Patent Grant
10959711
This application is a U.S. National Stage entry of PCT Application No. PCT/KR2015/005547, filed on Jun. 3, 2015, which claims priority to KR Application No. 10-2014-0139308, filed Oct. 15, 2014, KR Application No. 10-2014-0122165, filed Sep. 15, 2014 and KR Application No. 10-2014-0070210, filed Jun. 10, 2014. The contents of the foregoing are incorporated by reference.
The present invention disclosed herein relates to an apparatus for HPV test, but in more detail it relates to a method and apparatus for self-collecting intravaginal sample for HPV test by inserting an apparatus herself.
Human papilloma virus; HPV has been a main cause of the uterine cervical cancer. The uterine cervical cancer is the fourth most frequent cancer by 10.1% among frequent cancer caused in women and when it includes epithelium cancer, it takes the first cancer as 22.3%. Every year, over 7,000 patients are occurred from this cancer and it is the most important cancer among Korean women as it occurs for 26.5 subject women out of 10,000 subject women. To decrease death rate caused by the uterine cervical cancer, an early diagnosis is required. Typical method to test uterine cervical test is a pap smear, which inserts a tool such as swab or cyto-brush into woman's vagina to collect sample, or a traditional method colposcopy. Although there are so many disadvantages of these methods there is no other method so these methods has been used until now.
However, since cervical cancer HPV test can only be tested by vising obstetrics and gynecology, a lot of women especially young women feel shame so they hesitate to take HPV test which leads to missing an early treatment. Also, when inserting a sample collecting apparatus in women's vagina could damage inner wall of the vaginal or cause pain by stimulating inner wall of the vaginal. After collecting sample from the vagina and during taking out the sample outside of the vagina, it could contaminate the collected sample by other secretion of inner side of the vagina.
An embodiment of the present invention is to provide to a method and an apparatus for self-collecting intravaginal sample for HPV test by inserting an apparatus woman herself.
An embodiment of the present invention is to provide to a method and an apparatus for self-collecting intravaginal sample for HPV test to prevent contamination of a sample after collecting the sample.
The objects of the inventive concept are not limited to the above mentioned descriptions. Other objects thereof will be understandable by those skilled in the art from the following descriptions.
According to an aspect of the present invention, the vaginal sample self-collecting apparatus comprises: a tube providing an inner space that a finger could enter to insert an apparatus into women's vagina and comprising a latter end having an open end part and a front end having a closed end part; and a collecting part that collects sample of the vagina, wherein the collecting part is provided at an outer surface of the closed end part of the tube.
Also, the apparatus for self-collecting intravaginal sample further comprises a turner to prevent the collecting part being contaminated from an outer contaminant by turning over the tube inside out so that the collecting part which collects a sample from the vagina may place inside of the tube.
Also, the turner comprises a pull string, wherein one end of the pull string is attached inner surface of the closed end part of the tube and the other end of the pull string is installed as exposed to the outside through an open end part of the tube.
Also, the turner may comprise a flow channel, wherein the flow channel provides a moving path for the sample to be provided to a diagnosis apparatus.
Also, the turner comprises a flexible hose that the flow channel is formed, wherein the flexible hose comprises a flow part and a leak part, wherein the flow part connects the flow channel and the closed end part of the tube, wherein the leak part is exposed to outside through the open end part of the tube. The leak part may be blocked.
Also, the collecting part may comprise a bumpy surface which is formed at the outer surface of the closed end part of the tube.
Also, the tube may further comprise an extension part which prevents friction between a finger and the tube so that the front end may turn inside out when taking out the finger, wherein the extension part places in between the front end and the latter end.
Also, the extension part may have wider area than the front end.
Also, the extension part may have at least one wrinkle.
Also, the front end may have relative higher flexibility and elasticity than the extension part.
Also, the tube may further comprise a tight band and a sealed member, wherein the sealed member is provided at circumference of the open end part.
Also, the tube may be composed of at least one of natural rubber, synthetic rubber, and silicon.
Also, the apparatus may further comprise a protective cover, wherein the protective cover encases the tube and protects the collecting part from the outer contaminants when it is inserted inside of the women's vagina. At the closed end part of the protective cover, a tear line may be formed.
According to an aspect of the present invention, the method for self-collecting sample of a vagina comprises: a inserting step inserting a finger in the tube then inserting the tube into women's vagina, wherein the tube has the open end part and the closed end part; a collecting step collecting a sample of vagina from the collecting part by using the finger that is inserted in the tube, wherein the collecting part is attached outer surface of the end part of the tube; a turnover step turning over inside out of the tube to place the colleting part inside of the tube and to prevent contaminating the collecting part from outside contaminants, wherein the collecting part has already collected the sample of the vagina.
Also, the turnover step turns over inside out of the tube by pulling the pull string after taking out a finger, wherein the tube is inserted in women's vagina, and wherein one end of the pull string is attached inner surface of the closed end of the tube.
Also, a sealing step may further be comprised, wherein the sealing step seals the open end part of the tube after the turnover step.
Also, an injecting step may further be comprised, wherein the injecting step injects a fixing solution inside of the tube to prevent deformation of the sample, after the turnover step.
Also, the collecting part may comprise a signal color material that could be identified by the naked eye in reacting to HPV.
According to an embodiment of the present invention, the apparatus for self-collecting intravaginal sample has particular effects which are: promoting user's convenience as it is easier for woman to collect a sample from her vagina; and increasing reliability of HPV test as we can treat a collected sample more sanitarily.
According to an embodiment of the present invention, there is a particular effect that we can easily provide the collected sample to a diagnosis apparatus.
The present invention may apply variety changes and have many embodiments. Certain embodiments are indicated in drawing and explained in detailed explanations. However, the present invention is not meant to be limited in certain embodiments, it should be understood that the present invention includes all the changes, equivalents, and alternatives. When explaining the present invention detailed descriptions of the prior art may be omitted when it is determined that it clouds the important points of the invention.
The words used in this application are to explain certain embodiments and it is not meant to limit the present invention. Singular forms include plural forms as well, unless the context clearly indicates otherwise. The terms “comprise” or “have,” etc. of the application is to specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof.
The first terms or second terms, etc. may be used to explain variety components, but the components should not be limited by the terms. The above terms are only used to differentiate a one component from the other components.
Various example embodiments will be described more fully hereinafter with reference to the accompanying drawings. In explaining embodiments referring to attached drawings, components which are the same or corresponding to each other regardless of drawing number have the same reference number and the duplicate explanations may be omitted.
Referring to
The tube 100 has an open end part 110 and a closed end part 120, and provides an inner space where a finger may enter so that the tube can insert inside of woman's vagina. The tube 100 is to pass through a passage of an inner side of a vagina so that the closed end part 120 of the tube can reach a cervix. Therefore, the tube 100 may be a cylinder structure that is easily inserted in inner side of vagina with a finger in it.
The tube 100 may be provided with a sealed member 130 and a tight band 140 at the circumference of the closed end part 110.
The tight band 140 provides an adhesion so that the tube 100 wouldn't take off from a finger by an artificial strength.
The sealed member 130 is to seal the open end part 110 when the tube 100 is turned over. In the embodiment the sealed member 130 may be provided as a bundle of string at the circumference of the open end part 110. However, the sealed member 130 may be provided with different sealed structures such as adhesively sealing the open end part 110 by applying glue at the outer surface of the open end part when the tube 100 is turned over or as zip locking the open end part 110.
Meanwhile, the tube 100 may be composed of at least one of a natural rubber, synthetic rubber, or silicon. For example, the tube 100 of the embodiment is provided with a silicon material.
The collecting part 200 may be provided as a pad form that attaches to the outer surface of the closed end part 120 of the tube 100. The collecting part 200 is to collect sample of the cervix, and may be provided with different hypo-allergenic forms like brush, cotton, wool, etc. that a cell could stick. Meanwhile, in the collecting part 200, a material that could cause an antigen-antibody reaction and a signal color material that could be seen by a naked eye in reacting to HPV may be comprised.
A turnover member 300 is provided to prevent the collecting part 200 contaminating from the outside contaminants, wherein the collecting part 200 collects intravaginal sample by turning over inside out of the tube 100 and placed inside of the tube 100. In an example, the turner 300 comprises a pull string 310, where the one end of the turner 300 is installed as exposed to the outside through the open end part 110 of the tube 100. The other end of the turner 300 is attached inner side of the closed end part 120 of the tube 100. That is, when the tube 100 is inserted inside of woman's vagina, the collecting part 200 is placed inside of the tube 100 by pulling the pull string 310 as taking out a finger and thereby turning over inside out of the tube 100.
The method for self-collecting intravaginal sample comprises an inserting step, a collecting step, a turnover step, and a sealing step.
(The inserting step) like
Like
Like this, an apparatus for self-collecting intravaginal sample 10 has no feeling of irritation as a user uses her finger to insert the tube 100 inside of her cervix through her vagina. Especially, as a user can insert the apparatus by adjusting her finger position depending on her vagina's position, form, and entry angle, the apparatus is useful easily collecting an intravaginal sample and inserting the apparatus inside of her cervix, and may prevent causing a pain by irritating an inner wall of the vagina or damaging the inner wall of the vagina.
Referring to
The tube 100 has the open end part 110 and the closed end part 120, and provides an inner space where a finger may enter so that the tube can insert inside of woman's vagina. The tube 100 is to pass through passage of an inner side of a vagina so that the closed end part 120 of the tube can reach a cervix. Therefore, the tube 100 may be a cylinder structure that is easily inserted in inner side of vagina with a finger in it.
The tube 100 may be provided with the sealed member 130 and the tight band 140 at the circumference of the closed end part 110.
The tight band 140 provides an adhesion so that the tube 100 wouldn't take off from a finger by an artificial strength.
The sealed member 130 is to seal the open end part 110 when the tube 100 is turned over. In the embodiment the sealed member 130 may be provided as a bundle of string at the circumference of the open end part 110. However, the sealed member 130 may be provided with different sealed structures such as adhesively sealing the open end part 110 by applying glue at the outer surface of the open end part when the tube 100 is turned over or as zip locking the open end part 110.
Meanwhile, the tube 100 may be composed of at least one of a natural rubber, synthetic rubber, or silicon. For example, the tube 100 of the embodiment is provided with silicon material.
The collecting part 200 may be provided as bumpy form that forms at the outer surface of the closed end part 120 of the tube 100. That is, the collecting part 200 may comprise several bumpy forms that form at the outer surface of the closed end part 120. The collecting part 200 is to collect intravaginal sample and may be provided with different forms like bumpy form or groove form that a cell could stick. Meanwhile, in the collecting part 200, a material that could cause an antigen-antibody reaction and a signal color material that could be seen by a naked eye in reacting to HPV may be comprised.
The turner 300 is provided to prevent the collecting part 200 contaminating from the outside contaminants, wherein the collecting part 200 collects intravaginal sample by turning over inside out of the tube 100 and placed inside of the tube 100. Also, the turner 300 provides a flow channel 320 that forms a sample moving route so that the sample may be provided to an apparatus 20 (shown in
In an example, the turner 300 is provided as a flexible hose 310 that the flow channel 320 is formed. The flexible hose 310 of the turner 300 comprises a flow part 312 and the leak part 314, wherein the flow part 312 is connected to the closed end part 120 of the tube 100 to be contacted, and wherein the leak part 314 exposed to the outside through the open end part 110 of the tube 100. The flow part 312 is opened so that a fixing solution (dilution sample solution) may inflow when the tube 100 is turned over. The leak part 314 is closed to prevent random leakage of the dilution sample solution, and is cut and used before providing the dilution sample solution to the apparatus 20 (shown in
That is, when the tube 100 is inserted inside of woman's vagina, the collecting part 200 is placed inside of the tube 100 by pulling the turner 300 as taking out a finger and thereby turning over inside out of the tube 100. After that, the fixing solution 900 (shown in
The method for self-collecting intravaginal sample comprises an inserting step, a collecting step, a turnover step, a fixing solution injecting step, a sealing step, and a dilution sample solution providing step.
(The inserting step) like
Like
Like
Like
Like this, the apparatus for self-collecting intravaginal sample 10 has no feeling of irritation as a user uses her finger to insert the tube 100 inside of her cervix through her vagina.
Especially, as a user can insert the apparatus by adjusting her finger position depending on her vagina's position, form, and entry angle, the apparatus is useful easily collecting an intravaginal sample and inserting the apparatus inside of her cervix, and may prevent causing a pain by irritating an inner wall of the vagina or damaging the inner wall of the vagina.
Also, contamination of a sample may be minimized when providing the sample from the apparatus for self-collecting intravaginal sample 10 to the apparatus 20, because the apparatus for self-collecting intravaginal sample 10 can easily provide the fixing solution (dilution sample solution) to the apparatus 20 through the flow channel 320 of the turner 300, wherein the fixing solution is mixed with a cell sample.
Referring to the
The tube 100 may comprise the latter end 110 having the open end part 112, the front end 120 having the closed end part 122, and an extension part 130 in between. The tube 100 provides an inner space that a finger could enter to insert a apparatus into women's vagina. The tube 100 is to pass through a passage of an inner side of a vagina so that the closed end part 120 of the tube can reach a cervix. Therefore, the tube 100 may be a cylinder structure that is easily inserted in inner side of vagina with a finger in it.
The extension part 130 is formed in between the latter end 110 and the front end 120 so that only the front end 120 may turnover when taking out a finger. The extension part 130 may be provided as there is no friction with a finger. In an example, the extension part 130 comprises at least one wrinkle 132. Also, the extension part 130 is appropriate to have wider cross-section area than the front end 120. Also, the extension part 130 is appropriate to be provided with certain distance with the finger. In another example, like
For reference, the front end 120 is appropriate to have relatively much flexibility and higher friction than the extension part 130 so that it will turnover easily when taking out a finger. That is, the front end 120 may be formed covering a fingertip tightly.
As described above, when taking out the finger where the tube 100 is inserted in woman's vagina, the tube 100 is overturned to the closed end part 122 of the front end 120 starting from a boundary of the extension part 130 and the front end 120. A reason for that is the front end 120 has a strong friction because it is adhere to skin of the finger and the extension part has a minimal friction because it is separated from the skin of the finger.
Meanwhile, the tube 100 may be provided with the tight band 140 in circumference of the latter part 110. The tight band 140 provides an adhesion so that the tube 100 wouldn't take off from a finger by an artificial strength.
The tube 100 may be composed of at least one of a natural rubber, synthetic rubber, or silicon. In an example, the tube 100 of the embodiment is provided with a silicon material. In another example, the extension part 130 and the frond end 120 may be composed of different material.
The collecting part 200 may be provided as bumpy form that forms at the outer surface of the front end 120 of the tube 100. That is, the collecting part 200 may comprise several bumpy forms that form at the outer surface of the front end 120 of the tube 100. The collecting part 200 is to collect intravaginal sample and may be provided with different forms like bumpy form or groove form that a cell could stick. Meanwhile, in the collecting part 200, a material that could cause an antigen-antibody reaction and a signal color material that could be seen by a naked eye in reacting to HPV may be comprised. In another example, the collecting part 200 may be provided as a pad form that attaches to the outer surface of the closed end part 120 of the tube 100. The collecting part 200 is to collect sample of the cervix, and may be provided with different hypo-allergenic forms like brush, cotton, wool, etc. that a cell could stick.
The method apparatus for self-collecting intravaginal sample using the apparatus for self-collecting intravaginal sample comprising above descriptions is like below.
The method for self-collecting intravaginal sample comprises an inserting step, a collecting step, a turnover step, and a sealing step.
(The inserting step) like
After the turnover step, a sample maybe prevented from contamination by sealing the extension part 130 of the tube 100. In here, a step injecting the fixing solution to overturned front end 120 may be comprised to prevent deformation of the sample after the turnover step. That is, to test a uterine cervical cancer, the sample should be maintained as alive and therefore should be sealed after injecting the fixing solution inside of the front end 120 where the collected sample is present inside of the collecting part 200. An alcoholic solution or a solution which combines the alcoholic solution and a solution that could optimize a polymerase chain reaction examination result is appropriate for the fixing solution. There are ethanol, methanol, and etc. for alcoholic solution, and there are PBS buffer solution, paraformaldehyde, and etc. for optimizing a polymerase chain reaction examination result.
Like this, an apparatus for self-collecting intravaginal sample 10 has no feeling of irritation as a user uses her finger to insert the tube 100 inside of her cervix through her vagina.
Especially, as a user can insert the apparatus by adjusting her finger position depending on her vagina's position, form, and entry angle, the apparatus is useful easily collecting an intravaginal sample and inserting the apparatus inside of her cervix, and may prevent causing a pain by irritating an inner wall of the vagina or damaging the inner wall of the vagina.
Described explanations indicate implementation form of the present invention and may be changed or corrected within the equal scope of the disclosed explanation and/or inventive concept or those skilled in art. Therefore, detailed descriptions of the present invention do not intend to limit the scope of the inventive concept but is to explain the present invention. Also, attached scope of claims may be understood to include other implementations.
| Number | Date | Country | Kind |
|---|---|---|---|
| 10-2014-0070210 | Jun 2014 | KR | national |
| 10-2014-0122165 | Sep 2014 | KR | national |
| 10-2014-0139308 | Oct 2014 | KR | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/KR2015/005547 | 6/3/2015 | WO | 00 |
| Publishing Document | Publishing Date | Country | Kind |
|---|---|---|---|
| WO2015/190738 | 12/17/2015 | WO | A |
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| Number | Date | Country | |
|---|---|---|---|
| 20170112478 A1 | Apr 2017 | US |
