JP2024045228A - Systems, devices and methods for treating vestibular abnormalities - Google Patents

Abstract

The present disclosure relates to a device capable of generating a vibration signal capable of affecting a subject's vestibular system. Described herein are apparatus and methods for providing a vibration device capable of applying a vibration signal to a portion of a user's head, whereby the vibration signal is conducted through the bone to the user's vestibular system and may move the portion of the vestibular system in a manner equivalent to that of a therapeutically effective vibration signal applied to an area overlying the user's mastoid bone. The vibration device may be associated with a frequency of less than 200 Hz. The vibration device may be effective in treating physiological abnormalities associated with the vestibular system. [Selected Figure]

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation-in-part of U.S. Provisional Patent Application No. 15/982,867, filed May 17, 2018, entitled "Systems, Devices, And Methods For Treating Vestibular Conditions," which is a continuation-in-part of U.S. Provisional Patent Application No. 15/481,457, filed April 7, 2017, entitled "Devices and Methods for Treating Motion Sickness," which claims priority to and the benefit of U.S. Provisional Patent Application No. 62/421,708, filed November 14, 2016, entitled "Devices and Methods for Treating Motion Sickness." The '867 Application also claims priority to and the benefit of U.S. Provisional Patent Application No. 62/629,197, filed February 12, 2018, entitled "Methods and Devices for Treating the Proprioceptive Vestibular System" (the "'197 Provisional Application"), and U.S. Provisional Patent Application No. 62/629,213, filed February 12, 2018, entitled "Methods and Devices for Reducing Motion Sickness in Virtual Reality and Travel Applications" (the "'213 Provisional Application"). This application also claims priority to and the benefit of the '197 Provisional Application and the '213 Provisional Application. The entire disclosures of each of the above-referenced applications are incorporated herein by reference in their entirety.
FIELD OF THEINVENTION
[0002] The disclosed embodiments relate to systems, devices and methods for treating disorders associated with a subject's vestibular system, such as, for example, motion sickness, non-rotational vertigo, vertigo, migraine headaches and loss of consciousness. More specifically, the present disclosure relates to devices capable of generating vibration signals that can affect the vestibular system of a subject.

background
[0003] The orientation, balance, position, and movement of the body 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 a sensory system in most mammals that provides sensory information primarily related to balance and spatial orientation. A subject's vestibular system is found in a subject's inner ear in a system of interconnected compartments that form the vestibular labyrinth, as shown in FIG. 1A.

[0004] FIG. 1A illustrates a portion of the anatomy of a subject 100, showing the vestibular system for the outer ear 110, portions of the skull 114, and the bony portions of the ear 116, the ear canal 111, the tympanic membrane 112, and the bones of the middle ear 113. The vestibular system includes the semicircular canals 122, 124, and 126, and the otolith organs 128 and 130 housed within the vestibule 121 in the bony labyrinth of the inner ear, which is continuous with the cochlea 120. FIG. 1B provides a more detailed illustration of the vestibular system shown in FIG. 1A, showing the vestibule 121 including the utricle 128 and the saccule 130.

[0005] The semicircular canals 122, 124, and 126 each orient in a plane along one of three directions in which the head can rotate or move, and detect movement in that direction: nodding up and down, rocking side to side, and tilting side to side. The otolith organs in the vestibule 121 of the inner ear detect gravity and acceleration in the anterior-posterior direction. The otolith organs include the utricle 128, which detects movement in the horizontal plane, and the saccule 130, which detects movement in the vertical plane. The semicircular canals 122, 124, and 126 and the otolith organs 128 and 130 are filled with endolymph, a fluid that moves with head or body movement.

[0006] Nerve cells with hair bundles can detect the movement of endolymphatic fluid in the vestibular system of the inner ear to determine head movement and orientation. The ampulla of the semicircular canal and the part of the otolithic organ called the poikilion contain hair cells, which function as sensory receptors in the vestibular system and contain hair bundles or stereocilia that detect the movement of endolymphatic fluid, convert it into signals of body movement, and report the signals to the brain. The otolithic organ also contains layers of calcium carbonate crystals called otoconia or otoliths, which move in response to changes in acceleration (e.g., movement or orientation relative to gravity), which leads to movement of the layer below the otoliths and movement of the hair bundles. In addition, the otoliths sink in the direction of gravity, pulling on the hair bundles of the hair cells, which help to distinguish between up and down, for example.

2A and 2B provide detailed views of the anatomical structure of the balanum and sensory receptors in the otolithic organs (e.g., the utricle 128 and saccule 130 shown in FIG. 1B) in upright and moving positions, respectively. FIG. 2A shows the balanum including the otolithic membrane 132 and a layer of cells including hair cells 134 and supporting cells 136. The hair cells 134 include trichomes or stereocilia 132 that extend into one or more gelatinous layers. The structure of the balanum also includes a layer of otoliths 138 that move in response to endolymphatic fluid movement and/or body acceleration. FIG. 2A shows the hair cells 134 and otoconia or otoliths 138 in an upright configuration, while FIG. 2B shows the hair cells 134 and otoconia 138 in a displaced or tilted configuration when a directional force 140 (e.g., gravity) acts on the otoliths 138. Similarly, movement of endolymphatic fluid within the semicircular canals 122, 124, and 126 can result in movement of hair cells within the ampulla of the semicircular canals (not shown) such that relative movement of the body and/or head (e.g., 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 eyes can affect the perception of orientation, balance and position, and differential tension on the neck muscles on both sides can affect the perception of head position and orientation. If the signals from these sources are inconsistent, a person may develop motion sickness, vertigo, non-rotational vertigo, vestibular migraine, loss of consciousness or other conditions. Inconsistencies in orientation, balance, position and movement signals can be the result of extreme or unfamiliar movements, for example, during travel in cars, trains, airplanes and other modes of transportation. Signal inconsistencies can also result from simulated perceived movements in three-dimensional (3D) movies, 3D video games and virtual reality devices, for example. It may therefore be desirable to have a device that treats a variety of vestibular abnormalities that can result from inconsistent signals being received from a subject's vestibular system, eyes or other anatomical structures.

overview
[0009] The apparatus and methods described herein are vibration devices configured to apply a vibration signal to a portion of a user's head, such that the vibration signal is transmitted through the bone. A vibration device that is capable of moving a portion of the vestibular system in a manner equivalent to that of a therapeutically effective vibration signal that is conducted to the user's vestibular system and applied to the area overlying the user's mastoid bone. can include. Therapeutically effective vibration signals (1) have a frequency less than 200 Hz and a force level greater than 87 dB re 1 dyne and less than or equal to 100 dB re 1 dyne, and (2) physiological abnormalities associated with the vestibular system. may be therapeutically effective for treating.

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

[0011] In some embodiments, the devices described herein can include a vibration element configured to apply a vibration signal to a portion of a user's head, whereby the vibration signal can be conducted through a bone to the vestibular system of the user to treat a physiological abnormality associated with the vestibular system. The vibration element can be configured to include a housing defining a chamber, a magnet movable within the chamber to generate the vibration signal, a suspension element configured to suspend the magnet at a location within the chamber, and a coil configured to generate a magnetic field to move the magnet about the location.

[0012] The method disclosed herein includes positioning a vibration device over a region of a user's head and, after positioning, energizing the vibration device to apply a vibration signal to the region, whereby the vibration signal can be conducted through the bone to the user's vestibular system. The vibration signal can be configured to (1) be applied to a region overlying the user's mastoid bone, and (2) move a portion of the vestibular system in a manner equivalent to that of a vibration signal having a frequency less than 200 Hz and a force level greater than 87 dB re 1 dyne and less than or equal to 100 dB re 1 dyne. The method can further include treating a physiological abnormality associated with the vestibular system in response to energizing the vibration device.

Brief description of the drawing
[0013] Figure 2 illustrates the anatomy of interest, including the bony labyrinth of the inner ear, which houses the vestibular system. [0014] FIG. 1B provides a detailed view of the vestibular system and cochlea within the bony labyrinth of FIG. 1A. [0015] FIG. 1B is an illustration of a portion of the otolithic equilibration plaque shown in FIG. 1B in an upright position. [0015] FIG. 1B is an illustration of a portion of the otolithic equilibrium plaque shown in FIG. 1B under directional force; [0016] FIG. 3 is a schematic diagram of an arrangement of vibration devices that apply vibration signals to the vestibular system, according to one embodiment. [0017] FIG. 1 is a schematic diagram of an example system for treating symptoms associated with vestibular abnormalities, according to one embodiment. [0018] FIG. 2 is a schematic diagram of an example system for treating symptoms associated with vestibular abnormalities, according to another embodiment. [0019] FIG. 2 is a schematic illustration of an example vibrating device of a system for treating symptoms associated with vestibular abnormalities, according to one embodiment. [0020] FIG. 3 is a schematic illustration of a cutaway view of an example vibrating device of a system for treating symptoms associated with vestibular abnormalities, according to another embodiment. [0021] FIG. 2 is a schematic illustration of a cross-sectional view of a vibrating device of a system for treating symptoms associated with vestibular abnormalities, according to one embodiment. [0022] FIG. 7B is a schematic illustration of a cross-sectional view of the vibration device of FIG. 7A incorporated within a physical platform for placement over a subject, according to one embodiment. [0023] FIG. 4 is a schematic illustration of a cross-sectional view of a vibrating device in a system for treating symptoms associated with vestibular abnormalities, according to another embodiment. [0024] FIG. 4 is a perspective view of a spring as a suspension element of a vibration device in a system for treating symptoms associated with vestibular abnormalities, according to one embodiment. [0025] FIG. 9B is a top view illustration of the spring of FIG. 9A. [0025] FIG. 9B is a bottom view illustration of the spring of FIG. 9A. [0026] FIG. 3 is a schematic illustration of an example vibrating device including and/or incorporated into different support elements, according to various embodiments. [0026] FIG. 3 is a schematic illustration of an example vibrating device including and/or incorporated into different support elements, according to various embodiments. [0026] FIG. 3 is a schematic illustration of an example vibrating device including and/or incorporated into different support elements, according to various embodiments. [0026] FIG. 3 is a schematic illustration of an example vibrating device including and/or incorporated into different support elements, according to various embodiments. [0026] FIG. 3 is a schematic illustration of an example vibrating device including and/or incorporated into different support elements, according to various embodiments. [0026] FIG. 3 is a schematic illustration of an example vibrating device including and/or incorporated into different support elements, according to various embodiments. [0027] FIG. 4 is a schematic diagram of a human skull illustrating an example location for placement of a vibration device in a system for treating symptoms associated with vestibular abnormalities, according to various embodiments. [0028] FIG. 4 illustrates example waveforms that can be used to energize a vibration device in a system for treating symptoms associated with vestibular abnormalities, according to various embodiments. [0028] FIG. 4 illustrates example waveforms that can be used to energize a vibration device in a system for treating symptoms associated with vestibular abnormalities, according to various embodiments. [0029] FIG. 4 illustrates an example 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. [0030] FIG. 3 is a flowchart of an example method of using a vibration device to treat symptoms associated with vestibular abnormalities. [0031] FIG. 2 is a flowchart of the steps of a study conducted to test a vibration device to treat symptoms associated with vestibular abnormalities. [0032] FIG. 20B is a schematic illustration of a still view of an example visual stimulus used in the procedure shown in FIG. 20A to test a vibratory device. [0033] FIG. 20A shows results from the research procedure shown in FIG. 20A, testing a vibrating device at different force levels. [0033] FIG. 20A shows results from the research procedure shown in FIG. 20A, testing a vibrating device at different force levels. [0034] Shown are results from the research procedure shown in FIG. 20A, testing a vibrating device at different frequencies. [0034] Shown are results from the research procedure shown in FIG. 20A, testing a vibrating device at different frequencies. [0035] In yet another example, a test procedure is used to present data related to questionnaires completed by subjects in a study conducted to test a vibrating device for treating symptoms associated with vestibular abnormalities. [0035] In yet another example, a test procedure is used to present data related to questionnaires completed by subjects in a study conducted to test a vibrating device for treating symptoms associated with vestibular abnormalities. [0036] In yet another example, the test procedure is used to present results from a study conducted to test a vibrating device for treating symptoms associated with vestibular abnormalities. [0037] FIG. 3 is a schematic illustration of a perspective view of a vibrating device as described herein, according to one embodiment. [0037] FIG. 4 is a schematic illustration of a side view of a vibrating device as described herein, according to one embodiment. [0037] FIG. 3 is a schematic illustration of an exploded view of a vibratory device as described herein, according to one embodiment. [0038] FIG. 25C is a cross-sectional view of the housing of the vibrating device illustrated in FIGS. 25A-25C. [0039] FIG. 3 is a schematic illustration of a perspective view of a vibrating device according to one embodiment. [0039] FIG. 4 is a schematic illustration of a side view of a vibrating device according to one embodiment. [0039] FIG. 3 is a schematic illustration of an exploded view of a vibration device according to one embodiment. [0040] FIG. 27C is a schematic illustration of a perspective view of the vibration device of FIGS. 27A-27C. [0040] FIG. 27C is a schematic illustration of a cross-sectional view of the vibrating device of FIGS. 27A-27C. [0041] FIG. 39 is a diagram of magnetic field lines associated with a magnet of a vibrating device, such as the vibrating device of FIG. 38; [0042] FIG. 4 is a plot of normalized magnetic flux density associated with a magnet of a vibrating device according to some embodiments. [0043] FIG. 3 is a schematic illustration of a perspective view of a vibration device according to one embodiment. [0043] FIG. 4 is a schematic illustration of a side view of a vibratory device according to one embodiment. [0043] FIG. 3 is a schematic illustration of an exploded view of a vibration device according to one embodiment. [0044] FIG. 31C is a schematic illustration of one of two different cross-sectional views of the vibrating device of FIGS. 31A-31C. [0044] FIG. 31C is a schematic illustration of one of two different cross-sectional views of the vibrating device of FIGS. 31A-31C. [0045] FIG. 31A-C is a schematic diagram of the magnet, coil, and metal plate in the vibrating device of FIGS. 31A-31C. [0046] FIG. 31A-31C is an illustration of magnetic field lines associated with the magnets of the vibrating device of FIGS. 31A-31C. [0047] FIG. 4 is a plot of normalized magnetic flux density associated with a magnet of a vibrating device according to some embodiments. [0048] FIG. 4 is a schematic illustration of a cross-sectional view of a vibrating device according to one of three different embodiments. [0048] FIG. 4 is a schematic illustration of a cross-sectional view of a vibrating device according to one of three different embodiments. [0048] FIG. 4 is a schematic illustration of a cross-sectional view of a vibrating device according to one of three different embodiments. [0049] FIG. 3 is a schematic illustration of a cross-sectional view of a vibratory device according to one embodiment. [0050] FIG. 3 is a schematic illustration of a perspective view of a vibration device according to one embodiment.

detailed description
[0051] Herein, a vibration device generates a vibration signal and applies the vibration signal to the vestibular system of a subject via bone conduction, whereby the vibration signal is transmitted to the vestibular system of the subject. An apparatus and method for treating vestibular abnormalities by using a vibrating device that can disturb anatomical structures is described.

[0052] As mentioned above, sensory signals from a subject's vestibular system aid in the perception of the subject's body orientation, balance, position and motion. In addition to signals from the vestibular system, other sensory modalities, such as visual signals from the eyes, can affect the perception of orientation, balance and position, and tension differences in the neck muscles on both sides can affect the perception of head position and orientation. When signals from these various sensory sources, such as the vestibular system, visual system and proprioceptive system, do not match, a person may develop abnormalities such as motion sickness, vertigo, non-rotational vertigo, vestibular migraine, loss of consciousness or other abnormalities. For example, mismatches in orientation, balance, position and motion signals can result from extreme or unfamiliar movements, for example, while traveling in cars, trains, airplanes and other modes of transportation, or from experiencing virtual or augmented 3D environments, such as 3D movies, 3D video games and virtual reality devices.

[0053] In a natural adaptive response, the brain may ignore sensory information that is chaotic, repetitive, or not novel or incomprehensible in the signal. For example, it has been shown that vibrations from sound can affect the vestibular organs of the inner ear and reduce responses (eg, the amplitude of electrical signals) in the cerebellum. 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 intensities are required for sound to affect the vestibular system. Therefore, conventional headphones, earphones and speakers used to generate sound from the generation of vibrational signals in the air can reduce symptoms such as motion sickness reactions, vertigo, vestibular migraine and other physiological reactions. Limited ability to treat. Many of these technologies are not designed to deliver high intensity signals. Furthermore, such high intensity signals can damage or inhibit a person's hearing.

[0054] As an alternative to using sound, mechanical vibrations can be used to affect the vestibular system to therapeutically treat various abnormalities. One technique that can be used to induce mechanical vibrations is surface or bone conduction transducers. However, currently available bone conduction transducers have several drawbacks associated with the treatment of vestibular system symptoms or abnormalities. For example, existing devices often have significant limitations, such as producing significant amounts of heat and/or audible noise, which prevents their use in direct contact with a person's skin or in close proximity to a person's ears. Usage may be hindered. Many existing devices are also large and bulky, making them impractical for use in environments where therapeutic efficacy is needed, such as while traveling, reading, or using virtual reality devices. It becomes irrelevant.

[0055] Existing devices such as surface or bone conduction transducers are inefficient at generating low frequency vibrations. Many generate vibration signals at high frequencies that are audible and therefore distracting. Thus, when such devices are used near a person's ear, the noise they cause can be confusing and irritating. Many existing devices generate high frequency vibrations primarily because power is directed to the higher resonant frequency of the vibration signal generated by such transducers instead of the lower fundamental frequency. Even when designed to generate low frequency vibrations, existing bone conduction transducers can be inefficient because they generate a wide spectrum of frequencies (e.g., frequencies at many harmonics) when the lower frequency is the frequency required. Thus, the disclosed systems and methods relate to the treatment of symptoms associated with abnormalities of the vestibular system that, among other features, do not generate high levels of heat or audible noise and have high efficiency in delivering lower frequency vibration signals.

[0056] FIG. 3 schematically illustrates the placement of a vibration device 200 near a subject's external ear 110. Vibratory device 300 can be configured to apply vibrational signals 202 that are conducted through the bones to treat one or more symptoms or abnormalities associated with the subject's vestibular system. Via the bone 116, a portion 204 of the vibrational signal 202 can be conducted to the bony labyrinth of the inner ear and the vestibular system. For example, portion 204 of the vibrational signal is transmitted through the bone to semicircular canals 122, 124, and 126 and vestibule 121, which contains the otolith organs, utricle, and saccule.

[0057] To reduce, alleviate or treat symptoms associated with a vestibular abnormality, the vibration device 200 can be positioned so as to apply a vibration signal to the vestibule 121 to cause the otolith organs and hair cells of the semicircular canals 122, 124 and 126 in the vestibule 121 to move in a chaotic or noisy, repetitive manner. Some examples of vestibular abnormalities include various types of motion sickness (e.g., seasickness, air sickness, car and train sickness, sickness from exposure to virtual reality or simulators, sickness from experiences such as roller coaster rides, and the effects of Sopite syndrome), rotational vertigo such as benign paroxysmal positional vertigo, nausea from various causes (e.g., vestibular system testing including caloric electronystagmography (ENG)/videonystagmography (VNG) testing, head impulse testing, vestibular evoked myogenic potential (VEMP) testing such as cervical VEMP and eye muscle VEMP testing, functional gait assessment, etc., or resulting from conditions such as chemotherapy, radiation therapy at the base of the skull, pregnancy-related nausea, nausea from alcohol or toxin consumption), infection, vestibular neuritis, vestibular schwannoma, Meniere's disease, migraine, disembarkation syndrome, spatial incongruence, Sopite syndrome, etc.

[0058] The vibration device 200, as described herein, can also be positioned to provide vibration signals conducted through bone to treat other abnormalities including, for example, circulatory disorders (e.g., orthostatic hypotension (low blood pressure), cardiomyopathy, heart attack, arrhythmia, poor circulation from transient ischemic attack), neurological disorders (e.g., Parkinson's disease, multiple sclerosis), medications (e.g., anticonvulsants, antidepressants, sedatives, tranquilizers, antihypertensives), anxiety disorders, anemia due to iron deficiency, hypoglycemia (low blood sugar), heat stroke, dehydration, and non-rotational vertigo, balance disorders, and the like caused by traumatic brain injury. The vibration signal can move a portion of the vestibular system in a manner equivalent to that of a therapeutically effective vibration signal to treat the abnormalities described above. Additionally, the vibration device 200 can be used to assist a pilot, such as, for example, to train the pilot to ignore or override his/her vestibular system under certain conditions. The vibration device 200 can also be used as a stroke diagnostic.

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

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

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

[0062] Electrical signals that control the vibration device 300 can be generated by the control unit 360 based on stored instructions. These electrical signals can be communicated between the control unit 360 and the vibration device 300 by wired or wireless (e.g., Bluetooth) methods. The electrical signals can include stored patterns of operation, for example, stored instructions accessed by the controller can be used to generate a series of electrical signals sent to the vibration device 300 to cause the vibration device 300 to turn "on" or "off" in a pattern favorable to the subject based on usage data collected, accumulated, and stored for a given user. One pattern can include a series of vibration signals that can vary the number of vibration signals generated and applied to the subject over a period of time (e.g., per minute), and a second pattern can include a series of vibration signals that can vary the force level in the plurality of vibration signals. Other types of control signals can be sent from the control unit 360 to the vibration device 300 based on data received from a sensor (e.g., sensor 390 or other sensor), such as control signals that can be used to control the force level and frequency of the vibration signals generated by the vibration device 300. For example, a portable electronic device (e.g., a mobile phone) may include an acceleration sensor that detects changes in the physical acceleration of the user. In one embodiment, the control unit 360 may be operable to receive data from the acceleration sensor indicative of the type of acceleration that may lead to motion sickness. Thus, the control unit 360 may be operable to generate an associated electrical signal after receiving such data and transmit such signal to the vibration device 300. Thus, the vibration device 300 may be operable to receive such electrical signal and generate a vibration signal that may be conducted through bones and applied to the vestibular system, for example to preemptively account for motion sickness. The vibration signal may cause parts of the vestibular system to move in a manner equivalent to that of a therapeutically effective vibration signal. For example, the vibration signal may cause parts of the vestibular system (e.g., hair bundles that form receptors in the semicircular canals and/or otolith organs) to move randomly simulating a noisy vestibular signal or a noisy vestibular sensation. In some cases, such a noisy vestibular sensation may cause a reduction in the effects caused by the inconsistency of other vestibular signals or signals perceived by the subject. Alternatively, a stored road map representing a route or course where a user has previously become unwell due to motion sickness may be stored in the control unit 360 or the mobile device together with a suitable positioning system, such as, for example, Global Positioning System (GPS), Galileo, GLONASS or Beidou. In some embodiments, when the positioning system indicates that the user is traveling along that route or course and reaches a location that may cause motion sickness, the control unit 360 may be operable to generate an associated electrical signal and transmit such signal to the vibration device 300. The vibration device 300 may thus be operable to receive such an electrical signal and generate a vibration signal that may be conducted through bones and applied to the vestibular system, for example to preemptively account for motion sickness before the user reaches that location.

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

[0064] FIG. 5 is a schematic diagram of an example vibration device 400, according to one embodiment. Vibratory device 400 includes a body (or housing) 410 that can define one or more chambers. Body 410 houses vibrating element 423, suspension element 420, drive circuit 440 and delivery interface 430. Vibrating element 423 is suspended by suspension element 420 and configured to be driven by drive circuit 440 to move (eg, oscillate or vibrate) to generate a vibration signal. The vibrating element 423 can be suspended within the body (eg, within the chamber) so as to be able to vibrate about the equilibrium position. Movement of the vibrating element 423 is relative to the suspension element 420 and/or body 410 of the vibrating device 400 and via the delivery interface 430 to treat one or more vestibular abnormalities as disclosed herein. A vibration signal that can be directed can be generated. The vibrating device 400 and/or the body 410 of the vibrating device 400 can be positioned on the subject's head with the delivery interface 430 over or in contact with the target area TA, and the vibration generated by the movement of the vibrating element 423 A vibration signal can be applied to the target area TA, and the vibration signal can then be conducted through the bony structure BS to the vestibular system VS of the subject.

[0065] Optionally, in some embodiments, the vibrating device 400 includes a built-in power source 414 that provides power to components of the vibrating device 400, a portion of the vibrating device 400, the vestibular system VS or another part of the body. a sensor 416 that detects one or more signals from a portion of the body to which the generated vibration signal is applied, such as, for example, the target area TA or the skin adjacent to and/or associated with the target area TA. and may include. In some embodiments, a remotely located power source (eg, a power source mounted within control unit 360) may be used to power vibrating device 400. In some embodiments, a remote sensor (e.g., sensor 390) is used to detect a portion of the vibration device 400, the vestibular system VS, or another part of the body (e.g., the body to which the generated vibration signal is applied). can detect signals from parts).

[0066] The sensor 416 can be configured to measure and/or record information related to the vibration device 400 and/or the subject (e.g., the vestibular system VS, the target area TA, etc.). For example, the sensor 416 can include one or more suitable transducers that measure and/or record information from the vibration device 400, including the current, voltage (e.g., a voltage change associated with an electrical signal across the vibration element 423), magnetic field (e.g., a directional magnetic field generated by the electrical signal and applied near the vibration element 423), or acceleration of the vibration element 423 during movement, etc.

[0067] In some embodiments, sensor 416 may be used to improve the efficiency of vibration device 400. For example, sensor 416 may include an ammeter that monitors the current of the electrical signal coming from vibrating element 423 and/or another portion of vibrating device 400. A low current is measured by the ammeter because at the resonant frequency of the vibrating device, the impedance of the vibrating device 400 (assuming a constant voltage) is higher than at other frequencies, and therefore the current is lower than at other frequencies. The frequency of the electrical signal provided to the vibrating device 400 can be adjusted until the vibration is reached. Accordingly, the ammeter can be used to tune (eg, adjust) the frequency of the electrical signal to a resonant frequency so that the vibration device 400 operates efficiently. That is, vibration device 400, in some embodiments, includes a processor configured to receive information from sensor 416 (e.g., information from an ammeter) and adjust the frequency of the electrical signal based on that information. can include. For example, the processor may be configured to adjust the frequency of the electrical signal over time so that the vibration device continues to operate at a reduced current and lowest resonant frequency.

[0068] As another example, sensor 416 may include a voltage sensor or voltmeter with a constant current amplifier. The voltage change in the electrical signal supplied to the portion of the vibrating device 400 that includes the vibrating element 423 can be measured using a voltmeter. At the resonant frequency of the vibrating device, the impedance of the vibrating device 400 is higher than other frequencies, and therefore the voltage is higher than other frequencies until a high voltage is measured by the voltmeter (e.g., The frequency of the electrical signal provided to the vibrating device 400 (from a different signal source) can be adjusted. Accordingly, the monitored voltage can be used to tune (e.g., adjust) the frequency of the electrical signal such that a 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 the magnetic field variation. 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 motion sensor (e.g., an accelerometer) that can measure the acceleration and/or velocity of the vibrating element 423 to determine when the resonant frequency is achieved.

[0070] Sensors 416 may also be provided to receive and/or measure information from the subject, such as movement associated with vibration signals transmitted to the subject's bony structures, the subject's temperature, the subject's orientation or posture, etc.

[0071] The vibration device 400 may also include a support element 418 that supports or positions the vibration device 400 at or on the target area TA of the subject to deliver a vibration signal, as disclosed herein. can. Support element 418 may be a device or fastening mechanism that can maintain contact and positioning of vibrating device 400 relative to a subject. For example, support element 418 can be a headband, glasses, a pillow, etc., as disclosed in more detail below. In some embodiments, support element 418 can be an adhesive component, such as a sticky pad, adhesive polymer, etc., that can maintain contact and positioning of vibration device 400, for example.

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

[0073] The target area TA of the subject to which the vibration signal is applied may be, for example, the surface of the head. Optionally, in some embodiments, the vibration device 423 may be embedded in the subject's head, and the target area TA may be an area that is proximate to and/or part of the bony structure BS. The vibration device may be configured to be engageable with the target area TA to effectively deliver the therapeutic vibration signal. In one case, the target area TA may be an area behind the subject's outer ear that covers the mastoid process of the subject's skull (or the mastoid bone or mastoid process of the temporal bone). In such a case, the mastoid bone may form part of the bony structure BS used to deliver the vibration signal to the vestibular system VS via the bony structure of the inner ear that houses the vestibular system VS. In some cases, the cheekbone or the zygomatic process of the temporal bone may be part of the bony structure BS used to deliver the vibration signal to the vestibular system VS. In other cases, the target area TA may be a part of the back or front of the head, where the area under the skull acts as a bone structure BS that conducts the vibration signal received from the vibration device 400. Depending on the selected target area TA and its distance from the vestibular system VS, different force levels can be used to operate the vibration device 400. For example, when the device is placed in a target area TA, such as the frontal area or the back of the head of the subject, i.e., an area farther from the vestibular system VS than the mastoid process, a higher force level can be used compared to when the device is placed over the mastoid process of the subject. As an example, when placed on the frontal area of the subject or the head of the subject, the vibration device 400 can be configured to apply a vibration signal at a force level up to 14 dB higher than the force level of the vibration signal that may be therapeutically effective when delivered to other locations (e.g., an area over the mastoid process). When the target area TA is an area overlying the mastoid process and the vibration device is placed over that area, a therapeutically effective force level for treating vestibular abnormalities may be 90-100 dB re 1 dyne, preferably 93-98 dB re 1 dyne.

[0074] The body 410 of the vibration device 400 can be configured to house various components of the vibration device 400. In some embodiments, the body 410 can house some of the components while providing an interface for coupling of one or more components not housed within the body 410, such as the power source 414, the sensor 416 and/or the support element 418. In some embodiments, the body 410 of the vibration device 400 can define one or more chambers or receptacles that house one or more components of the vibration device, such as the vibration element 423, the suspension element 420, the drive circuitry 440 and/or the delivery interface 430. The body 410 can also be shaped and/or configured for desired positioning of the delivery interface 430 against a target area TA of the subject's body (e.g., the body 410 can have a curved surface or a surface that is malleable or flexible). In some embodiments, the body 410 and/or one or more of its chambers can be filled with air or possibly a liquid, such as a lubricant, that aids in the generation and delivery of the vibration signal. In some embodiments, the body 410 and/or one or more of its chambers can also include a material having properties such as an audible noise attenuator, a heat dissipating material, for example, a sponge or a sound absorbing material.

[0075] Vibrating element 423 of device 400 may be configured to vibrate to generate a vibration signal. In some embodiments, vibrating element 423 can be housed within a chamber of body 410. Suspension element 420 may suspend vibrating element 423 in an equilibrium position, and an electrical signal may be used to cause vibrating element 423 to oscillate about its equilibrium position to generate a vibration signal. The characteristics of the vibrating element 423 and/or the suspension element 420, such as material, composition, structure, etc., can be selected to meet predetermined requirements for the generated vibration signal (eg, a low frequency signal).

[0076] For example, the vibrating element 423 can be a spring or an elastic material with a stiffness criterion (e.g., spring constant) that enables the generation of a low frequency (e.g., frequency less than 200 Hz) vibration signal with high efficiency. . In one embodiment, the vibrating element 423 may be a mass suspended by a suspension element 420 that is a spring. The natural resonance of such a system is given by the formula

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。

The amplitude of the mass movement is greater at the resonant frequency than at other frequencies for a given power output because the mass and spring system at the resonant frequency can be associated with a purer sound (e.g., a sinusoidal waveform). Thus, a stronger vibration signal is generated by operating the vibration device 400 at its resonant frequency, and the properties of the vibration element 423 and/or the suspension element 420 can be selected to achieve a particular resonant frequency.

[0077] Other factors that may affect and/or determine the generated vibration signal may be, for example, the mechanism of the driving force (e.g., mechanical, magnetic), the ease of movement of the vibration element (e.g., how frictionless the movement is), the location of the target area TA (e.g., mastoid bone, cheekbone, skull near the forehead of the subject, etc.), reduction of secondary or tertiary paths of energy dissipation (e.g., off-axis movement, heat, friction, etc.), the direction of movement relative to external forces (e.g., pressure during use, gravity, etc.), requirements for ease of use by the subject under various conditions (e.g., limitations on subject mobility, degree of inattention, etc.), etc.

[0078] The vibrating element 423 is configured to be capable of being driven to generate vibratory motion along or about an axis of the vibrating device 400 (e.g., the longitudinal axis of the body 410). and such motion generates a vibration signal having characteristics (eg, frequency, amplitude, force level, etc.) suitable for treating vestibular abnormalities. The vibrating device 400 is an electromechanical transducer that, in some embodiments, includes 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 these embodiments are discussed below with reference to FIGS. 6-9C.

[0079] Another way to generate a low frequency vibration signal is to modulate an 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. Vibration of the piezoelectric transducer at this higher frequency can generate acoustic radiation pressure. The driving electrical signal can be clocked on and off at a lower frequency, i.e., less than 200 Hz (e.g., 60 Hz), and pressure from the piezoelectric transducer applied on and off at the lower frequency generates a corresponding vibration signal at the lower frequency. The use of a piezoelectric transducer can reduce the size and weight of the vibration device 400, since piezoelectric transducers are typically smaller and lighter than other types of electromechanical transducers.

[0080] Depending on where the vibration device 400 is placed, the dimensional constraints of the vibration device 400, and/or the configuration or shape of the vibration device 400, a therapeutically effective level of vibration signal is provided to treat vestibular abnormalities. Predetermined components of vibrating device 400 can be selected as follows. Although FIG. 5 illustrates one vibrating element 423, those skilled in the art will appreciate that the vibrating devices 400 can function together and/or independently to generate vibration signals to treat vestibular abnormalities. It will be appreciated that one or more additional vibrating elements may be included.

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

[0082] In some embodiments, the vibrating element 423 vibrates at a first resonant frequency along a first axis (e.g., an axis in the z direction) and at a first resonant frequency along a second axis (e.g., an axis in the xy plane). ) at a second resonant frequency. To reduce vibrations along the second axis, the first resonant frequency is not a harmonic of the second resonant frequency or vice versa (e.g., the first resonant frequency is a harmonic of the second resonant frequency and/or the second resonant frequency). 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 is activated at the first resonant frequency (a few Hertz off a harmonic of the resonant frequency). In this case, vibrations along the second axis can be reduced. Vibration along the second axis may result in internal collisions between components of vibrating device 400 and/or audible sounds, for example.

[0083] The vibration device 400 can be positioned in different regions of the subject's head. FIG. 16 shows a human skull and illustrates some example regions of the skull where the vibration device 400 can be positioned to apply therapeutic vibration signals to treat vestibular disorders as disclosed herein. For example, as shown in FIG. 16, the vibration device 400 can be optionally positioned over the mastoid bone 1502 of the subject's skull. Although the left mastoid bone 1502 is identified in FIG. 16, one of ordinary skill in the art will understand that the vibration device 400 can be positioned over the left or right mastoid bone of the subject. In other cases, the vibration device 400 can be positioned over a portion of the occipital region (e.g., over the left, right or central portion of the occipital bone 1501) or over a portion of the forehead (e.g., the left, right or central portion of the frontal bone 1504) to deliver vibration signals to treat vestibular disorders and other disorders as disclosed herein. Depending on the area in which the vibration device 400 is placed (e.g., proximity to the vestibular system, whether vibrations from the device need to cross suture line 1503), the power level of the vibration signal can be adjusted so that a therapeutically effective level of vibration is delivered to the vestibular system to treat the abnormality.

[0084] When the vibration device 400 is positioned over the mastoid bone (e.g., the mastoid bone 1502 shown in FIG. 16), the vibration device 400 can apply a vibration signal that is therapeutically effective in treating abnormalities of the vestibular system (i.e., a therapeutically effective vibration signal) having a resonant frequency of less than 200 Hz and a force level of 90-100 dB re 1 dyne. When the vibration device 400 is positioned over a different region of the subject's head that is further away from the subject's vestibular system than the mastoid bone (e.g., the cheekbone 1505 or the frontal bone 1504 or the occipital bone 1501 shown in FIG. 16), the vibration device 400 can generate a vibration signal that has a greater force level to affect a portion of the vestibular system in a manner equivalent to that of a therapeutically effective vibration signal applied to a region over the mastoid bone (e.g., 1502 shown in FIG. 16). For example, when the vibration device 400 is positioned over the subject's frontal bone (e.g., frontal bone 1504 in FIG. 16), the vibration device 400 can generate a vibration signal having a force level greater than (e.g., up to 14 dB re 1 dyne greater than) the force level of a therapeutically effective vibration signal applied to the area overlying the mastoid bone.

[0085] The suspension element 420 of the vibration device 400 can include one or more components housed within the body 410 and interacting with the vibration element 423. In some embodiments, the suspension element 420 and/or the vibration element 423 can be configured to be compatible structures that receive one another. For example, the suspension element 420 can include a component that can extend through an opening defined in the vibration element 423.

[0086] In some embodiments, the suspension element 420 can be housed in a chamber of the body 410 and can optionally be disposed 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 driven to move by application of a driving vibration. For example, the suspension element 420 can be a spring coupled to the vibration element 423 (e.g., a magnet). Alternatively or additionally, the suspension element 420 can include a pair of magnets, each arranged with the vibration element 423 (e.g., another magnet) such that applying a force (e.g., opposing or repelling magnetic forces) in an opposite direction to the vibration element 423 holds the vibration element 423 in an equilibrium position together with a force acting therebetween (e.g., opposing or repelling magnetic forces). In such an embodiment, a driving force (e.g., an applied magnetic field of a predetermined magnitude and acting along a predetermined direction) can induce the vibration element 423 (e.g., a magnet in an equilibrium position) to move between the pair of magnets. In other embodiments, the suspension element 420 may be an elastic material or a fluid. Although one suspension element 420 is shown in FIG. 5, one skilled in the art will appreciate that multiple suspension elements 420 may be used to support and/or suspend the vibration element 423. The multiple suspension elements 420 may include one or more different types of suspension elements (e.g., magnets, springs, elastic materials, etc.).

[0087] The drive circuit 440 of the vibration device 400 can include one or more suitable components capable of generating an electrical signal. The electrical signal can generate a force that causes movement of the vibration element 423 along an axis to generate a therapeutic vibration signal. The drive circuit 440 can receive an electrical signal from a control unit (such as the control unit 360 in Figures 4A and 4B) in some embodiments. In some other embodiments, the drive circuit 440 itself can 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 movement of the vibrating element 423 is of suitable characteristics to produce a vibration signal having a predetermined frequency and force level. It can be something. For example, the electrical signal can be selected to cause the vibrating element 423 to generate a vibrating signal having a particular range of frequencies (eg, less than 200 Hz) to treat one or more predetermined vestibular abnormalities. In some embodiments, the control unit (e.g., control unit 360) can use the sensor 416 to change the frequency of the electrical signal until the electrical signal causes the vibration device 400 to vibrate at a resonant frequency, such as described above. can.

[0089] In some embodiments, the drive circuit 440 includes a built-in signal generator that generates an electrical signal, an amplifier that amplifies the signal, and one that converts the electrical signal into an appropriate modality for moving the vibrating element 423. one or more elements. For example, drive circuit 440 can include one or more coils that can generate a magnetic field that moves 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 area TA of the subject and conduct the vibration signal to the vestibular system VS through the underlying bony structure BS. It can be configured to do so. The delivery interface 430 is configured to conform to the structure and/or shape of the user's target area TA such that the delivery interface can engage and/or maintain contact during use for transmission of therapeutic vibration signals. may be configured and/or adaptable to. In some embodiments, the delivery interface 430 can be configured for comfort and ease of use for the user, such as during use of the vibration device 400, to alleviate vestibular abnormalities. Delivery interface 430 can be further configured to reduce potentially undesirable secondary effects, such as heat generation and buildup, generation of audible noise, lack of air circulation, and application of pressure to target area TA. can. For example, 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 over the mastoid process). Memory foam materials can also help dissipate heat, attenuate audible noise, promote air circulation, minimize discomfort from pressure exerted by support elements such as headbands, and so on.

[0091] FIG. 6 is a diagram of an example vibrating device 500 according to one embodiment. Vibratory device 500 includes a body (or housing) 510 that includes a tube 526 and end caps 525a, 525b. In some embodiments, the body 510 of the vibration device 500 can define a chamber. The body 510 houses a vibration element implemented as a magnet 523 and a suspension element implemented as a magnet 520a, 520b. As shown in the cutaway view of FIG. 6, the suspension elements include magnets 520a, 520b, and the vibrating element 523 includes magnets 523. Magnets 520, 520b act as suspension elements by exerting an opposing force on magnet 523 to suspend magnet 523 in an equilibrium position, as shown in FIG. For example, magnet 520a may be configured to apply a force to first magnet 523 in a first direction, and magnet 520b may be configured to apply a force to first magnet 523 in a second direction (e.g., a second direction moved 180 degrees from the first direction). It can be configured to apply a force to the first magnet 523 (for example, a force equal in magnitude to the force applied by the second magnet 520a to the magnet 523). Accordingly, a first magnet 523 can be disposed within the body 510 (e.g., a chamber) between a second magnet 520a and a third magnet 520b, and the second magnet 520a and the third magnet 520b collectively A first magnet 523 is suspended within 510 in a position (eg, an equilibrium position).

[0092] Magnet 523 acts as a vibrating element that is configured to move (eg, vibrate) to generate a vibration signal. The vibrating elements 523 can be suspended together within the body 510 (eg, within the chamber) by suspension elements 520a, 520b so as to be able to vibrate about an equilibrium position.

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

[0094] In operation, vibration device 500 is driven using an electrical signal comprising a sine wave or another type of signal waveform at a low frequency (e.g., less than 200 Hz). Coil 524 is operable to generate a magnetic field in the induced electrical signal. The magnetic field thus applies a magnetic force to magnet 523. When the magnetic force is applied to magnet 523, it causes magnet 523 to move along an axis indicated by arrow "A" in FIG. 6. Magnet 523 is configured to move in either of the directions indicated depending on the direction of the magnetic field vector.

[0095] Magnets 520a and 520b forming the suspension element each provide a constant magnetic field, each of which is applied to magnet 523 (i.e., the north pole side of magnet 520a faces the north pole side of magnet 523). However, the south pole side of magnet 520b faces the south pole side of magnet 523). Thus, magnets 520a, 520b apply opposing forces to magnet 523. The opposing forces induced by magnets 520a, 520b are operable to suspend magnet 523 in the equilibrium position such that magnet 523 oscillates about the equilibrium position and generates one or more vibration signals. be. The electrical signal causes magnet 523 to vibrate or move along axis A, which may be the same or substantially coincident with the longitudinal direction of pin 521.

[0096] In some embodiments, to ensure that the magnets 520a, 520b, and 523 do not vibrate or move in any direction other than axis A (which can affect the efficiency of the system and increase undesirable friction that can cause secondary vibration signals (e.g., whining noises)), the vibration device 500 can be configured such that the movement of the magnets 523 is restricted by the pins 521. In some embodiments, each of the magnets 520a, 520b can be secured to the end caps 525a, 525b of the vibration device 500 by glue, epoxy, or another form of adhesive. The magnets 523 can be attached around the pins 526 by a bushing 522c interface that allows the magnets 523 to move smoothly over the pins 521 while restricting any movement other than along axis A. Glue, epoxy, or any other form of adhesive can also be used to secure the pins 521 to the end caps 525a, 525b through the openings or holes 522a, 522b.

[0097] In some embodiments, tube 526 has a lubricant (e.g., a ferrofluid) or It contains and/or can include a low friction material (eg, polytetrafluoroethylene). The reduction in friction 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 bushing 522c and pin 521.

[0098] In some embodiments, the outer surface of the tube 526 and/or the end caps 525a, 525b can be covered with a sound absorbing material. Additionally, in some embodiments, one or more of the end caps 525a, 525b can be covered with a friction-reducing material (e.g., a smooth material) or a shock-absorbing or padding material, such as cork, thereby making the end caps 525a, 525b When the cap comes into contact with a person's skin or body, the contact results in less friction than if the end caps 525a, 525b were not covered by such material. Additionally, 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 caps, such that when the end caps come into contact with a person's skin or body, , the contact is spread over a larger area and the pressure exerted by the end cap on the skin or body is reduced.

[0099] It should be understood that magnets 520a, 520b are one example of a resilient object that can be used to form a suspension element on vibration device 500. In other embodiments, magnets 520a, 520b can be replaced with other resilient objects (eg, springs, resilient polymers).

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

[0101] As shown in the cross-sectional schematic diagram of FIG. 7A, vibration device 600 can include suspension elements embodied as springs 620a, 620b in place of magnets 520a, 520b in vibration device 500 shown in FIG. 6. Magnets 623 can be suspended collectively by springs 620a, 620b within housing 610 (e.g., within a chamber) such that magnets 623 can oscillate about an equilibrium position when energized with an electrical signal.

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

[0103] The springs 620a, 620b can be supported by elongated members, cavities in the end caps 625a, 625b, and/or any other suitable structures (not shown in FIG. 7A) extending from the end caps, such as, for example, rigid and/or flexible structures (e.g., pins, foam, rubber, or any other material). The springs 620a, 620b can be configured to expand and contract along an axis (e.g., a longitudinal axis), and the magnets 623 attached to the springs 620a, 620b can be configured to vibrate along the same axis to generate a therapeutic vibration signal. The springs used as elastic objects forming the suspension elements can be secured to other parts of the vibration device 600 (e.g., the magnets 623, the tubes 626, and/or the end caps 625a, 625b) using glue, epoxy, or another form of adhesive. The springs 620a, 620b can be configured to reduce vibration of the magnet along any axis other than the axis of the spring (e.g., the longitudinal axis).

[0104] The springs 620a, 620b may be made of any suitable material (e.g., stainless steel) and may be selected to have a constant stiffness relative to a spring constant k such that, when actuated by an electrical signal, they permit movement of the magnet 623 along the axis indicated by the arrow labeled "B". The springs 620a, 620b may be configured to be attached to the magnet 623 and to a portion of the housing 610. For example, each spring (620a and 620b) may have a first end that may be attached to a portion of the housing 610 and a second end that is attached to the magnet 623. The springs may thus be configured to apply a force to the magnet to suspend the magnet in its position within the chamber. For example, the springs 620a and 620b can exert equal forces in opposite directions, the movement of the magnet 623 can cause one spring (e.g., 620a) to expand while the other spring (e.g., 620b) contracts, and vice versa, the magnet 623 can vibrate along an axis (e.g., the longitudinal axis of the spring), and the movement of the magnet 623 can be configured to be about a position of suspension (e.g., an equilibrium position). The vibration 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 are operable to prevent contact between the magnet 623 and the inner surface of the tube 626. As described above with respect to the vibration device 500, the tube 626 of the vibration device 600 may contain and/or include a lubricant (e.g., ferrofluid) or a low friction material (e.g., polytetrafluoroethylene) on the inner surface to reduce possible friction from any contact between the magnet 623 and the inner surface of the tube 626 during movement of the magnet 623. In some embodiments, a rod or pin (not shown in FIG. 7A) and a bushing (not shown in FIG. 7A) may be included to further limit movement of the magnet 623 in directions other than along the axis B.

[0106] FIG. 7B illustrates a cross-sectional view of the vibration device 600 from FIG. 7A attached to a delivery interface 630 for delivering a therapeutic vibration signal. As described below, a magnet 623 acts as a vibration element suspended by springs 620a, 620b. The delivery interface 630 may be a memory foam pad configured to transmit the vibration signal from the vibration device 600 to the subject's body. Although magnets and springs are provided as examples of suspension elements, one skilled in the art will appreciate that other types of elastic objects may be used in place of and/or in addition to magnets and/or springs.

[0107] The vibrating devices disclosed herein (e.g., vibrating devices 400, 500, 600, 700) can have high Q values (e.g., can vibrate at higher amplitudes in a narrow range of frequencies). can). In some embodiments, the vibrating device may be operable at the lowest fundamental frequency, such as a frequency of 50-70 Hz, with lower amounts of power directed to higher and more audible resonant frequencies.

[0108] FIG. 8 illustrates a cross-sectional view of a vibration device 700 according to one embodiment. The vibration device 700 can be similar to the vibration devices 500, 600. For example, the vibration device 700 can include a housing 710, a vibration element embodied as a magnet 723, a suspension element embodied as a spring 720, and a drive circuit including a coil 724 that drives the movement of the magnet 723 to generate a vibration signal used to treat a vestibular disorder as disclosed herein. The magnet 723 can be suspended by the spring 720 within the housing 710 (e.g., within a chamber) such that the magnet 723 can oscillate about an equilibrium position when energized by an electrical signal delivered by the drive signal.

[0109] In some embodiments, the length of the spring 720 can be increased to reduce the spring constant of the spring 720 and thereby affect the resonant frequency of the vibration device 700, thereby allowing the generation of lower frequencies. To change the length of the spring without changing the size of the vibration device 700, the spring 720 can be configured to pass through an opening 723a defined by the magnet 723. As shown in FIG. 8, the spring 720 can be attached to a mounting plate 728 and attached to the far side of the magnet 723 rather than being attached to the near side of the magnet 723. In this way, the length of the vibration 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 (e.g., approximately 95% of its length), and the spring 720 can extend through the opening and be attached to the distal end of the magnet 723 similar to how the spring 720 is attached to the mounting plate 728.

[0110] Similar to the vibration device 600 as shown in FIG. 7B, the vibration device 700 illustrated in FIG. Can be done. Delivery interface 730 can include padding material, such as a memory foam pad, along the surface of the target area and act as an interface between vibration device 700 and the target area to effectively deliver the vibration signal. .

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

[0112] Vibration device 700 can have a high Q value. Selecting the frequency of the signal used to activate the vibration device 700 such that, in operation, the vibration device 700 operates at a resonant frequency to increase the amplitude of vibration for a given power input. Can be done. In one embodiment, sensor 790 can include a Hall effect sensor configured to monitor magnetic field fluctuations. When the frequency of the electrical signal provided to the vibrating device 700 from a signal source (e.g., signal generator 370 and/or amplifier 380) that can vary the force level and/or frequency matches the resonant frequency of the vibrating device 700; Magnet 723 can move even more (eg, vibrate with a larger amplitude) than at other frequencies. Therefore, the magnetic field fluctuations caused by the vibrations of magnet 723 can be increased when the frequency of the electrical signal matches the resonant frequency of vibration device 700. This relative variation can be monitored by a Hall effect sensor.

[0113] More particularly, a microcontroller or microprocessor (e.g., control unit 360) is used to receive signals from the Hall effect sensor and power the vibration device 700 based on the sensor readings. It may be operable to adjust the frequency of the electrical signal. For example, the microcontroller may be operable to scan through a set frequency range (eg, 50-65 Hz) and select the frequency of the electrical signal that produces the highest level of magnetic field variation. This process can be referred to as "tuning." The sensor 790 and microcontroller combination can then continue to tune the frequency of the electrical signal provided to the vibrating device 700 to maintain its efficiency each time the device is turned on. Additionally, after the frequency of the electrical signal is selected, the frequency may be varied around the selected frequency such that the frequency of the electrical signal associated with peak efficiency is determined by the components of the vibrating device 700 (e.g., the spring 720). It can be determined whether the properties of the material change over time due to temperature, wear, or other variables that may change the properties of the material over time.

[0114] In some embodiments, sensor 790 includes an ammeter, voltmeter, An accelerometer or some other type of sensor similar to sensor 390 may be included.

[0115] Integrated circuit 706 can function as an end cap, thereby further reducing the size of vibrating device 700. Delivery interface 730 functions as a structure that can transmit vibration signals from vibration device 700 to the body, such as along the surface of the user's skin, so that they can be conducted through the bones to the vestibular system. It can be a foam pad that can be operated like this. Delivery interface 730 can be configured such that good coupling allows efficient transmission of vibration signals to the head.

[0116] In some embodiments, to avoid audible sounds (ie, noise, buzzing), vibration device 700 can be configured to reduce friction and/or contact between internal structures. For example, magnets 723, coils 724, housing 710, etc. are positioned with sufficient tolerances between each other to allow for inherent rocking and wobbling of the components while reducing contact between the various components. can do.

[0117] As with magnet 623 of vibration device 600, magnet 723 may also oscillate in a direction other than along axis C, which may cause magnet 723 to contact the inner surface of vibration device 700. This contact may result in audible noise and/or reduced efficiency of vibration device 700. In some such embodiments, noise may be minimized by selecting spring 720 and magnet 723 with properties that cause the axial resonant frequency to be different from the oscillation resonant frequency or any of its harmonics. Thus, by operating vibration device 700 at a frequency that corresponds to the axial resonant frequency rather than the oscillation resonant frequency, oscillation and unintended contact between magnet 723 and other components of vibration device 700 may be reduced.

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

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

[0120] Figures 10-15 are diagrams of different embodiments of vibration devices that can be included and/or incorporated within the various support elements. While one or two vibration devices may be shown in the figures, one of ordinary skill in the art will understand that any number of vibration devices may be included in various embodiments. In the case of multiple vibration devices, the force level of the vibration signal from each device may be reduced, since the combined effect of the vibration signals may be at a therapeutically effective level for treating the vestibular abnormality.

10 illustrates a vibration device 900 in which the main body 910 is incorporated into a headband 918 that is attached to the subject's head HD. The vibration device 900 includes a control unit 906 similar to the control unit 360 described above. The headband 918 can be made of elastic, Velcro, metal or plastic, or another material that allows the headband 918 to hold the vibration device 900 on the subject's head HD so as to effectively deliver a vibration signal that can be conducted to the vestibular system via the bones. The vibration device 900 can include an internal power source (e.g., a battery) that provides power to the control unit 906 and/or other components of the vibration device 900, or the vibration device 900 can be attached to a power source (e.g., a battery pack) separate from the headband 918 via electrical wires. The control unit 906 can include the electrical drive circuitry necessary to generate a vibration signal that treats a vestibular or other abnormality as disclosed herein. Alternatively, such circuitry and power source can be operatively connected to the vibration device 900. In some embodiments, the headband 918 can incorporate additional devices such as a headlamp or other suitable headgear to accommodate the various needs of the subject.

[0122] FIG. 11 illustrates the use of vibration devices 1000a, 1000b integrated into a support element in the form of headphones 1002, according to one embodiment. The headphones 1002 can include audio speakers 1003a, 1003b and an elongated portion 1018 (e.g., a band) connecting the audio speakers 1003a, 1003b. In some embodiments, the headphones 1002 can be a passive noise reduction device such as an earpiece, without including a component such as an audio speaker. The vibration devices 1000a, 1000b can be similar to any other vibration devices described herein (e.g., vibration devices 300, 400, 500, 600, 700, 800). The headphones 1002 can include noise cancellation circuitry that can be used to reduce the level of audible sounds caused by vibrations generated by the vibration devices 1000a, 1000b, but not cancel other vibrations that are conducted to the vestibular system (e.g., via bone as a result of the vibration signals generated by the vibration devices 1000a, 1000b). For example, the system 1002 can include a noise cancellation circuit that generates a signal (or signals) that is out of phase (e.g., 180 degrees out of phase) with the audible signals generated by the vibration devices 1000a, 1000b. Such out-of-phase signals act to reduce the signal level of such audible signals detected by the subject's vestibular system, such that the subject may not hear the audible sounds.

[0123] When used with headphones 1002, vibration devices 1000a, 1000b can be positioned adjacent to audio speakers 1003a, 1003b such that when audio speakers 1003a, 1003b are positioned over the ears, vibration devices 1000a, 1000b are in position to cover the mastoid bone. Alternatively or additionally, in some embodiments, one or more of vibration devices 1000a, 1000b can be incorporated into the ear cups of headphones 1002, which can be co-located with speakers 1003a, 1003b so as not to affect the decorative shape or profile of headphones 1002.

[0124] Alternatively or additionally, in some embodiments, one or more of the vibration devices 1000a, 1000b (or additional vibration devices not shown) are disposed along the headband 1018 or along the headphone 1002. It can extend from one part. Alternatively or additionally, in some other embodiments, one or more of the vibration devices 1000a, 1000b (or additional vibration devices not shown) are incorporated into an attachment that is attached to and removed from the headphones 1002. This allows the user to select between headphones without the vibration devices 1000a, 1000b or headphones with the vibration devices 1000a, 1000b.

[0125] FIG. 12 illustrates yet another embodiment of vibration devices 1100a, 1100b that can be incorporated into or connected to a pillow 1110 (e.g., a travel pillow, cushion, etc.). The location of vibration devices 1100a, 1100b on pillow 1110 can be configured such that when a subject places their head on pillow 1110, vibration devices 1100a, 1100b cover, for example, the subject's mastoid bone. In other embodiments, vibration devices 1100a, 1100b can be positioned to cover other areas of the subject's head.

[0126] FIG. 13 illustrates yet another embodiment of a vibration device 1200 that can be incorporated into or connected to a seat 1210 (eg, a car seat, office chair, etc.). The seat 1210 and the vibration device 1200 are configured such that, for example, when the subject's head leans against the seat headrest 1212, the vibration device 1200 can cover a portion of the subject's head and transmit a vibration signal to the head. Can be configured. In some embodiments, the vibration device can be removably 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 a vibrating device 1300a, 1300b that can be incorporated into or connected to eyeglasses 1310. Although eyeglasses are shown in FIG. 14, those skilled in the art will appreciate that other types of eyewear (e.g., goggles, sunglasses, safety glasses) may also be suitable for having one or more vibration devices. will. The vibrating devices 1300a, 1300b may be positioned on the ear portions 1311a, 1311b of the eyeglasses 1310 that may contact adjacent the subject's head during use of the eyeglasses 1310. The vibrating devices 1300a, 1300b are configured such that when the subject is wearing the glasses 1310, the vibrating devices 1300a, 1300b cover a portion of the head so that vibration signals can be transmitted onto the head and vestibular system. Can be positioned.

[0128] FIG. 15 illustrates another embodiment of a vibration device 1420 mounted or incorporated into a virtual reality device 1410 (e.g., a device that can be used to experience a virtual reality or augmented reality environment). The vibration 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 on the subject's head and can be in adjacent contact with the head during use of the virtual reality device 1410. One or more vibration devices can be mounted anywhere along the band 1441 of the virtual reality device 1410. The vibration device 1400 can be positioned on the virtual reality device 1410 such that when the subject wears the virtual reality device 1410, the vibration device 1400 covers a portion of the subject's head such that the vibration device 1400 can transmit a vibration signal to the head and onto the vestibular system (e.g., via a delivery interface).

17A and 17B illustrate example waveforms of electrical signals powering a vibration device. FIG. 17A shows a sinusoidal waveform 1600 having a wavelength 1604 and an amplitude 1602 that can be used to modulate a magnetic field vector to move a vibration element of a vibration device. FIG. 17B illustrates a square waveform 1610 that can be used to modulate a piezoelectric vibration element in a vibration device to generate a vibration signal, for example, as described above. The piezoelectric device can vibrate at a high frequency to generate pressure when activated by the square wave, or the square wave can cycle at a lower frequency (e.g., less than 200 Hz) so that the pressure cycles on and off at a lower modulation frequency (e.g., 60 Hz) and functions similarly to a low frequency vibration signal.

[0130] FIG. 18 is a graph 1700 showing the rise and fall of an electrical signal that powers a vibration device to generate a vibration signal. Graph 1700 shows how the amplitude of the electrical signal changes over time. As shown in FIG. 18, the amplitude can increase during an onset phase 1702, where the amplitude increases at a predefined rate. Once a predefined level is reached, the amplitude is maintained constant during a steady-state phase 1706, which can last for any suitable time to treat the vestibular abnormality (as represented by the dashed line). Thus, the amplitude can be reduced at a predefined rate until the signal is turned off. The onset phase 1702 and offset phase 1704 of the waveform can have different slope profiles, as shown in FIG. 18. For example, the increase in applied voltage amplitude during the onset phase 1702 can be a sloped increase where the amplitude increases at a constant rate per unit time. Thus, the offset phase 1704 may be a downward ramp or sloped decrease in amplitude where the amplitude decreases at a constant rate per unit time that is different from the rate of increase. In some embodiments, the rate of increase in amplitude in the onset phase 1702 may be higher than the rate of decrease in amplitude in the offset phase 1704, as indicated by the different slopes. In some cases, the sloped increase in the onset phase 1702 and/or sloped decrease in the offset phase 1704 may also be achieved at a varying rate (e.g., rate of increase and/or decrease over time).

[0131] In some cases, the rate of increase and/or decrease can be specified based on the vestibular abnormality being treated, the subject's personal preferences, environmental factors, etc. In some embodiments, the rate of increase and/or decrease of the amplitude can be adjusted by the user. In some embodiments, the rate of amplitude or the rate of increase and/or decrease can be adjusted automatically (e.g., by the control unit 360) based on sensor readings. For example, a sensor incorporated in the vibration device can be configured to measure a physical or physiological state and/or response (e.g., changes in sweating, body temperature, heart rate, etc.) when the vibration device is powered on and/or off. By monitoring the physical state and/or response, the rise and/or fall rates can be adjusted to accommodate different responses (e.g., by a more sensitive or first-time user versus a more regular user of the device). Additionally, for subjects with chronic conditions (e.g., vertigo), the onset and/or offset can be selected to reduce the neurological effects of transitioning between turning the device on and/or off, such as a sudden return of the vestibular abnormality and a more pronounced onset of symptoms associated with the vestibular abnormality.

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

[0133] At 1804, an electrical signal is provided to the vibrating device to energize the device and cause movement of a vibrating element within the vibrating device. At 1805, a vibration signal is applied to the subject's head to treat the vestibular abnormality. At 1806, information associated with the energized vibrating device is monitored, including, for example, current, voltage, magnetic field fluctuations, and the like. At 1808, the subject's physiological state and/or comfort level is monitored. For example, physiological signs such as a subject's heart rate, sweating, body temperature, breathing, oxygen saturation, etc. can be monitored. Optionally, appropriate sensors and actuators integrated with the vibration 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 at 1806 and 1808 can be accomplished using one or more sensors (eg, sensor 390, sensor 416) and/or a control unit (eg, control unit 360).

[0134] At 1810, the vibration device and/or a control unit coupled to the vibration device determines whether the electrical signal should be adjusted or modified. If the electrical signal does not need to be adjusted (1810: NO), the vibration device can continue to treat the vestibular abnormality at 1805, continue to monitor information related to the vibration device at 1806, and continue to monitor information related to the subject at 1808, as described above.

[0135] If the electrical signal needs to be adjusted (1810: YES), the frequency or force level of the electrical signal is changed at 1812, a new electrical signal is applied to the vibrating device at 1804, and the flowchart is as described above. Continue. Information gathered from vibrating device monitoring and subject monitoring can be used to determine whether and by how much and in what form force levels and/or frequencies need to be changed. . For example, if the measured voltage, current and/or magnetic field fluctuations indicate that the current frequency is not the 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 vestibular abnormalities are no longer present (e.g., motion sickness is gone), the vibrating device may turn off the device (e.g., via falling motion). The frequency can be adjusted as desired. As another example, the force level may be reduced in response to an indication of discomfort by the subject.

[0136] Experimental studies were conducted to test an experimental vibration device similar to the example vibration devices disclosed herein for treating symptoms associated with vestibular abnormalities. The experimental vibration device included a vibration element implemented as a magnet suspended between two other magnets, similar to vibration device 500 shown in FIG. 6. The vibration device included a microcontroller, an external coil with an impedance of 4 ohms, energized by a custom designed Arduino board. The microcontroller was capable of energizing the external coil to generate a magnetic field used to vibrate the suspended magnet. The 3 magnet/voice coil assembly was located inside a body or housing and connected to and powered by a rechargeable battery. The vibration device was capable of coupling to a human head and generating vibrations that could be conducted through the bones to the vestibular system.

[0137] In the study, subjects wore an experimental vibration device placed behind their ears in contact with the area covering the mastoid bone, and the vibration signals generated by the device were transmitted through the bone to the subject's vestibular system. It was made possible to conduct the transmission to Subjects were exposed to various conditions causing motion sickness, nausea and/or other vestibular abnormalities, and the effectiveness of the vibration device was evaluated based on information reported by the subjects.

[0138] For experiments, the force level of the vibrations produced by the vibration device was measured using a calibrated B&K mastoid (no. 4930) coupled to a Bruel & Kjaer (B&K) sound level meter (no. 2234). It was measured using A vibrating device was inserted into a holder within the B&K mastoid designed to hold a bone conduction hearing aid. A force of 3.5 to 8 newtons was applied on the vibrating device located in contact with the B&K mastoid. Bone conduction levels were quantified using a B&K sound level meter and expressed as dB re 1 dyne (ie, force level).

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

Experimental Study I
[0140] Figure 20A shows a flow chart 1900 of the procedure for the first experimental study. Study participants in this first experimental study had no history of vestibular disorders, including non-rotational vertigo. For the duration of the study, participants were seated in an office chair and asked to wear an Oculus Rift DK2 virtual reality system and a vibration device according to the design example described above. The vibration device was held in place by a head strap.

[0141] The study was conducted according to the testing procedure outlined in FIG. 20A. Each participant completed the testing procedure multiple times, first with the vibration device off and then with the vibration device on. During testing with the vibration device on, the frequency and/or power level of the vibration device was varied to test whether a particular frequency and/or power level was more effective in treating vestibular abnormalities associated with the use of the virtual reality device. During testing, the order of the frequencies and/or power levels was randomized among participants. Participants were also given the opportunity to stop the study at any time to recover from non-rotational vertigo or other vestibular abnormalities caused by the use of the virtual reality device.

[0142] At 1902, a visual stimulus 1950 shown in FIG. 20B is presented to the participant via the display of the virtual reality device. Visual stimulus 1950 includes a disc-shaped area 1956 with a plurality of spheres 1954. Participants were instructed to focus their attention on the central sphere 1952, which was a different hue from the rest of the spheres 1954 within the disc-shaped area 1956. Disk-shaped area 1956 was designed to represent a three-dimensional space that could be viewed using a virtual reality device such as the Oculus Rift.

[0143] At 1904, the participant initiates rotation of sphere 1954 in a disc-shaped area 1956 around a center point (ie, central sphere 1952) by pressing the space bar on the keyboard. Upon pressing the spacebar, the sphere 1954 begins to rotate and gradually accelerates at 1906 at a rate of 4 degrees/second/second. At 1908 and 1909, participants were instructed to press the space bar again if they felt discomfort or non-rotational dizziness, at which point the angular velocity of the rotating sphere 1954 was recorded and the participant It was stored as the "maximum angular velocity" for If a particular participant did not press the spacebar to indicate discomfort or non-rotational dizziness, the angular velocity of sphere 1954 increased until it reached a predefined angular velocity of 90 degrees/second.

[0144] At 1910, the angular velocity of the image was reduced to 90% of the velocity before the user's instruction (i.e., 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). At 1911, the sphere 1954 is lowered until the participant presses the spacebar again to indicate a return of discomfort or irrotational dizziness or until a predefined period of time (e.g., 120 seconds) has elapsed at 1912. rotate at the same speed. Upon the participant's instruction at 1911 or after a predefined period of time has elapsed at 1912, the amount of time the participant looks at the disc-shaped area 1956 at that reduced speed is recorded as the "Length of Display Time."

[0145] A given participant was first asked to perform the test procedure with the vibration device off. The participant underwent the test procedure twice, once with the sphere 1954 rotating in a clockwise direction and once with the sphere 1954 rotating in a counterclockwise direction. The same was then repeated with the vibration device on. Study participants were asked to wear the vibration device behind the participant's ear and flush with the ear canal above the flat part of the mastoid bone. Participants were allowed time to rest (e.g., 10-60 seconds) between clockwise and counterclockwise trials as needed to recover from any discomfort or non-rotational vertigo.

[0146] Participants using the vibration device were asked to test a set of different force levels or a set of different frequencies. For participants testing different force levels, the frequency of the vibration signal remained constant (i.e., 50 Hz) while the force levels were set at 87, 92, 94, 96, 98, 99, 100, and 101 dB re 1 dyne. For participants testing different frequencies, the power level of the vibration signal was set at a constant level (i.e., 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 willingly participated in the study did not experience any motion sickness from the experiment. These participants gazed at the presented visual stimulus (FIG. 20B) until the rotating sphere 1954 reached 90 degrees/second, and then continued to gaze at the visual stimulus at a reduced speed for 120 seconds. These motion sickness-prone participants were instructed to repeatedly expose themselves to the visual stimulus with the vibration device turned on to test whether the vibrations from the device caused motion sickness. None of these participants reported experiencing any negative side effects during and after using the vibration device with the vibrations generated by the vibration device set to 97 dB re 1 dyne or less.

[0148] The experimental data for the remaining eleven participants (i.e., participants who indicated experiencing motion sickness or non-rotational vertigo at any time during the experimental study) are shown in Figures 21A, 21B, 22A, and 22B. For the data points in the graphs shown in Figures 21A, 21B, 22A, and 22B, the clockwise and counterclockwise "maximum angular velocity" and "length of display time" were averaged for each participant under each test condition, and the "with vibration device" data was reference-normalized based on the "without vibration device" data (i.e., data collected for a participant while using a vibration device set to a particular frequency and/or force level was normalized based on that participant's data while not using the vibration device). After calculating these ratios for each participant, the ratios were averaged for the eleven participants to arrive at the data points shown in the graphs shown in Figures 21A, 21B, 22A, and 22B.

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

[0150] At 87 dB re 1 dyne, the ratio is not statistically different from 1, indicating that the device is not effective in treating vestibular abnormalities. At levels of about 100 dB re 1 dyne or higher, many participants reported worsening mood with the vibration device turned on. Discomfort thresholds at these higher power levels varied slightly from participant to participant, with some reporting discomfort at levels as low as 99 dB, but once that threshold was reached for a particular participant, the participant reported that the vibrations caused them discomfort almost immediately. All participants tested at 102 dB reported discomfort regardless of whether they were using a virtual reality system, as the vibrations from the vibration device alone caused discomfort to them.

[0151] Figures 22A and 22B show normalized and averaged "display duration" and "maximum angular velocity" ratios for 11 participants across a range of frequencies. As shown, these results indicate that the effectiveness of the experimental vibration device in mitigating or delaying virtual reality sickness does not appear to depend on the frequency of the vibration signal. However, graphs 2100 and 2102 show relatively large ratio values from 45 to 65 Hz.

[0152] Several factors may have limited the results of this first experimental study. For example, the angular velocity of sphere 1954 in disk-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 a 2 ms afterimage. These factors prevented the rotational speed of sphere 1954 in disk-shaped region 1956 from rotating more than approximately 90 degrees/second. When the rotation speed increased above 90 degrees/second, the virtual reality display started flickering. Many study participants reached this upper limit while wearing the vibrating device, which caused a ceiling effect on the measurements.

[0153] Similarly, while viewing sphere 1954 rotating at a reduced speed, some subjects complained of eye strain and no complaints of discomfort or nausea. Participants are therefore also limited in how long they can look at the rotating disk, which puts a ceiling on the measured effectiveness of experimental vibrations in delaying the onset of virtual reality sickness. This was another factor contributing to the effect.

[0154] Considering these factors, this first experimental study demonstrated that the vibration device was effective in treating virtual reality sickness at a statistically significant level. The data shown in the graphs of Figures 20A and 20B demonstrated that variations in force level had a statistically significant effect on the effectiveness of the vibration device. Specifically, force levels below 93 dB re 1 dyne were shown to be ineffective in treating the vestibular abnormality, and force levels above 100 dB were shown to cause discomfort and non-rotational vertigo that exacerbated the vestibular abnormality, and thus the data demonstrated that force levels between 93 dB and 98 dB re 1 dyne were more effective in treating the vestibular abnormality. On the other hand, the data shown in the graphs of Figures 21A and 21B demonstrated that changes in vibration frequency had a smaller effect on the effectiveness of the vibration device in treating the vestibular abnormality, as the effectiveness of the vibration device did not have a clear trend or peak from 45 Hz to 65 Hz.

Experimental Study II
[0155] In a second experimental study, the results from the first experimental study disclosed above were used to measure the effectiveness of the experimental vibration device in mitigating or preventing motion sickness experienced by users of the virtual reality game "EVE: Valkyrie."

[0156] "EVE: Valkyrie" is a first-person spaceship shooter game in which the player navigates through a field of asteroids and meteorites using an Xbox 360 handheld controller. The game is known to induce motion sickness in many players. The game involves flying through "gates" located in the field of asteroids and spaceships. In addition to movement in the three spatial dimensions, most "gates" require the player to rotate around a third dimensional axis of rotation (e.g., a "roll", "pitch" or "yaw" axis).

[0157] In this study, subjects played the virtual reality game "EVE: Valkyrie" for up to 15 minutes using an Oculus Rift CV1 system. For the study, participants were instructed to play the game in two sessions on 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 vibration device. Participants were instructed to stop if they began to feel nauseous before the end of the 15 minutes. Experienced gamers could choose to go directly to the mission and skip the training mission and proceed directly to the virtual reality space flight. On the second day, the same experimental procedure continued, but participants wore the experimental vibration device set to a frequency of 60 Hz and a power level of 96.5 dB, which were found to be effective according to the results of the first experimental study. The device was applied to the skull behind the right ear, level with the ear canal and over the flat part of the mastoid process, exerting a force of approximately 3.5-8 Newtons. Any participant who experienced non-rotational vertigo or discomfort during the study was allowed to stop at any time of their choosing.

[0158] Participants were asked to complete the Motion Sickness Assessment Questionnaire ("MSAQ") approximately 10 minutes after they stopped playing the game. The 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. contains 16 assertions or expressions useful for identification and categorization. MSAQ scores range from 1 (not at all) to 9 (severe) for 16 possible manifestations of motion sickness. Table 1 shows the 16 manifestations of the MSAQ that were used to assess motion sickness experienced by participants.

[0159] When participants were asked to play the game for 15 minutes on day 1 without wearing the experimental vibration device, 11 of 17 participants were able to play for the entire 15 minutes. The duration of play for the remaining 6 participants ranged from 4:05 to 14:50 minutes. The average play time was 13:25 minutes. In contrast, when participants wore the experimental vibration device while playing, all 17 participants were able to play for the 15 minute duration. Data from the MSAQ were collected and are presented in Table 1. MSAQ scores range from 1 (not at all) to 9 (severe).

[0160] MSAQ results are presented in graphical form in FIGS. 23A and 23B. Each graph shows the ratio of MSAQ scores obtained while not wearing the device to MSAQ scores obtained while wearing the device. FIG. 23A shows a plot 2200 showing the average scores from the MSAQ across all four categories of motion sickness, and FIG. 23B shows the four categories of motion sickness defined by the MSAQ, specifically (1) gastrointestinal; Four subplots 2202, 2204, 2206, 2208 are shown showing scores for each of (2) central nervous system, (3) peripheral nervous system, and (4) sleepiness related. The line 2205 through each graph represents when the MSAQ scores with and without the vibration device are the same, and therefore represents the case where the vibration device has no effect on motion sickness.

[0161] As shown in Figures 23A and 23B, the data indicates that the vibration device was effective in treating motion sickness as all of the data points fell below line 2250. The data points showed a significant reduction in MSAQ scores from 9 (severe) to 1 (none). Even when separated into different categories of motion sickness, as shown in plots 2202, 2204, 2206, and 2208 of Figure 23B, the vibration device was significantly more effective in treating motion sickness in each category.

Experimental research III
[0162] In a third experimental study, participants were asked to assume the role of back seat occupants of a four-door sedan and drive the vehicle along a stretch of road based on a fixed 20-minute journey. Three road tests were conducted on this established route on the same day. During each drive, participants were asked to read an article on their smartphone or other small handheld device. The onset time was recorded and each participant reported the time when they first felt the first symptoms of motion sickness.

[0163] For each participant, a baseline measure of motion sickness was established by having the participant experience a drive without wearing any type of assistive device and read an article on their smartphone. After the first drive, each participant was asked to wear either (1) an experimental vibration device described herein placed over the participant's right mastoid bone, or (2) a sound generator that emitted a low-frequency sound that faced outward, was isolated from the participant's head by a rubber pad, and provided an audible level equivalent 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 intermediate points (ie at approximately 10 minutes) and no traffic lights. The fixed route took approximately 20 minutes and had less than 10% variation between runs. Subjects were tested only on the first half of the ride up to the stop sign. Subjects were given breaks during the session.

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

[0166] Figure 24 shows seconds to first onset of motion sickness experienced by participants during the third experimental study. Bar 2302 represents seconds to first onset of motion sickness without the device, bar 2304 represents seconds to first onset of motion sickness with sound generator, and bar 2306 represents seconds to first onset of motion sickness with the experimental vibration device. Represents the seconds until the first onset of motion sickness. As shown, use of the experimental vibration device described herein led to a significant increase in seconds to onset of motion sickness in bar 2306. Specifically, the experimental vibration device was effective because the time to onset of motion sickness was more than double compared to those without the device (bar 2302) and with the sound generator attached (bar 2304). It turned out to be. Data from this study demonstrate the effectiveness of an experimental vibration device in preventing motion sickness in a simulated real-life reading situation while riding in the back seat of a car as a passenger. None of the subjects who used the experimental vibration device reported any discomfort when exiting the car.

Summary of experimental studies and other findings
[0167] Results from the experimental studies described above indicate that vibration devices such as the example vibration devices disclosed herein may be effective in treating various vestibular abnormality symptoms. Such devices have a small profile and can be coupled to the surface of a subject's head so that vibrations can be conducted to the subject's vestibular system via bone (e.g., skull). The experimental vibration devices used in the three experimental studies have been shown to be effective in mitigating and reducing motion sickness caused by motion and/or virtual reality. The described experiments and results demonstrate that the effectiveness of the disclosed vibration devices in reducing motion sickness is substantially instantaneous without any apparent adverse side effects.

[0168] Through subsequent experimentation, the force and frequency levels found to be effective herein are also effective in reducing vertigo and nausea caused by caloric tests performed in medical facilities. It was shown that For example, in the case of vertigo, people with chronic or frequent episodes of vertigo were fitted with an experimental vibration device and asked to report the effects of wearing the device. Generally, people reported a reduction in symptoms related to vertigo when using the device. In another example, for caloric testing, an ear, nose and throat ("ENT") physician performed caloric testing on five subjects with and without wearing 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. All five subjects reported a significant reduction in nausea, including no nausea, when the device was worn the next day, and subjects who were unable to complete the test on day one reported significantly reduced nausea on day two. were able to attach the device and complete the test. Testing on both days showed the same level of vestibular function with and without the vibration device.

25A-25C show schematic diagrams of a housing 2410 of a vibration device 2400. The vibration device 2400 may be similar in structure and/or function to any of the vibration devices described herein. For example, the vibration device 2400 may be similar to the vibration devices 500, 600, and/or 700 described above. As shown in FIGS. 25A-25C, the vibration device 2400 may include a delivery interface 2430 and an inner housing 2426 within an outer housing 2410. In some embodiments, the outer housing 2410 may be formed by joining two parts 2410a and 2410b, as shown in the exploded view of FIG. 25C. FIG. 26 illustrates a cross-sectional view of the housing 2410, showing the joining of the two parts 2410a and 2410b, which may be via mechanical attachments, adhesives, etc. The inner housing 2426 may house a vibration element (e.g., a magnet), coils, and/or other structures associated with the vibration devices described herein.

27A, 27B, and 27C illustrate perspective, side, and exploded views, respectively, of vibration device 2500 according to one embodiment. FIGS. 28A and 28B show perspective and side cross-sectional views, respectively, of vibration device 2500. Vibration device 2500 may be substantially similar in structure and/or function to other vibration devices described herein (e.g., vibration devices 500, 600, and 700). For example, vibration device 2500 may include housing 2510, delivery interface 2530, and end cap 2525. Vibration device 2500 may include electromagnetic coils 2524a and 2524b configured to generate a magnetic field that moves magnet 2523. In some embodiments, coils 2524a and 2524b may be wound in opposite directions, for example, to generate magnetic fields of opposite polarity. Although shown with two coils 2524a and 2524b, in some embodiments, the vibration device 2500 can include a single coil configured to generate a magnetic field of varying polarity to cause movement of the magnet. The 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 vibration device 2500 can include a spring 2520 coupled to the magnet 2523 and configured to act as a suspension element. The vibration device 2500 can include mounting plates 2528a and 2528b, and the magnet 2523 can have an opening extending through a portion of its length such that the spring 2520 can extend through the opening and be attached to the distal end of the magnet 2523 via the mounting plate 2528b in a manner similar to that described for the spring 720 being attached to the mounting plate 728 in the vibration device 700.

[0171] Magnet 2523 of vibration device 2500 can include metal end plates 2529a and 2529b. In one embodiment, end plate 2529b can function as a mounting plate 2328b for 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 magnetic field lines that stray away from the magnet and allow the vibrating device to be magnetically attracted to a metal object. This magnetic force can have undesirable side effects and make the vibrating device difficult to handle during use. End plates 2529a and 2529b can reduce such stray magnetic flux, so that vibrating device 2500 can be used near other metal objects without being as attracted to those objects. Additionally, end plates 2529a and 2529b are used to direct magnetic field lines out of the ends of the magnets in a direction perpendicular to (e.g., toward) coils 2524a and 2524b, and parallel to (e.g., toward) the coils. For example, a magnetic field can be generated such that more of the magnetic field lines are directed to enable movement of the magnet relative to the vibrating device 2500, while reducing stray loss or leakage of magnetic field lines in directions (e.g., away from the coil).

[0172] FIG. 38 illustrates a perspective view of a portion of a vibration device 2600 according to another embodiment. Vibratory device 2600 may be substantially similar in some aspects of structure and/or function to other vibratory devices described herein (eg, vibratory devices 500, 600, 700, and 2500). For example, vibrating device 2600 can include a housing and a delivery interface (not shown in FIG. 38). Vibratory device 2600 can include an end cap 2625 that can be coupled to electromagnetic coils 2624a and 2624b that are configured to generate a magnetic field that moves magnet 2623. In some embodiments, end cap 2625 can include an electrical interface 2627 suitable for sending electrical signals to electromagnetic coils 2624a and 2624b. In some embodiments, coils 2624a and 2624b can be wound in opposite directions to generate magnetic fields of opposite polarity. In some embodiments, coils 2624a and 2624b can be spaced a suitable distance apart from each other as shown in FIG. In embodiments, the coils may be placed spatially closer together.

[0173] The vibration device 2600 can include a spring 2620 coupled to a magnet 2623 and configured to act as a suspension element. The vibration device 2600 can include a mounting plate (not shown in FIG. 38) and the magnet 2623 can have an opening extending through its length such that the spring 2620 can extend through the opening and be attached to a distal end of the magnet 2623 via the mounting plate in a manner similar to the manner described for the spring 2520 being attached to the mounting plate 2528b in the vibration device 2500. The magnet 2623 of the vibration 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 vibration device 2500. The end plates 2629a and 2629b can be configured to reduce stray magnetic flux as described for the vibration device 2500. For example, the end plates 2629a and 2629b can limit any stray magnetic flux so that the vibration device 2600 can be used in close proximity to other metal objects without being attracted to those objects. Metal end plates 2629a and 2629b can be used to generate a magnetic field such that more of the magnetic field lines are directed to allow movement of the magnet relative to the vibration device 2600 while directing the magnetic field lines in a direction perpendicular to (e.g., toward) the coils 2624a and 2624b to exit the ends of the magnet, reducing stray losses or leakage of magnetic field lines in a direction parallel to (e.g., away from) the coils.

[0174] FIG. 29 shows an example 2700a of magnetic lines of force concentrated by metal end plates 2629a and 2629b. Plot 2700b of normalized magnetic flux density measured over the distribution of arc lengths in FIG. 30 shows the reduced flux leakage (line 2704) of vibrating device 2600 with end plates 2629a and 2629b versus the vibrating device without end plates. The 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, end plates 2629a and 2629b can enable more efficient use of the magnetic field energy generated by coils 2624a and 2624b, thereby facilitating the generation of therapeutically effective vibrational signals. A smaller driving force can be used to cause the desired movement of magnet 2623. In some embodiments, metal end plates 2629a and 2629b are used to concentrate the magnetic field lines of the magnet in such a way that less power is required to drive the movement of the magnet (e.g., in a direction toward the coil). can be done. In such embodiments, a smaller magnet 2623 can be used to generate a vibration signal of a given strength, thereby reducing the size of the vibration device 2600. Metal plates 269a and 2629b may be made of any suitable material capable of concentrating magnetic field lines as described above. In one embodiment, end plates 2529a and 2529b and/or end plates 2629a and 2629b can be made from low carbon steel.

[0175] FIGS. 31A, 31B, and 31C illustrate perspective, side, and exploded views, respectively, of a vibration device 2800 according to one embodiment. 32A and 32B show two cross-sectional views of the vibrating device 2800 of FIGS. 31C-31C. Vibratory device 2800 may be substantially similar in structure and/or function to other vibratory devices described herein (eg, vibratory devices 500, 600, 700, 2500, and/or 2600). For example, 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. End plates 2829a and 2829b may be substantially similar to end plates 2529a and 2529b described with respect to vibration device 2500. In one embodiment, metal end plates 2829a and 2829b can be made from low carbon steel. Metal end plates 2829a and 2829b concentrate the field lines of magnet 2823 in a direction perpendicular to coil 2824 while reducing stray losses or leakage of the magnetic field in parallel directions (e.g., the field lines of magnet 2823 fall into coil 2824). The magnet can be configured such that it exits from the end of the magnet in a direction perpendicular to the magnet. FIG. 33 illustrates the relative positioning of magnet 2823 with respect to metal end plates 2829a and 2829b and coil 2824. FIG. 34 is an illustration 3000 of magnetic field lines concentrated by metal end plates 2829a and 2829b as shown in FIG. A plot 3100 of normalized magnetic flux density measured over a distribution of arc lengths in FIG. 35 compares the relative magnetic flux leakage of different vibrating devices. Line 2702 is the magnetic flux density for the vibrating device without end plates, line 2704 is the magnetic flux density with the end plate configuration shown in FIG. 38, described above with respect to FIGS. 29 and 30, and line 3102 is Magnetic flux density of vibrating device 2800 with end plates 2829a and 2829b. As shown, the use of metal end plates 2829a and 2829b allows the vibration caused by the drive circuit of vibration device 2800 to be significantly reduced compared to that of other vibration devices described herein (e.g., vibration devices 2500 or 2600). Magnetic flux leakage can be reduced.

[0177] Instead of springs as described in some of the vibration devices described above, vibration device 2800 includes suspension elements 2820a and 2820b (e.g., springs) configured to suspend and support the motion of magnet 2823. Suspension elements 2820a and 2820b may be, for example, annular pieces of elastic and/or deformable material such as fabric, spider springs, or flexible membranes. The annular pieces may be coupled to magnet 2823 and configured to suspend magnet 2823 at a balance point such that a magnetic field generated by coil 2824 can move the magnet about the balance point in the direction indicated by arrow E. By having the suspension elements 2820a and 2820b extend laterally from the magnet as opposed to longitudinally from the magnet (such as the springs 2520 of the vibration device 2500), the suspension elements 2820a and 2820b can reduce off-axis movement or rocking of the magnet 2823 outside of the axis defined by the arrow E while allowing for a reduction in the overall height of the device 2800. FIGS. 36A, 36B, and 36C illustrate a comparison of the height of the vibration devices according to the embodiments 700, 2500, and 2800 as described above. Additionally, the suspension elements 2820a and 2820b can be configured to expand and contract to provide a restoring force in one or more directions angled relative to the axis of movement of the magnet 2823, thereby reducing vibration of the magnet 2823 in that one or more directions.

[0178] FIG. 37 illustrates a vibration device 3200 according to one embodiment. Vibratory device 3200 may be substantially similar in structure and/or function to other vibratory devices described herein (eg, vibratory devices 500, 600, 700, 2500, 2600, and/or 2800). For example, 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.

[0179] The 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 with respect to the vibration 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 concentrate the magnetic field lines in a direction perpendicular to the coil 3224 while reducing stray losses or leakage of the magnetic field in a horizontal direction.

[0180] Vibratory device 3200 can include a suspension element 3220 (eg, a spring) configured to suspend magnet 3223 and support its movement. Suspension element 3220 may be substantially similar in structure and/or function to suspension elements 2820a and 2820b described above for vibration device 2800. For example, suspension element 3220 can be one or more annular pieces of material. The annular piece can be coupled to the magnet 3223 via a metal end plate 3229b, as shown in FIG. 37. Suspension element 3220 is coupled (e.g., glued) to metal end plate 3229b in any suitable manner such that the magnetic field generated by coil 3224 moves the magnet about the equilibrium point in the direction shown by arrow F. The magnet 3223 can be configured to suspend the magnet 3223 at a point of equilibrium so that the magnet 3223 can be suspended. Similar to vibration device 2800, suspension element 3220 can be configured to reduce the overall height of device 3200 and also reduce off-axis movement or rocking of magnet 3223 outside of the axis defined by arrow F. . Furthermore, because the suspension element 3220 is located between the end plate 3229b and the coil 3224, the lateral dimensions of the vibrating device 3200 can also be reduced relative to the vibrating device 2800 shown in FIGS. 32A and 32B. For example, suspension element 3220 may be configured to expand and contract to provide a restoring force in one or more directions angular to the axis of movement of magnet 3223, such that suspension element 3220 , reducing vibrations of the magnet 3223 in one or more of its directions.

[0181] In some embodiments, an additional component (e.g., a post or pin such as pin 521) can be added to improve the stability of magnet 3223, and magnet 3223 can be configured such that there is an opening through magnet 3223 to receive the component, similar to magnet 523 of vibration device 500.

[0182] Application of vibration signals that mask the signals sent by the disease-causing vestibular system, also known as vestibular masking, through the application of bone-conducted vibration signals can be effective in alleviating many vestibular abnormalities. . For example, applied bone conduction vibration signals can treat vertigo caused by a damaged vestibular system. However, sometimes, if 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 are achieved by gradually reducing the power of the applied vibrations over a period of time (i.e., by turning the power off) instead of abruptly turning off the device. (there is a downward slope), this can be minimized.

[0183] As another example, vestibular masking may be effective in mitigating motion sickness that occurs when a person uses a virtual reality device, such as those disclosed herein. Because virtual reality devices do not always cause motion sickness, in one embodiment, a vibration device, such as those disclosed herein, may be operable to generate vibrations that mask the vestibular system when certain conditions and/or situations associated with causing motion sickness are displayed and/or presented to a user of the virtual reality device. The vibration device may be controlled, for example, by a microcontroller that is operable to store dedicated instructions that control the vibration elements. Such instructions may be stored in an on-board memory or a separate memory. Furthermore, such instructions are designed to incorporate dedicated functions and features into the controller to perform certain functions, methods and processes associated with treating abnormalities of the vestibular system. In one embodiment, the microcontroller may be programmed with instructions using a software development kit ("SDK").

[0184] It should be understood that the microcontroller may generate electrical signals based on stored instructions that control and/or drive the generation of vibration signals. These electrical signals may be communicated between the microcontroller and the vibration device via wired or wireless (e.g., Bluetooth) methods. Additionally, the electrical signals may include stored patterns of operation. For example, stored instructions accessed by the microcontroller may be used by the microcontroller to generate a series of electrical signals that are sent to the vibration element to cause the vibration element to be "on" or "off" in a pattern that is advantageous to a given user based on usage data accumulated and stored in the device that includes the microcontroller and the vibration element. One pattern may include a series of vibrations that may vary the number of vibrations generated and applied over a period of time (e.g., per minute), while a second pattern may include a series of vibrations that may vary the force level in the plurality of vibrations. Other types of electrical signals may be sent from the vibration device to the microcontroller, such as those that may be used to control the force level and frequency of vibrations generated by the vibration element based on data received from the sensor. For example, an acceleration sensor may be included in a portable electronic device (e.g., a mobile phone) to detect changes in the physical acceleration of a user. In one embodiment, the microcontroller may be operable to receive data from the acceleration sensor indicative of a type of acceleration that may result in motion sickness. The microcontroller may then be operable to generate an associated control signal after receiving such data and to transmit such a signal to the vibrating element. The vibrating element may then be operable to receive such a control signal and generate a vibration that may be applied in real time to the proprioceptive-vestibular system to, for example, preemptively minimize motion sickness. Alternatively, the microcontroller or portable device may store a stored road map along with a GPS circuit that represents a route or course along which a user may become unwell due to motion sickness. In one embodiment, when the GPS circuit indicates that the user is traveling along the route or course and reaches a location that may cause motion sickness, the microcontroller may be operable to generate an associated control signal and transmit such a signal to the vibrating element. The vibrating element may then be operable to receive such a control signal and generate a vibration that may be applied to the vestibular system to, for example, take into account the possibility of motion sickness before the user reaches the location.

[0185] It should be noted that several different types of medical tests are administered by audiologists and otolaryngologists to test a subject's vestibular function, including caloric, VNG, and ENG tests. be. As part of the test, some forms of vertigo can be induced in patients, which can have the negative side effect of causing nausea. Vestibular masking can be used to reduce the nausea these patients feel while undergoing these tests. Accordingly, the devices described herein can be included in medical testing systems used to complete such medical tests, or alternatively to alleviate or reduce such negative side effects. It can be used (e.g., worn) with such medical testing systems.

[0186] In some embodiments, the described devices and methods can be used for applications not related to the treatment of vestibular abnormalities. For example, some embodiments of a vibrating device can be used as a device to perform tactile communication using a suitable communication channel. In some cases, silent and tactile-based communication methods may be useful, such as in military or surveillance situations. One embodiment of the vibration device may be used with suitable adaptive structures with reduced detectability, such as invisible and inaudible usage conditions, to enable tactile communication between subjects, such as operatives.

[0187] Although various inventive embodiments have been described and illustrated herein, those of ordinary skill in the art will readily envision a variety of other means and/or structures for performing the functions and/or obtaining one or more of the results and/or advantages described herein, and each of such variations and/or modifications are deemed to be within the scope of the inventive embodiments described herein. More generally, those of ordinary skill in the art will readily appreciate that all parameters, dimensions, materials and/or configurations described herein are intended to be exemplary, and that the actual parameters, dimensions, materials and/or configurations will depend on the particular application or applications in which the inventive teachings are used. Those of ordinary skill in the art will recognize or be able to ascertain, using no more than routine experimentation, many equivalents to the particular inventive embodiments described herein. Thus, it should be understood that the above-described embodiments are presented by way of example only, and that within the scope of the appended claims and their equivalents, the inventive embodiments may be practiced otherwise than as specifically described and claimed. Inventive embodiments of the present invention relate to each individual feature, system, article, material, kit and/or method described herein. Furthermore, any combination of two or more of such features, systems, articles, materials, kits, and/or methods is within the scope of the present disclosure, provided such features, systems, articles, materials, kits, and/or methods are not mutually inconsistent.

[0188] Additionally, various inventive concepts may be embodied as one or more methods, examples of which have been provided. The acts performed as part of the method may be ordered in any suitable manner. Thus, although acts may be shown as sequential in an example embodiment, embodiments may be constructed in which the acts are performed in a different order than illustrated, which may include performing some acts simultaneously.

Claims (31)

a vibration device configured to apply a vibration signal to a portion of the user's head, whereby the vibration signal is conducted through the bones to the vestibular system of the user; an apparatus comprising a vibration device capable of moving a portion of the vestibular system in a manner equivalent to that of a therapeutically effective vibration signal applied to an area overlying the mastoid bone of a person, the apparatus comprising:
The therapeutically effective vibration signal (1) has a frequency of less than 200 Hz and a force level that is greater than 87 dB re 1 dyne and less than or equal to 100 dB re 1 dyne, and (2) a physiological signal associated with the vestibular system. A device that is therapeutically effective for treating a medical abnormality. the vibration device is engageable in at least one of the region covering the mastoid bone of the user, the region behind the head of the user, or the region of the forehead of the user; A device according to claim 1. The apparatus of claim 2, wherein when the vibration device is engaged with an area of the head other than the area overlying the mastoid bone, the vibration device is configured to apply the vibration signal at a force level that is 14 dB or less greater than a force level of the therapeutically effective vibration signal. 2. The device of claim 1, wherein the physiological abnormality includes at least one of vertigo, non-rotational vertigo, motion sickness, virtual reality sickness, spatial mismatch, sopaito syndrome, nausea, headache, migraine, or tinnitus. . The vibration device includes:
a housing defining a chamber;
a magnet disposed within the chamber and configured to vibrate to generate the vibrational signal;
10. The apparatus of claim 1, wherein the apparatus is an electromechanical transducer including at least one suspension element configured to suspend the magnet within the chamber such that the magnet can oscillate about an equilibrium position. The vibration device is associated with a resonant frequency, and the apparatus comprises:
a signal source configured to provide an electrical signal to the vibration device to vibrate the vibration device;
and a sensor configured to measure information comprising at least one of a current of the electrical signal, a voltage change of the electrical signal across the vibration device, a magnetic field generated near the vibration device, and an acceleration of the vibration device. 7. The apparatus of claim 6, further comprising a processor configured to adjust the frequency of the electrical signal based on the information such that the electrical signal causes the vibration device to vibrate at the resonant frequency. The apparatus of claim 1, wherein the force level of the therapeutically effective vibration signal is 93-98 dB re 1 dyne. A vibration device configured to apply a set of vibration signals to a portion of a user's head, wherein the set of vibration signals is configured to cause a physiological abnormality associated with the user's vestibular system. An apparatus comprising a vibration device that can be conducted through the bone to the vestibular system for treatment, the apparatus comprising:
the vibrating device is associated with a set of resonant frequencies including a lowest resonant frequency that is less than 200 Hz;
The set of vibration signals collectively has an amount of power at the lowest resonant frequency that is greater than an amount of power at the remaining resonant frequencies from the set of resonant frequencies. a signal generator configured to generate an electrical signal;
further comprising an amplifier configured to amplify the electrical signal to generate an amplified electrical signal,
10. The apparatus of claim 9, wherein the vibration device is configured to receive the amplified electrical signal and generate the set of vibration signals in response to receiving the amplified electrical signal. . The device according to claim 9, wherein the lowest resonant frequency is between 50 and 70 Hz. 10. The apparatus of claim 9, wherein the physiological abnormality includes at least one of vertigo, irradiation, motion sickness, virtual reality sickness, spatial mismatch, sopaito syndrome, or nausea. The vibration device includes:
an elongate member having a longitudinal axis;
a magnet configured to vibrate along the longitudinal axis of the elongate member to generate the set of vibration signals;
10. The apparatus of claim 9, wherein the elongate member extends through an opening in the magnet and is configured to reduce vibration of the magnet along an axis other than the longitudinal axis of the elongate member. The vibration device is
a spring configured to extend and contract along an axis;
a magnet attached to the spring and configured to vibrate along the axis to generate the set of vibration signals;
10. The apparatus of claim 9, wherein the spring is configured to reduce vibrations of the magnet along an axis other than the axis of the spring. The vibration device is
a magnet configured to oscillate along an axis to generate the set of oscillating signals;
at least one spring attached to and extending radially from the magnet, the spring expanding and contracting to provide a restoring force in one or more directions angular to the axis; 10. The apparatus of claim 9, wherein the spring is an electromechanical transducer comprising at least one spring configured to reduce vibrations of the magnet in the one or more directions. A vibration device configured to apply a vibration signal to a portion of a user's head, whereby the vibration signal is configured to treat a physiological abnormality associated with the user's vestibular system. An apparatus comprising a vibrating device that can be conducted through bone to the vestibular system, the vibrating device comprising:
a housing defining a chamber;
a magnet movable within the chamber to generate the vibration signal;
a suspension element configured to suspend the magnet at a location within the chamber;
a coil configured to generate a magnetic field for moving the magnet about 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 a first direction;
a third magnet configured to apply a force to the first magnet in a second direction opposite to the first direction;
The first magnet is connected to the second magnet and the third magnet within the chamber such that the second magnet and the third magnet together suspend the first magnet at the position within the chamber. 17. The device of claim 16, located between. The suspension element (i) has a first end attached to a portion of the housing and a second end attached to the magnet, and (ii) has a first end attached to the magnet at the location within the chamber. 17. The apparatus of claim 16, including a spring configured to apply a force to the magnet to suspend the magnet. further includes a mounting plate;
the magnet defines an opening extending from a first end to a second end of the magnet, the second end of the magnet being attached to the mounting plate;
The suspension element includes 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. 17. The apparatus of claim 16, comprising: the suspension element includes a spring coupled to the magnet and configured to apply a force to the magnet to suspend the magnet at the position;
17. The apparatus of claim 16, wherein the spring has a spring constant associated with a natural frequency of the magnet that is less than 200 Hz. The apparatus of claim 16, wherein the suspension element comprises a solid elastic material coupled to the magnet and configured to apply a force to the magnet to suspend the magnet at the position within the chamber. 17. The apparatus of claim 16, wherein the suspension element is configured to reduce movement of the magnet along an axis other than a longitudinal axis of the chamber. further comprising an elongate member extending along a longitudinal axis of the chamber;
17. The apparatus of claim 16, wherein the elongate member extends through an opening in the magnet and is configured to reduce movement of the magnet along an axis other than the longitudinal axis of the chamber. The apparatus of claim 16, wherein the suspension element is configured to suspend the magnet to reduce contact between the magnet and the housing. 17. The apparatus of claim 16, wherein the physiological abnormality includes at least one of vertigo, irrotational vertigo, motion sickness, virtual reality sickness, spatial mismatch, sopaito syndrome, nausea, headache, migraine, or tinnitus. . Positioning a vibration device over a region of a user's head;
After said positioning, energizing the vibration device to apply a vibration signal to the area, whereby the vibration signal can be conducted through bone to the user's vestibular system, the vibration signal being configured to (1) be applied to an area overlying the user's mastoid bone and (2) move a portion of the vestibular system in a manner equivalent to that of a vibration signal having a frequency of less than 200 Hz and a force level of greater than 87 dB re 1 dyne and less than or equal to 100 dB re 1 dyne;
and treating a physiological abnormality associated with the vestibular system in response to energizing the vibration device. 27. The method of claim 26, wherein the physiological abnormality includes at least one of vertigo, non-vertigo, motion sickness, virtual reality sickness, spatial disparity, sopite syndrome, or nausea. 27. The method of claim 26, further comprising securing the vibration device over the region of the head using a rigid or elastic headband. 27. The method of claim 26, wherein the vibrating device includes a magnet, and the energizing includes vibrating the magnet to generate the vibration signal. The energizing step includes:
Generating an electrical signal;
amplifying the electrical signal to generate an amplified electrical signal;
and providing the amplified electrical signal to the vibration device to cause the vibration device to generate the vibration signal. The energizing includes providing an electrical signal to the vibration element to vibrate the vibration element, the method comprising:
using a sensor to measure information including at least one of a current of the electrical signal, a voltage change of the electrical signal across the vibration device, a magnetic field generated near the vibration device, and an acceleration of the vibration device;
27. The method of claim 26, further comprising adjusting a frequency of the electrical signal based on the information such that the electrical signal causes the vibration device to vibrate at a resonant frequency associated with the vibration device.

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