JP2012521791A5 - - Google Patents

Description

Devices for the suppression of nitric oxide ventilation and upper airway disease in the sinuses

This invention is a device for suppression of the vent and upper respiratory tract of nitric oxide in the sinus, in particular, to a device for washing the sinuses inhibiting the respiratory disease, a housing, said housing A vibration generator disposed therein, an energy supply unit in communication with (connected to) the vibration generator, and mechanical / physical contact with the vibration generator , partly within the housing And a vibration transmitter disposed on the device. The proposed device, upper and lower respiratory tract and the respective diseases pulmonary circulation, for example, rhinitis, sinusitis of various origins, nasal congestion, colds (common in cold), influenza, bronchitis, bronchoconstriction, and chronic obstructive pulmonary disease Suitable for treatment and inspection of (COPD) and the like.

Organisms skull, for example, a human skull bone, some space filled with air, includes a sinus Ru so-called, which is in communication with the nasal cavity. The largest one among sinus, a cavity of a so-called maxillary sinus or face, its volume is 4 ^{cm 3} ~35cm 3 in adults, a 12cm ³ on average. The paranasal sinus is connected to the nasal cavity through a small opening having a diameter of 1 to 3 mm . Mucosa lining the sinuses bonded with the mucosa of the nasal cavity Runode, as nasal and disease sinuses are usually sinusitis, resulting in association.

There are several types of sinusitis. The most common is the common cold, which means inflammation caused by a weak infection of the upper respiratory tract . Foreign substances that cause inflammation, mainly sinusitis caused allergy caused by pollen of plants also often occurs.

So-called "drug-resistant rhinitis" develops by a station nasal vein shrinkage agents for Tokoroteki (locally applicable nasal vein-contracting preparations ) the continuous use over a 7-10 day.

Airway hygiene acts mainly mucociliary transport function may Oite critical importance in the development of respiratory diseases. Mucociliary transport function, mucous membrane of the cilia occurs therefore dynamic Kukoto as whip in one direction. Transport function is affected in the viscoelastic properties of the motion of cilia and mucous substances.

Respect onset of respiratory disease, passing air sinuses are equally important. Obstructed or aeration bad sinus prone to inflammation.

Known methods for ventilation inspecting sinuses is associated with the measurement of nitric oxide gas (NO) amount discharged through the nose. NO is Ri substance der produced in the human body, it has a protective effect.

Treatment of rhinitis and upper respiratory tract disease is usually very simple . Patients rest and hydration, is required, and, in order to alleviate symptoms, towns pain agents and antipyretics, furthermore, antihistamine agents, vitamins, viscosity Eki溶 solution agent (mucus-dissolvent) and expectorants Medicines such as may be given . For the treatment of rhinitis caused by pathogens, there is virtually no suitable drug against the virus. Antibiotics are used for the anti Tome及 beauty treatment of bacterial infections. If rhinitis does not improve with the action of the drug, it may have spread to the sinuses .

Of the diseases of the lower respiratory tract, drugs are used to treat asthma and COPD, but the sudden temporary aggravation of asthma and COPD usually enters the human body suddenly with air since due to the substances that can not be effectively prevented such an event (event) in drug therapy. Thus, if necessary, it makes sense to use a treatment that can rapidly enhance the self-clearing mechanism of the lower respiratory tract respiratory system.

U.S. Patent Application Publication No. 2003/0172939 discloses a method and device that can achieve the elimination of congestion in the internal cavity of the face using vibration. The proposed device for its action includes a handle portion including a power source and vibration generator connected to the external vibration transmitter to transmit the vibration to the hard tissue through the body surface, the external vibration transmitter a, there is a need Keru with press for the selected body surface. According to this document, it is a unique feature of this method is designed device based on it, mainly the ear pain relief or eliminate preparative mechanically congestion mechanical vibrations transmitted Rijo-out, also, the vibration transmitter is designed so as to be firmly sandwiched Mukoto teeth of a pair of user-facing, in the case can be alleviated toothache in the device. Device, subsonic frequency (subsonic frequency), i.e. by applying a frequency lower than the audible range of the human ear, to achieve the purpose. This document, nothing not mention the possibility of liberating NO by vibration, therefore, do not include also proposed specific solutions for that effect.

U.S. Patent Application Publication No. 2008/0195001, which describes devices and methods for alleviating the pain of sinus, again, the device is implemented as a device for transmitting the vibration to the human body. The device in order to be applied in the supine, it has a special curved shape, the vibration transmitter for transmitting the vibration to the body surface is at an angle relative to the longitudinal axis of the device. This configuration also, although intended to remove mechanically loosened debris (or contaminants) and congestive, this document does not mention about the vibration frequency used. The main drawback of this configuration is similar to the devices described above, it is Tei Rukoto tried Rukoto is divided Ward or final sintering takes discomfort deposits and general by producing a mechanical action.

NO concentration in the sinuses, in the healthy human body are well known and exceptionally's go high, 20 to 30 ppm: can reach (parts per million molecules fraction against 1,000,000 molecule). Therefore, a high NO concentrations within the paranasal sinuses, which may have also some protection functions. Attempts to increase the concentration of NO in the nose is to effectively utilize this possibility. Outflow of NO from the paranasal sinuses towards the nose Runode impaired interfere, various technical solutions in order to increase the NO concentration of the nose have been devised.

Lundberg J. and Weitzberg E. found that gas exchange between the sinuses and the nasal cavity increased at the resonance frequency of the sinuses , so that the amount of N 2 O in the nose was significantly increased by vibrating the airflow. (See International Patent Application Publication No. WO 03/063703). According to WO03 / 063703, by utilizing the airflow vibration, or by a device for producing such a stream can be increased N O of the main nose cavity. Airflow vibration by humming close the mouth (that is, to originating voice sounds nasal "m" and "n"), or by the outer Buon source can live Ji Rukoto. Such a device can be used by humans for diagnostic purposes.

However, strong Hamming is rather tired Rukoto, also if the air flow from the nose by swollen nasal mucosa already inhibited, and Hamming to be out wear air through the nose, the external inhaling air was vibrated by using a device from the nose can not be realized. Therefore, in most patients, applying an oscillating airflow to ventilate the sinuses is not clinically applicable.

International Patent Application Publication WO 03/013653 discloses another possibility for the treatment of rhinitis. This is the application of light to be irradiated (point) through the nose, in other words Rhino phototherapy (light therapy nose (rhinophototherapy)). Similar solutions have also been placing serial, for example, in U.S. Patent Application No. 2006/0271024. Rhino photo therapy also, there is a disadvantage not be used in the case of a stuffy nose.

One of rhinitis or treatment definitive main problems of sinusitis is that patient cooperation think of uncomfortable but not dangerous diseases tends to be low. They are, symptoms might stop the mitigation Then treatment, when Tsu return the element Te symptoms is a matter of course, such but not to La same treatment is less effective, or no effect. Thus, there is considerable demand against the simple and effective method of treatment that can kick receiving is patient in parallel with daily day Tsunekatsu movement.

The vibration parameters of maxillary sinus and frontal sinus can be represented by Helmholtz's formula , which is a well-known formula , and the resonance frequency is the volume of the cavity and the neck of the cavity at a constant vibration spread velocity. measured diameter is a function of the length of及beauty neck portion.

We, when I was measured using the method described in International Patent Publication WO03 / 063,703 mentioned above, we, higher NO levels in the nose against the diseases of the upper and lower airways treatment It was unexpectedly found and Turkey, which have a effect. In addition, care that method can not be applied in the case of a significant or complete nasal congestion, further, there is a significant difference in the therapeutic effect by man, in therapy of those diseases, which vibrates the application of flow is not advantageous. Thus, to treat a patient, a method or device is suitable for providing and therapeutic effect suitable for increasing the amount of NO in the upper airways and Shitaki canal in the case of nasal congestion is required .

As disclosed in U.S. Patent Application No. 2008/0200848, there is applied a result therapeutic effect vibration to sinus near the face. However, vibration generated in the vicinity of the maxillary sinus spreads over the entire root of the upper molar, so that the vibration generator described in US Patent Application No. 2008/0200848 is very sensitive to toothache. -ache). While it is possible to reduce the performance of the vibration generator that apply to maxilla or near, a result, reduces the amount of NO flowing vigorously from the maxillary sinus to the main nasal cavity, therefore, the treatment of nasal The effect will be reduced as well. Accordingly, the vibrational energy to a vibration generating device such as to transmit only the top side of a top portion of the upper Agohora, and the vibration is not spread to the roots in the Kabe及 beauty / or near the lower maxillary sinus Things are sought. Considering the complexity of the human skull, the actual behavior of the mechanical vibration at spatial surface is provided with a an elaborate shape sutures, because they have no Ki De advance modeling parameter, this the manufacturing of the species of the vibration generating device, requires careful experimentation analysis.

From our experiments, surprisingly, perpendicular to the longitudinal section of the nose, vibrations transfer our from between the skull above the cheekbones, without being provoked toothache, increasing the amount of NO in the nose and Turkey was revealed. Vibration generated on cheekbones, a part is reflected at the junction between the cheekbone and the maxilla I through the three extensions of the cheekbone, and partially, the upper jaw bone and the frontal bone and the temporal bone Although of the mastoid penetrate, where the vibrations penetrate already echoes while a multiple direction changes of dispersed and Ru significantly weakened Empire. 3-way split vibration wave direction, the next to the total nasal (common nasal cavity), recombine in the region of the so-called Chuhana canal natural port root (osteomeatal complex). The top side of a top portion of the maxillary sinus is located in the cheekbones. More than 90 percent of the volume of the maxillary sinus existing in the maxillary bone, but surprisingly, by the vibration of the cheekbones that reachable on top of the upper maxillary sinus, in a total amount of NO accumulated in the maxillary sinus itself may also be washed away even whole nasal cavity.

However, even that part of the device which is brought into contact with is human facial described in U.S. Patent Application Publication No. 2008/0200848 in contact with the cheekbones, did not occur increase of NO in the nose. Perhaps, the frequency of the vibration generated by the device is not adapted to the resonance frequency of the maxillary sinus, believed therefore gas exchange between the maxillary sinus and the nasal cavity was not enhanced.

First, the volume and the resonance frequency of the maxillary sinus, varies greatly depending on individuals, further Niso Re et together continuously changing and between time even individuals, are known generally that. Contact Keru change over time to a particular individual is due to the so-called Nezaru cycle (nasal cycle). During Nezaru cycle, mainly by tumor are changes in the mucous membranes, internal cross-section of the nose varies periodically. Changes in mucosal thickness affect both the cross-section and length of the paranasal stoma (natural mouth) . Resonance parameter, a narrowing of the opening of the natural port Ru good to Re tumor mucosal therewith continuously changed by the influence of the result of increased length of the natural port at the same time, it is difficult to calculate for them. Therefore, we, the vibrations are applied to the actual resonant frequency and the number of times of the sinuses to match, in a preset range by manual control of the duration of one treatment cycle, continuously frequency it is require a vibration generating device that can be changed. However, the mechanical structure according to US Patent Application Publication No. 2008/0200848, such as cause strong noise if the frequency change is fast, mechanical pressing on the track advances free some inert mass (masses) includes, and the output of the impulse (power impulse), resulting in the early decrease of the suspension point of the dynamic rather mass (suspension points) a (erosion).

It Helmholtz resonance frequency of the paranasal sinuses would that differ for each person, even more particular individuals, since the Helmholtz resonance frequency of the paranasal sinuses is continuously changed by Nezaru cycle, above vibrations generated by the device teeth can be scanned without straining pulling force toothache, a and resonant frequency suitable for the treatment of human respiratory diseases suitable for Ru typical increasing N O amount nasal cavity to the human sinus spread to, There is a need to develop vibration generating devices for therapeutic purposes .

We recognize that there are fast rotation change (revolution change) is possible, necessary that have a its components significant wear (attrition) as not subjected to a mechanical vibration generator in the desired frequency range did.

The vibration generating devices known in the prior art typically include a power source, a switch, and other subunits to facilitate their use, which provide attached vibration component ( s) . However, vibration due to the multiple component system generates more noise. Frequency noise, whereas there is a possibility to reach the tooth roots of the upper teeth, the low frequency noise can cause eye injury. Therefore, such a device, the human body, any potentially harmful noise is required bets go a reach Den.

In order to reduce noise, it is possible to use internal and external damping structures ( damping structures ) , for example. Inside noise damping (noise reduction) can be achieved by the incorporation of damping material, or by tight mechanical fitting of the various vibratory parts. Using the inside of the vibration damping material (damping material) is limited by an increase in size of the device. Meanwhile, the tight integration of the inner Busa subunit of the device, thereby deteriorating the exchange of power.

We have surprisingly engaged the human face so that vibrations above 1500 Hz are not transmitted to the facial bone, and also operated in intermittent mode , reducing the vibration frequency from lower to upper limit in 30 seconds. when changing at least 10 times, only those versions of the vibration generating device manufactured in various technical shape has been found that it is suitable for the treatment of each disease of the upper and lower airways.

The purpose of these and other inventions, as claimed in claim 1, which is achieved by a device particularly for inhibiting the disease of passing Ki及 beauty upper respiratory tract of nitric oxide in the paranasal sinuses.

Some further advantageous condition like of the invention are described in the dependent claims.
In the following, the invention will be described in more detail with reference to the accompanying drawings which show typical embodiments of the proposed device.

FIG. 1 schematically shows the part of the face affected by the present invention with respect to the details of the human face. Figures 2a and 2b are diagrams device proposed stressed around the maxillary sinus to exert effects. FIG. 3 is a possible block diagram of a vibration generator. FIG. 4 is a possible schematic diagram for a device according to the invention. FIG. 5 is a diagram illustrating a possible time course of the vibration frequency generated by the vibration generator. Figures 6a and 6b are diagrams illustrating another possible time course of the vibration frequency generated by the vibration generator. Figure 7 is a diagram showing the jig 療効 results of the device of the present invention in different vibration. Figure 8 is a diagram showing the jig 療効 results of the device of the present invention in different vibration. 9, with each adult men and women is a diagram showing the Lab Kiwamuyui results of typical acoustic nasal measurement method (acoustic rhinometry). Figure 10 is attached to each of the adult men and women is a diagram showing the Lab Kiwamuyui results of typical acoustic nasal measurement method. Figure 11 is a graph showing changes in resonant frequency of the maxillary sinus by men and women of Nezaru cycle. FIG. 12 is a diagram showing the vibration frequency in a possible embodiment of the device according to the invention. 13A and 13B, when the typical maximum nitric oxide signal caused can pull on each of men and women, is a diagram showing a vibration spectrum in a manner of possible device according to the invention. Figure 14 is a schematic diagram of a block diagram of how a potential manipulation of the device according to the invention.

<Best form>
Figure 1 shows a part of the appearance of a human face, which region the affected of the present invention is shown. This figure includes a frontal sinuses 1, and maxillary sinus 2 illustrates a lacrimal 3 line. Within maxilla, vibrations extending down direction in line of the lacrimal 3 reaches the upper teeth, causing toothache.

FIG. 2a provides a close-up view of the cheekbone 4 and the arrow 5 indicates the direction of vibration applied. Figure 2b is a maxillary sinus 2, the middle meatus natural port Route 6 (position of the small holes in the nasal cavity), shows the position of the upper teeth 7. The direction in which vibration is to be transmitted to the cheekbone 4 is again indicated by arrows 5.

Figure 3 is a block diagram level, shows a state like that may of the device according to the invention. The specific configuration of each unit should be particularly noted is obvious taking to those skilled in the art based on their function. The vibration generator known from the prior solutions is associated with the present invention with a new type of control unit. In Example shown herein, the function generator for generating a applied waveform (function generator) has sawtooth generator formed by a microprocessor 8 (saw-tooth generator) - may also sometimes something else - - and, if example embodiment, it may be of a type Atmel aT tiny 26 1 that operates in a normal connection. Sawtooth generator is intended to start by the switch 9, the switch 9 is not shown separately diagram in FIG surface, manually operated so is facilitated, in the case of predetermined on the housing of the device of the present invention You may implement | achieve as a push button comprised in this . Microprocessor 8 generates a preset voltage value and frequency value by it, is led to the motor 11 through the vibration sensor 10. Motor 11, which essentially constitutes the main part of the vibration generator, and in certain instances, for example, Penny motor series (Penny motor Series) 1202 or foul Harbor Motor Series (Faulhaber motor Series) of 0206 such as a high it is a vibration motor rotation speed, a variety of motor 11 commonly used in such devices can also be used to properly set the parameters.

Furthermore, the sawtooth generator of the microprocessor 8 is partly ideal and essential according to our measurements, in part for linking the power supply 13 of the device to the sawtooth generator and in part optional. in order to provide the 30 seconds treatment cycle, Ru is connected to the switching timing stage. The vibration sensor 10 utilizes one or several electrical transducers to monitor the generated frequency and amplitude, and by a sawtooth generator with (or with) a nominal frequency and amplitude defined. Provide feedback that affects the generation of expected vibrations. Stage 12 is connected to the spatial position switch (spatial position switch) 20, for its role will be described later herein.

A preferred embodiment of the device according to the present invention includes a microprocessor 8 which can be reprogrammed from several modes of operation in external computer, The optimum frequency scan mode of operation can be started from memory. Thus, the device can be efficiently used for several different patient groups. To ensure the optimal effect, preferred embodiments according to the present invention can write Mukoto set the rotation sensor or vibration sensor on a portion of Lud vice be in contact with the human body, its From there the microprocessor in a known manner 8 and provide feedback to, it will maintain the operation parameters to the desired numerical value within range.

FIG. 4 is a schematic diagram of a possible physical realization for a device according to the invention , but can vary within the scope of availability , need and possibilities. To provide a handheld resistance (hand-holdability), rod de-shaped housing 16 which is disposed within the outer shell member (mantle) 15 designed, when using the electric vibration generator, the power supply 17 (Which may be a battery, an accumulator or other current source). Vibration controller includes a switching timer stage 12, a microprocessor 8 having a sawtooth generator, and a vibration sensor 10. Then in may vibration generator, an electric motor 11, seen including an eccentric wheel 11 formed from the axis (ax) and with or is wedged thereon (wedged) the same piece, the housing of the device 16 (essentially vibration transmitter) hammer 19, shown with and abstract protruded from the side surface to transmit vibration through the. Spatial position switch 20 ensures the operation of the device only when held in the correct position, it is the correct attitude elements are indicated by the sound emitters 21. The entire device is a length 50 to 100 mm, the width (when using a cylindrical housing which diameter) can be designed as a unit of 15 to 35 m m, attached to key holder to cut the apply any time You can also.

According to the present invention, in order to avoid toothache, vibration transmitters of the device of the present invention which makes touching contact with the human body comprises partially damping material (vibration damper element or damping element 22), the on the other hand, by its design, not Rukoto vibrations generated by the device is spread downwardly toward the tooth, but is divided along three extensions of zygomatic 4, and the upper teeth significantly attenuated was only as arrival reached in a form, it is possible to hold the device in a natural grip.

With respect to its technical structure, the device is no more than two independent mechanical subparts (piezoceramic, or axis of polarization Kokoroho Eel 18, or mechanical elements moving in electromagnets) a vibration generator constructed from, Contains at most one. Furthermore, the device comprises at least one internal vibration damping element is flexible or elastic (internal damping element) (e.g., a spring such as depressing the power supply 17) and, to come in contact to the human face, gently and cleaning the skin easy includes at least one external vibration damping element (external damping element) 22, a. Known vibration damping material friendly to the skin, but the PVC there is a free Ndei no urethane foam rubber, since a long period of time or hunt for drying the moisture (moisture) that has entered the inside off Omu, easy to clean is not. There are also skin-friendly silicone rubber vibration damping materials with a waterproof surface, but these have low low sound attenuation.

The simplest mechanical vibration generating device is an eccentric wheel mounted on the rotating shaft, rotation of the shaft, the magnetic field or caused depending on the mechanical force of some kind related to the axis. Eccentric wheel which rotates results in vibration of the shaft of the motor 11, it is fixed part of the shaft, the housing 1 6 of electric motor 11, and, transmitted to the casing 15 of the electric motor 11, a hammer part 19 located thereon vibrations Is designed to convey to the human body. Hammer part 19 is perpendicular to the axis of the electric motor 11, also the surface of the hammer part 19 in contact with the human body, namely the vibration damping element (damping element) 22 is either flat line with respect to the axis of the motor 11, also is at an angle of 45 ° at the maximum. Vibration wave divided into cheekbone 4 3-way direction, in the region of the so-called Chuhana canal natural port routes 6 are recombined on outside side wall of the total nasal (lateral wall), therefore, the vibration caused by the device reaches mainly arrival at the top of the upper maxillary sinus 2. Vibration penetrate the maxilla, after even long distances hundreds of times, at a significantly dispersed by weak wait form is only reachable on teeth, no teeth pain is caused to follow.

FIG. 5 shows a typical frequency time course generated by the sawtooth generator of the microprocessor 8. In the present case, the sawtooth generator produces intermittent linear frequency strokes , which take a frequency range from 50 Hz to 1500 Hz over a period of about 1 second in one vibration cycle. Scan several times. As already mentioned, the time of the entire treatment session (total treatment session) will not exceed 30 seconds, this is ensured by the switching timing stage 12.

6a and 6b show a diagram similar to FIG. 5, but the duration of the oscillation cycle here is much shorter than 1 second. The frequency stroke depicted in FIG. 6a is generated by the alternating polarity current shown in FIG. 6b, and in fact, the opposite is such that the amplitude of vibration in the opposite direction is equal. This means that the vibration is realized in the direction of rotation . Change in polarity, the electric motor 11 for generating vibration check (check or suppression: check) and is, therefore, time individual frequency stroke is shorter, and, the entire treatment session exceeds 30 seconds Absent.

7 and 8 show the effect of treatment using the device according to the invention with different vibrations. FIG. 7 shows nasal NO release levels at various vibration parameters. If the device is applied in scan mode, the highest NO levels arise. As can be seen from FIG. 8, NO washed out from the sinuses improves mucociliary transport in the nose , as shown by a decrease in mucociliary transport time (saccharin test) . The greatest change occurs when the device is used in scan mode.

Furthermore, as shown in FIGS. 7 and 8, the male and the female, the degree of induced effects are different. This Nezaru cycle about influence to the resonant frequency of the paranasal sinuses is different for men and women, it is explained by the fact that.

9 and 10, a continuous and sex-specific for internal parameters of the nose during Nezaru cycle indicates the (sex-specific) measurement experiments showing changes result, even acoustic nasal measurement method if example embodiment Can be inspected. In During Nezaru cycle, when reducing the swelling Hananeba film (decongestants), the opening of the sinus in the nasal cavity (stoma) is expanded, therefore, the resonance frequency of the paranasal sinuses is increased. Figure 9 shows a diagram of an exemplary acoustic nasal calibration method for an adult male, the volume is increased to 6 cm ^3. Figure 10 shows the same measurements for adult women, changes are larger than normal, the device was no longer able to detect it. It was recorded in 1 minute intervals. Point P indicated by the arrow, left a small hole in the maxillary sinus 2 of the right side their respective. Nezaru when stoma during cycle has expanded, the arrow in the upper (Above arrow) of the measurement curve cross-sectional area of good Ri have large nose indicates Kan which ultrasound is refracted from the sinuses (J.Appl. Physiol. 99: 616-623 2005).

Another reason change in resonance frequency due Nezaru cycles that are different for men and women is a benzalkonium different the values of flat HitoshiHiroshi product of sinus. Women is the volume of the sinuses is small, therefore, the defect resonance frequency sinus opening becomes high. If sinus is Ji or partially closed closed, the difference between men and women is less pronounced. This can be seen in Figure 11, which shows the change in the man (front row) and the woman (back row) with in the resonance frequency of the on Agohora 2 Ru good to Nezaru cycle. In men, the resonance frequency is turned into strange in the range of 9~164Hz. Due to the therapeutic effect with the device according to the invention , the sinuses open and the resonance frequency of the open sinuses is in the range of 132-164 Hz, with an average of 144 Hz (n = 5). In women, the resonance frequency is you are changes in the range of 9~348Hz. Due to the therapeutic effect with the device according to the invention , the sinuses open and the resonance frequency of the open sinuses is in the range of 111 to 348 Hz, with an average of 227 Hz (n = 5).

Maximum vibration device, when operating at the resonant frequency of a typical sinus of the actual, and the ventilation of the sinuses filled with nitrogen oxide (NO), and N O amount therewith measured simultaneously in in the nose to become. Accordingly, devices used to treat aeration various diseases maxillary sinus 2 through elevated NO levels nasal, men, women, children or other subgroups (Asians, Africans or white) for to, should be to allow operation at a particular frequency scan mode, respectively. Figure 12 shows a representative sample of the vibration frequency of the possible states like the device according to the present invention. First vibration (12A) is wax that vented by opening the maxillary sinus 2 male Caucasian, second oscillation (12B) is vented by opening the maxillary sinus 2 of Caucasian women. Vibration modalities illustrated with a simple example shown (vibration Form: Vibration modality) was added to the 12A and 12B, other vibration pattern may also comprises generating, for example for children. During the treatment session, vibration modality that has been shown Hisage herein, in the order in which they were selected in the individual's discretion, repeatedly been able to combine, against gender, in different individuals of like age depending on it it is ensured that the effective use of the device according to the present invention Te. Although Ru Oh obvious to one of ordinary skill in the art, the device according to the present invention, for use as a treatment device of the target group, can also be designed as a device which only vibrations of one type can occur.

Theoretical resonance frequency of the paranasal sinuses that open, can be calculated by a formula, in fact, since the anatomical parameters measurability is very inaccurate, calculated effective resonant frequency significantly different , And moreover, they undergo continuous changes due to the nasal cycle . From a therapeutic point of view, an effective resonant frequency or resonant frequency band should be one that results in maximum NO efflux from the sinuses .

FIGS. 13A and 13B show vibrational spectra in a possible embodiment for a device according to the present invention when causing a maximal nitric oxide signal , typical for males and females , respectively. For males, the measured resonant frequency is lower than the value calculated based on the formula, and for females , the resonant frequency defined by the measurement is higher than the corresponding calculated value. NO measurements nasal 5ppb definition (5 ppm definition), in men, instead of the average resonance frequency 144H z, which is calculated between the minimum 1 30 Hz and maximum 1 64 Hz, in practice, the optimum value a vibration of 120 Hz, while in women, instead of the average resonance frequency 227H z, which is calculated between the minimum 1 11 Hz and maximum 3 48 Hz, in practice, the secondary vibration of 380h z is opened the nasal cavity is indicates that provide maximum NO concentration rise at the nose. Similar shifts are found with respect to reduced mucociliary transport time. The cause of these deviations, calculated resonant frequency, the actual Toko filtration individual sinuses, for example, while the Ru can be provided only for the maxillary sinus maximum capacity product, in fact, vibration has spread to the sinus of all, we through a change in NO concentration, was applied to all sinuses including NO, probably because defining the resonant frequency resulting from the actual .

The specification of the device according to the present invention the protocol, the effect of vibration, and have a lower resonant frequency (9-46Hz), can open a closed or partially closed had large maxillary sinus 2, as a result, the resonant frequency resulting, particularly in the case of women, will increase rapidly and significantly (111~348Hz), and should take into account that say. Therefore, according to the present invention, treatment should always be performed in scan mode within a specific frequency range. Until open sinuses closed by the effect of the treatment, it is preferable to apply the vibration of a low frequency (0~111Hz).
Thereafter, to cause the increase of the maximum NO concentration nose, a higher resonance frequency of the paranasal sinuses open, it is necessary to apply a more long vibration. For efficiency, the vibration frequency, is raised above the expected resonant frequency of at a short time, it is preferable to allow air flow smaller than the average volume sinuses. At the same time, in order to prevent any negative effects, it is necessary to attenuate the noise generated in higher vibration frequencies simultaneously.

- As an example of a possible - operation mode of the device according to the present invention described above is shown as a flowchart in FIG. 14, in addition to applying unprecedented previous scan mode, after the device 2 One of the essential and characteristic is emphasized, raw pharmacologically suitable location and parameters, i.e. is observed only in the control of the control and duration of use / cycle vertical position.

In order to ensure partial refilling by NO sinus, no gap vibration after each oscillation cycle must put (0.1-3.0 ms, see Fig. 12), while Thus, the low frequency cycle in the restarted vibration cycle facilitates the opening of a partially closed sinus that did not fully open during the previous vibration cycle. All treatment session of 20 to 30 seconds, Ru consists oscillation cycle that is repeated several times.

Sinus to fully refilled with NO gas, between the therapy session and treatment session, it is necessary to take a break for 4-5 minutes. Thus, in a preferred embodiment of the proposed device, the device, a certain time but only the operation after switching, then automatically stopped, and the next period of 4 minutes, switching timer stage 12 interfere (block: block) not be restarted because (see FIG. 3).

The above-described example, the calculated resonant frequency, and is measured resonant frequency from the change in NO concentration of the nose, since some non-identical due to factors, at the resonance frequency calculated for each sinus device operating is in proof that not suitable for aeration of the biologically effective nO gas from the sinuses. That is, a vibration frequency of the device that is used for therapeutic purposes that suited to improve the NO concentration nose, advance can not be defined with appropriate accuracy, further, constant vibration frequency application of, all of the individual to take it not be said to be appropriate and is not a Ma違. Over time route optimum vibrational mode (chronological courses) There are several types, among them, preferred protocols taking a particular group of people can be determined experimentally to result only.

The device, as indicated by the arrows out jump on the device outer casing For example, in a state where the portion including the energy source located at the top, and the cheekbone cheekbone of (zygomatic bone) 4 in the region (cheekbone) Contacted. In one preferred technical embodiment, the device is to take only the correct orientation almost vertically device during operation includes an inner space position 置Su switch 20. Oite to the substantially vertical attitude, vibration transmitted to the skull, will be spread to the mainly towards the part in the nasal passages natural opening root 6 of the above Agohora 2.

Assuming that an attempt that directs vibrations down was made, (in an upward arrow) correctly held device,
i) placed against its size because the temporal bone or the frontal bone becomes Rukoto, (inwardly and upper facing towards the orbit) or can not change the orientation, or ii) the internal spatial position location switch 20 but either blocking the operation of the device, it is either.

Thus, the direction of vibration transmitted by the device to the skull cannot spread directly toward the root of the upper teeth .

Since the device held at the wrong angle cannot be triggered, if an individual uses the device on the nasal bone or frontal area, the correctly held device should be placed so that the vibration spreads downward toward the teeth 7. it can not also be tilted. Thus, the device, since it is only possible to operate at shows Suyo a correct orientation in the figure, the vibration devices therefore apply to the guide will not cause a toothache.

For devices according to the present invention, if possible mechanical and are suitable, child structure electrodeposition will be apparent and easily understood by those skilled in the art. Adopted may solutions are U.S. Patent Application No. 2008/0200848, each of the No. 2008/0195001 item and the second 2003/0172939, one by one and in various combinations, are described in detail, they disclosure of, in carrying out the device according to the present invention, is considered to be references a sufficient extent.