EA022211B1 - Vibration device for treating the upper respiratory tract - Google Patents

Abstract

The present invention relates to a vibration device for treating the upper respiratory tract, comprising a housing (16), a vibration generator (11) configured in the housing, an energy supply unit (17) in communication with the vibration generator (11), a vibration transmitter (19) partly configured in the housing, in mechanical/physical contact with the vibration generator (11). The proposed device is characterised in that the vibration transmitter (19) is designed as a unit that prevents the transmission of vibrations below the threshold value of 50 Hz to the human body, wherein the treatment part of the vibration transmitter (19) which gets in contact with the human body is designed as treatment component vibrating with maximum 1500 Hz frequency, wherein the vibration generator (11) produces at least 10 vibration periods that increase from the bottom threshold in 50 Hz value to the ceiling threshold in 1500 Hz value and decrease from the ceiling value to the bottom value, wherein the time for all the periods is 30 seconds, wherein the vibration device is designed as a unit of 50-100 mm length and 15-35 mm width, wherein the vibration device comprises a spatial position switch (20) which guarantees the operation of the device exclusively if held in the right position, and also comprises a sound emitter (21) indicating the right position of the device operation. The proposed device is suitable for the treatment and diagnosis of diseases of the lower and the upper respiratory tracts, the pulmonary circulation, and respectively, the diseases such as, for example, rhinitis, rhinosinusitis of different origin, nose congestion, common cold, flu, bronchitis, bronchus contractions, asthma and chronic obstructive pulmonary disease (COPD).

Description

FIELD OF THE INVENTION

The present invention relates to a vibratory device for the treatment of diseases of the upper respiratory tract, in particular for the purification of paranasal sinuses for the treatment of respiratory diseases. The device comprises a housing; a vibrator placed in the specified case; power supply connected to a vibrator; vibration transmission element having mechanical / physical contact with the vibrator and partially placed in the housing. The proposed device is suitable for the treatment of diseases of the upper and lower respiratory tract, examination of pulmonary circulation and, for example, diseases such as rhinitis, rhinosinusitis of various origins, nasal congestion, colds, flu, bronchitis, constriction of the bronchi and chronic obstructive pulmonary disease (COPD) .

State of the art

The skull of a living creature, such as a human skull, contains several air-filled cavities, the so-called paranasal sinuses, communicating with the nasal cavity. The largest of the paranasal sinuses is the so-called maxillary sinus or facial cavity, the volume of which in an adult is 4-35 cm ³ , on average 12 cm ³ . Paranasal sinuses are connected to the nasal cavity through small openings with a diameter of 1-3 mm. Since the mucous membrane lining the sinuses is a single unit with the mucous membrane of the nasal cavity, diseases of the nasal cavity and sinuses usually occur correlated with each other in the form of rhinosinusitis.

Rhinosinusitis has several forms. The most common form is a common cold, which means inflammation caused by a mild infection in the upper respiratory tract. Allergic rhinosinusitis caused by foreign substances, mainly plant pollen, and leading to inflammation, is also common.

The so-called drug rhinitis develops due to the constant local use for more than 7-10 days of nasal vasoconstrictor drugs.

The hygienic state of the respiratory tract is mainly a function of mucociliary transport and plays a decisive role in the development of respiratory diseases. Mucociliary transport is carried out due to the unilateral whipping action of the cilia of the mucous membrane. The activity of transport is affected by the movement of the cilia and the visco-elastic properties of the mucous material.

Sinus ventilation is equally important for the development of respiratory diseases: blocked or poorly ventilated sinuses will be prone to inflammation.

A well-known method for checking the state of sinus ventilation involves measuring the amount of nitric oxide (N0) gas exhaled through the nose. Nitric oxide is a substance that produces the human body and which performs a protective function.

Treating rhinitis and upper respiratory tract infections is usually a fairly simple task. The patient needs rest and fluid reimbursement, as well as to alleviate symptoms - in medicines, for example painkillers and antipyretics, in addition, antihistamines, vitamins, mucus thinners and expectorants. As for rhinitis caused by pathogenic factors, there is no adequate effective treatment for viruses. Antibiotics are used to prevent and treat bacterial infections. If rhinitis is not amenable to the action of drugs, then it can spread to the sinuses.

Of the diseases of the lower respiratory tract, medications are used in the treatment of asthma and COPD, but sudden temporary attacks of asthma and COPD cannot be effectively prevented by medications, since such events are usually caused by substances that enter the human body suddenly with air. Therefore, it is justified to use a treatment that can quickly enhance the self-cleaning mechanism in the lower respiratory system, if necessary.

US 2003/0172939 discloses a method and apparatus that can be implemented to eliminate congestion of the internal sinuses through vibration. To this end, the proposed device contains a handle in which a power source and a vibrator are located, which is connected to an external vibration transmission element, and the specified transmission element should be applied to the intended surface of the body in order to transfer vibration through the surface of the body to hard tissues. In particular, the difference between this method and the corresponding device is that it is intended to mechanically reduce or eliminate congestion by transmitting mechanical vibrations and reduce or eliminate pain in the ear, and the design of the vibration transmission element is designed so that the user can clamp it with a pair of opposing teeth , in this case, according to the document, the device is able to reduce toothache. The device achieves the effect by creating a vibration of the infrasound frequency, i.e. frequencies below the hearing range of the human ear. The document does not mention the possibility of the release of N0 due to vibration and, therefore, it also does not contain any specific solutions or proposals for such an effect.

US 2008/0195001 describes a device and method for alleviating sinus pain, the device being again implemented as a device that transmits vibrations to the human body. So that the device can be used in a lying position, it has a special curved shape, and a vibration transmission element that transmits vibration of the body surface is located at an angle to the longitudinal axis of the device. This design is also intended to mechanically liquefy and remove accumulations and eliminate congestion, but the document does not mention the vibration frequency that is used. The main disadvantage of this design is the same as that of the previously mentioned device, and is that it is intended to stop the formation of clusters and eliminate congestion, as well as unpleasant sensations in general, due to mechanical stress.

It is well known that in a healthy person, the concentration of N0 in the sinuses is extremely high: it can reach 20 ppm (fractions per million molecules). Therefore, it is likely that a high concentration of N0 in the sinuses may also play some protective role. The desire to increase the concentration of N0 in nasal air is based on this assumption. Since the outflow of N0 from the sinuses in the direction of the nasal cavity is difficult, various technical solutions are invented to increase the concentration of N0 in nasal air.

It has been established (see international application 03/063703) that an air stream in which vibrations are excited significantly increases the amount of N0 in nasal air, since gas exchange between the sinus and nasal cavity is enhanced at the resonance frequency of the sines. According to application 03/063703, it is possible to increase the amount of N0 in the main new cavity using an oscillating air stream or using devices that generate such an air stream. A vibrating air stream can be created if you make a buzz with your mouth closed, i.e. with nasal phonation of sounds m and n, or due to an external sound source. Such devices can be used for human diagnostic purposes.

However, a strong buzz is quite tiring, and a buzz when inhaling through the nose and exhaling through the nose of a jet of air in which vibration is generated by an external device cannot be realized if the swollen mucous membrane of the nose already obstructs the flow of air through the nose. Therefore, for most patients it is clinically impossible to ventilate the sinuses using an oscillating air stream.

In the international publication \ U0 03/013653 another possibility of treating rhinitis is disclosed. This is the use of a light beam directed into the nasal cavity, in other words - rhinophototherapy. Similar solutions are also described, for example, in application US 2006/0271024. Rhinotherapy also has a drawback - it cannot be used with a stuffy nose.

SUMMARY OF THE INVENTION

One of the main problems in the treatment of rhinitis and rhinosinusitis is the low tendency of patients to cooperate with a doctor - patients consider this disease unpleasant, but not dangerous. Patients stop treatment when symptoms are relieved, and when symptoms return, the same treatment is naturally less effective or has no effect at all. Therefore, there is a significant need for such simple and effective methods of treatment that the patient can apply in parallel with his daily routine.

The vibration parameters for the maxillary and frontal sinuses can be respectively described by well-known mathematical formulas, the Helmholtz equation, where the resonant frequency is a function of sinus volume, diameter measured at the site of sinus anastomosis with nasal cavity and length of anastomosis at a constant speed of oscillation propagation. During measurements by the method described in the aforementioned international publication \ U0 03/063703, it was found that a higher level of N0 concentration in the nasal cavity has a therapeutic effect in diseases of the upper and lower respiratory tract. At the same time, the use of an oscillating air stream is not effective in the treatment of such diseases, since with significant or complete nasal congestion, the considered methods are not applicable, and, in addition, there is a significant individual scatter in the therapeutic effect. Therefore, in order to treat patients, a method or device is needed suitable for increasing the amount of N0 and initiating a therapeutic effect in the upper and lower respiratory tract, respectively, also in case of nasal congestion.

As set forth in US application 2008/0200848, the therapeutic effect is exerted by vibration induced on the face near the sinuses. However, the vibrator described in the application 2008/0200848 causes toothache in a significant part of patients, since the vibration created near the maxillary sinus extends to the roots of the molars of the upper teeth. Although it is possible to reduce the power of the vibrator applied to or near the maxillary bone, the amount of N0 ventilated from the maxillary sinus to the main nasal cavity, and, consequently, the therapeutic effect achieved in the nasal cavity, will also be reduced. Therefore, such a device that creates a vibration is required that will transmit vibrational energy exclusively to the apex of the maxillary sinus and so that the vibrations do not propagate to the lower wall of the maxillary sinus and / or to the roots of the teeth that are close below it. Due to the complexity of the structure of the human skull, the creation of a vibration excitation device of this type requires careful experimental analysis, since the actual behavior of mechanical vibrations on spatial surfaces of complex shape with seams cannot be modeled in advance.

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Experiments show that vibrations transmitted from the bones of the skull perpendicular to the longitudinal section of the nose, above the zygomatic bone, can increase the amount of N0 in the nasal cavity without causing toothache. Oscillations excited in the zygomatic bone are partially reflected when passing through three processes of the zygomatic bone, as well as at the junction of the zygomatic and maxillary bones, and partially penetrate the jaw and frontal bones, as well as into the mastoid region of the temporal bone, where they are reflected in many directions , disperse and significantly weaken. Oscillation waves, divided into three directions, are again gathered together in the area of the so-called osteomeatal complex on the lateral side of the common nasal cavity. The top of the maxillary sinus is located in the zygomatic bone. Although more than 90% of the maxillary sinus is located in the zygomatic bone, vibrations of the zygomatic bone that reach the apex of the maxillary sinus are themselves capable of evacuating the entire volume of N0 that has accumulated in the maxillary sinus to the nasal cavity.

However, when touching the zygomatic bone with a part of the device that is described in US application 2008/0200848 and which is brought into contact with the patient's face, no increase in the concentration of N0 in nasal air has been found. Presumably, the frequency of oscillations generated by the device does not correspond to the resonant frequency of the maxillary sinus, and, therefore, there is no increase in gas exchange between the maxillary sinus and the nasal cavity.

It is well known that the volume and resonant frequency of the maxillary sinus are primarily very different from patient to patient, and, in addition, these parameters for each person are constantly changing over time. Changes in time in a particular individual are explained by the so-called nasal cycle. During the nasal cycle, the internal section of the nasal passages periodically changes, mainly due to swelling of the mucous membrane. Changes in the thickness of the mucous membrane affect both the section and the length of the anastomoses of the maxillary sinuses. Resonance parameters are constantly changing under the influence of the resulting narrowing of the lumen and a simultaneous increase in the length of the anastomoses caused by swelling of the mucous membrane, and therefore they are difficult to calculate. Therefore, a vibration excitation device is necessary, the frequency of which can be changed in a predetermined interval by manual control during one treatment cycle, so that the frequency of the excited oscillations is equal several times to the actual resonant frequency of the sines. However, the mechanical construction corresponding to the application US 2008/0200848 contains several inertial masses driven by a mechanical chain that cause a lot of noise when the frequency changes rapidly, and force pulses lead to rapid wear of the suspension points of the mechanical masses.

Since the Helmholtz resonance frequency of paranasal sinuses can vary from person to person, and since the resonant frequency of the paranasal sinuses of a particular individual continuously changes with the course of the nasal cycle, it is necessary to develop a therapeutic vibration excitation device that will scan for possible resonant frequencies typical of human paranasal sinuses, and which will be suitable for increasing the amount of N0 in nasal air, and for treating respiratory diseases in humans and to a vibration generated by such a device does not extend to the upper teeth and cause tooth pain.

Technical solution

Thus, it is necessary to have a mechanical vibrator, which has the ability to quickly change the frequency in the required frequency range in both directions and whose details are not subject to significant frictional wear.

Vibration excitation devices known in the art typically comprise a power source, a circuit breaker, and other components that facilitate their use, which are fixed components that oscillate. However, vibration of multi-element systems creates more noise. High-frequency noise can reach the roots of the upper teeth, while low-frequency noise can cause damage to the eyeball. Therefore, a device is needed that will not transmit any potentially dangerous noise to the human body.

To reduce noise, for example, designs with internal and external vibration damping can be used. Internal noise damping can be obtained by incorporating vibration damping materials into the design or by tight mechanical assembly of various parts oscillating. The use of materials for internal vibration damping is limited by the growth of the size of the device. On the other hand, the tight assembly of internal components makes it difficult to replace power supplies.

It has been established that of vibration excitation devices made in various technical forms, for the treatment of diseases of the upper and lower respiratory tract, only those variants are suitable, respectively, which, when in contact with the patient’s face, do not transmit oscillations with a frequency of more than 1500 Hz to the bones of the facial skull and whose frequency oscillations during cyclic operation varies from minimum to maximum value at least ten times in 30 seconds.

These and other objectives of the invention are solved by means of a vibration device, in particular for the treatment of diseases of the upper respiratory tract, corresponding to paragraph 1 of the claims.

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Some additional refinements of the invention are given in the dependent claims.

List of drawings

Embodiments of the present invention will be described in more detail below with reference to the accompanying drawings, in which:

FIG. 1 shows a fragment of a person’s face, on which are marked those parts of the face that are affected by the device of the invention;

FIG. 2A, 2B depict structures surrounding the maxillary sinus, which are affected by the device of the invention;

FIG. 3 is a possible block diagram of a vibration excitation device;

FIG. 4 is a sketch of a possible embodiment of a device according to the invention;

FIG. 5 shows a possible cycle of changing the vibration frequency generated by the vibration excitation device;

FIG. 6A, 6B depict other possible cycles of changing the vibration frequency generated by the vibration excitation device;

FIG. 7 and 8 depict the treatment effect of the device according to the invention at various vibration frequencies;

FIG. 9 and 10 depict representative results of a study by acoustic rhinometry, respectively, in men and women;

FIG. 11 depicts changes in the resonant frequency of the maxillary sinus caused by the nasal cycle in men and women;

FIG. 12 is a graph of vibration frequency variation for a possible embodiment of a device according to the present invention;

FIG. 13A and 13B depict vibration spectra for a possible embodiment of the device of the present invention when the maximum nitric oxide signal is provided, respectively, for men and women; and FIG. 14 schematically, in block diagram form, depicts a possible method of operating the apparatus of the present invention.

Information confirming the possibility of carrying out the invention

FIG. 1 generally depicts a portion of a person’s face in which areas of the present invention are indicated. The figure shows the frontal sinus 1, maxillary sinus 2 and the line of the lacrimal duct 3. Vibration, propagating along the line of the lacrimal duct 3 down into the maxillary bone, reaches the upper teeth and causes toothache.

FIG. 2A in an enlarged view depicts the zygomatic bone 4, and arrow 5 shows the direction of propagation of the excited vibrations.

FIG. 2B shows the maxillary sinus 2, the osteomeatal complex 6 (the location of the opening leading to the nasal cavity) and the position of the upper teeth 7. The direction in which the transmission of vibrations to the zygomatic bone 4 should occur is again indicated by arrow 5.

In FIG. 3 shows a possible embodiment of a vibrating device according to the invention at the level of a block diagram. It should be noted that, based on the function, the specific structure of each block should be understandable to specialists in this field. The vibrator, known from previous designs, according to the invention is associated with a control device of a new type. In the presented example, the functional generator generating a periodic signal is a sawtooth voltage generator (although this may be some other form of voltage) made on microprocessor 8, which can be used as a microprocessor type L1ts1 ATOPu 261 operating in the standard connection mode. The sawtooth voltage generator is turned on by a switch 9, which in this case is made in the form of a button, which is placed in the housing of the device corresponding to the present invention, so that convenient manual control is provided (the button is not shown separately in the drawing). The microprocessor 8 generates a voltage supplied to the electric motor 11, and thereby the vibration frequency measured by the sensor 10. The electric motor 11, which essentially makes up the main part of the vibrator, in this example is a high-speed motor, for example, of the Reppu series 1202 or RaiBaeg Series 0206, however, with the appropriate setting of parameters, any electric motor 11 that is standard for such devices can be used.

In addition, the sawtooth voltage generator of the microprocessor 8 is connected to the stage 12 on and hold time, intended in part to connect the power source 13 of the device with a sawtooth generator and partially, as an option, to provide a 30-second treatment cycle, which, according to research, is ideal and necessary . The vibration sensor 10, through one or more electrical converters, controls the frequency and amplitude of the excited oscillations and provides feedback that affects the formation of vibrations with a certain nominal frequency and amplitude by means of a sawtooth generator. Stage 12 is connected to a switch 20 that is sensitive to the spatial position of the device, the role of which will be discussed below.

A preferred embodiment of a vibrating device according to the invention comprises a microprocessor 8, which can be reprogrammed using an external computer into several operating modes and can trigger optimal frequency scanning modes from memory. Therefore, the device can be effectively used with several types of patient groups. In order to guarantee an optimal effect, in a preferred embodiment of the invention, it is possible to integrate a speed or vibration sensor into that part of the device that is in contact with the human body and which then in a known manner provides a feedback signal to microprocessor 8 and maintains operating parameters within the required limits.

FIG. 4 is a sketch of a possible physical implementation of a device according to the invention, which can always be modified in accordance with the scope, requirements and capabilities. So that the device can be held in hand, the housing 16 in the form of a rod located in a special casing 15 contains a power source 17, which may be a battery, battery or other source of electric current if an electric vibrator is used. The vibration control device comprises a step 12 for turning on and holding the time, a microprocessor 8 with a sawtooth voltage generator, and a vibration sensor 10. These devices are followed by a vibrator, which contains an electric motor 11 with an eccentric 18, which is made in the form of a single part with an axis or in the form of a wheel with a wedge mounted on it, while the eccentric transmits vibrations further through the vibration transmitter 19 (hammer), which protrudes from the side side of the housing 16 of the device, and shown symbolically. The switch 20, which is sensitive to the spatial position of the device, guarantees the operation of the device provided that it is held in the correct position indicated by the acoustic emitter 21. Structurally, the entire device can be made in the form of a block 50-100 mm long and 15-35 mm wide ( or diameter, if a cylindrical case is used), which can even be mounted on a key ring, in readiness for use at any time.

According to the invention, in order to avoid toothache, the vibration transmitter provided for contact with the patient’s body is partially equipped with a vibration damping material (vibration damping element 22). In addition, thanks to the design, the device can be held with a natural grip, so that the vibrations excited by the device do not propagate downward in the direction of the teeth, but are separated and directed along the three processes of the zygomatic bone 4, and reach the upper teeth significantly weakened.

As for the technical design, the device contains a maximum of one vibrator, which consists of no more than two independent mechanical components (piezoceramic vibrator, eccentric 18 in the form of a wheel or a wheel with a wedge or a mechanical element driven by an electromagnet); in addition, the device comprises at least one elastic or elastic inner vibration damping element (for example, a spring pressing the power source 17) and at least one elastic external vibration damping element 22 that comes into contact with the patient’s face, is pleasant to the skin and easy to clean. Well-known, skin-friendly vibration damping materials include PVC-free polyurethane foam rubber, but such materials are difficult to clean because moisture takes a long time to penetrate the foam during cleaning. There are also vibration-damping materials that are pleasant for the skin in the form of silicone rubber with a waterproof surface, but these materials are less likely to absorb low-frequency vibrations.

The simplest vibration excitation device is an eccentric wheel mounted on a rotating axis, the rotation of which is provided by a magnetic field or any mechanical force acting on the axis. The rotation of the eccentric wheel causes vibration of the axis of the electric motor 11, which is transmitted to the attachment points of the axis, the housing 16 of the electric motor 11, and then to the casing 15 of the electric motor 11, on which the vibration transmitter 19 is mounted, transmitting vibration to the patient’s body. The vibration transmitter 19 is located perpendicular to the axis of the electric motor 11 or at a maximum angle of 45 ° to the axis of the electric motor. Oscillation waves, which diverged in three directions in the zygomatic bone 4, again converge on the lateral wall of the common nasal cavity, in the region of the so-called osteomeatal complex 6, and, therefore, the vibrations excited by the device mainly reach the apex of the maxillary sinus 2. Oscillations penetrating in the maxillary bone, reach the upper teeth, only after passing a distance that is hundreds of times greater, moreover, in a diffuse and weakened form, and therefore do not cause toothache.

In FIG. Figure 5 shows an example of the tuning of the oscillation frequency generated by the sawtooth voltage generator of the microprocessor 8. In the presented case, the sawtooth voltage generator creates periodic sections of linearly varying frequency, which respectively scan the frequency range several times from 50 to 1500 Hz, while one vibration cycle takes about 1 s. As already mentioned, the duration of the full treatment cycle does not exceed 30 s; this is provided by the step 12 of inclusion and time delay.

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In FIG. 6A and 6B show graphs similar to FIG. 5, but in this case, the duration of the vibration cycle is much shorter than 1 s. The frequency variation shown in FIG. 6A is obtained by the alternating polarity current shown in FIG. 6B, which in practice means vibration obtained when the engine rotates in opposite directions, while the vibration amplitudes are the same when rotating in opposite directions. A change in polarity leads to a sharp stop of the electric motor that creates the vibration, and therefore, individual sections of the frequency change become shorter in time, and the total treatment cycle does not exceed 30 s.

In FIG. 7 and 8 show the effect of treatment with a vibrating device according to the present invention for various vibration parameters. FIG. 7 shows the concentration level of nitric oxide N0 released into the nasal cavity at various vibration parameters. The highest level N0 was obtained when the device was used in scanning mode. From FIG. Figure 8 shows that the removal of N0 from the sinuses increases the activity of mucociliary transport in the nose, as indicated by the reduction in the time of mucociliary transport (saccharin test). The biggest changes occur if the device is used in scanning mode.

Furthermore, as shown in FIG. 7 and 8, the degree of effect achieved respectively in men and women is different. This is due to the fact that the degree of influence of the nasal cycle on the resonant frequency of paranasal sinuses differs in men and women.

In FIG. Figures 9 and 10 show the results of experimental measurements that demonstrate a continuous and sex-specific change in the internal parameters of the nose during the nasal cycle, which can be obtained, for example, by acoustic rhinometry. During the nasal cycle, with a decrease in the swelling of the nasal mucosa (decay of edema), the area of entry (mouth) into the paranasal sinuses of the nasal cavity expands and, therefore, the resonant frequency of the sinuses increases. FIG. 9 depicts a representative picture of acoustic rhinometry for an adult male, in which the volume has increased to 6 cm ³ . FIG. 10 depicts an identical measurement for an adult woman, in which the change was larger than usual and the device could not register a further increase. Records were made with an interval of 1 min. Point P, indicated by an arrow, represents the mouth of the maxillary sinus 2, respectively, on the left and right sides. When the mouth widens during the nasal cycle, the measurement curves above the arrow show an enlarged cross section of the nose, since ultrasound also reflects from the sinuses (1. Αρρί. ΡΗνκίοΙ. 99: 616-623, 2005).

Another reason that changes in the resonant frequency during the nasal cycle are different for men and women is that the average values of the sinus volume also differ from each other: in women, the sinus volume is less, and therefore, with open sines, the resonance frequency is higher. In the case of closed or partially closed sinuses, the difference between men and women is negligible. This can be seen in FIG. 11, which shows changes in the course of the nasal cycle of the resonant frequency of the maxillary sinus 2 in men (first row) and women (back row). In men, the resonant frequency varies in the range of 9-164 Hz. As a result of treatment using the device according to the invention, the sine opens and the resonant frequency of open sines is in the range 132-164 Hz, averaging 144 Hz (n = 5). In women, the resonant frequency varies in the range of 9348 Hz, and as a result of treatment with the indicated device, the sinus opens, and the resonant frequency of the open sinus is in the range of 111-348 Hz, averaging 227 Hz (n = 5).

Ventilation of sinuses filled with nitric oxide (N0), and simultaneously measured in the nasal cavity, the amount of N0 will reach a maximum when the vibrators will operate at the actual typical resonant frequency of the paranasal sinus. Therefore, a device designed for ventilation of the maxillary sinus 2 and for the treatment of various diseases by increasing the concentration of N0 in the nasal cavity should be able to work in special frequency scanning modes for men, women, children and, accordingly, other subgroups of patients (Asian, African or European type). In FIG. 12, a representative example shows vibration frequencies for a possible embodiment of the present invention. Vibration in the first mode 12A will open and ventilate the maxillary sinus 2 men of the European type, while vibration in the second mode 12A will open and ventilate the maxillary sinus 2 women of the European type. In addition to vibration modes 12A and 12B, which are shown by way of example only, other modes, for example for children, may also be provided. During the treatment procedure, the presented vibration modes can be repeated and combined in a certain order chosen at their discretion, which will ensure the effective use of the device for patients of different sexes, ages, etc. Specialists in this field should be obvious that the device in question can be designed as a device that can excite only one type of vibration and is intended for use in a specific target group.

Although the theoretical values of the resonant frequencies of open sines can be calculated using mathematical formulas, in practice the measurements of the anatomical parameters are so inaccurate that the calculated and effective values of the resonant frequencies vary significantly and, moreover, are subject to constant change due to the nasal cycle. From a therapeutic point of view, the effective resonant frequency or band of resonant frequencies should be the one at which the sinuses are derived

- 6,022,211 maximum N0.

In FIG. 13A and 13B show an oscillation spectrum for a possible embodiment of the present invention, which provides a maximum concentration signal N0, respectively, for men and women. In the case of men, the measured resonant frequency is lower than the frequency calculated by the formula, while for women, the resonant frequency established by the measurements is higher than the corresponding calculated value. Measurements of the concentration of N0 in the nasal cavity with a resolution of 5 ppb (fractions per billion molecules) show that instead of the average resonant frequency of 144 Hz calculated for men between the minimum value of 130 Hz and the maximum value of 164 Hz, in reality, vibration with a frequency of 120 Hz is optimal. while for women, instead of the average resonant frequency of 227 Hz, calculated between the minimum value of 111 Hz and the maximum value of 348 Hz, in reality, vibration with a frequency of 380 Hz provides a maximum increase in the concentration of N0 in the nasal fats in the case of open sinuses. A similar discrepancy was found with respect to the reduction of mucociliary transport time. The reason for these discrepancies may be that the calculated value of the resonant frequency can actually be obtained only for individual sinuses, for example, for the largest sinus sinus, while in practice the oscillations propagate to all paranasal sinuses, and we determine by changing the concentration of N0 the actual resulting resonant frequency, which refers to each paranasal sinus that contains N0.

The protocol of requirements for the device corresponding to the present invention should also take into account the fact that under the influence of vibration, closed or partially closed maxillary sinuses 2 having a low resonant frequency (9-46 Hz) can open, due to which the resulting resonant frequency will increase sharply and significantly (111-348 Hz), especially in women. Therefore, according to the invention, treatment should always be carried out in a certain frequency range, in a scanning mode. The use of low-frequency vibration (0-111 Hz) is preferable only until the closed sinuses open under the influence of treatment. After that, the effect of vibration should be maintained further at a higher resonant frequency of open sines in order to maximize the concentration of N0 in nasal air. To increase efficiency, it is preferable to raise the vibration frequency for a short time above the expected resonant frequency, so as to also ventilate the paranasal sinuses, which have a volume below the average. At the same time, the accompanying high-frequency noise should be damped to avoid all sorts of negative influences.

The operation of the vibrating device according to the invention and, as an example described above, is shown in FIG. 14 in the form of an algorithm that (in addition to the unique scanning mode of operation) emphasizes two more distinctive features of the device, due to which the device can be used only with its proper position and proper parameters, i.e. The device is characterized by the presence of vertical position control and the period of use / cycles.

After each vibration cycle, a pause (0.1-3.0 ms, see Fig. 12) should be introduced to some extent in order to provide partial replenishment of the sinuses with nitric oxide N0, and on the other hand, because the renewed cycle vibration in the range of its low frequencies contributes to the opening of partially closed sines, which have not yet fully opened during the previous vibration cycle. The general treatment cycle lasting 20-30 s is composed of vibration cycles repeated several times.

Between treatment cycles, 4-5 min breaks should be made to allow the paranasal sinuses to be completely filled with N0 gas. Therefore, in the preferred embodiment, the proposed device is configured to work for a certain time only after being turned on, then the device automatically stops working and cannot be turned on again for the next 4 minutes, because the power-on and time delay stage 12 (Fig. 3) blocks the power-on .

The above examples demonstrate that a device operating in accordance with the calculated resonant frequency of the individual paranasal sinuses is not suitable for ventilation of the biologically active gas N0 from the paranasal sinuses, since this calculated resonant frequency and the resonant frequency measured by changing the concentration of N0 in nasal air are not the same due to several factors. That is, the proper vibration frequency of devices used for therapeutic purposes and suitable for increasing the concentration of N0 in nasal air cannot be determined in advance with sufficient accuracy, and in addition, it is undoubted that the use of a constant vibration frequency will not be suitable for each individual. Several types of time cycles of optimal vibration modes can exist, of which only the experimental protocol can determine the preferred protocol for this group of patients.

The device is brought into contact with the face in the region of the zygomatic bone 4 in such a way that the part of the device where the power source is located is on top, which, for example, is indicated by a protruding arrow on the outer casing of the device. In one preferred embodiment, the device comprises an internal switch 20 that is sensitive to the spatial position of the device,

- 7 022211 which makes it possible to turn on the device only in the correct, close to vertical position. In the indicated position, close to vertical, the vibrations transmitted to the cheekbone will mainly propagate in the direction of the zone of the osteomeatal complex 6 of the maxillary sinus 2. If you try to direct the vibrations down, then the device is held in the correct way (up arrow):

ί) by virtue of its size, it will lie on the temporal or frontal bone and cannot be turned in the direction of the eyeball (inward and upward) or ϊϊ) the internal switch 20, sensitive to the spatial position of the device, will block its operation.

Because of this, the direction of propagation of the vibrations transmitted by the device to the bones of the skull cannot be such that the vibrations directly propagate in the direction of the roots of the upper teeth.

If the consumer began to use the device on the nasal or frontal bone, it would again be impossible to tilt the correctly held device so that the vibrations propagate downward in the direction of the teeth 7, since it is impossible to start the device if it is held at the wrong angle. Therefore, the use of the vibration excitation device in accordance with the instructions will not lead to toothache, since the operation of the device is possible only in the correct position shown in the drawing.

A possible mechanical and, if required, electronic design of the device according to the invention should be obvious to specialists in this field and easy to implement. Possible technical solutions are described one by one and in various combinations in detail in US applications 2008/0200848, 2008/0195001 and 2003/0172939, respectively, the contents of which in relation to the practical implementation of the device can be fully considered as reference material.

Claims (10)

CLAIM 1. Vibration device for the treatment of diseases of the upper respiratory tract, containing a housing (16); mechanical vibrator (11) installed in the specified housing; a power source associated with a mechanical vibrator (11); a mechanical vibration transmitter (19) partially located in the housing and in mechanical and / or physical contact with a vibrator (11), characterized in that the mechanical vibration transmitter (19) is made in the form of a hammer, preventing the transmission of mechanical vibrations with a frequency below the lower threshold values of 50 Hz to the human body, while part of the transmitter (19) of mechanical vibration, which is in direct contact with the human body, is made in the form of an element oscillating at a frequency not exceeding 1500 Hz, and m the mechanical vibrator (11) generates oscillations in the form of a series of at least 10 cycles of increasing the frequency from the lower threshold value of 50 Hz to the upper threshold value of 1500 Hz and decreasing the frequency from the upper threshold value to the lower threshold value, and the execution of the entire specified series is performed for a period of 30 s, while the vibration device is made in the form of a block with a length of 50-100 mm and a width of 15-35 mm, and the vibration device contains a switch (20) that is sensitive to the spatial position, which th guarantees the operation of the device, provided that it is held in the correct position, and the device also contains an acoustic emitter (21) indicating the correct position of the device. 2. The device according to claim 1, characterized in that the vibrator (11) is connected to a control device that determines the frequency of vibration. 3. The device according to claim 2, characterized in that the vibrator (11) contains means of an electric drive, and the control device associated with the drive contains a sawtooth voltage generator supplying the drive means during frequency changing cycles. 4. The device according to claim 3, characterized in that the sawtooth voltage generator is a sawtooth voltage generator with alternating polarity. 5. The device according to claim 3 or 4, characterized in that the sawtooth voltage generator is a sawtooth voltage generator with an interrupted output signal. 6. The device according to any one of claims 3 to 5, characterized in that the sawtooth voltage generator is a sawtooth voltage generator with asymmetric amplitude and alternating polarity. 7. A device according to any one of the preceding paragraphs, characterized in that the control device comprises a time delay stage allowing operation of the vibrator (11) for 30 s. 8. The device according to any one of the preceding paragraphs, characterized in that it contains at least one elastic external vibration damping element (22), which is designed to contact a person's face, does not irritate the skin and can be cleaned. - 8 022211 9. The device according to claim 8, characterized in that the external vibration damping element (22) is located on that surface of the vibration transmitter (19), which is intended for contact with a person’s face. 10. Device according to any one of the preceding paragraphs, characterized in that it contains at least one elastic inner element (22) of vibration damping located between the element of the vibrator (11) and the housing (16).