WO2019112475A1

WO2019112475A1 - Obstetric pessary

Info

Publication number: WO2019112475A1
Application number: PCT/RU2018/000532
Authority: WO
Inventors: Михаил Григорьевич ШНЕЙДЕРМАН; Марина Михайловна ШНЕЙДЕРМАН
Original assignee: Михаил Григорьевич ШНЕЙДЕРМАН; Марина Михайловна ШНЕЙДЕРМАН
Priority date: 2017-12-05
Filing date: 2018-08-14
Publication date: 2019-06-13

Abstract

The claimed solution relates to obstetric pessaries and can be used in the treatment of pregnant women with cervical incompetence, and in pregnant women with a history of recurrent miscarriage, and can also be used in non-pregnant women suffering from pelvic organ prolapse, uterine prolapse, and stress urinary incontinence. The technical result is that of eliminating the problems of misalignment and displacement of a pessary inside the vagina, while preserving all of the advantages of the prototype. The claimed technical result is achieved in that an obstetric pessary in the form of a ring made of silicone and comprising equally spaced concavities in the edges of the ring and convexities inside the ring which are oriented toward the inside of the central aperture of the ring, said concavities being situated opposite said convexities, and said concavities and convexities being arranged symmetrically, is characterized in that it comprises equally spaced rounded projections mounted on the outer surface of the ring on the rounded portions thereof and extending in a direction along the axis of the ring such that the edges of the projections stop short of the concavities.

Description

OBSTETRIC PESSARIA

DESCRIPTION

The solution relates to obstetric pessaries and can be used in the treatment of pregnant women with isthmic-cervical insufficiency and

pregnant women with a habitual miscarriage in history, and can also be used in non-pregnant women suffering from prolapse and prolapse of the pelvic organs, prolapse of the uterus, and stress urinary incontinence.

The problem of miscarriage is of great medical and social importance, primarily due to the fact that the unfavorable outcome of pregnancy causes the strongest psycho-emotional trauma of parents.

Despite the progress achieved in the prevention and treatment of threatened abortion and its habitual loss, the frequency of miscarriages remains stable and quite high. So, according to different authors, it ranges from 2% to 55%, reaching 50% in the first trimester.

The causes of miscarriage are many and varied. Among the causes of miscarriage, genetic, anatomical, endocrine, infectious, immunological, and thrombophilic factors are distinguished. About 15% of women with habitual miscarriage had anomalies of the anatomical structure of the uterus as the main cause. These anomalies can be divided into 3 categories:

- Violations of the normal process of fusion of the uterine rudiments (anomalies of the Muller duct),

- violation of the size or blood supply of the uterus due to mimoma, endometrial polyps or connective tissue (Asherman syndrome),

- dysfunction of the cervix.

Anatomical changes in the genital organs include infantilism (uterine underdevelopment), uterine malformations, isthmic-cervical insufficiency, traumatic injuries of the uterus during abortion and childbirth, various tumors (myoma uterus).

A common cause of preterm labor is cervical

failure state in which there is a premature dilation of the cervix in pregnant women and, as a consequence, premature birth.

There are various methods of treatment for this pathology and a number of, stitching on the cervix (cerclage), devices that mechanically support an insolvent cervix. During pregnancy, progression of cervical canal opening causes shortening and softening of the cervix, protrusion of the fetal membranes into the dilated canal of the cervix, and, as a result, deprivation of physiological support for the ovum, infection and opening of the fetal membranes, birth of the fetus from the uterus. To prevent the development of the above complications, you can install the unloading medical pessary, which is injected into the cavity of the vagina and set in a certain physiological position. The mechanism of action of the pessary is to "close" the cervix by the elastic walls of the inner central opening of the pessary and prevent further disclosure of the cervix as well as partial transfer of intrauterine pressure to the anterior wall of the uterus.

In recent years, more and more women go to doctors about a rather serious disease - the omission and prolapse of the pelvic organs. Often, the pelvic organ prolapse is accompanied by urinary incontinence during tension, sneezing, coughing and lifting weights, i.e. stress type. The prolapse of the genitals in the early stages is characterized by protrusion of the posterior or anterior walls of the vagina, often

both walls, which is accompanied by a number of unpleasant feelings and leads to many problems in various aspects of the quality of life, including in the sexual and social spheres.

This disease occurs in women mainly after 40 years, but it also happens in young, women who have not given birth (2%). The main role in the occurrence of the disease plays a violation of synergism of the muscles of the pelvic floor, anterior abdominal wall, diaphragm, perineal tears in labor, damage and stretching of the pelvic floor muscles, congenital or acquired disorders in the process of innervation. Often, together with the anterior wall of the vagina, the bladder is lowered, and the prolapse and prolapse of the posterior wall of the vagina leads to the prolapse of the anterior wall of the rectum.

As a result, stress urinary incontinence occurs (coughing, weight lifting), involuntary gassing, constipation.

The problem of urinary incontinence includes three factors: medical, social and environmental. Every fourth woman in the world suffers from urinary incontinence.

Every eleventh woman in the world operates on the omission of the genitals and urinary incontinence. Of these, 30% of women are operated on repeatedly.

Among the effective treatments for pelvic dysfunctions in women in conservative tactics, urogynecological pessaries are widely known.

There are different supporting pessaries (ring, cup-shaped, etc.) and pessaries, which fill the inner space (cube, inflatable, mushroom-shaped, etc.). The study of the existing varieties of pessaries and uterine rings revealed a number of shortcomings in their design and the upcoming complications of their use. The most frequent of these is the emergence of a feeling of pain and loss of pessaries introduced into the vagina. This is due, primarily, to the uncomfortable form of the pessary,

poor quality material from which it is made. The appearance of abundant vaginal discharge and the formation of ulcers on the cervix is also associated with the quality of the material used, its density, the possibility of infection and partial chemical decomposition.

Pinchings, fistulas, urinary or intestinal obstruction are the result of an unsuccessful form of pessaries, increased density of the materials used, strong elasticity and deformation with prolonged use. In addition, the existing pessaries do not take into account such factors as a wide genital slit, short vaginal length, a combination of ptosis of the vagina and stress urinary incontinence.

The disadvantage of existing uterine pessaries is the difficulty of their introduction by women themselves, especially in old age. All this makes it necessary to look for new forms of pessaries and new materials for their manufacture. This problem is solved by the new types of pessaries presented. The implementation of new models of obstetric urogynaecological pessaries facilitates the introduction of the pessary in the vagina, its correct installation, creating additional outflow tract vaginal discharge, reducing the area of contact with the vaginal pessary wall facilitating removal of the pessary and holding the body of the uterus, urinary bladder and vagina urethrovesical angle fixing in the correct anatomical physiological position and prevents the disclosure of the cervix in the presence of pregnancy in the period from 12 to 39 weeks.

Known pessary "Juno" [http://medfarm.org/katalog/akusherstvo-iginekologiya / pessarij-matochnyj-yunona], made in the form of a ring located on the edges of the cup with a central hole, and containing openings for outflow of vaginal discharge along perimeter of the central hole. The Yuno uterine pessary is made of inert plastic and is used for the conservative correction of the prolapse and prolapse of the female genital organs.

The disadvantage of this pessary is the lack of fixation

urethrovesical angle in the correct anatomical and physiological position, insufficiently effective outflow of vaginal discharge, the complexity and inconvenience of extracting the pessary from the vagina.

Known obstetric pessary made in the form of a ring of silicone, characterized in that it contains at least two cuts from the edges of the ring and at least two protuberances in the inner side of the central hole of the ring (patent RU 142309U, publ .: 06/27/2014).

The technical problem of the known solution is the periodic mowing of the pessary during the movements of the woman, resulting in its subsequent fallout.

The closest analogue is Dr. Schneiderman's obstetric pessary [http://intimestetik.ru/glavnaya/product/akusherskiye-pessarii-doktora-shneydermana # shop2-tabs-2; publ .: 17.05.2017], which is intended for the treatment of pregnant women, cervical support in patients with additional complaints of prolapse (painful pressure "down" while standing and walking), pregnant women who are subject to physical exertion (for example, have to stand for a long time), with elevated intrauterine pressure, for example, with multiple pregnancies or when ultrasound examines signs of insolvency of the cervix.

In the prototype, the obstetric pessary is made in the form of a silicone ring, contains recesses located at an equal distance from the edges of the ring and protuberances inside the ring facing the inner side of the central opening of the ring, the recesses being opposite to the protuberances, the recesses and protuberances are made with a symmetrical arrangement.

The prototype provides additional fixation of the pessary in the vagina due to external cuts, is easily and painlessly inserted into the vagina by an obstetrician-gynecologist, during pregnancy it reliably keeps the cervix from disclosing when there is cervical insufficiency (due to the presence of bulges on the inner surface of the ring), does not cause the development of bedsores and ulcers on the mucous membrane of the vagina, provides free flow of vaginal discharge (prevention of colpitis), provides protection from stress urinary incontinence (during stress enii, coughing, sneezing), absence of allergic complications.

The technical problem of the prototype is the periodic displacement of the pessary during movements of the woman, resulting in its subsequent fallout.

The technical result of the claimed solution is to eliminate problems with the skew of the pessary inside the vagina while retaining all the advantages of the prototype.

The claimed technical result is achieved due to the fact that an obstetric pessary, made in the form of a silicone ring, contains recesses located at an equal distance from the edges of the ring and bulges inside the ring, facing the inner side of the central hole of the ring, and the grooves are opposite to the bulges, notches and bulges made with symmetrical

location, characterized in that it contains located at an equal interval of rounded protrusions installed from the outer surface of the ring on the rounded sections and extending in the direction along its axis so that the edges of the projections do not reach the grooves. The protuberances on the inner side of the ring can be made round and repeat the shape of the grooves on the outer side of the pessary.

Preferably, the protrusions are made in the form of segments of a circle.

Preferably, the protrusions and the pessary are molded in a single solid form.

The solution is illustrated in the drawing.

Figure 1 shows the design of the pessary, where 1 is the pessary, 2 is a notch on the outer side of the ring, 3 is a bulge on the inner side of the ring, 4 is a protrusion, 5 is the axis of the ring of the pessary.

The device can be made in the form of a ring of silicone, preferably high-quality silicone of a certain elasticity and density, specially selected for optimum use as a pessary.

In the obstetric pessary 1, notches 2 are made along the borders of the ring, and convexities 3 are made on the inner side of the ring. A necessary condition is the availability of such a number of notches and convexes that allows them to be placed at regular intervals. If the grooves and bumps are two pieces each, then they are made through an interval of 180 degrees, if there are three of them, then they are made through an interval of 120 degrees, if the grooves and bumps are four pieces (as in the example in FIG.), Then they are made after an interval of 90 degrees, if there are five of them, then they are performed at an interval of 72 degrees, etc.

From this principle of placement at regular intervals, a condition is formed that notches 2 and convexities 3 are made in a symmetrical arrangement.

The notches on the outer 2 side of the ring make it easy to grip and squeeze the device with your fingers. The bulge 3 on the inner side of the ring attached

additional elasticity with pressure on the walls of the vagina and keep the cervix from progressive disclosure in the presence of uterus in the uterus (with isthmic-cervical insufficiency).

Equal intervals between the protuberances and grooves are necessary for uniform compression of the device and uniform elasticity with pressure on the walls of the vagina.

Also, the notches 2 on the outer side of the ring reduce the contact area of the pessary with the mucous walls of the vagina (prevention of pressure sores) and are additional holes for the free flow of vaginal discharge and easy removal of the pessary from the vaginal cavity by a woman herself.

The above properties of the device are also partially ensured by the fact that there is a pressure of the pessary on the walls of the vagina in the area of its dome and preventing it from moving down to the genital slit of the body and neck, uterus, vagina and bladder. New is that the pessary 1 contains spaced rounded protrusions (petals) 4, located at an equal distance, installed from the outer surface of the ring on rounded areas and extending in the direction along its axis 5 so that the edges of the protrusions do not reach the notches 2.

In this case, the protuberances 2 on the inner side of the ring can be made round and repeat the shape of the recesses 3 on the outer side of the pessary.

The protrusions 4 can be made of silicone as the pessary itself, as well as in the form of segments of a circle. Preferably, the protrusions 4 and the pessary itself are molded in a single solid form. In the process of using the pessary, the projections 4 inside the vagina form a large area of contact with its walls, thereby

preventing the bias and displacement of the pessary inside the body while maintaining all

advantages of the prototype.

Equal gaps between the protrusions 4 are necessary for uniform

distribution of elasticity with pressure on the walls of the vagina. The protrusions 4 must be installed with the outer surface of the ring on the rounded areas and extend in the direction along its axis 5 so that the edges of the protrusions do not reach the notches 2 so that the notches 2 can function as openings for free flow of the vaginal discharge. If the protrusions 4 block the notches 2, this outflow will not be.

Claims

FORMULA

1. Obstetric pessary, made in the form of a ring of silicone, containing recesses located at an equal distance from the edges of the ring and convexity inside the ring, facing the inner side of the central opening of the ring, and the notches are opposite the convexes, the notches and convexes are made with a symmetrical arrangement, characterized by that contains located at an equal interval of rounded protrusions mounted from the outer surface of the ring on rounded areas and extending in the direction along its axis so that the projections do not reach the edges of the recesses.

2. Obstetric pessary according to claim 1, characterized in that the protuberances on the inner side of the ring are rounded and repeat the shape of the notches on the outer side of the pessary.

3. Obstetric pessary according to claim 1, characterized in that the projections are made in the form of segments of a circle.

4. Obstetric pessary according to claim 1, characterized in that the protrusions and the pessary are cast in the form of a single solid form.