RU26942U1 - DEVICE FOR ENDOAURAL ELECTRICAL STIMULATION - Google Patents

Description

DEVICE FOR ENDOAURAL ELECTRICAL STIMULATION

This technical solution relates to the field of medicine, namely to otorhinolaryngology and can be used to conduct endaural electrostimulation for hearing loss.

Sensoneural hearing loss in frequency of occurrence ranks first among various forms of hearing loss and accounts for 78.9% of the total number of diseases accompanied by hearing loss. The treatment of sensorineural hearing loss is challenging. In recent years, various methods of electrophysiological effects have been increasingly used.

The anatomical structural features of the external auditory meatus, associated with its bends, direction and size variability, make it difficult to conduct endaural influences.

Studies on the medical, scientific and patent literature have revealed various devices for electrical stimulation in sensorineural hearing loss.

A device for indirect electrical stimulation with sensorineural hearing loss described by V.N. Rostovtsev, R.F. Kofanov in the article “Indirect electrical stimulation of auditory neural structures in the treatment of sensorineural hearing loss and subjective ear noise (Bulletin of otorhinolaryngology. 1992. No. 3. S.13-14), including plate electrodes on the skin, with an active electrode

It is located in the precarp region and is connected to the domestic electric stimulator ES-50-1. The disadvantages of the method include the low treatment efficiency within 32.3%, the marginal location of the active electrode, which contributes to its remoteness from the lesion.

The device described by Yu.V. Sukhanova, M.A. Rymsha, V.V. Pedder in the article “Physiotherapeutic Treatment of Hearing Impairment and Ear Noise (Otorhinolaryngology and Logopathology News. - 2002. - No. 1. - P.111-114), which includes an endaural electrode for electrical stimulation using the Audioton device (NPF Metromed, Omsk, State Register of Inventions 10/20/97). The device comprises a holder of dielectric material ending in a loop of titanium wire moistened with a solution of a medicinal substance. To conduct electrical stimulation, an endoural electrode is inserted into the ear canal and an endaural electrode is inserted until its loop contacts the eardrum. After fixing the passive cylindrical electrode in the hand, the electrical stimulation unit is turned on. The disadvantages of this device is the contact of the active electrode loop with the eardrum during electrical exposure, which has a traumatic effect on it, causes local pain and creates a high probability of injury to the eardrum and the skin of the external auditory canal.

A device is known for electrical stimulation by fluctuating currents in case of sensorineural hearing loss, including an industrial otorhinolaryngological apparatus “Hearing-OTO 1 (manufacturer 000“ Hearing, Moscow) with electrodes for the external auditory canal and nasopharynx. The disadvantages of this device are the need to prepare the electrodes by wrapping them with cotton wool, impregnated with an electrically conductive liquid, the large size of the electrodes in contact with the skin on the outside

the auditory meatus and with the surface of the mucous membrane of the nasal cavity and nasopharynx, which has a traumatic effect on the skin and mucous membranes, causes local pain.

A device is known (RF patent No. 2102956, IPC A 61 F 11/00, A 61 N 1/36, published in BIPM No. 3, 01/27/1998.- P.143) for the treatment of hearing loss and deafness by electrical stimulation of the auditory system, which they are performed percutaneously with a multichannel electrode, the contacts of which are located in the behind-the-ear region. In this case, electrical stimulation is carried out by applying bipolar electrical pulses in series to each contact. The disadvantages of this method are: the complexity of the design of the multichannel electrode used in the implementation of the method, the distance from the anatomical substrate of the lesion, which reduces the specific impact, the duration of the total exposure due to alternate electrical stimulation through each contact of the multichannel electrode.

The closest in essence is the device used to implement the method proposed by Ya.A. Goldstein "The method of exposure to the body and electrodes for exposure to an auricle by electric current (RF patent No. 2152774, IPC A 61 H 39/00, A 61 N 1/18, 1/32, 1/04, published in BIPM, 2000. - No. 20.- P.240). The exposure is carried out using a device containing elastic electrodes that are inserted into both ears with contacts adjacent to the skin surface of the outer ear. This device is chosen by us as a prototype. When we used this device, it was found that in most patients dizziness occurs due to the bilabyrinth effect of bicuspid electrodes, which is associated with the excitation of the maze. In addition, direct contact of the electrodes with the skin of the external auditory meatus causes local pain. Thus, the disadvantages of this device are:

1. Direct contact of the electrode with the surface of the skin of the outer ear, which causes pain;

2. The presence of two electrodes in a structure with a bipolar effect on the labyrinth, which causes a complication - labyrinth phenomena;

3. The need to have several elastic electrodes of different sizes due to the significant individual and age-related variability of the width of the external auditory canals;

4. The inability to use modern methods of sterilization for fragments of the device directly in contact with the skin of the external auditory canals, due to the peculiarities of the elastic material, the sterilization of which is highly likely to deform.

The purpose of this technical solution is to eliminate the pain syndrome during endaural electrostimulation by reducing the traumatic effect of the electrode with its tight fixation in the external auditory canal of any configuration, ease of operation, and the possibility of sterilization by modern methods.

The goal is achieved by the fact that the active electrode is removable with the possibility of fixing in the collet clamp, the working end of the electrode is bent at an angle of 30 ° with fixing in one of the holes behind the ear of the electrode holder, which eliminates contact with the skin during electrical exposure through the ear canal filled with an electrically conductive fluid during sensorineural hearing loss.

In FIG. 1 presents a General view of the proposed device, in FIG. 2 - behind-the-ear holder of the active electrode (top view).

The device consists of the following components:

1 - active removable electrode with a working end bent at an angle of 30 °;

2- behind-the-ear holder of the active electrode;

3 - openings of the behind-the-ear holder, the size of which corresponds to the diameter of the working part of the active electrode, for the possibility of moving the active electrode, depending on age and individual structural features of the outer ear;

4- collet electric clamp of the active electrode;

5- connecting wire;

6- electrical stimulator;

7- passive electrode.

Work with the device as follows.

A patient with sensorineural hearing loss is filled with an external auditory canal with an electrically conductive fluid (saline solution heated to 37 °), after tilting his head to the shoulder of the same name. A passive electrode of an electrostimulator (7) with a gauze pad moistened with saline is installed on the patient’s forearm. The active electrode (1) is fixed in a collet electrical clamp (4) connected via an connecting wire (5) to an electric stimulator (6) (000 Sensors, Rostov-on-Don; RF patent No. 2094067 on “A method for the treatment of sensorineural hearing loss, Bull. No. 30, 1997). Then the behind-the-ear holder of the active electrode (2) is fixed on the auricle. The working part of the active electrode (1) is passed through one of the guide holes (3) of the behind-the-ear holder, depending on the features of the structure of the outer ear, immersed in an electrically conductive liquid, turn on the electric stimulator (6) and carry out electrical exposure in a predetermined mode.

An example of the operation of the proposed device is visible from the extract from the medical history.

Patient K., 59 years old, medical history No. 684, was admitted to the ENT clinic of the Russian State Medical University with a diagnosis of bilateral sensorineural hearing loss. From the anamnesis

it was found that hearing loss was noted for several years, subsequently, hearing loss progressed, after suffering an acute respiratory illness about 1 week ago, hearing deteriorated. Previously used14 different methods of medical and physiotherapeutic treatment without a special effect.

On examination: both eardrums are gray, pale, identification marks are clearly defined. On the tonal threshold audiogram: increase in auditory thresholds for air and bone sound conduction on both sides, descending types of thebes, on both sides there are “breaks of the curve at 6000 - 8000 Hz. The auditory structures were electrostimulated using the proposed device for endaural electrostimulation. The external auditory meatus was filled with warm saline. A passive electrode with a gauze pad moistened with saline was installed on the patient's forearm. The active electrode was fixed in a collet electrical clamp connected through an connecting wire to the ESOT-1 electric stimulator. The behind-the-ear holder of the active electrode was attached to the auricle. The working part of the active electrode was passed through the middle guide hole of the ear holder, corresponding to the patient’s anatomical central axis of the external auditory meatus, immersing it in an electrically conductive fluid. An electric stimulator was turned on and electric exposure was carried out by rectangular electric pulses in a burst mode for 7-10 minutes. During the session, the patient’s ability to displace the patient’s head without the risk of trauma to the eardrum and the skin of the external auditory meatus remained, there was no pain, and there was no dizziness. Conducted 10 sessions of electrical stimulation. On the control tonal threshold audiogram after treatment, an improvement in auditory function was noted in the form of -:

/ decrease in auditory thresholds in the speech range by 10 - 15 dB, the appearance of a frequency perception of 6000 Hz.

The proposed device for endaural electrostimulation was tested in an ENT clinic in 50 patients with sensorineural hearing loss and showed ease of use and the absence of complications, high efficiency of use. A photograph of the proposed device is attached (Photo 1).

Compared with the prototype of the claimed device has the following advantages:

1. When conducting electrical stimulation, the working part of the electrode does not come into contact with the tissues of the outer ear, which eliminates the pain syndrome;

2. The possibility of one-ear exposure, which allows the use of the device with unilateral hearing loss and prevents bilabyrinth stimulation, eliminating complications in the form of labyrinth phenomena;

3. A design feature is the multifactorial use of the electrode, which allows it to be inserted into the external auditory meatus of various configurations with reliable fixation;

4. The possibility of sterilization of any kind.

 --Zolotova T.V.

-t Volkov A.G.

Negievich A.D. Petrovsky V.V.

/ H

Claims (1)

A device for endaural electrostimulation, containing an electrostimulator and electrodes, characterized in that the active electrode is removable and secured with a collet electric clamp, and its working end is located at an angle of 30 ^o with fixation in one of the guide holes of the ear holder.