RU2412683C1 - Ozone-ultrasound apparatus for treating exudative sinusitis - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention refers to medical equipment, and concerns an apparatus for conservative treatable exudative sinusitis of various forms and aetiology. The apparatus comprises a sinus catheter accommodating a bearing case enclosing a back nasopharyngeal cylinder for blocking a nasopharynx and an inflating valve adjacent to an adapter connector of a manipulation syringe; a movable cuff placed on the bearing case and comprising a front cylinder for blocking vestibule of nose coupled with the inflating valve and the adapter connector of the front cylinder of the manipulation syringe, and a nonrigid metal rod for movable cuff hold lock, as well as a branch pipe with a working channel adjacent to the adapter connector of the working channel for the manipulation syringe. In addition, an ozone/NO-containing air mix generator is coupled through the branch pipe to an ozone/NO-containing drug substance preparation tank covered by a lid with mounted bubble flask, adapter connector for connecting the tank cavity with an excess ozone deactivator and adapter connector for prepared ozone/NO-containing drug substance intake from the tank. The working channel comprises an inserted fluoroplastic reflector tube with its working end tapered at an angle 30° to create a shield, contacting with a wave guide tool attached to an acoustic unit coupled with a low-frequency ultrasonic vibration generator.

EFFECT: invention provides more efficient sanitation of a site of infection in nasal cavities and connected sinuses.

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Description

The invention relates to medicine and medical equipment and relates to methods and devices used in otorhinolaryngology for the conservative treatment of exudative sinusitis and rhinitis of various forms and etiology.

Exudative sinusitis is one of the most common purulent-inflammatory diseases of the ENT organs. They are difficult to treat and, as a rule, require a large investment of time and the use of a large number of expensive drugs to combat anaerobic and associative pathogenic microflora, which in 70-80% of cases infect the mucous membranes of the nasal cavity and paranasal sinuses, as well as hypoxic tissue lesions infections. It is known that anaerobes and associated aerobic-anaerobic microflora in purulent-inflammatory diseases, as well as tissue hypoxia at the site of infection, are one of the main pathogenetic links in the “vicious circle” of inflammation.

Known devices that implement methods for treating biological tissues (hereinafter referred to as tissues) of the foci of infection in the treatment of exudative sinusitis, as well as drugs for influencing the foci of infection available in the arsenal of an otorhinolaryngologist [1, 2, etc.] often cannot ensure its high-quality sanitation, the maximum possible bactericidal effect on anaerobic and associative microflora, as well as stopping the effects of tissue hypoxia. The specified protracts reparative processes and significantly increases the duration of treatment of patients.

A device is known for implementing the method of ultrasonic therapy of exudative sinusitis [3], the basis of which is a device for ultrasonic treatment of the middle ear cavity [4, 5], consisting of a supply and exhaust system for supplying and discharging a drug solution in the form of a cylindrical structure with a channel in which it is installed a waveguide tool connected to an acoustic unit, as well as an ultrasonic generator. The device is equipped with a fitting for supplying a solution to the channel and supplying it to the infection site, as well as a discharge fitting from the channel for the “spent” solution. In this case, the working part of the device is equipped with a movable obturator-limiter of the position restricting the deep penetration of the working part during cavity scoring of the foci of infection, as well as a window for directed scoring of the foci of infection during its sanitation. The device is used after preliminary adrenalization of the nasal mucosa and aspiration of the paranasal sinuses with an antiseptic solution by creating negative pressure created, for example, by an electric suction device while voicing the mucous membrane of the nasal cavity and paranasal sinuses with low-frequency ultrasound.

However, the use of this device to implement the known method of ultrasound therapy of exudative sinusitis is not without drawbacks associated with:

- repeated reversibility due to relapses of the disease due to insufficient quality of sanitation of the focus of infection and the mucous membranes of the nasal cavities affected by it, as well as sinuses from anaerobic and associated aerobic-anaerobic microflora, which contributes to the further spread of the infectious process, its generalization or a sluggish, protracted course and chronic disease;

- high consumption and insufficient antimicrobial action of the used antiseptics and, especially, antibiotics, including expensive ones, often leading to paralysis of the ciliary epithelium of the nasal cavity;

- not providing in a single technological cycle of treatment of exudative sinusitis, the possibility of forced impregnation into the tissue of the focus of infection and the infected cavities (nasal cavity and nasopharynx) of highly active treatment agents, for example, ozone / NO-containing drugs, which promote pronounced oxygenation and stop hypoxia in areas of the focus of infection, and therefore stimulating reparative regeneration;

- the danger of a medicinal solution getting into the respiratory tract of a patient with a violation of the treatment procedure.

The closest in technical essence in relation to the proposed technical solution is a device for the conservative treatment of exudative sinusitis in the form of a "Yamik" sinus catheter, which allows the creation in the nasal cavity and paranasal sinuses of a controlled variable (intermittent) pressure of the order of + (-) 10-15 mbar [ 6]. The device comprises a supporting body, including a rear nasopharyngeal balloon blocking the nasopharynx and a valve for inflating it, coupled with an adapter for a handling syringe; a movable cuff placed on a supporting body, comprising a front balloon for blocking the vestibule of the nose, connected to a valve for inflation and an adapter for the front balloon for the manipulation syringe, and a deformable metal rod for fixing the position of the movable cuff; a nozzle with a working channel associated with the adapter of the working channel for the handling syringe. The manipulation syringe is designed to inflate the cylinders of the sinus catheter, inject the drug solution into the paranasal sinuses, and also evacuate the secretion from the paranasal sinuses.

However, this device, despite its known effectiveness in comparison with traditionally used agents for the conservative treatment of exudative sinusitis, is not without drawbacks associated with:

- insufficient quality of sanitation of the focus of infection in the nasal cavities and paranasal sinuses that are associated with them, infected with anaerobic and associated aerobic-anaerobic microflora, which leads to severe hypoxia, generalization of the process or to a sluggish, protracted course and chronicity of the disease;

- low antimicrobial effect of the used antiseptics and, especially, antibiotics with a high concentration, leading to paralysis of the ciliary epithelium of the nasal cavity;

- high consumption of antibacterial drugs, including expensive ones;

- the impossibility of providing, due to low functionality, in a single technological cycle of treatment of exudative sinusitis, complex ultrasound exposure through an intermediate highly active drug substance (for example, ozone / NO-containing drug substance) on the mucous membranes affected by the process, its forced impregnation of the drug substance in the tissue of the focus of infection and infected nasal cavities and paranasal sinuses that communicate with them, which contributes to pronounced oxygenation, relief of hypoxia in area of the focus of infection and stimulation of reparative regeneration.

The objective of the invention is to improve the quality of sanitation of the focus of infection in the nasal cavities and the sinuses that communicate with them.

The problem is achieved due to the fact that the device for the conservative treatment of exudative sinusitis, containing a sinus catheter, comprising a supporting body, comprising a posterior nasopharyngeal balloon blocking the nasopharynx and a valve for inflating it, coupled with an adapter for a manipulation syringe; a movable cuff placed on a supporting body, comprising a front balloon for blocking the vestibule of the nose, connected to a valve for inflation and an adapter for the front balloon for the manipulation syringe, and a deformable metal rod for fixing the position of the movable cuff; the nozzle with a working channel associated with the working channel adapter for the handling syringe further comprises an ozone / NO-containing air mixture generator connected to the nozzle with a container for preparing ozone / NO-containing medicinal substance having a lid with an ozone / NO- bubbler fixed to it containing air mixture, an adapter for communicating the cavity of the container with a decontaminant of excess ozone and an adapter for taking from the container of prepared ozone / NO-containing medicinal substance for manipulation a syringe, and a fluoroplastic reflector tube is led into the working channel, the working end of which is beveled at an angle of 30 ° with the formation of a protective visor, made with the possibility of contact with a waveguide-tool connected to an acoustic unit connected to a generator of low-frequency ultrasonic vibrations.

An analysis of the known technical solutions shows that at the filing date of the application for the invention, no technical solutions are known in relation to the proposed device for the conservative treatment of exudative sinusitis, which implements the ozone / NO-ultrasonic therapy of exudative sinusitis, with the above distinguishing features.

In a single technological process for ozone / NO ultrasound therapy of exudative sinusitis, the proposed device for the conservative treatment of exudative sinusitis provides exposure to the focus of infection in the nasal cavities and paranasal sinuses associated with them by a complex of physical and physicochemical factors, namely controlled by variable pressure, an ozone solution / NO-containing medicinal substance, for example, ozonized physiological saline or ozonized 5-10% oil-in-water oil emulsion, infused during ozonation of ozone / NO-containing air mixture, respectively, of physiological saline or vegetable oil (olive, sunflower, etc.), as well as low-frequency ultrasound. Moreover, each of the influencing factors realizes the properties and indicators that are significant for the successful solution of the problems of the proposed technical solution:

1) the effect of controlled variable pressure on the nasal cavity and paranasal sinuses provides for the forced evacuation of pathological secretions from the paranasal sinuses into the nasal cavity and then through the pipe with a working channel into the manipulation syringe, as well as the introduction of a medicinal solution into the sinuses;

2) exposure to low-frequency ultrasound provides local high-amplitude scoring of the tissues of the infection site with low-frequency ultrasound (f = 26.5 kHz) through an intermediate solution of the drug substance, while a complex of physical and physicochemical factors is initiated in the solution (G.A. Nikolayev, V.I. .Loshchilov, 1980; V.V. Pedder, 1982 and others): cavitation, acoustic flows, alternating sound pressure, sound-capillary and sound-chemical effects, heating of the medium, etc., affecting the course of processes at the “biological tissue-fiber” interface organic solution ”, which lead to intensive circulation of the drug substance solution in the area of sounding of the focus of infection, intensification of the evacuation and drainage of pathological secretions from the sinus and nasal cavities communicating with it, high-quality sanitation of the focus of infection from the remains of necrotic masses, protein layers, pus, etc. suppression of pathogenic microflora, as well as diffusion and impregnation of a drug substance deep into the tissues and accelerate the physiological processes of their healing and regeneration;

3) the exposure to an ozone / NO-containing medicinal substance implements the therapeutic effects of exogenous ozone, ozonides and nitric oxide (NO) obtained from ozone / NO-containing air mixture generated by the Ozotron gas ozone therapy apparatus (NPP Metromed, g .Omsk), and acting on the site of infection in the form, for example, ozone / NO-containing physiological saline or ozonide / NO-containing oil emulsion of the oil-in-water type.

These ozone / NO-containing medicinal substances (in the form of intermediate medicinal solutions introduced into the nasal cavity and paranasal sinuses) affect many pathogenetic links in the manifestation of exudative sinusitis, accompanied by impaired blood and lymph circulation at the microcirculatory level, leading to diffuse hypoxia, anaerobic metabolism, the production of anaerobic and associative pathogenic microflora, the accumulation of toxic radicals, etc., which manifests itself (S. Rilling, R. Viban, 1985; V.V. Pedder et al. 1986-2008; S.P. Pe .. Etyagin, 1992; V.A.Maksimov, 1998; A.F.Vanin, 1998; A.B.Shehter et al, 1998; G.I.Klebanov, 2003, and others) in:

- initiation of local and general bactericidal, fungicidal and virucidal effects;

- activation of oxygen-dependent processes in the body, normalization of lipid peroxidation, the acid-base state and potential of the antioxidant system, leading to an increase in the deformability of red blood cells and the oxygen-transport function of the blood;

- normalization of the rheological properties of blood and lymph, vasodilation, improved microcirculation in the blood and lymph systems, vascular trophism and tissue metabolism;

- increase the synthetic activity of the body by enhancing peroxisomal oxidation and the functioning of glutathione-dependent systems that protect cells from toxins;

- correction and stimulation of the general detoxification, immunocorrecting, vasodilating, oxygenation, antihypoxic, analgesic effects, etc.

Unlike antibacterial drugs, exogenous ozone (ozonides) and nitric oxide (NO) in ozone and ozonide / NO-containing drugs used in various phase states have several important clinical benefits:

- they are azeotropic with respect to the body, i.e. behave as pure and biologically compatible substances with the body;

- their therapeutic doses do not adversely affect the body (with the exception of direct exposure to ozone in the respiratory tract);

- exclude the development of resistance to them pathogenic microflora;

- affect the bioobject regardless of the initial etiological factor that caused the disease;

- enhance oxygen utilization by tissues, stabilize cell membranes, increase the body's defenses in the fight against infection;

- correct violations of the synthesis of endogenous vasodilator nitric oxide (NO) that occurs during the inflammatory process due to depletion and deficiency of NADPH;

- are strong immunomodulators, etc .;

- have a positive effect (at the body level) on the central nervous system, endocrine, respiratory, hematopoietic, immune, other body systems, etc.

The combined effect on the nasal cavity and paranasal sinuses with controlled variable pressure, low-frequency ultrasound and an ozone / NO-containing drug leads to a sharp decrease in the level of bacterial contamination of the tissues of the focus of infection (primarily in relation to anaerobic and associative pathogenic microflora), vasodilation, impregnation and depon ozone / NO-containing medicinal substance - ozone (ozonides) and nitric oxide (NO) in the tissue of the affected area and its "forced" exogenous oxygenation and nitrogen monoxidation, which allows blocking acidosis in the inflammation focus by utilizing the elements of the inflammatory reaction, neutralizing toxic products, etc., to provide stimulation of the normalization of the sanno-genetically-potent functions of the lymphatic system in the area of the infection focus. The involvement of blood and lymph systems in the process of diffusion mass transfer through ultrasound and transport of exogenous ozone (ozonides) and nitric oxide (NO), absorbed by tissues, as well as blood and lymph systems deep into the tissues affected by the inflammatory process, allows us to consider them as the main routes for the introduction of highly active drugs substances in the body to provide targeted therapeutic effects in the treatment of exudative sinusitis. The invention is illustrated by drawings, where:

- figure 1 shows a generalized scheme for the introduction into the nasal cavity and paranasal sinuses of a solution of ozone / NO-containing medicinal substance (for example, ozone / NO-containing physiological saline or ozonide / NO-containing oil emulsion of the oil-in-water type) prepared using ozone / NO-containing air mixture generated by the Ozotron gas ozone therapy apparatus;

- figure 2 shows a generalized scheme of local ozone / NO-ultrasonic treatment of the site of infection in the nasal cavities and paranasal sinuses by sanitizing them by sounding through an intermediate solution of ozone / NO-containing medicinal substance (for example, ozone / NO-containing saline or ozonide / NO-containing oil-in-water oil emulsion);

- figure 3 shows a device for the conservative treatment of exudative sinusitis (section);

- figure 4 shows a cross section of the end of the pipe of the sinus catheter with a working channel and a fluoroplastic reflector tube installed in it, having a working end, beveled at an angle of 30 °, with a waveguide tool inserted into it (Figure 3).

A device for the conservative treatment of exudative sinusitis by their ozone / NO-ultrasound therapy contains (Figs. 1, 2, 3 and 4): a sinus catheter 1 (made of natural latex resistant to ozone), consisting of: an elastic hollow supporting body 2 ( hereinafter referred to as a supporting body 2), which includes a posterior nasopharyngeal balloon 3 (hereinafter referred to as balloon 3) of blocking the nasopharynx and a valve 4 for inflating it, coupled with an adapter 5 for a manipulating syringe 6 (temporarily attached at the stage of inflating balloon 3), a deformable metal a rye 7 with a loop at the end, providing a fixation of the position of the movable cuff 8, placed on the supporting body 2. The movable cuff 8, contains a front balloon 9 for blocking the vestibule of the nose, connected to the valve 10 for inflation, associated with the adapter 11 for the manipulation syringe 6 ( temporarily attached at the stage of inflating the front balloon 9); a pipe 12 with a working channel 13, coupled with a fluoroplastic reflector tube 14 inserted into it, the working end of which is beveled at an angle of 30 °, and an adapter 15, which is mated at different stages of treatment with both the manipulation syringe 6 and the waveguide tool 16, designed to sound the nasal cavities and paranasal sinuses.

Manipulation syringe 6 serves:

- to inflate the shell of the balloon 3 by introducing 6-12 ml of air into it or closing the shell by removing air from this balloon; before that, the manipulation syringe 6 is connected to the adapter 5 mounted on the line of the supporting body 2, and after the balloon 3 is inflated, the manipulation syringe 6 is disconnected from the adapter 5;

- to inflate the shell of the front balloon 9 on the movable cuff 8 by introducing 2-3 ml of air into it or closing the shell by removing air from this balloon; before that, the manipulation syringe 6 is connected to the adapter 11 mounted on the line of the nozzle connected to the front balloon 9, and after the front balloon 9 is inflated, the manipulation syringe 6 is disconnected from the adapter 11;

- to collect from the container 17 with a bubbler 18 the ozone / NO-containing drug substance 19 prepared therein using an ozone / NO-containing air mixture generator 20 and introducing said drug substance 19 into the nasal cavity and paranasal sinuses; wherein the handling syringe 6 is connected to an adapter 21 mounted on the cover 22 of the container 17 for preparing ozone / NO-containing drug substance 19, and it is drawn into the syringe tube;

- for introducing into the nasal cavity and paranasal sinuses through the nozzle 12 with the working channel 13, a manipulation syringe 6 connected to the adapter 15, ozone / NO-containing medicinal substance 19, previously taken from the tank 17;

- for the evacuation (if necessary) of the spent medicinal substance 19 and secretion from the paranasal sinuses and nasal cavities through the pipe 12 with the working channel 13 with a manipulation syringe 6 attached to the adapter 15.

The device is also equipped with a single-half-wave (n = 1) waveguide tool 16 made of a titanium alloy (for example, VT3-1, VT-5), having a radiating end face inclined at a 45 ° angle (a waveguide tool with a hemispherical radiating end may be used) .

The waveguide tool 16 is installed at the stage of sounding of the nasal cavities and paranasal sinuses through an adapter 15 and a nozzle 12 with a working channel 13 equipped with a fluoroplastic reflector tube 14 inserted into it, the working end of which is beveled at an angle of 30 ° with the formation of a protective peak that excludes direct contact waveguide tool 16 with the surrounding tissues of the nasal cavity. This ensures their protection against possible damaging contact interaction with them of the emitting end of the waveguide tool 16, which can cause their thermal and mechanical destruction in the field of high-amplitude low-frequency ultrasound. The indicated, on the one hand, eliminates the "swelling" of ultrasound from the waveguide tool 16 to the nozzle 12, and on the other hand, it allows providing targeted ozone / NO-ultrasonic impact on the infection site, including intense hydroflows and cavitation. The waveguide instrument 16 is connected to an acoustic unit 23 connected to a generator of low-frequency ultrasonic vibrations 24 (for example, an ultrasound otorhinolaryngological device of the Tonsillor-MM type (NPP Metromed, Omsk). An ozone / NO-containing air mixture generator 20 is connected a nozzle with a capacity of 17 for the preparation of ozone / NO-containing medicinal substance 19 in the form, for example, of ozonized physiological saline or ozonized 5-10% oil-in-water oil emulsion (use refined olive or saline oil), having a lid 22 with an ozone / NO-containing air mixture bubbler 18 fixed to it, supplied from an ozone / NO-containing air mixture generator 20, an adapter 21 for a handling syringe 6, which takes the prepared ozone / NO- solution from the container 17 containing the medicinal substance 19, as well as an adapter 25, which communicates the cavity of the container 17 with the decontaminant of excess ozone 26, which excludes the formation of increased concentrations of excess ozone unreacted with the solution 19 near the treatment area.

A device for the conservative treatment of exudative sinusitis by their ozone / NO-ultrasound therapy is used as follows. Preparing the patient for treatment is carried out according to the generally accepted method of examining a patient with diseases of the paranasal sinuses. After analyzing the examination data, treatment tactics are chosen, drugs are selected taking into account the causative agent of the disease and its drug sensitivity, the number of treatment procedures is planned taking into account the degree of damage to the nasal cavities and sinuses, as well as the duration of the disease.

Preliminarily, the sinus catheter 1 is prepared for its installation in the nasal cavity according to the instructions [7], taking into account the choice of the distance between the balloon 3 and the front balloon 9, which varies from 25 to 35 mm depending on the individual dimensions of the total nasal passage, as well as the amount of air introduced during the procedure in the specified cylinders. In a balloon 3 - for children and women inject 8 ml, and for men - 12 ml of air. The amount of air required to inflate the front balloon 9 of the movable cuff 8 is determined individually and depends on the vestibule of the nasal cavity (on average, 2-3 ml of air is introduced into it). As a result of inflating the front balloon 9, the vestibule of the nose should be tightly obturated.

Then the patient is placed in the otorhinolaryngological chair in the “sitting” position, anesthesia and anemization of the mucous membrane of the nasal cavity are carried out and its cleaning by blowing. After that, under the control of anterior rhinoscopy, the supporting body 2 of the sinus catheter 1 is inserted into the nasal cavity along the lower part of the common nasal passage parallel to the lower nasal concha until the installation of the movable cuff 8 containing the front balloon 9 in anticipation of the nasal cavity. A movable cuff 8 containing the front balloon 9 is installed by moving along the supporting body 2 in anticipation of the nose in accordance with the individual dimensions of the common nasal passage, in front of the front end of the lower turbinate. To fix the movable cuff 8 in a predetermined position, the bearing casing 2 is bayonet-shaped bent behind the movable cuff 8 due to plastic deformation of the rod 7 with a loop at the end located inside the bearing casing 2.

Next, through the adapter 5 with the valve 4 (for inflating the balloon 3), they are connected to the manipulation syringe 6 (20 ml capacity) and the balloon 3 is inflated through the nozzle of the supporting body 2 to achieve obturation of the nasopharynx, after which the manipulation syringe 6 is disconnected. Then, through the adapter 11 of the sinus catheter 1, the valve 10 (for inflating the front balloon 9) is connected to the manipulation syringe 6 and inflated through the nozzle on the line of the front balloon 9 on the movable cuff 8 to achieve a tight obturation of the vestibule of the nasal cavity, after which the manipulation syringe 6 is disconnected . This ensures the creation of an enclosed space, including the nasal cavity and paranasal sinuses.

Then, in the established sequence, the known procedures are performed [6, 7], implemented by the sinus catheter 1, associated with the evacuation of pathological secretions from the nasal cavities and paranasal sinuses, their washing, the injection of drug solutions into the tissue of the infection site, as well as the washing of the material from the nasal cavity and paranasal sinuses for research by connecting these cavities through an adapter 15, a pipe 12 with a working channel 13 with a manipulation syringe 6 that creates a controlled variable in the nasal cavity and paranasal sinuses (ne emezhayuscheesya) positive and negative pressures of the order of + (-) 10-15 mbar.

To improve the quality of the sanation of the focus of infection in the nasal cavities and sinuses communicating with them, as well as to expand the functionality of the sinus catheter 1 at the final stage of using the sinus catheter 1 (the patient is lying on his side) in the nasal cavity and paranasal sinuses using the manipulation the syringe 6, attached to the adapter 15, through the pipe 12 with the working channel 13 injected previously prepared ozone / NO-containing drug substance 19, taken from the tank 17, where it is preliminarily obtained by sparging he / NO-containing air mixture created by the ozone generator / NO-containing air mixture 20, for example ozone / NO-containing physiological saline or ozonide / NO-containing oil-in-water oil emulsion. After that, the manipulation syringe 6 is withdrawn from the nozzle 12 with the working channel 13, coupled to the fluoroplastic reflector tube 14 inserted into it, and instead the waveguide tool 16, connected to the acoustic unit 23, is introduced and the ultrasonic generator 24 is turned on. previously an intermediate solution of ozone / NO-containing medicinal substance 19 filling the confined space (between the shells of the balloon 3 and the front balloon 9 on the movable cuff 8), which includes nasal cavities and paranasal sinuses, a comp a lex of physical and physico-chemical factors: cavitation, acoustic flows, alternating sound pressure, sound capillary and sound chemical effects, heating of the medium, etc., affecting the intensification of processes at the “biological tissue - drug solution” interface, leading to the appearance of hydrodynamic flows of the solution in the region sounding the focus of infection, intensifying the processes of cleaning pathologically altered surfaces from necrotic masses, suppressing pathogenic anaerobic and associated aerobic-anaerobic microflora, inactivation of toxins, drainage of pathological secretions, the introduction of a solution of ozone / NO-containing medicinal substance 19 into the sanitized mucosa, etc. The latter is ensured by the activation in the field of high-amplitude ultrasound of a solution of ozone / NO-containing medicinal substance 19 interacting with the surfaces of the mucous membranes of the nasal and paranasal cavities sinuses, a foci of infection (mucus, pus, protein layers, toxins, pathogenic microflora, etc.), as well as tissue fluids that absorb ozone to form ozonides and produce water ozone, and after their hydrolytic cleavage with peroxides (superoxide and hydroxyl radicals, hydrogen peroxides, etc.), which have high antibacterial, fungicidal, and virucidal activity, which are highly effective catalysts that affect the lipid oxidation of cell membranes of facultative anaerobic and aerobic microorganisms of the outbreak into peroxide compounds, causing their “poisoning” with oxygen through free radicals (R. Gershman, 1954, 1978). In addition, they, influencing the processes of destruction and / or inactivation of toxins in the contents of the focus of infection, form toxoids, additionally providing anti-acidosis and bactericidal effects, normalization of enzymatic metabolic reactions.

The parameters and modes of ozone / NO-ultrasonic exposure are as follows:

- frequency of ultrasonic vibrations - 26.5 kHz;

- the amplitude of the ultrasonic vibrations of the waveguide tool is 30-80 microns;

- dubbing mode - intermittent, with a duty cycle of 2: 1 (dubbing - 5-10 s, pause - 2.5-5 s);

- total exposure to ozone / NO-ultrasonic exposure - not less than 60 s;

- the concentration of ozone in ozonized physiological saline is not less than 2 mg / l;

- the concentration of ozonides in ozonized 5-10% of the oil emulsion of the oil-in-water type is at least 100 mmol O ₂ / kg of the emulsion.

At the end of the last procedure, a manipulation syringe 6 connected to the adapter 15, through the pipe 12 with the working channel 13 fill the nasal cavity and paranasal sinuses with ozone / NO-containing medicinal substance 19 without voicing. This completes the procedure. After its completion, air is sequentially removed from the shells of the balloon 3 and the front balloon 9 on the movable cuff 8 through their respective valves 4 and 10 using a manipulation syringe 6. The sinus catheter 1 is removed from the nose.

The result of each scoring procedure is to achieve high-quality sanitation of the nasal cavities and paranasal sinuses from pathological contents, namely, to “clear waters”. Depending on the stage of the disease and the degree of activity of the pathological process, the number of alternating manipulations associated with ozone / NO-ultrasonic treatment of the infection site, subsequent evacuation of the spent solution and filling with the manipulation syringe 6 nasal cavities and paranasal sinuses with a fresh solution, carried out during one procedure, is determined the attending physician, and the total number of procedures is determined by the dynamics of the relief of the inflammatory process and can vary from 1 to 3, carried out daily. All further manipulations associated with the completion of the treatment session are carried out in the prescribed manner. Perhaps a two-stage application of the device. At the first stage, only voicing of the nasal cavities and paranasal sinuses through ozone / NO-containing medicinal substance 19 is performed until the inflammatory process subsides, and then at the second stage, joint sequential (as described above) effect on the nasal cavities and paranasal sinuses with ozone / NO-containing drug substance 19, controlled by variable pressure, and then their scoring by low-frequency ultrasound.

The proposed device for ozone / NO-ultrasonic therapy of exudative sinusitis has been tested and implemented in clinics of the departments of otorhinolaryngology of the South Kazakhstan State Medical Academy (Shymkent, Republic of Kazakhstan) and Altai State Medical University (Barnaul, Russian Federation) since 2007. 48 patients aged 18 to 42 years with acute form of exudative sinusitis - 20 patients and with exacerbation of chronic exudative sinusitis - 28 patients (of which about 70% are male, the rest are female).

After treatment using the proposed device for the conservative treatment of exudative sinusitis by performing their ozone / NO-ultrasound therapy, almost all patients showed improvement. A positive treatment result is confirmed by rhinoscopic, radiological, laboratory and functional studies carried out both during treatment and in the period immediately following treatment. The functions of respiration and smell were restored, the microbial landscape returned to normal, headaches ceased, and overall health improved. Follow-up examinations of patients conducted in the next 3-6 months did not reveal relapses of the disease, which exceeds the remission rates in patients with these forms of exudative sinusitis treated with traditional methods. Moreover, the duration of treatment of patients decreased on average by 2-2.5 times (depending on the severity, localization and severity of the inflammatory process) in the absence of relapse of the disease. This was achieved through the use of the proposed multifunctional device for the implementation of ozone / NO-ultrasonic effect on the tissues of the focus of infection of the nasal cavities and paranasal sinuses, which allows to improve the quality of their rehabilitation, to ensure pronounced oxygenation and relief of hypoxia in the nasal cavities and in the paranasal sinuses infected with them anaerobic and associative microflora, which, ultimately, helps to accelerate reparative regeneration. The device can also be used in the conservative treatment of various forms of sinusitis and rhinitis.

Information sources

1. I.A. Kyulev. Irrigation therapy of the upper respiratory tract. - M.: Medicine, 1987. - 128 p.

2. Low-frequency ultrasound in the treatment of diseases of ENT organs: Methodological recommendations / Ed. V.V. Peddera and Yu.M. Ovchinnikova. - Omsk, 1999 .-- 60 s.

3. RF patent 2195348 "Method for ultrasound therapy of exudative sinusitis" / K. I. Nesterova, I. A. Nesterov, class. A61N 7/00, A61H23 / 00, 2002.

4. Ultrasound otorhinolaryngological device "Tonsillor-2" (GKTE 943533.13.000.000TU). Developer: NPP Metromed (headed by V.V. Pedder), Omsk, 1994.

5. RF patent 2076750 "Method for processing postoperative cavities of the middle ear and device for its implementation" / V.V. Pedder, Yu.M. Ovchinnikov, V. G. Papulov, S. N. Afanasyev, class. A61N 1/30, A61H 23/00, 1997.

6. RF patent 1768141 "Device for the treatment of sinusitis" / V.S. Kozlov, G.I. Markov, class. A61B 17/12, 17/24, 1992.

7. Instructions for use of the Yamik-321 sinus catheter. Developer: LLC "Yartek Medical. Medical Catheters", Yaroslavl. / Www. yartec.ru. (prototype).

Claims (1)

A device for the conservative treatment of exudative sinusitis, comprising a sinus catheter, comprising a supporting body, comprising a posterior nasopharyngeal nasopharyngeal blocking balloon and a valve for inflating it, coupled to an adapter for a manipulation syringe; a movable cuff placed on a supporting body, comprising a front balloon for blocking the vestibule of the nose, connected to a valve for inflation and an adapter for the front balloon for the manipulation syringe, and a deformable metal rod for fixing the position of the movable cuff; a nozzle with a working channel associated with the working channel adapter for a handling syringe, characterized in that it further comprises an ozone / NO-containing air mixture generator connected to the nozzle with a container for preparing ozone / NO-containing medicinal substance having a lid with a bubbler fixed to it ozone / NO-containing air mixture, an adapter for communicating the cavity of the container with a decontaminant of excess ozone and an adapter for taking from the container of the prepared ozone / NO-containing drug exists for the manipulation of the syringe, and inserted into the working channel tube fluoroplastic-reflector, the operating end of which is chamfered at an angle of 30 ° to form a sun visor, made to be in contact with the waveguide, a tool attached to the acoustic node associated with a generator of low frequency ultrasonic vibrations.

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