RU46429U1 - DEVICE FOR TREATMENT OF MIDDLE EAR DISEASES - Google Patents

Abstract

The utility model relates to medical equipment and can be used in otorhinolaryngology, specifically for the administration of drugs through perforation of the tympanic membrane in diseases of the middle ear. A new technical result - increasing the effectiveness of treatment by reducing the time and expanding the scope, is achieved using a device in which the device for hermetic connection to the ear canal is a mobile obturating cuff connected through the outer end of the tube of the adapter channel with a syringe for supplying a medicinal solution, and on the other hand, through a non-return valve with a syringe for pumping air.

Description

The utility model relates to medical equipment and can be used in otorhinolaryngology, specifically for the administration of drugs through perforation of the tympanic membrane in diseases of the middle ear.

Closest to the claimed utility model is a device for the treatment of middle ear diseases by pneumatic massage of the tympanic membrane and subsequent administration of the drug into the external auditory canal and through perforation in the tympanic membrane into the middle ear [1]. The device contains a device for hermetic attachment to the external auditory canal, communicated using an elastic tube with a device for hermetic attachment to the mouth of the same person. To introduce the drug into the middle ear using a known device, it is necessary to introduce the drug into the external auditory canal, then tightly attach the device to the ear and mouth, and then by injecting air, inject the drug into the middle ear cavity through the perforation of the eardrum.

The disadvantages of the known device is the need to remove the device from the ear canal before infusion of the drug, which leads to depressurization of the system and reduce efficiency. Another disadvantage of the device is the impossibility of controlling the flow of the drug into the middle ear air-beds, which also reduces the effectiveness of the treatment. Given the active participation in the treatment of the patient himself, the scope of use of the device is limited only to adult patients. It is impossible for children to explain the sequence of work with the device, as well as to obtain reliable information about the ongoing changes in the middle ear during treatment. This limits the scope of the device only for the adult patient population.

A new technical task is to increase the efficiency of use by reducing timelines, expanding the scope.

The problem is solved by a new device for the treatment of middle ear diseases, consisting of a device for hermetically connecting to the external auditory meatus, connected to a device for creating pressure, and the device for hermetic connection to the auditory meatus consists of a mobile obturating cuff connected through the outer end of the tube of the adapter channel with a syringe for supplying a medicinal solution, and on the other hand, through a non-return valve with a syringe for pumping air.

The device in figure 1 consists of: a mobile obturating cuff (1) with a non-return valve (2), a polymer tube channel with a diameter of 4-5 mm and a length of 30-40 mm (3), two syringes with a volume of 2 ml (4, 5) .

The device works as follows: the position of the patient lying on his side, with a sick ear up. A movable cuff (1) is put on the channel tube (3) so that its inner end protrudes 1.5-2 mm from the cuff balloon. The assembled system is introduced into the membrano-cartilaginous part of the external auditory canal. A syringe (5) with 1 ml of air is attached to the non-return valve (2) of the movable cuff (1). Depending on the diameter of the ear canal and the canal tube, 0.4-1.0 ml of air is introduced into the balloon. Inflating, the cuff balloon seals the device in the ear canal. In a sterile syringe (4), 1 ml of a medicinal solution is added, heated in a water bath to body temperature. By connecting a syringe (5) to the outer end of the tube-channel (3), the piston is traction “towards itself”. Through the collected drug solution, air in the form of bubbles begins to flow into the syringe. After that perform the reverse movement of the piston to its original position. In this case, the medicine enters the ear canal and the cavity of the middle ear. After 5-7 reciprocating movements with the piston of the syringe, the entire drug solution replaces the air contained in the cavities of the middle ear. Monitoring the effectiveness of the introduction is carried out by the intensity of air bubbles in the syringe and the decrease in the volume of the drug solution in it. Further, performing reciprocating movements of the syringe piston within 0.2-0.8 ml from the initial level, an additional, deeper injection of the drug solution is performed. When filling the middle ear airway cells, further attempts to administer the drug solution lead to the system leakage due to the expulsion of the mobile cuff (1) together with the tube-channel (3) from the ear canal. This proves the safety of the procedure for the patient.

The penetration of a medicinal substance into the tympanic cavity, cave and cells of the mastoid process, the bony part of the auditory tube is ensured by negative pressure in the system within 40-75 mm RT. When creating positive pressure, when there is no block of the auditory tube, the drug is discharged through it into the nasopharynx. Such pressure values are three times less than the average pressure, causing a violation of the integrity of the round window membrane [2], which is a safety condition for the procedure for introducing the drug into the middle ear.

The device was tested in the office of an ENT specialist - a polyclinic doctor and an ENT specialist - department and MKLPMU City Hospital No. 3 in Tomsk in the treatment of 60 patients aged 2 to 75 years with various types of perforated otitis media: 28 patients with chronic purulent otitis media, 10 patients with exudative otitis media, 16 patients with acute purulent otitis media, 6 patients after anthromastoidotomy and radical surgery on the middle ear. The use of the proposed device allowed for 3-5 procedures to achieve improvement in chronic otitis media. Recovery in acute purulent otitis media occurred on the 4th-5th day of treatment. There were no complications when using this device. In all cases, without the use of surgical treatment, improvement was achieved during chronic

disease, or recovery in an acute process. The following clinical examples demonstrate the effectiveness of the device.

Example 1. Patient R. 2.2 years. Parents of a sick child asked for help in an ENT hospital: for two weeks on an outpatient basis, the child was given an ear canal toilet, a solution of 1% dioxidine was injected into the ear in the form of drops, penicillin sodium salt was injected intramuscularly three times a day, three times a day a solution of 0.05% naphthyzine was instilled into the nose. The treatment did not give a result: the discharge from the right ear intensified, the child began to behave uneasily, a swelling appeared in the behind-the-ear area on the right. On examination: the condition of the child is moderate, the skin is pale, the child is restless, crying. Body temperature 36.7 ° C. Pharyngoscopy is a mild hyperemia of the mucous membrane; a yellowish mucous discharge flows from the nasopharynx along the back wall. Rhinoscopy: the mucous membrane is pink, swollen in the common nasal passages; from under the middle nasal concha mucous membrane flows, yellowish discharge; difficulty breathing. Otoscopy: on the left, the norm option, on the right, behind the behind-the-ear region, soft tissue pastiness, enlarged, painless lymph nodes. Pressure in the behind the ear area does not cause a pain reaction. The auditory meatus is viscous, yellowish mucous. The eardrum is not completely visible, pink in color, perforation in the posterior upper quadrant, not marginal, 0.2 cm in diameter.

Based on the foregoing, the diagnosis was made: acute respiratory infections, right-sided acute purulent perforated otitis media. It was recommended treatment in the ENT department using the above device. Appointed: at an age-related dosage of amoxiclav in suspension, diazolin, ascorutin, rinofluimucil endonasally, sinupret in drops. In the middle ear cavity, instead of the air removed from them, a drug solution was introduced, consisting of a 1% solution of dioxidine, dexamethasone phosphate and a 0.1% solution of adrenaline hydrochloride. The next day, parents noted the cessation of discharge from the ear canal, the child slept quietly the first night of all days of the illness, and appetite appeared. On examination: the child is active, independently goes into the arms of a doctor, plays. Swelling of the skin and subcutaneous tissue in the behind the ear region is insignificant, lymph nodes have decreased in size. With otoscopy in the bone section of the ear canal, a small amount of the mucous contents of gray-yellow color, the perforation is closed by a viscous mucous plug. The treatment procedure was again performed, the child with pleasure transferred it. At the end of the administration of dioxidine, dexamethasone, and epinephrine, when positive intra-tympanic pressure of 30-35 mm Hg was created, air was released into the nasopharynx. Day Three According to the parents, there was no discharge from the ear canal, the appetite and sleep are good, the child is active. On examination: in the behind-the-ear region, the skin and subcutaneous tissue of natural color, pressure in the projection of the antrum of the mastoid process, augmentation of the auricle are painless. There is no discharge in the auditory meatus, round perforation 0.15 cm in diameter. Introduction completed

of the aforementioned drug mixture without adrenaline hydrochloride, at the end of administration, when a positive hydraulic pressure of the drug was created within 7-10 mm Hg, the drug was dumped into the nasopharynx, which manifested itself as a “failure” of the drug. Day four. According to the parents, the child recovers, eats and sleeps as usual before the illness, there are no discharge from the ear. The body temperature is normal. On examination: the skin of the body is pink in color, the child is active, free to communicate, easily and independently goes to the doctor. Otoscopically: there are no overlaps in the ear canal, the eardrum is gray, perforation is 0.1 cm in diameter. The introduction of the drug mixture. The passage of the drug into the nasopharynx occurred freely when creating hydraulic pressure within 5 mm Hg. Rhinoscopically, the mucous membrane is pink, the scanty mucous membrane is separated, and breathing is satisfactory. Further treatment was continued without using the device. When examining the eardrum on day 6 - perforation is epithelized. The course of treatment was completed on the 8th day, was discharged under the supervision of an ENT specialist - a clinic doctor. When viewed after a week, one month is otoscopy a normal option.

Example 2. Patient G., 48 years old, asked for help in the ENT specialist - office of MKLPMU "City Hospital No. 3" in Tomsk. Upon treatment, he complained about the constant flow of purulent fluid from the left ear canal for 6 months, hearing loss, and noise in the ear. Has been sick with otitis media since childhood. Otoscopy on the left - the auditory meatus is wide, the skin in the bones is hyperemic. In the bone section, mucopurulent deposits of yellowish, odorless, completely cover the eardrum. After removal of pathological contents from the ear canal, the eardrum is stagnantly hyperemic, edematous. Perforation in the anterior quadrants, non-marginal, up to 0.5 cm in diameter, hyperemic edges, edematous. In the tympanic cavity, the mucopurulent contents are taken for bacteriological examination and sensitivity to antibiotics. Patency of the auditory tube is absent. Radiography of the temporal bones according to Schuller and Mayer. Conclusion: on the left is the sclerotic type of structure of the mastoid process, the veil of individual cells around the cave, the cave itself and the tympanum, there are no signs of destruction of the temporal bone. Based on the data obtained, the diagnosis was made: left-sided chronic purulent mesothympanitis, exacerbation.

A treatment was prescribed with the introduction of a solution of sodium hypochlorite in a concentration of 800 mg / l into the middle ear cavity using the above device. Second day. According to the patient, there was no discharge from the ear canal over the past 24 hours. hearing improved, noise decreased. Otoscopy: the auditory meatus is wide, the skin is slightly hyperemic at the tympanic membrane, the last pink color on the periphery, in the central part of gray. A scanty amount of mucous secretion in the ear canal and tympanum. The mucous membrane of the medial wall of the tympanic cavity is hypertrophied, swollen, pink in color. Patency of the auditory tube is absent. During injection of the drug, the latter

there is no nasopharynx, the volume of the administered drug increased by 0.2 ml. The third day. There is no discharge from the ear canal, the hearing has improved, the noise in the ear does not bother. Otoscopy: no overlap in the ear canal and tympanic cavity. Eardrum is slightly pink in color on the periphery. Patency of the auditory tube has recovered: with a Valsalva sample, air enters through the perforation into the external auditory canal. The volume of drug administered by the above device in the middle ear cavity increased by 0.1 ml. Fourth day. Otoscopy: the eardrum is gray, there are no pathological contents in the cavities of the middle ear. With the introduction of the drug, the passage of the drug into the nasopharynx is observed in the form of a "failure". Fifth day. The patient does not show complaints, there is no noise in the ears. Otoscopy: unchanged from a previous examination. The ventilation and drainage functions of the auditory tube are good. The treatment is over. When viewed after 1 and 6 months, the patient did not show complaints, otoscopically - dry central perforation, mucous membrane without signs of inflammation.

Thus, the proposed device allows for visually controlled administration of drug solutions in the middle ear cavity. In this case, the inflammatory block of anastomosis is eliminated or reduced, the patency of the auditory tube is restored. The topical administration of a drug solution in the middle ear cavity by means of the above device is superior to traditional methods of penetration treatment.

The advantages of the claimed device are as follows: the device is easy to use, safe, has high efficiency in the treatment of various types of acute and chronic otitis media in both adults and children. During the procedure, it is possible to control the flow of the drug into the middle ear airways. When using the device, the treatment time for the disease is reduced. The use of the device can be recommended both in outpatient practice and in stationary conditions. 1 ill.

Sources of information

1. Busel O.I. A device for the treatment of ear diseases // No. 2195908, B.I. 01/10/2003.

2. Lebedev Yu.A., Shakhov V.Yu., Polukhina T.A. Transmeatal hyperbaric aerosol therapy in the treatment of some forms of chronic purulent otitis media // Bulletin of otorhinolaryngology. - 1999. - No. 4. - S. 4-7.

Claims (1)

A device for treating diseases of the middle ear, consisting of a device for hermetic attachment to the external auditory canal, connected to a device for creating pressure, characterized in that the device for hermetic attachment to the auditory canal is a movable obturating cuff connected through the outer end of the tube of the adapter channel with a syringe for supplying a medicinal solution, and on the other hand, through a non-return valve with a syringe for pumping air.