System, device, and method for treating vestibular disorder

Abstract

To provide a device capable of generating a vibratory signal capable of having an influence on a vestibule system of an object.SOLUTION: An apparatus and method provide a vibratory device that can apply a vibratory signal to a portion of the head of a user such that the vibratory signal can be conducted via bone to the vestibular system of the user and cause a portion of the vestibular system to move in a manner equivalent to that of a therapeutically effective vibratory signal applied to an area overlaying the mastoid bone of the user. The vibratory device can be associated with frequencies less than 200 Hz. The vibratory device can be effective at treating a physiological condition associated with the vestibular system.SELECTED DRAWING: Figure 8

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application is a continuation-in-part of U.S. Provisional Patent Application No. 15 / 982,867, entitled "Systems, Devices, And Methods For Treating Vestibular Conditions," filed May 17, 2018 (the "'867 Application"), which is a continuation-in-part of U.S. Provisional Patent Application No. 15 / 481,457, entitled "Devices and Methods for Reducing the Symptoms of Maladies of the Vestibular System," filed April 7, 2017, 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 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 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 technology]

[0002] background

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

[0003]

[0004] FIG 1A illustrates a portion of the anatomy of a subject 100, showing the vestibular system relative to 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 otolithic 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 saccule 130.

[0004]

[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.

[0005]

[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 of the vestibular system and contain hair bundles or stereocilia that detect the movement of endolymphatic fluid, convert it into a signal of body movement, and report the signal to the brain. The otolithic organ also contains a layer 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. Furthermore, the otoliths sink in the direction of gravity, pulling the hair bundles of the hair cells, which helps to distinguish, for example, up and down.

[0006]

[0007] 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 in motion, 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 otoliths 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. Summary of the Invention [Problem to be solved by the invention]

[0007]

[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 tension differences on the neck muscles on both sides can affect the perception of head position and orientation. If the signals from these sources are not in agreement, a person may develop motion sickness, vertigo, non-rotational vertigo, vestibular migraine, loss of consciousness, or other conditions. Inconsistencies in the signals of orientation, balance, position and movement can be the result of extreme or unfamiliar movements, for example, during travel in cars, trains, airplanes, and other modes of transportation. Inconsistencies in signals can also result from simulated perceived movements, for example, in three-dimensional (3D) movies, 3D video games, and virtual reality devices. Therefore, it may be desirable to have a device that treats various vestibular abnormalities that can result from inconsistent signals received from the vestibular system, eyes, or other anatomical structures of a subject. [Means for solving the problem]

[0008] overview

[0009] The apparatus and methods described herein may include a vibration device configured to apply 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 therapeutically effective vibration signal (1) has a frequency less than 200 Hz and a power level greater than 87 dB re 1 dyne and less than or equal to 100 dB re dyne, and (2) may be therapeutically effective for treating a physiological abnormality associated with the vestibular system.

[0009]

[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, whereby the set of vibration signals can be conducted to the vestibular system via bone to treat a physiological abnormality associated with the vestibular system of the user. The vibration device can be associated with a set of resonant frequencies including a lowest resonant frequency that is less than 200 Hz. The set of vibration signals can collectively have an amount of power at the lowest resonant frequency that is greater than the amount of power at the remaining resonant frequencies from the set of resonant frequencies.

[0010]

[0011] In some embodiments, 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.

[0011]

[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 to the user's vestibular system via the bone. 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 drawings]

[0012] BRIEF DESCRIPTION OF THE DRAWINGS [Figure 1A]

[0013] Illustrated are anatomical structures of interest, including the bony labyrinth of the inner ear, which houses the vestibular system. [Figure 1B]

[0014] FIG. 1A provides a detailed view of the vestibular system and cochlea within the bony labyrinth. [Figure 2A]

[0015] FIG. 1C is a diagram of a portion of the otolith organ ballast shown in FIG. 1B in an upright position. [Figure 2B] FIG. 1C is a diagram of a portion of the otolith organ palsy shown in FIG. 1B under a directional force. [Diagram 3]

[0016] FIG. 1 is a schematic diagram of the placement of a vibration device to apply a vibration signal to the vestibular system, according to one embodiment. [Figure 4A]

[0017] FIG. 1 is a schematic diagram of an example system for treating symptoms associated with vestibular abnormalities, according to one embodiment. [Figure 4B]

[0018] FIG. 1 is a schematic diagram of an example system for treating symptoms associated with vestibular abnormalities, according to another embodiment. [Diagram 5]

[0019] FIG. 1 is a schematic diagram of an example vibration device of a system for treating symptoms associated with vestibular abnormality, according to one embodiment. [Figure 6]

[0020] FIG. 1 is a schematic diagram of a cutaway view of an example vibration device of a system for treating symptoms associated with vestibular abnormalities, according to another embodiment. [Figure 7A]

[0021] FIG. 1 is a schematic diagram of a cross-sectional view of a vibration device of a system for treating symptoms associated with vestibular abnormality, according to one embodiment. [Figure 7B]

[0022] FIG. 7B is a schematic diagram of a cross-sectional view of the vibration device of FIG. 7A incorporated into a physical platform for placement over a subject, according to one embodiment. [Figure 8]

[0023] FIG. 13 is a schematic diagram of a cross-sectional view of a vibration device in a system for treating symptoms associated with vestibular abnormality, according to another embodiment. [Figure 9A]

[0024] FIG. 1 is a perspective view of a spring as a suspension element for a vibration device in a system for treating symptoms associated with vestibular abnormality, according to one embodiment. [Figure 9B]

[0025] FIG. 9B is a top view of the spring of FIG. 9A. [Figure 9C] FIG. 9B is a bottom view of the spring of FIG. 9A. [Figure 10]

[0026] 1A-1C are schematic diagrams of example vibration devices including and / or integrated into different support elements, according to various embodiments. [Figure 11] 1A-1C are schematic diagrams of example vibration devices including and / or integrated into different support elements, according to various embodiments. [Figure 12] 1A-1C are schematic diagrams of example vibration devices including and / or integrated into different support elements, according to various embodiments. [Figure 13] 1A-1C are schematic diagrams of example vibration devices including and / or integrated into different support elements, according to various embodiments. [Figure 14] 1A-1C are schematic diagrams of example vibration devices including and / or integrated into different support elements, according to various embodiments. [Figure 15] 1A-1C are schematic diagrams of example vibration devices including and / or integrated into different support elements, according to various embodiments. [Figure 16]

[0027] 1 is a schematic diagram of a human skull showing example locations for placement of vibration devices in a system for treating symptoms associated with vestibular abnormalities, according to various embodiments. [Figure 17A]

[0028] 1 illustrates example waveforms that may be used to energize a vibration device in a system for treating symptoms associated with vestibular abnormalities, according to various embodiments. [Figure 17B]

[0028] FIG. 1 illustrates example waveforms that may be used to energize a vibration device in a system for treating symptoms associated with vestibular abnormalities, according to various embodiments. [Figure 18]

[0029] 1 illustrates an example energization profile that may be used to energize a vibration device in a system for treating symptoms associated with vestibular abnormality, according to one embodiment. [Figure 19]

[0030] 1 is a flowchart of an example method of using a vibration device to treat symptoms associated with vestibular abnormality. [Figure 20A]

[0031] 1 is a flowchart of the procedures for a study conducted to test a vibration device for treating symptoms associated with vestibular abnormalities. [Figure 20B]

[0032] FIG. 20B is a schematic diagram of a still view of an example visual stimulus used in the procedure shown in FIG. 20A to test the vibration device. [Figure 21A]

[0033] 20B shows results from the research procedure shown in FIG. 20A, which tests a vibration device at different force levels. [Figure 21B]

[0033] Results are shown from the research procedure shown in Figure 20A, which tests the vibration device at different force levels. [Figure 22A]

[0034] 20B shows results from the research procedure shown in FIG. 20A, which tests a vibration device at different frequencies. [Figure 22B]

[0034] Results are shown from a research procedure shown in Figure 20A, which tests a vibration device at different frequencies. [Figure 23A]

[0035] In yet another example, the testing procedure is used to present data relating to questionnaires filled out by subjects of a study conducted to test a vibration device for treating symptoms associated with vestibular abnormalities. [Figure 23B]

[0035] In yet another example, data relating to questionnaires filled out by subjects of a study conducted to test a vibration device for treating symptoms associated with vestibular abnormalities using a testing procedure is presented. [Figure 24]

[0036] In yet another example, the testing procedure is used to present results from a study conducted to test a vibration device for treating symptoms associated with vestibular abnormalities. [Figure 25A]

[0037] FIG. 2 is a schematic diagram of a perspective view of a vibration device as described herein, according to one embodiment. [Figure 25B]

[0037] FIG. 1 is a schematic diagram of a side view of a vibration device as described herein, according to one embodiment. [Figure 25C]

[0037] FIG. 1 is a schematic diagram of an exploded view of a vibration device as described herein, according to one embodiment. [Figure 26]

[0038] 25A to 25C. FIG. 25B is a cross-sectional view of a housing of the vibration device illustrated in FIG. [Figure 27A]

[0039] FIG. 2 is a schematic diagram of a perspective view of a vibration device according to one embodiment. [Figure 27B]

[0039] FIG. 1 is a schematic diagram of a side view of a vibration device according to one embodiment. [Figure 27C] FIG. 1 is a schematic diagram of an exploded view of a vibration device according to one embodiment. [Figure 28A]

[0040] FIG. 27D is a schematic diagram of a perspective view of the vibration device of FIGS. 27A to 27C. [Figure 28B] FIG. 27B is a schematic diagram of a cross-sectional view of the vibration device of FIGS. 27A-27C. [Figure 29]

[0041] FIG. 40 is a diagram of magnetic field lines associated with a magnet in a vibration device such as the vibration device of FIG. 38. [Diagram 30]

[0042] 1 is a plot of normalized magnetic flux density associated with a magnet of a vibration device in accordance with some embodiments. [Figure 31A]

[0043] FIG. 2 is a schematic diagram of a perspective view of a vibration device according to one embodiment. [Figure 31B]

[0043] FIG. 1 is a schematic diagram of a side view of a vibration device according to one embodiment. [Figure 31C]

[0043] Schematic diagram of the exploded view of the vibration device according to an embodiment. [Figure 32A]

[0044] Schematic diagram of one of the two different cross-sectional views of the vibration device in FIGS. 31A to 31C. [Figure 32B]

[0044] Schematic diagram of one of the two different cross-sectional views of the vibration device in FIGS. 31A to 31C. [Diagram 33]

[0045] Schematic diagram of the magnet, coil, and metal plate in the vibration device in FIGS. 31A to 31C. [Diagram 34]

[0046] Diagram of the magnetic field lines related to the magnet of the vibration device in FIGS. 31A to 31C. [Diagram 35]

[0047] Plot of the normalized magnetic flux density related to the magnet of the vibration device according to some embodiments. [Figure 36A]

[0048] Schematic diagram of the cross-sectional view of the vibration device according to one of three different embodiments. [Figure 36B]

[0048] Schematic diagram of the cross-sectional view of the vibration device according to one of three different embodiments. [Figure 36C]

[0048] Schematic diagram of the cross-sectional view of the vibration device according to one of three different embodiments. [Figure 37]

[0049] Schematic diagram of the cross-sectional view of the vibration device according to an embodiment. [Figure 38]

[0050] Schematic diagram of the perspective view of the vibration device according to an embodiment.

Mode for Carrying Out the Invention

[0013] Detailed Description

[0051] In this specification, a vibration device that generates a vibration signal and applies the vibration signal to the vestibular system of a subject via bone conduction, whereby the vibration signal can inhibit the anatomical structure of the vestibular system of the subject, is used to describe an apparatus and method for treating vestibular disorders.

[0014]

[0052] As mentioned above, the sensory signals from the vestibular system of a subject contribute to the perception of the orientation, balance, position and movement of the subject's body. In addition to the 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 the position and orientation of the head. When the signals from these various sensory sources, such as the vestibular system, visual system and proprioceptive system, are not in agreement, a person may develop abnormalities such as motion sickness, vertigo, non-rotational vertigo, vestibular migraine, loss of consciousness or other abnormalities. For example, the inconsistency of the signals of orientation, balance, position and movement may result from extreme or unfamiliar movements, for example, during travel 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.

[0015]

[0053] In a natural adaptive response, the brain may ignore sensory information that is chaotic, repetitive, or not novel or comprehensible in the signal. For example, it has been shown that vibrations from sound can affect the vestibular organs of the inner ear and reduce the response (e.g., the amplitude of the electrical signal) 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 a very high intensity is required for sound to affect the vestibular system. Thus, conventional headphones, earphones, and speakers used to generate sound from the generation of vibration signals in the air are limited in their ability to treat conditions such as motion sickness responses, vertigo, vestibular migraines, and other physiological responses. Many of these technologies are not designed to deliver high-intensity signals. Furthermore, such high-intensity signals can impair or inhibit a person's hearing.

[0016]

[0054] As an alternative to using sound, mechanical vibrations can be used to affect the vestibular system to therapeutically treat various disorders. One technology that can be used to induce mechanical vibrations is a surface or bone conduction vibrator. However, currently available bone conduction vibrators have several drawbacks related to treating vestibular symptoms or disorders. For example, existing devices often have significant limitations, such as generating a significant amount of heat and / or audible noise, which can prevent their use in direct contact with a person's skin or in close proximity to a person's ear. Many existing devices are also large and bulky, making them impractical for use in environments where a therapeutic effect is required, such as while traveling, reading, using a virtual reality device, etc.

[0017]

[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 system and method relate to the treatment of symptoms associated with abnormalities of the vestibular system that, among other features, does not generate high levels of heat or audible noise and has high efficiency in delivering lower frequency vibration signals.

[0018]

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

[0019]

[0057] To reduce, alleviate or treat symptoms associated with vestibular abnormalities, 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 within 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 ocular 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 sickness syndrome, spatial incongruence, Sopite syndrome, etc.

[0020]

[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 diagnosis.

[0021]

[0059] 4A illustrates a schematic of an example system 350 for treating vestibular abnormalities. The system 350 includes a vibration device 300 and a control unit 360 coupled to the vibration device 300 for activating and / or controlling the operation of the vibration device 300. The vibration device 300 may be an electromechanical transducer configured to generate a vibration signal when driven and energized by an appropriate electrical signal from a signal source. The control unit 360 may include a memory 362, a processor 364, and an input / output (I / O) device 366 for receiving electrical signals from and / or transmitting electrical signals to other components of the system 350. The vibration device 300 may be configured to receive electrical signals from and / or transmit electrical signals to the control unit 360. Optionally, the system 350 may include a sensor 390 for measuring voltage, current, impedance, movement, acceleration, or other data associated with the vibration device 300. The sensor 390 may also be configured to measure information related to the subject's vestibular system VS and / or other body metrics (e.g., body temperature, skin conductivity, etc.). The sensor 390 may send and receive signals to and from the control unit 360, the vibration device 300, and / or the vestibular system VS. The system 350 may include a signal generator 370 and / or an amplifier 380. The signal generator 370 may generate one or more signals that drive the vibration device 300 to vibrate to generate a vibration signal. The amplifier 380 may be operatively coupled to the signal generator 370, and may amplify a signal from the signal generator 370 before the signal is used to drive the vibration device 300. The control unit 360 may control the operation of the signal generator 370 and / or the amplifier 380.

[0022]

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

[0023]

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

[0024]

[0062] The 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 controller to turn the vibration device 300 "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 a user. In one embodiment, the control unit 360 may be operable to receive data from the acceleration sensor indicative of a 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 a signal to the vibration device 300. Thus, the vibration device 300 may be operable to receive such an electrical signal and generate a vibration signal that can be conducted through bones and applied to the vestibular system, for example to preemptively account for motion sickness. The vibration signal may cause a portion of the vestibular system to move in a manner equivalent to that of a therapeutically effective vibration signal.For example, the vibration signal can cause parts of the vestibular system (e.g., hair bundles forming receptors in the semicircular canals and / or otolith organs) to move randomly simulating noisy vestibular signals or noisy vestibular sensations. In some cases, such noisy vestibular sensations can cause a reduction in the effects caused by other vestibular signals or inconsistencies in the signals perceived by the subject. Alternatively, a stored road map representing a route or course where the user has previously become ill due to motion sickness can 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 has reached 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 therefore be operable to receive such electrical signals and generate a vibration signal that can be conducted via bones and applied to the vestibular system, for example to preemptively account for motion sickness before the user arrives at the location.

[0025]

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

[0026]

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

[0027]

[0065] Optionally, in some embodiments, the vibration device 400 can include an on-board power source 414 that provides power to the components of the vibration device 400, and a sensor 416 that detects one or more signals from a portion of the vibration device 400, the vestibular system VS, or another portion of the body (e.g., 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 and / or associated with the target area TA). In some embodiments, a remotely located power source (e.g., a power source mounted in the control unit 360) can be used to power the vibration device 400. In some embodiments, a remote sensor (e.g., sensor 390) can be used to detect signals from a portion of the vibration device 400, the vestibular system VS, or another portion of the body (e.g., a portion of the body to which the generated vibration signal is applied).

[0028]

[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 a current, a voltage (e.g., a voltage change associated with an electrical signal across the vibration element 423), a magnetic field (e.g., a directional magnetic field generated by an electrical signal and applied near the vibration element 423), or an acceleration of the vibration element 423 during movement, etc.

[0029]

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

[0030]

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

[0031]

[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 variations. The magnetic field variations 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.

[0032]

[0070] Sensors 416 may also be included 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.

[0033]

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

[0034]

[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 .

[0035]

[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 bone 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 a part of the bone 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 a part of the bone 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 occipital or forehead, and an area under the skull acts as the bone structure BS that conducts the vibration signal received from the vibration device 400. Depending on the target area TA selected and its distance from the vestibular system VS, different force levels can be used to operate the vibration device 400. For example, if the device is placed in a target area TA, such as the frontal region or the back of the head of the subject, i.e., an area that is further 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 forehead of the subject or on the head of the subject, the vibration device 400 can be configured to apply a vibration signal at a force level that is up to 14 dB higher than the force level of the vibration signal that may be therapeutically effective when delivered elsewhere (e.g., an area overlying the mastoid process). When the target area TA is an area overlying the mastoid process and the vibration device is placed over that area, the therapeutically effective force level may be 90-100 dB re 1 dyne, preferably 93-98 dB re 1 dyne, to treat the vestibular abnormality.

[0036]

[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.

[0037]

[0075] The vibration element 423 of the device 400 can be configured to vibrate to generate a vibration signal. In some embodiments, the vibration element 423 can be housed within a chamber of the body 410. The vibration element 423 can be suspended at an equilibrium position by the suspension element 420, and an electrical signal can be used to cause the vibration element 423 to vibrate about its equilibrium position to generate the vibration signal. Properties of the vibration element 423 and / or the suspension element 420, such as material, composition, structure, etc., can be selected to meet certain requirements for the generated vibration signal (e.g., a low frequency signal).

[0038]

[0076] For example, the vibrating element 423 can be a spring or elastic material with a stiffness measure (e.g., spring constant) that allows for efficient generation of a vibration signal at low frequencies (e.g., frequencies below 200 Hz). In one embodiment, the vibrating element 423 can be a mass suspended by a suspension element 420, which is a spring. The natural resonance of such a system is given by the equation

[0039]

number

[0040]

[0077] Other factors that may influence 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., the mastoid bone, the cheekbone, the 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.

[0041]

[0078] The vibration element 423 can be configured to be drivable to generate a vibrational motion along or about an axis of the vibration device 400 (e.g., the longitudinal axis of the body 410), which generates a vibration signal having suitable characteristics (e.g., frequency, amplitude, force level, etc.) for treating a vestibular disorder. The vibration device 400 can be an electromechanical transducer that includes the vibration element 423, in some embodiments, implemented as a magnet that can be driven to move about an axis using a suitable driving force, such as a magnetic field. Further details regarding such embodiments are described below with reference to Figures 6-9C.

[0042]

[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.

[0043]

[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, certain components of the vibration device 400 can be selected to provide a therapeutically effective level of a vibration signal to treat a vestibular abnormality. Although one vibration element 423 is illustrated in Figure 5, one skilled in the art will understand that the vibration device 400 can include one or more additional vibration elements that can function in concert and / or independently to generate a vibration signal that treats a vestibular abnormality.

[0044]

[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 be of 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.

[0045]

[0082] In some embodiments, the vibration element 423 may vibrate at a first resonant frequency along a first axis (e.g., an axis in the z-direction) and at a second resonant frequency along a second axis (e.g., an axis in the xy-plane). To reduce vibration along the second axis, the vibration element 423, the suspension element 420 and / or other elements of the vibration device 400 may be selected such that the first resonant frequency is not a harmonic of the second resonant frequency and vice versa (e.g., the first resonant frequency is offset by a few Hertz from the second resonant frequency and / or a harmonic of the second resonant frequency), and vibration along the second axis may be reduced when the vibration device 400 is activated at the first resonant frequency. Vibrations along the second axis may result in, for example, internal collisions between components of the vibration device 400 and / or audible sounds.

[0046]

[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 on the mastoid bone 1502 of the subject's skull. Although the left mastoid bone 1502 is identified in FIG. 16, one skilled in the art will understand that the vibration device 400 can be positioned on the left or right mastoid bone of the subject. In other cases, the vibration device 400 can be positioned on a portion of the occipital region (e.g., on the left, right or central portion of the occipital bone 1501) or on 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 lines 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.

[0047]

[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 power 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 farther 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 with a greater power level to affect a portion of the vestibular system in a manner equivalent to that of a therapeutically effective vibration signal applied to an area over the mastoid bone (e.g., 1502 shown in FIG. 16). For example, when the vibration device 400 is positioned over a 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 dyne greater than) the force level of a therapeutically effective vibration signal applied to an area overlying the mastoid bone.

[0048]

[0085] The suspension element 420 of the vibration device 400 can include one or more components that are housed within the body 410 and that interact with the vibration element 423. In some embodiments, the suspension element 420 and / or the vibration element 423 can be configured with matching structures to 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.

[0049]

[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 Figure 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.).

[0050]

[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 the vibration element 423 to move 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 FIGS. 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.

[0051]

[0088] The electrical signal generated or received by the drive circuit 440 and used to cause movement of the vibration element 423 may be of suitable characteristics to generate a vibration signal having a predetermined frequency and force level. For example, the electrical signal may be selected to cause the vibration element 423 to generate a vibration signal having a particular range of frequencies (e.g., less than 200 Hz) to treat one or more predetermined vestibular disorders. In some embodiments, the control unit (e.g., control unit 360) may use the sensor 416 to vary the frequency of the electrical signal until the electrical signal causes the vibration device 400 to vibrate at a resonant frequency as described above.

[0052]

[0089] In some embodiments, the driver circuit 440 can include an internal signal generator that generates an electrical signal, an amplifier that amplifies the signal, and one or more elements that convert the electrical signal into an appropriate modality that moves the vibrational element 423. For example, the driver circuit 440 can include one or more coils that can generate a magnetic field that moves the vibrational element 423.

[0053]

[0090] The delivery interface 430 of the vibration device 400 can be configured to transmit the vibration signal generated by the vibration element 423 to the target area TA of the subject, and conduct the vibration signal through the underlying bony structure BS to the vestibular system VS. The delivery interface 430 can be configured and / or adaptable to the structure and / or shape of the target area TA of the user, such that the delivery interface can engage and / or maintain contact during use for the transmission of the therapeutic vibration signal. In some embodiments, the delivery interface 430 can be configured for comfort and ease of use for the user, for example, during use of the vibration device 400, to alleviate vestibular abnormalities. The delivery interface 430 can be further configured to reduce potentially undesirable secondary effects, such as heat generation and accumulation, audible noise generation, lack of air circulation, application of pressure to the target area TA, etc. For example, the delivery interface 430 can include a layer of memory foam material, which can help to conform to the contours of the target area (e.g., the area behind the ear over the mastoid process). Memory foam materials can also aid in heat dissipation, attenuate audible noise, promote air circulation, minimize discomfort from pressure exerted by support elements such as headbands, etc.

[0054]

[0091] FIG. 6 is a diagram of an example vibration device 500 according to one embodiment. The vibration device 500 includes a body (or housing) 510 including 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 magnets 520a, 520b. As shown in the cutaway view of FIG. 6, the suspension element includes magnets 520a, 520b, and the vibration element 523 includes a magnet 523. The magnets 520, 520b act as suspension elements by exerting opposing forces on the magnet 523 to suspend the magnet 523 in an equilibrium position, as shown in FIG. 6. For example, magnet 520a can be configured to apply a force to first magnet 523 in a first direction, and magnet 520b can be configured to apply a force to first magnet 523 in a second direction (e.g., a second direction displaced 180° from the first direction) (e.g., a force equal in magnitude to the force exerted by second magnet 520a on magnet 523). Thus, first magnet 523 can be disposed within body 510 (e.g., chamber) between second magnet 520a and third magnet 520b, which collectively suspend first magnet 523 at a position (e.g., an equilibrium position) within body 510.

[0055]

[0092] The magnet 523 acts as a vibration element configured to move (e.g., vibrate) to generate a vibration signal. The vibration element 523 can be suspended collectively by suspension elements 520a, 520b within the body 510 (e.g., within the chamber) such that the vibration element 523 can oscillate about an equilibrium position.

[0056]

[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 the openings 522a, 522b defined in the end caps 525a, 525b of the vibration device 500, the openings defined in the magnets 520a, 520b, and the 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.

[0057]

[0094] In operation, the 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). The coil 524 is operable to generate a magnetic field with the induced electrical signal. The magnetic field thus applies a magnetic force to the magnet 523. When the magnetic force is applied to the magnet 523, it causes the magnet 523 to move along the axis indicated by the arrow "A" in FIG. 6. The magnet 523 is configured to move in either of the directions indicated depending on the direction of the magnetic field vector.

[0058]

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

[0059]

[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 not 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.

[0060]

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

[0061]

[0098] In some embodiments, the exterior 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), such as cork, or a shock absorbing or padding material, such that when the end cap comes into contact with a person's skin or body, the contact creates less friction than if the end cap 525a, 525b were not covered with such a 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 cap, such that when the end cap comes 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 against the skin or body is reduced.

[0062]

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

[0063]

[0100] 7A illustrates an 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.

[0064]

[0101] As shown in the cross-sectional schematic diagram of Figure 7A, vibration device 600 can include suspension elements embodied as springs 620a, 620b instead of magnets 520a, 520b in vibration device 500 shown in Figure 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.

[0065]

[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.

[0066]

[0103] The springs 620a, 620b may 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 rigid and / or flexible structures (e.g., pins, foam, rubber, or any other material). The springs 620a, 620b may be configured to expand and contract along an axis (e.g., longitudinal axis), and the magnets 623 attached to the springs 620a, 620b may be configured to vibrate along the same axis to generate a therapeutic vibration signal. The springs used as elastic objects forming the suspension elements may be secured to other parts of the vibration device 600 (e.g., magnets 623, tubes 626, and / or 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 (eg, the longitudinal axis).

[0067]

[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 driven by an electrical signal, they allow movement of the magnet 623 along an axis indicated by the arrow labeled "B." The springs 620a, 620b may be configured to be attached to the magnet 623 and 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, movement of the magnet 623 can cause one spring (e.g., 620a) to expand while the other spring (e.g., 620b) contracts, or vice versa, the magnet 623 can oscillate 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.

[0068]

[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, rods or pins (not shown in FIG. 7A ) and bushings (not shown in FIG. 7A ) may be included to further limit movement of the magnet 623 in directions other than along the axis B.

[0069]

[0106] 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 understand that other types of elastic objects may be used instead of and / or in addition to magnets and / or springs.

[0070]

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

[0071]

[0108] 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.

[0072]

[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 far end of the magnet 723 similar to how the spring 720 is attached to the mounting plate 728.

[0073]

[0110] Similar to the vibration device 600 shown in Fig. 7B, the vibration device 700 illustrated in Fig. 8 can also be attached to a delivery interface (e.g., delivery interface 730) to deliver a vibration signal to the subject's vestibular system. The delivery interface 730 can include a padding material, such as a memory foam pad, that conforms to the surface of the target area to effectively deliver the vibration signal and act as an interface between the vibration device 700 and the target area.

[0074]

[0111] 8, some embodiments of the vibration device can include an integrated circuit 706 that includes circuitry to generate a signal that activates the vibration device 700. The integrated circuit 706 can include one or more leads or connections 708 (e.g., leads) for connecting to other components (e.g., a control unit 360 such as a microcontroller). The integrated circuit 706 can also include and / or be coupled to a sensor 790.

[0075]

[0112] The vibration device 700 can have a high Q factor. In operation, the frequency of the signal used to activate the vibration device 700 can be selected so that the vibration device 700 operates at a resonant frequency to increase the amplitude of vibration for a given power input. In one embodiment, the sensor 790 can include a Hall effect sensor configured to monitor magnetic field variations. When the frequency of an electrical signal provided to the vibration device 700 from a signal source (e.g., the signal generator 370 and / or the amplifier 380) that can change the force level and / or frequency matches the resonant frequency of the vibration device 700, the magnet 723 can move more (e.g., vibrate with a larger amplitude) than at other frequencies. Thus, the magnetic field variations caused by the vibration of the magnet 723 can be increased when the frequency of the electrical signal matches the resonant frequency of the vibration device 700. This relative variation can be monitored by the Hall effect sensor.

[0076]

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

[0077]

[0114] In some embodiments, sensor 790 may include an ammeter, a voltmeter, an accelerometer, or some other type of sensor similar to sensor 390 to measure information (e.g., current, voltage, acceleration, etc.) that can enable selection of a resonant frequency that provides maximum efficiency.

[0078]

[0115] The integrated circuit 706 can function as an end cap, further reducing the size of the vibration device 700. The delivery interface 730 can be, for example, a foam pad operable to conform to the surface of the user's skin and act as a structure that can transmit the vibration signal from the vibration device 700 to the body via the bones and into the vestibular system. The delivery interface 730 can be configured to provide good coupling to enable efficient transmission of the vibration signal to the head.

[0079]

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

[0080]

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

[0081]

[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 in addition, the frequency of the electrical signal can be adjusted to a resonant frequency to adjust the output force level of the vibration signal.

[0082]

[0119] FIG. 9A illustrates a perspective view of a spring 820 (e.g., 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, swaying, or undesired movement of a magnet (e.g., magnet 723) in a secondary direction. As shown in FIGS. 9B and 9C, which provide views of two ends of the spring 820, the spring 820 can be oriented such that a first end 820a of the spring 820 starts at a 0° position and a second end 820b of the spring 820 ends at a 180° position. In other embodiments, depending on the effect of gravity on the vibration device (e.g., the orientation of the spring 820 relative to the direction of gravity), the spring 820 can start and end at other angular intervals, e.g., 90°, 270°, etc. In some embodiments, the orientation of the spring 820 can be selected based on the placement of a sensor, e.g., an accelerometer or a Hall effect sensor.

[0083]

[0120] 10-15 are diagrams of different embodiments of vibration devices that can be included and / or integrated into various support elements. While one or two vibration devices may be shown in the figures, one skilled 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 vestibular abnormalities.

[0084]

[0121] FIG. 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 bone. 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 the vestibular or other abnormality 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.

[0085]

[0122] 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 may include noise cancellation circuitry that may 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 bones as a result of the vibration signals generated by the vibration devices 1000a, 1000b). For example, the system 1002 may include noise cancellation circuitry that generates a signal (or signals) that are 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.

[0086]

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

[0087]

[0124] Alternatively or additionally, in some embodiments, one or more of the vibration devices 1000a, 1000b (or additional vibration devices not shown) may be disposed along the headband 1018 or extend from a portion of the headphones 1002. Alternatively or additionally, in some other embodiments, one or more of the vibration devices 1000a, 1000b (or additional vibration devices not shown) may be incorporated into an attachment that is attached to and detached from the headphones 1002, allowing the user to choose between headphones without the vibration devices 1000a, 1000b or headphones with the vibration devices 1000a, 1000b.

[0088]

[0125] 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 the vibration devices 1100a, 1100b on the pillow 1110 can be configured such that when a subject places their head on the pillow 1110, the vibration devices 1100a, 1100b cover, for example, the subject's mastoid bone. In other embodiments, the vibration devices 1100a, 1100b can be positioned to cover other areas of the subject's head.

[0089]

[0126] 13 illustrates yet another embodiment of a vibration device 1200 that can be incorporated into or connected to a seat 1210 (e.g., a car seat, an office chair, etc.). The seat 1210 and vibration device 1200 can be configured, for example, such that when a subject's head rests against a seat headrest 1212, the vibration device 1200 can cover a portion of the subject's head and transmit a vibration signal to the head. In some embodiments, the vibration device can be removably attached to the seat 1210 using a support element 1218 such that it can be removed when not in use.

[0090]

[0127] FIG. 14 illustrates another embodiment of vibration devices 1300a, 1300b that can be integrated into or connected to glasses 1310. Although glasses are shown in FIG. 14, one skilled in the art would understand that other types of eyewear (e.g., goggles, sunglasses, safety glasses) may also be suitable for having one or more vibration devices. The vibration devices 1300a, 1300b may be positioned on the glasses 1310 over ear portions 1311a, 1311b that may be adjacent to and in contact with the subject's head during use of the glasses 1310. When the subject is wearing the glasses 1310, the vibration devices 1300a, 1300b may be positioned such that they cover a portion of the head so that vibration signals can be transmitted onto the head and vestibular system.

[0091]

[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 a 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 a vibration signal can be transmitted to the head and onto the vestibular system (e.g., via a delivery interface).

[0092]

[0129] 17A and 17B illustrate example waveforms of an electrical signal that powers 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. A 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) whereby the pressure cycles on and off at a lower modulation frequency (e.g., 60 Hz) and functions similarly to a low frequency vibration signal.

[0093]

[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. The 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 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 ramped increase where the amplitude increases at a constant rate per unit time. Thus, the offset phase 1704 can be a downward slope or ramped 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 during the onset phase 1702 can be higher than the rate of decrease in amplitude during the offset phase 1704, as indicated by the different slopes. In some cases, the ramped increase during the onset phase 1702 and / or ramped decrease during the offset phase 1704 can also be achieved at a varying rate (e.g., a rate of increase and / or decrease over time).

[0094]

[0131] In some cases, the rate of increase and / or rate of 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 rate of 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, sensors integrated into the vibration device can be configured to measure physical or physiological conditions and / or responses (e.g., changes in sweating, body temperature, heart rate, etc.) when the vibration device is powered on and / or off. By monitoring the physical conditions and / or responses, the rise and / or fall rates can be adjusted to accommodate different responses (e.g., by more sensitive or first-time users versus more regular users 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 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.

[0095]

[0132] 19 illustrates a method 1800 of using a vibration device (e.g., vibration devices 300, 400, 500, 600, 700) to treat a condition associated with a vestibular disorder as disclosed herein. At 1802, the vibration device is positioned on the head of a subject or user over a suitable area (e.g., over a suitable bone structure) such that the vibration signal can be effectively transmitted to the subject's vestibular system.

[0096]

[0133] At 1804, an electrical signal is provided to the vibration device to energize the device and cause movement of vibration elements in the vibration device. At 1805, a vibration signal is applied to the subject's head to treat the vestibular abnormality. At 1806, information related to the energized vibration device is monitored, including, for example, current, voltage, magnetic field fluctuations, etc. At 1808, the subject's physiological state and / or comfort level is monitored. For example, physiological signs such as the subject's heart rate, sweating, body temperature, respiration, oxygen saturation, etc. can be monitored. Optionally, suitable sensors and actuators integrated with the vibration device can be used to monitor any feedback from the subject, such as feedback reporting a level of comfort or discomfort perceived by the user. Such monitoring at 1806 and 1808 can be achieved using one or more sensors (e.g., sensor 390, sensor 416) and / or a control unit (e.g., control unit 360).

[0097]

[0134] The vibration device and / or a control unit coupled to the vibration device determines whether the electrical signal should be adjusted or modified at 1810. 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.

[0098]

[0135] If the electrical signal needs to be adjusted (1810: YES), the frequency or power level of the electrical signal is changed at 1812, a new electrical signal is applied to the vibration device at 1804, and the flow chart continues as described above. Information collected from monitoring the vibration device and monitoring the subject can be used to determine whether and how much and in what form the power level and / or frequency needs 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 vibration device. As another example, if a signal is received from the user indicating that the vestibular abnormality is no longer present (e.g., motion sickness is no longer present), the vibration device can adjust the frequency to turn off the device (e.g., via a falloff). As another example, the force level can be reduced in response to an indication of discomfort by the subject.

[0099]

[0136] An experimental study was conducted to test an experimental vibration device similar to the example vibration devices disclosed herein to treat symptoms associated with vestibular abnormalities. The experimental vibration device included a vibrating element implemented as a magnet suspended between two other magnets, similar to the 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.

[0100]

[0137] In the study, subjects wore an experimental vibration device placed behind the ear against the area overlying the mastoid bone, allowing vibration signals generated by the device to be conducted via the bone to the subject's vestibular system. The subjects were exposed to various conditions that induce motion sickness, nausea, and / or other vestibular abnormalities, and the effects of the vibration device were evaluated based on subject-reported information.

[0101]

[0138] For the experiments, the force levels of the vibrations generated by the vibration device were measured using a calibrated B&K mastoid prosthesis (No. 4930) coupled to a Bruel & Kjaer (B&K) sound level meter (No. 2234). The vibration device was inserted into a holder within the B&K mastoid prosthesis designed to hold a bone conduction hearing aid. A force of 3.5-8 Newtons was applied on top of the vibration device, which was positioned against the B&K mastoid prosthesis. Bone conduction levels were quantified using the B&K sound level meter and expressed as dB re dyne (i.e., force level).

[0102]

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

[0103] Experimental Study I

[0140] FIG. 20A shows a flow chart 1900 of the procedure for the first experimental study. The 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.

[0104]

[0141] The study was conducted according to the test procedure outlined in FIG. 20A. Each participant completed the test procedure multiple times, first with the vibration device turned off and then with the vibration device turned on. During testing with the vibration device turned on, the frequency and / or power level of the vibration device was changed to test whether a particular frequency and / or power level was more effective in treating vestibular abnormalities associated with the use of a virtual reality device. During testing, the order of the frequency and / or power levels was randomized between 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.

[0105]

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

[0106]

[0143] At 1904, the participant begins rotating the sphere 1954 in a disk-like region 1956 around a central point (i.e., central sphere 1952) by pressing the space bar on their keyboard. Upon pressing the space bar, the sphere 1954 begins to rotate and gradually accelerates at a rate of 4 degrees / sec / sec at 1906. At 1908 and 1909, the participant is instructed to press the space bar again if they experience discomfort or non-rotational dizziness, at which point the angular velocity of the rotating sphere 1954 is recorded and stored as the "maximum angular velocity" for that participant. If a particular participant did not press the space bar to indicate discomfort or non-rotational dizziness, the angular velocity of the sphere 1954 increased until it reached a predefined angular velocity of 90 degrees / sec.

[0107]

[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 to 90% of 90 deg / sec (i.e., 81 deg / sec) if the participant did not press the space bar. At 1911, the sphere 1954 rotates at the reduced velocity until the participant presses the space bar again to indicate a return of discomfort or non-rotational vertigo or until a predefined time (e.g., 120 seconds) has elapsed at 1912. Upon the participant's instruction at 1911 or the predefined time has elapsed at 1912, the time the participant viewed the disk-shaped region 1956 at the reduced velocity is recorded as the "length of viewing time."

[0108]

[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. The study participant was 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 given time to rest (e.g., 10-60 seconds) between clockwise and counterclockwise trials as needed to recover from any discomfort or non-rotational vertigo.

[0109]

[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.

[0110]

[0147] The study involved 18 participants. 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 (Figure 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 lower.

[0111]

[0148] The experimental data for the remaining 11 participants (i.e., participants who indicated that they experienced 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 "maximum angular velocity" and "length of display time" in clockwise and counterclockwise directions 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 for the 11 participants were averaged to arrive at the data points shown in the graphs shown in Figures 21A, 21B, 22A, and 22B.

[0112]

[0149] FIG. 21A shows a graph 2000 of the average "length of display time" ratios of 11 participants across a range of different force levels. Values ​​greater than 1 indicate an increase in display time before experiencing discomfort while using the vibration device versus while not using the vibration device. FIG. 21B shows a graph 2002 of the average "maximum angular velocity" ratios of 11 participants across a range of different force levels. Values ​​greater than 1 in FIG. 21B indicate an increase in angular velocity that did not cause discomfort while using the vibration device versus while not using the vibration device. The experimental data showed that for the 11 participants, the vibration device had the greatest effect when its vibration force level 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" ratios peaked at 96.5 dB re 1 dyne. The "length of display time" and "maximum angular velocity" ratios at force levels ranging from 93 dB to 98 dB were statistically significantly different from and greater than 1, indicating that vibration devices set at these force levels are effective in treating vestibular abnormalities.

[0113]

[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 approximately 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 for a given participant, once that threshold was reached, the participant reported that the vibrations caused 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 those participants.

[0114]

[0151] 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.

[0115]

[0152] Several factors may have limited the results of this first experimental study. For example, the angular velocity of the sphere 1954 in the disk-shaped region 1956 was limited by the visual display system. Specifically, the refresh rate of the Oculus DK2 screen is 90 Hz. The device's panel is an organic LED (OLED) with a 2 millisecond persistence of image. These factors prevented the rotational velocity of the sphere 1954 in the disk-shaped region 1956 from rotating faster than approximately 90 degrees / second. As the rotational velocity increased beyond 90 degrees / second, the virtual reality display began to flicker. Many test participants reached this upper limit while wearing the vibration device, which caused a ceiling effect in the measurements.

[0116]

[0153] Similarly, some subjects reported eye strain, but no discomfort or nausea, while viewing the reduced speed rotating globe 1954. Thus, participants were also limited in how long they could view the rotating disk, another factor that may have contributed to a ceiling effect on the measured efficacy of the experimental vibration in delaying the onset of virtual reality sickness.

[0117]

[0154] Considering these factors, this first experimental study showed that the vibration device is effective in treating virtual reality sickness at a statistically significant level. The data shown in the graphs of Figures 20A and 20B showed that the variation in power level has a statistically significant effect on the effectiveness of the vibration device. Specifically, power levels below 93 dB re 1 dyne were shown to be ineffective in treating the vestibular abnormality, and power levels above 100 dB were shown to cause discomfort and non-rotational vertigo that exacerbated the vestibular abnormality, and therefore the data showed that power 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 showed that the change in vibration frequency had a smaller effect on the effectiveness of the vibration device in treating the vestibular abnormality, since the effectiveness of the vibration device did not have a clear trend or peak at 45 Hz to 65 Hz.

[0118] Experimental Study II

[0155] In the second experimental study, the results obtained 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."

[0119]

[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 has been 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 three-dimensional rotational axis (e.g., a "roll", "pitch" or "yaw" axis).

[0120]

[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, skipping the training mission and proceeding 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 force 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, at the same height as the ear canal and above the flat part of the mastoid process, applying a force of approximately 3.5 to 8 Newtons. During the study, any participant who experienced non-rotational vertigo or discomfort was able to stop at any time of their choosing.

[0121]

[0158] Participants were asked to complete the Motion Sickness Assessment Questionnaire ("MSAQ") approximately 10 minutes after they had stopped playing the game. The MSAQ contains 16 manifestations or manifestations that help identify and categorize independent descriptors of motion sickness by grouping them into four categories of motion sickness: (1) gastrointestinal, (2) central nervous system, (3) peripheral nervous system, and (4) drowsiness-related. MSAQ scores range from 1 (none) to 9 (severe) for the 16 possible manifestations of motion sickness. Table 1 shows the 16 manifestations of the MSAQ that were used to assess the motion sickness experienced by participants.

[0122] [Table 1]

[0123]

[0159] When participants were asked to play the game for 15 minutes without wearing the experimental vibration device on day 1, 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 presented in Table 1. Scores on the MSAQ range from 1 (not at all) to 9 (severe).

[0124]

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

[0125]

[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 were 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, 2208 of Figure 23B, the vibration device was significantly more effective in treating motion sickness in each category.

[0126] Experimental Study III

[0162] In the third experimental study, participants were asked to assume the role of rear seat passengers in a four-door sedan and driven along a section of road based on a fixed 20-minute itinerary. Three road tests were conducted along this set route on the same day. During each drive, participants were asked to read an article on their smartphone or other small handheld device. Onset times were recorded and each participant reported the time when they first felt the first symptoms of motion sickness.

[0127]

[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.

[0128]

[0164] The driving route was a fixed roundabout route with only one stop sign along the way (i.e., at approximately the 10-minute mark) and no traffic lights. The fixed route took approximately 20 minutes and the variability between drives was less than 10%. Subjects were only tested on the first half of the ride, up to the stop sign. Subjects were given breaks during the sessions.

[0129]

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

[0130]

[0166] FIG. 24 shows the seconds to first onset of motion sickness experienced by participants during the third experimental study. Bar 2302 represents the seconds to first onset of motion sickness without the device, bar 2304 represents the seconds to first onset of motion sickness with the sound generator, and bar 2306 represents the seconds to first onset of motion sickness with the experimental vibration device. As shown, the 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 found to be effective as it more than doubled the time to onset of motion sickness compared to without the device (bar 2302) and with the sound generator (bar 2304). The data from this study demonstrate the effectiveness of the 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 using the experimental vibration device reported any discomfort when exiting the car.

[0131] Summary of experimental studies and other findings

[0167] Results from the experimental studies described above show that vibration devices such as the example vibration devices disclosed herein can 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 obvious adverse side effects.

[0132]

[0168] Subsequent experiments have shown that the power and frequency levels found to be effective herein are also effective in reducing vertigo and nausea resulting from caloric testing performed in a medical facility. For example, in the case of vertigo, individuals with chronic or frequent episodes of vertigo were asked to wear the experimental vibration device and report the effects of wearing the device. In general, individuals reported a reduction in symptoms associated with 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 the experimental vibration device. On day 1, when the device was not worn, all subjects experienced nausea, and one subject was unable to complete the test due to severe nausea. On the next day, when the device was worn, all five subjects reported a significant reduction in nausea, including no nausea, and the subject who was unable to complete the test on day 1 was able to wear the device and complete the test on day 2. Testing on both days showed the same level of vestibular function with and without the vibration device.

[0133]

[0169] 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.

[0134]

[0170] 27A, 27B, and 27C illustrate perspective, side, and exploded views, respectively, of a vibration device 2500 according to one embodiment. FIG. 28A and 28B show perspective and side cross-sectional views, respectively, of the vibration device 2500. The 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, the vibration device 2500 may include a housing 2510, a delivery interface 2530, and an end cap 2525. The vibration device 2500 may include electromagnetic coils 2524a and 2524b configured to generate a magnetic field that moves the magnet 2523. In some embodiments, the coils 2524a and 2524b may be wound in opposite directions, for example, to generate magnetic fields of opposite polarity. Although illustrated 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.

[0135]

[0171] The magnet 2523 of the vibration device 2500 can include metal end plates 2529a and 2529b. In one embodiment, the end plates 2529b can serve as the mounting plate 2328b for the spring 2520. The end plates can be configured to reduce stray magnetic flux. For example, a vibration device with a magnet acting as a vibration element can have magnetic field lines that stray away from the magnet and cause the vibration device to be attracted to metal objects by magnetic forces. This magnetic force can result in undesirable side effects and make the vibration device cumbersome during use. The end plates 2529a and 2529b can reduce such stray magnetic flux, allowing the vibration device 2500 to be used near other metal objects without being significantly attracted to those objects. Additionally, end plates 2529a and 2529b can be used to generate a magnetic field such that magnetic field lines in a direction perpendicular to (e.g., toward) the coils 2524a and 2524b are directed 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, while directing more of the magnetic field lines to allow movement of the magnet relative to the vibration device 2500.

[0136]

[0172] FIG. 38 illustrates a perspective view of a portion of a vibration device 2600 according to another embodiment. The vibration device 2600 may be substantially similar in some aspects of structure and / or function to other vibration devices described herein (e.g., vibration devices 500, 600, 700, and 2500). For example, the vibration device 2600 may include a housing and a delivery interface (not shown in FIG. 38). The vibration device 2600 may include an end cap 2625 that may be coupled to electromagnetic coils 2624a and 2624b configured to generate a magnetic field that moves the magnet 2623. In some embodiments, the end cap 2625 may include an electrical interface 2627 suitable for sending an electrical signal to the electromagnetic coils 2624a and 2624b. In some embodiments, the coils 2624a and 2624b may 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 one another as shown in FIG. 38, while in other embodiments (e.g., as shown in FIGS. 28A and 28B), the coils can be spaced closer together in space.

[0137]

[0173] The vibration device 2600 can include a spring 2620 coupled to the 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 in which the spring 2520 is attached to the mounting plate 2528b in the vibration device 2500 described. 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 with respect to 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 the magnetic field lines in a direction parallel to (e.g., away from) the coils.

[0138]

[0174] 29 shows an example 2700a of magnetic field lines concentrated by metal end plates 2629a and 2629b. A plot 2700b of normalized magnetic flux density measured over a distribution of arc lengths in FIG. 30 compares the relative magnetic flux leakage of a vibration device without end plates (line 2702) to the reduced magnetic flux leakage of vibration device 2600 with end plates 2629a and 2629b (line 2704). As shown, the use of metal end plates (e.g., 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 allowing a smaller driving force to be used to cause a desired movement of magnet 2623 to generate a therapeutically effective vibration signal. In some embodiments, metal end plates 2629a and 2629b can be used to concentrate the magnetic field lines of the magnets in such a way that less power is required to drive the movement of the magnets (e.g., in the directory towards the coil). 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. The metal plates 269a and 2629b can be made of any suitable material that can concentrate the magnetic field lines as described above. In one embodiment, the end plates 2529a and 2529b and / or the end plates 2629a and 2629b can be made of low carbon steel.

[0139]

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

[0140]

[0176] The magnet 2823 may include metal end plates 2829a and 2829b. The end plates 2829a and 2829b may be substantially similar to the end plates 2529a and 2529b described with respect to the vibration device 2500. In one embodiment, the metal end plates 2829a and 2829b may be made from low carbon steel. The metal end plates 2829a and 2829b may be configured to concentrate the magnetic field lines of the magnet 2823 in a direction perpendicular to the coil 2824 (e.g., to have the magnetic field lines of the magnet 2823 exit the end of the magnet in a direction perpendicular to the coil 2824) while reducing stray losses or leakage of the magnetic field in the parallel direction. FIG. 33 illustrates the relative positioning of the magnet 2823 with respect to the metal end plates 2829a and 2829b and the coil 2824. FIG. 34 is an example 3000 of magnetic field lines concentrated by metal end plates 2829a and 2829b as shown in FIG. 33. 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 vibration devices. Line 2702 is the magnetic flux density of a vibration device without end plates, line 2704 is the magnetic flux density with end plates in the configuration shown in FIG. 38, discussed above with respect to FIGS. 29 and 30, and line 3102 is the magnetic flux density of vibration device 2800 with end plates 2829a and 2829b. As shown, the use of metal end plates 2829a and 2829b can reduce magnetic flux leakage caused by the drive circuitry of vibration device 2800 compared to that of other vibration devices described herein (e.g., vibration device 2500 or 2600).

[0141]

[0177] The vibration device 2800 includes suspension elements 2820a and 2820b (e.g., springs) configured to suspend and support the motion of the magnet 2823, instead of springs as described in some of the vibration devices above. The suspension elements 2820a and 2820b can be, for example, annular pieces of elastic and / or deformable material such as fabric, spider springs, or flexible membranes. The annular pieces can be coupled to the magnet 2823 and configured to suspend the magnet 2823 at a balance point such that the magnetic field generated by the coil 2824 can move the magnet about the balance point in the direction shown 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, for example, the springs 2520 of the vibration device 2500), the suspension elements 2820a and 2820b may allow for a reduction in the overall height of the device 2800 while also reducing off-axis movement or rocking of the magnet 2823 outside of the axis defined by arrow E. FIGS. 36A, 36B, and 36C illustrate a comparison of the height of vibration devices according to embodiments 700, 2500, and 2800 as described above. Additionally, the suspension elements 2820a and 2820b may 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.

[0142]

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

[0143]

[0179] The magnet 3223 may include metal end plates 3229a and 3229b. The end plates 3229a and 3229b may 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 may be made from low carbon steel. The metal end plates 3229a and 3229b may 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.

[0144]

[0180] The vibration device 3200 may include a suspension element 3220 (e.g., a spring) configured to suspend and support the movement of the magnet 3223. The suspension element 3220 may be substantially similar in structure and / or function to the suspension elements 2820a and 2820b described above for the vibration device 2800. For example, the suspension element 3220 may be one or more annular pieces of material. The annular pieces may be coupled to the magnet 3223 via metal end plates 3229b as shown in FIG. 37. The suspension element 3220 may be coupled (e.g., glued) to the metal end plates 3229b in any suitable manner and configured to suspend the magnet 3223 at a balance point such that the magnetic field generated by the coil 3224 can move the magnet about the balance point in the direction shown by arrow F. Similar to vibration device 2800, the suspension elements 3220 can be configured to reduce the overall height of the device 3200 as well as reduce off-axis movement or rocking of the magnet 3223 outside of the axis defined by arrow F. Additionally, because the suspension elements 3220 are disposed between the end plates 3229b and the coil 3224, the lateral dimensions of the vibration device 3200 can also be reduced relative to the vibration device 2800 shown in Figures 32A and 32B. For example, the suspension elements 3220 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 3223, thereby reducing vibration of the magnet 3223 in that one or more directions.

[0145]

[0181] In some embodiments, further components (e.g., posts or pins such as pin 521) can be added to improve the stability of magnet 3223, and similar to magnet 523 of vibration device 500, magnet 3223 can be configured to have an opening through magnet 3223 to receive the component.

[0146]

[0182] Through the application of bone conduction vibration signals, the application of vibration signals that mask the signals transmitted by the disease-causing vestibular system, also known as vestibular masking, can be effective in alleviating many vestibular disorders. For example, the applied bone conduction vibration signals can treat vertigo caused by a damaged vestibular system. However, sometimes, when the applied vibration signal is suddenly removed (e.g., when the vibration device is turned off), the vibration signal may have adverse reactions. In some embodiments, such as those detailed above, these adverse reactions can be minimized by gradually reducing the power of the applied vibration (i.e., there is a drop in power) for a period of time instead of suddenly turning off the device.

[0147]

[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. Since 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 operable to store dedicated instructions that control the vibration element. Such instructions may be stored in an internal 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").

[0148]

[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 behavior. 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 favorable 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 a 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 the user. In one embodiment, the microcontroller may be operable to receive data from the acceleration sensor that indicates the type of acceleration that may cause motion sickness. The microcontroller may then be operable to generate an associated control signal after receiving such data and transmit such a signal to the vibration element. The vibration 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 preemptively minimize motion sickness, for example. Alternatively, the microcontroller or mobile device may be stored with a GPS circuit as well as a stored road map that represents a route or course along which a user may become ill due to motion sickness.In one embodiment, when the GPS circuit indicates that the user is traveling along the path 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 vibration element. The vibration element may then be operable to receive such a control signal and generate vibrations that may be applied to the vestibular system, for example, to take into account the possibility of motion sickness before the user reaches the location.

[0149]

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

[0150]

[0186] In some embodiments, the described apparatus and methods can be used for applications not related to the treatment of vestibular disorders. For example, some embodiments of the vibration 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 can be useful in military or surveillance situations, etc. One embodiment of the vibration device can be used with suitable adaptive structures with reduced detectability, such as in invisible and inaudible usage conditions, to enable tactile communication between subjects, such as operatives.

[0151]

[0187] While 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 described herein 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 given inventive embodiments described herein. Thus, it is to 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 such features, systems, articles, materials, kits, and / or methods, if such features, systems, articles, materials, kits, and / or methods are not mutually inconsistent, is within the inventive scope of the present disclosure.

[0152]

[0188] Also, 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 are shown as sequential in the example embodiments, embodiments may be constructed in which acts are performed in a different order than illustrated, which may include performing some acts simultaneously.

Claims

1. An apparatus comprising:

1. A vibration device configured to generate one or more vibration signals having a frequency less than 200 Hz and a force level greater than 87 dB re 1 dyne and less than or equal to 101 dB re dyne, the vibration device comprising: a housing defining a chamber; a magnet disposed within the chamber and configured to oscillate about an equilibrium position to generate the one or more vibrational signals; a coil configured to generate a magnetic field, the magnetic field configured to cause the magnet to vibrate; and and a head-mounted structure configured to position the vibration device over a portion of a user's head to apply the one or more vibration signals generated by the vibration device to the portion of the user's head, whereby a portion of the one or more vibration signals are conducted via bone to the user's vestibular system and result in movement of a portion of the vestibular system that treats a physiological abnormality associated with the vestibular system.

2. 10. The apparatus of claim 1, wherein the vibration device further comprises a set of metallic components coupled to ends of the magnet and configured to reduce stray magnetic flux and direct the magnetic field of the magnet in a direction to enable vibration of the magnet.

3. a sensor configured to measure an electrical characteristic of the vibration device, the electrical characteristic including at least one of a voltage, a current, an impedance, a magnetic field, or an acceleration associated with one or more components of the vibration device; a processor operatively coupled to the vibration device and the sensor, the processor configured to adjust a frequency of an electrical signal provided to the coil to generate the magnetic field based on measurements received from the sensor; The apparatus of claim 1 further comprising:

4. a sensor configured to measure a biological characteristic of the user indicative of an onset of the physiological abnormality or a change in severity of the physiological abnormality; a processor operatively coupled to the vibration device and the sensor, the processor configured to control the vibration device to generate the one or more vibration signals based on measurements received from the sensor; The apparatus of claim 1 further comprising:

5. 5. The device of claim 4, wherein the biological characteristic comprises at least one of body temperature, skin conductivity, electrical activity of the user's brain, electrical activity of the user's muscle tissue, electrical activity of the user's heart, heart rate, changes associated with the user's eyes, blood pressure, oxygen saturation, neural evoked potentials, sweat toxicity, or stress hormone levels.

6. 5. The apparatus of claim 4, wherein the processor is configured to control the vibration device by activating the vibration device to generate the one or more vibration signals or by increasing a force supplied to the vibration device to increase the force level of the one or more vibration signals.

7. The apparatus of claim 1 , wherein the vibration device further comprises one or more elastic elements configured to suspend the magnet within the chamber such that the magnet can oscillate about the equilibrium position.

8. 8. The apparatus of claim 7, wherein the one or more resilient elements include a spring having a first end attached to the housing and a second end disposed within an opening formed in the magnet.

9. The apparatus of claim 7 , wherein the one or more resilient elements include at least two springs each defining an opening through which the magnet moves as the magnet oscillates about the equilibrium position.

10. 8. The apparatus of claim 7, wherein the one or more resilient elements include at least two annular pieces of resilient material disposed around a circumference of the magnet at different locations along the longitudinal length of the magnet.

11. 8. The apparatus of claim 7, wherein the vibration device further comprises one or more end plates each coupled to the magnet, and wherein at least one of the one or more elastic elements is coupled to at least one of the one or more end plates.

12. 2. The apparatus of claim 1, wherein the physiological abnormality comprises at least one of vertigo, non-rotational vertigo, motion sickness, virtual reality sickness, spatial disparity, sopite syndrome, nausea, headache, migraine, or tinnitus.

13. The device of claim 1 , wherein the head-mounted structure is headgear configured to be worn by the user, the headgear including at least one of headphones or earphones.

14. The device of claim 1 , wherein the head-mounting structure is a headband configured to be worn by the user.

15. 10. The apparatus of claim 1, wherein the head-mounted structure is eyewear configured to be worn by the user, including at least one of eyeglasses, goggles, sunglasses, or safety glasses.

16. The apparatus of claim 1 , wherein the head-mounted structure is a headset configured to be worn by the user as a virtual reality device.

17. 2. The apparatus of claim 1, wherein the magnet is a first magnet and the vibration device further comprises a pair of magnets including a second magnet and a third magnet, the pair of magnets configured to suspend the first magnet within the chamber such that the first magnet can oscillate about the equilibrium position.

18. The apparatus of claim 1 , wherein the coil is further configured such that the generated magnetic field is an alternating magnetic field that causes the magnet to vibrate along a longitudinal axis of the vibration device.

19. 2. The apparatus of claim 1, wherein the coil is further configured such that the generated magnetic field causes the magnet to vibrate along a longitudinal axis of the vibration device while being restricted from vibrating along axes other than the longitudinal axis.

20. a sensor configured to determine a measurement of a biological characteristic of the user indicative of an onset of the physiological abnormality or a change in severity of the physiological abnormality; a processor operatively coupled to the vibration device and the sensor, the processor configured to control the vibration device to modify at least one of the force level or the frequency of the one or more vibration signals based on the measurements; The apparatus of claim 1 further comprising:

Images