RU2537779C2 - Method for local treatment of inflammatory diseases of uterine cavity and device for implementing it - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: group of inventions refers to medicine and medical equipment, namely to obstetrics and gynaecology, and can be used for the local treatment of inflammatory diseases of the uterine cavity. The method is implemented by inserting a waveguide of a presented device in a protection enclosure into the uterine cavity. A taper base of a narrow portion of the enclosure leans on an external orifice of the cervical uterus to prevent accidental perforation of the uterus. An infusion system regulator is used to set the spray supply of a therapeutic solution into an irrigation canal of the ultrasonic device. Thereafter ultrasonic vibrations are generated, and the uterine cavity is treated with the sounded therapeutic solution. The exposure length is 3-5 minutes at the ultrasonic vibration frequency of 25 kHz, infusion rate approximately 100-150 ml/min. The total infusion volume is not less than 300 ml. The ultrasonic treatment enables providing the continuous outflow of the uterine discharge. The device comprises an US generator, an acoustic assembly, the waveguide with the protection enclosure, the infusion system for the therapeutic solution supply. The acoustic assembly and waveguide comprises the irrigation canal. A working tip of the waveguide represents a short cylinder having a diameter greater than the rest portion. The irrigation canal of the waveguide has a diameter of 2 mm. The protection metal thin-wall enclosure has a crimped distal end and drain holes and represents two cylindrical elements of various diameters connected by a taper junction with milled grooves arranged so that to enable the fluid access to the working tip cylinder, the length of which makes no more than 3 mm.

EFFECT: inventions provide the effective cleansing of the uterine cavity from infected and necrotised tissues with improved comfort and safety of the procedure with using no endoscopic equipment, cervical dilation manipulations and uterine pre-probing.

2 cl, 3 dwg, 3 ex

Description

The invention relates to medicine, in particular to obstetrics and gynecology, and relates to methods and devices intended for the treatment of inflammatory diseases of the uterus, namely endometritis, postpartum and post-abortion complications.

Issues of prevention and treatment of purulent-inflammatory diseases of the internal genital organs are one of the most pressing problems of obstetric and gynecological practice.

Among various inflammatory diseases, endometritis is one of the common forms. In the structure of postpartum inflammatory diseases, endometritis accounts for 80-90%, of which up to 30% is endometritis after cesarean section. According to domestic and foreign authors, its frequency in the postpartum period is 0.4-0.8% among the total number of puerperas and 6.3-40% among patients with postpartum inflammatory diseases.

In the structure of infectious and inflammatory complications after artificial abortions, endometritis accounts for up to 30% of cases. The frequency of postabortion endometritis ranges from 1.7 to 20% of cases (Serov V.N., 2008; Magomedova Z.A., 2007). Acute endometritis after abortion, which turned into a chronic form, is 14.6-19.2% and is often the cause of subsequent reproductive disorders in young women (Melnik T.N., 2007; Jasveer V., 2007). Endometritis occurs in 12-16% of women who have terminated a pregnancy.

One of the main causes of the occurrence of endometritis after childbirth, abortion, surgery is infection of the uterine cavity in the presence of residues of the fetal egg. Infection most often penetrates the uterus in an ascending way during childbirth, abortion, intrauterine intervention, in the postpartum or postabortion periods. However, even with bacterial contamination of the uterine cavity, endometritis does not always develop. The severity and duration of the disease is largely determined by the prevalence of the process, the nature of the lesion and the type of pathogen.

When bacteria enter the blood serum and the remains of the fetal egg, the conditions of the so-called “thermostat” are created, which contributes to the rapid multiplication of microorganisms. The antibacterial therapy prescribed in these cases is not effective enough, since antibiotics from the blood do not enter the blood clots in the uterus and the remains of the ovum. Such therapy is mainly designed to prevent the spread of infection outside the uterus. The cessation of the infectious process is facilitated by the release of the uterus from infected and necrotic tissues.

Known methods for topical treatment of endometritis slightly differ from each other and consist in the mechanical or instrumental removal of infected residues of the ovum during perfusion, washing or drainage of the uterine cavity.

A known method for the diagnosis and treatment of endometritis after childbirth with the help of hysteroscopy, which allows you to clarify the variant of endometritis, the presence of residual fetal eggs, wash the uterine cavity from blood clots. In this case, solutions of furatsilin 1: 5000 or 0.5% chlorhexidine in an amount of 1-1.5 liters are used. Diagnosed residues of the fetal egg are removed, followed by careful curettage of the walls of the uterine cavity, which is a pathogenetically substantiated therapeutic measure. However, a single washing of the uterine cavity is clearly not enough in the treatment of true endometritis, since subsequent removal of wound detritus is not ensured.

A known method of treating endomyometritis by means of intrauterine lavage, which consists in introducing a catheter into the uterus, filling the uterine cavity with a medicinal solution through the catheter, ensuring the forced circulation of the medicinal solution through the sanitized uterine cavity (double-lumen catheter). However, this method requires a long time procedure. In addition, the laminar flow of the solution created during the implementation of this method does not have sufficient kinetic energy for effective rehabilitation of the uterine cavity and saturation of the endometrium with a drug substance.

A known method of treating inflammatory diseases of the female genital area and a device for its implementation, known from patent RU 2086275 C1. The method consists in introducing a medicinal solution into the uterine cavity, initially expanding the cervical canal, filling the uterine cavity with a medicinal solution through the channel of the distal part of the fiber-optic endoscope inserted into the uterine cavity, under the control of which the mouths of the fallopian tubes are sealed with obturators, after which a lattice expander is introduced instead of a fiber-optic endoscope coupled to the waveguide tool, and carry out a circular sounding of the uterine cavity through a drug solution with low energy frequency ultrasound exposure for 2-3 minutes. The infusion rate is at least 150 ml / min. A device for implementing the method comprises an acoustic unit, a trellis expander provided with a holder, a working tool in the form of a waveguide without an internal channel, a drug solution supply system and a pneumatic system for sealing the fallopian tubes. This method allows for quality sanitation of the uterine cavity, however, it has significant disadvantages, namely:

- the need for manipulations to expand the cervical canal, which increases the invasiveness of the procedure, and also slows down the process of closing the cervical canal, which occurs against the background of ongoing treatment of endometritis, aimed at stimulating involutive processes;

- the need to use endoscopic equipment increases the cost of treatment;

- the complexity of the procedure requires the involvement of highly qualified medical personnel for its implementation;

- carrying out this procedure requires a lot of time, which creates difficulties for its widespread use in clinics with a large flow of patients.

As the closest analogue of the claimed invention, a device for the treatment of inflammatory diseases of the female genital area in the form of a Gineton-MM apparatus (Ozone / NO-ultrasound treatment technologies in obstetrics and gynecology. Methodical recommendations. Omsk - 2011, p.12-19, Fig. .4), in which the cavity is rinsed with a drug solution and the cavity is supplied with a cavitated liquid through the drug solution through the drug solution, which automatically leads to sparging of the solution. The device contains an ultrasound generator (Fig. 4), an acoustic unit, a waveguide tool with a protective casing, an infusion system for supplying a medicinal solution (p.19-20). An irrigation channel is made inside the acoustic unit and the instrument waveguide with a diameter of 4.5 mm, and the working end of the instrument waveguide is made in the form of a short cylinder with a diameter slightly larger than the rest (waveguide instrument VI-17, p.16). The protective casing is made thin-walled with a sealed distal end and drainage holes (Fig. 9).

When using the claimed invention, a technical result is achieved, which consists in increasing the efficiency of the outflow of fluid from the uterine cavity during the treatment of inflammatory diseases of the uterus with “voiced” drug solutions, as well as improving the convenience and safety of this procedure due to the presence of a special protective casing with drainage holes, which performs several functions:

- protects the fabric from accidental contact and damage with an activated ultrasonic instrument;

- provides an effective outflow of fluid from the uterine cavity during the procedure (to exclude the upward spread of infection as a result of increased pressure in the uterine cavity above atmospheric pressure and the solution entering the fallopian tubes);

- allows you to safely insert an ultrasound instrument into the uterine cavity without the use of endoscopic equipment, manipulations to expand the cervical canal and preliminary sounding of the uterine cavity.

The method of local treatment of inflammatory diseases of the uterine cavity using the inventive device is claimed, in which the cavity is washed with a drug solution and cavitated liquid is supplied to the cavity through the waveguide instrument through the drug solution, characterized in that the waveguide instrument is introduced into the uterine cavity in a protective the casing, while the conical base of the narrow part of the casing is abutted in the external pharynx of the cervical canal to prevent accidental perforation of the uterus, using of the infusion system, set the jet supply of the drug solution to the irrigation channel of the ultrasonic instrument, then start the ultrasonic vibrations and treat the uterine cavity with the “voiced” drug solution for 3-5 minutes at an ultrasonic vibration frequency of 25 kHz and an infusion rate of about 100-150 ml / min, while the total volume of infusion is not less than 300 ml, during the ultrasonic treatment provide a constant outflow of contents from the uterine cavity.

A device for implementing this method is also claimed, comprising an ultrasound generator, an acoustic unit, a waveguide tool with a protective cover, an infusion system for supplying a drug solution, while inside the acoustic node and waveguide tool there is an irrigation channel, the working end of the waveguide tool is made in the form a short cylinder with a diameter larger than the rest, and the protective casing is made thin-walled with a rolled distal end and drainage holes, characterized in that irr Tool NAVIGATION waveguide channel has a diameter of 2 mm, the protective casing is a metal in the form of two cylindrical elements of different diameter, connected by a tapered transition profrezirovannymi with grooves arranged with the possibility of fluid access to the cylinder working end, whose length is not more than 3 mm.

The invention is illustrated by illustrations.

Figure 1-3 shows a device for ultrasonic treatment of the uterine cavity, where:

1 - ultrasonic generator;

2 - acoustic unit;

3 - waveguide tool:

4 - a protective casing;

5 - a system for supplying a medicinal solution;

6 - regulator of the flow rate of the drug solution;

7 - fitting of the acoustic unit;

8 - internal irrigation channel of the acoustic unit;

9 - internal irrigation channel of the waveguide tool;

10 - conical transition;

11 - the uterus;

12 - heat shrink tube;

13 - the working end of the waveguide tool (short cylinder);

14 - grooves;

15 - drainage holes.

Figure 2 shows the design of the heat shrink tube.

Figure 3 presents the design of the protective casing and the waveguide tool.

A device for the local treatment of inflammatory diseases of the uterine cavity consists of an ultrasound generator 1, an acoustic unit 2 with an ultrasound waveguide tool 3 attached to it, a protective casing 4 and a system for supplying a drug solution 5 (Figs. 1-3).

The system for supplying a drug solution 5 contains a container for a drug solution, an infusion system with a roller regulator of fluid flow 6, which is connected through a silicone element to the fitting 7 of the acoustic unit.

The acoustic unit 2 has an internal irrigation channel 8, designed to deliver fluid to the distal end of the ultrasonic waveguide tool 3, also having a channel for irrigation 9. The presence of the irrigation channel 8, passing through the loaded sections of the acoustic unit 2, allows for efficient removal of heat generated during operation and, consequently, the long-term operation of the acoustic unit without overheating at high power. The acoustic unit is sealed, which allows its sterilization by the widespread method of autoclaving.

Ultrasonic waveguides-tools 3 with an internal irrigation channel 9 of small diameter (2 mm) allow for moderate volumetric flow rates (100-150 ml / min) to obtain an increased (in comparison with instruments with holes of large diameters) flow rate of the cavitation jet, which provides better washing fibrin and necrotic tissue. In addition, with the specified diameter of the irrigation canal, it is possible to keep the outer diameter of the ultrasonic tool small. This makes it possible not only to increase the amplitude of the oscillations of the distal end of the ultrasonic waveguide tool (power of the cavitation jet, the intensity of sparging), but also to use a thin-walled protective casing 4.

The protective casing 4 is two cylindrical elements of different diameters, interconnected through a conical transition 10. The outer diameter of the narrow part of the casing (which is inserted into the cervical canal) can have a size of 7 to 4.8 mm, the length of the narrow part of the casing is 4.5 see. The protective casing dimensions given above allow the treatment of both postpartum endometritis (7 mm) and the use of this ultrasound instrument in gynecological practice (4.8 mm) without additional manipulations to expand the cervical canal and the anterior Tel'nykh sensing uterine cavity 11. To reduce injury channel when inserted therein, the distal housing portion tapers slightly ultrasonic instrument (zavaltsovyvaetsya). For the same purpose, a thin-walled fluoroplastic heat-shrinkable tube 12 can be deposited on the part of the casing introduced into the cervical canal, which increases the sliding between the casing and the walls of the cervical canal, which makes it easier to insert the instrument into the uterine cavity. Until the uterine cavity is filled with the drug, the main active factor is the cavitation stream generated by the ultrasound instrument. In the process of filling the cavity, this factor is supplemented by cavitation bubbling of fluid accumulated in the uterine cavity, which prompts the use of technical solutions that ensure maximum efficiency of bubbling. To intensify the bubbling process, it is necessary to increase the contact area of the ultrasound instrument 3 with the liquid being treated, as well as to ensure the presence of a step (transition from one diameter to another) at the distal end of the instrument for more intensive mixing of the fluid inside the cavity with acoustic flows diverging from the ultrasonic instrument. To solve this problem, the distal end of the ultrasonic waveguide-tool 3 ends with a short cylinder 13 with a length of not more than 3 mm, i.e. slightly larger diameter than the rest of it. The irrigation channel of the waveguide tool has a diameter of 2 mm, the protective casing 4 is made of metal in the form of two cylindrical elements of different diameters connected by a cone-shaped transition, with milled grooves placed with the possibility of fluid access to the cylinder of the working end, the length of which is no more than 3 mm. Due to the fact that additional grooves 14 are milled in the protective casing 4, the access of fluid in the cavity to the cylindrical part of the ultrasound instrument 13 is provided. For effective sanitation of the uterine cavity, it is necessary to ensure sufficient "pressure" of the cavitation stream. The pressure determining this pressure is set by the height of the raising of the container with the drug solution relative to the cavity. With a tight coverage of the inserted part of the casing in the cervical canal, if additional measures are not taken, the pressure in the uterine cavity can increase to a value determined by the height of the water column of the drug delivery system 5, which increases the risk of ascending infection through the fallopian tubes. To eliminate this danger, additional drainage holes 15 are provided in the protective casing 4, through which free outflow of fluid from the uterine cavity and equalizing the pressure in the cavity to, practically, atmospheric is provided.

The inventive method using the above device is as follows. Before the rehabilitation of the uterine cavity, the cervix is treated with an antiseptic solution, for example, a 0.05% aqueous solution of chlorhexidine. Then produce ultrasonic treatment of the uterine cavity. To do this, connect the acoustic unit 2 to the ultrasonic generator 1, connect the drug solution 5 system to the nozzle 7 of the acoustic unit. Then, the waveguide tool 3 is inserted into the uterine cavity through the cervical canal 3 in the protective casing 4, while the conical base 10 of the narrow part of the casing abuts into the external pharynx of the cervical canal, which prevents the possibility of accidental perforation of the uterus as a result of excessively deep insertion of the instrument into the organ cavity. Next, with the help of the regulator of the infusion system 6, a jet supply of the drug solution to the irrigation channel of the ultrasonic instrument 9 is established. After this, ultrasonic vibrations are started and the uterine cavity is treated with “voiced” drug solution for 3-5 minutes at an ultrasonic oscillation frequency of 25 kHz and the infusion rate about 100-150 ml / min, while the total volume of infusion should be at least 300 ml.

As medicinal solutions, you can use: 0.9% saline solution, including with the addition of 1% dioxidine in a ratio of 40: 1, a solution of furatsilina 1: 5000 or others.

The drug solution supplied through an ultrasonic instrument is transformed by means of ultrasonic vibrations into a directed jet of “voiced” liquid, which contains many cavitation bubbles filled with gas and / or steam. When treating the walls of the uterus with a cavitating stream, they are qualitatively cleaned of infected and necrotic tissues. After filling the treated cavity with a medicinal solution, the effect of the cavitating stream is supplemented by cavitation bubbling of the liquid. The effect of cavitation vesicles and other factors of low-frequency ultrasound on the infection site leads to the purification of the wound surface from purulent-necrotic masses, mechanical destruction of bacteria, micromassage of underlying tissues, and stimulation of reparative processes. Active chemicals formed in the "voiced" fluid have a bactericidal effect on the causative agents of wound infections and stimulate redox processes in the tissues.

In the process of ultrasonic treatment provides a constant outflow of contents from the uterine cavity. The spent fluid from the uterine cavity enters the space between the ultrasound instrument and the protective casing and flows out through the drainage holes in the casing. If the walls of the cervical canal do not tightly cover the protective casing, then the outflow of fluid also occurs along the walls of the cervical canal. At the same time, a uniform supply of fresh medicinal solution from the infusion system to the uterine cavity occurs through the internal irrigation channel of the ultrasound instrument.

After the procedure is completed, the ultrasonic oscillation generator is turned off, the drug solution is stopped from the infusion system, the ultrasound instrument in the protective case is removed from the uterine cavity, the infusion system is disconnected from the acoustic unit. The procedure is performed once a day. The duration of treatment depends on the severity of the disease and averages from 3 to 7 procedures.

According to the proposed method for the treatment of inflammatory diseases of the uterine cavity using a device for its implementation in the obstetric observatory of the Central city hospital No. 7 of Yekaterinburg, 15 people were treated with complications in the postpartum period. Of these, 5 women were admitted to the department with septic metroendometritis and 10 women with moderate to mild endometritis. Additional sanitation of the uterine cavity by the proposed device with the above exposure parameters allowed to increase the effectiveness of treatment, reduce the drug load on the patient, reduce the percentage of surgical sanitation of the uterus, reduce the duration of treatment by an average of 2-3 times (depending on the severity of the disease). Moreover, the procedure is well tolerated, comfortable and safe for the patient, does not require large time and material costs for its implementation

Example 1. Patient P. 26 years. Received in the department of postpartum infections with postpartum endometritis. Complaints of pain in the lower abdomen, bloody pus from the genital tract, weakness, fatigue. Objectively, the uterus is enlarged to 14-15 weeks of pregnancy, painful on palpation, the cervical canal passes for one finger beyond the internal pharynx, the discharge is “tomato” with a smell. Ultrasound examination showed an increase in the uterus to 154 × 108 × 112 mm, which is significantly more than the norm for the postpartum period. The uterine cavity is expanded to 38 mm. Studies on the microflora showed a massive increase in opportunistic flora (E. coli). Conducted 4 daily procedures for ultrasonic treatment of the uterine cavity with a solution of furatsilina 1: 5000. Without anesthesia and without expansion of the cervical canal, the waveguide instrument in a protective cover was inserted beyond the internal pharynx into the uterine cavity. Then, using the roller regulator of the infusion system, the drug solution was sprayed into the irrigation channel of the ultrasound instrument, ultrasonic vibrations were started, and the uterine cavity was treated with “voiced” drug solution for 3 minutes at an ultrasonic vibration frequency of 25 kHz and an infusion rate of about 100 ml / min , the total infusion volume was 300 ml of solution. The patient did not experience any discomfort during the procedure. On the first day after the end of the procedures, the pain subjectively passed, the state of health improved. Objectively, the discharge became mucous and sucrose, the uterus decreased to 7 weeks of pregnancy, the internal pharynx closed, which was confirmed by ultrasound. Sowing excreta on microflora showed the absence of bacterial growth. The patient was discharged on the 7th day. Standard antibiotic therapy in combination with physiotherapy, even after curettage of the uterine cavity against the background of hysteroscopy, leads to positive results no earlier than 7 days and postpones discharge.

Example 2. Patient C. 27 years. Transferred from the maternity hospital on the 8th day with a diagnosis of endometritis after cesarean section. Worried about pulling pains in the lower abdomen, “tomato” discharge from the genital tract with a smell, fever up to 37.8 ° C. An examination revealed an increase in the uterus up to 16 weeks. The uterus is of a soft consistency, painful on palpation, the internal pharynx of the cervix freely passes 2 examination fingers. In the analysis of a smear of leukocytes up to 70 in the field of view, the flora is coccal. In the sowing of secretions on the microflora, an abundant growth of Escherichia coli was detected. According to the result of ultrasound examination, the uterus is 162 × 82 × 144 mm, the endometrium is 19 mm, myometrium infiltration, fibrin clots. Manual vacuum aspiration of the contents of the uterine cavity was performed. Low-frequency ultrasonic treatment of the uterine cavity with a solution of furatsilina 1: 5000 was carried out 5 times daily. Without anesthesia and without expansion of the cervical canal, an ultrasonic waveguide instrument in a protective case was inserted beyond the internal pharynx into the uterine cavity. Then, using the roller regulator of the infusion system, the drug solution was sprayed into the irrigation channel of the ultrasound instrument, ultrasonic vibrations were started, and the uterine cavity was treated with “voiced” drug solution for 3 minutes at an ultrasonic vibration frequency of 25 kHz and an infusion rate of about 100 ml / min . The patient noted the sensations during the procedure as comfortable. On the third day from the beginning of the procedures, the pain subjectively decreased, the state of health improved. Objectively, the temperature returned to normal, the discharge became red, the uterus decreased to 10 weeks of pregnancy, the internal pharynx closed. On the 7th day, the uterus decreased, its cavity closed, which was confirmed by ultrasound. The patient was discharged on the 9th day. Endometritis after cesarean section is a serious complication and can lead to organ removal. The average treatment time for this pathology is 21 days. Thus, the use of this treatment technique significantly reduces the treatment time for patients with endometritis.

Example 3. Patient K., 37 years old. Received from the maternity hospital on the 4th day after spontaneous delivery with a diagnosis of postpartum septic endometritis. Concerned about pain in the lower abdomen, spotting from the genital tract, weakness. Objectively: the uterus is enlarged up to 12 weeks, soft, the internal pharynx passes the tip of the finger. Inoculation of the discharge on the microflora revealed an abundant growth of enterococcus feces. Ultrasound examination showed an increase in the uterus of 125 × 85 × 105 mm, the endometrium was thickened to 22 mm, a large amount of fibrin. Conducted 3 procedures for low-frequency ultrasonic treatment of the uterine cavity according to the above method with a solution of furatsilina 1: 5000. By the end of the treatment, all subjective sensations passed. Ultrasound monitoring performed on the 5th day confirmed the reduction of the uterus to normal sizes, the endometrium became homogeneous, the uterine cavity closed. Thus, the use of ultrasonic treatment of the uterine cavity with antiseptic solutions for endometritis leads to a significant reduction in the treatment time, reduces the likelihood of an increase in the inflammatory process and the need for subsequent surgical treatment of a woman.

Claims (2)

1. A method for the local treatment of inflammatory diseases of the uterine cavity, in which the cavity is rinsed with a drug solution and the cavitated liquid is supplied to the cavity through the waveguide instrument through a drug solution, characterized in that the exposure is carried out using the device according to claim 2, through the cervical canal into the cavity the uterus introduces the waveguide-tool in the protective casing, while the conical base of the narrow part of the casing is abutted in the external pharynx of the cervical canal to prevent accidental perforation of the uterus, using the regulator of the infusion system, establish a jet supply of the drug solution to the irrigation channel of the ultrasound instrument, then start ultrasonic vibrations and treat the uterine cavity with “voiced” drug solution for 3-5 minutes at an ultrasonic oscillation frequency of 25 kHz and an infusion rate of about 100 150 ml / min, while the total volume of infusion is not less than 300 ml, during the ultrasonic treatment provide a constant outflow of contents from the uterine cavity. 2. The device for implementing the method according to claim 1, containing an ultrasound generator, an acoustic unit, a waveguide tool with a protective cover, an infusion system for supplying a drug solution, while inside the acoustic node and waveguide tool there is an irrigation channel, the working end of the waveguide tool made in the form of a short cylinder with a diameter larger than the rest, and the protective casing is made thin-walled with a rolled distal end and drainage holes, characterized in that the irrigation channel of the waves Water-based tool has a diameter of 2 mm, the protective casing is a metal in the form of two cylindrical elements of different diameter, connected by a tapered transition profrezirovannymi with grooves arranged with the possibility of fluid access to the cylinder working end, whose length is not more than 3 mm.

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