Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
  • A61H23/00—Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms
  • A61H23/02—Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms with electric or magnetic drive
  • A61H23/0218—Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms with electric or magnetic drive with alternating magnetic fields producing a translating or oscillating movement
  • A61H23/0236—Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms with electric or magnetic drive with alternating magnetic fields producing a translating or oscillating movement using sonic waves, e.g. using loudspeakers
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
  • A61H7/00—Devices for suction-kneading massage; Devices for massaging the skin by rubbing or brushing not otherwise provided for
  • A61H7/002—Devices for suction-kneading massage; Devices for massaging the skin by rubbing or brushing not otherwise provided for by rubbing or brushing
  • A61H7/004—Devices for suction-kneading massage; Devices for massaging the skin by rubbing or brushing not otherwise provided for by rubbing or brushing power-driven, e.g. electrical
  • A61H7/005—Devices for suction-kneading massage; Devices for massaging the skin by rubbing or brushing not otherwise provided for by rubbing or brushing power-driven, e.g. electrical hand-held
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B06—GENERATING OR TRANSMITTING MECHANICAL VIBRATIONS IN GENERAL
  • B06B—METHODS OR APPARATUS FOR GENERATING OR TRANSMITTING MECHANICAL VIBRATIONS OF INFRASONIC, SONIC, OR ULTRASONIC FREQUENCY, e.g. FOR PERFORMING MECHANICAL WORK IN GENERAL
  • B06B1/00—Methods or apparatus for generating mechanical vibrations of infrasonic, sonic, or ultrasonic frequency
  • B06B1/02—Methods or apparatus for generating mechanical vibrations of infrasonic, sonic, or ultrasonic frequency making use of electrical energy
  • B06B1/0207—Driving circuits
  • B06B1/0223—Driving circuits for generating signals continuous in time
  • B06B1/023—Driving circuits for generating signals continuous in time and stepped in amplitude, e.g. square wave, 2-level signal
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
  • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
  • A61H2201/01—Constructive details
  • A61H2201/0119—Support for the device
  • A61H2201/0153—Support for the device hand-held
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
  • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
  • A61H2201/01—Constructive details
  • A61H2201/0173—Means for preventing injuries
  • A61H2201/0176—By stopping operation
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
  • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
  • A61H2201/16—Physical interface with patient
  • A61H2201/1602—Physical interface with patient kind of interface, e.g. head rest, knee support or lumbar support
  • A61H2201/1604—Head
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
  • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
  • A61H2201/50—Control means thereof
  • A61H2201/5023—Interfaces to the user
  • A61H2201/5041—Interfaces to the user control is restricted to certain individuals
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
  • A61H2205/00—Devices for specific parts of the body
  • A61H2205/02—Head
  • A61H2205/022—Face
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
  • A61H2205/00—Devices for specific parts of the body
  • A61H2205/02—Head
  • A61H2205/022—Face
  • A61H2205/023—Nose
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
  • A61H2205/00—Devices for specific parts of the body
  • A61H2205/02—Head
  • A61H2205/022—Face
  • A61H2205/025—Forehead

Definitions

• the invention relates to a device for ventilation of nitric oxide in the paranasal sinuses and the suppression of diseases of the upper respiratory tract , especially to wash over the paranasal sinuses to suppress respiratory disorders, said device comprising a housing; a vibration generator arranged in the housing; an energy supply unit connected to the vibration generator; a vibration transfer unit in mechanic/physical contact with the vibration generator, partly configured in the house.
• the proposed device is preferably suitable for the treatment and examination of diseases of the lower and upper respiratory tracts and of the pulmonary circulation, respectively, such as, for example, rhinitises, rhinosinusitises of various origins, nasal congestion, common cold, flu, bronchitis, bronchus contraction and chronic obstructive pulmonary disease (COPD).
• diseases of the lower and upper respiratory tracts and of the pulmonary circulation respectively, such as, for example, rhinitises, rhinosinusitises of various origins, nasal congestion, common cold, flu, bronchitis, bronchus contraction and chronic obstructive pulmonary disease (COPD).
• COPD chronic obstructive pulmonary disease
• a skull of a living being e.g. a human skull contains several air-filled spaces, so-called paranasal sinuses, communicating with the nasal cavity.
• the biggest of the paranasal sinuses is the so-called maxillary sinus or facial cavity, the volume of which is, in adult humans, 4 cm 3 to 35 cm 3 , on average 12 cm 3 .
• Paranasal sinuses are joined to the nasal cavity via small orifices of a diameter of 1 to 3 mm. Since the mucous membrane which lines the sinuses is united with the mucous membrane of the nasal cavity, the diseases of the nasal cavity and of the sinuses usually occur in correlation, as rhinosinusitis.
• Rhinosinusitis has several forms. The most frequent one is common cold, meaning inflammation due to a weak infection of the upper respiratory tract. Rhinosinusitis of allergic origin, due to alien substances, mainly vegetable pollens, causing inflammation is also frequent.
• Mucociliar transport is produced by the one-way whip-like motion of the cilia of the mucous membrane. Transport is influenced by the movement of the cilia and the viscoelastic properties of the mucous material.
• NO nitric oxide gas
• US 2003/0172939 discloses a method and the device whereby it can be realised to eliminate congestion in the internal facial cavities with the help of vibration.
• the device proposed to that effect comprises a handle part containing a power source and a vibration generator, connected to an external vibration transmitter, and it is this external vibration transmitter that must be pressed against the selected body surface, so as to transmit vibration through the body surface to the hard tissues.
• the device is designed accordingly, that it is to eliminate congestions mechanically, via the transmitted mechanical vibrations, mainly to reduce or eliminate ear pain, and the vibration transmitter is designed so that the user can grip it between an opposing pair of teeth, in which case the device can relieve tooth-ache according to the document.
• the device achieves its purposes by applying subsonic frequency, i.e., a frequency below the audibility range of the human ear.
• subsonic frequency i.e., a frequency below the audibility range of the human ear.
• US 2008/0195001 describes a device and a method to alleviate pain in the sinuses, where the device is again realised as a device which transmits vibrations to the human body. To make the device applicable also in lying position, it has a specially curved shape, and the vibration transmitter that transfers the vibrations to the body surface is at an angle with the longitudinal axis of the device.
• This configuration too, is meant to mechanically loosen and eliminate debris and congestion, but the document makes no mention of the vibration frequency being used.
• the main drawback of this configuration the same as of the device mentioned before, is that it tries to eliminate or terminate the deposits and the bad general feeling by producing a mechanical effect.
• WO 03/013653 discloses another possibility for the treatment of rhinitis. This is the application of light pointed into the nose, in other words: rhinophototherapy. Similar solutions are described also in e.g. US 2006/0271024. Rhinophototherapy, too, has the disadvantage that it cannot be used with a stuffy nose. Disclosure of Invention Technical Problem
• vibration parameters of the maxillary and frontal sinuses can be described by a known mathematical formula, the Helmholtz equation, where resonance frequency is the function of the volume of the cavity, the diameter measured at the neck of the cavity and the length of the neck at constant vibration spread velocity.
• the upper apex of the maxillary sinus is located in the zygomatic bone. Although more than 90 percent of the volume of the maxillary sinus is in the maxillary bone, surprisingly, the vibrations in the zygomatic bone which attain the upper apex of the maxillary sinus are capable also in themselves to wash over to the nasal cavity the total amount of NO stored in the maxillary sinus.
• the volume and resonance frequency of the maxillary sinus is, firstly, highly different by individual and, furthermore, it changes continuously with time in each individual. Change with time in a given individual is due to the so-called nasal cycle.
• the nasal cycle the internal cross-section of the nose changes periodically due mainly to the change in the swelling of the mucous membrane.
• the changes in the thickness of the mucous membrane affect both the cross-section and the length of the ostium of the sinuses.
• the resonance parameters change continuously under the effect of the resultant of the narrowing of the opening and the simultaneous increase of the length of the ostium due to the swelling of the mucous membrane, and hence they are difficult to calculate.
• the Helmholtz resonance frequency of the paranasal sinuses may differ in humans, and since the Helmholtz resonance frequency of the paranasal sinus of a given individual changes continuously with the nasal cycle, it is necessary to develop a vibration generator device for therapeutic purposes which will scan the possible resonance frequencies typical of paranasal sinuses in humans and is suitable for increasing the quantity of NO in the nasal cavity and for the treatment of respiratory diseases in humans, so that the vibrations generated by the device shall not spread on the upper teeth and cause tooth-ache.
• Vibration generator devices known in the art usually comprise a power source, a switch and other sub-units to promote their use, which represent attached vibrating components.
• the vibration of multi-component systems generates more noise. High-frequency noise can reach the roots of the upper teeth, whereas low- frequency noise can cause eyeball impairment. Therefore, such device is needed as will not transfer any potentially harmful noise to the human body.
• Figure 1 is a detail of the human face where the facial parts affected by the invention are sketched;
• Figures 2a, 2b highlight the surroundings of the maxillary sinus upon which the proposed device exerts its effect
• FIG. 3 is a possible block diagram of the vibration generator
• Figure 4 is a sketch of a possible embodiment of the device according to the invention.
• Figure 5 shows a possible course of the vibration frequency produced by the vibration generator
• Figures 6a, 6b show other possible courses of the vibration frequency produced by the vibration generator;
• Figures 7 and 8 show the effect of treatment with the device according to the invention at different vibrations;
• Figures 9 and 10 show representative acoustic rhynometric study results in adult males and females, respectively;
• Figure 11 shows the changes in the resonance frequency of the maxillary sinus due to the nasal cycle in males and females
• Figure 12 shows the vibration frequency of a possible embodiment of the device according to the invention.
• Figures 13A and 13B show the vibration spectrum of a possible embodiment of the device according to the invention when the maximum nitric oxide signal typical of men and women, respectively, is triggered, and
• Figure 14 sketches a possible method of the operation of the device according to the invention on a block diagram. Best Mode
• Figure 1 shows the general overview of a part of the human face, in which areas affected by the invention are indicated.
• the figure shows frontal sinus 1, maxillary sinus 2 and the line of tear duct 3. Vibrations spreading downward in the maxillary bone, in the line of tear duct 3, reach the upper teeth and cause tooth-ache.
• Figure 2a provides a closer view of zygomatic bone 4, where arrow 5 indicates the direction of the applied vibrations.
• Figure 2b shows maxillary sinus 2, osteomeatal complex 6 (location of the ostium of the nasal cavity), and the position of the upper teeth 7. The direction in which the vibration is to be transmitted to zygomatic bone 4 is again marked by arrow 5.
• FIG. 3 shows a possible embodiment of the device according to the invention at block diagram level. Note that, on the basis of its function, the concrete structure of each unit will be obvious to a person skilled in the art.
• the vibration generator known from earlier solutions is associated according to the invention with a novel-type control unit.
• a function generator producing the applied wave form is a saw-tooth generator - by the way, it may be something else -, made of microprocessor 8, which can be, for example, of the type Atmel AT tiny 261 operating in the customary connection.
• the saw-tooth generator is activated by a switch 9, which is realised in the given case as a push-button configured on the housing of the device according to the invention, not indicated separately in the drawing, in a way that provides for easy manual operation.
• Microprocessor 8 produces pre-set voltage values and through that frequency values, conducted through vibration sensor 10 to motor 11.
• Motor 11, which essentially constitutes the main part of the vibration generator is, in the given example, a high-revolution vibration motor, such as Penny motor Series 1202 or Faulhaber motor Series 0206, but any motor 11 customary in such devices can be used with appropriate parameter settings.
• the saw-tooth generator of microprocessor 8 is connected to a switching and timing stage 12, partly to link power source 13 of the device to the saw-tooth generator, and partly, optionally, to provide for the 30 second treatment cycle which is ideal and necessary according to our measurements.
• Vibration sensor 10 monitors with the help of one or several electrical transducers the frequency and amplitude of the vibration produced, and provides feedback which influences the production of the envisaged vibration, with a defined nominal frequency and amplitude, by the saw-tooth generator.
• Stage 12 is connected to spatial position switch 20, the role of which will be described in the document later on.
• a preferred embodiment of the device according to the invention contains a microprocessor 8 that can be re-programmed from an external computer in several modes of operation, and the optimum frequency scanning modes of operation can be activated from the memory. Consequently, the device can be used efficiently with several kinds of patient groups.
• a preferred embodiment according to the invention makes it possible to build in a revolution or vibration sensor into the part of the device which gets into contact with the human body, which will then in the known way provide feedback to microprocessor 8 and keep the operation parameters within the desired values.
• FIG. 4 shows a sketch of a possible physical realisation of the device according to the invention which, however, may be altered in line with the area of utilisation, needs and possibilities ever.
• a rod-shaped housing 16 located in the designed mantle 15 contains, one after the other, power source 17, which may be a battery, an accumulator or some other source of electric current, if an electric vibration generator is used.
• a vibration controller contains switching and timer stage 12, microprocessor 8 with saw-tooth generator and vibration sensor 10.
• the vibration generator which contains electric motor 11 and eccentric wheel 11 made of the same piece as its axe or wedged onto it, which transmits the vibrations through hammer 19, essentially the vibration transmitter, protruding from the side of housing 16 of the device and indicated symbolically.
• Spatial position switch 20 guarantees the operation of the device exclusively if held in the right position, and the right position is indicated by sound emitter 21.
• the total device can be designed as a unit of 50-100 mm length and 15-35 mm width (or diameter, if a cylindrical housing is used), which can be fixed even on a key-ring, ready for application at any time.
• the vibration transmitter of the device according to the invention in contact with the human body is partly provided with vibration damping material (vibration damper component 22) and, on the other hand, due to its design, the device can be held by a natural grip so that vibration generated by the device shall not spread downwards, towards the teeth, but be divided along the three extensions of 4 zygomatic bone 4, and reach the upper teeth only in a significantly weakened form.
• vibration damping material vibration damper component 22
• the device includes a maximum of one vibration generator which consists of no more than two independent mechanical sub-parts (piezo-ceramic, or axe and eccentric wheel 18, or mechanical component moved by electromagnet); furthermore, the device contains at least one flexible or elastic internal vibration damping element (e.g. spring to press down power source 17), and at least one elastic external vibration damping component 22 which gets in contact with the human face, is skin-friendly and easy to clean.
• the device contains at least one flexible or elastic internal vibration damping element (e.g. spring to press down power source 17), and at least one elastic external vibration damping component 22 which gets in contact with the human face, is skin-friendly and easy to clean.
• Well-known skin-friendly vibration damping materials include polyurethane foam rubbers free of PVC, but these are difficult to clean, since it takes a long time for the humidity entering the inside of the foam to dry.
• the simplest mechanical vibration generator device is an eccentric wheel fitted on a rotating axe, where the rotation of the axe is provided for by a magnetic power field or some mechanical force bearing on the axe.
• the revolving eccentric wheel results in the vibration of the axe of motor 11, which is transferred to the fixing points of the axe, to housing 16 of electric motor 11, then to casing 15 of electric motor 11, on which a hammer part 19 is designed that transmits the vibrations to the human body.
• Hammer par 19 is perpendicular to the axe of electric motor 11, and the surface area of hammer part 19 in contact with the human body, that is, vibration damping component 22, is parallel with the axe of motor 11 or it is at an angle of maximum 45° with it.
• the vibration waves divided into three directions in zygomatic bone 4 re-unite on the lateral wall of the common nasal cavity, in the area of the so-called osteomeatal complex 6, and hence the vibrations produced by the device mainly reach the upper apex of maxillary sinus 2. Vibrations penetrating the maxillary bone will only reach the upper teeth after a distance that is hundreds of times bigger, with significant dispersion and in a weakened form, and therefore, they do not cause tooth-ache.
• Figure 5 shows an exemplary frequency course produced by the saw-tooth generator of microprocessor 8.
• the saw-tooth generator produces intermittent linear frequency strokes, which appropriately scan the frequency range from 50 Hz to 1500 Hz several times, so that one vibration cycle takes around 1 second.
• the duration of the total treatment session does not exceed 30 seconds; this is ensured by switching and timing stage 12.
• Figures 6a and 6b show diagrams similar to that in Figure 5, but here the duration of the vibration cycle is much shorter than 1 second.
• the frequency stroke depicted in Figure 6a is produced by the current of alternating polarity shown in Figure 6b which, in practice, means vibrations realised in opposite rotation directions, so that the amplitudes of the vibrations in opposing directions are equal.
• the change in polarity checks electric motor 11 producing the vibrations and hence the individual frequency strokes get shorter in time and the total treatment session does not exceed 30 seconds.
• Figures 7 and 8 show effects of treatment with the device according to the invention at different vibrations.
• Figure 7 indicates the level of nasal NO release at various vibration parameters. The highest NO level is produced if the device is applied in scanning mode. As can be observed in Figure 8, NO washed out from the sinuses enhances mucociliar transport in the nose, as indicated by the decreasing mucociliar transport time (saccharin test). The biggest change occurs if the device is used in scanning mode.
• Figures 9 and 10 show experimental measurement results which demonstrate the continuous and sex-specific change of the inner parameters of the nose during the nasal cycle , which can be examined for example also by acoustic rhynometry.
• Figure 9 shows a representative acoustic rhynometry figure for an adult male where the volume increased to 6 cm 3 .
• Figure 10 depicts an identical measurement for an adult female, where the change was bigger than usual, and the device could not detect it any more. The records were made at intervals of 1 minute.
• Point P indicated with an arrow is the ostium of maxillary sinus 2 on the left and the right side, respectively.
• the measurement curves above the arrow show a bigger cross-section of the nose, because the ultrasound is refracted also from the sinuses (J. Appl. Physiol. 99:616-623 2005).
• FIG. 12 shows the vibration frequency of a possible embodiment of the device according to the invention on a representative sample.
• the first vibration, 12A will open and ventilate the maxillary sinus 2 of men of the Caucasian race
• the second vibration, 12B will open and ventilate the maxillary sinus 2 of women of the Caucasian race.
• other vibration patterns can also be produced, for example for children.
• the vibration modalities presented here can be repeated and combined at an order chosen at one's discretion, which ensures the efficient use of the device in individuals of different sex, age etc.
• the device can also be designed as a device capable of the emission of a single type of vibration only, to be used as therapeutic device with a targeted group.
• the effective resonance frequency or resonance frequency band should be the one that results in maximum NO wash-out from the sinuses.
• Figures 13A and 13B show the vibration spectrum of a possible embodiment of the device according to the invention when it triggers the maximum nitric oxide signal typical of men and women, respectively.
• the measured resonance frequency is lower for men than the one calculated on the basis of the formula, whereas in women the resonance frequency defined by measurement is higher than the corresponding calculated value.
• Nasal NO measurements with 5 ppb definition indicate that, instead of the 144 Hz average resonance frequency calculated for men between the minimum 130 Hz and maximum 164 Hz, in reality, the optimum is 120 Hz vibration, whereas in women, instead of the 227 Hz average resonance frequency calculated between the minimum 111 Hz and maximum 348 Hz, in reality, vibration by 380 Hz provides for maximum NO concentration enhancement in the nose in case of open sinuses.
• the specification of the protocol of the device according to the invention should also take into consideration that, under the effect of the vibrations, the closed or partly closed large maxillary sinuses 2 with low resonance frequency (9-46 Hz) may open, as a result of which the resultant resonance frequency will increase suddenly and significantly (111-348 Hz), especially in women. Therefore, according to the invention, treatments must always be carried out in a certain frequency range, in scanning mode.
• the application of low-frequency (0-111 Hz) vibrations is preferable only until the closed sinuses open up under the effect of treatment. After that, the vibrations must be applied for a longer time at the higher resonance frequency of the open sinuses to provoke maximum nasal NO concentration enhancement.
• the vibration frequency shall preferably be raised for a short time above the expected resonance frequency, to ensure also the ventilation of paranasal sinuses of a lower- than-average volume.
• the noise concurrent with the high vibration frequency must be dampened to prevent any negative effects.
• a vibration-free interval (0.1-3.0 ms, cf. Figure 12) must be inserted after each vibration cycle, partly to ensure the partial re-fill of the sinuses with NO and, on the other hand, since the low frequency range of the re-started vibration cycle promotes the opening of the partially closed sinuses that have not opened fully yet during the previous vibration cycle.
• the total treatment session of 20-30 s, is made up of vibration cycles reiterated several times.
• the device operates for a definite time only after switch-on, then it automatically stops and cannot be started again in the next 4 minutes, because switching and timer stage 12 blocks that (cf. Figure 3).
• the device is brought into contact with the cheekbone in the area of zygomatic bone
• the device contains an internal spatial position switch 20 that will only let the device be put in operation in the correct, close-to- vertical position. In this close- to- vertical position, vibrations transmitted to the skull bone will mainly spread towards the osteometal complex 6 part of maxillary sinus 2. If an effort is made to direct the vibrations downward, the device held correctly (arrow upward) will either

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