RU199407U1 - DEVICE FOR REMOVING THE TOP ENDOMETRY LAYER WITHOUT DAMAGE TO THE GROWTH LAYER - Google Patents

Abstract

A useful model for removing the upper layer of the endometrium relates to medical technology, namely to gynecological devices and devices for surgical interventions on the uterine cavity. A device for removing the endometrium without damaging the growth layer, consisting of a handle and a body made in the form of a hollow tube, characterized by rounded edges hollow tube of the body from the distal end, a rounded blade from the distal end of the body, opening in a vertical plane up to 30 degrees, an adjusting screw with a thread from the proximal part of the body, leading a loop, fittings for connecting working media. The effects of using the utility model are: complete removal of the endometrium development of inflammatory complications. Reducing the risk of bleeding in the postoperative period. Reducing the risk of infertility. The device contributes to the observance of the ablastic principle in case of confirmation, during histological examination, of a malignant process.

Description

A useful model for removing the upper layer of the endometrium relates to medical technology, namely to gynecological devices and devices for surgical interventions on the uterine cavity.

Despite the socio-economic growth, the abortion rate remains high in Russia. The proportion of abortions in non-developing pregnancies is 45-88.6% of all episodes of fetal loss, in 10-20% of these women, after curettage, complications develop in the long-term period [5], and in the early period ranges from 1.6 to 52.3 and more than percent [2, 7, 4]. The proportion of deaths after abortion due to other etiological factors in the structure of maternal mortality is 13-25% [7].

Endometrial hyperplasia occurs in 70-90% of gynecological patients. The predominant age for the development of endometrial hyperplastic processes ranged from 46 to 80 years (61%) [6]. The hyperplastic process of the endometrium is dangerous with the risk of malignancy. Endometrial cancer is diagnosed on the basis of cytological examination after curettage [3]. This type of pathology has a significant share in the structure of oncopathology in women. Malignant tumors of the female genital area account for 40-45% of all cancer localizations, of which 17.9% are endometrial cancer. Every year, 6000 patients die due to endometrial cancer, which makes this disease the 7th leading cause of death from malignant tumors in women.

Another pathology in which curettage is used is abnormal uterine bleeding, which occupies a leading position in the structure of gynecological diseases, and the frequency of their occurrence steadily increases with age, reaching 30-50% in pre- and postmenopausal women [8].

All of the above data indicate a high frequency of pathological conditions accompanied by uterine curettage. However, the currently existing methods of manual curettage, as the most affordable, have a high percentage of complications, which implies the search for new technical solutions.

State of the art

The predominant, most accessible and frequent method of medical abortion is curettage or curettage, which is performed for both therapeutic and diagnostic purposes. The indications for this manipulation are: uterine bleeding, incomplete abortion, suspected hyperplastic process [1].

The known device is an obstetric instrument for scraping the uterine cavity (copyright certificate No. 166450 dated 01/18/1963), containing a loop with a sharp edge, a rod and a handle with transverse cutouts, made of polymer material. The disadvantage of this device is the insufficient depth of excision of the endometrium due to the small size of the cutting edge of the working part of the instrument, the absence of a limiter on the rod, unreliability of capture and evacuation of detritus.

Known gynecological curette (patent No. RU 2055534 C1 from 27.11.1992), containing a loop with a cutting edge and a circular edge, a rod and a handle, characterized in that the loop is made with two additional platforms, one of which has an angle of inclination to the longitudinal axis of the carriage no more than 15 °, while the angle of the cutting edge of the loop is no more than 35 °, and the angle of inclination of its outer edge is no more than 45 °. The disadvantage of this device is the insufficient depth of excision of the endometrium due to the small size of the cutting edge of the working part of the instrument, the absence of a stop on the rod.

A known device is a gynecological curette (copyright certificate No. SU 1666082 A1 dated 06/08/1988), consisting of a body having a working conical end, a lateral opening with a cutting edge communicating with a longitudinal groove. The disadvantage of this device is its predominant use for curettage of the cervical canal.

The known device is a vacuum curette (copyright certificate No. 1003810 dated 09/12/1980), consisting of a branch pipe, a hollow handle, a tube in which a cutout is made. The branch pipe is connected to the suction branch pipe. At the base of the handle, a tube is reinforced, which passes through the cavity of the handle and the tube and is rigidly attached at the spherical visor so that its opening faces the larger spherical visor, the zenith of which is made in the form of a plane. Both visors are positioned to form a slot. The disadvantage of this device is the insufficient area of excision of the endometrium due to the small working part, the impossibility of evacuating large-sized fragments of the remote endometrium, the possibility of blocking the outlet pipe.

For the prototype, the authors took a device for vacuum aspiration of the uterine cavity (patent No. 2113246 dated 20.06.1996), consisting of a drug and a vacuum chamber, a double-walled aspiration tube, divided by a partition into an injecting and removing sector, with an axial screw and an elastic nozzle, connected through a collet handpiece with a micromotor with an operating voltage of 12 V and a speed of 0-70 per 1 min, providing separation and crushing of tissues. The tissues to be removed are collected in a settling glass placed in a survey glass with the possibility of their visual control and determination of the volume corresponding to the volume of liquid displaced from the settling glass. The medicine is supplied from the medicine chamber through the pumping sector of the aspiration tube, which is connected to the medicine chamber, made, like all other parts, of transparent plastics. The device is connected to a vacuum source and a micromotor, which rotate the screw with separation, crushing of tissues in the uterine cavity and suction of liquid contents from the uterine cavity.

The disadvantage of this device is the obvious trauma of the growth and deep-lying layers of the uterus, which in the future can lead to massive bleeding and inflammation, a large diameter of the aspiration tube inserted into the uterine cavity, which leads to severe pain in the woman during the procedure, due to the movable " antennae "may be inadequate removal of the endometrial layer, which can lead to septic complications in the future, the small diameter of the removal sector of the aspiration tube, which does not exclude the possibility of blockage by aspiration masses. The significant mass of the device leads to rapid fatigue of the doctor's hand and, as a consequence, a change in fine motor skills necessary for accurate manipulation.

Disclosure of the essence of the utility model. The device consists of:

handle (1), which consists of a dense polymer material (according to GOST 26996-86), which does not irritate the skin of the doctor's hand. Textured for better grip. Overall dimensions of the handle - length - 85 mm, height - 130 mm, thickness - 29 mm. Such dimensions of the handle, according to the authors, will be the most ergonomic;

device body (2) made of medical steel in accordance with GOST 30208-94. The body is made smooth, without roughness, which contributes to a more painless introduction of the device into the uterine cavity. Made in the form of a hollow tube. The case length is 275 mm, the case diameter is 16 mm. According to the authors, with such a diameter, the risk of trauma to the cervix is reduced, and the length will not limit the doctor's freedom of movement;

the distal part of the body is represented by a rounded blade (3), which is attached to a movable axis (4). Made of medical steel in accordance with GOST 30208-94. The edges of the case in the distal part are rounded to prevent injury to the cervix when using the device. The movement of the rounded blade is carried out in a vertical plane and is limited to 30 degrees. It is this deviation that contributes to the best excision of the upper layer of the uterus - the endometrium, without damaging the growth layer. In addition, the size of the rounded blade allows for a gentle and adequate excision in the most inaccessible places of the uterus - the corners. When inoperative, the rounded blade is in a folded state - completely adhered to the body, without gaps;

the movable shaft (4) is mounted horizontally in the distal part of the body. Movable axle length - 16 mm, diameter - 2 mm;

the movable axis and the rounded blade are interconnected by a stiffener (5);

the proximal part of the body is represented by a threaded adjusting screw (6), when rotated clockwise, the rounded blade at the distal end of the body is opened by 30 degrees. Made of medical steel in accordance with GOST 30208-94. The threaded adjusting screw is textured for more comfortable handling, prevents slipping;

in the lower part of the body there are 2 nipples for connecting working media (7). In the course of medical or diagnostic manipulation, it is possible to use air or water for a more adequate performance of medical manipulation;

Directly in the body there is a driving spoke (8) connecting the threaded adjusting screw with the proximal part of the body and a stiffener from the distal part of the body. Needle diameter - 2 mm, length - 275 mm;

fastening screws (9) - used to fasten parts of the handle.

The essential positive qualities of the presented utility model of a device for removing the upper layer of the endometrium without damaging the growth layer are ease of use. Made of materials that are not pyrogenic or toxic (GOST 26996-86, GOST 30208-94). The ability to perform chemical and physical sterilization will lead to multiple uses, which is cost effective. The rounded edges of the housing tube at the distal end facilitate painless and safe insertion of the device through the cervix into the uterine cavity. The diameter and smoothness of the body make it possible to carry out medical and diagnostic measures in the uterine cavity with minimal complications. Light weight and comfortable handling reduce fatigue of the doctor's hand. A rounded blade that opens at a certain angle is capable of excising the endometrium without damaging the growth layer and in hard-to-reach areas of the uterine cavity. The dimensions of the blade will allow not only total removal of the endometrium, but also biopsy samples. The ability to connect working environments will lead to more adequate treatment and diagnostic manipulation. The textured grip results in a firmer and more comfortable grip in the hand without slipping.

The effects of using the useful model are: complete removal of the endometrium, without the development of inflammatory complications. Reducing the risk of bleeding in the postoperative period. Reducing the risk of infertility. The device contributes to the observance of the ablastic principle in case of confirmation, during histological examination, of a malignant process.

Implementation of the utility model. The patient is placed on the gynecological chair in a typical position. Warm, warmed up to room temperature, aqueous solution of antiseptic, the skin of the inner surfaces of the thighs, external genitals, and the vagina is treated. Using a vaginal mirror according to Simps, the cervix is exposed, then the cervix is fixed with bullet forceps. The dilator according to Guigard is used to expand the cervical canal. The device for removing the endometrium without damaging the growth layer is taken by the handle with the right hand, the distal end of the body is treated with sterile vaseline oil and the device is slowly screwed into the uterine cavity. Holding the device by the handle with his right hand, the doctor with his left hand turns the threaded adjusting screw clockwise from the proximal end until movement stops. At the same time, a driving spoke in the body sets in motion, which, through a stiffening rib, from the distal end of the device, sets in motion a rounded blade that opens along a horizontal plane by 30 degrees. Then the device is ready for use. After the manipulation, the threaded adjusting screw is turned counterclockwise, the rounded blade closes and completely adheres to the body without gaps. The device is removed from the uterine cavity with gentle and smooth movements. After completing the procedure, the patient should be in a horizontal position for at least 2 hours. The device for removing the upper layer of the endometrium is subjected to pre-sterilization treatment and further sterilization. All of the listed components make up a single functioning system, the single purpose of which is to remove the endometrium.

List of used literature:

1. Copyright certificate No. 166450 dated January 18, 1963

2. Copyright certificate No. SU 1666082 A1 dated 06/08/1988

3. Copyright certificate No. 1003810 dated 09/12/1980

4. Patent No. RU 2055534 C1 dated 27.11.1992

5. Patent No. 2113246 dated 20.06.1996.

6.GOST 26996-86

7.GOST 30208-94

8. Gorina E.A., Vostroknutova A.Yu. // Complications of curettage of the uterine cavity. Bulletin of modern research. 2018. No. 4.1. P. 24.

9. Divakova T.S., Podgornaya A.S. // Individualization of management of patients with uterine endometriosis based on the use of levonorgestrel-containing intrauterine system and hysteroresectoscopic endometrial ablation. Health and ecology problems. 2017.S. 22-27.

10. Dobrokhotova Yu.E., Saprykina LV, Chulkova OV. Methods of treatment of atypical endometrial hyperplasia // Medical business. 2011.S. 71-75.

11. Zakharova E.A. On the question of methods of termination of non-developing pregnancy // News of higher educational institutions. Volga region. Medical sciences. 2017. No. 4. S. 73-78.

12. Krasnikova M.B., Yuldasheva V.L., Trubina T.B. // Features of the course of pregnancy, childbirth, the postpartum period and the condition of newborns in adolescent girls. Medical Bulletin of Bashkortostan. 2011.S. 15-19.

13. Karkusova A.V., Gudieva I.R. // Endometrial hyperplasia is a problem of the XXI century. Young scientist. 2019. No. 5. S. 57-61.

14. Maltseva L.I., Boronbaev A.K. // Medical abortion and reproductive potential of women. Medical Almanac. 2010. No. 3. From 160-163.

15. Chernyshenko T.A., Nenakhov F.V., Kovaleva O.S., Sumedi T.N., Chertkova N.R., Mamadzhanyan M.G., Sopina A.V. // Possibilities of intrauterine surgery in the treatment of patients with abnormal uterine bleeding in the premenopausal period. Kremlin medicine. Clinical Bulletin. 2017. No. 4-2. S. 26-33.

Claims (1)

A device for removing the endometrium without damaging the growth layer, consisting of a handle and a body made in the form of a hollow tube, characterized by rounded edges of the hollow body tube from the distal end, a rounded blade from the distal end of the body, opening in a vertical plane up to 30 degrees, a threaded adjusting screw from the proximal part of the body, leading with a loop, with nipples for connecting working media.

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