the capillary tube (10). The cartridge of a measuring device according to claim 1, wherein the injection portion (61) is provided with a membrane filter layer (61a) and a solution absorbing layer (61b). The method according to any one of claims 1 to 9, wherein the upper housing 20 and the lower housing 60 has a hexahedral shape,
A guide protrusion 71 and a guide rail 72 extending along the lengthwise direction may be paired to a contact surface where the upper housing 20 and the lower housing 60 are in contact with each other. Cartridge of the measuring device, characterized in that formed. 11. The method of claim 10, wherein the guide protrusions 71 protrude outwardly and extend in the longitudinal direction at both sides of the contact surface of the upper housing 20, the guide rail 72 is the contact surface of the lower housing Cartridge of the measuring device, characterized in that the concave in the shape corresponding to the guide projections on both sides of the extending in the longitudinal direction. The method of claim 11, wherein the guide protrusion 71 and the guide rail 72, the other opening of the first storage portion 22 and the second storage portion 23 in a position close to the injection portion 61 And a stopper (73) for temporarily fixing the upper housing (20). The method according to any one of claims 1 to 9, wherein the upper housing 20 and the lower housing 60 has a hexahedron shape,
The upper housing 20 and the lower housing 60 is formed by pairing the rotary shaft 73 and the rotary groove 74, the upper housing 20 is rotated about the rotary shaft 73 and moved position Cartridge of the measuring device, characterized in that. The capillary tube 10 is recessed so that the capillary tube 10 can be temporarily seated and the capillary tube 10 into which the biomaterial is inserted is inserted into one opening, and the sample preparation work therein is performed. An upper housing 20 having at least one reservoir 22, 23 filled with a required solution;
A cover 51 covering the other opening of the storage units 22 and 23;
A lower housing 60 mounted on the upper housing 20 in a state where the other openings of the storage units 22 and 23 are covered, and having an injection unit 61 into which a sample is inserted; So,
The cartridge of the measuring device, characterized in that the position of the upper housing (20) is moved so that the other opening of the reservoir (22, 23) overlaps the injection portion (61). 15. The method of claim 14, wherein the solution to be filled in any one of the reservoir 22 is mixed with a biological material, characterized in that consisting of a reagent to undergo an incubation process in the reservoir 22 Cartridge of the measuring device. 15. The cartridge of the measuring device according to claim 14, wherein the solution filled in the other one of the reservoirs (23) is made of a washer solution which allows the injection of the washer solution into the inlet (61). 15. The method of claim 14, wherein the upper housing 20, the tube reservoir 21 and the reservoir (22, 23) is a geometrical movement trajectory during the movement of the upper housing 20 and the lower housing 60 Cartridge of the measuring device, characterized in that arranged along. 15. The method of claim 14, wherein as the at least one of the upper housing 20 and the lower housing 60 is moved, the injection portion 61 is exposed to the outside so that it can be measured by the measuring means Cartridge of the device.

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