JP2021513381A - Systems, devices and methods for treating vestibular abnormalities - Google Patents

Abstract

As used herein, a vibrating device is capable of applying a vibrating signal to a portion of the user's head, whereby the vibrating signal is conducted through the bone to the user's vestibular system and Devices and methods are described that provide a vibrating device capable of moving a portion of the vestibular system in a manner equivalent to that of a therapeutically effective vibrating signal applied to the area covering the user's mastoid bone. The vibrating device can be associated with frequencies below 200 Hz. Vibration devices can be effective in treating physiological abnormalities associated with the vestibular system.

Description

Cross-reference of related applications
[0001] This application claims priority and interests in US Provisional Patent Application No. 62 / 421,708, filed November 14, 2016, entitled "Devices and Methods for Treating Motion Sickness". "Systems," which is a partial continuation of US Patent Application Publication No. 15 / 481,457 filed on April 7, 2017, entitled "Devices and Methods for Reducing the Symptoms of Maladies of the Vestibular System." This is a partial continuation of US Patent Application Publication No. 15 / 982,867 (“'867 Application”) filed on May 17, 2018, entitled “Devices, And Methods For Treating Vestibular Conditions”. The '867 application was filed on February 12, 2018 under the name "Methods and Devices for Treating the Proprioceptive Vestibular System" in US Provisional Patent Applications Nos. 62 / 629,197 ("'197 Provisional Application") and ". Priority to US Provisional Patent Application No. 62 / 629,213 (“'213 Provisional Application”) filed on February 12, 2018, entitled Methods and Devices for Reducing Motion Sickness in Virtual Reality and Travel Applications. It also claims its benefits. This application also claims priority and its benefits over the '197 provisional application and the '213 provisional application. The entire disclosure of each of the above-mentioned applications is incorporated herein by reference in its entirety.

Field of invention
[0002] The disclosed embodiments relate to systems, devices and methods for treating abnormalities associated with the subject's vestibular system, such as motion sickness, non-vertigo, vertigo, migraine and loss of consciousness. More specifically, the present disclosure relates to devices capable of generating vibration signals that can affect the vestibular system of interest.

background
[0003] Body orientation, equilibrium, position and movement can be determined by the brain through a combination of signals received from various parts of the anatomy, including the eyes, ears and muscles. For example, the vestibular system is, in most mammals, a sensory system that provides sensory information primarily related to equilibrium and spatial orientation. The subject's vestibular system is found in the subject's inner ear in a system of interconnected compartments that form the vestibular maze, as shown in FIG. 1A.

[0004] FIG. 1A illustrates a portion of the anatomical structure of subject 100 with respect to the outer ear 110, the portion of the skull 114, and the bony portion of the bones of the ear 116, the ear canal 111, the eardrum 112, and the middle ear 113. Shows the vestibular system. The vestibular system includes semicircular canals 122, 124 and 126 and otoliths 128 and 130 housed within the vestibular 121 in the bony labyrinth of the inner ear and is continuous with the cochlea 120. FIG. 1B provides a more detailed illustration of the vestibular system shown in FIG. 1A, showing the vestibular 121 including the utricle 128 and the saccule 130.

[0005] The semicircular canals 122, 124 and 126 are respectively oriented in a plane along one of the three directions in which the head can rotate or move, and detect movement in that direction, which direction is Nod up and down, shake left and right, and tilt left and right. The otoliths in the vestibule 121 of the inner ear detect gravity and acceleration in the anterior-posterior direction. The otolith device includes an utricle 128 that detects movement in a horizontal plane and a saccule 130 that detects movement in a vertical plane. The semicircular canals 122, 124 and 126 and the otoliths 128 and 130 are filled with endolymph, a fluid that is moved by the movement of the head or body.

[0006] Nerve cells with hair bundles can detect the movement of endolymph in the vestibular system of the inner ear to determine the movement and orientation of the head. The ampulla in the semicircular canals and the macula in the otoliths contain hair cells, which function as sensory receptors in the vestibular system and detect the movement of endolymph to detect the movement of the body. Includes hair bundles or stereocilia that convert to signals and report the signals to the brain. The otolith also contains a layer of calcium carbonate crystals called otolith or otolith, which moves in response to changes in acceleration (eg, movement or orientation with respect to gravity), which is the otolith. It leads to the movement of the lower layer and the movement of the hair bundle. In addition, the otolith sinks in the direction of gravity and pulls on the hair bundles of hair cells, helping to identify, for example, up and down directions.

[0007] FIGS. 2A and 2B show the anatomy of macula and sensory receptors in the otoliths (eg, utricle 128 and saccule 130 shown in FIG. 1B) in an upright and moving state, respectively. Provides a detailed view of. FIG. 2A shows the macula containing the otolithic membrane 132 and the cell layer containing the hair cells 134 and the supporting cells 136. Hair cells 134 include trichomes or stereocilia 132 extending within one or more gelatinous layers. The structure of the macula also includes a layer of otolith 138 that moves in response to endolymph movement and / or body acceleration. FIG. 2A shows hair cells 134 in an upright morphology and otolith or otolith 138, and FIG. 2B shows displaced or tilted when a directional force 140 (eg, gravity) acts on the otolith 138. Shows hair cells 134 and otoliths 138 in different morphologies. Similarly, the movement of endolymph in the semicircular canals 122, 124 and 126 can result in the movement of hair cells within the ampulla of the semicircular canals (not shown), with relative movement of the body and / or head (not shown). For example, the angular acceleration of the head) is perceived and signaled.

[0008] In addition to signals from the vestibular system, horizontal and vertical visual patterns received by the eye can affect perception of orientation, equilibrium, and position, and tension differences to the cervical muscles on both sides are the head. It can affect the perception of position and orientation. If the signals from these sources do not match, a person may develop motion sickness, resulting in vertigo, non-vertigo, vestibular migraine, loss of consciousness or other conditions. Mismatches in orientation, equilibrium, position and movement signals can be the result of extreme or unfamiliar movements while traveling, for example in cars, trains, planes and other forms of transportation. Signal discrepancies can also result from, for example, simulated perceived movements in three-dimensional (3D) movies, 3D video games and virtual reality devices. Therefore, it may be desirable to have a device that treats various vestibular abnormalities that may result from inconsistent signals received from the subject's vestibular system, eye or other anatomy.

Overview
[0009] The devices and methods described herein are vibration devices that are configured to apply a vibration signal to a portion of the user's head, whereby the vibration signal is transmitted through the bone. A vibrating device that can move parts of the vestibular system in a manner consistent with that of a therapeutically effective vibration signal that is conducted to the user's vestibular system and applied to the area covering the user's mastoid bone. Can be included. Therapeutically effective vibration signals have (1) frequencies below 200 Hz and force levels greater than 87 dB re 1 dyne and less than 100 dB re 1 dyne, and (2) physiological abnormalities associated with the vestibular system. Can be therapeutically effective for treating.

[0010] The device and method are described herein and, in some embodiments, are vibration devices configured to apply a set of vibration signals to a portion of the user's head, thereby. The set of vibration signals includes a vibration device that can be conducted to the vestibular system via the bone to treat the physiological abnormalities associated with the user's vestibular system. The vibrating device can be associated with a set of resonant frequencies including the lowest resonant frequency below 200 Hz. The set of vibration signals can collectively have an amount of power at the lowest resonance frequency that is greater than the amount of power at the remaining resonance frequencies from the set of resonance frequencies.

[0011] In some embodiments, the apparatus described herein is a vibrating element, configured to apply a vibrating signal to a portion of the user's head, whereby the vibrating signal is dissipated. , Can include vibrating elements that can be conducted to the vestibular system via the bone to treat physiological abnormalities associated with the user's vestibular system. The vibrating elements are centered on a housing that defines the chamber, a magnet that is movable within the chamber to generate a vibration signal, a suspension element that is configured to suspend the magnet at a position in the chamber, and that position. Can be configured to include a coil configured to generate a magnetic field for moving the magnet.

[0012] The method disclosed herein is to position the vibrating device over an area of the user's head and, after positioning, energize the vibrating device to apply a vibrating signal to that area. Thus, the vibration signal includes energization, which can be conducted through the bone to the user's vestibular system. The vibration signal is (1) applied to the area covering the user's mastoid bone and has (2) a frequency of less than 200 Hz and a force level greater than 87 dB re 1 dyne and less than 100 dB re 1 dyne. It can be configured to move parts of the vestibular system in a manner consistent with that of the vibration signal. The method can further include treating physiological abnormalities associated with the vestibular system in response to energizing the vibrating device.

A brief description of the drawing
[0013] Illustrates the anatomy of a subject, including a bony labyrinth of the inner ear that houses the vestibular system. [0014] A detailed view of the vestibular system and the cochlea within the bone labyrinth of FIG. 1A is provided. [0015] FIG. 6 is a partial view of the macula of the otoliths shown in FIG. 1B in an upright position. [0015] FIG. 5 is a partial view of the macula of the otoliths shown in FIG. 1B under directional force. [0016] It is a schematic diagram of the arrangement of the vibration device which applies the vibration signal to the vestibular system according to one Embodiment. [0017] FIG. 6 is a schematic diagram of an example system for treating symptoms associated with vestibular abnormalities according to one embodiment. [0018] FIG. 6 is a schematic representation of an example system for treating symptoms associated with vestibular abnormalities according to another embodiment. [0019] FIG. 6 is a schematic representation of an example vibration device of a system for treating symptoms associated with vestibular abnormalities according to one embodiment. [0020] FIG. 6 is a schematic cut-out view of an example vibration device of a system for treating symptoms associated with vestibular abnormalities according to another embodiment. [0021] FIG. 6 is a schematic cross-sectional view of a vibration device of a system for treating symptoms associated with vestibular abnormalities according to one embodiment. [0022] FIG. 7 is a schematic cross-sectional view of the vibrating device of FIG. 7A incorporated within a physical platform for placement on an object, according to one embodiment. [0023] FIG. 6 is a schematic cross-sectional view of a vibrating device in a system for treating symptoms associated with vestibular abnormalities, according to another embodiment. [0024] FIG. 6 is a perspective view of a spring as a suspension element of a vibrating device in a system for treating symptoms associated with vestibular abnormalities, according to one embodiment. [0025] FIG. 9 is a top view of the spring of FIG. 9A. [0025] FIG. 9 is a bottom view of the spring of FIG. 9A. [0026] FIG. 6 is a schematic representation of an example vibration device that includes and / or is incorporated into different support elements, according to various embodiments. [0026] FIG. 6 is a schematic representation of an example vibration device that includes and / or is incorporated into different support elements, according to various embodiments. [0026] FIG. 6 is a schematic representation of an example vibration device that includes and / or is incorporated into different support elements, according to various embodiments. [0026] FIG. 6 is a schematic representation of an example vibration device that includes and / or is incorporated into different support elements, according to various embodiments. [0026] FIG. 6 is a schematic representation of an example vibration device that includes and / or is incorporated into different support elements, according to various embodiments. [0026] FIG. 6 is a schematic representation of an example vibration device that includes and / or is incorporated into different support elements, according to various embodiments. [0027] Schematic representation of a human skull, showing location examples for placement of vibrating devices in a system for treating symptoms associated with vestibular abnormalities, according to various embodiments. [0028] Shown are examples of waveforms that can be used to energize vibrating devices in systems that treat symptoms associated with vestibular abnormalities, according to various embodiments. [0028] Shown are examples of waveforms that can be used to energize vibrating devices in systems that treat symptoms associated with vestibular abnormalities, according to various embodiments. [0029] An example of an energization profile that can be used to energize a vibrating device in a system for treating symptoms associated with vestibular abnormalities according to one embodiment is shown. [0030] FIG. 6 is a flow chart of an example method of using a vibrating device to treat symptoms associated with vestibular abnormalities. [0031] FIG. 6 is a flow chart of the procedure of a study conducted to test a vibrating device for treating symptoms associated with vestibular abnormalities. [0032] FIG. 6 is a schematic still view of a visual stimulus example used in the procedure shown in FIG. 20A to test a vibrating device. [0033] The results from the study procedure shown in FIG. 20A, in which the vibrating device is tested at different force levels, are shown. [0033] The results from the study procedure shown in FIG. 20A, in which the vibrating device is tested at different force levels, are shown. [0034] The results from the study procedure shown in FIG. 20A, in which vibrating devices are tested at different frequencies, are shown. [0034] The results from the study procedure shown in FIG. 20A, in which vibrating devices are tested at different frequencies, are shown. [0035] In yet another case, the test procedure is used to show data related to a questionnaire completed by the subject of a study conducted to test a vibration device that treats symptoms associated with vestibular abnormalities. [0035] In yet another case, the test procedure is used to show data related to a questionnaire completed by the subject of a study conducted to test a vibration device that treats symptoms associated with vestibular abnormalities. [0036] In yet another case, we show the results from a study conducted to test a vibrating device that treats symptoms associated with vestibular abnormalities using test procedures. [0037] FIG. 6 is a schematic perspective view of a vibrating device as described herein according to an embodiment. [0037] FIG. 6 is a schematic side view of a vibration device as described herein according to an embodiment. [0037] FIG. 6 is a schematic assembly exploded view of a vibrating device as described herein according to an embodiment. [0038] FIG. 6 is a cross-sectional view of the housing of the vibrating device illustrated in FIGS. 25A-25C. [0039] It is the schematic of the perspective view of the vibration device by one Embodiment. [0039] It is the schematic of the side view of the vibration device by one Embodiment. [0039] It is the schematic of the assembly exploded view of the vibration device by one Embodiment. [0040] It is the schematic of the perspective view of the vibration device of FIGS. 27A-27C. [0040] It is the schematic of the cross-sectional view of the vibrating device of FIGS. 27A-27C. [0041] FIG. 3 is a diagram of magnetic field lines related to a magnet of a vibrating device such as the vibrating device of FIG. 38. [0042] A plot of normalized magnetic flux densities associated with magnets in vibrating devices according to some embodiments. [0043] It is the schematic of the perspective view of the vibration device by one Embodiment. [0043] It is the schematic of the side view of the vibration device by one Embodiment. [0043] It is the schematic of the assembly exploded view of the vibration device by one Embodiment. [0044] FIG. 3 is a schematic view of one of two different cross-sectional views of the vibrating device of FIGS. 31A-31C. [0044] FIG. 3 is a schematic view of one of two different cross-sectional views of the vibrating device of FIGS. 31A-31C. It is the schematic of the magnet, the coil and the metal plate in the vibrating device of FIGS. 31A-31C. [0046] It is a figure of the magnetic field line related to the magnet of the vibration device of FIGS. 31A-31C. It is a plot of the normalized magnetic flux density associated with the magnet of the vibrating device according to some embodiments. [0048] FIG. 6 is a schematic cross-sectional view of a vibrating device according to one of three different embodiments. [0048] FIG. 6 is a schematic cross-sectional view of a vibrating device according to one of three different embodiments. [0048] FIG. 6 is a schematic cross-sectional view of a vibrating device according to one of three different embodiments. It is the schematic of the cross-sectional view of the vibration device by one Embodiment. [0050] It is the schematic of the perspective view of the vibration device by one Embodiment.

Detailed explanation
[0051] In the present specification, it is a vibration device, which generates a vibration signal and applies the vibration signal to the target vestibular system via bone conduction, whereby the vibration signal is transmitted to the target vestibular system. Devices and methods for treating vestibular abnormalities by using vibrating devices capable of inhibiting anatomical structure are described.

[0052] As mentioned above, sensory signals from the subject's vestibular system help perceive the subject's body orientation, equilibrium, position and movement. In addition to signals from the vestibular system, other sensory modalities, such as visual signals from the eye, can affect perception of orientation, balance and position, and tension differences in the bilateral cervical muscles are head positions. And may affect the perception of orientation. When signals from these various sensory sources such as the vestibular system, visual system and autoreceptive system do not match, a person has motion sickness, vertigo, non-vertigo, vestibular migraine, loss of consciousness or other abnormalities. There is a possibility of developing abnormalities such as. For example, discrepancies in orientation, balance, position and movement signals can result from extreme or unfamiliar movements while traveling, for example in cars, trains, planes and other forms of transportation, or 3D movies, 3D. It may come from the experience of virtual or extended 3D environments such as video games and virtual reality devices.

[0053] In a natural adaptive response, the brain may ignore chaotic, repetitive, non-new, or incomprehensible sensory information in signals. For example, vibrations from sound have been shown to affect the vestibular organs of the inner ear and may reduce responses in the cerebellum (eg, amplitude of electrical signals). See H. Sohmer et al., “Effect of noise on the vestibular system --Vestibular evoked potential studies in rats,” 2 Noise Health 41 (1999). However, the same study shows that very high intensity is required for sound to affect the vestibular system. Therefore, conventional headphones, earphones and speakers used to generate sound from the generation of vibration signals in the air cause symptoms such as motion sickness, vertigo, vestibular migraine and other physiological reactions. Limited ability to treat. Many of these techniques are not designed to deliver high intensity signals. Moreover, such high intensity signals can impair or interfere with human hearing.

[0054] As an alternative to using sound, mechanical vibrations can be used to affect the vestibular system to treat various abnormalities therapeutically. One technique that can be used to cause mechanical vibration is a surface or bone conduction oscillator. However, currently available bone conduction transducers have some drawbacks associated with the treatment of vestibular symptoms or abnormalities. For example, existing devices often have significant limitations, such as the generation of significant amounts of heat and / or audible noise, which allow them to come into direct contact with human skin or close to human ears. Use may be hindered. Many existing devices are also large and bulky, which makes them practical for use in environments where therapeutic effects are required, such as while traveling, reading, or using virtual reality devices. It becomes untargeted.

Existing devices, such as surface or bone conduction oscillators, are inefficient at producing low frequency vibrations. Many are audible and therefore produce vibration signals at high frequencies that distract. Therefore, when these devices are used near the human ear, the noise they cause can be confusing and annoying. Many existing devices generate high frequency vibrations primarily because power is directed to the higher resonant frequency instead of the lower fundamental frequency of the vibration signal generated by these oscillators. Even if designed to generate low frequency vibrations, existing bone conduction transducers have a wide spectrum of frequencies (eg, at many harmonics) if the lower frequency is the required frequency. It can be inefficient because it produces frequencies). Therefore, the systems and methods disclosed have other features, but are particularly efficient in delivering lower frequency vibration signals without producing high levels of thermal or audible noise, in the anomaly of the vestibular system. Regarding the treatment of related symptoms.

[0056] FIG. 3 schematically illustrates the placement of the vibrating device 200 near the target outer ear 110. The vibration device 300 can be configured to apply a vibration signal 202 conducted through the bone to treat one or more symptoms or abnormalities associated with the vestibular system of interest. A portion 204 of the vibration signal 202 can be conducted through the bone 116 to the bone labyrinth of the inner ear and the vestibular system. For example, portion 204 of the vibration signal is transmitted through the bone to the semicircular canals 122, 124 and 126 and to the vestibule 121, which houses the otoliths, utricles and saccules.

[0057] To reduce, alleviate, or treat the symptoms associated with vestibular abnormalities, a vibration signal is applied to the vestibular 121 to apply vibration signals to the otoliths and semicircular canals 122, 124, and 126 in the vestibular 121. The vibrating device 200 can be positioned so that it can be moved repeatedly in a chaotic or noisy manner. Some examples of vestibular anomalies include various types of motion sickness (eg, sea sickness, air sickness, car and train sickness, sickness from contact with virtual reality or simulators, sickness from experiences such as riding a jet coaster. (Effects of Sopite Syndrome), vertigo such as benign paroxysmal head dizziness, nausea from various causes (eg, caloric electric tremor record (ENG) / video tremor record (VNG) test, head impulse test , Vestibular system tests or chemotherapy including vestibular evoked myoelectric potential (VEMP) tests such as cervical VEMP and eye muscle VEMP tests, functional gait assessment, radiotherapy at the base of the skull, nausea associated with pregnancy, alcohol or toxins (Causes from conditions such as nausea from consumption), infection, vestibular neuritis, vestibular nerve sheath tumor, Meniere's disease, migraine, disembarkation disease syndrome, spatial disagreement, sopite syndrome, etc. can be mentioned.

[0058] The vibrating device 200, as described herein, from, for example, circulatory disorders (eg, orthostatic hypotension (lowering of blood pressure), myocardial disease, heart attack, arrhythmia, transient ischemic attack). Anemia due to poor circulation), neurological disorders (eg Parkinson's disease, polysclerosis), drugs (eg, anticonvulsants, antidepressants, sedatives, tranquilizers, antihypertensive agents), anxiety disorders, iron deficiency Conducted through bones to treat other abnormalities, including non-vertigo, imbalance, caused by illness, hypoglycemia (lowering of blood glucose), heat stroke, dehydration and traumatic brain injury It can also be positioned to provide a vibration signal. The vibration signal allows a part of the vestibular system to move in a manner equivalent to that of a therapeutically effective vibration signal for treating the above-mentioned abnormalities. In addition, the vibration device 200 can be used to assist the pilot, for example, to train the pilot to ignore or disable the pilot's vestibular system under predetermined conditions. The vibration device 200 can also be used as a stroke diagnosis.

[0059] FIG. 4A schematically illustrates System 350 as an example of treating vestibular abnormalities. The system 350 includes a vibrating device 300 and a control unit 360 coupled to the vibrating device 300 that activates and / or controls the operation of the vibrating device 300. The vibration device 300 may be an electromechanical transducer configured to generate a vibration signal when driven and energized by an appropriate electrical signal from the signal source. The control unit 360 includes a memory 362, a processor 364, and an input / output (I / O) device 366 that receives electrical signals from and / or sends electrical signals to other components of the system 350. Can include. The vibration device 300 can be configured to receive an electrical signal from the control unit 360 and / or transmit an electrical signal to the control unit 360. Optionally, the system 350 may include a sensor 390 that measures voltage, current, impedance, motion, acceleration or other data associated with the vibrating device 300. The sensor 390 can also be configured to measure information and / or other body metrics related to the subject's vestibular VS (eg, body temperature, skin conductivity, etc.). The sensor 390 can send and receive signals to and from the control unit 360, the vibrating device 300 and / or the vestibular VS. The system 350 may include a signal generator 370 and / or an amplifier 380. The signal generator 370 can generate one or more signals that drive the vibrating device 300 to vibrate to generate a vibrating signal. The amplifier 380 can be operatively coupled to the signal generator 370, which can amplify the signal from the signal generator 370 before the signal is used to drive the vibrating device 300. it can. The control unit 360 can control the operation of the signal generator 370 and / or the amplifier 380.

[0060] In some embodiments, the signal generator 370, amplifier 380 and / or sensor 390 may be integrated with the control unit 360 and / or form part of the control unit 360. Alternatively, in other embodiments, the signal generator 370, amplifier 380 and / or sensor 390 may be operatively coupled, although separate from the control unit 360. In some embodiments, the vibrating device 300 can include one or more of a control unit 360, a signal generator 370, an amplifier 380 or a sensor 390.

[0061] In some embodiments, the control unit 360 can operate to store dedicated instructions for controlling the vibrating device 300. Such instructions can be stored in memory 362 or a separate memory. In addition, such instructions can be designed to incorporate into the controller specialized functions and features to complete certain functions, methods and processes associated with the treatment of vestibular abnormalities disclosed herein. In some embodiments, the control unit 360 can be programmed with instructions using a software development unit.

[0062] The electrical signal controlling the vibrating device 300 can be generated by the control unit 360 based on the stored instructions. These electrical signals can be communicated between the control unit 360 and the vibrating device 300 by a wired or wireless (eg, Bluetooth) method. The electrical signal can include a stored pattern of operation, for example, the stored instructions accessed by the controller are used by the controller in the vibrating device 300 for a given user. Based on the data, it can be used to generate a series of electrical signals transmitted to the vibrating device 300 to "on" or "off" the object in a favorable pattern. One pattern can include a series of vibration signals that can be generated and that the number of vibration signals applied over a period of time (eg, per minute) can be varied, and the second pattern can include a plurality of vibration signals. It can include a series of vibration signals that can change the force level in the vibration signal. Other types of control signals, such as control signals that can be used to control the force level and frequency of the vibration signal generated by the vibration device 300, are received from the sensor (eg, sensor 390 or other sensor). It can be transmitted from the control unit 360 to the vibration device 300 based on the collected data. For example, an acceleration sensor that detects a change in the physical acceleration of a user can be included in a portable electronic device (for example, a mobile phone). In one embodiment, the control unit 360 may be operational to receive data from the accelerometer indicating the type of acceleration that can lead to motion sickness. Therefore, after receiving such data, the control unit 360 may be capable of generating relevant electrical signals and transmitting such signals to the vibrating device 300. Thus, the vibrating device 300 can operate to receive these electrical signals and generate a vibrating signal that can be conducted through the bone and applied to the vestibular system, for example to preemptively consider motion sickness. Can be. The vibration signal allows a part of the vestibular system to move in a manner equivalent to that of a therapeutically effective vibration signal. For example, due to vibration signals, parts of the vestibular system (eg, hair bundles that form receptors in the semicircular canals and / or otoliths) move randomly, simulating a noisy vestibular signal or a noisy vestibular sensation. be able to. In some cases, such noisy vestibular sensations can cause a reduction in the effects caused by discrepancies in other vestibular signals or signals perceived by the subject. Instead, a stored road map showing a route or course that the user previously became ill due to vehicle sickness was sent to the control unit 360 or portable device, eg, Global Positioning System (GPS), Galileo, GLONASS or. It can be stored with a suitable positioning system such as Beidou. In some embodiments, the control unit 360 indicates that the positioning system reaches a location where the user is moving along its path or course and can cause motion sickness. It may be operational to generate signals and transmit these signals to the vibrating device 300. Thus, the vibrating device 300 receives these electrical signals and, for example, conducts them through the bone and applies them to the vestibular system to preemptively consider motion sickness before the user arrives at that position. It may be able to operate to generate a vibration signal that can.

[0063] FIG. 4B schematically illustrates System 350'as another example of treating vestibular abnormalities according to one embodiment. The system 350'may be similar to the system 350 in that it includes a control unit 360 and a vibrating device 300 coupled to the control unit 360 and energized and / or controlled by the control unit 360. Further, the system 350'can have a second vibrating device 300', which can also be coupled to the control unit 360 and have its activation controlled by the control unit 360. The control unit 360 can be configured to control the vibration devices 300 and 300'so that the vibration signals generated by the vibration devices 300 and 300'can be simultaneously, alternately and / or independently delivered. .. Although not shown in FIG. 4B, like the system 300 shown in FIG. 4A, the system 350'is optionally a signal generator (eg, signal generator 370), signal generator coupled to the control unit 360. Can include an amplifier (eg, amplifier 380) and / or a sensor (eg, sensor 390) coupled to. In some embodiments, the two vibrating devices 300 and 300'can be coupled to the equilibrium 382, which vibrates the signal generated by the signal generator and optionally amplified by the amplifier. It is configured to be distributed among the devices 300 and 300'. In some embodiments, the vibrating devices 300 and 300'can be configured to be coupled to each other and transmit and / or receive signals from each other. Although FIG. 4B shows two vibrating devices 300 and 300', one of ordinary skill in the art will appreciate that any number of vibrating devices can be used.

[0064] FIG. 5 is a schematic view of an example vibration device 400 according to an embodiment. The vibrating device 400 includes a body (or housing) 410 capable of defining one or more chambers. The body 410 accommodates a vibrating element 423, a suspension element 420, a drive circuit 440 and a delivery interface 430. The vibrating element 423 is suspended by the suspension element 420 and is configured to be driven by the drive circuit 440 to move (eg, oscillate or vibrate) to generate a vibration signal. The vibrating element 423 can be suspended in the body (eg, in the chamber) so that it can vibrate around the equilibrium position. The movement of the vibrating element 423 is with respect to the suspension element 420 and / or the body 410 of the vibrating device 400 and via the delivery interface 430 to treat one or more vestibular abnormalities as disclosed herein. It can generate a vibrating signal that can be directed. The vibrating device 400 and / or the body 410 of the vibrating device 400 can be positioned with the delivery interface 430 on or in contact with the target region TA and generated by the movement of the vibrating element 423. The vibration signal to be generated can be applied to the target region TA, and then the vibration signal can be conducted to the target vestibular system VS via the bone structure BS.

[0065] Optionally, in some embodiments, the vibrating device 400 is a built-in power supply 414 that powers the components of the vibrating device 400 and a portion of the vibrating device 400, vestibular VS or body separate. Sensor 416 that detects one or more signals from a portion of the body (eg, a part of the body to which the generated vibration signal is applied, such as the target region TA or the skin adjacent and / or associated with the target region TA). And can be included. In some embodiments, a remotely located power source (eg, a power source mounted within the control unit 360) can be used to power the vibrating device 400. In some embodiments, a remote sensor (eg, sensor 390) is used to apply a portion of the vibrating device 400, a vestibular VS or another portion of the body (eg, a generated vibration signal) of the body. The signal from the part) can be detected.

The sensor 416 can be configured to measure and / or record information related to the vibrating device 400 and / or the object (eg, vestibular VS, target region TA, etc.). For example, the sensor 416 may apply a current, voltage (eg, voltage change associated with an electrical signal across the vibrating element 423), magnetic field (eg, generated by an electrical signal and near the vibrating element 423) of the moving vibrating element 423 It may include one or more suitable transducers that measure and / or record information from the vibrating device 400, including directional local) or acceleration and the like.

[0067] In some embodiments, the sensor 416 can be used to improve the efficiency of the vibrating device 400. For example, the sensor 416 can include an ammeter that monitors the current of electrical signals coming from the vibrating element 423 and / or another part of the vibrating device 400. At the resonance frequency of the vibrating device, the impedance of the vibrating device 400 (assuming a constant voltage) is higher than the other frequencies, and therefore the current is lower than the other frequencies, so the low current is measured by the current meter. Until this is done, the frequency of the electrical signal supplied to the vibrating device 400 can be adjusted. Therefore, an ammeter can be used to tune (eg, adjust) the frequency of the electrical signal to the resonant frequency so that the vibrating device 400 operates efficiently. That is, in some embodiments, the vibrating device 400 is configured to receive information from the sensor 416 (eg, information from an ammeter) and adjust the frequency of the electrical signal based on that information. Can be included. For example, the processor can be configured to adjust the frequency of the electrical signal over time so that the vibrating device continues to operate at reduced current and lowest resonant frequency.

[0068] As another example, the sensor 416 can include a voltage sensor or voltmeter with a constant current amplifier. The voltage change of the electrical signal supplied to the portion of the vibrating device 400 including the vibrating element 423 can be measured using a voltmeter. At the resonance frequency of the vibrating device, the impedance of the vibrating device 400 is higher than the other frequencies, and therefore the voltage is higher than the other frequencies, so until the high voltage is measured by the voltmeter (eg, suitable). The frequency of the electrical signal supplied to the vibrating device 400 can be adjusted. Therefore, the monitored voltage can be used to tune (eg, tune) the frequency of the electrical signal so that the high voltage is measured to achieve high efficiency.

[0069] As another example, if the vibrating element 423 is driven by a modulated magnetic field, the sensor 416 can include a Hall effect sensor that monitors magnetic field fluctuations. The magnetic field variation can be measured while the frequency of the electrical signal used to generate the magnetic field is changed to tune the frequency of the electrical signal to be the resonant frequency of the vibrating device 400. As another example, the sensor 416 can include a mobile sensor (eg, an accelerometer) that can measure the acceleration and / or velocity of the vibrating element 423 to determine when a resonant frequency is achieved.

[0070] A sensor 416 that receives and / or measures information from the subject, such as movement, body temperature of the subject, orientation or position of the subject, etc., associated with a vibration signal transmitted to the bone structure of the subject can also be provided.

[0071] The vibrating device 400 may also include a support element 418 that supports or positions the vibrating device 400 in or in contact with or in contact with the target region TA of interest to deliver a vibrating signal, as disclosed herein. it can. The support element 418 can be a device or fastening mechanism capable of maintaining contact and positioning of the vibrating device 400 with respect to the object. For example, the support element 418 can be a headband, eyeglasses, pillows, etc., as will be disclosed in more detail later. In some embodiments, the support element 418 can be a sticky component, such as a sticky pad, a sticky polymer, which can maintain contact and positioning of the vibrating device 400.

[0072] The power supply 414, the sensor 416 and / or the support element 418 can be housed in and / or attached to the body 410 of the device 400.

The target region TA to which the vibration signal is applied can be, for example, the surface of the head. Optionally, in some embodiments, the vibrating device 423 can be implanted within the head of the subject, and the target region TA is in close proximity to and / or is part of the bone structure BS. It can be an area. The vibration device can be configured to be engageable with the target region TA to effectively deliver the therapeutic vibration signal. In one case, the target region TA can be the region posterior to the subject's outer ear that covers the mastoid process (or mastoid or mastoid process of the temporal bone) of the subject's skull. In such cases, the mastoid bone can form a portion of the bone structure BS used to deliver a vibration signal to the vestibular VS via the bony structure of the inner ear that houses the vestibular VS. Optionally, the zygomatic process of the zygomatic or temporal bone can be part of the bone structure BS used to deliver vibrational signals to the vestibular VS. In other cases, the target region TA can be part of the occipital region or frontal region, and the region under the skull acts as a bone structure BS that conducts the vibration signal received from the vibration device 400. Different force levels can be used to operate the vibrating device 400 based on the target region TA selected and its distance from the vestibular system VS. For example, if the device is placed in a target area TA, such as the frontal region of the subject or behind the head, i.e. the region away from the mastoid process from the vestibular VS, the device is placed over the mastoid process of the subject. Higher force levels can be used compared to the case. As an example, when placed on or on the subject's head, the vibrating device 400 is therapeutically effective when delivered elsewhere (eg, the area covering the mastoid process). The vibration signal can be configured to be applied at a force level up to 14 dB higher than the force level of the possible vibration signal. When the target area TA is the area overlying the mastoid process and the vibrating device is placed over that area, a therapeutically effective force level for treating vestibular abnormalities is 90-100 dB re 1 dyne, Desirably it can be 93-98 dB re 1 dyne.

[0074] The body 410 of the vibrating device 400 can be configured to accommodate various components of the vibrating device 400. In some embodiments, the body 410 contains some of the components and at the same time one or more components that are not housed within the body 410, such as the power supply 414, sensor 416 and / or support element 418. An interface for binding can be provided. In some embodiments, the body 410 of the vibrating device 400 may contain one or more components of the vibrating device, such as a vibrating element 423, a suspension element 420, a drive circuit 440 and / or a delivery interface 430. Multiple chambers or receptacles can be defined. The body 410 can also be shaped and / or configured to contact the target region TA of the body of interest for the desired positioning of the delivery interface 430 (eg, the body 410 is curved or malleable). Or it can have a flexible surface). In some embodiments, one or more of the body 410 and / or its chambers can be filled with air or, optionally, a liquid such as a lubricant that helps generate and deliver vibration signals. In some embodiments, one or more of the body 410 and / or its chamber may also include materials having properties such as audible noise attenuators such as sponges or sound absorbing materials, heat dissipation materials and the like.

[0075] The vibrating element 423 of the device 400 can be configured to vibrate to generate a vibrating signal. In some embodiments, the vibrating element 423 can be housed in the chamber of the body 410. The suspension element 420 allows the vibration element 423 to be suspended at an equilibrium position, and an electrical signal can be used to vibrate the vibration element 423 around its equilibrium position to generate a vibration signal. The properties of the vibrating element 423 and / or the suspension element 420, such as material, composition, structure, etc., can be selected to meet certain requirements (eg, low frequency signals) of the vibrating signal to be generated.

によって表されるように、フックの法則に基づいて求めることができ、式中、ｆは、共振周波数であり、ｋは、ばね定数であり、ｍは、質量である。質量の移動の振幅は、所与の出力に対して、共振周波数の方が他の周波数より大きくなり、それは、共振周波数での質量及びばねシステムがより純度の高い音（例えば、正弦波形）に関連することができるためである。したがって、振動デバイス４００をその共振周波数で動作させることにより、より強力な振動信号が生成され、振動要素４２３及び／又は懸架要素４２０の特性は、特定の共振周波数を達成するように選択することができる。 [0076] For example, the vibrating element 423 can be a spring or elastic material having a stiffness reference (eg, spring constant) that allows the generation of highly efficient and low frequency (eg, frequencies below 200 Hz) vibration signals. .. In one embodiment, the vibrating element 423 can be the mass suspended by the suspension element 420, which is a spring. The intrinsic resonance of such a system is

As represented by, it can be obtained based on Hooke's law. In the equation, f is the resonance frequency, k is the spring constant, and m is the mass. The amplitude of mass transfer is greater at the resonant frequency than at other frequencies for a given output, which makes the mass at the resonant frequency and the spring system sound more pure (eg, sinusoidal waveform). Because it can be related. Therefore, by operating the vibrating device 400 at its resonant frequency, a stronger vibrating signal is generated and the characteristics of the vibrating element 423 and / or the suspension element 420 can be selected to achieve a particular resonant frequency. it can.

Other factors that can affect the vibrating signal generated and / or determine the vibrating signal generated are, for example, the mechanism of the driving force (eg, mechanical, magnetic), the movement of the vibrating element. Ease of ease (eg, how much friction there is in movement), location of target area TA (eg, milky protrusions, cheekbones, skull near the subject's frontal region, etc.), energy dissipation (eg, off-axis) Reduction of secondary or tertiary paths of movement, heat, friction, etc., direction of movement with respect to external forces (eg, pressure during use, gravity, etc.), requirements for ease of use by the subject under various conditions (eg, subject) Mobility, restrictions on the degree of carelessness, etc.).

[0078] The vibrating element 423 is configured to be able to be driven to generate a vibrating motion along or around an axis of the vibrating device 400 (eg, the longitudinal axis of the body 410). Such exercise produces a vibration signal with properties suitable for treating vestibular abnormalities (eg, frequency, amplitude, force level, etc.). The vibrating device 400, in some embodiments, is an electromechanical conversion comprising a vibrating element 423 implemented as a magnet that can be driven to move about an axis using a suitable driving force such as a magnetic field. It can be a vessel. Further details regarding such an embodiment will be described later with reference to FIGS. 6 to 9C.

Another way to generate a low frequency vibration signal is to modulate the ultrasonic signal. In some embodiments, the vibration device 400 can be a piezoelectric transducer driven by an electrical signal to generate vibrations in the ultrasonic frequency range. The vibration of the piezoelectric transducer at this higher frequency can generate acoustic radiation pressure. The drive electrical signal can be clock controlled on and off at lower frequencies, i.e. less than 200 Hz (eg 60 Hz), and is more due to the pressure from the piezoelectric transducer applied on and off at lower frequencies. The corresponding vibration signal is generated at a low frequency. Piezoelectric transducers are usually smaller and lighter than other types of electromechanical transducers, so the use of piezoelectric transducers can reduce the size and weight of the vibrating device 400.

[0080] Provide a therapeutically effective level of vibration signal for treating vestibular abnormalities, depending on where the vibration device 400 is located, the dimensional constraints of the vibration device 400 and / or the configuration or shape of the vibration device 400. As described above, a predetermined component of the vibration device 400 can be selected. Although one vibrating element 423 is illustrated in FIG. 5, one of ordinary skill in the art can function the vibrating device 400 in a coordinated and / or independent manner to generate a vibrating signal for treating a vestibular anomaly. It will be appreciated that one or more additional vibrating elements may be included.

[0081] As with other vibrating devices or systems, the vibrating device 400 can be associated with a set of resonant frequencies. In some embodiments, the amount of output of the vibration signal generated at the lowest resonance frequency associated with the vibration device 400 is that of the vibration signal at the remaining resonance frequency associated with the vibration device 400 (eg, a higher resonance frequency). The oscillating element 423 can be configured to move according to the driving force so as to be greater than the amount of output. For example, a vibrating device can be configured to have a lowest resonant frequency of 50-70 Hz, and the vibrating signal generated at the lowest resonant frequency in this range is greater than the vibrating signal that may be generated at other resonant frequencies. The amount of power can be large. In some embodiments, the vibrating element 423, the suspension element 420 and / or other elements of the vibrating device 400 can be selected such that the vibrating device 400 vibrates at a minimum fundamental frequency below 200 Hz.

[0082] In some embodiments, the vibrating element 423 oscillates at a first resonant frequency along a first axis (eg, an axis in the z direction) and a second axis (eg, an axis in the xy plane). ) May vibrate at the second resonance frequency. To reduce vibration along the second axis, the first resonance frequency is not a harmonic of the second resonance frequency and vice versa (eg, the first resonance frequency is the second resonance frequency and / or the second. The vibrating element 423, the suspending element 420 and / or other elements of the vibrating device 400 can be selected so that they deviate from the harmonics of the resonating frequency by a few hertz) If so, the vibration along the second axis can be reduced. Vibration along the second axis can result in, for example, internal collisions and / or audible sounds between the components of the vibrating device 400.

[0083] The vibrating device 400 can be positioned in different regions of the subject's head. FIG. 16 shows a human skull and shows examples of some areas of the skull in which the vibration device 400 can be positioned to apply a therapeutic vibration signal to treat vestibular abnormalities disclosed herein. .. For example, as shown in FIG. 16, the vibrating device 400 can optionally be placed on the mastoid bone 1502 of the target skull. Although the left mastoid bone 1502 is identified in FIG. 16, one of ordinary skill in the art will appreciate that the vibrating device 400 can be placed on the left or right mastoid bone of interest. In other cases, to deliver the vibration signal to treat the vestibular and other abnormalities disclosed herein, the vibration device 400 is placed over a portion of the occipital region (eg, left, right or right of the occipital bone 1501). It can be placed above the central portion) or part of the frontal region (eg, left, right or central portion of the frontal bone 1504). A therapeutically effective level for treating anomalies, depending on the area in which the vibrating device 400 is located (eg, proximity to the vestibular system, whether vibration from the device needs to cross suture line 1503). The force level of the vibration signal can be adjusted so that the vibration of the vibration is delivered to the vestibular system.

[0084] When the vibrating device 400 is positioned over the mastoid bone (eg, the mastoid bone 1502 shown in FIG. 16), the vibrating device 400 has a resonance frequency of less than 200 Hz and a 90-100 dB re 1 dyne. A therapeutically effective vibration signal (ie, a therapeutically effective vibration signal) can be applied in the treatment of anomalies of the vestibular system with a force level of. Vibration when the vibrating device 400 is positioned over a different region of the subject's head away from the mastoid bone of the subject's vestibular system (eg, cheekbone 1505 or frontal bone 1504 or occipital bone 1501 shown in FIG. 16). The device 400 can affect a part of the vestibular system in a manner equivalent to that of a therapeutically effective vibration signal applied to the area covering the mastoid bone (eg, 1502 shown in FIG. 16). It is possible to generate a vibration signal having a higher force level. For example, if the vibrating device 400 is positioned on the frontal bone of interest (eg, the frontal bone 1504 in FIG. 16), the vibrating device 400 is a therapeutically effective vibrating signal applied to the area covering the mastoid bone. It is possible to generate an oscillating signal having a force level greater than (eg, up to 14 dB re 1 dyne greater).

[0085] The suspension element 420 of the vibrating device 400 may include one or more components that are housed within the body 410 and interact with the vibrating element 423. In some embodiments, the suspension elements 420 and / or the vibrating elements 423 can be configured to be compatible structures that accept each other. For example, the suspension element 420 can include components that can extend through an opening defined in the vibrating element 423.

[0086] In some embodiments, the suspension element 420 can be housed in the chamber of the body 410 and optionally in a fluid such as a lubricant. The suspension element 420 can be configured to apply a force to the vibration element 423 to suspend, hold or support the vibration element 423 in an equilibrium position until it is driven to move by the application of drive vibration. .. For example, the suspension element 420 can be a spring coupled to a vibrating element 423 (eg, a magnet). Alternatively or further, the suspension element 420 can include a pair of magnets, which pair of magnets by applying a force (eg, opposite or repulsive magnetic force) to the vibrating element 423 in opposite directions. It is arranged with the vibrating element 423 (eg, another magnet) so as to hold the vibrating element 423 together in an equilibrium position by a force acting between them (eg, opposite or repulsive magnetic force). In such an embodiment, a driving force (eg, an applied magnetic field of a predetermined magnitude and acting along a predetermined direction) moves a vibrating element 423 (eg, a magnet in equilibrium position) between a pair of magnets. Can be induced to do. In other embodiments, the suspension element 420 can be an elastic material or fluid. Although FIG. 5 shows one suspension element 420, one of ordinary skill in the art will appreciate that multiple suspension elements 420 can be used to support and / or suspend the vibrating element 423. The plurality of suspension elements 420 may include one or more different types of suspension elements (eg, magnets, springs, elastic materials, etc.).

[0087] The drive circuit 440 of the vibrating device 400 may include one or more suitable components capable of generating electrical signals. The electrical signal can generate a force that causes the vibrating element 423 to move along the axis to generate a therapeutic vibration signal. In some embodiments, the drive circuit 440 can receive electrical signals from control units (such as control unit 360 in FIGS. 4A and 4B). In some other embodiments, the drive circuit 440 itself may include a built-in unit capable of generating an electrical signal.

[0088] The electrical signal generated or received by the drive circuit 440 and used to cause the movement of the vibrating element 423 has properties suitable for producing a vibrating signal having a predetermined frequency and force level. It can be a thing. For example, the electrical signal can be selected to cause the vibration element 423 to generate a vibration signal having a frequency in a specific range (eg, less than 200 Hz) to treat one or more predetermined vestibular abnormalities. In some embodiments, the control unit (eg, control unit 360) may use the sensor 416 to change the frequency of the electrical signal until the vibrating device 400 vibrates at the resonant frequency as described above. it can.

[0089] In some embodiments, the drive circuit 440 is a built-in signal generator that generates an electrical signal, an amplifier that amplifies the signal, and transforms the electrical signal into a suitable modality that moves the vibrating element 423. It can include one or more elements. For example, the drive circuit 440 may include one or more coils capable of generating a magnetic field that moves the vibrating element 423.

[0090] The delivery interface 430 of the vibration device 400 can transmit the vibration signal generated by the vibration element 423 to the target region TA of the target and conduct the vibration signal to the vestibular system VS via the bone structure BS directly below. It can be configured to allow. The delivery interface 430 is adapted to the structure and / or shape of the user's target region TA so that the delivery interface can engage and / or maintain contact during use for the transmission of therapeutic vibration signals. Can be configured and / or adaptable to. In some embodiments, the delivery interface 430 can be configured to alleviate vestibular anomalies, eg, during use of the vibrating device 400, for user comfort and ease of use. The delivery interface 430 may be further configured to reduce potentially unwanted secondary effects such as heat generation and accumulation, audible noise generation, lack of air circulation, and pressure application on the target region TA. it can. For example, the delivery interface 430 can include a layer of memory foam material that can help conform to the contours of the target area (eg, the area behind the ear that covers the mastoid process). Memory foam materials can help dissipate heat, attenuate audible noise, promote air circulation, minimize discomfort from pressure exerted by supporting elements such as headbands, and the like.

[0091] FIG. 6 is a diagram of the vibration device 500 as an example according to one embodiment. The vibrating device 500 includes a body (or housing) 510 that includes a tube 526 and end caps 525a and 525b. In some embodiments, the body 510 of the vibrating device 500 can define a chamber. The main body 510 accommodates a vibrating element implemented as a magnet 523 and a suspension element implemented as a magnet 520a, 520b. As shown in the cut-out view of FIG. 6, the suspension element includes magnets 520a and 520b, and the vibration element 523 includes magnets 523. As shown in FIG. 6, the magnets 520 and 520b act as suspension elements by applying an opposite force to the magnet 523 so as to suspend the magnet 523 at an equilibrium position. For example, the magnet 520a can be configured to apply a force to the first magnet 523 in the first direction, and the magnet 520b in the second direction (eg, a second direction 180 ° moved from the first direction). It can be configured to apply a force (for example, a force applied to the magnet 523 by the second magnet 520a and a force having the same magnitude) to the first magnet 523. Therefore, the first magnet 523 can be arranged between the second magnet 520a and the third magnet 520b in the main body 510 (for example, the chamber), and the second magnet 520a and the third magnet 520b are collectively the main body. The first magnet 523 is suspended in 510 at a certain position (for example, an equilibrium position).

[0092] Magnet 523 acts as a vibrating element configured to move (eg, vibrate) to generate a vibrating signal. The vibrating element 523 can be suspended in the main body 510 (for example, in the chamber) by the suspension elements 520a and 520b so that the vibration element 523 can vibrate around the equilibrium position.

[0093] In some embodiments, the vibrating device 500 can include an elongated member having a longitudinal axis. The elongated member can be configured to extend through the opening of the vibrating element 523 so that the vibrating element 523 can be configured to vibrate along the longitudinal axis of the elongated member. The elongated member can be further configured to reduce vibration of the vibrating element 523 along any axis other than the longitudinal axis. As shown in FIG. 6, the vibrating device 500 further includes an elongated member in the form of a pin 521 that can be secured to the end caps 525a and 525b. The pin 512 penetrates the openings 522a and 522b defined in the end caps 525a and 525b of the vibration device 500, the openings defined in the magnets 520a and 520b, and the openings defined in the magnet 523. The pin 521 provides an axis for the movement of the magnet 523 (eg, along the longitudinal axis of the pin 521). The vibrating device 500 further includes a drive circuit including a coil 524 configured to generate a magnetic field capable of driving the vibrating device using an electrical signal. The vibrating device 500 is configured to fit within an opening defined in magnet 523 and allows smooth movement of magnet 523 over pin 521 to provide an interface between pin 521 and magnet 523. Includes a bushing 522c configured in.

[0094] During operation, the vibrating device 500 is driven at low frequencies (eg, less than 200 Hz) using an electrical signal that includes a sine wave or another type of signal waveform. The coil 524 can operate to generate a magnetic field with the induced electrical signal. Therefore, the magnetic field applies a magnetic force to the magnet 523. When a magnetic force is applied to the magnet 523, the magnet 523 is made to move along the axis indicated by the arrow "A" in FIG. The magnet 523 is configured to move in any of the indicated directions depending on the direction of the magnetic field vector.

[0095] The magnets 520a and 520b forming the suspension element each provide a constant magnetic field, and each of them is applied to the magnet 523 (that is, the north pole side of the magnet 520a faces the north pole side of the magnet 523. However, the S pole side of the magnet 520b faces the S pole side of the magnet 523). Therefore, the magnets 520a and 520b apply an opposite force to the magnet 523. The opposite force caused by the magnets 520a and 520b can act to suspend the magnet 523 at the equilibrium position so that the magnet 523 vibrates around the equilibrium position and generates one or more vibration signal signals. is there. The electrical signal causes the magnet 523 to vibrate or move along an axis A that can be the same as or substantially the same as the longitudinal direction of the pin 521.

[0096] In some embodiments, to ensure that the magnets 520a, 520b and 523 do not vibrate or move in directions other than axis A (such vibrations and movements affect the efficiency of the system, two). The vibration device 500, which can increase unwanted friction that causes the next vibration signal (eg, growl), can be configured such that the movement of the magnet 523 is restricted by the pin 521. In some embodiments, each of the magnets 520a and 520b can be secured to the end caps 525a and 525b of the vibrating device 500 with glue, epoxy resin or another form of adhesive. The magnet 523 can be mounted around the pin 526 by a bushing 522c interface that allows the magnet 523 to move smoothly over the pin 521 while limiting any movement not along the axis A. Glue, epoxy resin or any other form of adhesive can also be used to secure the pin 521 to the end caps 525a and 525b through the openings or holes 522a and 522b.

[0097] In some embodiments, the tube 526 is a lubricant (eg, ferrofluid) configured on its inner surface to reduce possible friction between the magnet 523 and the inner surface of the tube 526. It may contain and / or may contain a low friction material (eg, polytetrafluoroethylene). Friction reduction can be configured to ensure quieter operation of the vibrating device 500 (eg, noise generated by possible friction from contact is reduced). Such lubricants can also be used to reduce friction between the bushing 522c and the pin 521.

[0098] In some embodiments, the outer surface of the tube 526 and / or the end caps 525a and 525b can be covered with a sound absorbing material. Further, in some embodiments, one or more of the end caps 525a, 525b can be covered with a friction reducing material (eg, a smooth material) such as cork or a shock absorbing or padding material, whereby the end. When the cap comes into contact with human skin or body, the friction caused by the contact is less than if the end caps 525a and 525b were not covered by these materials. Further, in some embodiments, one or more of the end caps 525a, 525b can be attached to a structure that increases the surface area of the end cap, whereby when the end cap comes into contact with human skin or body. The contact spreads over a larger area and its end cap reduces the pressure exerted on the skin or body.

It should be understood that the magnets 520a and 520b are examples of elastic objects that can be used to form suspension elements in the vibrating device 500. In other embodiments, the magnets 520a and 520b can be replaced with other elastic objects (eg, springs, elastic polymers).

[0100] FIG. 7A illustrates an embodiment of a vibrating device 600 that includes a spring as a suspension element. The vibrating device 600 can be similar to the vibrating device 500 shown in FIG. 6 described above. For example, the vibrating device 600 can include a housing 610 that includes a tube 626 (eg, a nylon tube) and end caps 625a, 625b. The vibrating device 600 includes a drive circuit that includes a magnet 623 that forms a vibrating element and a coil 624 that drives the movement of the magnet 623 to generate a vibration signal used to treat the vestibular anomaly disclosed herein. And can be further included.

[0101] As shown in the schematic cross-sectional view of FIG. 7A, the vibrating device 600 can include suspension elements implemented as springs 620a, 620b instead of the magnets 520a, 520b in the vibrating device 500 shown in FIG. .. The magnets 623 can be collectively suspended by springs 620a, 620b in the housing 610 (eg, in the chamber) so that the magnets 623 can vibrate around the equilibrium position when energized by an electrical signal.

[0102] As mentioned above with respect to the vibrating device 500, in some embodiments, the vibrating device 600 may include an elongated member having a longitudinal axis. The elongated member can be configured to extend through the opening of the vibrating element magnet 623 so that the magnet 623 can be configured to vibrate along the longitudinal axis of the elongated member. The elongated member can be further configured to reduce vibration of the magnet 623 along an axis other than the longitudinal axis.

[0103] The springs 620a, 620b are long members, cavities in end caps 625a, 625b, and / or, for example, rigid and / or flexible structures (eg, pins, foams, rubber or any other material), etc. , Can be supported by any other suitable structure (not shown in FIG. 7A) extending from the end cap. The springs 620a, 620b can be configured to stretch and contract along an axis (eg, longitudinal axis), and the magnets 623 attached to the springs 620a, 620b are the same to generate a therapeutic vibration signal. It can be configured to oscillate along an axis. The spring used as the elastic object forming the suspension element uses glue, epoxy resin or another form of adhesive to other parts of the vibrating device 600 (eg, magnet 623, tube 626 and / or end cap). It can be fixed to 625a, 625b). The springs 620a, 620b can be configured to reduce the vibration of the magnet along any axis other than the spring axis (eg, longitudinal axis).

[0104] The springs 620a, 620b are made of any suitable material (eg, stainless steel) and when driven by an electrical signal, the movement of the magnet 623 along the axis indicated by the arrow labeled "B". To enable it, it can be selected to have a constant stiffness with respect to the spring constant k. The springs 620a, 620b can be configured to be attached to a part of the magnet 623 and the housing 610. For example, each spring (620a and 620b) can have a first end that can be attached to a portion of the housing 610 and a second end that is attached to the magnet 623. Therefore, the spring can be configured to apply a force to the magnet to suspend it at that position in the chamber. For example, the springs 620a and 620b can apply equal forces in opposite directions, respectively, and the movement of the magnet 623 causes one spring (for example, 620a) to expand and the other spring (for example, 620b) to contract. And vice versa, the magnet 623 can oscillate along an axis (eg, the longitudinal axis of the spring) and the movement of the magnet 623 is centered on the suspension position (eg, equilibrium position). Can be configured to: The vibrating device 600 can include one or more glue pockets 632, 634 as coupling points between the springs 620a, 620b and the magnet 623, respectively.

[0105] In some embodiments, the springs 620a, 620b can operate to prevent contact between the magnet 623 and the inner surface of the tube 626. As mentioned above with respect to the vibrating device 500, the tube 626 of the vibrating device 600 lubricates the inner surface of the vibrating device 600 so as to reduce possible friction from any contact between the magnet 623 and the inner surface of the tube 626 during the movement of the magnet 623. It may contain and / or contain an agent (eg, ferrofluid) or a low friction material (eg, polytetrafluoroethylene). In some embodiments, rods or pins (not shown in FIG. 7A) and bushings (not shown in FIG. 7A) may be included to further limit the movement of the magnet 623 in directions not along axis B. it can.

[0106] FIG. 7B illustrates a cross-sectional view of the vibration device 600 from FIG. 7A attached to the delivery interface 630 to deliver a therapeutic vibration signal. As will be described later, the magnet 623 acts as a vibrating element suspended by the springs 620a, 620b. The delivery interface 630 may be a memory foam pad configured to transmit a vibration signal from the vibration device 600 to the body of interest. Magnets and springs are provided as examples of suspension elements, but one of ordinary skill in the art will appreciate that other types of elastic objects can be used in place of and / or in addition to magnets and / or springs. There will be.

[0107] The vibrating devices disclosed herein (eg, vibrating devices 400, 500, 600, 700) can have a high Q value (eg, vibrate at higher amplitudes over a narrow range of frequencies). it can). In some embodiments, the vibrating device may be able to operate at the lowest fundamental frequencies, such as frequencies of 50-70 Hz, and lower amounts of power are directed to higher and more audible resonant frequencies.

[0108] FIG. 8 illustrates a cross-sectional view of the vibrating device 700 according to one embodiment. The vibrating device 700 can be similar to the vibrating devices 500, 600. For example, the vibrating device 700 comprises a housing 710, a vibrating element implemented as a magnet 723, a suspension element implemented as a spring 720, and a vibrating signal used to treat the vestibular anomaly disclosed herein. It can include a drive circuit that includes a coil 724 that drives the movement of the magnet 723 to generate. Suspending the magnet 723 by a spring 720 within the housing 710 (eg, in the chamber) so that the magnet 723 can oscillate around an equilibrium position when energized by an electrical signal delivered by a drive signal. Can be done.

[0109] In some embodiments, the length of the spring 720 can be increased in order to reduce the spring constant of the spring 720, thereby affecting the resonant frequency of the vibrating device 700, and thereby more. It is possible to generate low frequencies. In order to change the length of the spring without changing the size of the vibrating device 700, the spring 720 can be configured to penetrate the opening 723a defined by the magnet 723. As shown in FIG. 8, the spring 720 can be attached to the mounting plate 728 and attached to the far side of the magnet 723 rather than to the closer side of the magnet 723. Thus, the length of the vibrating device 700 can remain the same, while the length of the spring 720 can be increased by a length equal to or substantially equal to the thickness of the magnet 723. In some embodiments, instead of having a mounting plate 728, the magnet 723 can have an opening that extends through a portion of its length (eg, approximately 95% of that length) and spring 720. Extends through the opening and can be attached to the far end of the magnet 723 in the same way that the spring 720 is attached to the attachment plate 728.

[0110] Similar to the vibrating device 600 as shown in FIG. 7B, the vibrating device 700 illustrated in FIG. 8 is also attached to a delivery interface (eg, delivery interface 730) to deliver the vibration signal to the vestibular system of interest. Can be done. The delivery interface 730 includes a padding material such as a memory foam pad along the surface of the target region to effectively deliver the vibration signal and can act as an interface between the vibration device 700 and the target region. ..

[0111] As shown in FIG. 8, some embodiments of the vibrating device can include an integrated circuit 706 that includes a circuit that generates a signal to activate the vibrating device 700. The integrated circuit 706 can include one or more leads or connection points 708 (eg, leads) for connecting to other components (eg, a control unit 360 such as a microcontroller). The integrated circuit 706 may also include and / or be coupled to the sensor 790.

[0112] The vibrating device 700 can have a high Q value. In operation, selecting the frequency of the signal used to activate the vibrating device 700 so that the vibrating device 700 operates at a resonant frequency to increase the amplitude of vibration for a given power input. Can be done. In one embodiment, the sensor 790 can include a Hall effect sensor configured to monitor magnetic field fluctuations. When the frequency of the electrical signal supplied to the vibrating device 700 from a signal source (eg, signal generator 370 and / or amplifier 380) capable of varying the force level and / or frequency matches the resonant frequency of the vibrating device 700, The magnet 723 can move even more (eg, oscillate with a larger amplitude) at other frequencies. Therefore, the magnetic field fluctuation caused by the vibration of the magnet 723 can be increased when the frequency of the electric signal coincides with the resonance frequency of the vibration device 700. This relative variation can be monitored by a Hall effect sensor.

[0113] More specifically, a microcontroller or microprocessor (eg, control unit 360) is used to receive a signal from a Hall effect sensor and power the vibrating device 700 based on sensor readings. It may be able to operate to adjust the frequency of the electrical signal. For example, a microcontroller can operate to scan through a set frequency range (eg, 50-65 Hz) and select the frequency of the electrical signal that produces the highest levels of magnetic field variation. This process can be referred to as "tuning". The combination of sensor 790 and microcontroller can then continue to tune the frequency of the electrical signal supplied to the vibrating device 700 to maintain its efficiency each time the device is turned on. Further, after the frequency of the electrical signal is selected, the frequency is changed around the selected frequency so that the frequency of the electrical signal related to peak efficiency is a component of the vibrating device 700 (eg, spring 720). It is possible to determine whether the properties of the are changed over time due to temperature, wear or other variables that can change over time.

[0114] In some embodiments, the sensor 790 is a current meter, voltmeter, to measure information (eg, current, voltage, acceleration, etc.) from which the resonance frequency that provides maximum efficiency can be selected. It can include an accelerometer or some other type of sensor similar to the sensor 390.

[0115] The integrated circuit 706 can function as an end cap, which further reduces the size of the vibrating device 700. The delivery interface 730 functions, for example, as a structure capable of transmitting vibration signals from the vibration device 700 to the body through bones to the vestibular system along the surface of the user's skin. It can be a foam pad that can work like this. The delivery interface 730 can be configured to allow efficient transmission of the vibration signal to the head with good coupling.

[0116] In some embodiments, the vibrating device 700 can be configured to reduce friction and / or contact between internal structures in order to avoid audible noise (ie, noise, growls). For example, magnets 723, coils 724, housings 710, etc. are positioned so that there is sufficient tolerance between them to allow the inherent sway and sway of the components while reducing contact between the various components. can do.

[0117] Like the magnet 623 of the vibrating device 600, the magnet 723 may also swing in a direction not along the axis C, which may cause the magnet 723 to come into contact with the inner surface of the vibrating device 700. This contact can produce audible sound and / or reduce the efficiency of the vibrating device 700. In some such embodiments, noise can be minimized by selecting a spring 720 and a magnet 723 that have the property of making the axial resonant frequency not the same as either the oscillating resonant frequency or its harmonics. it can. Therefore, operating the vibrating device 700 at a frequency that corresponds to the axial resonance frequency rather than the oscillating resonant frequency reduces oscillating and unintended contact between the magnet 723 and the other components of the vibrating device 700. Can be made to.

[0118] In order to adjust the output force level of the mechanical vibration signal output by the vibration device 700, the voltage of the electric signal input into the vibration device 700 can be increased. Alternatively or further, the frequency of the electrical signal can be adjusted to the resonant frequency to adjust the output force level of the vibration signal.

[0119] FIG. 9A illustrates a perspective view of a spring 820 (eg, a spring 720 in the device 700 described above) that can act as a suspension element in a vibrating device. The orientation of the spring can reduce the amount of rocking, swaying or unwanted movement of the magnet (eg, magnet 723) in the secondary direction. As shown in FIGS. 9B and 9C, which present a view of the two ends of the spring 820, the spring 820 starts at the first end 820a of the spring 820 at the 0 ° position and the second end 820b of the spring 820. Can be oriented so that it terminates at the 180 ° position. In another embodiment, depending on the influence of gravity on the vibrating device (eg, the orientation of the spring 820 with respect to the direction of gravity), the spring 820 may start and end at other angular intervals, such as 90 °, 270 °, etc. Can be done. In some embodiments, the orientation of the spring 820 can be selected based on the placement of the sensor, such as an accelerometer or Hall effect sensor.

[0120] FIGS. 10-10 are diagrams of different embodiments of vibrating devices that can be included and / or incorporated within various support elements. Although these figures may show one or two vibrating devices, one of ordinary skill in the art should understand that any number of vibrating devices may be included in various embodiments. In the case of a plurality of vibration devices, the combined effect of the vibration signals can be a therapeutically effective level for treating vestibular abnormalities, so that the force level of the vibration signals from each device can be reduced.

[0121] FIG. 10 illustrates a vibration device 900 in which the main body 910 is incorporated in a headband 918 worn on the target head HD. The vibration device 900 includes a control unit 906 similar to the control unit 360 described above. The headband 918 allows the headband 918 to hold the vibrating device 900 over the head HD of interest so as to effectively deliver a vibrating signal that can be conducted through the bone to the vestibular system. It can be made of elastic, Velcro, metal or plastic or another material. The vibrating device 900 can include a built-in power source (eg, a battery) that powers the control unit 906 and / or other components of the vibrating device 900, or headband 918 the vibrating device 900 via electrical wires. It can be attached to a separate power source (eg, battery pack). The control unit 906 may include an electrical drive circuit required to generate a vibration signal for treating the vestibular anomaly or other anomaly disclosed herein. Alternatively, such circuits and power supplies can be operatively connected to the vibrating device 900. In some embodiments, the headband 918 can incorporate additional devices such as headlamps or other suitable headgear to adapt to the various needs of the subject.

[0122] FIG. 11 illustrates the use of vibration devices 1000a, 1000b incorporated in a support element in the form of headphones 1002, according to one embodiment. Headphones 1002 can include audio speakers 1003a, 1003b and a long portion 1018 (eg, a band) that connects the audio speakers 1003a, 1003b. In some embodiments, the headphones 1002 do not include components such as audio speakers and can be passive noise reduction devices such as earmuffs. The vibrating devices 1000a, 1000b can be similar to any other vibrating device described herein (eg, vibrating devices 300, 400, 500, 600, 700, 800). Headphones 1002 reduce the level of audible sound caused by the vibrations generated by the vibration devices 1000a, 1000b, but the vestibular system (eg, through the bone as a result of the vibration signals generated by the vibration devices 1000a, 1000b). It can include a noise canceling circuit that can be used so as not to cancel other vibrations conducted to. For example, the system 1002 includes a noise canceling circuit that generates one signal (or a plurality of signals) that is out of phase (eg, 180 degree phase difference) with the audible signals generated by the vibrating devices 1000a, 1000b. be able to. Such out-of-phase signals act to reduce the signal level of such audible signals detected by the subject's vestibular system so that the subject may not hear the audible sound.

[0123] When used with the headphones 1002, the vibrating devices 1000a, 1000b can be placed adjacent to the audio speakers 1003a, 1003b, whereby when the audio speakers 1003a, 1003b are positioned above the ears. The vibrating devices 1000a and 1000b are positions that cover the mastoid bone. Alternatively or additionally, in some embodiments, the vibrating device 1000a in the earcup of the headphone 1002 can be co-located with the speakers 1003a, 1003b so as not to affect the decorative shape or outer shape of the headphone 1002. , 1000b can be incorporated.

[0124] Alternatively or additionally, in some embodiments, one or more of the vibrating devices 1000a, 1000b (or additional vibrating devices not shown) are placed along the headband 1018 or of the headphones 1002. It can be extended from some. Alternatively or additionally, in some other embodiments, one or more of the vibrating devices 1000a, 1000b (or additional vibrating devices not shown) are incorporated into an accessory attached to and removed from the headphone 1002. This allows the user to choose between headphones without vibrating devices 1000a and 1000b or headphones with vibrating devices 1000a and 1000b.

[0125] FIG. 12 illustrates yet another embodiment of vibrating devices 1100a, 1100b that can be incorporated or connected to pillows 1110 (eg, travel pillows, cushions, etc.). The location of the vibrating devices 1100a and 1100b on the pillow 1110 can be configured such that when the subject rests his or her head on the pillow 1110, the vibrating devices 1100a and 1100b cover, for example, the mastoid bone of the subject. In other embodiments, the vibrating devices 1100a and 1100b can be positioned to cover other areas of the head of interest.

[0126] FIG. 13 illustrates yet another embodiment of a vibrating device 1200 that can be incorporated or connected to a seat 1210 (eg, a car seat, office chair, etc.). The seat 1210 and the vibration device 1200, for example, allow the vibration device 1200 to cover a part of the target head and transmit a vibration signal to the head when the target head leans against the seat headrest 1212. Can be configured. In some embodiments, the vibrating device can be detachably attached to the seat 1210 using a support element 1218 so that it can be removed when not in use.

[0127] FIG. 14 illustrates another embodiment of vibrating devices 1300a, 1300b that can be incorporated or connected to eyeglasses 1310. Although spectacles are shown in FIG. 14, those skilled in the art will appreciate that other types of eyewear (eg, goggles, sunglasses, protective spectacles) may also be suitable for having one or more vibrating devices. Will do. The vibrating devices 1300a and 1300b can be positioned on the spectacles 1310 on the ears 1311a, 1311b which may come into contact adjacent to the head of the object while the spectacles 1310 are in use. When the subject is wearing spectacles 1310, the vibrating devices 1300a and 1300b are placed so that the vibrating devices 1300a and 1300b cover part of the head so that vibration signals can be transmitted over the head and vestibular system. Can be positioned.

[0128] FIG. 15 illustrates another embodiment of a vibrating device 1420 mounted on or incorporated into a virtual reality device 1410 (eg, a device that can be used to experience a virtual reality or augmented reality environment). To do. The vibrating device 1400 can be positioned in the virtual reality device 1410 on a band 1441 of the virtual reality device 1410 that can be used to fasten or support the virtual reality device 1410 over the subject's head. Adjacent contact with the head can be made while using the virtual reality device 1410. One or more vibrating devices can be mounted at any position along the band 1441 of the virtual reality device 1410. When the subject wears the virtual reality device 1410, the vibration device 1400 covers a portion of the subject's head so that vibration signals can be transmitted to the head and over the vestibular system (eg, via a delivery interface). As such, the vibrating device 1400 can be positioned on top of the virtual reality device 1410.

[0129] FIGS. 17A and 17B illustrate examples of waveforms of electrical signals that power vibrating devices. FIG. 17A shows a sinusoidal waveform 1600 with a wavelength of 1604 and an amplitude of 1602 that can be used to modulate the magnetic field vector to move the vibrating element of the vibrating device. FIG. 17B illustrates, for example, a rectangular waveform 1610 that can be used to modulate a piezoelectric vibrating element in a vibrating device to generate a vibrating signal, as described above. The piezoelectric device can oscillate at a high frequency to generate pressure when activated by a square wave, which can circulate at a lower frequency (eg, less than 200 Hz), thereby causing pressure. Circulates on and off at lower modulation frequencies (eg, 60 Hz) and functions like a low frequency vibration signal.

[0130] FIG. 18 is a graph 1700 showing the rise and fall of an electrical signal that powers a vibrating device to generate a vibrating signal. Graph 1700 shows how the amplitude of the electrical signal changes over time. As shown in FIG. 18, the amplitude can be increased during the onset step 1702, where the amplitude is increased at a predefined rate. Upon reaching the predefined levels, the amplitude remains constant during the steady-state stage 1706, which stage can continue for any suitable time to treat vestibular abnormalities (as indicated by the dashed line). .. Therefore, the amplitude can be reduced at a predefined rate until the signal is turned off. The waveform onset step 1702 and offset step 1704 can have different tilt profiles, as shown in FIG. For example, the increase in the applied voltage amplitude in the onset step 1702 can be a sloping increase in which the amplitude increases at a constant rate per unit time. Therefore, the offset step 1704 can be a downward slope or a sloped reduction of the amplitude in which the amplitude is reduced at a constant rate per unit time, which is different from the rate of increase. In some embodiments, the rate of amplitude increase in the onset step 1702 can be higher than the rate of amplitude reduction in the offset step 1704, as indicated by the different gradients. Optionally, the sloping increase and / or the sloping reduction in the offset stage 1704 can also be achieved with a rate of change (eg, a rate of increase and / or decrease over time).

[0131] In some cases, the rate of increase and / or the rate of decrease can be specified based on the vestibular abnormality being treated, the subject's personal preference, environmental factors, and the like. In some embodiments, the rate of increase and / or rate of decrease in amplitude can be adjusted by the user. In some embodiments, the rate of amplitude or rate of increase and / or decrease can be adjusted automatically (eg, by control unit 360) based on sensor readings. For example, a sensor built into a vibrating device may have a physical or physiological condition and / or response (eg, sweating, body temperature, heart rate) when the vibrating device is powered on and / or off. It can be configured to measure (changes in numbers, etc.). Rise and / or fall to adapt to different reactions (eg, by more delicate or first-time users to more routine users of the device) by monitoring their physical condition and / or response. The rate can be adjusted. In addition, in subjects with chronic symptoms (eg, vertigo), nerves that transition between device on and / or off, such as a sudden return of vestibular abnormalities and a more prominent onset of symptoms associated with vestibular abnormalities. Rising and / or falling can be selected so as to reduce the adverse effect on the patient.

[0132] FIG. 19 illustrates method 1800 using a vibrating device (eg, vibrating device 300, 400, 500, 600, 700) to treat symptoms associated with vestibular abnormalities disclosed herein. At 1802, the vibrating device is positioned on the subject or user's head. Positioning is on a suitable region (eg, on a suitable bone structure) such that the vibration signal can be effectively transmitted to the vestibular system of interest.

At 1804, an electrical signal is supplied to the vibrating device to energize the device and cause the vibrating element to move within the vibrating device. At 1805, a vibration signal is applied to the subject's head to treat the vestibular anomaly. At 1806, information related to the energized vibrating device is monitored, including, for example, current, voltage, magnetic field fluctuations, and the like. At 1808, the subject's physiological condition and / or comfort level is monitored. For example, physiological signs such as the subject's heart rate, sweating, body temperature, respiration, oxygen saturation, etc. can be monitored. Optionally, appropriate sensors and actuators integrated with the vibrating device can be used to monitor any feedback from the subject, such as feedback reporting the level of comfort or discomfort perceived by the user. Such monitoring in 1806 and 1808 can be achieved using one or more sensors (eg, sensors 390, sensor 416) and / or control units (eg, control unit 360).

[0134] At 1810, the vibrating device and / or the control unit coupled to the vibrating device determines whether the electrical signal should be tuned or altered. If there is no need to adjust the electrical signal (1810: NO), as mentioned above, the vibrating device can continue to treat vestibular abnormalities at 1805, continue monitoring information related to the vibrating device at 1806, and 1808. Continue to monitor information related to the subject at.

[0135] If the electrical signal needs to be adjusted (1810: YES), in 1812 the frequency or force level of the electrical signal is changed and in 1804 a new electrical signal is applied to the vibrating device, the flowchart as described above. Continue. Information gathered from the monitoring of the vibrating device and the monitoring of the subject can be used to determine if the force level and / or frequency needs to be changed and to what extent and in what form. .. For example, if the measured voltage, current and / or magnetic field fluctuations indicate that the current frequency is not a resonant frequency, the frequency can be adjusted to improve the efficiency of the vibrating device. As another example, if a signal is received from the user indicating that the vestibular anomaly is no longer present (eg, motion sickness is gone), the vibrating device turns off the device (eg, via falling). The frequency can be adjusted to. As another example, the force level can be reduced in response to an indication of discomfort by the subject.

[0136] To treat symptoms associated with vestibular abnormalities, an experimental study was conducted to test experimental vibration devices similar to the vibration device examples disclosed herein. The experimental vibration device included a vibration element implemented as a magnet suspended between two other magnets, similar to the vibration device 500 shown in FIG. The vibrating device included a microcontroller, an external coil with a 4 ohm impedance powered by a custom designed Arduino board. The microcontroller was able to energize the external coil to generate a magnetic field used to vibrate the suspended magnet. A three-magnet / voice coil assembly was placed inside the body or housing and connected to a rechargeable battery, thereby supplying power. The vibrating device was able to generate vibrations that could be attached to the human head and conducted through the bones to the vestibular system.

[0137] In the study, the subject wore an experimental vibrating device located behind the ear in contact with the area covering the mastoid bone, and the vibration signal generated by the device was transmitted through the bone to the subject's vestibular system. Made it possible to conduct to. Subjects were exposed to a variety of conditions that caused motion sickness, nausea and / or other vestibular abnormalities, and the effectiveness of the vibrating device was assessed based on the information reported by the subject.

[0138] For the experiment, the force level of vibration generated by the vibrating device used a calibrated B & K mastoid process (4930) coupled to a Bruel & Kjaer (B & K) sound level meter (2234). Was measured. A vibrating device was inserted into a holder within a B & K mastoid process designed to hold a bone conduction hearing aid. A force of 3.5-8 Newton was applied onto the vibrating device located in contact with the B & K mastoid process. Bone conduction levels are quantified using a B & K sound level meter and expressed as dBre 1 dynes (ie, force levels).

[0139] Further information related to each of the studies is provided below.

Experimental Study I
[0140] FIG. 20A shows a flowchart 1900 of the procedure of the first experimental study. Participants in this first experimental study had no history of vestibular disease, including non-vertigo. During the time of the study, participants were asked to sit in office chairs and wear the Oculus Rift DK2 virtual reality system and the vibrating device according to the design example described above. The vibrating device was held in place by a head strap.

[0141] The study was performed according to the test procedure outlined in Figure 20A. Each participant performed the test procedure multiple times, first turning off the vibrating device and then turning on the vibrating device. By changing the frequency and / or force level of the vibrating device during testing with the vibrating device turned on to treat vestibular abnormalities where a particular frequency and / or force level is associated with the use of the virtual reality device. It was tested for effectiveness. During the test, the order of frequency and / or force levels was randomized among the participants. Participants were also given the opportunity to constantly stop studying to recover from non-vertigo or other vestibular abnormalities caused by the use of virtual reality devices.

[0142] In 1902, participants are given the visual stimulus 1950 shown in FIG. 20B via the display of a virtual reality device. The visual stimulus 1950 includes a disc-shaped region 1956 with a plurality of spheres 1954. Participants were instructed to focus their attention on the central sphere 1952, which has a different hue than the rest of the sphere 1954 in the disc-shaped region 1956. The disc-shaped region 1956 was designed to represent a three-dimensional space that can be viewed using a virtual reality device such as the Oculus Rift.

[0143] At 1904, the participant initiates the rotation of the sphere 1954 in the disc-shaped region 1956 around the center point (ie, the central sphere 1952) by pressing the spacebar on the keyboard. When the space bar is pressed, the sphere 1954 begins to rotate and gradually accelerates at a speed of 4 degrees / sec / sec in 1906. In 1908 and 1909, participants were instructed to press the spacebar again if they felt discomfort or non-vertigo, at which point the angular velocity of the spinning sphere 1954 was recorded and the participant Was memorized as "maximum angular velocity". If a particular participant did not press the spacebar to indicate discomfort or non-vertigo, the angular velocity of the sphere 1954 increased until it reached a predefined angular velocity of 90 degrees / sec.

[0144] In 1910, the angular velocity of the image was reduced to 90% of the velocity prior to the user's instruction (ie, 90% of the velocity was recorded as the "maximum angular velocity"), or the participant pressed the spacebar. If not, it was reduced to 90% of 90 degrees / second (ie 81 degrees / second). In 1911, the sphere 1954 is lowered until the participant presses the spacebar again to indicate a return of discomfort or non-vertigo, or until a predefined time in 1912 (eg, 120 seconds) has elapsed. It rotates at the speed of When instructed by the participant in 1911 or when the predefined time in 1912 elapses, the time the participant sees the disc-shaped region 1956 at its reduced speed is recorded as the "length of display time".

[0145] Given participants were initially asked to perform the test procedure with the vibrating device turned off. Participants took the test procedure twice, the first with the sphere 1954 rotating clockwise and the second with the sphere 1954 rotating counterclockwise. The same was then repeated with the vibrating device turned on. Study participants were asked to wear the vibrating device behind their ears and flush with the ear canal above the flat portion of the mastoid bone. Participants were given time to rest (eg, 10-60 seconds) between the clockwise and counterclockwise tests as needed to recover from any discomfort or vertigo.

[0146] Participants using vibrating devices were asked to test different force level pairs or different frequency pairs. For participants testing different force levels, the frequency of the vibration signal remained constant (ie 50 Hz), while the force levels were 87, 92, 94, 96, 98, 99, 100 and 101 dB re 1. Set to Dyne. For participants testing different frequencies, the output level of the vibration signal was set to a constant level (ie 96.5 dB re 1 dyne) and the frequency was varied from 30 to 75 Hz.

[0147] Eighteen participants participated in the study. Approximately one-third of these participants who were willing to participate in the study did not experience any motion sickness from the experiment. These participants gazed at the presented visual stimulus (FIG. 20B) until the spinning sphere 1954 reached 90 degrees / sec, and then continued to gaze at the visual stimulus at a reduced rate for 120 seconds. Participants who were resistant to motion sickness were instructed to repeat contact with visual stimuli with the vibration device turned on to test whether vibration from the device caused motion sickness. None of these participants reported experiencing any negative side effects during and after using the vibrating device with the vibration generated by the vibrating device set to 97 dBre 1 dyne or less. ..

[0148] Experimental data for the remaining 11 participants (ie, participants who showed that they experienced motion sickness or vertigo at some point during the experimental study) are shown in FIGS. 21A, 21B, FIG. It is shown in 22A and FIG. 22B. For the data points in the graphs shown in FIGS. 21A, 21B, 22A and 22B, the "maximum angular velocity" and "length of display time" of clockwise and counterclockwise rotation are averaged for each participant under each test condition. And based on the "without vibrating device" data, the "with vibrating device" data was standardized (ie, collected for participants while using the vibrating device set to a specific frequency and / or force level). The data was normalized based on the participant's data while not using the vibrating device). After calculating these ratios for each participant, the ratios of 11 participants were averaged to reach the data points shown in the graphs shown in FIGS. 21A, 21B, 22A and 22B.

[0149] FIG. 21A shows Graph 2000 of the average "length of display time" ratio of 11 participants over a range of different force levels. A value greater than 1 indicates an increase in display time before experiencing discomfort while using the vibrating device relative to when not using the vibrating device. FIG. 21B shows a graph 2002 of the average "maximum angular velocity" ratio of 11 participants over a range of different force levels. A value greater than 1 in FIG. 21B indicates an increase in angular velocity that did not cause discomfort while using the vibrating device relative to when not using the vibrating device. Experimental data showed that for 11 participants, the vibrating device had the greatest effect when its vibrating force level was set to 96 dB re 1 dyne. Based on the interpolated fit of the data, the "length of display time" and "maximum angular velocity" ratio peaked at 96.5 dB re 1 dyne. The "length of display time" and "maximum angular velocity" ratios at force levels in the range of 93 dB to 98 dB are statistically significantly different from and greater than 1, vibrating devices set to these force levels. , Shows that it is effective in treating vestibular abnormalities.

At 87 dB re 1 dyne, the ratio is statistically no different from 1, indicating that the device is not effective in treating vestibular abnormalities. At about 100 dB re 1 dyne or higher, many participants reported mood deterioration with the vibrating device turned on. The discomfort thresholds at these higher force levels differed slightly from participant to participant, with some reporting discomfort at levels as low as 99 dB, but for certain participants, when that threshold was reached, The participant reported that the vibration caused discomfort almost immediately. Participants tested at 102 dB all reported discomfort with or without using a virtual reality system, as vibration from the vibrating device alone caused discomfort to them.

[0151] FIGS. 22A and 22B show the normalized and averaged "length of display time" and "maximum angular velocity" ratios for 11 participants over a range of frequencies. As shown, these results show that the effectiveness of the experimental vibration device for alleviating or delaying virtual reality sickness does not appear to be determined by the frequency of the vibration signal. However, graphs 2100 and 2102 show values with relatively large ratios of 45-65 Hz.

[0152] Several factors may have limited the results of this first experimental study. For example, the angular velocity of the sphere 1954 in the disc-shaped region 1956 was limited by the visual display system. Specifically, the refresh rate of the Oculus DK2 screen is 90Hz. The panel of the device is an organic LED (OLED) with an afterimage of 2 milliseconds. These factors prevented the rotation speed of the sphere 1954 in the disc-shaped region 1956 from rotating above approximately 90 degrees / sec. When the rotation speed increased above 90 degrees / sec, the virtual reality display started flicker. Many test participants reached this limit while wearing the vibrating device, which caused a ceiling effect on the measurements.

[0153] Similarly, while looking at the sphere rotating at a reduced rate of 1954, some subjects complained of eye fatigue and no discomfort or nausea. Therefore, participants are also limited in how long they can see the spinning disk, which is a measure of the effectiveness of experimental vibrations in delaying the onset of virtual reality sickness. It was another factor that had an effect.

[0154] Given these factors, this first experimental study showed that vibrating devices are effective in treating virtual reality sickness at statistically significant levels. The data shown in the graphs of FIGS. 20A and 20B showed that fluctuations in force levels had a statistically significant effect on the effectiveness of the vibrating device. Specifically, force levels below 93 dB re 1 dyne are not effective in treating vestibular abnormalities, and force levels above 100 dB can cause discomfort and vertigo that exacerbate vestibular abnormalities. It was shown and therefore the data showed that force levels of 93 dB to 98 dB re 1 dyne were more effective in treating vestibular abnormalities. On the other hand, according to the data shown in the graphs of FIGS. 21A and 21B, the change in vibration frequency did not have a clear tendency or peak in the effectiveness of the vibration device from 45Hz to 65Hz, so the change in vibration frequency is vibration for treating vestibular abnormalities. It has been shown to have a smaller effect on device effectiveness.

Experimental Study II
[0155] In the second experimental study, the results obtained from the first experimental study disclosed above are used to alleviate or prevent the ride sickness experienced by the user of the virtual reality game "EVE: Valkyrie". The effectiveness of the experimental vibration device was measured against.

[0156] "EVE: Valkyrie" is a first-person spaceship shooter game in which the player uses an Xbox 360 handheld controller to move on a spaceship and meteorite field. This game is known to cause motion sickness in many players. This game involves flying through "gates" located in the fields of asteroids and spacecraft. In addition to movement in the three spatial dimensions, most "gates" now rotate about a three-dimensional rotation axis (eg, "roll", "pitch" or "yaw" axis) with respect to the player. Request.

[0157] In this study, subjects used the Oculus Rift CV1 system to play the virtual reality game "EVE: Valkyrie" for up to 15 minutes. For the study, participants were instructed to play the game in two sessions for two consecutive days, with and without the use of the experimental vibration device described above. On the first day of the experiment, participants were asked to play the training mission portion of the virtual reality game for up to 15 minutes without the experimental vibrating device. Participants were instructed to stop if they began to feel nausea before the end of the 15 minutes. Experienced gamers could choose to go directly to the mission, skip training missions and embark on virtual reality space flights directly. On the second day, the same experimental procedure was continued, but participants were provided with an experimental vibration device set to a frequency of 60 Hz and a force level of 96.5 dB, which was found to be effective according to the results of the first experimental study. I put it on. The device was applied behind the right ear of the skull with a force of approximately 3.5-8 Newton applied at the same height as the ear canal and on the flat portion of the mastoid process. During the study, any participant who felt vertigo or discomfort could be stopped at any time of his choice.

[0158] Participants were asked to complete a motion sickness evaluation questionnaire (“MSAQ”) approximately 10 minutes after they stopped playing the game. MSAQ groups independent descriptors of motion sickness into four categories of motion sickness: (1) gastrointestinal system, (2) central nervous system, (3) peripheral nervous system, and (4) drowsiness-related. Includes 16 statements or manifestations that help identify and categorize by. MSAQ scores range from 1 (not at all) to 9 (severe) for 16 possible manifestations of motion sickness. Table 1 shows 16 representations of MSAQ used to assess the motion sickness experienced by participants.

[0159] If participants were asked to play the game for 15 minutes on day 1 without the experimental vibrating device, 11 out of 17 participants could play for the entire 15 minutes. It was. The duration of play for the remaining six players ranged from 4:05 to 14:50 minutes. The average play time was 13:25 minutes. In contrast, if participants wore experimental vibration devices during play, all 17 participants were able to play for a duration of 15 minutes. Data from MSAQ will be collected and presented in Table 1. MSAQ scores range from 1 (not at all) to 9 (severe).

[0160] The results of MSAQ are presented in graph form in FIGS. 23A and 23B. Each graph shows the ratio of the MSAQ score obtained while wearing the device to the MSAQ score obtained while wearing the device. FIG. 23A shows a plot 2200 showing the average score from MSAQ across all four categories of motion sickness, and FIG. 23B shows the four categories of motion sickness defined by MSAQ, specifically (1) the gastrointestinal system. Four subplots 2202, 2204, 2206, 2208 showing scores for each of (2) central nervous system, (3) peripheral nervous system, and (4) motion sickness-related are shown. Line 2205 passing through each graph represents the case where the MSAQ score with and without the vibrating device is the same, and thus the vibrating device does not affect motion sickness.

[0161] As shown in FIGS. 23A and 23B, the data indicate that the vibrating device was effective in treating motion sickness, as all of the data points were located below line 2250. Data points showed a significant reduction in MSAQ scores from 9 (severe) to 1 (not at all). As shown in plot 2202, 2204, 2206, 2208 of FIG. 23B, the vibrating device was significantly effective in treating motion sickness in each category, even when divided into different categories of motion sickness.

Experimental Study III
[0162] In a third experimental study, participants were asked to be occupants of the backseat of a four-door sedan and drove on a section of road based on a fixed 20-minute journey. On the same day, three road tests were conducted on this set route. During each drive, participants were asked to read the article on their smartphones or other small handheld devices. The start time was recorded and each participant reported when he first felt the first symptoms of motion sickness.

[0163] For each participant, a reference measurement for motion sickness was established by allowing participants to experience driving without any type of auxiliary device and read articles on their smartphones. After the initial drive, for each participant, (1) the experimental vibrating device described herein placed over the participant's right mastoid bone, or (2) an outward facing rubber pad. We asked them to wear a low-frequency sound generator that was isolated from the participants' heads and provided an audible level equal to that of the experimental vibration device. The order in which each device was worn was randomized for each participant.

[0164] The driving route was a fixed detour route with only one stop sign at some point along the way (ie at about 10 minutes) and no traffic lights. The fixed route took approximately 20 minutes and the variability between operations was less than 10%. Only the first half of the ride was tested on the subject up to the stop sign. The subject was given a break during the session.

[0165] Based on feedback from participants, this study showed that participants did not experience motion sickness in a row, but generally when the vehicle accelerated, decelerated, or turned. Participants reported motion sickness as an accumulating effect until the threshold was reached, such as the first turn causing mild discomfort and the second turn increasing the effect of the first turn. While using the experimental vibration device, participants felt discomfort during acceleration and turns, but this discomfort quickly returned to zero when the car returned to a constant speed, and the car's acceleration was continuous. It was reported that there was no effect of nausea that accumulated during the change to.

[0166] FIG. 24 shows the seconds to the first onset of motion sickness hosted by participants during the Third Experimental Study. Bar 2302 represents the seconds to the first onset of motion sickness without a device, bar 2304 represents the seconds to the first onset of motion sickness with a voice generator, and bar 2306 represents the seconds to the first onset of motion sickness with an experimental vibration device. Represents the seconds to the first onset of motion sickness. As shown, the use of the experimental vibration devices described herein has led to a significant increase in seconds to onset of motion sickness at bar 2306. Specifically, the experimental vibration device is effective because it takes more than twice as long to develop motion sickness as compared with the device without the device (bar 2302) and the sound generator with the sound generator (bar 2304). It turned out to be. The data from this study demonstrate the effectiveness of experimental vibration devices in preventing motion sickness in simulated real-life reading situations while in the backseat of a car as a occupant. None of the subjects who used the experimental vibration device reported any discomfort when getting out of the car.

Outline of experimental research and other points
Results from the experimental studies described above indicate that vibrating devices such as the vibrating device examples disclosed herein may be effective in treating the symptoms of various vestibular abnormalities. Such devices have a small outer shape and can be coupled to the surface of the subject's head so that vibrations can be conducted to the subject's vestibular system through the bone (eg, the skull). The experimental vibration devices used in the three experimental studies have been shown to be effective in alleviating and reducing motion sickness caused by motion and / or virtual reality. The experiments and results described demonstrate that the effectiveness of the disclosed vibrating device in reducing motion sickness is substantially instantaneous without any obvious adverse side effects.

[0168] The force and frequency levels found to be effective herein by subsequent experiments are also effective in reducing vertigo and nausea caused by caloric tests performed in medical facilities. Was shown. For example, in the case of vertigo, we asked people with chronic or frequent symptoms of vertigo to wear an experimental vibration device and report the effect of wearing the device. In general, humans have reported reductions in symptoms associated with vertigo when using the device. In another example, for a caloric test, an otolaryngologist (“ENT”) performed a caloric test on five subjects with and without an experimental vibration device. If the device was not worn on day 1, all subjects felt nausea and one subject was unable to complete the test due to severe nausea. When wearing the device the next day, all five subjects reported a significant reduction in nausea, including no nausea, and subjects who failed to complete the test on day 1 reported on day 2. Was able to put on the device and complete the inspection. Examinations on both days showed the same level of vestibular function with and without vibrating devices.

[0169] FIGS. 25A-25C show a schematic view of the housing 2410 of the vibrating device 2400. The vibrating device 2400 may be similar in structure and / or function to any of the vibrating devices described herein. For example, the vibrating device 2400 can be similar to the vibrating devices 500, 600 and / or 700 described above. As shown in FIGS. 25A-25C, the vibrating device 2400 can include a delivery interface 2430 and an inner housing 2426 within the outer housing 2410. In some embodiments, the outer housing 2410 can be formed by joining the two portions 2410a and 2410b, as shown in the exploded view of FIG. 25C. FIG. 26 illustrates a cross-sectional view of the housing 2410 and shows the coupling of two portions 2410a and 2410b that can be mediated by mechanical fixtures, adhesives and the like. The inner housing 2426 can accommodate vibrating elements (eg, magnets), coils and / or other structures associated with the vibrating devices described herein.

[0170] FIGS. 27A, 27B and 27C illustrate perspective views, side views and assembly exploded views of the vibration device 2500 according to one embodiment, respectively. 28A and 28B show a perspective view and a side sectional view of the vibration device 2500, respectively. The vibrating device 2500 may be substantially similar in structure and / or function to other vibrating devices described herein (eg, vibrating devices 500, 600 and 700). For example, the vibrating device 2500 can include a housing 2510, a delivery interface 2530 and an end cap 2525. The vibrating device 2500 can include electromagnetic coils 2524a and 2524b configured to generate a magnetic field that moves the magnet 2523. In some embodiments, the coils 2524a and 2524b can be wound in opposite directions, eg, to generate magnetic fields of opposite polarities. Although illustrated to have two coils 2524a and 2524b, in some embodiments the oscillating device 2500 is configured to generate a magnetic field of varying polarity that causes the movement of the magnet. A coil can be included. A single coil can be driven, for example, by two separate drive circuits that generate drive signals of different polarities. In some other embodiments, a single drive circuit can be used to generate signals of different polarities, for example by using a phase switching circuit. The vibrating device 2500 can include a spring 2520 coupled to a magnet 2523 and configured to act as a suspension element. The vibrating device 2500 can include mounting plates 2528a and 2528b, the magnet 2523 can have an opening extending through a portion of its length, whereby the spring 2520 extends through that opening. The spring 720 can be attached to the far end of the magnet 2523 via the attachment plate 2528b in the same manner as described for attaching the spring 720 to the attachment plate 728 in the vibrating device 700.

[0171] The magnet 2523 of the vibrating device 2500 can include metal end plates 2529a and 2529b. In one embodiment, the end plate 2529b can function as a mounting plate 2328b for the spring 2520. The end plate can be configured to reduce stray magnetic flux. For example, a vibrating device with a magnet acting as a vibrating element may have lines of magnetic force that drift away from the magnet and allow the vibrating device to be attracted to a metal object by magnetic force. This magnetic force has undesired side effects and can make the vibrating device unwieldy during use. The end plates 2529a and 2529b can reduce these stray magnetic fluxes so that the oscillating device 2500 can be used near other metal objects without being less attracted to them. In addition, end plates 2529a and 2529b are used to direct magnetic lines of force out of the ends of the magnet in a direction perpendicular to (eg, towards them) the coils 2524a and 2524b, parallel to the coils (eg). For example, it is possible to generate a magnetic field such that more of the magnetic field lines are directed to allow the magnet to move with respect to the vibrating device 2500, while reducing drift loss or leakage of the magnetic field lines in the direction (not facing the coil).

[0172] FIG. 38 illustrates a partial perspective view of the vibrating device 2600 according to another embodiment. The vibrating device 2600 may be substantially similar in some aspects of structure and / or function to other vibrating devices described herein (eg, vibrating devices 500, 600, 700 and 2500). For example, the vibrating device 2600 can include a housing and a delivery interface (not shown in FIG. 38). The vibrating device 2600 can include an end cap 2625 that can be coupled to electromagnetic coils 2624a and 2624b configured to generate a magnetic field that moves the magnet 2623. In some embodiments, the end cap 2625 may include an electrical interface 2627 suitable for delivering electrical signals to the electromagnetic coils 2624a and 2624b. In some embodiments, the coils 2624a and 2624b can be wound in opposite directions to generate magnetic fields of opposite polarities. In some embodiments, the coils 2624a and 2624b can be placed at suitable distances from each other as shown in FIG. 38, while others (eg, as shown in FIGS. 28A and 28B). In embodiments, the coils can be spatially placed closer to each other.

[0173] The vibrating device 2600 can include a spring 2620 coupled to a magnet 2623 and configured to act as a suspension element. The vibrating device 2600 can include a mounting plate (not shown in FIG. 38), the magnet 2623 can have an opening extending through its length, whereby the spring 2620 can have that opening. The spring 2520 can be attached to the far end of the magnet 2623 via the attachment plate in a manner similar to that described for attaching the spring 2520 to the attachment plate 2528b in the vibrating device 2500. The magnet 2623 of the vibrating device 2600 can include metal end plates 2629a and 2629b (shown in FIG. 29) that are substantially similar in structure and / or function to the metal end plates 2529a and 2529b of the vibrating device 2500. The end plates 2629a and 2629b can be configured to reduce stray magnetic flux as described for the oscillating device 2500. For example, the end plates 2629a and 2629b can limit any stray magnetic flux so that the vibrating device 2600 can be used in close proximity to other metal objects without being attracted to them. Metal end plates 2629a and 2629b are used to direct magnetic lines of force out of the ends of the magnet in a direction perpendicular to (eg, towards them) the coils 2624a and 2624b and parallel to the coils (eg). It is possible to generate a magnetic field such that more of the magnetic field lines are directed to allow movement of the magnet with respect to the vibrating device 2600, while reducing drift loss or leakage of the magnetic field lines in the direction (not facing the coil).

[0174] FIG. 29 shows an example 2700a of magnetic field lines concentrated by the metal end plates 2629a and 2629b. The normalized flux density plot 2700b measured over the arc length distribution in FIG. 30 shows the end plateless vibrating device against the reduced flux leakage (line 2704) of the vibrating device 2600 with the end plates 2629a and 2629b. Relative flux leakage (line 2702) is compared. As shown, the use of metal end plates (eg 2629a and 2629b) can reduce magnetic flux leakage. In some embodiments, the end plates 2629a and 2629b can allow for more efficient use of the magnetic field energy generated by the coils 2624a and 2624b, thereby producing a therapeutically effective vibration signal. A smaller driving force can be used to cause the desired movement of the magnet 2623. In some embodiments, metal end plates 2629a and 2629b are used to focus the magnetic field lines of the magnet in such a way that the power required to drive the movement of the magnet is smaller (eg, in the directory towards the coil). Can be made to. In such an embodiment, a smaller magnet 2623 can be used to generate a vibration signal of a given intensity, thereby reducing the size of the vibration device 2600. The metal plates 269a and 2629b can be made of any suitable material capable of concentrating the lines of magnetic force as described above. In one embodiment, the end plates 2529a and 2529b and / or the end plates 2629a and 2629b can be made from low carbon steel.

[0175] FIGS. 31A, 31B and 31C illustrate perspective views, side views and assembly exploded views of the vibrating device 2800 according to one embodiment, respectively. 32A and 32B show two cross-sectional views of the vibrating device 2800 of FIGS. 31C-31C. The vibrating device 2800 may be substantially similar in structure and / or function to other vibrating devices described herein (eg, vibrating devices 500, 600, 700, 2500 and / or 2600). For example, the vibrating device 2800 can include a housing 2810, a delivery interface 2830 and housing portions 2825a and 2825b. The vibrating device 2800 can include an electromagnetic coil 2824 configured to generate a magnetic field that moves a magnet 2823 acting as a vibrating element along the direction of arrow E shown in FIG. 32B.

[0176] Magnet 2823 can include metal end plates 2829a and 2829b. The end plates 2829a and 2829b can be substantially similar to the end plates 2529a and 2529b described for the vibrating device 2500. In one embodiment, the metal end plates 2829a and 2829b can be made from low carbon steel. The metal end plates 2829a and 2829b concentrate the magnetic field lines of the magnet 2823 in the direction perpendicular to the coil 2824 (eg, the magnetic field lines of the magnet 2823 on the coil 2824, while reducing the drift loss or leakage of the magnetic field in the parallel direction. It can be configured to come out of the end of the magnet in the direction perpendicular to it). FIG. 33 illustrates the relative positioning of the magnet 2823 with respect to the metal end plates 2829a and 2829b and the coil 2824. FIG. 34 is an example 3000 of the magnetic field lines concentrated by the metal end plates 2829a and 2829b, as shown in FIG. 33. The normalized flux density plot 3100 measured over the arc length distribution in FIG. 35 compares the relative flux leakage of different vibrating devices. Line 2702 is the magnetic flux density of the vibrating device without an end plate, line 2704 is the magnetic flux density with the end plate of the configuration shown in FIG. 38 described above with respect to FIGS. 29 and 30, and line 3102 is the magnetic flux density. The magnetic flux density of the vibrating device 2800 with the end plates 2829a and 2829b. As shown, the use of metal end plates 2829a and 2829b is caused by the drive circuit of the vibrating device 2800 as compared to that of other vibrating devices described herein (eg, vibrating device 2500 or 2600). Magnetic flux leakage can be reduced.

[0177] The vibrating device 2800 has suspension elements 2820a and 2820b (eg, springs) configured to suspend and support the operation of magnets 2823 instead of springs as described in some of the vibrating devices described above. )including. Suspension elements 2820a and 2820b can be annular pieces of elastic and / or deformable material, such as cloth, spider springs or flexible membranes. The annular piece is coupled to the magnet 2823 and is configured to suspend the magnet 2823 at the equilibrium point so that the magnetic field generated by the coil 2824 can move the magnet around the equilibrium point in the direction indicated by arrow E. Can be done. By extending the suspension elements 2820a and 2820b laterally from the magnet as opposed to extending longitudinally from the magnet (eg, the spring 2520 of the vibrating device 2500, etc.), the suspension elements 2820a and 2820b are Off-axis movement or swing of the magnet 2823 outside the axis defined by the arrow E can also be reduced while allowing a reduction in the overall height of the device 2800. 36A, 36B and 36C illustrate the height comparison of vibrating devices according to embodiments 700, 2500 and 2800 as described above. Further, the suspension elements 2820a and 2820b may be configured to extend and contract to provide restoring forces in one or more directions at an angle to the axis of movement of the magnet 2823, whereby the suspension elements The 2820a and 2820b reduce the vibration of the magnet 2823 in one or more of its directions.

[0178] FIG. 37 illustrates the vibration device 3200 according to one embodiment. The vibrating device 3200 may be substantially similar in structure and / or function to other vibrating devices described herein (eg, vibrating devices 500, 600, 700, 2500, 2600 and / or 2800). For example, the vibrating device 3200 can include a housing 3210, a delivery interface 3230 and housing portions 3225a and 3225b. The vibrating device 3200 can include an electromagnetic coil 3224 configured to generate a magnetic field that moves a magnet 3223 acting as a vibrating element along the direction of arrow F shown in FIG. 37.

[0179] Magnet 3223 can include metal end plates 3229a and 3229b. The end plates 3229a and 3229b can be substantially similar to the end plates 2829a and 2829b described for the vibrating device 2800. In one embodiment, the metal plates 3229a and 3229b can be made from low carbon steel. The metal end plates 3229a and 3229b can be configured to reduce drift loss or leakage of the magnetic field in the horizontal direction while concentrating the lines of magnetic force in the direction perpendicular to the coil 3224.

[0180] The vibrating device 3200 can include a suspension element 3220 (eg, a spring) configured to suspend the magnet 3223 and support its movement. The suspension element 3220 may be substantially similar in structure and / or function to the suspension elements 2820a and 2820b described above for the vibrating device 2800. For example, the suspension element 3220 can be one or more annular pieces of material. The annular piece can be coupled to the magnet 3223 via the metal end plate 3229b, as shown in FIG. The suspension element 3220 is coupled to the metal end plate 3229b in any suitable manner (eg, glued) and the magnetic field generated by the coil 3224 moves the magnet around the equilibrium point in the direction indicated by arrow F. It may be configured to suspend the magnet 3223 at the equilibrium point so that it can be. Similar to the vibrating device 2800, the suspension element 3220 can be configured to reduce the overall height of the device 3200 and also reduce the off-axis movement or swing of the magnet 3223 outside the axis defined by the arrow F. .. Further, since the suspension element 3220 is arranged between the end plate 3229b and the coil 3224, the lateral dimension of the vibration device 3200 can be reduced with respect to the vibration device 2800 shown in FIGS. 32A and 32B. For example, the suspension element 3220 may be configured to extend and contract to provide restoring forces in one or more directions at an angle to the axis of movement of the magnet 3223, whereby the suspension element 3220 may be configured. , Reduces vibration of the magnet 3223 in one or more of its directions.

[0181] In some embodiments, additional components (eg, pins such as posts or pins 521) can be added to improve the stability of the magnet 3223, similar to the magnet 523 of the vibrating device 500. The magnet 3223 can be configured so that there is an opening through the magnet 3223 to receive its components.

[0182] Through the application of bone conduction vibration signals, the application of vibration signals that mask the signals transmitted by the disease-causing vestibular system, also known as vestibular masking, can be effective in alleviating many vestibular abnormalities. .. For example, the applied bone conduction vibration signal can treat vertigo caused by an injured vestibular system. However, sometimes, when the applied vibration signal is suddenly removed (eg, when the vibration device is turned off), the vibration signal may have an adverse reaction. In some embodiments, such as those detailed above, these adverse reactions gradually reduce the output of the applied vibration over a period of time (ie, power up) instead of suddenly turning off the device. It can be minimized by (there is a descent).

[0183] As another example, vestibular masking can be effective in alleviating motion sickness that occurs when a person uses a virtual reality device, such as those disclosed herein. Since virtual reality devices do not always cause motion sickness, in one embodiment, vibration devices such as those disclosed herein have some conditions and / or situations associated with causing motion sickness. It may be able to operate to generate vibrations that mask the vestibular system when displayed and / or presented to the user of the virtual reality device. The vibrating device can be controlled, for example, by a microcontroller that can operate to store dedicated instructions that control the vibrating element. These instructions can be stored in internal memory or separate memory. In addition, these instructions are designed to incorporate into the controller specialized functions and features to perform any function, method or process associated with the treatment of vestibular abnormalities. In one embodiment, the microcontroller can be programmed with instructions using a software development kit (“SDK”).

It should be understood that the microcontroller can generate electrical signals that control and / or drive the generation of vibration signals based on stored instructions. These electrical signals can be communicated between the microcontroller and the vibrating device via a wired or wireless (eg, Bluetooth) method. In addition, electrical signals can include stored patterns of operation. For example, stored instructions accessed by a microcontroller can be used by the microcontroller to generate a series of electrical signals that are transmitted to the vibrating element to the microcontroller and vibration. Based on the usage data stored and stored in the device containing the element, the vibrating element is turned "on" or "off" in a pattern that is favorable to a given user. One pattern can include a series of vibrations that occur over a period of time (eg, per minute) and can vary the number of vibrations applied, while the second pattern is the force in multiple vibrations. It can include a series of vibrations whose levels can be changed. Based on the data received from the sensor, other types of electrical signals can be transmitted from the vibrating device to the microcontroller, such as those that can be used to control the force level and frequency of the vibration generated by the vibrating element. it can. For example, an accelerometer can be included in a portable electronic device (eg, a mobile phone) to detect changes in the physical acceleration of the user. In one embodiment, the microcontroller may be able to operate to receive data from the accelerometer indicating the type of acceleration that can lead to motion sickness. Thus, the microcontroller may be able to operate to generate relevant control signals after receiving such data and transmit these signals to the vibrating element. Thus, the vibrating element may be capable of receiving such control signals and producing vibrations that can be applied in real time to the proprioceptive vestibular system, eg, to preempt and minimize motion sickness. Alternatively, the microcontroller or portable device can store a stored road map, along with a GPS circuit, that represents a route or course that the user may become ill due to motion sickness. In one embodiment, when the GPS circuit indicates that the user is moving along its path or course and reaches a location that can cause motion sickness, the microcontroller generates the relevant control signal. It may be possible to operate to transmit such a signal to the vibrating element. Thus, the vibrating element receives these control signals and causes, for example, to generate vibrations that can be applied to the vestibular system so that the user considers the possibility of motion sickness before reaching the location. Can be operational.

[0185] It should be noted that several different types of medical tests, including Caloric, VNG and ENG tests, are performed by hearing trainers and otolaryngologists to test the subject's vestibular function. is there. As part of the test, certain forms of vertigo, which can have negative side effects that cause nausea, can be caused in the patient. Vestibular masking can be used to reduce the nausea felt by these patients while undergoing these tests. Thus, the devices described herein can be included in the medical testing system used to complete these medical tests, or instead to reduce or reduce these negative side effects. It can be used (eg, worn) with such a medical examination system.

[0186] In some embodiments, the devices and methods described can be used for applications not related to the treatment of vestibular abnormalities. For example, some embodiments of vibrating devices can be used as devices that perform haptic communication using suitable communication channels. In some cases, silent and tactile communication methods may be useful in military or surveillance conditions, etc. One embodiment of the vibrating device can be used with a suitable adaptive structure with reduced detectability, such as invisible and inaudible use, to allow tactile communication between objects such as operatives.

[0187] Although embodiments relating to various inventions have been described and exemplified herein, those skilled in the art will perform the functions described herein and / or the results and / or the results described herein. It is believed that various other means and / or structures for obtaining one or more of the benefits / or advantages are readily envisioned, and each of these variants and / or modifications of the embodiments relating to the invention described herein. It is considered to be within range. More generally, those skilled in the art will appreciate that all parameters, dimensions, materials and / or configurations described herein are intended to be exemplary and that the actual parameters, dimensions, materials It will be readily appreciated that and / or the configuration depends on one or more predetermined uses in which the teachings of the invention are used. One of ordinary skill in the art will be able to recognize or ascertain many equivalents to embodiments of a given invention described herein using experiments that are merely conventional. Therefore, the embodiments described above are merely presented as examples, and the embodiments relating to the invention are specifically described and described in the claims within the scope of the appended claims and their equivalents. It should be understood that it can be done in ways other than those mentioned above. Embodiments of the present invention relate to each individual feature, system, article, material, kit and / or method described herein. Further, if any combination of two or more of these features, systems, articles, materials, kits and / or methods does not match these features, systems, articles, materials, kits and / or methods, the present. Included within the scope of the disclosed invention.

[0188] Also, the concepts relating to various inventions can be embodied as one or more methods, and an example thereof is provided. The actions performed as part of that method can be ordered in any suitable way. Thus, although shown as a series of actions in an exemplary embodiment, it constitutes an embodiment in which the actions are performed in a different order than those illustrated, which may include performing several actions at the same time. be able to.

Claims (31)

A vibrating device that is configured to apply a vibrating signal to a portion of the user's head, whereby the vibrating signal is conducted through the bone to the user's vestibular system and the use. A device that includes a vibrating device capable of moving part of the vestibular system in a manner equivalent to that of a therapeutically effective vibrating signal applied to the area covering the mastoid bone of a person.
The therapeutically effective vibration signal has (1) a frequency below 200 Hz and a force level greater than 87 dB re 1 dyne and less than 100 dB re 1 dyne, and (2) physiology associated with the vestibular system. A device that is therapeutically effective for treating a target abnormality. The vibrating device can engage at least one of the area covering the mastoid bone of the user, the area behind the user's head, or the area of the user's frontal region. The device according to claim 1. When the vibrating device is engaged with a region of the head other than the region covering the mastoid bone, the vibrating device is at a force level 14 dB or less greater than the therapeutically effective vibration signal force level. The device according to claim 2, which is configured to apply the vibration signal. The device of claim 1, wherein the physiological abnormality comprises at least one of vertigo, non-vertigo, motion sickness, virtual reality sickness, spatial inconsistency, Sopite syndrome, nausea, headache, migraine or tinnitus. .. The vibration device is
The housing that defines the chamber,
A magnet that is located in the chamber and is configured to vibrate to generate the vibration signal.
The first aspect of the present invention is an electromechanical transducer including at least one suspension element configured to suspend the magnet in the chamber so that the magnet can vibrate around an equilibrium position. apparatus. The vibrating device is associated with a resonant frequency and the device is
A signal source configured to supply an electrical signal to the vibrating device to vibrate the vibrating device.
With a sensor configured to measure information including at least one of the current of the electrical signal, the voltage change of the electrical signal across the vibrating device, the magnetic field generated near the vibrating device and the acceleration of the vibrating device. The device according to claim 1, further comprising. The device of claim 6, further comprising a processor configured to adjust the frequency of the electrical signal based on the information so that the electrical signal vibrates the vibrating device at the resonant frequency. The device of claim 1, wherein the force level of the therapeutically effective vibration signal is 93-98 dB re 1 dyne. A vibrating device that is configured to apply a set of vibration signals to a portion of the user's head, whereby the set of vibration signals causes physiological abnormalities associated with the user's vestibular system. A device that includes a vibrating device that can be conducted through the bone to the vestibular system for treatment.
The vibrating device is associated with a set of resonant frequencies, including a minimum resonant frequency of less than 200 Hz.
A device that collectively has an amount of power at the lowest resonance frequency that is greater than the amount of power at the remaining resonance frequencies from the set of resonance frequencies. A signal generator configured to generate an electrical signal,
Further including an amplifier configured to amplify the electrical signal and generate an amplified electrical signal.
The device according to claim 9, wherein the vibration device receives the amplified electric signal and is configured to generate a set of the vibration signals in response to receiving the amplified electric signal. .. The device according to claim 9, wherein the lowest resonance frequency is 50 to 70 Hz. The device of claim 9, wherein the physiological abnormality comprises at least one of vertigo, non-vertigo, motion sickness, virtual reality sickness, spatial inconsistency, Sopite syndrome or nausea. The vibration device is
A long member with a longitudinal axis and
An electromechanical transducer comprising a magnet configured to vibrate along the longitudinal axis of the elongated member to generate the set of vibration signals.
The ninth aspect of the present invention, wherein the long member extends through an opening of the magnet and is configured to reduce vibration of the magnet along an axis other than the longitudinal axis of the long member. Equipment. The vibration device is
With springs configured to stretch and contract along the axis,
An electromechanical transducer that includes a magnet attached to the spring and configured to vibrate along the axis to generate a set of vibration signals.
The device according to claim 9, wherein the spring is configured to reduce vibration of the magnet along an axis other than the axis of the spring. The vibration device is
A magnet configured to vibrate along an axis to generate the set of vibration signals,
At least one spring attached to the magnet and extending radially from the magnet that stretches and contracts to provide restoring force in one or more directions at an angle to the axis. 9. The device of claim 9, wherein the spring is an electromechanical converter comprising at least one spring that reduces vibration of the magnet in one or more directions. A vibrating device that is configured to apply a vibrating signal to a portion of the user's head, whereby the vibrating signal is used to treat physiological abnormalities associated with the user's vestibular system. A device comprising a vibrating device that can be conducted to the vestibular system via the bone, said vibrating device.
The housing that defines the chamber and
A magnet that is movable within the chamber to generate the vibration signal,
A suspension element configured to suspend the magnet at a position in the chamber.
A device comprising a coil configured to generate a magnetic field for moving the magnet around the position. The magnet is a first magnet, and the suspension element is
A second magnet configured to apply a force to the first magnet in the first direction,
Including a third magnet configured to apply a force to the first magnet in a second direction opposite to the first direction.
The first magnet includes the second magnet and the third magnet in the chamber so that the second magnet and the third magnet are collectively suspended at the position in the chamber. The device according to claim 16, which is arranged between the devices. The suspension element has (i) a first end attached to a portion of the housing and a second end attached to the magnet, and (ii) said at said position in the chamber. 16. The device of claim 16, comprising a spring configured to apply a force to the magnet to suspend the magnet. Including mounting plate
The magnet defines an opening extending from the first end to the second end of the magnet, and the second end of the magnet is attached to the mounting plate.
The suspension element is a spring having a first end attached to a portion of the housing and a second end extending through the opening of the magnet and attached to a portion of the mounting plate. 16. The apparatus of claim 16. The suspension element comprises a spring that is coupled to the magnet and is configured to apply a force to the magnet to suspend the magnet at the position.
16. The device of claim 16, wherein the spring has a spring constant associated with the natural frequency of the magnet, which is less than 200 Hz. 16. The 16th aspect of the invention, wherein the suspension element comprises a solid elastic material that is coupled to the magnet and is configured to apply a force to the magnet to suspend the magnet at the position in the chamber. apparatus. 16. The device of claim 16, wherein the suspension element is configured to reduce the movement of the magnet along an axis other than the longitudinal axis of the chamber. Further including a long member extending along the longitudinal axis of the chamber.
16. The apparatus of claim 16, wherein the elongated member extends through the opening of the magnet and is configured to reduce the movement of the magnet along an axis other than the longitudinal axis of the chamber. 16. The device of claim 16, wherein the suspension element is configured to suspend the magnet in order to reduce contact between the magnet and the housing. The device of claim 16, wherein the physiological abnormality comprises at least one of vertigo, non-vertigo, motion sickness, virtual reality sickness, spatial inconsistency, Sopite syndrome, nausea, headache, migraine or tinnitus. .. Positioning the vibrating device over the area of the user's head,
After the positioning, the vibration device is energized to apply a vibration signal to the region, whereby the vibration signal can be conducted through the bone to the user's vestibule system and the vibration. The signal is (1) applied to the region covering the user's papillary process and (2) has a frequency of less than 200 Hz and a force level greater than 87 dB re 1 dyne and less than 100 dB re 1 dyne. Energizing, configured to move part of the vestibule system in a manner equivalent to that of the vibration signal,
A method comprising treating a physiological abnormality associated with the vestibular system in response to energizing the vibrating device. 26. The method of claim 26, wherein the physiological abnormality comprises at least one of vertigo, non-vertigo, motion sickness, virtual reality sickness, spatial inconsistency, Sopite syndrome or nausea. 26. The method of claim 26, further comprising fixing the vibrating device onto said region of said head using a rigid or elastic headband. 26. The method of claim 26, wherein the vibrating device comprises a magnet, and energizing comprises vibrating the magnet to generate the vibration signal. The energization is
Generating electrical signals and
Amplifying the electric signal to generate the amplified electric signal,
26. The method of claim 26, comprising supplying the vibrating device with the amplified electrical signal to generate the vibrating signal. The energization involves supplying an electrical signal to the vibrating element to vibrate the vibrating element, the method.
A sensor is used to measure information including at least one of the current of the electrical signal, the voltage change of the electrical signal across the vibrating device, the magnetic field generated near the vibrating device and the acceleration of the vibrating device. When,
26. 28, further comprising adjusting the frequency of the electrical signal based on the information so that the electrical signal vibrates the vibrating device at a resonant frequency associated with the vibrating device. Method.

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