RU2795079C1 - Device for aspiration of the cervical canal of the uterus after endocervical curettage and method of its use - Google Patents

Abstract

FIELD: medicine; gynecology.

SUBSTANCE: invention can be used for aspiration of the contents of the cervical canal of the uterus after endocervical curettage in the diagnosis of cervical intraepithelial lesions of the cervix. The device for aspiration of the contents of the cervical canal after endocervical curettage contains a hollow cylindrical body with a polymer piston installed inside. The distal end of the device is narrowed and has a hole. In the distal part of the body there is a side hole for material intake. The hole for taking the material is made in the form of a cut around the circumference of the tube and located at an angle with respect to the plane of the circumference of the tube. In the upper part, along the entire cutout, there is a protruding rib made of the same material as the body material, and the distal end of the device is sealed with a plug that can be removed. The method of using the above-described device for sampling histological material is characterized by the fact that after treatment of the external genitalia and cervix, the distal end of the sterile device with the piston inserted into it and the distal end previously sealed with a stopper is inserted into the cervical canal to the internal os. The sampling of the material is performed simultaneously with the retraction of the piston and the removal of the device from the cervical canal, while rotating the housing clockwise. After that, the device is removed without touching the walls of the vagina. Then, the plug is squeezed out by pushing out the piston. After that, the aspirate remaining inside the tube is squeezed out through the opened distal end into a sterile container for further histological examination. The technical result of the invention is its ensuring the exclusion of impurities from the epithelial cells of the vagina when taking material from the cervical canal.

EFFECT: invention increases the diagnostic value of histological studies and is convenient to use.

3 cl, 4 dwg

Description

The invention relates to medicine (gynecology), can be used for aspiration of the contents of the cervical canal of the uterus after endocervical curettage in the diagnosis of cervical intraepithelial lesions of the cervix.

In recent years, cervical cancer (CC) has occupied a leading position in the structure of female oncological morbidity. According to the WHO, more than 600,000 new cases of cervical cancer are detected annually [Bray F., 2018, WHO, 2020].

Squamous intraepithelial lesions (SIL - squamous intraepithelial lesions) of the cervix associated with the human papillomavirus precede the development of cervical cancer. Cellular changes can be localized in the transformation zone (junction of stratified squamous and columnar epithelium), outside the transformation zone, and in endocervical crypts. Today, the diagnosis of SIL is extremely important for the development of further tactics for managing the patient. The histological method for diagnosing SIL is the "gold standard", however, it is limited by technical difficulties. Material for histological examination is obtained by targeted point biopsy, in some cases, the patient undergoes targeted multifocal biopsy from the most altered areas of the cervical epithelium for the final verification of the diagnosis.

However, often the pathological process is localized in the cervical canal, which requires the procedure of scraping the endocervical crypts of the cervix. Indications for scraping of the cervical canal are the absence of visualization of the junction of stratified squamous and columnar epithelium in HPV-positive women with a cytological conclusion of ASCUS (atypical squamous cells of undetermined significance), LSIL (low-grade squamous intraepithelial lesions) or HSIL (high-grade squamous intraepithelial lesions). ) (The cervix, vagina, vulva. Physiology, pathology, colposcopy, aesthetic correction: a guide for practitioners. - 2nd ed., Revised and added. / Edited by S.I. Rogovskaya, E.V. Lipova - M.: Publishing house of the journal StatusPraesens, 2016 - p.103). In addition, endocervical curettage is performed for abnormal cytological findings, in particular, for cervical intraepithelial glandular lesions. It should be noted that with the results of HSIL cytology, it is recommended to perform a targeted biopsy or excision of the transformation zone (ST) of the cervix (depending on the results of colposcopy), followed by curettage of the cervical canal and pathoanatomical examination of the material to confirm the diagnosis (Russian Society of Obstetricians and Gynecologists, All-Russian Public Organization society of specialists in the prevention and treatment of tumors of the reproductive system "(ROSORS), Clinical recommendations Cervical intraepithelial neoplasia, erosion and ectropion of the cervix, 2020. P.18).

The procedure is usually performed under local paracervical or local anesthesia using a special small curette. Technique for performing the procedure: the instrument is inserted to the internal pharynx, tightly pressed with a pointed surface to the wall, after which movements are carried out from top to bottom in the direction from the internal pharynx to the outer one gradually along all the walls of the canal (Cervical diseases and genital infections / V. N. Prilepskaya, P R. Abakarova, G. R. Bairamova [et al.] Edited by V. N. Prilepskaya Moscow: Limited Liability Company Publishing Group "GEOTAR-Media", 2016. - 384 pp. - ISBN 9785970434062). The material is collected in a vessel and sent for histology. The procedure can be performed on an outpatient basis.

According to a number of authors, residual lesions are more common if endocervical glands are involved in the initial lesion along with the surface epithelium, which also indicates the need for a complete and thorough assessment of the endocervical epithelium (Diagnosis of residual / recurrent precancerous diseases of the cervix after electroexcision / G. N Minkina, I. B. Manukhin, M. V. Gavrikova [et al.] // Issues of gynecology, obstetrics and perinatology. - 2009. - V. 8. - No. 5. - P. 23-27).

The main disadvantages of endocervical curettage is obtaining scanty material consisting of mucus, blood, fragments of the cervical canal and fragments of squamous epithelium, rarely - stroma sections, which makes it difficult to interpret the histological picture.

A similar device is known [Clinical-bacteriological and clinical-morphological comparisons for non-specific inflammatory diseases of the internal genitalia of women. - Kodkina T.G., diss. … cand. honey. Sciences. - Chelyabinsk., 1975.]. The analogue consists of a funnel-shaped tube, 60 mm long with a hole diameter of 3 mm. The narrow end of the tube is closed with a metal cap fixed with a hinge. A needle with a diameter of 2 mm with a sharpened blunt end is inserted through the device, which pushes back the metal cover. The disadvantages of this device include: the danger of perforation of the uterus when the needle is inserted, the lack of mass production of this model, the complexity of the method.

A pipel is known for taking material from the uterine cavity for histological and microbiological studies [Eckert L.O., Watts D.H., Thwin S.S., Kiviat N., Agnew K.J., Eschenbach D.A. Histologic Endometritis in Asymptomatic Human Immunodeficiency Virus-Infected Women: Characterization and Effect of Antimicrobial Therapy. - Obstetrics & Gynecology 2003; 102: 962-969], consisting of an outer polymer body and an inner piston. The disadvantages of this design include the lack of asepticity of the taken material, due to contamination of the distal part of the device and the first portions of the aspirate, and the impossibility of targeted taking of biopsy material.

The closest analogue is a paypel biopsy used to determine the pathology of the endometrium (Utility Model Patent No. 62523 U1 Russian Federation, IPC A61M 1/00. Paypel: No. 2006136288/22: Appl. 13.10.2006: publ. 27.04.2007 / E. B. Rudakova, A. A. Luzin, A. V. Likhachev, O. N. Bogdanova; applicant GOU VPO Omsk State Medical Academy).

Paypel prototype contains a polymer cylindrical body and a polymer piston, and the distal part of the paypel contains a sterile gelatin plug. In the distal part of the body there is a side hole for material intake.

The technical problem of the prototype and other analogs is that they are basically designed to take the microflora from the uterine cavity and prevent the taking of microflora from the cervical canal.

When solving the inverse problem, they do not allow taking the microflora from the cervical canal and minimizing the intake of microflora from the uterine cavity.

In addition, the collection of material from the cervical canal is technically difficult using known analogues, because:

- it is difficult to determine the moment when the material sampling hole is located strictly inside the cervical canal;

- when taking material from the cervical canal, the collection goes strictly along the sections of the cervical canal along the line of the hole slipping when the tube is removed, and not along the entire inner diameter of the cervical canal, which reduces the accuracy of diagnosis in case of a pathological process only in a certain area of the cervical canal.

The objective of the invention is to ensure the asepticity and accuracy of sampling histological material from the entire cervical canal.

The technical result of the invention is that it ensures the exclusion of impurities from the epithelial cells of the vagina when taking material from the cervical canal. The present invention increases the diagnostic value of histological studies and is convenient to use.

This technical result is achieved due to the fact that a device is claimed for aspiration of the contents of the cervical canal after endocervical curettage, containing a hollow cylindrical body with a polymer piston installed inside, the distal end of which is narrowed and has a hole, and in the distal part of the body there is a side hole for material sampling , characterized in that the material intake hole is made in the form of a cutout along the circumference of the tube and located at an angle with respect to the plane of the tube circumference, and in the upper part along the entire cutout there is a protruding rib made of the same material as the body material, and the distal end of the device is sealed with a plug that can be removed.

It is possible that the device contains additional holes located at the same level as the main one, and the body is made of a polymer material or silicone.

Also claimed is a method of using the above-described device for sampling histological material, characterized in that after treatment of the external genitalia and cervix, the distal end of the sterile device with a piston inserted into it and the distal end previously sealed with a stopper is inserted into the cervical canal to the internal os, at the same time, the material is taken at the same time as the piston is retracted and the device is removed from the cervical canal, while rotating the body clockwise, after which the device is removed without touching the walls of the vagina, then the plug is squeezed out by pushing the piston, after which the aspirate remaining inside the tube through the opened distal end is squeezed into a sterile container for further histological examination.

Brief description of the drawings

Figure 1 shows a schematic device for aspiration of the contents of the cervical canal after endocervical curettage.

Figure 2 shows the principle of changing the position of the cutout in the body of the device during clockwise rotation (view A - initial position, view B - after turning 90 degrees relative to the axis of rotation).

Figure 3 shows an example of additional cutouts.

Figure 4 shows an example of a plug with a safety thread.

On the drawings: 1 - housing, 2 - piston, 3 - longitudinal cutout, 3.1 - additional longitudinal cutout, 4 - distal part, 5 - internal cervical os, 6 - cervical canal, 7 - uterine cavity, 8 - protruding rib, 9 - mucous membrane of the cervical canal to be taken, 10 - gelatin plug, 10.1 - polymer or silicone plug, 11 - distal end, 12 - axis of rotation, 13 - safety thread.

Implementation of the invention

The device (see Fig.1) consists of a hollow cylindrical polymer or silicone body 1, tightly ground polymer inner piston 2. In the distal part of the body is a side hole for sampling material. Piston 2 moves freely in housing 1.

The distal end 11 of the device is narrowed and has a hole. Also on the distal part 4 of the body 1 is a side hole 3 for taking material.

What is new is that the material intake hole is made in the form of a cutout 3 along the circumference of the tube and located at an angle with respect to the plane of the tube circumference, and in the upper part along the entire cutout 3 there is a protruding rib 8 made of the same material as the material corps.

When removing the polymer body 1 from the tube, piston 2 creates a negative pressure in it and sucks in the aspiration material, and when the piston is pushed out, it squeezes out all the taken aspirate into a sterile container.

Located in the region of the distal part 4 around the circumference of the tube at an angle, for example, 45° (this angle is optimal), the cutout 3, which has a protruding rib 8 in the upper part, provides scraping of the mucous membrane 9 of the cervical canal 6. At the distal end of the tube, for ease of insertion, there can be made limiter length of the tube inserted into the cervical canal 6 (not shown in the drawings).

The execution of the body 1 is possible precisely from a polymer or silicone material in order to give softness and flexibility to the tip, with the condition that it retains its shape. Such materials in the form of polymers and silicone make it possible to provide the indicated properties of the body 1, without which the cervical canal 6 may be injured either by the body 1 itself or by the rib 8.

The described device is used in the diagnosis of cervical intraepithelial lesions of the cervix as follows.

The distal end 11 of the device is pre-plugged with a plug 10. Temporary plugging of the distal end 11 with a plug 10 can be done in a variety of ways.

For example, a polymer or silicone plug 10.1 can be used, as shown in Figure 4, having a thin safety thread 13 attached to it, for which, after the plug 10 accidentally falls out inside the cervical canal 6 or the uterine cavity 7, it can then be taken out. The safety thread 13 is located inside the housing 1, and is in contact with the piston 2, but at the same time does not interfere with the material intake, since it is very thin. The negative pressure created by the piston 2 is reduced very slightly by the thread 13.

Also, clogging of the distal part 4 can be carried out by analogy with the prototype, when the distal part 4 of the body 1 is filled with a standard sterile 10% gelatin solution by pulling the piston 2 to a length of 10 mm.

The device prepared in this way (by the distal end 11 of the sterile body 1 with the piston 2 inserted into it) after treatment of the external genital organs, the cervix and its fixation, is inserted into the cervical canal 6 to the internal os in the uterine cavity 7.

The material is then taken as follows.

Simultaneously with the retraction of the piston 2 and the slow removal of the housing 1 of the device from the cervical canal 6, the tube of the housing 1 is rotated clockwise as shown in Fig.2. At the same time, the protruding ribs 8 in the area of the cutouts 3 around the circumference of the tube of the body 1 scrape off the mucous membrane 9 of the cervical canal 6, which is sucked through the slots 3 into the cavity of the tube of the body 1. After that, the body 1 of the device is removed without touching the walls of the vagina.

Then, first, the gelatin solution or plug 10 is squeezed out by pushing out the piston 2.

After that, the aspirate remaining inside the tube is squeezed out through the opened distal end 11 into a sterile container for further histological examination.

At the same time, the hole for taking the material may not be the only one. May contain additional holes in the form of similar cutouts 3.1, located at the same level as the main one (see example in Fig.3).

The presence of additional holes increases the efficiency of taking histological material from the entire cervical canal, since in the process of rotation they cover the entire inner surface of the cervical canal to a greater extent than one notch 3.

The length of the longitudinal cutout can be in the range of 1-2 cm in the presence of three cutouts as in Fig.3. When using only one cutout (see Fig.1, Fig.2) the length of the cutout 3 must be greater and reach values up to half the circumference.

Thus, when using this device, it is possible to take cell material from the cervical canal 9 from the cervical canal without contamination with an admixture of vaginal epithelium cells 7.

When evaluating the effectiveness of the invention, tests were carried out during which, using the claimed device and the claimed method, biomaterial was taken from the cervical canal in 20 HPV-positive women, with no complete visualization of the junction of the stratified squamous and columnar epithelium (according to extended colposcopy) and the ASCUS cytological conclusion , LSIL, HSIL, or cervical intraepithelial glandular lesion. All patients were divided into two groups using envelopes: the first group of patients underwent scraping of the cervical canal using only the Volkmann spoon, the second group was performed scraping using the Volkmann spoon, followed by aspiration of the contents of the cervical canal. Subsequently, a histological examination of the collected material was performed. Results of the study: in group 1, scraping was sufficient, but scarce, in contrast to the second group, in which the material for histological examination was recorded in full. At the same time, in 3 patients from the second group with suspected intracervical glandular lesions according to the cytological conclusion, the diagnosis was clarified, which was confirmed by the data of histological verification of the excisional material of the cervix.

Thus, the invention showed the efficiency of taking material from the cervical canal, which made it possible to start treatment in a timely manner. This indicates that the invention increases the diagnostic value of histological studies and is convenient to use.

Claims (3)

1. A device for aspiration of the contents of the cervical canal after endocervical curettage, containing a hollow cylindrical body with a polymer piston installed inside, the distal end of which is narrowed and has a hole, and in the distal part of the body there is a side hole for taking material, characterized in that the hole for taking the material is made in the form of a cutout around the circumference of the tube and located at an angle with respect to the plane of the circumference of the tube, and in the upper part along the entire cutout there is a protruding rib made of the same material as the body material, and the distal end of the device is clogged with a plug, made with the possibility of its extraction. 2. The device according to claim 1, characterized in that it contains additional holes located at the same level as the main one, and the body is made of a polymer material or silicone. 3. The method of using the device according to claim 1 for sampling histological material, characterized in that after treatment of the external genitalia and cervix, the distal end of the sterile device with the piston inserted into it and the distal end previously sealed with a plug is inserted into the cervical canal to the inner pharynx, while the material is taken simultaneously with the retraction of the piston and the removal of the device from the cervical canal, while rotating the body clockwise, after which the device is removed without touching the walls of the vagina, then the plug is squeezed out by pushing the piston, after which the remaining inside the aspirate tubes are squeezed through the opened distal end into a sterile container for further histological examination.

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