RU2198662C2 - Method for contraception - Google Patents

Abstract

FIELD: medicine, gynecology. SUBSTANCE: it is suggested to introduce endovaginal aerosol spray-coating onto surface of uterine cervix and that of vaginal walls from its mouth to arches. Spray-coating is carried out with aerosol's notch of ozonecontaining gas-liquid emulsion as solution of ozonized oily emulsion of "oil-in-water" type. EFFECT: higher degree of contraception. 2 dwg, 2 ex

Description

 The invention relates to medicine, namely to obstetrics and gynecology, and relates to means and methods of preventing pregnancy.

 Known methods, tools and devices aimed at preventing pregnancy associated with the use of contraceptives (see YP Prokopenko. Physiology and pathology of family life. - M .: Knowledge, 1989, 64 S.).

The most commonly used methods and means of contraception have the following indicators: degree of reliability:
- douching with chemotherapy solutions - 60-70%;
- biological calendar method - 70-75%;
- male and female condoms - 60-90%;
- intrauterine devices (IUDs) - 95-97%;
- chemical hormonal contraceptives - 90-98%;
However, the known methods and means of contraception are not without drawbacks.

 The methods of hormonal contraception, with its high efficiency, are not indifferent to health, because cause dysfunction of the ovaries. With prolonged use, this method turns into uterine bleeding, nervousness, depression. It is contraindicated in case of cardiovascular diseases, tumors of the reproductive system, diabetes mellitus, liver diseases, over the age of 35 years and smoking, neuropsychiatric diseases.

 The biological calendar method of contraception requires punctuality, constant self-monitoring and has a low degree of reliability even with punctual implementation.

 When using the IUD, with the incorrect selection of its size, as well as the errors in the method of introducing the IUD into the uterus, it is possible to expel the IUD (expulsion) and pregnancy. Often arising pain and bleeding increase the likelihood of medical indications for removal of the IUD.

 Male and female condoms reduce sexual sensations, require use at a certain stage of sexual intercourse, are prone to tearing, and can cause allergies.

 Douching with solutions of chemicals leads to a violation of the complex balance of microorganisms of the vaginal flora, often causing irritation of the vaginal mucosa and allergies. Due to frequent douching with the introduction of chemically active contraceptives, the normal, vaginal microflora are suppressed, destroyed and washed out, which provoke excessive growth of pathogenic microorganisms (anaerobic and associative microflora, etc.), which ultimately lead to dysbiosis, allergies, candidiasis, colpitis, etc. In addition, the need for immediate douching immediately after coitus causes the woman to break it during the post-orgasm period, which neurotizes the woman and reduces satisfaction from coitus.

 There is a method of contraception by endovaginal administration of contraceptive aerosols in the form of foam (see Glukhov S.A., Eidelshtein S.I. Technical equipment for aerosol therapy. - M .: Medicine, 1974, - S.97-132).

 However, due to the fact that the contraceptive aerosol in the form of a foam is administered intravaginally once a few minutes before coitus, with prolonged or intermittent sexual intercourse with long passive phases, a decrease in the concentration of the foamy spermicidal preparation in the vagina is possible (due to its partial evacuation from the vagina to time of frictions or interruption of sexual intercourse) or exhaustion of the resource of the effective effect of the drug on the sperm after ejaculation (due to its biochemical inactivation). This reduces the reliability of contraception and neurotizes a woman. Repeated use of foamy spermicidal preparations during intercourse violates hygienic conditions and a psycho-emotional mood during intercourse, stains clothes, etc., often causes irritation of the vaginal mucosa and allergies.

 Closest to the proposed one is a contraceptive method, which consists in the endovaginal aerosol administration of a spermicidal preparation containing a 2% alcohol solution of gramicidin C, a 40% solution of lactic acid, liquid paraffin and freon-12, by spraying it onto the surface of the cervix and the walls of the vagina from its mouth to the arches (see RF Patent 2088166 "Method of contraception and a device for its implementation", CL A 61 B 17/42, CL A 61 M 15/00, 1997).

 However, despite the rather high efficiency of the above method of contraception, it requires the use of a complex composition, often scarce and expensive drugs, constituting the spermicidal agent used in contraception. At the same time, in some partners, some of the medicinal substances (in the composition and during prolonged and frequent use) can cause an allergic reaction and irritation of the genital mucosa.

 The objective of the invention is the provision of high contraceptive effectiveness when used in a spermicidal composition biocompatible with the body of medicinal substances.

 In the claimed method of contraception, which consists in the endovaginal aerosol administration of a spermicidal preparation by aerosol spraying it on the surface of the cervix and the walls of the vagina from its mouth to the arches, the objective of the invention is achieved by spraying with an aerosol torch of an ozone-containing gas-liquid emulsion, which is a solution of an ozonized oil type emulsion "oil in water".

A feature of the proposed method of contraception is that when a spermicide is applied to the spermicides in the form of an aerosol ozone-gas-liquid emulsion, which is a solution of an ozonized oil emulsion, at the same time, such beneficial properties as ozone and ozone-sorting oil are realized, properties such as:
- direct: spermicidal, bactericidal, fungicidal and virucidal properties;
- anti-inflammatory, anti-allergic and detoxifying effects;
- immunomodulating effect of ozone and its derivatives, which consists in stimulating general and local immunity;
- activation of the antioxidant system of the body, normalization of the acid-base state;
- improving the rheological properties of blood and its oxygen transport function;
- a large sorption capacity of an oil solution (emulsion) that binds in a peroxide form a large amount of active oxygen and ozone derivatives (peroxide number P over 300), providing long-term and prolonged - spermicidal, anti-inflammatory, anti-allergic and detoxifying effects during and after coitus (see V. Landauer, Practical Results of Ozonized Oil Treatment, Compilation of Ozone Therapy Symposium, Baden-Baden, 1981.- P.93-98; Ozone in medicine. Proceedings of the 11th ozone world congress. San-Francisco, 1993 . - 147 p.; A positive decision on the application for the invention 98107771/13 (008420) "Method for producing ozonized oil" Otrisan "from 01/25/1999).

 The implementation, in the proposed method of contraception, of the properties of a spermicidal preparation in the form of an aerosol ozone-containing gas-liquid emulsion in the form of a solution of an ozonized oil emulsion of the oil-in-water type provides biocompatibility with the body of natural, environmentally friendly medicinal components in a spermicidal composition: ozone is an allotropic form of oxygen, refined vegetable oil, contributing on the one hand - ensuring high reliability of contraception, and on the other - eliminating irritation of the vaginal mucosa looking for allergic manifestations with coition and after it. In addition, the proposed method of contraception, which uses a spermicidal preparation in the form of an aerosol to affect spermatozoa, is characterized by its minimum consumption and practically does not affect the moisture of the vagina and the amount of vaginal contents before, during and after coitus, thereby providing emotional comfort during intercourse.

As a spermicidal preparation, a composition of medicinal substances is used, consisting of the following components:
- ozone-oxygen mixture providing direct spermicidal effect;
- a solution of an oil-in-water oil emulsion, including refined vegetable oil, such as olive oil, providing indirect spermicidal effect, emulsifying effect, aerosol formation stability, as well as adhesion of a spermicidal ozone-containing agent dissolved in the oil emulsion to the vaginal mucosa and cervix.

 The release of a spermicidal composition (without propylene) into the atmosphere and its dispersion with the formation of a torch of aerosol particles is ensured by the well-known design of pneumomechanical sawing heads screwed onto the neck of a vessel filled with an emulsion of a spermicidal preparation.

 The proposed method of contraception is carried out using the contraception device shown in figure 1, which shows a view of the device in cross section; in FIG. 2 - effect of an ozone-containing gas-liquid oil emulsion on an sperm cell with an aerosol flare.

 The main structural elements of the device for implementing the proposed method of contraception are (Fig. 1): a limiting case 1, a vaginal limiter-expander, consisting of a supporting part - a holder 2 and a perforated part 3 formed by cylindrical bars symmetrically located along the generatrix, a vessel 4 filled with spermicidal the preparation in the form of a solution of pre-ozonized oil emulsion 5. On the neck of the vessel 4 is fixed (for example, by screwing) a valve system 6 with a siphon tube 7 and a spring-loaded rod valve 8 with a perforated tube (perforation not shown) having a central hole 9. The rod valve 8 through the tube 9 is mated to a spray head 10 having a nozzle hole 11. In turn, the spray head 10 is tightly mated to the holder 2 limiter-expander, and that, in turn, through a threaded connection with the limiting case 1. The design of the device allows, when there is a need for contraception, to ensure during the introduction of the device into the vagina 12 its full expansion from the mouth to the arches with exposure of the vaginal part of the cervix 13. At the same time, the straightened vagina and its arches, as well as the exposed cervix, can be freely pollinated with the aerosol torch of the spermicidal preparation 14 (Fig. 2) created by ejecting a solution of spermicidal preparation from the vessel 4 through the valve system 6 and the nozzle hole 11 of the spray head 10 during the opening of the valve stem 8 of the valve system 6, which is carried out by simultaneously abruptly pressing the bottom of the vessel 4 and the supporting part La 2. At the same time, the spermicidal preparation aerosols can be freely supplied to the expanded mucous membrane of the vagina and vaginal part of the cervix both before and after sexual intercourse in any position of the woman (“lying”, “sitting”, “standing”, etc.), thereby ensure reliable contact of the ozone-containing spermicidal preparation with spermatozoa (sperm) 15, causing their inactivation and death.

A woman, before, during, or immediately after the end of sexual intercourse, in the supine position, providing an angle of inclination of the axis of the vaginal cavity within 70-80 ^o relative to the horizontal or in the position of "squatting", "standing", etc. ., spreads the labia and introduces the limiter-expander 2 of the contraceptive device into the vagina to a depth of 8-10 cm and brings it to the vaginal arches (Fig. 2). Supporting the device inserted into the vagina with one hand, the woman abruptly presses the finger of the same hand or the other hand on the bottom of the vessel 4 until it stops, achieving its sharp movement inside the limiting body 1. The valve system 6 coupled to the vessel 4 also moves abruptly and, resting against the bottom part of the spray head 10 is biased by a spring-loaded stem valve 8. The sharp surge of excess pressure created inside this vessel 4 causes the release of approximately 0.1-0.2 ml of a solution of spermicidal preparation 5 from vessel 4 through s the background tube 7, the cavity of the valve system 6, the perforated tube of the valve stem 8 and its central hole 9 to the nozzle outlet 11 of the spray head 10. In this case, the jet ejected through the nozzle hole 11 experiences a sharp pressure drop and “explodes” into the smallest particles forming the torch aerosol 14, which has significant kinetic energy and surface interaction energy (Gibbs energy). During the interaction of aerosol particles of a spermicidal preparation with the surface of the vaginal mucosa 12 and the vaginal part of the cervix 13, they, due to Gibbs' activated energy, adhesion of aerosol particles to the mucosa, form an ozone-containing oil film firmly bound to the mucosa. When an ozone-containing spermicidal preparation interacts with sperm 15, it implements a spermicidal effect with a high degree of reliability, which increases due to the fact that aerosol 14 reaches hard to reach areas of the vagina and is also in an activated ozone-containing aerosol form with a high concentration of ozone, which is ensured by the huge sorption ability of oily solutions. Through peroxides and ozonides, which are formed in oil under the action of ozone, simultaneously and simultaneously with spermicidal, pronounced bactericidal, fungicidal and virucidal effects are achieved in relation to various pathogenic microorganisms, including against dangerous infections, for example, viral hepatitis, HIV infection etc., as well as pronounced oxygenation of the tissues of the vagina and cervix due to the transition of active oxygen to the blood when ozonide contacts the mucous membranes of the lower genitalia (see S.P. Peretyagin et al., 1991; N.M. Lebedinsky , V.M. Zuev et al., 1992; G.V. Kornilayeva et al., 1992 and others). The last property of an ozone-containing spermicidal preparation is all the more important because it allows to stop hypoxic conditions in the tissues of the lower genital area and detoxification of vaginal contents in women suffering from colpitis and other types of inflammatory diseases, the known methods of contraception in which often cause an allergic reaction and irritation of vaginal, vulvar and etc. For one introduction of the contraceptive device into the vagina, the woman makes 3-4 aerosol sprays by pressing the bottom of the vessel 4 with sperm acid ozone-containing drug. It is possible reciprocating movement of the vaginal limiter-expander 2 in the vagina 12 (figure 2) with the implementation of 1-2 sprayings in the arch of the vagina 12, where there is, as a rule, the bulk of sperm 15 after ejaculation, the 1st spraying the middle region of the vagina 12 and the 1st spray at the entrance to the vagina 12. This ensures a sufficient concentration of the ozone-containing spermicidal preparation and its uniform distribution on the walls of the vagina and cervix. After that, the vaginal organizer-expander 2 is removed from the vagina 12. These manipulations can be carried out immediately before the coitus, during coition during a long and intermittent in time with large intervals passive phase of sexual intercourse, as well as immediately after coition.

 This method of contraception allows, along with reliable, at any phase of intercourse and after it, contraception, to reduce the risk of allergic reactions and irritations of the tissues of the vagina and vulva during contraception, as well as to ensure the prevention of sexually transmitted diseases, including especially dangerous ones ( HIV, viral hepatitis, tuberculosis, etc.).

 Example 1. Patient S., 26 years old. Before intercourse in the prone position, a pre-prepared and seasoned spermicidal preparation in the form of an ozone-containing oil emulsion of the oil-in-water type is used to insert a contraceptive device into the vagina. At the same time, the device’s limiter-expander is introduced to the entire depth of the vagina, followed by its gradual withdrawal to the outside and cyclical spraying, with a spermicidal preparation: one spray in the cervical region, one spray in the middle region of the vagina and one spray at the entrance to the vagina. After coitus in the prone position, another spermicidal preparation was sprayed in the area of the vaginal arches by introducing a vaginal limiter-expander to a depth of about 10 cm. These manipulations were carried out for six months with regular sexual intercourse (2-3 times a week). Other contraceptives have not been used. During this time of observation, the menstrual cycle is not broken, menstruation arrived on time after 28 days, menstruation moderate and painless. No features were observed. The patient noted a feeling of lightness that occurs immediately after spraying an ozone-containing spermicidal preparation, the absence of burning and irritation, and even more so allergic manifestations in the vulva, more comfortable contraception conditions compared to existing and previously used methods.

 Example 2. Patient N., 39 years old. Celebrates intense sex life with her husband, including prolonged, often interrupted sexual intercourse. Before intercourse, in the prone position, a contraceptive device filled with an ozone-containing spermicidal preparation is inserted into the vagina to the full depth. After performing one or two sprays of the spermicidal preparation in the area of the vaginal fornixes and the vaginal part of the cervix, the vaginal limiter expander was gradually withdrawn with a single spraying of the drug in the midline of the vagina, as well as in the area of its mouth. After interruption of coitus in the absence of ejaculation, before the coitus was continued, the contraceptive device was introduced into the vagina and the spermicidal preparation was sprayed once again in the middle region of the vagina, and after ejaculation in the squatting position, the device was again inserted into the vagina and the spermicidal preparation was sprayed in the vaginal fornix area . When using the proposed method using an ozone-containing contraceptive, the menstrual cycle is not broken during six months of regular sexual intercourse, menstruation came on time after 28 days, menstruation is normal. The patient noted - a sharp reduction in the first months of using an ozone-containing contraceptive drug, whitewash that previously took place, with their complete cessation in the next 3-4 months and until now, as well as the disappearance of burning and pain noted earlier in the coitus process. Also noted - the ease of implementation of the proposed method of contraception and its reliability, the absence of neurotizing factors, improved hygiene of sexual intercourse.

Claims (1)

 The method of contraception, which consists in the endovaginal aerosol administration of a spermicidal preparation by aerosol spraying it on the surface of the cervix and the walls of the vagina from its mouth to the arches, characterized in that the spraying is carried out with an aerosol torch of an ozone-containing gas-liquid emulsion, which is a solution of ozonized oil-in-water emulsion of oil type "

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