RU222091U1 - Device for self-collection of cervico-vaginal discharge - Google Patents

Abstract

The utility model relates to medicine, namely to obstetrics and gynecology, and is intended for taking biological material from the vagina. The technical result is the availability of collection of cervico-vaginal material at home. The device for self-collection of cervico-vaginal discharge is a plastic rod with a tip and holder. The plastic rod is equipped with a limiter in the form of elastic semi-ovals, the tip of the rod is made of soft, easily absorbent material, in front of the tip the rod is made of less thickness, the holder is made in the form of a flat ring.

Description

The utility model relates to medicine, namely to obstetrics and gynecology, and is intended for taking biological material from the vagina.

Cervical cancer is the fourth most common cancer among women worldwide. There were 604,000 new cases and 342,000 deaths from the disease in 2020. There is effective prevention: primary - vaccination against high-risk HPV (not yet included in the national vaccination calendar) and secondary - cervical cancer screening. The screening program includes oncocytological examination of material taken from the cervix and testing for HPV using the PCR method. Despite the ongoing activities, the coverage of the female population is very low (according to various experts, it does not exceed 30%). Many patients ignore visiting an obstetrician-gynecologist for various reasons: fear of a positive result, anticipation of pain from the upcoming examination, discomfort during the insertion of a gynecological speculum, etc. In order to increase the coverage of the screening program in precisely this group of patients, the use of devices for self-collection of vaginal discharge and subsequent testing for high-oncogenic risk HPV is proposed. The sensitivity of the HPV test after taking the material by the doctor and the patient independently is comparable. If HPV is detected, the patient will be placed at risk for developing cervical cancer and invited for further examination.

Thus, the issue of actively identifying precancerous processes of the cervix and conducting an HPV test is relevant, and performing express tests will reduce the time for visiting a doctor and the discomfort during a gynecological examination.

There are known analogues of devices used for collecting cervico-vaginal material.

A device is known for collecting biological material from the vagina for bacterial vaginosis (patent No. 134777, application No. 2013130359, published November 27, 2013, bulletin No. 33, IPC class A61B10/02).

A known device for collecting biological material from the vagina for bacterial vaginosis is a transparent tube. The tube consists of three sections that communicate with each other: the proximal section of the tube is a hollow cylinder, onto the end of which a suction device is placed; the middle section has a hollow oval reservoir for depositing biological material; the distal section of the tube is bent at an angle of 45° and has lip-like thickenings at the end.

The disadvantage of the known device is that it cannot be used for self-sampling; it requires certain additional actions, since the material is collected after inserting a speculum into the vagina and requires time to fill the reservoir.

A device for collecting biological material from vaginal biofilm is known (patent No. 118541, application No. 2012111175, published 07.27.12, bulletin No. 21).

A known device for collecting biological material from a vaginal biofilm contains an elongated tip with a closed, rounded working end. The closed working end is made with holes, and at the non-working end of the tip there is a balloon made of elastic material.

The disadvantage of the known device is that the instructions for use are quite complex and are described for taking the material by a doctor, and not by the patient herself. There is a need to place the biological material into a container after taking the material, which requires additional steps. The working part of the tip does not allow collecting a sufficient volume of cervico-vaginal discharge.

A device is known for collecting biological material for the purpose of microbiological research of vaginal microflora (patent No. 75563, application No. 2008112390, published on August 20, 2008, IPC class A61I10/00).

The device for collecting cervico-vaginal secretions contains a flexible polypropylene tube with a hole, inside of which a piston is movably located along the entire length. The total length of the tube is 275 mm, and the hole is made at the working end of the tube and has an outer diameter of 2.6 mm.

The disadvantage of the known device is that there is no tip that allows you to effectively collect material from the cervix; this type of device is more suitable for collecting vaginal discharge for the purpose of diagnosing disorders of the vaginal microflora, but not for collecting material from the cervix. In this device, it is also necessary to place the resulting discharge on a glass slide, which is inconvenient when the patient takes the material independently, where it is necessary to clearly indicate in the instructions how in the future this sample will be sent to the laboratory.

In the dissertation of Bashirova L.K. “Optimizing the cervical cancer screening method” on page 34 describes the method of taking a smear using the Qvintip test.

In our opinion, the disadvantage of using this test is that collecting material on a plastic tube is insufficient, there is no limiter on the depth of insertion of the device, and there is an additional need to separate the plastic swab for placement in a test tube for research.

The description of patent No. 2364340 (Method of collecting biological material for microbiological research of vaginal microflora) describes a device for collecting analysis, consisting of a polypropylene tube with a hole at the end and a movable piston.

In general, all devices are divided into the use of a tube, inside of which there is a movable piston, the use of various types of cytobrushes and tubes with hollow holes at the end for collecting material.

The technical result is the availability of cervico-vaginal material collection at home.

A device for self-sampling of cervico-vaginal material is proposed, which is a plastic rod equipped with a limiter in the form of elastic semi-ovals in the form of “wings” with a tip made of soft, easily absorbent material.

An analogue of the device is shown in Fig.1 and Fig.2. The proposed device is shown in Fig.3. Figure 4 shows a zip-log bag that can be used to package the device after sample collection.

The analogue is a plastic rod with a handle with a holder with an applicator made of plastic attached to the end. The device is inserted all the way into the vagina, then the plastic rod must be turned 5 turns. Once removed, allow the plastic tip to dry within a minute. Next, the white part of the applicator is broken off, placed in a test tube and sent to the laboratory.

The proposed device for self-collection of cervicovaginal discharge is a plastic rod with a tip and a holder; the difference is that the plastic rod is equipped with a limiter in the form of semi-ovals “wings”, the tip is made of soft, easily absorbent material, the holder is made in the form of a flat ring.

The proposed utility model is made in the form of a plastic rod 1, contains a limiter 2 in the form of elastic and flexible semicircles in the form of “wings”. To simplify the manufacture of a utility model, the semi-oval can be made of any soft material. Considering that the device is intended for use at home, the shape of the holder 5 has been changed. The holder 5 is proposed in the form of a ring, which increases the reliability of its holding in the hand. The tip 4 of the device rod is equipped with a soft, easily absorbent material, for example, in the form of a cotton swab, it can be in the form of a brush made of strips of soft, easily absorbent material, in the form of a soft brush, etc. In this case, the tip of the rod (device) can be made not only in the form of a cotton swab, but also from any easily absorbent material that can be used for these purposes. At the distal end there is a place for a break 3; the rod in this place is made with a smaller thickness. At the point of fracture, the rod can also be simply sawed, i.e., thus reducing its thickness. After taking the analysis, the rod at the fracture site 3 is “rolled up” for its further packaging and transportation. This feature will allow you to easily and quickly package the obtained tests at home without outside help.

Using, for example, a cotton swab, firstly, significantly reduces the cost of the device, which makes it more affordable compared to foreign analogues, and secondly, using a soft cotton swab at home is safe. Unlike the plastic applicator in the analogue, the cotton swab does not need to be dried additionally and can be immediately placed in a plastic bag with a zip lock and sent to the laboratory.

A sample device was manufactured at the Department of Obstetrics and Gynecology named after Professor G.A. Ushakova FSBEI HE Kemerovo State Medical University of the Ministry of Health of Russia. The reliability and accessibility of using the device for self-sampling of cervico-vaginal material has been confirmed.

Claims (1)

A device for self-collection of cervico-vaginal discharge, which is a plastic rod with a tip and a holder, characterized in that the plastic rod is equipped with a limiter in the form of elastic semi-ovals, the tip of the rod is made of absorbent material, and at the distal end of the rod in front of the tip there is a break point with smaller rod thickness, the holder is made in the form of a flat ring.