KR102264289B1 - Sample insertion type diagnostic kit - Google Patents

Abstract

The present invention relates to a sample insertion type diagnostic kit. The sample insertion type diagnostic kit comprises: a body having an accommodating space therein; a sample input unit provided on one side of an inner side of the body and communicating with the outside so that a cotton swab for sample collection can be inserted; a reaction unit having a sample solution wrapped in a protective film in the accommodating space and displaying a reaction that occurs when the sample solution comes into contact with the swab for sample collection input from the sample input unit; and an operation unit having one end of a sliding member coupled to the other side of the body to be reciprocally movable toward the reaction unit with the reaction unit interposed therebetween, and having the other end of the sliding member being provided with a pressing member protruding toward the other side of the body so that one end of the sliding member bursts the protective film when the pressing member is pressed. Accordingly, the sample insertion type diagnostic kit can block the sample from being evaporated during a process of causing a chemical reaction between the sample solution and the sample, and can effectively prevent the sample from being damaged due to contact with the outside.

Description

Specimen insertion type diagnostic kit {SAMPLE INSERTION TYPE DIAGNOSTIC KIT}

The present invention relates to a sample insertion type diagnostic kit for sample diagnosis, and more particularly, by providing a sample solution that exhibits a chemical reaction upon contact with a sample inside the body, the phenomenon of infection by minimizing direct contact with the outside. It relates to a sample-insertable diagnostic kit that can prevent this.

In general, a device for easily and quickly diagnosing infection of various diseases by examining or irradiating the presence of a single or a plurality of substances in a liquid sample, for example, a saliva, urine, or blood sample is called a diagnostic kit.

In a conventional immunochromatographic analysis system, the detection antibody polymerized with the label is accumulated in a dry state on the conjugation pad. When the sample is added, the conjugate is dissolved and reacted with the analyte in the liquid phase. Such a reaction occurs when the sample solution moves according to the fluid flow caused by capillary action, and an immune conjugate is formed between the conjugate and the analyte by sandwich bonding. These immune conjugates move to the top of the membrane and are captured by an immobilized antibody that specifically reacts with the analyte, thereby generating a signal proportional to the analyte concentration.

In the form of a conventional immunochromatography diagnostic kit, there is an absorbent rod protruding from a plastic case, so it is a mid-stream type, designed to detect and determine diagnostic indicators in body fluids by immersing body fluids such as urine into a dropper. There are the caseette type designed to take a small amount with an instrument such as a kit and drop it into the sample inlet of the kit for testing, and the dip-stick type designed not to use a plastic case.

The sample is dripped onto the sample pad of the assay strip at the lower part of the sample inlet through the sample inlet in the upper case of the diagnostic kit and absorbed, and the absorbed sample is moved to the adjacent conjugate pad to bind with colored particles, and then nitrous oxide occurs by capillary action. It spreads along the cellulose membrane. The developed sample displays the test result on the test line at a specific location of the membrane, and the test result is judged from the outside through the test result window of the upper case, and the developed sample continues to move and is finally absorbed by the absorbent pad.

Therefore, since the test result window of the upper case of the membrane of the analysis strip is exposed to the outside, the sample may evaporate and the test result may be deformed over time, while the test result may be damaged by direct contact with the outside of the membrane. There is a big problem that could be. In particular, the advantage of the cassette-type diagnostic kit is prevention of infection by minimizing direct contact between the analysis strip and the outside. There is a big problem.

Republic of Korea Patent Publication No. 10-1805451

An object of the present invention is to provide a sample-insertable diagnostic kit according to an embodiment of the present invention as a countermeasure to the problems of the prior art. The sample insertion type diagnostic kit according to an embodiment of the present invention forms a body part communicating with the outside so that a sample is introduced into the inside, and a receiving space formed inside the body part is provided with a sample solution wrapped with a protective film, Chemical reaction between the sample solution and the sample by inserting a cotton swab for collecting the sample with the sample in the space, blocking the reaction part communicating with the outside through a separate stopper or opening and closing part, and making the reaction occur by contacting the sample solution and the sample It relates to a sample-inserted diagnostic kit that can effectively prevent the evaporation of the sample in the process of causing the test and effectively prevent damage to the test result by contact with the outside.

The technical problems to be solved by the present invention are not necessarily limited to the technical problems mentioned above, and other technical problems not mentioned will be clearly understood by those of ordinary skill in the art to which the present invention belongs from the description below. will be able

The sample insertion type diagnostic kit according to the present invention for realizing the above-described object includes a main body having a receiving space therein, one side inside the main body, and communicating with the outside so that a cotton swab for sample collection can be inserted. a reaction unit having a sample input unit and a sample solution wrapped with a protective film in the receiving space, and displaying a reaction that occurs when the sample solution comes into contact with the swab for sample collection input from the sample input unit; and one end of the sliding member is coupled to the other side of the main body to reciprocate toward the reaction unit with the reaction unit interposed therebetween, and the other end of the sliding member is provided with a pressing member protruding to the other side of the body unit. Including, one end of the sliding member is configured to burst the protective film during the pressing operation of the pressing member.

More preferably, at least one groove is provided on the outer periphery of the sliding member, and the inner peripheral surface of the main body includes a locking device provided with a projection for selectively engaging or releasing the engagement in the groove when the pressing member is rotated. , it is possible to limit the operation of the manipulation unit.

More preferably, the sliding member may further include one coupled through an elastic member to enable return to the original position when the pressing member is released.

More preferably, one end of the sliding member may include a needle provided to puncture the protective film.

More preferably, a guide hole for guiding the needle may be formed in the center of the partition wall.

More preferably, a stopper for blocking communication with the reaction unit and the outside may be coupled to the opening of the sample input unit.

More preferably, the stopper may be integrally formed with the swab for sample collection.

More preferably, the body portion may further include a transparent window formed so that the reaction occurring inside the reaction portion can be identified from the outside.

More preferably, an opening/closing ball having a through hole communicating with the moving body insertion hole at a predetermined angle is rotatably provided inside the sample input unit, and an opening/closing handle for rotating the opening/closing ball is provided on the outside of the sample input unit. , it may be configured to selectively open and close the insertion hole when the opening and closing handle is rotated.

The sample-insertable diagnostic kit according to the present invention according to the above configuration has the following effects.

That is, a body part communicating with the outside is formed so that a sample is introduced into the inside, a sample solution wrapped with a protective film is provided in the receiving space formed inside the body part, and a cotton swab for collecting a sample with the sample is put into this receiving space, , By blocking the receiving space communicating with the outside through a separate stopper or opening and closing part, and making the reaction occur by contacting the sample solution and the sample, it blocks the evaporation of the sample in the process of causing a chemical reaction between the sample solution and the sample. It has the effect of effectively preventing the damage of test results by contact with

In addition, by providing a sample solution inside, a separate sample solution is provided and the process of contacting the sample with the sample is reduced, thereby shortening the inspection time and increasing the efficiency of work.

In addition, since the effects of the present invention described as described above are naturally exhibited by the configuration of the described content regardless of whether the inventor is aware, the above-described effects are only a few effects according to the described content, and all effects recognized or actual by the inventor It should not be accepted as written.

In addition, the effect of the present invention should be further understood by the overall description of the specification, and even if it is not described in an explicit sentence, a person of ordinary skill in the art to which the described content belongs through this specification If it is an effect that can be recognized as the effect, it should be considered as the effect described herein.

1 is a perspective view illustrating a sample-insertable diagnostic kit according to an embodiment of the present invention.
2 is an exploded perspective view illustrating a sample-insertable diagnostic kit according to an embodiment of the present invention.
3 is a side cross-sectional view illustrating a sample-insertable diagnostic kit according to an embodiment of the present invention.
4 (a), (b) is a view showing an operation process of the operation unit according to an embodiment of the present invention.
5 is a perspective view illustrating a sample insertion type diagnostic kit according to another embodiment of the present invention.
6 is an exploded perspective view illustrating a sample-insertable diagnostic kit according to another embodiment of the present invention.
7 (a) to (b) are diagrams illustrating the operation process of the specimen insertion type diagnostic kit illustrated in FIG. 5 .
8A is a view illustrating an operation unit according to another embodiment of the present invention.
(a) and (b) of FIG. 8B are views illustrating an operation process of the operation unit illustrated in FIG. 8A .

Hereinafter, the configuration and operation of specific embodiments of the present invention will be described in detail with reference to the accompanying drawings.

Here, in adding reference numerals to the components of each drawing, it should be noted that only the same components are marked with the same reference numerals as much as possible even though they are displayed on different drawings.

The sample insertion type diagnostic kit 1 according to the present invention includes a body portion 10 having a receiving space 210 therein, and a cotton swab 500 for sample collection, which is provided on one side of the inside of the body portion 10. A sample input unit 100 that communicates with the outside so that the input is possible, and a sample solution 400 wrapped with a protective film 400a in the receiving space 210 are provided, and the sample inputted from the sample input unit 100 is collected. A sliding member ( 200 ) with the reaction unit 200 on the other side of the inner side of the reaction unit 200 and the body unit 10 indicating a reaction when the cotton swab 500 and the sample solution 400 come into contact with each other ( One end of the 310) is coupled to be reciprocally movable toward the reaction unit 200, and the other end of the sliding member 310 is provided with a pressing member 320 protruding to the other side of the main body 10. ( 300), one end of the sliding member 310 may burst the protective film 400a when the pressing member 320 is pressed.

Hereinafter, the configuration of the present invention divided as described above will be described in detail with reference to the illustrated drawings.

First, the body portion 10,

As illustrated in FIGS. 1 and 2, it is made in the form of a rod having an accommodating space therein, the shape of which does not need to be determined in any one shape, and as well as polygons or ovals, as well as cylindrical as in the embodiment of the present invention. can

The main body 10 is largely divided into a sample input unit 100 , a reaction unit 200 , and an operation unit 300 , and may have a structure separable from each other.

The sample input unit 100,

As illustrated in FIG. 3 , the sample insertion hole 110 opened from one end of the main body 10 so that the swab 500 for sample collection can be inserted into the internal receiving space 210 of the body 10 described above. ) can be formed. The specimen insertion hole 110 is formed in a tunnel shape along the longitudinal direction of the main body 10 and may communicate with the reaction unit 200 to be described later.

Here, the specimen refers to the material required for the examination, and clinically, blood, fluid, pleural fluid, ascites, joint fluid, secretion fluid, sputum, etc. are used as specimens. In the present invention, it should be noted that the above-described sample and the cotton swab 500 for collecting the sample stained with the sample are defined as the same components, and can be used interchangeably.

The cotton swab 500 for sample collection is coupled to a rod portion 500b of the same diameter having a length of approximately 10 to 20 cm and a state wound around one end of the rod portion 500b, for example, soft to the touch. It may be composed of a sample collection unit (500a) made of cotton or cloth that can sufficiently absorb the secretions in the nasal cavity or oral cavity.

Meanwhile, a stopper 120 capable of blocking communication with the reaction unit 200 and the outside may be coupled to the end opening of the sample input unit 100 . The shape and material of the stopper 120 does not need to be limited to any one, for example, it may be formed of a soft rubber material and coupled by an interference fit method, or may be formed of a synthetic resin material and screwed together.

Referring back to FIG. 2 , in another embodiment of the stopper 120 , the above-described cotton swab 500 for sample collection may be integrally provided at the center of the surface coupled to the sample input unit 100 . In this case, the length of the cotton swab 500 is preferably formed to a length that can enter the reaction unit 200 .

On the other hand, an opening/closing part 600 including an opening/closing ball 620 and an opening/closing handle 610 for rotating the opening/closing ball 620 may be provided inside the sample input unit 100 .

Referring to Figs. 5 to 7, when described in more detail,

An opening/closing ball 620 having a through hole 620a communicating with the specimen insertion hole 110 at a predetermined angle is rotatably provided inside the specimen input unit 100, and the specimen input unit 100 is externally provided. An opening/closing handle 610 for rotating the opening/closing ball 620 may be provided to selectively open and close the specimen insertion hole 110 when the opening/closing handle 610 is rotated.

The reaction unit 200,

The accommodating space 210 may be formed in the body portion 10 as described above to accommodate the swab 500 for sample collection inserted through the sample insertion hole 110 . In addition, a sample solution 400 wrapped with a protective film 400a is provided in the receiving space 210 , and a cotton swab 500 for sample collection on which the sample input from the sample input unit 100 is stained and the sample solution 400 are provided. ) can indicate the reaction that occurs upon contact. In this case, a part of the main body 10 may be formed as a transparent window 230 so that the reaction occurring inside the reaction unit 200 can be identified from the outside.

The sample solution 400 is

As a solution in which the analyte sample is dissolved, it may be concentrated or diluted to a predetermined concentration. The composition of the sample solution 400 is not limited to any one, and a reagent having an accurate concentration commonly used in titration analysis experiments, that is, a standard solution may be preferable.

In addition, the protective film 400a surrounding the sample solution 400 may be formed in the form of a hydration gel, that is, a gel using water as a dispersion medium. For example, a polymer film such as poly(vinyl chloride) {poly(vinyl chloride)}, polytetrafluoroethylene, silicone rubber, polyurethane, hyaluronic acid, etc. have.

As described above, the sample solution 400 may cause a reaction by contacting the cotton swab 500 with the sample. Accordingly, the manipulation unit 300 for pressing and bursting the protective film 400a surrounding the sample solution 400 may be provided.

The operation unit 300,

One end of the sliding member 310 is coupled to the other side of the body 10 with the reaction unit 200 interposed therebetween to be reciprocally moved toward the reaction unit 200, and the sliding member 310 The other end of the body portion 10 may be composed of a pressing member 320 protruding to the other side. When the pressing operation of the pressing member 320 is performed, the protective film 400a may burst.

The operation unit 300 does not need to be limited to any one shape, and may preferably have a shape similar to a push bar of a syringe, or may have a cap shape similar to a push button of a ballpoint pen. Since this is a commonly used known form, a detailed description thereof will be omitted.

In addition, a needle 330 with a sharp tip may be provided at one end of the manipulation unit 300 to puncture and burst the protective film 400a surrounding the sample solution 400 . In this case, a guide hole 221 for guiding the needle 330 may be formed in the center of the partition wall 220 so that the needle 330 passes through the partition wall 220 and comes into contact with the protective film 400a. have.

On the other hand, the manipulation unit 300 may be coupled via the elastic member 340 so as to be able to return to the original position when the pressing member 320 is pressed. In other words, the elastic member 340 may be interposed between one end of the manipulation unit 300 and the partition wall 220 to have a force to always push the manipulation unit 300 .

In addition, the operation unit 300 may be provided with a locking device 350 for limiting the pressing operation of the pressing member (320).

The locking device 350 is

As illustrated in FIGS. 8A and 8B , at least one recess 350a is provided on the outer periphery of the sliding member 310 , and the inner circumferential surface of the main body 10 is rotated when the pressing member 320 is rotated. By including a locking device 350 provided with a projection 350b for selectively engaging or releasing the engagement in the recess 350a, it is possible to limit the operation of the operation unit 300.

That is, when the groove 350a of the manipulation unit 300 is crossed with the protrusion 350b formed on the inner circumferential surface of the main body 10, the sliding movement of the manipulation unit 300 is limited, and the manipulation unit 300 is moved in the central axis direction. When the concave groove (350a) and the protrusion (350b) are matched to face each other by rotating at a predetermined angle, the protrusion (350b) passes through the concave groove (350a), thereby enabling sliding movement of the manipulation unit (300). Accordingly, it is possible to prevent malfunction of the pressing member 320 when the diagnostic kit 1 is stored or used.

The process of inserting a sample into the body part through the sample insertion type diagnostic kit configured as described above and contacting the sample solution inside will be described as follows.

First, a specimen is collected through a cotton swab 500 for specimen collection.

As an example in which the swab 500 for sample collection is used, secretions may be collected from the nasal cavity or the mucous membrane of the oral cavity after insertion into the upper respiratory tract of the subject (not shown).

The cotton swab 500 that has been collected is inserted into the receiving space 210 through the specimen insertion hole 110 . At this time, in the case of an embodiment comprising a separate stopper 120, the reaction unit 200 communicates with the outside by coupling the stopper 120 to the end of the sample input unit 100 after inserting the cotton swab 500. blocks the

Referring back to FIG. 7 , as another embodiment of the sample input unit 100 , when the opening/closing unit 600 is provided, the opening/closing handle 610 is first rotated at a predetermined angle to the through hole 620a of the opening/closing ball 620 . ) is opened so that it coincides with the specimen insertion hole (110). Then, after inserting the cotton swab 500, the opening and closing handle 610 is rotated again by a predetermined angle so that the through hole 620a of the opening and closing ball 620 forms a right angle, so that the receiving space 210 communicating with the outside can be blocked. In addition, since the cotton swab 500 may be formed to have a longer length than the body portion 10, even after the sample collection portion 500a enters the receiving space 210, the rod portion 500b of the cotton swab may be formed in the body portion 10. can come out At this time, when the opening and closing handle 610 is rotated without the need to separately cut the rod portion 500b, the through hole 620a of the opening and closing ball 620 is bent at a right angle to cut the rod portion 500b.

As a result, the cotton swab 500 soaked with the sample is accommodated in the reaction unit 200 , and after the reaction unit 200 is cut off from the outside, the cotton swab 500 for sample collection is brought into contact with the sample solution 400 .

In this case, the pressing operation of the manipulation unit 300 may be limited by the locking of the locking device 350 . Accordingly, by rotating the pressing member 320 of the manipulation unit 300 at a predetermined angle in the direction of the central axis, the groove 350a formed on the outer periphery of the sliding member 310 and the protrusion 350b provided on the inner circumferential surface of the main body 10 ) By matching them to face, it enables the pressing operation of the manipulation unit 300 . When the locking device 350 is released and the pressing member 320 is pressed, the needle 330 is slidably moved, and the needle 330 is guided to the guide hole 221 formed in the partition wall 220 to accommodate the space 210 . The protective film 400a surrounding the sample solution 400 is broken. At the same time, the operation unit 300 is returned to its original position by the elastic force of the elastic member 340, and the sample solution 400 is ejected to the outside of the protective film 400a, and the sample is deposited on the cotton swab 500 for sample collection. contact is made with After a predetermined time elapses by the contact between the sample solution 400 and the sample, a chemical reaction occurs, and this reaction allows the diagnosis result to be confirmed from the outside through the transparent window 230 formed in the body part 10 .

As described above, in the detailed description of the present invention, specific embodiments have been described, but various modifications are possible without departing from the scope of the described content. Therefore, the scope of the described content does not need to be limited to the described embodiments, and should be defined by the claims described below as well as the claims and equivalents.

1: diagnostic kit 10: body part
100: sample input unit 110: sample insertion hole
120: stopper 200: reaction unit
210: accommodation space 220: bulkhead
221: guide ball 230: transparent window
300: operation unit 310: sliding member
320: pressing member 330: needle
340: elastic member 350: locking device
350a: groove 350b: protrusion
400: sample solution 400a: protective film
500: cotton swab for sample collection 500a: sample collection unit
500b: rod 600: opening and closing part
610: opening and closing handle 620: opening and closing ball
620a: through hole

Claims (9)

a body portion having an accommodation space therein;
a sample input unit provided on one inner side of the main body and communicating with the outside so that a cotton swab for sample collection can be inserted;
a reaction unit having a sample solution wrapped with a protective film in the receiving space and displaying a reaction that occurs when the sample solution comes into contact with a cotton swab for sample collection input from the sample input unit; and
an operation unit having one end of the sliding member coupled to the other side of the main body to be reciprocally movable toward the reaction unit with the reaction unit interposed therebetween, and the other end of the sliding member having a pressing member protruding toward the other side of the body; Including, when the pressing operation of the pressing member, one end of the sliding member will burst the protective film.
The method of claim 1,
At least one groove is provided on the outer periphery of the sliding member, and the inner peripheral surface of the main body includes a locking device provided with a projection for selectively engaging or releasing the engagement in the groove when the pressing member is rotated. A sample-insertable diagnostic kit that limits the manipulation of
The method of claim 1,
The sliding member,
The sample insertion type diagnostic kit further comprising a combination of an elastic member as a medium so that it can return to its original position when the pressing member is released.
The method of claim 1,
At one end of the sliding member,
Specimen insertion type diagnostic kit comprising a needle provided to puncture the protective film.
5. The method of claim 4,
A septum is formed on one side of the reaction unit, and a guide hole for guiding the needle is formed in the center of the septum.
The method of claim 1,
In the opening of the sample input unit,
Specimen insertion type diagnostic kit further comprising a stopper for blocking communication with the reaction unit and the outside is coupled.
7. The method of claim 6,
The stopper is
A sample insertion type diagnostic kit that is integrally formed with the swab for sample collection.
The method of claim 1,
In the body part,
The specimen insertion type diagnostic kit further comprising a transparent window formed so that the reaction occurring inside the reaction unit can be identified from the outside.
The method of claim 1,
An opening/closing ball having a through hole communicating with the specimen insertion hole at a predetermined angle is rotatably provided inside the specimen input unit,
Including that provided with; an opening/closing handle for rotating the opening/closing ball on the outside of the sample input unit;
A sample insertion type diagnostic kit that allows the sample insertion hole to be selectively opened/closed when the opening/closing handle is rotated.

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