A method for the treatment of external and middle ear infections and device for its implementation

 

(57) Abstract:

The invention relates to medicine and can be used for effective treatment of external and middle ear infections. The method and apparatus achieve efficiency in the treatment of purulent processes external and middle ear, stimulating the tissue and humoral immunity, regenerative processes by suppressing pathogenic flora, resulting in shortening of the duration of treatment. In the method of treatment is simultaneously affected by the laser radiation wavelength of 0.337 nm, average power of 1-5 mW and an ozone-oxygen mixture temperature corresponding to the temperature of the patient's body. The ozone concentration is 0.05-0.15 mg/m3. The flow rate of the gas mixture is 1-2 l/min Simultaneously remove waste gas mixture and pathological content. Treatment of 5-10 sessions. In the device of the laser radiation to the treatment site down through the light guide located in the nozzle. The output end of the pipe is covered by a second nozzle for supplying an ozone-oxygen mixture to the treatment site. Proven gas mixture and pathological contents are removed from the ear funnel through the side hole of the optical head. 2 S. p. f-crystals, 1 innego otitis media.

There is a method of treatment of acute and chronic suppurative otitis media by instillation of ozone-rich vegetable oil into the cavity of the middle ear, within 6-8 days (see RF patent N 2040235, class A 61 F 1/00, from 31.08.92).

The disadvantage of this method is that the oil impedes the outflow of pus from the middle ear cavity. Also, before dropping into the middle ear, the oil should be heated to body temperature of the patient, which causes decomposition and ozone, i.e., decreases its concentration and, naturally, therapeutic effect.

It is known device used for exposure of the ear of the patient by laser radiation, containing the ear hole with the lens and secured in the funnel flexible light guide through which is fed the laser radiation to the site of irradiation (see Mechaniken N. In., Tikhomirov centuries, moles Y. A., Kachaev I. M., Pedder centuries of Low-energy lasers in teatree. Novosibirsk: publishing house of Novosibirsk University, 1991, S. 56-61).

The disadvantage of this device is the lack of supply of ozone-oxygen mixture to the site of irradiation and channel removal of the waste gas mixture that does not provide effective treatment.

Known spooney cavity light helium-neon laser (see auth. St. USSR N 1165416, class A 61 N 5/06, publ. 7.07.85). The method consists in pre-anesthesia of the mucous membrane of the total nasal passage and nasopharynx with 0.5% solution dikaina by lubrication, followed by irradiation with radiation from a He-Ne laser using quartz fiber, administered through the ear catheter in the pharyngeal lumen of the mouth of the auditory tube, the exposure time of 5-10 minutes at a power density of 0.8-10 mW/cm2treatment consists of 5 treatments.

The disadvantage of this method is that it is not significant bacteriostatic effects on the microflora that does not provide the desired therapeutic effect.

Known apparatus for the treatment of recurring infections of the ear, containing the skeleton, which is the main channel for leading the laser radiation to the eardrum. The skeleton also provides an extra channel, one end of which communicates with a source of compressed air, and the other end with the main channel (see U.S. patent N 4712537, class A 61 B 1/22, publ. 1987).

The disadvantage of this apparatus is that after forming the hole in the eardrum surgical laser processing tympanic cavity only compressed wasdue closest treatment to the claimed combination of features is a method of treatment of external and otitis media by irradiating the laser wavelength of 1.06 μm, a light spot of 0.7-1.5 mm, the power density of 30-50 W/mm2and duration of 0.3-0.5 s (see ed.mon. USSR N 1465061, class A 61 N 5/06, publ. 15.03.89), adopted for the prototype.

The disadvantage of this method is low efficiency of treatment, as therapeutic effect of only the laser radiation, and to use some other effect simultaneously with the laser in this way it is impossible.

The closest device of the same purpose to the declared object on a set of attributes is a device for the treatment of external and otitis media containing the main and auxiliary lasers, radiation which through a system of mirrors is served in the ear funnel, on which are fixed optical cap, a closed lens (see U.S. patent N 4622967, class A 61 B 17/36, publ. 1986). On the side surface of the nozzle made a hole for leading the laser radiation to the treatment site. Taken as a prototype.

When the instrument auxiliary laser is used for visual inspection of the formation in the eardrum holes of the main laser. The auxiliary radiation of the laser used for irradiation and after forming the hole in the eardrum.

Nedela removal of the waste gas mixture, that does not provide effective treatment of the inflammatory process, lengthen the treatment time.

The objective of the proposed invention is a method and device for effective treatment of the outer and middle ear as well as the reduction of treatment time and increase the length of remission in chronic diseases.

The technical result that can be obtained by carrying out the method and device - the intensification of rehabilitation outer and middle ear, the activation of regenerative processes by suppressing the pathogenic flora and activation of tissue and humoral immunity of the patient.

This technical result in the treatment of external and otitis media by irradiating the laser radiation is achieved by the fact that in addition to therapeutic effects of laser radiation with a wavelength of 0.337 μm and an average power of 1-5 mW irradiated on the surface of the external and middle ear serves a gas mixture of ozone and oxygen temperature corresponding to the temperature of the patient's body, with the ozone concentration of 0.05-0.15 mg/m3during 2-25 min with a flow rate of the gas mixture 1-2 l/min, with simultaneous removal by suction of the waste gas mixture and pathological sod the device of the invention is achieved by in the device for the treatment of external and middle ear infections, ear containing a funnel, an optical attachment with a hole on the side to bring the laser radiation to the treatment site, on the side surface of the optical attachment made two additional holes, one of which serves to supply an ozone-oxygen mixture to the treatment site, and the other is to remove the spent gas mixture and pathological content, while the laser light passes through the light guide located in the pipe, the end of which is covered by another nozzle for supplying an ozone-oxygen mixture.

The implementation of two additional holes, one of which served ozone-oxygen mixture with a temperature corresponding to the temperature of the patient's body, with the ozone concentration of 0.05-0.15 mg/m3and the flow rate of the gas mixture 1-2 l/min, for 2-25 minutes provides reception of the two treatment factors: ultraviolet laser irradiation wavelength of 0.337 nm and an average power of 1-5 mW and ozone therapy. The combined effect of these therapeutic factors can significantly increase the effectiveness of treatment, to reduce the duration of treatment to obtain a positive result, uvelichenie waste gas mixture and pathological content that provides anti-inflammatory effect. Through the use of an ear funnel, duct ozone-oxygen mixture and channel removal of the waste gas mixture is possible to maintain the optimum pressure of the ozone-oxygen mixture and the concentration of ozone in the treatment place. Summary of laser radiation through the optical fiber located in the pipe, the end of which is covered by the nozzle for supplying an ozone-oxygen mixture, you can influence the location of the treatment laser radiation and ozone-oxygen mixture. In addition, due to the difference of the squares of the input and output ends of tube feeding ozone-oxygen mixture and create excessive pressure could be blasting the place of treatment, an ozone-oxygen mixture, and this gives the decrease in hypoxic tissue damage and stimulation of local immunity, atraumatic removes vibrissae overlay. The combination of ultraviolet irradiation with ozone-oxygen therapy provides a complete bactericidal and anti-inflammatory effect. Optical head and the laser ultraviolet radiation allow to visually determine the location of treatment. Channel removal of the waste gas mixture and pathological content investmet the requirement of unity of invention, because they form a single inventive concept, one of the declared objects of the group - "Device for treatment of external and middle ear" is for implementation of the Method of treatment of the outer and middle ear", in this case, both the object of the claimed group of inventions aimed at solving the same problem for a single technical result.

Conducted by the applicant's analysis of the prior art, including searching by the patent and scientific and technical information sources and identify sources that contain information about the equivalents of the claimed inventions, has allowed to establish that the applicant is not detected analogues characterized by signs, identical to all the essential features of the claimed inventions and the definition of the list of identified unique prototypes, as the most similar set of features analogues, has identified a set of essential towards perceived by the applicant to the technical result of the distinctive features in the claimed objects set forth in the claims.

Therefore, each of the objects of the claimed group of inventions to meet the requirement of "novelty" under the current Zakonodatelstva conducted an additional search of the known solutions in order to identify signs, match the distinctive features of prototypes signs of the claimed inventions, the results of which show that the claimed invention is not to follow the expert in the obvious way from the prior art because the prior art defined by the applicant, not the influence provided the essential features of each of the objects of the claimed group of inventions transformations to achieve a technical result. Therefore, the claimed invention meet the requirement of "inventive step" by applicable law.

In Fig. 1 shows a device for implementing the method of treatment of external and otitis media:

(a) shows the device in front of the incision;

b) shows the device from the top (optical lens conditionally missing).

Device for the treatment of external and middle ear contains the ear funnel 1, an optical attachment 2, on the side which made three holes 3, 4, 5. In one hole 3 is a pipe 6 with the light guide 7 for submission to the treatment area of the laser radiation. In the hole 4 is another pipe 8 for supplying the treatment area ozone-oxygen mixture. Hole 5 is used to remove trabot the m 8, employees for filing an ozone-oxygen mixture. At the end of the optical attachment 2 is closed by a lens 9. The optical fiber 7 is connected through a matching optics 10 with a source of laser radiation. The pipe 8 is connected with a hose 11 filing system ozone-oxygen mixture, and the hole 5 is connected through the hose 12 with the disposal system, the waste gas mixture and pathological content.

A method of treating external and otitis media performed in the following way. Pre-sterilized and disinfected working tool in the solution "Sidex or alcohol solution hlorgeksedina. Is objective examination of the external and middle ear of the patient to assess the patient's condition and fence separated for study. The optical fiber 7 is connected through a matching optics 10 to a source of laser radiation. The optical conduit 8 of the nozzle 2 connected through the hose 11 with feed ozone-oxygen mixture, and the aperture 5 are connected to a hose 12 to the pumping system waste gas mixture and pathological content. On an optical attachment 2 is attached removable ear funnel 1, corresponding to the size of the auricles of the patient. Are set on the basis of the characteristics of the disease treated ear, RASO content should create a negative pressure of not less than 0.5 ATM. Funnel 1 of the working tool hermetically introduced into the ear canal of the patient and directed to the most pronounced inflammation. Turns on the laser beam delivery system ozone-oxygen mixture and removal system waste gas mixture and pathological content. Simultaneously with the laser radiation wavelength of 0.337 μm and an average power of 1-5 mW, through the light guide 7 in the radiation zone is fed through a pipe 8 a mixture of ozone and oxygen temperature corresponding to the body temperature of the patient. The concentration of ozone in the mixture is 0.05-0.15 mg/m3and the flow rate of the gas mixture is equal to 1-2 l/min Processing designated treatment is performed with simultaneous removal of the through hole 5 of the waste gas mixture and pathological content. Treatment location treatment is carried out under visual control through the lens 9 and the optical nozzles 2, a move which allows you to change the direction of flow of the gas mixture and the laser radiation to a full cleanup of all departments of the outer and middle ear. The duration of the exposure processing is from 2 to 25 minutes. At the end of processing is simultaneous disabling therapeutic apparatus and odesilatele. Treatment provocatively between courses. The thickness of 1-5 mW and the exposure time 2-25 minutes specified on the basis of need not exceeding the damage threshold doses used power density of the ultraviolet radiation (see Dumin O. C., Bohlin S. M., Yakovenko, I., and Privalov, A. P., Taftan S. N. Ultraviolet laser in otorhinolaryngology. Journal of the ear, nose and throat diseases, N 1, Kiev, 1993). The value of the ozone concentration of 0.05-0.15 mg/m3in the ozone-oxygen or ozone-air environment corresponds to the maximum permissible concentrations of ozone.

Due to excess pressure and difference of squares the input 11 and output ends of the pipe 8 are generated vortical flows ozone-oxygen mixture, penetrating in all departments as the outer and middle ear, is an active clearance from pathological content, which together with the waste gas mixture is removed by suction. The impact of the two treatment factors, laser ultraviolet radiation and ozone, along with the evacuation of pathological content provides General and local incentive effects, stimulates regenerative processes, eliminate hypoxia inflamed tissue, reduces the time of treatment of the patient.

Examples, the dock is the basis of therapeutic units with the following characteristics:

the wavelength of the laser radiation is of 0.337 μm;

the average output power of the fiber - 1-5 mW;

the duration of the laser pulse of 6 NS;

the pulse frequency of the laser radiation is 1-250 Hz;

the ozone concentration is 0.05-0.15 mg/m3;

the flow rate of the gas mixture of 1-2 l/min

Device for treatment of external and otitis media allows you to connect with therapeutic setting by means of two flexible hoses and a fiber length of 1.0 m

Device for the treatment of external and middle ear infections are conducted medical research in regional clinical hospital n.a.Semashko, Ryazan. The research results gave a pronounced positive effect.

Observation I. A. Patient 72 years old, diagnosis: exacerbation of chronic suppurative operated otitis media on the left, is complicated by the limited labyrinthitis. Coronary heart disease, angina. Hypertension II Art.

History of the disease left ear since 1943 after his concussion. In 1976, produced radical surgery on the left temporal bone about acute exacerbation of chronic purulent epimastigote complicated limited labyrinthitis. Gnetaceae from the left UIE, insufflation of powders, instillation different drops, tube-quartz ear, antibiotic therapy. Gnetaceae decreased, but not completely stopped. Newly emerged "fiscalny" symptom, therefore, hospitalized in the clinic of otorhinolaryngology, RMGU them. academician I. P. Pavlov at the regional clinical hospital.N. A. Semashko.

When applying the General condition of the patient is satisfactory. When otoscopy left: trepanation cavity well contoured, large amount of granulated pus with a greenish tinge, in the region of the lateral semicircular canal friable granulation, positive fiscalny" symptom of the auditory tube is not passable. Bacteriological examination of detachable detected Pseudomonas aeruginosa and fungi of the genus Candida. On radiographs of the temporal bones of additional pathological foci no. On the audiogram hearing loss on the mixed type.

Patients received treatment by the proposed method. Produced toilet left ear 3% solution of hydrogen peroxide. Processing trepanations cavity started with the mastoid through the ear canal, as cleaning processing section, the tube was moved to the entrance of the cave, and then hermetically was recorded at the entrance of the external acoustic meatus. All manipulations were carried out under visual control through the optical head. Exposure processing each plot was 20-30 with a total duration of about 6 min, flow rate of the gas mixture of 1 l/min, the temperature of its 37oC, the laser power of 2 mW, a wavelength of 337 nm, the ozone concentration is 0.1 mg/l

Treatment the patient endured well, only in the processing region of the entrance to the cave in the projection capsules side channel was noted only slight dizziness, which took place after the end of the session.

After the first treatment session, the patient noted the "lightness" in the ear. Trepanation cavity was cleansed from abnormal discharge, granulation turned pale and fell, appeared patency of the auditory tube.

Patients received 10 sessions daily, to the third session stopped Escherichia do it daddy, and at 6 - and mushrooms. From the second session, the patient began to feel faint smell of ozone in the throat, speaking of the restoration of the patency of the auditory tube.

During treatment the patient received a multivitamin with minerals in prophylactic dosage, antihypertensive drugs according to the prescription of a physician.

The patient was discharged on the 12th day of recovery: t is otrivautsa skin, the auditory tube is freely passable.

After 2 months at the control examination: General condition of the patient was satisfactory, no complaints, trepanation cavity completely epidermization, detachable no, auditory tube is freely passable.

The same condition of the patient remained after 6 and 12 months, when he received prophylactic treatment in this procedure for 5 sessions in a day.

Therefore, the proposed Method..." can be used for the treatment of patients with chronic suppurative otitis media when other conservative methods of treatment are ineffective.

However, despite the constant suction of the waste gas mixture, ozone can penetrate into the upper respiratory tract of the patient through the auditory tube, therefore, the ozone concentration should be kept to a minimum in the gas mixture, but in combination with ultraviolet laser radiation to provide a complete bactericidal effect.

Observation II. Patient S. 56 years old, diagnosis: acute suppurative otitis media on the right. Diabetes mellitus type II.

The right ear disease within two months after the SARS. Treatment in the clinic antibiotics lincomycin, lopomo replaced Maninil 5 to insulin, resulting in a normalized level of blood glucose, insulin solution dioksidina was buried in his ear. The disease took the slow character and had a tendency of transition in the chronic form. Sent to hospital treatment.

When applying the General condition of the patient is satisfactory. Concerned about General weakness, profuse purulent discharge and hearing loss in the right ear. Objectively: the skin of the auricle and external ear canal redness, infiltrated, maseribane, Muco-purulent discharge up to 8 Vinnikov, eardrum hyperemic, infiltrated, a large Central perforation in the lower quadrants with a pulsed reflex. Bacteriological examination of detachable detected Staphylococcus aureus. On radiographs of the temporal bone - the reduction in the transparency of the cells of the mastoid process to the right without hearth destruction. On the audiogram hearing loss right type of lesion, zvukoprovodnost, whispered speech perceives the ear.

Patients received treatment by the proposed method. First performed toilet right ear 3% hydrogen peroxide solution, then put 8-10 drops of 0.1% solution of epinephrine and several subsequent passage of the gas mixture. Tube funnel with silicone sleeve tightly was inserted in the external auditory meatus and sent to the perforation in the eardrum. Session duration was 5 minutes, the consumption of ozone-oxygen mixture of 1 l/min, temperature of 36.5oC, the laser power of 2 mW, a wavelength of 337 nm, the ozone concentration is 0.1 mg/L. Treatment of the patient tolerated well, the side effects were not. The level of glucose in the blood remains normal.

A noticeable clinical effect occurred after 4 sessions, when the discharge was reduced to 1 watnick became slimy character and pathogenic flora was not sown. After 7 session of ear discharge has ceased, the skin of the auricle and external ear canal is normalized, eardrum became pale, the swelling of the mucous membrane of the tympanic cavity and appeared patency of the auditory tube. After 10 session - the mucous membrane of the tympanic cavity pale pink color, detachable no. The hearing has improved to the perception of whispered speech with 3 m

Medical treatment included: insulin scheme and multivitamin with minerals in prophylactic dosage.

Discharged on day 14 with improvement.

At the control examination after 1 Mei membrane normal color, perforation decreased hearing perceives the whispered speech with 3 m Endocrinologist insulin cancelled and newly appointed Maninil 5.

Thus, it is confirmed by a high therapeutic effect in the combined effect of low-intensity laser radiation with a wavelength of 337 nm and an ozone-oxygen mixture.

The immediate impact of the two treatment factors on the primary inflammation localized in the outer and middle ear, and the selected processing modes provide suppression of pathogenic microorganisms with minimal exposures and concentration of ozone.

In the blasting process gas mixture formed whirling flows in the cavity of the outer and middle ear promote intensive treatment from pathological content and the simultaneous elimination of hypoxia inflamed tissue. Simultaneous evacuation of the waste gas mixture and detachable maintains constant ozone concentration in the treated area.

The proposed "way ... and ... allow you to reduce the treatment time, to eliminate the use of expensive drugs and avoid otogenic complications.

The proposed "way ... and device the clinic.

These examples show that the claimed group of inventions to meet the requirement of industrial applicability".

1. A method of treating external and otitis media by irradiating the laser radiation area of the eardrum and the tympanal orifice of the auditory tube, characterized in that simultaneously with the laser radiation wavelength of 0.337 μm and an average power of 1-5 mW in the area of radiation injected a mixture of ozone and oxygen, the temperature corresponding to the temperature of the patient's body, when the ozone concentration of 0.05-0.15 mg/m3and the flow rate of the gas mixture 1-2 l/min, for 2-25 minutes, with simultaneous removal of waste gas mixture and pathological content on treatment for 5-10 sessions.

2. Device for the treatment of external and middle ear infections, ear containing a funnel, an optical attachment with a hole on the side to bring the laser radiation to the treatment area, wherein the side surface of the optical attachment made two additional holes, one of which is a nozzle for supplying an ozone-oxygen mixture to the treatment site, and the other is connected through a hose to the waste removal system of the gas mixture and pathological sodeoka covered by the nozzle for supplying the treatment area ozone-oxygen mixture in the form of vortex flows by creating the difference of the squares of the input and output ends of the pipe.

 

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FIELD: medicine, otolaryngology.

SUBSTANCE: the present innovation deals with introducing neomycin sulfate antibiotic in granules prepared by the following technique. Tablet of neomycin sulfate 1.0g should be put into a vial with 100 ml distilled water till tablet's decomposition. Then vial's content should be shaken and kept till suspension sedimentation. In a day one should take 1 ml of supernatant liquid to be put into another vial and diluted with distilled water at 1:100 ratio. This procedure should be repeated 4 times more, moreover, during the last procedure one should apply alcohol for dilution. Then one should transfer the drop of alcoholic solution into a vial with granules out of milk sugar to then shaken and kept open for 1 d till granules" drying up. The suggested preparation should be applied per 1 granule under the tongue, moreover, multiplicity and duration of the above-suggested intake should be matched individually by patient's sensitivity and obtaining the clinic effect. The method enables to improve the value of tonic threshold audiometry by about 30-50 dB, decrease perception threshold of vocal range frequencies and widen the range towards high frequencies.

EFFECT: higher efficiency of therapy.

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