RU90333U1 - DEVICE FOR DRAINING AND AERATION OF THE MIDDLE EAR - Google Patents

Abstract

A device for drainage and aeration of the middle ear, consisting of a tee connecting the device that creates pressure, a manometer for measuring it and the working part, hermetically connected to the external auditory canal of the patient, characterized in that the device that creates pressure is made in the form of a rubber balloon, and the working part is a Siegel funnel equipped with an obturating cuff connected on one side through a non-return valve with a syringe for pumping air, and on the other, with an op nical device in a place where the pressure gauge connection additionally installed bacterial filter.

Description

The utility model relates to medical equipment, specifically, to devices for treating diseases of the middle ear in the presence of perforation of the eardrum.

A device for the treatment using vacuum of patients suffering from all types of hearing loss, except purulent otitis media [1]. The device consists of a rarefaction cylinder with a ball valve connected through a tee to a pressure gauge and two tubes ending in rubber olives. Olives are tightly inserted into the external auditory canals and are held there by the patient himself. During the procedure, due to compression of the balloon, a negative pressure is achieved in the auditory canals, which gradually aligns with atmospheric. In this case, the tension of the tympanic membranes decreases, the balance of the auditory ossicles and the sprain are caused.

The disadvantages of the known device are the need for fixation of olives in the external auditory canals by the patients themselves, which reduces the efficiency of use.

Closest to the proposed is a device for the treatment of middle ear diseases by dosed vacuum therapy in patients with chronic catarrhal and exudative otitis media [2]. The device consists of a Jeanne syringe connected by a connector through a tee to a pressure gauge and individual earmolds located on the stethoscope springs. A Jeanne syringe creates a negative pressure in the external auditory canals, controlled by a manometer.

The latter are obstructed by earmolds; system sealing is achieved by stethoscope springs.

The disadvantages of the known device is the limited scope - only for chronic catarrhal and exudative otitis media .. Also, the device has a limited scope, because the treatment of purulent otitis media and otitis media with perforations with it is impossible because of the danger of penetration of pathogenic microflora during drainage from the cavities of the middle ear into the manometer with subsequent cantamization (infection) of patients with subsequent use of this device. It is not possible to sterilize the internal parts of the manometer without impairing its function.

A new technical task is to increase the effectiveness of treatment due to the prevention of the penetration of pathogenic microflora when using the device. reducing complications and expanding the scope.

To solve the problem in the device for drainage and aeration of the middle ear, consisting of a tee connecting the device, creating pressure, a manometer for measuring it and the working part, hermetically connected to the external auditory canal of the patient, the device creating pressure is made in the form of a rubber balloon, and the working the part is a Siegel funnel equipped with an obturating cuff connected on one side through a non-return valve with a syringe for pumping air and, on the other, located m on it with an optical device, moreover, at the point where the manometer is connected, a bacterial filter is additionally installed.

The device in Fig.1a, b (Fig.1a is an external view, Fig.1b is a schematic diagram) consists of: a Siegel funnel (1) with an optical nozzle (2), a 32 ml rubber balloon (3), and a mobile cuff with non-return valve (4), pressure gauge (5), bacterial filter (6), 2 ml syringe (7), two PVC pipes with a diameter of 7 mm and a length of 20 mm (8), one PVC pipe with a diameter of 7 mm and a length of 220 mm (9), a tee (10) for connecting the entire device into a single unit and an adapter channel located on the Siegel funnel (11) for connecting the last one with a T-piece (10).

The device works as follows: the position of the patient sitting on a chair. In the membranous-cartilaginous part of the external auditory canal, the Siegel funnel (1) is hermetically seated by inflating the obstructing cuff (4) with a syringe (7). On the side surface of the optical nozzle of the Siegel funnel (2) there is an adapter channel (11), which is connected via a polyvinyl chloride tube (8) to a tee, the latter, in turn, is connected via a polyvinyl chloride tube (8 and 9) to a bacterial rubber cylinder (3) filter (6) and pressure gauge (5).

The rubber balloon of the device is compressed to ½ of the volume, the nozzle is hermetically connected to the Siegel funnel. Under the control of vision, through the optical nozzle, they monitor changes in the auditory canal and tympanic cavity. Holding back the elastic return to the initial volume of the cylinder wall, create an adjustable negative pressure of up to - 30-75 mm. Hg Performing additional pressure on the cylinder, create a positive pressure of up to + 30-75 mm. Hg Pressure is 75 mm. Hg (or 10 kPa), created by a rubber balloon due to the elastic elasticity of its walls, is three times less than the average pressure (29 kPa), causing a violation of the integrity of the round window membrane. The alternating atmospheric pressure, controlled by magnitude and time, in the cavities of the middle ear drives the liquid and gaseous contents in the direction of the rubber balloon and vice versa. Content under the influence of negative pressure is evacuated from the cavities of the middle ear into the ear canal, flowing onto its lower wall. Further, when equalized to atmospheric pressure, air is drawn from the ear canal into the free cavities of the middle ear. The exudate entering the external auditory meatus from the cavities of the middle ear is removed through the Siegel funnel with an ear pad. Then the optical nozzle is reattached, the procedure is repeated until the pathological contents are removed from the middle ear cavities as much as possible.

Sterilization of the device after a complete analysis of the main parts is carried out by standard methods of processing medical equipment. However, it is not possible to sterilize the internal parts of the manometer without impairing its function. A pressure gauge (5) is necessary to control the magnitude of the created positive and negative pressure in the cavities of the middle ear. The probability of penetration of pathogenic microflora into the manometer during drainage of the middle ear cavities is quite high. The bacterial filter (6) excludes the possibility of pathogenic flora entering the manometer during the evacuation of exudate from the cavities of the middle ear.

The proposed device was tested on the basis of the ENT department and the ENT doctor’s office at the Polyclinic MKLPMU City Hospital No. 3 in Tomsk in the treatment of 40 patients with various types of perforated otitis media: 25 patients with chronic purulent otitis media and 15 patients with acute purulent otitis media. The use of the proposed device eliminated the possibility of iatrogenic introduction of pathogenic flora during drainage of the middle ear cavities. There were no complications when using this device. In all cases, it was possible to achieve improvement during a chronic disease, or recovery in an acute process.

The following clinical examples demonstrate the effectiveness of the method.

Example 1. Patient N., 34 years old, went to the ENT doctor of the clinic with complaints of purulent discharge from the left ear, hearing loss in the right ear, periodic non-intense headaches, fever up to 38.2 ° C.

Anamnesis of the disease: sick for 2 weeks, noted periodic pain in the ear, was treated independently, the effect of the treatment is negligible. The pains significantly increased over time, discharge from the ear canal appeared, after which the pain stopped. I went to the ENT doctor in the clinic.

With otoscopy: in the left external auditory canal is a profuse purulent discharge, which is aimed at bacteriological examination and the sensitivity of the identified microflora to antibiotics. The eardrum is hyperemic, edematous, linear perforation is visualized in the posterior-lower quadrant. With percussion of the mastoid process, pain is not noted. With acumetry and tuning fork samples, conductive hearing loss was detected on the left. The patient was prescribed therapy for acute perforated purulent otitis media. For drainage of the middle ear, a device not equipped with a bacterial filter was used.

In the first procedure, up to 1.5 ml of purulent discharge was obtained from the cavities of the middle ear. The patient noted improvement in well-being: the feeling of heaviness in the ear disappeared, headaches decreased, and hearing was slightly improved.

The drainage of the cavities of the middle ear during the creation of negative and positive pressure was carried out daily. On the fourth day of treatment, otoscopy of the discharge in the external auditory canal was not observed, the condition improved significantly. During visual inspection through the Siegel funnel and optical nozzle during use, the device cannot be detached from the deep sections of the middle ear. The results of a microbiological study - Streptococcus pneumoniae, were obtained, it is recommended to continue the antibacterial therapy prescribed during the initial treatment.

On the 7th day from the moment of the initial visit to the ENT doctor: the discharge did not resume, the hearing almost completely recovered, the headaches stopped, the ear was still slightly stuffy, with otoscopy the eardrum was gray, thickened, the perforation was tightened with a delicate scar.

On the 11th day, the patient repeatedly turned to the ENT office of the clinic with complaints of renewed otorrhea, hearing loss in the left ear. The patient was sent to the ENT department of the city hospital №3.

With otoscopy: in the left external auditory canal, there is scanty discharge, which is aimed at bacteriological examination and the sensitivity of the identified microflora to antibiotics. The eardrum is cloudy, thickened, perforation in the posterior-lower quadrant.

Prescribed treatment: ciprofloxacin intramuscularly; clarithin, paracetamol, ascorutin per os; xylometazoline nasal drops, physiotherapy, local treatment (expansion of the perforation edges, daily toilet, cypromed drops).

After 3 days, the results of a microbiological study were obtained; Haemophilus influenzae susceptible to ciprofloxacin was seeded.

The patient with recovery was discharged from the hospital on the 9th day.

When viewed after a month no complaints, audiometric hearing examination is normal.

Example 2. Patient Yu., 28 years old, was admitted to the ENT department with complaints of purulent discharge, hearing loss, noise on the right; feeling of heaviness, headache in the right temporal and behind the ear area.

From the anamnesis: it is sick about 2 weeks. After hypothermia, a runny nose, cough appeared. Treated on their own. After some time, I began to notice throbbing pain in my right ear. I went to the ENT doctor of the polyclinic at the place of residence, treatment was prescribed. The treatment was not carried out regularly. Gradually, the intensity of the pain intensified significantly, throbbing pains appeared in the behind-the-ear area. The night before, purulent discharge from the right external auditory canal appeared; the patient called an ambulance crew. Delivered to the ENT department, hospitalized on an emergency basis.

When otoscopy - abundant purulent discharge in the right external auditory canal, odorless, with aspiration of the detached overhang of the posterior-upper wall of the external auditory canal is not observed, the eardrum is moderately hyperemic, swollen, perforation of the tympanic membrane is not determined. The skin in the behind-the-ear area of natural color, with pressure and striking in the area of the site of the mastoid process, notes slight pain. When radiography of the temporal bones in the projection of Schüller and Mayer, a decrease in pneumatization and veiling of the cells of the mastoid process were found on the right. The diagnosis was established: right-sided acute purulent perforated otitis media, complication - serous mastoiditis, on the right.

A standard course of therapy has been prescribed (antibiotics, antihistamines, vasoconstrictor drops in the nose, local treatment, etc.). The patient was treated using the proposed device. In the first procedure, up to 3.0 ml of purulent, odorless discharge was obtained from the cavities of the middle ear. Obtained from the deep parts of the middle ear of the discharge, it was sent for bacteriological research, the sensitivity of the identified microflora to antibiotics. The drainage of the cavities of the middle ear during the creation of negative and positive pressure was carried out daily. During treatment, the patient noted a significant improvement in health:

the feeling of heaviness in the ear disappeared, headaches decreased significantly.

On the fourth day, the results of a microbiological study - Streptococcus pneumoniae, sensitive to the prescribed antibacterial drug. Pain and parasthesia in the right temporal region do not bother. When draining the cavities of the middle ear, no discharge from the tympanic cavity was obtained; air was discharged into the nasopharynx at 15-10 mm. Hg.

In the following days, treatment was performed without applying the method. At discharge on the 9th day, epidermization of perforation of the tympanic membrane was detected. When viewed after a month no complaints, audiometric hearing examination is normal.

Thus, the presented clinical examples illustrate that the use of the proposed device with a bacterial filter excludes the possibility of the penetration of pathogenic flora into the manometer during the evacuation of the middle ear cavity and iatrogenic infection of patients.

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. When using the device, the possibility of penetration of pathogenic microflora is excluded, the treatment time for the disease is reduced. The use of the device can be recommended both in outpatient practice and in stationary conditions.

Sources of information used in the preparation of the description:

1. Ioffe NS The therapeutic and diagnostic value of the vacuum in the external auditory canals // Journal of ear, nose and throat diseases.-1968.-No. 1.-C.81-84.

2. Karpov V.P. Yenin I.P. Lopotko A.I. The method of dosed vacuum therapy in patients with chronic catarrhal and exudative otitis media and a device for its implementation // No. 2221527, B. I. 01/20/2004 (prototype).

Claims (1)

A device for drainage and aeration of the middle ear, consisting of a tee connecting the device that creates pressure, a manometer for measuring it and the working part, hermetically connected to the external auditory canal of the patient, characterized in that the device that creates pressure is made in the form of a rubber balloon, and the working part is a Siegel funnel equipped with an obturating cuff connected on one side through a non-return valve with a syringe for pumping air, and on the other, with an op nical device in a place where the pressure gauge connection additionally installed bacterial filter.