RU2738548C1 - Device preventing premature opening of uterine cervix in pregnant woman - Google Patents

Abstract

FIELD: medicine.SUBSTANCE: invention refers to medical equipment, namely to a device for preventing premature opening of the uterine cervix in a pregnant woman. Device for preventing premature opening of uterine cervix in a pregnant woman comprises a body with a hole for the uterine cervix, which is configured to insert and retain a pregnant woman in the vagina in the form of an obstetric pessary. Device is equipped with a cervical closure connected to the body and comprising an annular element located in the uterine opening and configured to change its diameter around the uterine cervix.EFFECT: use of the invention enables non-invasive methods to close the uterine cervix of a pregnant woman in a given range virtually regardless of anatomical features and dimensions of the corresponding organs of the pregnant woman.4 cl, 4 dwg

Description

The proposed device belongs to the field of medicine and can be used in the treatment of pregnant women with isthmic-cervical insufficiency (ICI).

Premature birth remains one of the most important problems of modern obstetrics, its frequency has remained constant for 25 years. Perinatal losses among premature babies of different gestational age (60-70%) play a leading role among all obstetric losses. Surviving premature babies develop serious complications in the near future.

Despite the huge list of risk factors for miscarriage and preterm birth, proven predictors of a real threat are fetal fibronectin and short cervix. Moreover, it has been known and proven for a long time that the earlier the neck is shortened, the earlier premature birth occurs. Isthmic-cervical insufficiency is recognized as one of the main reasons for termination of pregnancy in the period of 16-28 weeks. It should be noted that the frequency of this pathology in the general population of pregnant women is 15-20%, and among women with recurrent miscarriage - 18-37%.

One of the known effective methods of treating ICI was a surgical - vaginal suture / cerclage (suture according to Mc Donald, according to Shirodkar, etc.).

However, the surgical - vaginal - suture is an invasive traumatic procedure with many medical contraindications.

At the same time, this procedure requires hospitalization of a pregnant woman, general anesthesia in the process of its implementation, which are economically costly methods.

Among the non-invasive means of correction and treatment of ICI, the use of special devices - obstetric pessaries - is known.

Such devices, in particular, include obstetric unloading pessaries (model "Juno"), silicone cervical pessaries manufactured by MP "Simurg" (www.simurg-mp.com), and Dr. Arabin (Germany), obstetric pessaries for utility model patents No. 142309, No. 143777, 180154, etc.

Known obstetric unloading pessaries are characterized by the presence of a housing capable of being installed and retained in the vagina of a pregnant woman, and having a central opening for the cervix.

The purpose of using obstetric pessaries, in particular, is to reduce the load on the insolvent neck due to the displacement of the pressure of the ovum; partial redistribution of intrauterine pressure to the anterior wall of the uterus due to the ventral-oblique location of the pessary; physiological sacralization of the cervix due to fixation in the posteriorly displaced central opening of the obstetric pessary; closure of the cervix with the walls of the central opening of the pessary.

At the same time, the known designs of pessaries differ, in particular, in the shape of the body (for example, in the form of a ring, cup-shaped, etc.) and its standard sizes, as well as in the type of material used.

For example, the body of an obstetric unloading pessary (model "Juno") from MP "Simurg" (www.simurg-mp.com) has a trapezoidal shape with concave sides and rounded corners, a central opening for the cervix and additional openings in the corners. Pessaries are available in three standard sizes and mainly in two materials: ultra-pure, biologically inert high-pressure polyethylene and elastic biological inert silicone.

However, the practice of using obstetric unloading pessaries, and in particular the described pessaries of the MP "Simurg" company (model "Juno"), showed that their effectiveness in preventing premature cervical dilatation in a pregnant woman is rather low. In particular, the central opening of the body of the pessary, the walls of which are designed to close the cervix, has a constant diameter, which does not allow for a tight girth of the neck of the mark with the walls of the body along the perimeter of the central opening, as well as to provide an individual fit of such a device, taking into account various anatomical features of pregnant women. Accordingly, the walls of the central opening of such a pessary cannot provide effective cervical closure to a predetermined value in the majority of pregnant women with ICI, and, as a result, effective treatment of pregnant women with ICI.

At the same time, in the process of using such devices, there is no possibility of correcting the degree of cervical closure with one device, which also negatively affects the effectiveness of treatment of pregnant women with ICI.

In addition, this device is not universal, that is, several standard sizes are required for selection depending on the physiological characteristics of a pregnant woman.

In addition, the described unloading pessary is poorly retained in the vagina when ICI is combined with prolapse of the vaginal walls. During the use of the obstetric unloading pessary, the appearance of abundant reactive leucorrhoea in a woman, soreness during the introduction and removal of the pessary, and psychological discomfort due to the relative rigidity of the plastic model are noted.

Known accepted as a prototype obstetric pessary cervical perforated, produced by ZAO Medical Enterprise Simurg (https: //medlabrus.ra/catalog/detail/pessariy-silikonovyy-tservikalnyy-perforirovannyy/).

The obstetric pessary has a concave bowl-shaped body with a central opening for the cervix and several lateral small openings designed to drain secretions from the vaginal vaults. The pessary is made of flexible silicone and is available in two standard sizes of the central hole diameters: 32 and 35 mm.

Due to the use of a softer material (in particular, flexible silicone) and a bowl-shaped shape, a well-chosen pessary does not cause discomfort to a pregnant woman during use and practically does not feel it, but at the same time provides reliable support for the uterus. The presence of perforations in the form of lateral small holes provides a better outflow of fluid with increased vaginal secretion.

However, this device, like the previously described obstetric unloading pessary of the Juno model, showed a rather low efficiency in preventing premature cervical dilatation in a pregnant woman, largely for the reasons described above, which are characteristic of known models of obstetric pessaries.

In particular, the central opening of the pessary body, the walls of which are designed to close the cervix, has a constant diameter, which does not allow for a tight girth of the neck of the mark with the walls of the body inside the central opening, as well as individual adjustment of such a device, taking into account various anatomical features of pregnant women. Accordingly, the walls of the central foramen cannot provide effective closure of the cervix to a predetermined value for a large number of pregnant women with ICI. Especially, such devices are not effective on the short and ultra-short (vaginal portion less than 18 mm) cervix and on the conical and subconical cervix.

At the same time, in the process of using such devices, there is no possibility of correcting the degree of cervical closure with one device.

In addition, this device, as described earlier, is not universal, that is, several standard sizes are required for selection, depending on the physiological characteristics of a pregnant woman.

The present invention is based on the task of creating a device that allows non-invasive methods to close the cervix of a pregnant woman in a predetermined range practically regardless of the anatomical features and sizes of the corresponding organs of the pregnant woman, and thereby increase the efficiency of the device for preventing premature dilatation of the cervix in a pregnant woman, and also to increase its versatility in the process of use.

The problem is solved in that a device for preventing premature dilatation of the cervix in a pregnant woman, comprising a housing with an opening for the cervix, made with the possibility of installing and holding in the vagina of a pregnant woman in the form of an obstetric pessary, according to the invention, it is equipped with a means of closing the cervix, connected to the body containing the annular element located in the opening for the cervix with the possibility of changing its diameter around the cervix.

Closure of the cervix with a means that covers the cervix with the possibility of changing its diameter is a non-invasive analogue of an effective surgical circular suture on the cervix.

At the same time, the possibility of changing the diameter of the means that closes the cervix of the uterus allows individual adjustment of this device to the anatomical features of a pregnant woman, and thereby effectively use the proposed device of one standard size for a wide range of pregnant women requiring correction and treatment of ICI, including with a short cervix the uterus and with the conical and subconical cervix.

At the same time, the studies carried out by the author showed that with a simple non-invasive tightening of the cervix with any material, for example, a surgical thread without a surgical suture, the thread (or other material) slides from the cervix during the woman's movement.

Fastening of the means for closing the cervix on the body, made with the possibility of holding in the vagina of a pregnant woman, ensures that this means is held on the cervix and the cervix is fixed in a predetermined position.

At the same time, the combination of an analogue of a non-invasive surgical suture provided by an annular element and the presence of an obstetric pessary providing redistribution of the intrauterine pressure of a pregnant woman, together give a high efficiency of the proposed device for preventing premature cervical dilatation in a pregnant woman.

It is advisable that said means comprise holders of the annular element inside the opening of the housing, fixed to the housing along the perimeter of its opening and a locking mechanism configured to hold said ring element in a predetermined position.

The studies carried out by the author have shown that the above design allows you to reliably close the cervix by tightening an annular element around it and fix the cervix of a pregnant woman in a given position.

In this case, the diameter of the annular element can be easily adjusted and / or changed by tightening and or loosening the element itself or its ends and fixing its position on the cervix with a locking mechanism.

The proposed embodiment of the means for closing the cervix is quite cheap and simple to implement.

It is advisable that the annular element is made of medical tape, and the holders of the annular element are in the form of elastic loops attached to the body along the perimeter of the opening for the cervix.

In this case, it is also advisable to use a silicone obstetric cervical pessary as a body, made with the possibility of redistributing the intrauterine pressure of a pregnant woman.

The studies carried out by the author have shown that in the proposed version of the device, the medical tape reliably tightens and fixes the cervix in a given position. The soft material of the medical strap and loops ensure the comfortable portability of the device by the pregnant woman with the least risk of pressure sores and other complications.

At the same time, the combination of an analogue of a non-invasive surgical suture, provided by tightening a medical tape around the cervix, and the presence of an obstetric pessary that redistributes the intrauterine pressure of a pregnant woman, together give a high efficiency of the proposed device for preventing premature cervical dilatation in a pregnant woman.

In the future, the alleged invention will be disclosed in more detail on specific examples of its implementation with reference to the drawings, which depict:

FIG. 1 - a device for preventing premature dilatation of the cervix in a pregnant woman with a body in the form of a bowl-shaped obstetric pessary, front view;

FIG. 2 - a device for preventing premature disclosure of the cervix in a pregnant woman with a body in the form of an obstetric pessary in the shape of a bowl, side view;

FIG. 3 - an embodiment of the device with a body in the form of a trapezoidal unloading pessary;

FIG. 4 shows an embodiment of a device with a body in the form of a ring.

Shown in FIG. 1, Fig. 2, a device for preventing premature disclosure of the cervix in a pregnant woman contains a housing 1 with an opening 11 for the cervix (not shown), configured to be installed and held in the vagina of a pregnant woman, a means 2 for closing the cervix, fixed on the housing 1 in the opening 11 for the cervix uterus. Said means 2 in the device embodiments shown in FIG. 1- FIG. 4., serves as a means of closing the cervix.

Various designs of the housing 1 of the device are possible. An obstetric pessary made of flexible silicone, made with the possibility of redistributing the intrauterine pressure of a pregnant woman, can be used as a body.

For example, as shown in FIG. 1, Fig. 2, the body 1 is made in the form of an obstetric pessary in the form of a bowl with a large central opening 11 for the cervix and several side small openings 12 intended for the outflow of secretions from the vaginal vaults. The shape of the body 1 and the material of its manufacture can be, for example, similar to the cervical perforated obstetric pessary of the company ZAO Medical Enterprise Simurg (https: //medlabrus.ra/catalog/detail/pessariy-silikonovyy-tservikalnyy-perforirovannyy/).

FIG. 3 and FIG. 4 shows embodiments of the device with housings of a different shape.

FIG. 3 shows a device with a body 1 in the form of a trapezoidal obstetric unloading pessary with concave sides and rounded corners, a central hole and additional holes in the corners. In particular, the body can be made similar to the known unloading pessary of the company MP "Simurg".

FIG. 4 shows a device with a body 1 in the form of a ring. For example, known pessaries - rings can be used.

In a preferred embodiment, the means 2 for closing the cervix contains an annular element 21 made of medical material, located in the opening 11 of the housing 1 along its perimeter with the possibility (when installed) of covering the cervix with a change in its diameter by tightening the said annular element 21 around the cervix ... To facilitate tightening, the annular element 21 has free ends 22. The annular element 21 is pulled through the holders 23 inside the opening 11 of the housing 1, fixed on the housing 1 along the perimeter of its opening 11. To fix the given diameter of the ring element 21, the means 2 for closing the cervix contains a locking mechanism 24 configured to hold said annular element 21 in a predetermined position.

In this case, in a preferred embodiment, the opening 11 for the cervix on the body 1 has a larger diameter of 3-5 mm than in the known obstetric pessaries produced.

The annular element 21 can preferably be made of a tape made of medical polyester.

It is possible to use another material acceptable in medicine, for example, such as a medical thread, or medical thread in a silicone braid to exclude the cutting moment, medical wire, silicone cord.

In a preferred embodiment, the holders 23 of the annular element 21 are made in the form of a set of silicone loops attached to the body 1, for example, in the slots 13 made on the body 1 along the perimeter of the central hole 11.

The described embodiment of the cervical closure means 2 is applicable to all shown embodiments of the housing 1.

A different design of the annular element and its holders is possible, for example in the form of an elastic ring with holders in the form of hooks or otherwise.

A different design of the holders 23 and their attachment to the body is possible, for example, the holders can be integral with the body, etc.

The locking mechanism 24 can be made of silicone and have a known design, for example, in the form of a plastic retainer for two cords, used in the garment industry, for example, in clothing (https://www.wellmart-msk.ru/catalog/fiksatory-plastikovye . html).

It is possible to implement the specified means 2 for closing the cervix without a locking mechanism 24. In this case, the holding of the annular element 21 in a given position around the cervix can be carried out by tying its ends 22 into a knot. However, this complicates the process of regulating the diameter of the annular element 21 and, accordingly, the degree of its tightening around the cervix, in particular strengthening or weakening the closure of the cervix.

A different embodiment of said means 2 is possible, for example, it can be a continuation of the body in the region of the central opening.

In the assembled form of the device, the annular element 21 in the form of a tape is pulled through the loops of the holders 23 and a locking mechanism 24 is threaded through the ends 22 of the tape of the annular element 21. The diameter of the annular element 21 is decreased or increased by moving the locking mechanism 24 along its ends 22.

The choice of the device design, namely the device body and its geometric dimensions, for example, the diameter of the central hole, depends on the anatomical features of the woman. In particular, the body of the cup-shaped cervical pessary is advisable to use in cases of ICI in primiparous women with a conical and subconical cervix; in cases of a combination of ICI and prolapse of the vaginal walls of one degree or another, with different sizes of the vaginal vaults, deformation of the bone pelvis. The same conditions apply for the ring pessary (Fig. 3). In obstetric situations, when the risks of termination of pregnancy are associated with a large intrauterine volume and pressure, that is, the risks are determined by a large force effect on the lower segment and the internal os of the cervix, it is advisable to use the trapezoidal corpus (Fig. 4) of the obstetric unloading pessary (with multiple pregnancies, polyhydramnios, etc.) etc.).

The proposed device for preventing premature cervical dilatation in a pregnant woman is recommended to be used under the following conditions:

- confirmation of the presence of ICI and / or short neck syndrome clinically and by ultrasound examination of the parameters of the cervix in a pregnant woman;

- the consent of the patient;

- absence of signs of infection of the urogenital tract, confirmed bacterioscopically and bacteriologically;

- lack of clinical signs of threatened abortion (pain, increased uterine tone);

- when the device is inserted, the gestational age must be at least 13 and no more than 30 weeks.

With a history of isthmic-cervical insufficiency (late miscarriage or premature birth up to 30 weeks; prolapse of the fetal bladder; suture on the cervix in a previous pregnancy), the device can be inserted from 13-14 weeks of pregnancy.

Below is an example of the installation method for the proposed device.

The device can be installed by a pregnant woman, both in inpatient and outpatient settings, by a trained physician. The insertion and removal of the device does not require anesthesia and special instrumentation, it is quite easily tolerated by patients.

Under aseptic conditions, when the bladder is emptied, the woman is examined in mirrors with concomitant treatment of the genital tract with an antiseptic solution (for example, chlohexidine). The area of the entrance to the vagina is lubricated with a small amount of any ointment approved for use in obstetric practice. Further, the body 1 of the device is compressed and, in a compressed state, is inserted into the vagina along its back wall. Then the body 1 is turned vertically so that its smaller diameter (opening 11) faces the vaginal vaults, and the cervix is located in its central opening 11 and the annular element 21 of the proposed device. Then fingers press on the edge of the body 1, further fixing the neck. Next, a spoon-shaped mirror and a lift are introduced, exposing the fixed neck in the mirrors, and with a forceps or fingers tighten the annular element 21 around the cervix to the desired diameter, moving the locking mechanism 24 along the ends 22. As a rule, the diameter of the tightening of the cervix is less than the diameter of the central opening 11 of the housing 1 by 5-8 mm.

In this case, the annular element 21, tightened around the cervix to a predetermined size, is a non-invasive analogue of a surgical suture, which has shown its high efficiency in preventing premature cervical dilatation in a pregnant woman.

The attachment of the annular element 21 to the housing 1, made with the possibility of holding a pregnant woman in the vagina, ensures reliable fixation and retention of the annular element 21 on the cervix during use.

At the same time, the combination of an analogue of a non-invasive surgical suture, provided by tightening the medical tape around the cervix, and the presence of an obstetric pessary, which ensures the redistribution of intrauterine pressure of a pregnant woman, together give a high efficiency of the proposed device for preventing premature cervical dilatation in a pregnant woman.

In a variant of the device without a locking mechanism, the annular element 21 is fixed in a predetermined position by tying the ends 22 of the annular element with a surgical knot.

Further, in the process of using the device when performing dynamic cervicometry, the state of the cervix is assessed by ultrasound, the length of the closed part, the presence of a funnel-shaped internal pharynx. With negative dynamics (an increase in the depth and width of the internal os), it is possible to tighten the ring element 21 around the cervix to a smaller diameter. And, conversely, when viewed in mirrors, with the appearance of signs of cervical edema, a high risk of pressure ulcers and necrosis of the cervix, it is possible to weaken the degree of tightening of the annular element 21 around the cervix, using the movement of the locking mechanism 24 at the ends 22 of the annular element 21. Thus, the proposed the device allows you to adapt the degree of closure of the cervix to the patient's condition during the development of pregnancy, as well as to use a device of the same standard size with different anatomical features of pregnant women.

The device is removed in a planned manner upon reaching the full-term gestational age (37/38 weeks) The extraction technique is the reverse of the introduction (the locking mechanism 24 is moved, loosening the tightening of the ring element 21, or the ring element 21 is cut in any convenient place, then the body 1 is removed).

The device is removed ahead of schedule in situations requiring emergency delivery, premature rupture of amniotic fluid, development of labor, progressive cervical edema, severe cervicitis and colpitis not amenable to pharmacological correction, development of chorioamnionitis.

The above examples of the preferred implementation of the invention, containing indications of individual embodiments, do not exhaust possible changes and additions obvious to a person skilled in the art, which do not affect the essence of the technical solution described by the claims.

Claims (4)

1. A device for preventing premature disclosure of the cervix in a pregnant woman, comprising a housing with an opening for the cervix, adapted to be installed and held in the vagina of a pregnant woman in the form of an obstetric pessary, characterized in that it is provided with a means for closing the cervix connected to the housing and containing an annular element located in the opening for the cervix and made with the possibility of changing its diameter around the cervix. 2. The device according to claim. 1, characterized in that said means comprises holders of the annular element, fixed on the body along the perimeter of its opening. 3. A device according to claim 1, characterized in that said means comprises a locking mechanism adapted to hold said annular element in a predetermined position. 4. The device according to claim 1, characterized in that the annular element is made of a medical polyester tape, and the holders of the annular element are made in the form of elastic loops attached to the body along the perimeter of the body opening.

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