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OBSTETRICS AND GYNECOLOGY

INVENTION
Patent of the Russian Federation RU2214190

METHOD AND DEVICE FOR PREVENTING PREGNANCY

METHOD AND DEVICE FOR PREVENTING PREGNANCY

The name of the inventor: Zhukovsky Yakov Grigorievich
The name of the patent holder: Zhukovsky Yakov Grigorievich
Address for correspondence: 125009, Moscow, PO Box 184, for the PPF "YUS", Pat. S.M. Kochemazov
Date of commencement of the patent: 2001.07.27

The invention relates to medicine, in particular to obstetrics and gynecology, and relates to means and methods of abortion at an early stage, within 49 days of amenorrhoea, which, in the 28-day menstrual cycle, limits the period to 21 days of delay in another unsuccessful menses. The method is that the effect on the decidual envelope leading to damage to the fetal egg is carried out by inserting into the uterus a source of thermal action that provides heating of the decidua and fetal eggs to a temperature of at least 43.0 ° C and not more than 55.0 ° C C. This method and device provide an opportunity to interrupt uterine pregnancy, from the moment of its establishment, already in the first week of menstruation delay.

DESCRIPTION OF THE INVENTION

The invention relates to medicine, in particular to obstetrics and gynecology, and relates to means and methods of abortion at an early stage, within 49 days of amenorrhoea, which, in the 28-day menstrual cycle, limits the period to 21 days of delay in another unsuccessful menses.

There is a known method of abortion, which involves medication by administering the drug mifepristone (mifegin, RU 486) (VG Abashin, TV Kuznetsova, AS Petrosyan, et al., Interruption of pregnancy in The first trimester with the drug Mifegin, "Obstetrics and Gynecology", 6, 2000, p.40, 41). This medication indirectly through the whole body (because it is taken orally) has an antiprogestronic effect, as it competitively binds to the receptors of progesterone in the uterus and thereby blocks the action of natural progesterone on the uterus, which leads to the termination of pregnancy.

Among the shortcomings of RU 486, it should be noted that its molecule, along with antiprogesterone, has an antiglucocorticoid action, in a ratio of 5: 3, which can be considered as a side effect, The effect on the adrenal gland with abortion is meaningless.

By itself RU 486 as an inducer of abortion is ineffective and only in combination with prostaglandins, which are prescribed after 36-48 hours, it is possible to achieve satisfactory results.

This is due to the fact that RU 486 acts only on the uterus and the decidual membrane, depriving them of progesterone support, but does not directly affect the embryo. In some cases, after ingestion of RU 486, the embryo retains its connection with the uterine wall, and sometimes the viability.

This explains the cases of increased blood loss when expelling the products of conception in the process of medical abortion, and sometimes there is a need for instrumental emptying of the uterine cavity. And there are cases of progression of pregnancy after the completion of the full scheme of medical abortion: reception of RU 486 and prostaglandins.

In addition, the application of RU 486 is approved only in several countries, and the price of the dose required for one abortion is $ 120 in Russia.

The closest to the described method is the method of aborting a pregnancy, including an intrauterine effect on the decidual envelope, resulting in damage to the fetal egg (RU 2145809, A 61 B 17/42, 27.02.2000). The method involves introducing into the uterine cavity a means containing a plastic base on which a layer of copper is placed. The working surface of the copper layer is not less than 400 mm 2 . With this method of abortion, there is a local, within the uterus, embryotoxic effect of copper ions, leading to the termination of pregnancy. After termination of pregnancy, the plastic base with the copper on it is removed from the uterus. However, this method has some limitations in the use, in particular in patients with an allergic reaction to copper, and its efficacy is less than 80%.

SUMMARY OF THE INVENTION

It is an object of the present invention to provide a method and device for aborting a pregnancy that has a high efficacy (more than 98%) and excludes hormonal and chemical effects on a woman's body.

As a result of this task, it is possible to obtain technical results that allow the interruption of uterine pregnancy, starting from the moment of its establishment (already in the first week of menstruation delay), the abortion trauma is significantly reduced, since a lethal, targeted effect on the embryo and decidual envelope Is achieved within a few minutes by the intrauterine effect of a physical factor without the expansion of the cervical canal and disruption of the integrity of the decidual membrane, the duration of rejection and ejection of the fetal egg and decidual membrane is reduced, which is accompanied by much less blood loss.

These technical results are achieved by the fact that in a method of aborting a pregnancy involving an intrauterine effect on the decidual membrane leading to damage to the fetal egg, the effect on the decidual envelope leading to damage to the fetal egg is accomplished by inserting into the uterus a source of thermal action that provides heating of the decidua And fetal eggs to a temperature of at least 43.0 ° C.

The method is realized by means of a device for aborting a pregnancy containing a catheter at the distal end of which a balloon is made of an elastic material, the balloon cavity being communicated with a pressure source, and the bulb is configured to heat its outer surface to a temperature of 43.0 to 55.0 ° C .

A distinctive feature of the method is that the effect on the decidual envelope, leading to damage to the fetal egg, is carried out by thermal exposure. To do this, a catheter is inserted into the uterine cavity, the elastic balloon of which, after being fed into its cavity of pressure, is straightened and directly in contact with the decidual membrane covering the walls of the uterus and the fetal egg. The heated outer surface of the elastic balloon raises the temperature of the fetal egg and decidua. The temperature of the outer surface of the elastic balloon is chosen to be at least 43.0 ° C, since a lower temperature value is not lethal to the embryo.

If the trophoblast is deliberately damaged along with the decidua, with simultaneous thrombosis of the vessels feeding these formations and subsequent rejection of the products of conception from the walls of the uterus, their expulsion from the cavity is faster, easier, painless and with much less blood loss, in a large percentage of cases spontaneously, without Administration of prostaglandins.

An additional positive moment of intrauterine thermal exposure is the antimicrobial effect, since practically all microorganisms parasitizing in the genital tract of a woman die at a temperature above 43.0 ° C.

It is advisable not to increase the temperature of heating of the heat source more than 55 o C to limit the damaging effect only by the decidual membrane and the trophoblast.

For heat exposure to the fetal egg and the decidual membrane, a heat source is used, which is injected into the uterine cavity. For this purpose, a device for aborting a pregnancy that contains a catheter is used, at the distal end of which a balloon of elastic material is placed. The internal cavity of the balloon is communicated with a pressure source, by means of which the cylinder is stretched and enlarged, until the outer surface of the balloon contacts the walls of the uterine cavity. As a result, the balloon fills the uterine cavity, repeating its shape. The outer surface of the cylinder, heated to a temperature of 43.0 to 55.0 ° C, contacts the decidua, which leads to the death of the fetal egg.

It is advisable to perform a catheter with an external diameter of not more than 3.5 mm, which allows the insertion of a catheter into the uterine cavity without first expanding the cervical canal, even in nulliparous women. To ensure a tight contact between the outer surface of the balloon and the walls of the uterine cavity, it is preferable to create a pressure of 50 mm Hg in the balloon cavity. Art. Up to 200 mm Hg. At a pressure of more than 200 mm Hg. Art. There are pronounced painful sensations.

METHOD AND DEVICE FOR PREVENTING PREGNANCY

In Fig. 1 depicts an apparatus for aborting a pregnancy in its original state;
In Fig. 2 shows the device for aborting the pregnancy in the working position.

DETAILED DESCRIPTION OF THE INVENTION

The abortion device comprises a catheter 1. At the distal end of the catheter 1, a balloon 2 is provided of an elastic material, for example, a latex. The inner cavity of the balloon 2 is communicated with the pressure source 3. The cylinder 2 is configured to heat its outer surface to a temperature of at least 43.0 ° C. The outer surface of the balloon 2 is heated to the desired temperature by any known means and methods. For this purpose, for example, a heating element 4 can be placed in the cavity of the balloon 2. The supply of thermal energy to the outer surface of the balloon 2 can be effected by supplying a heated coolant to the inner cavity of the balloon or by light energy transmitted to the inner cavity of the bulb through the light guide (not Shown). As a heat source, any device that provides heating of the decidua and fetal eggs to a temperature of at least 43.0 ° C can be used.

Interruption of pregnancy is carried out as follows

After establishing the diagnosis of uterine pregnancy of early terms and the appropriate examination, the patient is introduced into the uterus cavity with the distal end of the catheter 2 in contact with the bottom of the uterus. Under the control of the manometer, sterile saline is injected into the balloon 5 until an intra-balloon pressure, for example, 150 mm Hg, is reached. Art. In this case, the outer surface of the balloon comes into direct contact with the surface of the uterine cavity. The heating element 4 is put into operation. The solution 5 and the outer surface of the balloon are heated to a temperature of at least 43.0 ° C. The expanded balloon 2 is left in the uterus cavity for at least 1 minute with its outer surface heated at least 43.0 ° C. The creation of intra-balloon pressure and heating of its outer surface can Be carried out by any known means, for example by feeding a heated gas (eg, CO 2 ) into the cylinder cavity. The volume of the balloon 2 can accommodate in the expanded state from 5 to 10 ml of liquid (gas) and is selected on the basis of the condition for filling it in the expanded state of the uterine cavity.

The heat flow from the heat source, in particular in the form of a balloon 2 provided with a heating element 4, heats the decidual shell 6, a and the fetal egg 7. As a result of increasing the temperature of the decidual envelope and fetal egg, at least 43.0 ° C occurs abortion.

The described method of abortion is illustrated by examples from clinical practice

Example 1 . The patient K., 26 years old, complained of a delay in menstruation for 19 days, i.e. On day 47 amenorrhea. In the anamnesis: one birth and one abortion. During ultrasound examination, a fetal egg with an average diameter of 17 mm was found in the uterine cavity. When gynecological examination found that the uterus is more normal, softened. Smear analysis - 11th degree of purity. Analysis of blood for syphilis, AIDS, hepatitis - negative. In aseptic conditions, a balloon catheter with a diameter of 3.5 mm is easily inserted into the uterine cavity to the bottom without a preliminary expansion of the cirvical canal. Then, 7 ml of a sterile saline solution was introduced into the catheter. At the same time, the pressure in the balloon rises to 80 mm Hg. Art. After this, the saline was heated to 44 ° C in the cylinder. This temperature was maintained in the balloon for 4 minutes. After that the heater is disconnected, the saline solution from the balloon is removed, the catheter from the uterus is removed. Substantial complaints during the procedure the patient did not show. 30 minutes after the end of the manipulation, the patient in a satisfactory condition was released home. A memo was issued to a woman about the post-abortion period and possible complications and the phone number of the doctor on duty. After 8 days at the next visit to the women's consultation, the observed reported that on day 3 after the manipulation, bloody discharge resembling menstruation began, but with a slightly higher volume of blood loss, which lasted 4 days and ended on their own. At control ultrasound examination of the fetal egg in the uterus was not detected. The methods of preventing unwanted pregnancy are discussed with the patient.

Example 2 . The female consultation was addressed by patient B., 34 years old about the termination of pregnancy. This pregnancy is the fifth. In the anamnesis: two kinds, two abortions. The patient underwent a pregnancy test with urine at home. The result is positive. The ultrasound study confirmed the diagnosis of uterine pregnancy (delay of menstruation two weeks). The duration of amenorrhea is 38 days. The necessary clinical and laboratory tests for abortion were carried out. There are no contraindications.

In the operating room, after appropriate treatment of the vulva and vagina, the cervix is ​​fixed with bullet forceps without anesthesia and the cervical canal widened to the bottom of the uterine cavity, a balloon catheter with a diameter of 3.5 mm was inserted into the cavity. According to the scheme of action of Example 1, the thermal effect on the fetal egg and decidual tissue was carried out for 5 minutes, with an intra-balloon pressure of 100 mm Hg. The same temperature regime. Discomfort during manipulations the patient did not notice. In a satisfactory condition, the woman is allowed to go home. The next day at the same time the patient came to the reception, notes the meager blood discharge from the vagina. At ultrasound examination - the fetal egg is deformed, reduced in volume, signs of detachment for 2 cm. Orally taken 400 mcg of prostaglandin misoprostol. After 2 hours there were cramping pains in the lower abdomen, bloody discharge intensified, when the toilet from the vagina dropped blood clots with tissue elements. Four hours after taking misoprostol, the pain stopped, and the bloody discharge decreased. With ultrasound, there is no fetal egg in the uterus.

A control examination is recommended after 2 weeks, in the plan, an intrauterine contraceptive is indicated.

CLAIM

1. A method for aborting a pregnancy comprising an intrauterine effect on the decidual envelope leading to damage to the fetal egg, characterized in that the effect on the decidual envelope leading to damage to the fetal egg is accomplished by inserting into the uterus a source of thermal action that provides heating of the decidual membrane and fetal Eggs to a temperature of at least 43.0 ° C and not more than 55.0 ° C.

2. A method according to claim 1, characterized in that the heating of the decidua and the fetal egg is carried out to a temperature of not more than 55.0 ° C.

3. A method according to claim 1 or 2, characterized in that, 6-24 hours after exposure to the decidual envelope leading to damage to the fetal egg, prostaglandins are taken.

4. The abortion device comprises a catheter at the end of which a balloon of elastic material is placed, the balloon cavity being in communication with the pressure source, and the container being configured to heat its outer surface to a temperature of 43.0 to 55.0 ° C.

5. The device of claim 4, wherein the outer diameter of the catheter is not more than 3.5 mm.

6. The device according to claim 4 or 5, characterized in that the pressure source is configured to pressurize the cylinder cavity from 50 to 200 mm Hg. Art.

print version
Date of publication 27.03.2007gg