KR101721488B1 - cervical specimen self gathering Apparatus and method for human papilloma virus examination - Google Patents

Abstract

The present invention provides a vaginal sample self-collection device for HPV testing. The vaginal sample self-sampling device of the present invention has an open end and a closed end, the tube providing an internal space into which the fingers are insertably insertable into the female vagina; A collecting part provided on a clogged end portion of the tube for collecting a sample of the cervix; And a turner for turning the inside and outside of the tube so that the sampling part is positioned inside the tube to prevent the sampling part of the cervix from being contaminated from external contaminants, And a flow channel forming a sample movement path to be supplied to the apparatus.

Description

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a method and apparatus for collecting vaginal specimens for human papilloma virus

The present invention relates to a device for testing human papilloma virus, and more particularly, to an apparatus and a method for self-sampling a vaginal specimen for inspecting a human papilloma virus which can be inserted into the vagina by itself to collect a sample of the cervix.

Human papilloma virus (HPV) has been found to be a major cause of cervical cancer. Cervical cancer is the most common cancer in women, accounting for 10.1% of all cancers, with 4% of cases and 22.3% of cases involving carcinoma in situ. The incidence rate of cancer is about 7,000 new cases each year, and the incidence rate is 26.5 per 100,000 women, which is the most important cancer of Korean women. Early diagnosis is essential to reduce mortality from cervical cancer. Typical tests for cervical cancer include the use of a device such as a cotton swab or a cyto-brush to insert into a woman's vagina, And there are many disadvantages and there is no alternative diagnosis method.

However, since the existing HPV test can only be performed through a gynecological examination at a gynecologist, many women, especially young women, tend to be reluctant to HPV testing for cervical cancer because of their shame. many. In addition, when the sampling device is inserted into a woman's vagina, the inner wall of the vagina may be irritated to cause pain or damage to the inner wall of the vagina. In the process of taking the sample from the cervix, There is a problem that a sample collected by another secretion of the sample is contaminated.

An embodiment of the present invention is to provide a vaginal sample self-sampling apparatus and method for a human papilloma virus test capable of collecting a sample of a cervix by a woman himself.

An embodiment of the present invention is to provide a vaginal sample self-sampling apparatus and method for testing a human papilloma virus which can prevent contamination of a sample after sampling.

The problems to be solved by the present invention are not limited thereto, and other matters not mentioned can be clearly understood by those skilled in the art from the following description.

According to one aspect of the present invention there is provided a device comprising: a tube having an open end and a closed end, the tube providing an internal space for inserting a finger into the interior of the vagina; A collecting part provided on a clogged end portion of the tube for collecting a sample of the cervix; And a turner for turning the inside and outside of the tube so that the sampling part is positioned inside the tube to prevent the sampling part of the cervix from being contaminated from external contaminants, An in vaginal sample self-sampling device including a flow channel that forms a sample movement path to be supplied to the apparatus may be provided.

Further, the turner may include a flexible hose having the flow channel formed therein.

The flexible hose may further include an inlet end connected to the flow channel to communicate with the clogged end of the tube and an outlet end exposed to the outside through the open end of the tube, the outlet end being clogged.

Further, the collecting part may include grooves formed in the clad end shell of the tube.

In addition, the tube may further comprise a sealing member provided around the open end.

In addition, the tube may further comprise a tightening band provided around the open end.

In addition, the tube may be made of at least one material selected from natural rubber, synthetic rubber, and silicone.

And a protective cover provided to wrap the tube so as to protect the collection portion from external contamination when inserted into a woman's vagina, A tear line may be formed at the closed end of the protective cover.

According to an aspect of the present invention, there is provided a method of inserting a tube into a vagina of a woman, the method comprising: inserting a finger into an inner space of a tube having an open end and a closed end; Collecting a sample of the cervix on a collection portion formed on a clipped end portion of the tube using a finger inserted into the tube; Reversing the inside and outside of the tube so that the sampling part from which a sample of the cervix is collected is not contaminated from an external contaminant and placing the sampling part inside the tube; Injecting fixative into the tube; And supplying the fixation solution mixed with the sample to a diagnostic device through a flow channel of a turner connected to the clogged end of the tube may be provided.

Also, the reversing step is characterized in that the fingers are pulled out while the tube is inserted into the vagina of a woman, and the inside and outside of the tube are reversed by pulling the turner.

The embodiments of the present invention have a remarkable effect of enhancing the reliability of the HPV test because it is easy for the female to collect the sample in the cervix by himself / herself, and the collected sample can be treated more hygienically.

The embodiments of the present invention have a remarkable effect that the collected sample can be easily supplied to the diagnostic apparatus.

1 is a perspective view showing a vaginal sample self-sampling device according to an embodiment of the present invention.
2 is a cross-sectional view showing a vaginal sample self-sampling device according to an embodiment of the present invention.
Figs. 3 to 7 are diagrams showing steps of a vaginal sample self-sampling method using a vaginal sample self-sampling device.
Figure 8 is a diagram illustrating a further embodiment of the present invention.

BRIEF DESCRIPTION OF THE DRAWINGS The present invention is capable of various modifications and various embodiments, and specific embodiments are illustrated in the drawings and will be described in detail in the detailed description. It is to be understood, however, that the invention is not to be limited to the specific embodiments, but includes all modifications, equivalents, and alternatives falling within the spirit and scope of the invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, the present invention will be described in detail with reference to the accompanying drawings.

The terminology used in this application is used only to describe a specific embodiment and is not intended to limit the invention. The singular expressions include plural expressions unless the context clearly dictates otherwise. In the present application, the terms "comprises" or "having" and the like are used to specify that there is a feature, a number, a step, an operation, an element, a component or a combination thereof described in the specification, But do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, or combinations thereof.

The terms first, second, etc. may be used to describe various components, but the components should not be limited by the terms. The terms are used only for the purpose of distinguishing one component from another.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Reference will now be made in detail to embodiments of the present invention, examples of which are illustrated in the accompanying drawings, wherein like reference numerals refer to the like elements throughout the specification and claims. The description will be omitted.

FIG. 1 is a perspective view showing a vaginal sample self-sampling device according to an embodiment of the present invention, and FIG. 2 is a sectional view showing a vaginal sample self-sampling device according to an embodiment of the present invention.

1 and 2, the vaginal sample self-sampling apparatus 10 includes a tube 100, a sampling unit 200, and a turner 300.

The tube 100 has an open end 110 and a closed end 120 and provides an internal space for the fingers to be insertably insertable into the female vagina. The tube 100 is for passing through the passage in the vagina so that the clogged end 120 of the tube can reach the uterine cervix. The tube 100 can have a cylindrical structure easily inserted into the vagina while being inserted in the fingers.

The tube 100 may be provided with a sealing member 130 and a fastening band 140 around the open end 110.

The tightening band 140 provides an adherence force so that the tube 100 is not peeled off the fingers without an artificial force when the fingers are inserted into the tube 100.

The sealing member 130 is provided to seal the open end 110 with the tube 100 turned upside down and in this embodiment can be made of a bundle string installed along the open end 110 . However, the sealing member 130 may be applied with various sealing structures such as a zip-lock method or a method of applying an adhesive to the opened end shell to seal the open end 110 in a state where the tube 100 is turned upside down .

Meanwhile, the tube 100 may be made of at least one material selected from natural rubber, synthetic rubber, and silicone. For example, the tube 100 of the present embodiment is made of a silicon material.

The collecting part 200 may be provided in the form of a groove formed in the outer surface of the clogged end 120 of the tube 100. That is, the collecting unit 200 may include a plurality of grooves formed on the outer surface of the clogged end 120. The sampling unit 200 is for sampling a cervix, and may be provided in various forms such as grooves, protrusions, and the like between which the cells can be inserted. Meanwhile, the groove of the collecting unit 200 may include a substance capable of causing an antigen-antibody reaction and a signal-generating substance which can be visually confirmed in response to HPV.

The turner 300 is used to prevent the sampling unit 200 from being contaminated by external contaminants by inverting the inside and outside of the tube 100 so that the sampling unit 200 is positioned inside the tube 100 / RTI > The turner 300 also provides a flow channel 320 that forms a sample flow path so that the sample is supplied to the diagnostic device 20 (shown in FIG. 7).

In one example, the turner 300 is provided with a flexible hose 310 in which a flow channel 320 is formed. The flexible hose 310 of the turner 300 has an inlet end 312 connected to communicate with the clogged end 120 of the tube 100 and an outlet end 312 exposed to the exterior through the open end 110 of the tube 100 And an outlet end 314. The inflow end 312 is opened to inflow the fixation solution (diluted sample solution) mixed with the cell sample in the inverted state of the tube 100, and the outflow end 314 is blocked to prevent any leakage of the diluted sample solution, It is cut and used before supplying the diluted sample solution to the diagnostic device 20 (shown in FIG. 7).

That is, when the tube 100 is inserted into the female vagina and the finger is pulled out and the turner 300 is pulled out, the inside and outside of the tube 100 are turned upside down and the collecting part 200 is positioned inside the tube 100 . 6) may be introduced into the tube 100 and mixed with the fixer 900 and then supplied to the diagnostic device 20 through the flow channel 320 of the turner 300. [

Figs. 3 to 7 are diagrams showing steps of a vaginal sample self-sampling method using a vaginal sample self-sampling device.

The vaginal sample self-collection method largely includes an inserting step, a collecting step, a flipping step, a fixing liquid supplying step, a sealing step, and a diluting sample liquid supplying step.

(Insertion Step) As shown in FIG. 3, the examinee inserts his / her finger into the tube 100 and inserts the tube 100 into the cervix through the inside of his / her vagina 1. (Sampling step) When the clogged end 120 of the tube 100 enters the cervix 1, the collected part 200 adhered to the clipped end sheath of the tube 100 using the fingertip, . (Flipping Step) When the turner 300 is pulled out, the inside and outside of the tube 100 are turned upside down and the collecting unit 200 is positioned inside the tube 100. Therefore, it is possible to prevent the sampling unit 200 from being contaminated by external contaminants.

 As shown in FIGS. 4 and 5, the flipping step is to remove the fingers while the tube 100 is inserted into the female vagina and pull the turner 300 so that the inside and outside of the tube 100 are turned upside down.

As shown in FIG. 6, the immersion liquid injection step injects the immobilizing liquid 900 into the tube 100. The fixing liquid 900 is injected into the tube 100 for the purpose of preventing deformation of the sample and for convenience of sample supply to the diagnostic apparatus 20. [ After the fixing liquid is injected, the open end 110 of the tube 100 is sealed to prevent contamination of the sample. For reference, the fixer 900 is preferably a solution obtained by mixing an alcoholic solution or a solution capable of optimizing the result of an alcoholic solution and a PCR reaction test. Alcoholic solutions include ethanol and methanol, and the solutions that can optimize the results of the polymerase chain reaction test are PBS buffer solution and paraformaldehyde.

As shown in FIG. 7, in the diluting sample liquid supply step, when the outlet end 314 of the turner is cut, the diluted sample liquid flows out through the flow channel 320 of the turner in the tube 100, So that it can be easily supplied to the diagnostic device 20.

As described above, the vaginal sample collecting apparatus 10 inserts the tube 100 into the user's own fingers and inserts the tube 100 into the cervix through the vaginal opening.

Particularly, since the user can insert the finger while adjusting the position of the finger according to the position, shape, and angle of entry of the user, it is easy to enter the cervix and enter the cervix and stimulate the inner wall of the vagina, It is possible to prevent damage.

Since the vaginal sample self-sampling device 10 can easily supply the fixer (diluted sample solution) containing the cell sample to the diagnostic device 20 through the flow channel 320 of the turner 300, the vaginal sample self- It is possible to minimize the contamination in the process of being supplied from the diagnostic apparatus 10 to the diagnostic apparatus 20.

FIG. 8 is a block diagram of a veneer sample self-sampling device 10a according to a further embodiment of the present invention. In the veneer sample self-sampling device 10a, A cover 500 was added. The protective cover 500 may have a cylindrical shape so as to enclose the tube 100 in a closed state with its tip closed. A tear line 512 is formed so that the end 510 of the protective cover 500 (the portion facing the clogged end of the tube) can be torn easily. That is, when the examinee inserts his / her finger into the tube 100, and the tube 100 is inserted into the cervix through the inside of his or her vagina, the protective cover 500 protects the collecting unit 200. When the tip end 520 of the protective cover 500 is pulled just before the sampling step, the end of the protective cover 500 is easily torn along the tear line 512 and pulled out of the vagina.

In addition to the human papilloma virus (hereinafter HPV), the vaginal sample self-sampling apparatus according to the present invention can be used for cytologic examination of the cervix, examination of chlamydia (sexually transmitted disease), gonorrhoea And the like), and the like.

The foregoing description is merely illustrative of the technical idea of the present invention, and various changes and modifications may be made by those skilled in the art without departing from the essential characteristics of the present invention. Therefore, the embodiments disclosed in the present invention are intended to illustrate rather than limit the scope of the present invention, and the scope of the technical idea of the present invention is not limited by these embodiments. The scope of protection of the present invention should be construed according to the following claims, and all technical ideas within the scope of equivalents should be construed as falling within the scope of the present invention.

10: vaginal sample self-sampling device 100: tube
200; Sampling unit 300: Turner

Claims (10)

A vaginal sample self-sampling apparatus comprising:
A tube having an open end and a closed end, the tube providing an internal space for inserting a finger into the interior of the vagina;
A collecting part provided on a clogged end portion of the tube for collecting a sample of the cervix; And
And a turner for turning the inside and outside of the tube so that the sampling part is positioned inside the tube to prevent the sampling part of the cervix from being contaminated from external contaminants,
The turner
And a flow channel for forming a sample movement path so that the sample is supplied to the diagnostic apparatus. The method according to claim 1,
The turner
And a flexible hose having the flow channel formed therein. 3. The method of claim 2,
The flexible hose
The flow channel including an inlet end communicating with the clogged end of the tube and an outlet end exposed through the open end of the tube,
Wherein the outlet end is clogged. 3. The method according to claim 1 or 2,
The sampling unit
And a groove formed in the closure end shell of the tube. 3. The method according to claim 1 or 2,
The tube
Further comprising a sealing member provided around the open end. 3. The method according to claim 1 or 2,
The tube
Further comprising a tightening band provided around the open end. 3. The method according to claim 1 or 2,
Wherein the tube is made of at least one material selected from natural rubber, synthetic rubber and silicone. 3. The method according to claim 1 or 2,
And a protective cover provided to wrap the tube so as to protect the collected portion from external contamination when inserted into a woman's vagina,
And a tear line is formed at the closed end of the protective cover. A method for self-sampling of vaginal specimens for HPV testing comprising:
Inserting the tube into a woman's vagina by inserting a finger into an inner space of the tube having an open end and a closed end;
Collecting a sample of the cervix on a collection portion formed on a clipped end portion of the tube using a finger inserted into the tube;
Reversing the inside and outside of the tube so that the sampling part from which a sample of the cervix is collected is not contaminated from an external contaminant and placing the sampling part inside the tube;
Injecting fixative into the tube; And
And supplying the fixation solution mixed with the sample to a diagnostic device through a flow channel of a turner connected to a clogged end of the tube. 10. The method of claim 9,
The reversing step
Wherein the tube is pulled out in a state in which the tube is inserted into the vagina of a woman, and pulling the turner so as to turn the tube in and out.

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