CN111712223A

CN111712223A - Systems, devices, and methods for treating vestibular conditions

Info

Publication number: CN111712223A
Application number: CN201980013128.2A
Authority: CN
Inventors: S·欧文; R·特鲁; J·阿克尔斯
Original assignee: Otolith Sound Inc
Current assignee: Otolith Sound Inc
Priority date: 2018-02-12
Filing date: 2019-02-11
Publication date: 2020-09-25
Also published as: JP2024045228A; CA3088682A1; JP2021513381A; EP3752120A1; AU2019216971A1; WO2019157443A1

Abstract

Apparatus and methods are described herein that provide a vibration device capable of applying a vibration signal to a portion of a user's head, such that the vibration signal is capable of being conducted to the user's vestibular system via bone, and such that a portion of the vestibular system moves in an equivalent manner to a therapeutically effective vibration signal applied to an area overlying the user's mastoid bone. The vibrating device can be associated with frequencies below 200 Hz. The vibratory device can be effective in treating a physiological condition associated with the vestibular system.

Description

Systems, devices, and methods for treating vestibular conditions

Cross Reference to Related Applications

This application is a continuation-in-part application entitled "Systems, Devices, And any method for managing the structural requirements" U.S. patent application No.15/982,867 ("the' 867 application") filed on 7.5.2018, month 17, which is a continuation-in-part application entitled "Devices And Methods for reducing the features of the structures of the structural System" U.S. patent application No.15/481,457 filed on 7.4.2017, which in turn claims priority And benefit of U.S. provisional application No.62/421,708 entitled "Devices And Methods for managing the vibrations". The' 867 application also claims priority and benefit from U.S. provisional patent application No.62/629,197 entitled "Methods and Devices for Treating the proposed pharmaceutical vehicle System" filed on 12.2.2018 ("197 temporary") and U.S. provisional patent application No.62/629,213 entitled "Methods and Devices for Reducing Motion Virtual Reality and Travel Applications" filed on 12.2.2018 ("213 temporary"). The priority and benefit of the '197 temporary and' 213 temporary are also claimed. The entire disclosure of each of the foregoing applications is incorporated herein by reference in its entirety.

Technical Field

The disclosed embodiments relate to systems, devices, and methods for treating conditions associated with the vestibular system of a subject, such as, for example, motion sickness, dizziness, vertigo, migraine, and loss of consciousness. More particularly, the present disclosure relates to devices capable of generating vibratory signals that may affect the vestibular system of a subject.

Background

The orientation, balance, position and movement of the body can be determined by the brain through signals received from various parts of the anatomy, including the eyes, ears and muscles. For example, in most mammals, the vestibular system is the sensory system that contributes primarily sensory information related to balance and spatial orientation. As shown in fig. 1A, the vestibular system of the subject is located in the inner ear of the subject in an interconnected compartment system that forms a vestibular labyrinth.

Fig. 1A illustrates a portion of the anatomy of a subject 100, showing the vestibular system relative to the bones of the outer ear 110, a portion of the skull 114, and the bony portion of the ear 116, the ear canal 111, the eardrum 112, and the middle ear 113. The vestibular system includes

semicircular canals

122, 124 and 126, and

otolith organs

128 and 130, which are housed within the vestibule 121 in the bony labyrinth of the inner ear and are continuous with the cochlea 120. Fig. 1B provides a more detailed illustration of the vestibular system shown in fig. 1A, depicting the vestibule 121 including a small capsule 128 and a balloon 130.

The three

semicircular tubes

122, 124 and 126 are each oriented in a plane in one of three directions in which the head can rotate or move and detect movement in that direction, which is nodding up and down, rocking left and right, and tilting left and right. The otolith organs within the vestibule of the inner ear 121 detect gravity and acceleration in the forward and backward directions. The otolith organ includes a small pocket 128 that detects movement in a horizontal plane and a balloon 130 that detects movement in a vertical plane. The

semicircular tubes

122, 124 and 126 and the

otolith organs

128 and 130 are filled with endolymph, which is a fluid that moves with the movement of the head or body.

The movement of the endolymph in the vestibular system of the inner ear can be sensed by nerve cells with hair bundles to determine the movement and direction of the head. The part of the semicircular canal known as the ampulla and otolith organs known as the macula includes hair cells which function as sensory receptors of the vestibular system and include hair bundles or solid hairs which detect and convert the movement of endolymphatic into signals of body movement and report to the brain. Otolith organs also include a layer of calcium carbonate crystals called an otolith or otolith that moves in response to changes in acceleration (e.g., movement or change in orientation relative to gravity), resulting in movement in the layer beneath the otolith and movement of the hair strands. Furthermore, the otolith sinks in the direction of gravity and pulls the hair cell bundle to help distinguish directions, e.g., from top to bottom.

Fig. 2A and 2B provide detailed views of the anatomy and sensory receptors of the macula in otolith organs (e.g., the small balloon 128 and the balloon 130 shown in fig. 1B) in an upright position and a displaced position, respectively. Fig. 2A shows the macula including the otolith membrane 132 and the cell layer, which includes the hair cells 134 and the supporting cells 136. The hair cells 134 include hair-like protrusions or solid hairs 132 that extend into one or more gel layers. The tissue of the macula also includes an eardrum layer or otolith layer 138 that moves in response to movement of the endolymph and/or acceleration of the body. Fig. 2A shows the hair cells 134 and the otolith 138 in an upright configuration, and fig. 2B shows the hair cells 134 and the otolith 138 in a displaced or angled configuration when a directional force 140 (e.g., gravity) acts on the otolith 138. Similarly, movement of endolymphates within the

semicircular tubes

122, 124 and 126 can cause movement of hair cells within the ampulla of the semicircular tubes (not shown), thereby sensing and signaling relative movement of the body and/or head (e.g., angular acceleration of the head).

In addition to signals from the vestibular system, horizontal and vertical vision patterns received by the eye can also affect the perception of orientation, balance, and position; and different strains on opposing neck muscles can affect the perception of head position and orientation. If the signals from these sources do not match, the individual may develop motion sickness, dizziness, vestibular migraine, obnubilation, or other conditions. Unmatched orientation, balance, position and movement signals may be the result of extreme or unfamiliar movements during driving in, for example, automobiles, trains, airplanes and other modes of transportation. Simulated perceived movement can also result in unmatched signals during three-dimensional (3D) movies, 3D video games, and virtual reality devices, for example. Accordingly, it may be desirable to have a device for treating various vestibular conditions, which may be due to mismatched signals received from the subject's vestibular system, eyes, or other anatomical structures.

Disclosure of Invention

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 such that the vibration signal may be conducted to the user's vestibular system via bone and such that the portion of the vestibular system moves in an equivalent manner to a therapeutically effective vibration signal applied to a region overlying the user's mastoid bone. The therapeutically effective vibratory signal may (1) have a frequency of less than 200Hz and a force level between 90 and 100dB re1 dynes, and (2) be therapeutically effective to treat a physiological condition associated with the vestibular system.

The apparatus and methods described herein may, in some embodiments, include a vibration device configured to apply a set of vibration signals to a portion of a user's head such that the set of vibration signals may be conducted to a vestibular system of the user via bone to treat a physiological condition associated with the vestibular system. The vibratory device may be associated with a set of resonant frequencies including a lowest resonant frequency of less than 200 Hz. The set of vibratory signals may collectively have an amount of power at the lowest resonant frequency that is greater than an amount of power at remaining resonant frequencies in the set of resonant frequencies.

In some embodiments, the devices described herein may include a vibrating element configured to apply a vibration signal to a portion of a user's head such that the vibration signal may be conducted to the user's vestibular system via bone to treat a physiological condition associated with the vestibular system. The vibrating element may be configured to include a housing defining a chamber, a magnet movable within the chamber to produce a 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.

The method disclosed herein comprises positioning a vibration device over a region of a user's head, and exciting the vibration device after positioning to apply a vibration signal to the region such that the vibration signal may be conducted to the vestibular system of the user via bone. The vibration signal may be configured to move a portion of the vestibular system in the same manner as the vibration signal (1) is applied to an area covering the mastoid bone of the user and has (2) a frequency of less than 200Hz and a force level between 90 to 100dB re1 dynes. The method may further include treating a physiological condition associated with the vestibular system in response to exciting the vibrating device.

Drawings

Fig. 1A illustrates the anatomy of a subject, including a bony labyrinth that houses the inner ear of the vestibular system.

Fig. 1B provides a detailed illustration of the intra-osseous labyrinth vestibular system and cochlea of fig. 1A.

Fig. 2A and 2B are illustrations of a portion of the macula lutea of the otolith organ shown in fig. 1B in an upright state and a state subjected to a directional force, respectively.

Fig. 3 is a schematic diagram of an arrangement of a vibrating device for applying a vibration signal to the vestibular system according to an embodiment.

Fig. 4A is a schematic diagram of an example system for treating a symptom associated with a vestibular condition, according to an embodiment.

Fig. 4B is a schematic diagram of an example system for treating a symptom associated with a vestibular condition, according to another embodiment.

Fig. 5 is a schematic diagram of an example vibratory device of a system for treating a symptom associated with a vestibular condition, according to an embodiment.

Fig. 6 is a schematic diagram of a cross-sectional view of an example vibratory device of a system for treating a symptom associated with a vestibular condition according to another embodiment.

Fig. 7A is a schematic illustration of a cross-sectional view of a vibrating device in a system for treating a symptom associated with a vestibular condition, according to an embodiment.

Fig. 7B is a schematic diagram of a cross-sectional view of the vibration device of fig. 7A integrated into a physical platform for placement on a subject, in accordance with an embodiment.

Fig. 8 is a schematic diagram of a cross-sectional view of a vibrating device in a system for treating a symptom associated with a vestibular condition, according to another embodiment.

Fig. 9A is a perspective view of a spring as a suspension element of a vibrating device in a system for treating a symptom associated with a vestibular condition according to an embodiment.

Fig. 9B and 9C are illustrations of top and bottom views, respectively, of the spring in fig. 9A.

Fig. 10-15 are schematic illustrations of example vibration devices included and/or integrated into different support elements, according to various embodiments.

Fig. 16 is a schematic diagram of a human skull indicating an example location for placement of a vibrating device in a system for treating a symptom associated with a vestibular condition, in accordance with various embodiments.

Fig. 17A and 17B depict two example waveforms that may be used to excite a vibrating device in a system for treating symptoms associated with vestibular conditions, in accordance with various embodiments.

Fig. 18 illustrates an example excitation profile that may be used to excite a vibrating device in a system for treating symptoms associated with vestibular conditions, according to an embodiment.

Fig. 19 is a flow diagram of an example method for treating a symptom associated with a vestibular condition using a vibratory device.

Fig. 20A is a flow chart of a process of a study conducted to test a vibratory device for treating symptoms associated with vestibular conditions.

Fig. 20B is a schematic diagram of a static view of an example visual stimulus for testing a vibrating device in the process depicted in fig. 20A.

Fig. 21A and 21B depict results from the study procedure depicted in fig. 20A for testing vibratory equipment at different force levels.

Fig. 22A and 22B depict results from the study procedure depicted in fig. 20A for testing vibratory equipment at different frequencies.

Figures 23A and 23B depict data associated with a questionnaire completed by a subject in another instance using a testing procedure to test a study conducted to test a vibrating device for treating symptoms associated with vestibular conditions.

Fig. 24 depicts the results of a study in another case using a testing procedure to test a vibrating device for treating symptoms associated with vestibular conditions.

Fig. 25A-25C are schematic illustrations of perspective, side, and exploded views, respectively, of a vibration apparatus as described herein, according to an embodiment.

Fig. 26 is a cross-sectional view of the housing of the vibration device shown in fig. 25A-25C.

Fig. 27A-27C are schematic diagrams of a perspective view, a side view, and an exploded view, respectively, of a vibration apparatus according to an embodiment.

Fig. 28A and 28B are schematic diagrams of perspective and cross-sectional views of the vibration apparatus of fig. 27A-27C.

Fig. 29 is a graphical representation of magnetic field lines associated with a magnet of a vibrating device, such as the vibrating device of fig. 38.

Fig. 30 is a graph of normalized magnetic flux density associated with a magnet of a vibratory device, in accordance with several embodiments.

Fig. 31A-31C are schematic diagrams of a perspective view, a side view, and an exploded view, respectively, of a vibration apparatus according to an embodiment.

Fig. 32A and 32B are schematic illustrations of two different cross-sectional views of the vibration device of fig. 31A-31C.

Fig. 33 is a schematic view of a magnet, a coil, and a metal plate in the vibration apparatus of fig. 31A to 31C.

Fig. 34 is a graphical representation of magnetic field lines associated with the magnet of the vibration apparatus of fig. 31A-31C.

Fig. 35 is a graph of normalized magnetic flux density associated with a magnet of a vibratory device, in accordance with several embodiments.

Figures 36A-36C are schematic illustrations of cross-sectional views of a vibration apparatus according to three different embodiments.

Fig. 37 is a schematic diagram of a cross-sectional view of a vibration apparatus according to an embodiment.

Fig. 38 is a schematic diagram of a perspective view of a vibration apparatus according to an embodiment.

Detailed Description

Described herein are apparatuses and methods for treating vestibular conditions by using a vibrating device capable of generating and applying a vibration signal to the subject's vestibular system via bone conduction such that the vibration signal can disrupt the anatomy of the subject's vestibular system.

As described above, sensory signals from the vestibular system of a subject help to perceive the orientation, balance, position, and movement of the subject's body. In addition to signals from the vestibular system, other sensory modalities (such as visual signals from the eye) can affect the perception of orientation, balance, and position; and different strains on opposing neck muscles can affect the perception of head position and orientation. When the signals from these various sensory sources, such as the vestibular, visual, and proprioceptive systems, do not match, the individual may develop motion sickness, dizziness, vestibular migraine, obnubilation, or other conditions. For example, unmatched orientation, balance, position and movement signals may be the result of extreme or unfamiliar movements, for example during driving in automobiles, trains, airplanes and other modes of transportation, or as a result of experiencing a virtual or augmented 3D environment (such as a 3D movie, a 3D video game, a virtual reality device, etc.).

In natural adaptive response, the brain can ignore sensory information in the signal that is chaotic, repetitive, or not novel or difficult to understand. For example, vibrations from sound have been shown to affect the vestibular apparatus of the inner ear and reduce the response of the cerebellum (e.g., the amplitude of the electrical signal). See "Effect of Noise on the flexible system-Flexible exposed patent students in rates", 2Noise Health41(1999) by Sohmer et al. However, the same study shows that very high intensities are required in order for sound to affect the vestibular system. Thus, conventional headphones, earplugs, and speakers for producing sound by generating a vibration signal in the air are limited in their ability to treat symptoms such as motion sickness, dizziness, vestibular migraine, and other physiological reactions. Many of these techniques are not intended to deliver high intensity signals. Moreover, such high intensity signals can damage or destroy human hearing.

As an alternative to the use of sound, mechanical vibrations may be used to influence the vestibular system to therapeutically treat various conditions. One technique that may be used to create mechanical vibrations is surface or bone conduction transducers. However, currently available bone conduction transducers have certain disadvantages associated with treating symptoms or conditions of the vestibular system. For example, existing devices often have significant limitations, such as generating significant amounts of heat and/or audible noise, which may prevent them from being used directly in contact with a person's skin or near a person's ear. Many existing devices are also large and bulky, which makes them unsuitable for situations where therapeutic effects are required, such as for example during trips, while reading, while using virtual reality devices, etc.

Existing devices, such as surface or bone conduction transducers, are inefficient at generating low frequency vibrations. Many generate vibration signals of high audible frequencies and are therefore distracting. Thus, when such devices are used close to a person's ear, the noise they produce can cause interference and irritation. Many existing devices produce high frequency vibrations, in large part due to the directing of power to a higher resonant frequency than the lower fundamental frequency of the vibration signal generated by such transducers. Existing bone conduction transducers can be inefficient even if designed to produce low frequency vibrations because they produce a large frequency spectrum (e.g., frequencies at many harmonics) when lower frequencies are needed. Thus, among other features, the disclosed systems and methods are directed to the treatment of symptoms associated with the condition of the vestibular system, which, among other things, do not generate high levels of heat or audible noise, and are highly efficient in delivering low frequency vibration signals.

Fig. 3 schematically illustrates the placement of a vibrating device 200 near the outer ear 110 of a subject. The vibration device 300 may be configured to apply the vibration signal 202 via bone conduction to treat one or more symptoms or conditions associated with the vestibular system of the subject. A portion 204 of the vibration signal 202 may be conducted to the bony labyrinth of the inner ear and to the vestibular system via the bone 116. For example, a portion 204 of the vibration signal travels through the bone to the

semicircular tubes

122, 124, and 126 and the vestibule 121 that houses the otolith organs, vesicles, and balloons.

The vibration device 200 may be positioned such that a vibration signal may be applied to the vestibule 121 to move the hair cells in the otolith organs in the vestibule 121 and the

semi-circular tubes

122, 124, and 126 in a repetitive, chaotic, or noisy manner to reduce, alleviate, or treat symptoms associated with the vestibular condition. Some example vestibular conditions may include various types of motion sickness (e.g., seasickness, motion sickness, car and train motion sickness, motion sickness due to contact with virtual reality or simulators, motion sickness due to experiences such as riding on a roller coaster, and the effects of sleep-onset syndrome), vertigo (such as benign paroxysmal positional vertigo), nausea due to various causes (e.g., vestibular system tests including hot Electrocardiography (ENG)/video oculography (VNG) tests, head pulse tests, vestibular-induced myogenic potential (VEMP) tests (such as cervical VEMP and ocular VEMP tests), functional gait assessment, and the like, or due to conditions such as chemotherapy, cranial base radiotherapy, nausea related to pregnancy, nausea due to alcohol or drugs), infection, vestibular neuritis, vestibular schwannomas, vestibular schwann, and the like), vestibular syndrome, or the like, Meniere's disease, migraine, Mal de deboque syndrome, spatial dissonance, sleep onset syndrome, etc.

As described herein, the vibratory apparatus 200 can also be positioned to provide vibration signals conducted via bone to treat other conditions, including, for example, dizziness, loss of balance, and the like, caused by circulatory problems (e.g., postural hypotension (blood pressure drop), cardiomyopathy, heart disease, arrhythmia, poor blood circulation due to transient ischemic attacks, neurological diseases (e.g., parkinson's disease, multiple sclerosis), medications (e.g., antiepileptics, antidepressants, sedatives, tranquilizers, hypotensive medications), anxiety, anemia resulting from low iron levels, hypoglycemia (blood glucose lowering), overheating, dehydration, and head trauma). The vibratory signal may cause a portion of the vestibular system to move in the same manner as a therapeutically effective vibratory signal for treating the above-mentioned conditions. Moreover, the vibration device 200 may be used to assist a pilot, such as, for example, training the pilot to ignore or reject their vestibular system under specific conditions. The vibration device 200 may also be used as a stroke diagnostic.

Fig. 4A schematically illustrates an example system 350 for treating vestibular conditions. The system 350 includes a vibration device 300 and a control unit 360 coupled to the vibration device 300, the control unit 360 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 excited by an appropriate electrical signal from a signal source. Control unit 360 may include a memory 362, a processor 364, and an input/output (I/O) device 366 for sending and/or receiving electrical signals to and/or from other components of system 350. The vibration device 300 may be configured to receive 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 associated with the vestibular system VS of the subject and/or other body metrics (e.g., temperature, skin conductivity, etc.). The sensor 390 may receive and send signals to 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 produce a vibration signal. The amplifier 380 may be operatively coupled to the signal generator 370 and may amplify the 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.

In some embodiments, the signal generator 370, the amplifier 380, and/or the sensor 390 may be integrated with the control unit 360 and/or formed as 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 the control unit 360 but operatively coupled to the control unit 360. In some embodiments, the vibration device 300 may include one or more of a control unit 360, a signal generator 370, an amplifier 380, or a sensor 390.

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 memory 362 or in a separate memory. Further, such instructions may be designed to integrate specific functions and features into the controller to accomplish specific functions, methods, and processes associated with treating the vestibular conditions disclosed herein. In some embodiments, the control unit 360 may be programmed with instructions using a software development kit.

The control unit 360 may generate an electrical signal for controlling the vibration device 300 based on the stored instructions. These electrical signals may be transmitted between the control unit 360 and the vibration device 300 by wired or wireless (e.g., bluetooth) methods. The electrical signals may include a stored mode of operation, for example, stored instructions accessed by the controller may be used by the controller to generate a series of electrical signals that are sent to the vibration device 300 to cause the vibration device 300 to "turn on" or "turn off" in favor of a particular subject's mode based on usage data that has been collected, accumulated, and stored for that user. One mode may involve a series of vibration signals in which the number of vibration signals generated and applied to the subject over a period of time (e.g., every minute) may vary, while a second mode may include a series of vibration signals in which the force level in a plurality of vibration signals may vary. Other types of control signals, such as control signals that may be used to control the force level and frequency of the vibration signal generated by the vibration device 300, may be sent from the control unit 360 to the vibration device 300 based on data received from a sensor (e.g., the sensor 390 or other sensor). For example, an acceleration sensor may be included in a portable electronic device (e.g., a mobile phone) to sense changes in body acceleration of a user. In an embodiment, the control unit 360 may be operable to receive data from the acceleration sensor indicating the type of acceleration that may cause motion sickness. Thus, upon receiving such data, the control unit 360 may be operable to generate associated electrical signals and transmit these signals to the vibration device 300. The vibration device 300 may in turn be operable to receive such electrical signals and generate vibration signals that may be conducted via bone and applied to the vestibular system to, for example, pre-address motion sickness. The vibration signal may cause a portion of the vestibular system to move in the same manner as the therapeutically effective vibration signal. For example, the vibration signal may cause a portion of the vestibular system (e.g., hair strands forming receptors in a semicircular canal and/or otolith organ) to move in a random manner, thereby simulating a noisy vestibular signal or a noisy vestibular sensation. In some cases, this noisy vestibular sensation may cause a reduction in the contribution caused by other vestibular signals or in the mismatch of signals perceived by the subject. Alternatively, stored roadmaps representing paths or routes that have previously caused the user to become sick due to motion sickness may be stored in the control unit 360 or in the portable device and in a suitable positioning system such as, for example, the Global Positioning System (GPS), galileo, GLONASS or Beidou (Beidou). In some embodiments, when the positioning system indicates that the user is moving along a path or route and arrives at a location that may cause motion sickness, the control unit 360 may be operable to generate associated electrical signals and send such signals to the vibration device 300. The vibration device 300 may in turn be operable to receive such electrical signals and generate vibration signals that may be conducted via the skeleton and applied to the vestibular system, for example to pre-resolve motion sickness before the user reaches the location, for example.

Fig. 4B schematically illustrates another example system 350' for treating vestibular conditions, according to an embodiment. System 350' may be similar to system 350 in that it includes a control unit 360 and a vibratory device 300 coupled to and excited and/or controlled by control unit 360. Furthermore, the system 350 'may have a second vibration device 300' also coupled to the control unit 360, the activation of which may be controlled by the control unit 360. The control unit 360 may be configured to control the vibration devices 300 and 300 'such that the vibration signals generated by the vibration devices 300 and 300' may be delivered simultaneously, alternately and/or independently. Although not depicted in fig. 4B, similar to system 300 depicted in fig. 4A, system 350' may optionally include a signal generator (e.g., signal generator 370) coupled to 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 vibrating devices 300 and 300 'may be coupled to a balance (balance)382, the balance 382 being configured to distribute the signal generated by the signal generator and optionally amplified by the amplifier between the vibrating devices 300 and 300'. In some embodiments, the vibratory devices 300 and 300' may be coupled to each other and configured to transmit and/or receive signals to each other. Although two vibratory devices 300 and 300' are depicted in fig. 4B, one of ordinary skill in the art will recognize that any number of vibratory devices may be used.

Fig. 5 is a schematic diagram of an example vibration device 400, according to an embodiment. The vibration device 400 includes a body (or housing) 410 that may 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 vibrating element 423 may be suspended within the body (e.g., within the chamber) such that the vibrating element 423 may vibrate about an equilibrium position. Movement of the vibration element 423 may be performed relative to the suspension element 420 and/or the body 410 of the vibratory device 400 to produce a vibration signal that may be directed via the delivery interface 430 to treat one or more vestibular conditions 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 against the target area TA so that vibration signals generated by movement of the vibration element 423 can be applied to the target area TA and then conducted to the subject's vestibular system VS via the skeletal structure BS.

Optionally, in some embodiments, the vibrating device 400 may include an on-board power supply 414 that provides power to components of the vibrating device 400, and a sensor 416 that senses one or more signals from a portion of the vibrating 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 skin adjacent to and/or associated with the target area TA). In some embodiments, the vibration device 400 may be powered using a remotely located power source (e.g., a power source contained in the control unit 360). In some embodiments, a remote sensor (e.g., sensor 390) may be used to sense a signal from a portion of the vibrating device 400, the vestibular system VS, or another portion of the body (e.g., the portion of the body to which the generated vibration signal is applied).

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

In some embodiments, the sensor 416 is used to increase the efficiency of the vibration apparatus 400. For example, the sensor 416 may include an ammeter for monitoring the current of the electrical signal from the vibrating element 423 and/or another portion of the vibrating device 400. The frequency of the electrical signal supplied to the vibration device 400 can be adjusted until the current meter measures a low current, the basic principle being that at the resonant frequency of the vibration device, the impedance of the vibration device 400 is higher than at other frequencies, and thus the current is lower than at other frequencies (assuming a constant voltage). Thus, the current meter may be used to tune (e.g., adjust) the frequency of the electrical signal to the resonant frequency such that the vibration device 400 operates efficiently. That is, in some embodiments, the vibration device 400 may include a processor configured to receive information from the sensor 416 (e.g., information from an ammeter) and adjust the frequency of the electrical signal based on the information. For example, the processor may be configured to adjust the frequency of the electrical signal over time such that the vibrating device continues to operate at a reduced current and a lowest resonant frequency.

As another example, sensor 416 may include a voltage sensor or voltmeter with a constant current amplifier. A voltage meter may be used to measure a voltage change in an electrical signal supplied to a portion of the vibration device 400 including the vibration element 423. The frequency of the electrical signal supplied to the vibration device 400 can be adjusted (e.g., from a suitable signal source) until a high voltage is measured by the voltmeter, the basic principle being that at the resonant frequency of the vibration device, the impedance of the vibration device 400 is higher than the impedance of other frequencies, and thus the voltage is higher than the voltage at other frequencies. Thus, the monitored voltage may be used to tune (e.g., adjust) the frequency of the electrical signal so that a high voltage is measured to achieve high efficiency.

As another example, where the vibrating element 423 is driven by a modulated magnetic field, the sensor 416 may comprise a hall effect sensor that monitors fluctuations in the magnetic field. The magnetic field fluctuations may be measured while changing the frequency of the electrical signal used to generate the magnetic field to tune the frequency of the electrical signal to be at the resonant frequency of the vibration device 400. As another example, the sensor 416 may include a movement sensor (e.g., an accelerometer) that may measure acceleration and/or velocity of the vibratory element 423 to determine when the resonant frequency is obtained.

The sensor 416 may also be equipped to receive and/or measure information from the subject, such as movement associated with the vibration signal transmitted to the subject's skeletal structure, the temperature, orientation, or body position of the subject, etc.

As disclosed herein, the vibration device 400 can also include a support element 418 to support or position the vibration device 400 on or against the target area TA of the subject to deliver the vibration signal. The support element 418 may be a device or fastening feature 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, or pillow, or the like, as disclosed in further detail below. In some embodiments, the support element 418 may be an adhesive component, such as, for example, an adhesive pad, an adhesive polymer, or the like, that may maintain contact and positioning of the vibration device 400.

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

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 implanted in the head of the subject, and the target area TA may be an area near 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 a therapeutic vibration signal. In an example case, the target area TA may be an area behind the outer ear of the subject that covers the mastoid of the subject's skull (or mastoid of the mastoid or temporal bone). In such a case, the mastoid bone may form part of the skeletal structure BS for conveying the vibration signal to the vestibular system VS via the skeletal structure of the inner ear housing the vestibular system VS. In some cases, the zygomatic bones or zygomatic processes of the temporal bone may be part of the skeletal structure BS used to deliver the vibration signal to the vestibular system VS. In other cases, the target area TA may be a portion of the back of the head or forehead, while the underlying region of the skull bone serves as the skeletal structure BS conducting the vibration signal received from the vibration device 400. The vibrating device 400 may be operated with varying force levels based on the selected target area TA and its distance from the vestibular system VS. For example, when the device is placed in a target area TA (such as the forehead area of the subject or an area behind the subject's head that is farther from the vestibular system VS than the papilla), a higher force level may be used than when the device is placed around the subject's papilla. As an example, when placed on the forehead of a subject or the head of a subject, the vibration device 400 may be configured to apply a vibration signal having a force level up to 14dB higher than that of a vibration signal that may be therapeutically effective when delivered elsewhere (e.g., the area covering the mastoid bone). When the target area TA is an area covering the mastoid bone and the vibration device is positioned to cover the area, the therapeutically effective force level may be between 90-100dB re1 dynes, and desirably between 93-98dB re1 dynes, for treating vestibular conditions.

The body 410 of the vibration device 400 may be configured to house various components of the vibration device 400. In some embodiments, the body 410 may house some of the components while providing an interface for coupling 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 may define one or more chambers or containers for housing one or more components of the vibration device (such as the vibration element 423, the suspension element 420, the drive circuit 440, and/or the delivery interface 430). The body 410 may also be shaped and/or configured for desired positioning of the delivery interface 430 relative to a target region TA of the subject's body (e.g., the body 410 may have a curved surface, or a malleable or flexible surface). In some embodiments, the body 410 and/or one or more chambers thereof may be filled with air or, in some cases, with a liquid (such as a lubricant) to help generate and deliver the vibration signal. In some embodiments, the body 410 and/or one or more chambers thereof may also include a material having properties, such as, for example, an audible noise attenuator (such as a sponge) or sound absorbing material, heat dissipating material, or the like.

The vibrating element 423 of the device 400 may be configured to oscillate or vibrate to generate a vibration signal. In some embodiments, the vibration element 423 may be housed within a cavity of the body 410. The vibrating element 423 may be suspended in an equilibrium position by the suspension element 420, and an electrical signal may be used to vibrate or oscillate the vibrating element 423 about the equilibrium position to generate a vibration signal. The characteristics (such as materials, compositions, structures, etc.) of the vibration element 423 and/or the suspension element 420 may be selected to meet the specific requirements of the generated vibration signal (e.g., low frequency signal).

For example, the vibration element 423 may be a spring or an elastic material having a degree of stiffness (e.g., a spring constant) that enables efficient generation of a low frequency vibration signal (e.g., a frequency less than 200 Hz). In an embodiment, the vibrating element 423 may be a mass suspended by a sprung suspension element 420. The natural resonance of such a system may be based on Hook law determination, as in equation

Shown, where f is the resonant frequency, k is the spring constant, and m is the mass. For a given power, the amplitude of the movement of the mass is greater at the resonant frequency than at other frequencies because at the resonant frequency the mass and spring system can be associated with a cleaner tone (e.g., a sinusoidal waveform). Thus, operating the vibration device 400 at its resonant frequency produces a stronger vibration signal, and the characteristics of the vibrating element 423 and/or the suspension element 420 may be selected to achieve a particular resonant frequency.

Other factors that may affect and/or determine the generated vibration signal may be, for example, the mechanism of the driving force (e.g., mechanical, electromagnetic), the ease of movement of the vibrating element (e.g., a frictionless degree of movement), the location of the target area TA (e.g., the subject's mastoid bone, zygomatic bone, skull near the forehead, etc.), a reduced secondary or tertiary energy dissipation path (e.g., off-axis movement, heat, friction, etc.), the direction of movement relative to external forces (e.g., pressure during use, gravity, etc.), the requirements of the subject for convenient use under various conditions (e.g., mobility of the subject, limits on the degree of interference, etc.), and so forth.

The vibrating element 423 may be configured such that it may be driven to generate a vibratory movement along or about an axis of the vibrating device 400 (e.g., a longitudinal axis of the body 410), wherein the movement produces a vibratory signal having suitable characteristics (e.g., frequency, amplitude, force level, etc.) for treating vestibular conditions. In some embodiments, the vibration device 400 may be an electromechanical transducer comprising a vibration element 423, for example implemented as a magnet, which vibration element 423 may be driven to move along an axis using a suitable driving force, such as a magnetic field. Further details regarding such embodiments are described below with reference to fig. 6-9C.

Another method of generating a low frequency vibration signal is to modulate the ultrasonic signal. In some embodiments, the vibration device 400 may be a piezoelectric transducer driven by an electrical signal to generate vibrations in the ultrasonic frequency range. Vibration of the piezoelectric transducer at such higher frequencies produces acoustic radiation pressure. The driving electrical signal may be timed and turned off at a lower frequency of less than 200Hz (e.g., 60Hz) such that the application and disconnection of pressure from the piezoelectric transducer at the lower frequency generates a corresponding vibration signal at the lower frequency. The use of piezoelectric transducers may reduce the size and weight of the vibration device 400 because piezoelectric transducers are typically smaller and lighter than other types of electromechanical transducers.

Depending on where the vibratory device 400 is placed, the dimensional limitations of the vibratory device 400, and/or the configuration or shape of the vibratory device 400, the specific components of the vibratory device 400 can be selected to provide therapeutically effective vibratory signal levels for treating vestibular conditions. Although one vibrating element 423 is illustrated in fig. 5, one of ordinary skill in the art will recognize that the vibrating device 400 may include one or more additional vibrating elements that may work together and/or independently to generate a vibration signal to treat vestibular conditions.

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

In some embodiments, the vibrating element 423 may vibrate at a first resonant frequency along a first axis (e.g., an axis in the z-direction) and may also vibrate at a second resonant frequency along a secondary axis (e.g., an axis in the x-y plane). To reduce vibration along the secondary axis, the vibrating element 423, the suspension element 420, and/or other elements of the vibrating 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), such that when the vibrating device 400 is excited at the first resonant frequency, vibration along the secondary axis may be reduced. The vibration along the secondary axis may, for example, cause internal collisions and/or audible sounds between components of the vibration device 400.

The vibration device 400 may be positioned in different areas on the subject's head. Fig. 16 depicts a human skull bone and indicates some example areas of the skull bone where a vibration device 400 may be placed to apply therapeutic vibration signals to treat the vestibular conditions disclosed herein. For example, as indicated in fig. 16, in some cases, the vibration device 400 may be placed over the mastoid bone 1502 of the subject's skull. While the left mastoid bone 1502 is identified in fig. 16, one of ordinary skill in the art will recognize that the vibration device 400 may be placed over either the left or right mastoid bone of the subject. In other cases, the vibration device 400 may be placed over a portion of the back of the head (e.g., over the left, right, or central portion of the occiput 1501) or a portion of the forehead (e.g., over the left, right, or central portion of the anterior bone 1504) to deliver a vibration signal to treat the vestibule and other conditions disclosed herein. Depending on the region in which the vibrating device 400 is placed (e.g., its proximity to the vestibular system, whether vibrations from the device need to pass through the sutures 1503), the force level of the vibration signal may be adjusted so that a therapeutically effective vibration level for the treatment condition is delivered to the vestibular system.

When the vibratory device 400 is positioned to cover a mastoid bone (e.g., the mastoid bone 1502 shown in fig. 16), the vibratory device 400 may apply a therapeutically effective vibratory signal (i.e., a therapeutically effective vibratory signal) at treating conditions of the vestibular system having a resonant frequency of less than 200Hz and a force level between 90 to 100dB re1 dynes. If the vibration device 400 is positioned to cover a different region of the subject's vestibular system (e.g., the zygomatic bone 1505 or the frontal bone 1504 or the occipital bone 1501, shown in fig. 16) on the subject's head that is further away from the subject's mastoid bone than the mastoid bone, the vibration device 400 may generate a vibration signal with a greater force level such that the vibration signal may affect a portion of the vestibular system in a manner equivalent to a therapeutically effective vibration signal applied to the region covering the mastoid bone (e.g., 1502, shown in fig. 16). For example, when the vibration device 400 is positioned over the frontal bone (e.g., frontal bone 1504 in fig. 16) of a subject, the vibration device 400 may generate a vibration signal having a force level greater than the force level of a therapeutically effective vibration signal applied to the area covering the mastoid bone (e.g., up to 14dB re1 dynes).

The suspension element 420 of the vibration device 400 may include one or more components housed in the body 410 and interacting with the vibration element 423. In some embodiments, the suspension element 420 and/or the vibration element 423 may be configured to be compliant to receive each other. For example, the suspension element 420 may include a component that may extend through an opening defined in the vibration element 423.

In some embodiments, the suspension element 420 may be housed within a cavity of the body 410, and in some cases, may be disposed in a fluid such as a lubricant. The suspension element 420 may be configured to exert a force on 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 drive signal. For example, the suspension element 420 may be a spring coupled to the vibration element 423 (e.g., a magnet). Alternatively or additionally, the suspension element 420 may include a pair of magnets (e.g., another magnet) arranged with the vibrating element 423 to each exert a force (e.g., an opposing or repulsive magnetic force) on the vibrating element 423 in an opposite direction to collectively hold the vibrating element 423 in an equilibrium position by virtue of a force (e.g., an opposing or repulsive magnetic force) acting between the vibrating elements 423. In such embodiments, a driving force (e.g., an applied magnetic field of a particular magnitude and acting in a particular direction) may cause the vibrating element 423 (e.g., a magnet in an equilibrium position) to move between a pair of magnets. In other embodiments, the suspension element 420 may be an elastomeric material or a fluid. Although one suspension element 420 is depicted in fig. 5, one of ordinary skill in the art will recognize that multiple suspension elements 420 may be used to support and/or suspend the vibration element 423. The plurality of suspension elements 420 may include one or more different types of suspension elements (e.g., magnets, springs, elastomeric materials, etc.).

The drive circuit 440 of the vibration device 400 may include one or more suitable components that can generate an electrical signal. The electrical signal may be such that a force is generated to cause movement of the vibratory element 423 along the axis to produce a therapeutic vibratory signal. In some embodiments, the drive circuit 440 may receive an electrical signal from a control unit (such as the control unit 360 in fig. 4A and 4B). In some other embodiments, the drive circuit 440 itself may comprise an on-board unit that may generate an electrical signal.

The electrical signal generated or received by the drive circuit 440 and used to cause movement of the vibratory element 423 may have suitable characteristics to produce a vibratory signal having a particular frequency and force level. For example, the electrical signal may be selected such that the electrical signal causes the vibratory element 423 to generate a vibratory signal having a particular frequency range (e.g., less than 200Hz) to treat one or more specific vestibular conditions. In some embodiments, a control unit (e.g., control unit 360) may be capable of changing the frequency of the electrical signal until the electrical signal causes the vibration device 400 to vibrate at a resonant frequency, such as described above with sensor 416.

In some embodiments, the drive circuit 440 may include an on-board signal generator for generating an electrical signal, an amplifier for amplifying the signal, and one or more elements for converting the electrical signal into the appropriate mode of movement for the vibrating element 423. For example, the drive circuit 440 may include one or more coils that may generate a magnetic field that moves the vibration element 423.

The delivery interface 430 of the vibration device 400 may be configured to deliver the vibration signal generated by the vibrating element 423 to the target area TA of the subject, such that the vibration signal may be conducted to the vestibular system VS via the underlying skeletal structure BS. The delivery interface 430 may be configured and/or adapted to the structure and/or shape of the target area TA of the user such that the delivery interface may engage and/or maintain contact during use for the transmission of the therapeutic vibration signal. In some embodiments, the delivery interface 430 may be configured to take into account the comfort and ease of use of the user, for example, during use of the vibration apparatus 400 to alleviate vestibular conditions. The delivery interface 430 may also be configured to reduce secondary effects that may be undesirable, such as the generation and accumulation of heat, the generation of audible noise, insufficient air circulation, the application of pressure to the target area TA, and the like. For example, the delivery interface 430 may include a layer of memory foam material that may help to conform to the contours of the target area (e.g., the area over the mastoid process above the ear). The memory foam material may also help dissipate heat, reduce audible noise, promote air circulation, minimize discomfort caused by pressure exerted by a support element (such as a headband, etc.).

Fig. 6 is an illustration of an example vibration device 500 according to an embodiment. The vibratory device 500 includes a body (or housing) 510, the body 510 including a conduit 526 and

end caps

525a, 525 b. In some embodiments, the body 510 of the vibration device 500 may define a chamber. The body 510 houses a vibrating element implemented as a magnet 523 and a suspension element implemented as

magnets

520a, 520 b. As shown in the cross-sectional view of fig. 6, the suspension element includes

magnets

520a, 520b, and the vibration element 523 includes a magnet 523. As shown in fig. 6, the magnets 520, 520b act as suspension elements by exerting opposing forces on the magnet 523 to suspend the magnet 523 in a balanced position. For example, the magnet 520a may be configured to exert a force on the first magnet 523 in a first direction, and the magnet 520b may be configured to exert a force (e.g., a force equal in magnitude to the force exerted by the second magnet 520a on the magnet 523) on the first magnet 523 in a second direction (e.g., a second direction 180 ° removed from the first direction). As such, the first magnet 523 can be disposed between the second and

third magnets

520a, 520b in the body 510 (e.g., the chamber) such that the second and

third magnets

520a, 520b collectively suspend the first magnet 523 in one position (e.g., a balanced position) within the body 510.

The magnet 523 acts as a vibrating element configured to move (e.g., oscillate or vibrate) to generate a vibration signal. The vibrating element 523 may be suspended together within the body 510 (e.g., within the chamber) by the

suspension elements

520a, 525b such that the vibrating element 523 may vibrate about a balance position.

In some embodiments, the vibration device 500 may include an elongated member having a longitudinal axis. The elongated member may be configured to extend through an opening in the vibrating element 523 such that the vibrating element 523 may be configured to vibrate along a longitudinal axis of the elongated member. The elongated member may also be configured to reduce oscillation or vibration of the vibrating element 523 along any axis other than the longitudinal axis. As shown in fig. 6, the vibratory device 500 further comprises an elongated member in the form of a pin 521, which may be fixed to the

end caps

525a, 525 b. The pins 521 pass through

openings

522a, 522b defined in the

end caps

525a, 525b of the vibratory device 500, openings defined in the

magnets

520a, 520b, and openings defined in the magnet 523. The pin 521 provides an axis (e.g., along the longitudinal axis of the pin 521) for movement of the magnet 523. The vibration device 500 further comprises a drive circuit comprising a coil 524, the coil 524 being 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 in an opening defined in the magnet 523 and configured to engage between the pin 521 and the magnet 523, thereby allowing smooth movement of the magnet 523 over the pin 521.

In operation, the vibratory device 500 is driven using an electrical signal comprising a low frequency (e.g., less than 200Hz) sine wave or another signal waveform. The coil 524 is operable to generate a magnetic field having an induced current. The magnetic field in turn exerts a magnetic force on the magnet 523. When a magnetic force is applied to the magnet 523, the magnetic force moves the magnet 523 along an axis as indicated by an arrow "a" in fig. 6. The magnet 523 is configured to move in either direction indicated depending on the direction of the magnetic field vector.

The

magnets

520a and 520b forming the suspension element each create a constant magnetic field, each applied to the magnet 523 (i.e., the north side of magnet 520a would face the north side of magnet 523, while the south side of magnet 520b would face the south side of magnet 523). Thus, the

magnets

520a, 520b exert opposing forces on the magnet 523. The opposing forces created 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 will cause the magnet 523 to oscillate or move along an axis a, which may be the same as or may substantially correspond to the longitudinal axis of the pin 521.

In some embodiments, to ensure that the

magnets

520a, 520b, and 523 do not oscillate or move in directions other than along axis a, which can affect the efficiency of the system and increase undesirable friction (e.g., buzzing) that causes secondary vibration signals, the vibration device 500 can be configured such that the movement of the magnet 523 is limited by the pin 521. In some embodiments, each of the

magnets

520a, 520b may be secured to the

end caps

525a, 525b of the vibratory device 500 with glue, epoxy, or another form of adhesive. The magnet 523 may be interfitted around the pin 526 through the bushing 522c, allowing the magnet 523 to move smoothly over the pin 521 while restricting any movement that does not occur along axis a. Glue, epoxy, or any other form of adhesive may also be used to secure the pins 521 to the

end caps

525a, 525b through the openings or

holes

522a, 522 b.

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

In some embodiments, the outer surfaces of the conduit 526 and/or the

end caps

525a, 525b may be covered with a sound absorbing material. Additionally, in some embodiments, one or more of the

end caps

525a, 525b may be covered with a friction-reducing material (e.g., a lubricious material) or an impact or filling absorbing material (such as, for example, a cork), and thus, less abrasive when the end caps are in contact with a person's skin or body than when the

end caps

525a, 525b are not covered by such material. Additionally, in some embodiments, one or more of the

end caps

525a, 525b can be attached to a structure that increases the surface area of the end cap such that when the end cap is in contact with a person's skin or body, the contact is spread over a larger area, thereby reducing the pressure exerted by the end cap on the skin or body.

It should be understood that the

magnets

520a, 520b are one example of a resilient object that may be used to form a suspension element in the vibration device 500. In other embodiments, the

magnets

520a, 520b may be replaced by other elastic objects (e.g., springs, elastic polymers).

Fig. 7A illustrates an embodiment of a vibration device 600 comprising springs as suspension elements. The vibration apparatus 600 may be similar to the vibration apparatus 500 depicted in fig. 6 described above. For example, the vibration device 600 may include a housing 610, the housing 610 including a tube 626 (e.g., a nylon tube) and

end caps

625a, 625 b. The vibratory device 600 may further include a magnet 623 forming a vibratory element, and a drive circuit including a coil 624, the coil 624 driving movement of the magnet 623 to produce a vibratory signal for treating the vestibular conditions disclosed herein.

As shown in the cross-sectional schematic of fig. 7A, the vibration device 600 may comprise suspension elements implemented as

springs

620a, 620b instead of the

magnets

520a, 520b in the vibration device 500 shown in fig. 6. The magnet 623 may be collectively suspended within the housing 610 (e.g., within the chamber) by the

springs

620a, 620b such that the magnet 623 may vibrate about an equilibrium position when excited by an electrical signal.

As described above with reference to the vibration apparatus 500, in some embodiments, the vibration apparatus 600 may comprise an elongated member having a longitudinal axis. The elongated member may be configured to extend through an opening in the vibrating element magnet 623 such that the magnet 623 may be configured to vibrate along a longitudinal axis of the elongated member. The elongated member may also be configured to reduce oscillation or vibration of the magnet 623 along any axis other than the longitudinal axis.

The

springs

620a, 620b may be supported by an elongated member, a cavity in the

end caps

625a, 625b, and/or other suitable structure(s) extending from the end caps (not shown in fig. 7A), such as, for example, a rigid and/or flexible structure (e.g., pins, foam, rubber, or any other material). The

springs

620a, 620b can be configured to expand and compress along an axis (e.g., a longitudinal axis), and the magnet 623 mounted on the

springs

620a, 620b is configured to oscillate or vibrate along the same axis to generate a therapeutic vibration signal. The springs, which act as elastic objects forming suspension elements, may be secured to other parts of the vibration device 600 (e.g., to the magnets 623, the conduit 626, and/or the

end caps

625a, 625 b) using glue, epoxy, or any form of adhesive. The

springs

620a, 620b may be configured to reduce oscillation of the magnet along any axis other than the axis (e.g., longitudinal axis) of the springs.

The springs 620a, 620B may be any suitable material (e.g., stainless steel) and are selected to have a stiffness (for spring constant k) such that they allow movement of the magnet 623 along the axis indicated by labeled arrow "B" when driven by an electrical signal. The

springs

620a, 620b may be configured such that they are 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 housing 610 and a second end that is attached to magnet 623. As such, the spring may be configured to exert a force on the magnet to suspend the magnet at a location within the chamber. For example, springs 620a and 620b may each exert an equivalent force in opposite directions such that as magnet 623 moves, one spring (e.g., 620a) may contract when the other spring (e.g., 620b) expands, and vice versa, such that magnet 623 may oscillate or vibrate along an axis (e.g., the longitudinal axis of the spring), and the movement of magnet 623 may be configured about a suspended position (e.g., a balanced position). The vibration device 600 may include one or more glue pockets 632, 634 as coupling points between the

springs

620a, 620b and the magnet 623, respectively.

In some embodiments, the

springs

620a, 620b are operable to prevent contact between the magnet 623 and the inner surface of the conduit 626. As described above with reference to the vibration device 500, the conduit 626 of the vibration device 600 may contain and/or include a lubricant (e.g., ferrofluid) or low friction material (e.g., polytetrafluoroethylene) on the inner surface to reduce potential friction during movement of the magnet 623 due to any contact between the magnet 623 and the inner surface of the conduit 626. In some embodiments, a lever or pin (not shown in fig. 7A) and a bushing (not shown in fig. 7A) may be included to further limit movement of magnet 623 in directions other than along axis B.

Fig. 7B illustrates a cross-sectional view of the vibration device 600 of fig. 7A, the vibration device 600 being attached to a delivery interface 630 for delivering therapeutic vibration signals. As previously described, magnet 623 acts as a vibrating element suspended by

springs

620a, 620 b. The transport interface 630 may be a memory foam pad configured to transmit the vibration signal from the vibration device 600 to the body of the subject. Although magnets and springs have been provided as examples of suspension elements, it will be understood by those of ordinary skill in the art that other types of elastic objects may be used instead of and/or in addition to magnets and/or springs.

The vibration devices disclosed herein (e.g.,

vibration devices

400, 500, 600, 700) may have a high Q factor (e.g., be capable of or oscillating with greater amplitude over a smaller frequency range). In some embodiments, the vibratory device may operate at the lowest fundamental frequency, such as a frequency between 50-70Hz, with a small amount of power directed to the higher and audible resonant frequency.

Fig. 8 illustrates a cross-sectional view of a vibration apparatus 700 according to an embodiment. The vibration apparatus 700 may be similar to the

vibration apparatuses

500, 600. For example, the vibrating device 700 may include a housing 710, a vibrating element implemented as a magnet 723, a suspension element implemented as a spring 720, and a drive circuit including a coil 724 to drive movement of the magnet 723 to generate a vibration signal for treating the vestibular conditions disclosed herein. The magnet 723 may be suspended within the housing 710 (e.g., within the chamber) by a spring 720 such that the magnet 723 may vibrate about an equilibrium position when excited by an electrical signal delivered by the drive circuit.

In some embodiments, to reduce the spring constant of the spring 720, thereby affecting the resonant frequency of the vibration device 700, the length of the spring 720 may be increased, which may allow lower frequencies to be generated. To change the length of the spring without changing the size of the vibration device 700, the spring 720 may be configured to pass through an opening 723a defined by the magnet 723. As shown in fig. 8, the spring 720 may be attached to the mounting plate 728 and adhered to the distal side of the magnet 723, rather than to the proximal side of the magnet 723. In this way, the length of the vibration device 700 may remain the same, while the length of the spring 720 may be increased by a length equal or substantially equal to the thickness of the magnet 723. In some embodiments, instead of having a mounting plate 728, the magnet 723 may have an opening extending through a portion of its length (e.g., about 95% of its length), and the spring 720 may extend through the opening and attach to the distal end of the magnet 723, similar to the manner in which the spring 720 would attach to the mounting plate 728.

Similar to the vibration device 600 depicted in fig. 7B, the vibration device 700 shown in fig. 8 may also be attached to a delivery interface (e.g., delivery interface 730) to deliver vibration signals to the vestibular system of a subject. The delivery interface 730 may include a filler material (such as a memory foam pad) to conform to the surface of the target area and to act as an interface between the vibration device 700 and the target area to efficiently deliver the vibration signal.

As shown in fig. 8, some embodiments of the vibration device may include an integrated circuit 706, the integrated circuit 706 including circuitry for generating a signal for activating the vibration device 700. The integrated circuit 706 may include one or more leads or connection points 708 (e.g., wires) to connect to other components (e.g., a control unit 360 such as a microcontroller). Integrated circuit 706 may also include and/or be coupled to sensor 790.

The vibration device 700 may have a high Q factor. In operation, the frequency of the signal used to activate the vibratory device 700 can be selected such that the vibratory device 700 operates at a resonant frequency to increase the amplitude of oscillation for a given power input. In an embodiment, the sensor 790 may include a hall effect sensor configured to monitor magnetic field fluctuations. When the frequency of the 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 vary the force level and/or frequency matches the resonant frequency of the vibration device 700, the magnet 723 may move more (e.g., oscillate or vibrate with greater amplitude) than at other frequencies. Thus, when the frequency of the electrical signal matches the resonant frequency of the vibration device 700, the magnetic field fluctuation caused by the vibration of the magnet 723 may increase. This relative fluctuation can be monitored using a hall effect sensor.

In more detail, a microcontroller or microprocessor (e.g., control unit 360) may be operable to receive signals from the hall effect sensors and adjust the frequency of the electrical signal used to power the vibratory device 700 based on the sensor readings. For example, the microcontroller may be operable to scan a set frequency range (e.g., 50-65Hz) and select the frequency of the electrical signal that generates the highest level of magnetic field fluctuations. This process may be referred to as "tuning". Thereafter, the combination of the sensor 790 and the microcontroller may continue to tune the frequency of the electrical signal provided to the vibratory device 700 to maintain this efficiency each time the device is turned on. Further, after the frequency of the electrical signal has been selected, the frequency may be modified around the selected frequency to determine whether the frequency of the electrical signal associated with peak efficiency changes over time due to temperature, wear, or other variables that may change the characteristics of the components of the vibratory device 700 (e.g., the spring 720) over time.

In some embodiments, sensor 790 may include a current meter, a voltage meter, an accelerometer, or some other type of sensor similar to sensor 390 to measure information (e.g., current, voltage, acceleration, etc.) that enables selection of a resonant frequency that provides the highest efficiency.

The integrated circuit 706 may serve as an end cap, further reducing the size of the vibration device 700. The delivery interface 730 may be, for example, a foam pad operable to serve as a structure that conforms to the surface of the user's skin and is capable of transmitting the vibration signal from the vibration device 700 to the body so that it may be conducted to the vestibular system via bone. The transport interface 730 may be configured such that a good coupling allows for an efficient transfer of the vibration signal to the head.

In some embodiments, to avoid audible tones (i.e., noise, hum), the vibration device 700 may be configured to reduce friction and/or contact between internal structures. For example, the magnet 723, the coil 724, the housing 710, etc. may be positioned with sufficient tolerances relative to one another to allow for natural rocking and rocking of the components while reducing contact between the various components.

Similar to the magnet 623 of the vibration device 600, the magnet 723 may also oscillate in a direction not along the axis C, which may cause the magnet 723 to contact the inner surface of the vibration device 700. Such contact may emit an audible sound and/or reduce the efficiency of the vibration device 700. In some such embodiments, noise can be minimized by selecting the spring 720 and the magnet 723 such that the characteristics of the spring 720 and the magnet 723 are such that the axial resonant frequency is different from the wobble resonant frequency or any harmonic thereof. Then, while operating the vibration device 700 at a frequency corresponding to the axial resonance frequency, rather than the rocking resonance frequency, rocking and accidental contact between the magnet 723 and other components of the vibration device 700 may be reduced.

In order 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 may be increased. Alternatively or additionally, the frequency of the electrical signal may be adjusted to a resonant frequency in order to adjust the output force level of the vibration signal.

Fig. 9A illustrates a perspective view of a spring 820, which spring 820 may be used as a suspension element in a vibrating device (e.g., spring 720 in device 700 described above). The orientation of the spring can reduce the amount of wobble, rocking, or unwanted movement of the magnet (e.g., magnet 723) in the secondary direction. As shown in fig. 9B and 9C, which present views of both ends of the spring 820, the spring 820 may be oriented such that a first end 820a of the spring 820 begins at the 0 ° position and a second end 820B of the spring 820 ends at the 180 ° position. In other embodiments, the springs 820 may be at and end at other degree intervals (e.g., 90 °, 270 °, etc.) depending on the effect of gravity on the vibrating device (e.g., the orientation of the springs 820 with respect to the direction of gravity). In some embodiments, the orientation of the spring 820 may be selected based on the placement of a sensor, such as, for example, an accelerometer or a hall effect sensor.

Fig. 10-15 are illustrations of different embodiments of vibratory devices that can be included and/or integrated into various support elements. Although one or two vibrating devices may be depicted in these figures, one of ordinary skill in the art will recognize that any number of vibrating devices may be included in various embodiments. In the case of multiple vibratory devices, the force level of the vibratory signals from each device may be reduced because the combined effect of the vibratory signals may be at a therapeutically effective level for treating vestibular conditions.

Fig. 10 illustrates a vibration device 900 having a body 910 integrated into a headband 918 worn on the head HD of a subject. The vibration device 900 includes a control unit 906 similar to the control unit 360 described above. The headband 918 may be made of an 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 to effectively deliver vibration signals that may be conducted to the vestibular system via the bone. The vibration device 900 may include an on-board power source (e.g., a battery) to power the control unit 906 and/or other components of the vibration device 900, or may be attached via a cord to a power source (e.g., a battery pack) that is separate from the headband 918. The control unit 906 may include the necessary electrical drive circuitry to generate vibration signals to treat the vestibular or other conditions disclosed herein. Alternatively, such circuitry and power source may be operatively connected to the vibration device 900. In some embodiments, the headband 918 may incorporate additional devices (such as headlights or other suitable head gears) to accommodate various needs of the subject.

Fig. 11 illustrates the use of a vibrating

device

1000a, 1000b according to an embodiment, the vibrating

device

1000a, 1000b being integrated into a support element in the form of a headset 1002. The headset 1002 may include

audio speakers

1003a, 1003b and an elongated portion 1018 (e.g., a band) to which the

audio speakers

1003a, 1003b are connected. In some embodiments, the headset 1002 may be a passive noise reduction device, such as an ear cup, and not include components such as an audio speaker. The

vibratory apparatus

1000a, 1000b can be similar to any other vibratory apparatus described herein (e.g.,

vibratory apparatus

300, 400, 500, 600, 700, 800). The headphones 1002 may include noise cancellation circuitry that may be used to reduce the level of audible sound caused by vibrations produced by the vibrating

devices

1000a, 1000b, but not cancel other vibrations that are conducted to the vestibular system (e.g., via bone conduction due to the vibration signals produced by the vibrating

devices

1000a, 1000 b). For example, the system 1002 may include noise cancellation circuitry that generates one or more signals that are out of phase (e.g., 180 degrees out of phase) with the audible signals produced by the

vibratory devices

1000a, 1000 b. Such out-of-phase signals are used to reduce the signal level of such audible signals detected by the vestibular system of the subject so that the subject may not hear audible sound.

When used in conjunction with a headset 1002, the

vibration devices

1000a, 1000b may be placed 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 cover the location of the mastoid bones. Alternatively or additionally, in some embodiments, one or more of the vibrating

devices

1000a, 1000b may be incorporated into an ear cup of the headset 1002, which may be co-located with the

speakers

1003a, 1003b, so that the ornamental shape or contour of the headset 1002 is not affected.

Alternatively or additionally, in some embodiments, one or more of the vibrating

devices

1000a, 1000b (or additional vibrating devices not shown) may be placed along the headband 1018, or extend from a portion of the headset 1002. Alternatively or additionally, in some other embodiments, one or more of the vibrating

devices

1000a, 1000b (or additional vibrating devices not shown) may be incorporated into an accessory that is attached to and detached from the headset 1002 so that a user may select to have the headset without the vibrating

devices

1000a, 1000b or to have the vibrating

devices

1000a, 1000 b.

Fig. 12 illustrates yet another embodiment of a

vibration device

1100a, 1100b that can be integrated into or attached to a pillow 1110 (e.g., a travel pillow, cushion, etc.). The position of the vibrating

devices

1100a, 1100b on the pillow 1110 can be configured such that when a subject rests his or her head on the pillow 1110, the vibrating

devices

1100a, 1100b cover, for example, the mastoid bones of the subject. In other embodiments, the

vibration devices

1100a, 1100b may be positioned such that they will cover other areas of the subject's head.

Fig. 13 illustrates yet another embodiment of a vibration device 1200, which may be integrated into or connected to a seat 1210 (e.g., a car seat, office chair, etc.). The seat 1210 and the vibration device 1200 may be configured such that, for example, when the subject's head rests on the seat headrest 1212, the vibration device 1200 covers a portion of the subject's head and is capable of transmitting a vibration signal to the head. In some embodiments, the vibration device may be removably attached to the seat 1210 using the support element 1218 such that it may be removed when the vibration device is not in use.

Fig. 14 illustrates another embodiment of a vibrating

device

1300a, 1300b that may be integrated into or connected to a pair of eyeglasses 1310. Although eyeglasses are depicted in fig. 14, one of ordinary skill in the art will recognize that other types of eyeglasses (e.g., goggles, sunglasses, safety glasses) may also be suitable with one or more vibrating devices. The vibrating

devices

1300a, 1300b can be positioned on eyeglasses 1310 on

ear portions

1311a, 1311b, and the

ear portions

1311a, 1311b can be in proximal contact with the subject's head during use of the eyeglasses 1310. The vibrating

devices

1300a, 1300b may be positioned such that, when the subject wears the eyeglasses 1310, the vibrating

devices

1300a, 1300b cover a portion of the head such that a vibrating signal may be transmitted to the head and onto the vestibular system.

Fig. 15 illustrates another embodiment of a vibrating device 1420 mounted or integrated into a virtual reality device 1410 (e.g., a device that may be used to experience a virtual reality or augmented reality environment). The vibrating device 1400 may be positioned on the virtual reality device 1410 on a band 1441 of the virtual reality device 1410, which band may be used to secure or support the virtual reality device 1410 on the subject's head during use of the virtual reality device 1410, and may be in proximal contact with the head. One or more vibrating devices may be mounted anywhere along the band 1441 of the virtual reality device 1410. The vibration device 1400 may 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 vibration signals may be transmitted (e.g., via a delivery interface) onto the head and vestibular system.

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

Fig. 18 is a graph 1700 depicting the rise and fall of an electrical signal used to power a vibratory device to produce a vibration signal. Graph 1700 shows how the amplitude of the electrical signal changes over time. As shown in fig. 18, the amplitude may be ramped up during a start phase 1702 in which the amplitude is increased at a predefined rate. After reaching the predefined level, the amplitude remains constant during the steady state phase 1706, which may last for any suitable amount of time to treat the vestibular condition (as indicated by the dashed line). The amplitude may then be ramped down at a predefined rate until the signal is turned off. The start phase 1702 and the offset phase 1704 of the waveform may have different ramp profiles, as shown in fig. 18. For example, the increase in the amplitude of the applied voltage in the start phase 1702 may be a ramped increase in the amplitude per unit time at a certain rate of increase. And offset phase 1704 may be a downward ramp or ramp decrease in amplitude, where a certain rate of decrease in amplitude per unit time is different from the rate of increase. In some embodiments, the rate of increase of the amplitude in the start phase 1702 may be higher than the rate of decrease of the amplitude in the offset phase 1704, as indicated by the different slopes. In some cases, the ramp up of the start phase 1702 and/or the ramp down of the offset phase 1704 may also be accomplished at varying rates (e.g., increasing and/or decreasing rates over time).

In some cases, the rate of increase and/or rate of decrease may be specified based on the vestibular condition being treated, the subject's personal preferences, environmental factors, and the like. In some embodiments, the rate of increase and/or decrease of the amplitude may be adjustable by a user. In some embodiments, the rate of increase and/or decrease of the amplitude may be adjusted automatically (e.g., by the control unit 360) based on the sensor readings. For example, a sensor integrated into the vibrating device may be configured to measure a physical or physiological condition and/or reaction (e.g., changes in sweat, temperature, heart rate, etc.) when the vibrating device is powered on and/or off. By monitoring the physical condition and/or the reaction, the ramp-up and/or ramp-down rates may be adjusted to accommodate different reactions (e.g., by more sensitive or first-time use users of the device versus more frequently used users). Also, for subjects with chronic conditions (e.g., vertigo), a ramp-up and/or ramp-down may be selected to reduce the tremor effects of the transitions between device activation and/or deactivation, such as, for example, a sudden return of the vestibular condition and a greater onset of symptoms associated with the vestibular condition.

Fig. 19 illustrates a method 1800 for treating a symptom associated with a vestibular condition disclosed herein using a vibratory device (e.g.,

vibratory devices

300, 400, 500, 600, 700). At 1802, a vibration device is positioned on a head of a subject or user. Positioned over a suitable area (e.g., over suitable skeletal structures) such that the vibratory signal can be effectively transmitted to the vestibular system of the subject.

At 1804, an electrical signal is supplied to the vibrating device to excite the device and cause movement of the vibrating element in the vibrating device. At 1805, a vibration signal is applied to the subject's head to treat the vestibular condition. At 1806, information associated with the excited vibratory device is monitored, including, for example, current, voltage, magnetic field fluctuations, and the like. At 1808, the physiological condition and/or comfort of the subject is monitored. For example, a subject may be monitored for physiological signs such as heart rate, sweat, temperature, respiration, oxygen saturation, and the like. In some cases, any feedback from the subject, such as feedback reporting the level of comfort or discomfort felt by the user, may be monitored using appropriate sensors and actuators integrated with the vibration device. Such monitoring at 1806 and 1808 may be accomplished using one or more sensors (e.g., sensor 390, sensor 416) and/or a control unit (e.g., control unit 360).

At 1810, the vibration device and/or a control unit coupled to the vibration device determines whether the electrical signal should be adjusted or changed. If no adjustment of the electrical signal is needed (1810: no), the vibrating device may continue to treat the vestibular condition at 1805, continue to monitor information associated with the vibrating device at 1806, and continue to monitor information associated with the subject at 1808, as described above.

When it is indeed desired to adjust the electrical signal (1810: yes), at 1812 the frequency or force level of the electrical signal is changed and a new electrical signal is applied to the vibrating device at 1804, following the flow chart described above. Information gathered from monitoring the vibrating device and from monitoring the subject can be used to determine whether the force level and/or frequency needs to be changed and the amount and form of the change. For example, if the measured voltage, current, and/or magnetic field fluctuations indicate that the current frequency is not the resonant frequency, then the frequency may be adjusted to increase the efficiency of the vibrating device. As another example, if a signal is received from the user indicating that vestibular status is no longer present (e.g., motion sickness is no longer present), the vibration device may adjust the frequency to turn the device off (e.g., via a ramp down). As another example, the force level may be decreased in response to an indication of discomfort of the subject.

Experimental studies were conducted to test experimental vibratory devices for treating symptoms associated with vestibular conditions, similar to the example vibratory devices disclosed herein. The experimental vibration device includes a vibration element implemented as a magnet suspended between two other magnets, similar to the vibration device 500 depicted in fig. 6. The vibrating device includes an external coil with an impedance of four ohms, which is excited by a microcontroller, custom designed Arduino board. The microcontroller may energize an external coil to generate a magnetic field that is used to vibrate the levitated magnet. A three magnet/voice coil assembly is placed within the body or housing and is connected to and powered by a rechargeable battery. A vibration device may be coupled to the head of the person and capable of generating vibrations that may be conducted to the vestibular system via the bones.

In the study, the subject worn the experimental vibration device, placed behind the ear, against the area covered by the mastoid bone, so that the vibration signal generated by the device can be conducted via the bone to the vestibular system of the subject. Subjects are subjected to various conditions to induce motion sickness, nausea, and/or other vestibular conditions, and the effectiveness of the vibrating device is assessed based on information reported by the subjects.

For the purpose of the experiment, with coupling B&Calibrated Br ü el for K Sound level Meter (No.2234)&

(B&K) The artificial mastoid (No.4930) measures the force level of the vibration generated by the vibration device. Inserting the vibrating device into B&K, designed for the fixation of bone conduction hearing aids. Applying a force of 3.5 to 8 newton on top of the vibrating device, which is in close proximity to B&K artificial mastoid. With B&The K-level meter quantifies the bone conduction level and expresses it as dB re1 dynes (i.e., force levels).

More information about each study is provided below.

Experimental study I

Fig. 20A depicts a flowchart 1900 of a process for a first experimental study. The study participants in this first experimental study did not have any history of vestibular discomfort, including dizziness. During the study, the participants were seated in office chairs and asked to wear an Oculus Rift DK2 virtual reality system and a vibrating device according to the example design described above. The vibrating device is held in place with a headband.

The study was conducted according to the test procedure outlined in fig. 20A. Each participant underwent multiple test sessions, first turning off the vibrating device and then turning on the vibrating device. During the test of turning on the vibrating device, the frequency and/or force level of the vibrating device is varied to test whether a particular frequency and/or force level will more effectively treat the vestibular condition associated with the use of the virtual reality device. The magnitude of the frequency and/or strength level between participants was random during the test. Participants may also have the opportunity to pause the study at any time to recover from dizziness or other vestibular conditions caused by the use of virtual reality devices.

At 1902, the visual stimulus 1950 depicted in fig. 20B is presented to the participant via a display of the virtual reality device. Visual stimulus 1950 includes a dished region 1956 having a plurality of spheres 1954. The participants are instructed to focus their attention on a central ball 1952 that is a different color tone than the remaining balls 1954 in the disc-shaped area 1956. The dished region 1956 is designed to represent a three-dimensional space that can be viewed using a virtual reality device (such as Oculus Rift).

At 1904, the participant initiates rotation of a sphere 1954 in the disk-shaped area 1956 about a center point (i.e., a center sphere 1952) by pressing the space key on the keyboard. After pressing the space key, the sphere 1954 will begin spinning and gradually accelerate at 1906 at a rate of 4 degrees/second. At 1908 and 1909, the participant is instructed to press the space key again when feeling uncomfortable or dizziness, at which time the angular velocity of the spinning sphere 1954 will be recorded and stored as the "maximum angular velocity" of the participant. If the particular participant does not press the space key to indicate discomfort or dizziness, the angular velocity of sphere 1954 will increase until a predetermined angular velocity of 90 degrees/second is reached.

At 1910, the angular velocity of the image will be reduced to 90% of the velocity before the user indicated (i.e., 90% of the velocity recorded as "maximum angular velocity") or 90% of 90 degrees/second (i.e., 81 degrees/second) when the participant did not press the space key. Sphere 1954 rotates at a reduced speed until the participant again presses the space key at 1911 to indicate a return of discomfort or dizziness or until a predetermined amount of time (e.g., 120 seconds) has elapsed at 1912. The time that the participant views the dished region 1956 at reduced speed is recorded as the "duration of the viewing time" according to either the participant's indication (at 1911) or the passage of a predefined amount of time (at 1912).

For a given participant, the participant is first asked to perform a test procedure with the vibratory device turned off. The participant will undergo two testing procedures, the first time sphere 1954 rotates in a clockwise direction and the second time sphere 1954 rotates in a counter-clockwise direction. The same steps are then repeated with the vibration device turned on. The study participants were asked to wear the vibrating device behind the ear and flush the flat portion of the mastoid bone with the ear canal. The participants had time to rest between the clockwise and counterclockwise tests (e.g., 10-60 seconds) as needed to recover from any discomfort or dizziness.

Participants were asked to test either a set of different force levels or a set of different frequencies while using the vibrating device. The frequency of the vibration signal was kept constant (i.e., at 50Hz) for participants testing different force levels, while the force levels were set at 87, 92, 94, 96, 98, 99, 100, and 101dB 1 dynes, respectively. For participants testing different frequencies, the power level of the vibration signal was set to a constant level (i.e., 96.5dB re1 dyne), with the frequency varying between 30 and 75 Hz.

Eighteen participants participated in the study. About one third of these volunteer study participants did not experience any motion sickness from the experiment. These participants view the presented visual stimulus (fig. 20B) until the spinning sphere 1954 reaches 90 degrees/second, and then continue to view the visual stimulus at a reduced speed for 120 seconds. These anti-motion sickness participants were instructed to repeat their exposure to visual stimuli with the vibrating device turned on to test whether the vibrations from the device would cause motion sickness. None of these participants reported that they experienced any adverse side effects during and after use of the vibrating device, which generated vibrations set to 97dB re1 dynes or below.

Experimental data for the remaining 11 participants (i.e., experimental data indicating that they experienced motion sickness or dizziness at some point in the experimental study) are depicted in fig. 21A, 21B, 22A, and 22B. For the data points in the graphs depicted in fig. 21A, 21B, 22A, and 22B, the clockwise and counterclockwise "maximum angular velocities" and "duration of time viewed" of each participant were averaged under each test condition, while the "with vibrating device" data was baseline normalized based on the "without vibrating device" data (i.e., the data collected for a participant when using a vibrating device set to a particular frequency and/or force level was normalized based on the data for that participant when not using a vibrating device). After these ratios are calculated for each participant, the ratios for the eleven participants are averaged to arrive at the data points depicted in the graphs shown in fig. 21A, 21B, 22A, and 22B.

Fig. 21A depicts a graph 2000 of the average "duration of viewing time" ratio of eleven participants over a range of different force levels. A value greater than one indicates an increase in the amount of viewing time before experiencing discomfort when using the vibrating device relative to when not using the vibrating device. Fig. 21B shows a graph 2002 of the average "maximum angular velocity" ratio of eleven participants over a range of different force levels. A value greater than one in fig. 21B indicates an increase in angular velocity that does not cause discomfort when using the vibration apparatus relative to when not using the vibration apparatus. Experimental data showed that the effect of vibrating the device was greatest for eleven participants when their force level of vibration was set to 96dBre 1 dynes. Based on the interpolated fit of the data, the ratio of "duration of time viewed" to "maximum angular velocity" peaks at 96.5dB re1 dynes. At force levels of 93dB to 98dB, the ratio of "duration of time viewed" to "maximum angular velocity" is statistically significantly different or greater than one, indicating that vibrating devices set at these force levels will effectively treat vestibular conditions.

At 87dB re1 dynes, the ratio is statistically indistinguishable, indicating that the device is not effective in treating vestibular conditions. At levels around or above 100dB re1 dynes, many participants report that turning on the vibrating device feels worse. Although participants had slightly different discomfort thresholds at these higher force levels, some reported discomfort levels as low as 99dB, once the threshold for a particular participant was reached, the participant reported vibration almost immediately causing them to feel uncomfortable. Participants tested at 102dB reported discomfort regardless of whether they were using a virtual reality system, since only vibrations from the vibrating device would cause them to feel uncomfortable.

Fig. 22A and 22B depict normalized and averaged "duration of viewing time" versus "maximum angular velocity" for eleven participants in a frequency range. As shown, these results indicate that the effectiveness of the experimental vibratory device in mitigating or delaying the onset of virtual reality disease does not appear to depend on the frequency of the vibratory signal. Nonetheless,

graphs

2100 and 2102 show larger ratio values from 45 to 65 Hz.

Certain factors may limit the results of this first experimental study. For example, the angular velocity of sphere 1954 in dished region 1956 is limited by the visual display system. Specifically, the refresh rate of the Oculus DK2 screen is 90 Hz. The panel of the device was an organic led (oled) with a persistence of 2 milliseconds. These factors prevent the rotation of the sphere 1954 in the dished region 1956 from exceeding about 90 degrees/second. When the rotational speed increases beyond 90 degrees/second, the virtual reality display will begin to blink. Many test participants reached this upper limit while wearing vibrating equipment, which caused a ceiling effect in the measurement.

Similarly, when looking at the rotating sphere 1954 at a reduced speed, several subjects complain of eye fatigue, no complaints of discomfort or nausea. Thus, how long a participant can view the rotating disk is also limited, another factor that results in measuring the ceiling effect of the experimental vibrator's effectiveness in delaying the onset of the virtual reality illness.

In view of these factors, this first experimental study indicated at a statistically significant level that the vibrating device was effective for treating virtual reality disorders. As can be seen from the data shown in the graphs in fig. 20A and 20B, changes in force levels will have a statistically significant effect on the effectiveness of the vibrating device. In particular, force levels below 93dB re1 dynes have been shown to be ineffective in treating vestibular conditions, while force levels above 100dB cause discomfort and dizziness that worsen vestibular conditions; thus, the data indicate that force levels between 93dB and 98dB re1 dynes are more effective in treating vestibular conditions. On the other hand, the data shown in the graphs in fig. 21A and 21B indicate that varying vibration frequencies have less impact on the effectiveness of the vibratory device in treating vestibular conditions because there is no significant trend or peak in the effectiveness of the vibratory device between 45Hz and 65 Hz.

Experimental study II

In a second experimental study, using the results obtained from the first experimental study disclosed above, the experimental vibration device was measured in mitigating or preventing the virtual reality game "EVE: effectiveness in motion sickness experienced by users of valkyrine ″.

"EVE: valkyrine "is a first-person spacecraft shooting game in which players move around spacecraft and space rock using an Xbox 360 handheld controller. The game is known to cause motion sickness for many players. The game involves flying through "doors" in the area of asteroids and airships. In addition to movement in three spatial dimensions, most "doors" also require the player to rotate about a three-dimensional axis of rotation (e.g., the "roll," "pitch," or "yaw" axis).

In this study, subjects played the virtual reality game "EVE: valkyriee "is up to fifteen minutes long. For this study, participants were instructed to play the game in two sessions on two consecutive days, with and without the experimental vibration device described above. On the first day of the experiment, the participants were asked to play the training session portion of the virtual reality game for up to fifteen minutes without using the experimental vibration device. If the participant began to feel nausea before the end of fifteen minutes, it is instructed to stop. Experienced players may choose to perform tasks directly, bypass training tasks and go directly into virtual reality space combat. On the following day, the same experimental procedure was followed, but the participants were wearing experimental vibration devices with a frequency set at 60Hz and a force level set at 96.5dB, which was considered valid according to the results of the first experimental study. The device is applied to the skull with a force of about 3.5 to 8 newtons, behind the right ear and flush with the ear canal, and on the flat portion of the mastoid. Any participant who felt dizziness or discomfort could choose to stop at any time during the study.

Participants were asked to fill out a motion sickness assessment questionnaire ("MSAQ") approximately ten minutes after stopping game play. MSAQ involves sixteen statements or manifestations that help identify and classify motion sickness by classifying its independent descriptors into four categories: (1) upper gastrointestinal, (2) central, (3) peripheral and (4) falling asleep. For sixteen possible manifestations of motion sickness, the MSAQ score varies from 1 (none at all) to 9 (severe).

Table 1 shows 16 MSAQ statements used to assess the motion sickness experienced by participants.

Table 1: the motion sickness assessment questionnaire was conducted ten minutes after the end of the OculusRift game experience described in experimental study II.

Eleven of these seventeen participants were able to play the full fifteen minutes when the participants were asked to participate in a game on the first day for fifteen minutes without wearing the experimental vibrating device. The remaining six are played for a period of 4: 05-14: 50 minutes. The average play time was 13:25 minutes. In contrast, seventeen participants were all able to participate in the game in fifteen minutes when the participants were wearing experimental vibration equipment while playing the game. Data from MSAQ was collected and presented in table 1. The fraction in MSAQ ranges from 1 (none at all) to 9 (severe).

The results of MSAQ are presented graphically in fig. 23A and 23B. Each graph depicts the ratio of MSAQ score obtained when the device is not worn to MSAQ score obtained when the device is worn. Fig. 23A depicts a graph 2200 showing the average score of MSAQ from all four categories of motion sickness, and fig. 23B depicts four sub-graphs 2202, 2204, 2206, 2208 showing the scores of the four categories of motion sickness defined by MSAQ-specifically (1) gastrointestinal tract, (2) central, (3) peripheral, and (4) falling asleep, respectively. The line 2250 on each graph represents the same MSAQ score when using and not using the vibrating device, and is therefore a line that represents the vibrating device has no effect on motion sickness.

As depicted in fig. 23A and 23B, the data indicates that the vibration device is effective for treating motion sickness because all data points lie below the 2250 line. Data points indicate a significant decrease in MSAQ score from 9 (severe) to 1 (none at all). Even when classified into various motion sickness categories, the vibration device is very effective in treating various categories of motion sickness, as shown by

curves

2202, 2204, 2206, 2208 in fig. 23B.

Experimental study III

In a third experimental study, the participants were asked to be rear seat passengers of a four-door sedan and to travel over a stretch of road based on a fixed 20 minute trip. Three road tests were performed on this set route on the same day. During each trip, the participant is asked to read an article on their smartphone or other small handheld device. The start time was recorded and each participant reported the time at which they first felt symptoms of motion sickness.

For each participant, a baseline measure of motion sickness was established by having the participant drive and read the article on their smart phone without wearing any type of auxiliary equipment. After the initial trip, each participant was asked to wear (1) a test vibration device as described herein placed to cover the participant's right mastoid bone, or (2) a sounder that faces outward and was isolated from the participant's head by a rubber pad and issued a low frequency sound that provided an equivalent hearing level to the test vibration device. For each participant, the order in which each device is worn is randomized.

The travel route is a fixed, circuitous route with only one stop sign and no traffic lights at intermediate points (i.e., approximately ten minutes). The fixed route takes approximately 20 minutes and the drive-to-drive difference is less than 10%. The subject was tested only on the first half of the ride until the stop sign. The subjects were provided with a rest time between the two sessions.

Based on the participant's feedback, studies have shown that participants do not continue to experience motion sickness, but generally experience motion sickness as the vehicle accelerates, decelerates, or turns. Participants reported motion sickness as a cumulative effect, with a first turn causing mild discomfort, a second turn increasing the effect of the first turn, and so on until a threshold was reached. In using the experimental vibrating device, participants reported that they felt discomfort during acceleration and cornering, but that this discomfort quickly returned to zero once the car returned to constant speed and did not produce the cumulative effect of nausea as the acceleration of the car was continuously changed.

Figure 24 depicts the number of start time seconds of motion sickness episodes experienced by participants during the third experimental study. Bar 2302 represents the number of seconds up to the initial onset of motion sickness without a device, bar 2304 represents the number of seconds up to the initial onset of motion sickness with a sound generator, and bar 2306 represents the number of seconds up to the initial onset of motion sickness with an experimental vibration device. As shown, at bar 2306, use of the experimental vibration apparatus described herein resulted in a significant increase in the number of seconds to the onset of motion sickness. Specifically, the experimental vibrating device was found to be effective because it increased the time before the onset of motion sickness more than one fold compared to not wearing the device (bar 2302) and wearing the sounder (bar 2304). The data from this study show the effectiveness of the experimental vibration device in simulating the real world in preventing motion sickness when read while riding in the rear seat of a car in the occupant's position. After alighting, none of the subjects using the experimental vibrating apparatus reported any discomfort.

Abstract and other indications of experimental studies

The results of the above experimental studies indicate that vibrating devices, such as the example vibrating devices disclosed herein, can effectively treat the symptoms of various vestibular conditions. Such a device may have a low profile and be capable of coupling to a surface of a subject's head such that vibrations may be conducted to the subject's vestibular system via bones (e.g., the skull). The experimental vibration devices used in the three experimental studies have been shown to be effective in mitigating and reducing motion and/or virtual reality induced motion sickness. The described experiments and results demonstrate that the effectiveness of the disclosed vibrating device in reducing motion sickness is substantially instantaneous with no significant deleterious side effects.

Subsequent experiments indicate that the force levels and frequency levels found herein to be effective also in reducing dizziness and nausea caused by heat testing conducted in a medical facility. For example, for vertigo, individuals with chronic or frequent vertigo attacks are required to wear experimental vibrating devices and report the effect of wearing the device. Generally, individuals report fewer vertigo-related symptoms when using the device. As another example, for thermal testing, an ear, nose, and throat ("ENT") physician performed thermal tests on five subjects with and without wearing experimental vibration equipment. When the device was not worn on the first day, all subjects felt nausea, and one of the subjects failed to complete the test due to severe nausea. All five subjects reported significantly less nausea, including no nausea, when wearing the device the next day, and subjects who failed to complete the test on the first day were able to complete the test on the next day. In both of these two days of testing, the vestibular function level was the same with or without the vibrating device.

Fig. 25A-25C show schematic views of the housing 2410 of the vibration device 2400. The vibration device 2400 can be similar in structure and/or function to any of the vibration devices described herein. For example, the vibration device 2400 can be similar to the

vibration devices

500, 600, and/or 700 described above. As shown in fig. 25A-25C, the vibration device 2400 can include a delivery interface 2430, and an inner housing 2426 within an outer housing 2410. In some embodiments, as shown in the exploded view of fig. 25C, the outer housing 2410 may be formed by coupling two

portions

2410a and 2410 b. Fig. 26 illustrates a cross-sectional view of the housing 2410 showing the coupling between the two

portions

2410a and 2410b, which can be via mechanical attachment, adhesives, or the like. The internal housing 2426 may contain a vibrating element (e.g., a magnet), a coil, and/or other structures associated with the vibrating devices described herein.

27A, 27B, and 27C illustrate perspective, side, and exploded views, respectively, of a vibration device 2500 according to an embodiment. Fig. 28A and 28B show a perspective view and a cross-sectional side view, respectively, of a vibratory device 2500. The vibration device 2500 can 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 vibratory 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, the

electromagnetic coils

2524a and 2524b configured to generate a magnetic field to move the magnet 2523. In some embodiments,

coils

2524a and 2524b may be wound, for example, in opposite directions to generate magnetic fields of opposite polarity. Although shown as having two

coils

2524a and 2524b, in some embodiments, the vibration device 2500 may include a single coil configured to generate a magnetic field of changing polarity to induce movement of the magnet. A single coil may be driven, for example, by two separate drive circuits that generate drive signals of different polarities. In some other embodiments, a single drive circuit may be used to generate signals of different polarities, for example by using phase switching circuits. The vibration device 2500 may include a spring 2520, the spring 2520 being coupled to a magnet 2523 and configured to act as a suspension element. The vibratory 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 attach to the distal end of the magnet 2523 via the mounting plate 2528b, similar to how the spring 720 is described as being attached to the mounting plate 728 in the vibratory device 700.

The magnets 2523 of the vibration device 2500 may include

metal end plates

2529a and 2529 b. In an embodiment, the end plate 2529b may serve as the mounting plate 2328b for the spring 2520. The end plates may be configured to reduce stray magnetic flux. For example, a vibrating device having a magnet as the vibrating element may have magnetic field lines that stray away from the magnet and cause the vibrating device to be magnetically attracted to a metal object. This attraction can produce undesirable side effects and can make it cumbersome during use. The

end plates

2529a and 2529b may reduce this stray magnetic flux so that the vibration device 2500 may be used close to other metal objects without being attracted too much by those objects. Furthermore,

end plates

2529a and 2529b may be used to direct magnetic field lines from one end of the magnet in a direction perpendicular to (e.g. towards) the

coils

2524a and 2524b generating the magnetic field, such that more magnetic field lines are oriented to enable the magnet to move relative to the vibration device 2500, while reducing stray dissipation or leakage of magnetic field lines in a direction parallel to (e.g. not towards) the coils.

Fig. 38 illustrates a perspective view of a portion of a vibration device 2600 in accordance with another embodiment. The vibration device 2600 may be substantially similar in 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). Vibration device 2600 can include an end cap 2625, where end cap 2625 can be coupled to

solenoids

2624a and 2624b, where

solenoids

2624a and 2624b are configured to generate a magnetic field to move magnet 2623. In some embodiments, end cap 2625 may include a suitable electrical interface 2627 to deliver electrical signals to

solenoids

2624a and 2624 b. In some embodiments,

coils

2624a and 2624b may be wound in opposite directions to generate magnetic fields of opposite polarity. In some embodiments, the coils 2624a and 2624B may be spaced a suitable distance apart from each other as shown in fig. 38, while in other embodiments (e.g., such as shown in fig. 28A and 28B), the coils may be placed closer together at a spatial station.

The vibration device 2600 may include a spring 2620, the spring 2620 being coupled to a magnet 2623 and configured to act as a suspension element. The vibration device 2600 may include a mounting plate (not shown in fig. 38), and the magnet 2623 may have an opening extending through a portion of its length such that the spring 2620 may extend through the opening and attach to the distal end of the magnet 2623 via the mounting plate, similar to the description of how the spring 2520 attaches to the mounting plate 2528b in the vibration device 2500. Magnets 2623 of 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

metal end plates

2529a and 2529b of vibration device 2500. The

end plates

2629a and 2629b may be configured to reduce stray magnetic flux, as described with reference to the vibratory apparatus 2500. For example,

end plates

2629a and 2629b may limit any stray magnetic flux so that vibration device 2600 can be used close to other metal objects without being attracted to those objects. The

metal end plates

2629a and 2629b can be used to direct magnetic field lines away from one end of the magnet in a direction perpendicular to (e.g., towards) the

coils

2624a and 2624b generating the magnetic field, such that more magnetic field lines cause the magnet to move relative to the vibration device 2600 while reducing stray dissipation or leakage of magnetic field lines in a direction parallel to the coils (e.g., not towards the coils).

An example illustration 2700a of magnetic field lines focused by

metal end plates

2629a and 2629b is shown in fig. 29. A plot 2700b of normalized flux density measured over the arc length distribution in fig. 30 compares the relative flux leakage of the oscillating apparatus without end plates (line 2702) with the reduced flux leakage of the oscillating apparatus 2600 with

end plates

2629a and 2629b (line 2704). As shown, the use of metal end plates (e.g., 2629a and 2629b) may reduce flux leakage. In some embodiments, the

end plates

2629a and 2629b may enable more efficient use of the magnetic field energy generated by the

coils

2624a and 2624b such that a smaller driving force may be used to induce the desired movement of the magnet 2623 to generate a therapeutically effective vibration signal. In some embodiments,

metal end plates

2629a and 2629b may be used to focus the magnetic field lines of the magnet in such a way (e.g., in a direction toward the coil) that less power is required to drive the movement of the magnet. In such embodiments, a smaller magnet 2623 may be used to generate a vibration signal of a given strength, thereby enabling a reduction in the size of the vibration device 2600. The

metal plates

2629a and 2629b may be any suitable material that can focus the magnetic field lines as described above. In an embodiment,

end plates

2529a and 2529b and/or

end plates

2629a and 2629b may be made of mild steel.

Fig. 31A, 31B, and 31C illustrate perspective, side, and exploded views, respectively, of a vibration device 2800 according to an embodiment. Fig. 32A and 32B show two cross-sectional views of the vibration device 2800 of fig. 31A-31C. 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, vibratory device 2800 may include housing 2810, delivery interface 2830, and

housing portions

2825a and 2825 b. The vibration device 2800 may include an electromagnetic coil 2824 configured to generate a magnetic field to move a magnet 2823 serving as a vibration element in the direction of an arrow E shown in fig. 32B.

The magnet 2823 may include metal end plates 2829a and 2829 b. Endplates 2829a and 2829b may be substantially similar to

endplates

2529a and 2529b described with reference to vibration device 2500. In an embodiment, the metal end plates 2829a and 2829b may be made of mild steel. The metal end plates 2829a and 2829b may be configured to focus magnetic field lines of the magnet 2823 in a perpendicular direction relative to the coil 2824 (e.g., to cause the magnetic field lines of the magnet 2823 to exit the ends of the magnet in a direction perpendicular to the coil 2824), while reducing stray dissipation or leakage of the magnetic field in a parallel direction. Fig. 33 illustrates the relative positions of the magnet 2823 and coil 2824 with metal end plates 2829a and 2829 b. Fig. 34 is an example illustration of magnetic field lines 3000 focused by metal end plates 2829a and 2829b as shown in fig. 33. The normalized flux density curve 3100 measured over the arc length distribution in fig. 35 compares the relative flux leakage for different vibratory devices. Line 2702 is the magnetic flux density of the vibrating device without the end plates, line 2704 is the magnetic flux density of the vibrating device with the end plates in the configuration shown in fig. 38, as described above with reference to fig. 29 and 30, and line 3102 is the magnetic flux density of the vibrating device 2800 with the end plates 2829a and 2829 b. As depicted, the use of metal end plates 2829a and 2829b may result in a reduction in magnetic flux leakage caused by the drive circuitry of the vibration device 2800 as compared to other vibration devices described herein (e.g., vibration devices 2500 or 2600).

The vibration device 2800 includes

suspension elements

2820a and 2820b (e.g., springs) that are configured to suspend and support the movement of the magnet 2823 in place of the springs as described in some of the vibration devices previously described. The

suspension elements

2820a and 2820b may be annular pieces of resilient and/or deformable material, such as cloth, spider springs, or flexible membranes, for example. The annuli may be coupled to the magnet 2823 and configured to suspend the magnet 2823 at a balance point such that a magnetic field generated by the coil 2824 may move the magnet about the balance point in a direction indicated by arrow E. By having the

suspension elements

2820a and 2820b extend laterally from the magnet rather than longitudinally from the magnet (e.g., such as the spring 2520 of the vibration device 2500), the

suspension elements

2820a and 2820b may allow the overall height of the device 2800 to be reduced while also reducing off-axis movement or oscillation of the magnet 2823 outside of the axis defined by arrow E. Fig. 36A, 36B, and 36C illustrate comparison of heights of the

vibration apparatuses

700, 2500, and 2800 according to the embodiments as described above. Additionally, the

suspension elements

2820a and 2820b may be configured to expand and compress to provide a restoring force in one or more directions that are angled relative to the axis of movement of the magnet 2823 such that the

suspension elements

2820a and 2820b reduce vibration of the magnet 2823 in one or more directions.

Fig. 37 illustrates a vibration device 3200 according to an embodiment. The vibratory apparatus 3200 may be substantially similar in structure and/or function to other vibratory apparatuses described herein (e.g.,

vibratory apparatuses

500, 600, 700, 2500, 2600, and/or 2800). For example, the vibrating device 3200 may include a housing 3210, a delivery interface 3230, and

housing portions

3225a and 3225 b. The vibration device 3200 may include an electromagnetic coil 3224 configured to generate a magnetic field to move a magnet 3223 serving as a vibration element in the direction of an arrow F shown in fig. 37.

The magnet 3223 may include

metal end plates

3229a and 3229 b. The

endplates

3229a and 3229b may be substantially similar to the endplates 2829a and 2829b described with reference to the vibration device 2800. In an embodiment, the

metal end plates

3229a and 3229b may be made of mild steel. The

metallic end plates

3229a and 3229b may be configured to focus magnetic field lines in a perpendicular direction relative to the coils 3224 while reducing stray dissipation or leakage of the magnetic field in parallel directions.

The vibrating device 3200 may comprise a suspension element 3220 (e.g., a spring), the suspension element 3220 configured to suspend and support movement of the magnet 3223. The suspension elements 3220 may be substantially similar in structure and/or function to the

suspension elements

2820a and 2820b previously described with reference to the vibration device 2800. For example, the suspension elements 3220 may be one or more annular pieces of material. The ring may be coupled to the magnets 3223 via metal end plates 3229b, as shown in fig. 37. The suspension element 3220 may be coupled to the metal end plate 3229b in any suitable manner (e.g., glued with an adhesive) and configured to suspend the magnet 3223 at a balance point such that the magnetic field generated by the coil 3224 may move the magnet about the balance point in the direction indicated by arrow F. As with the vibrating device 2800, the suspension element 3220 may be configured to reduce the overall height of the device 3200, while also reducing off-axis movement or oscillation of the magnet 3223 outside the axis defined by arrow F. Furthermore, since suspension elements 3220 are disposed between end plates 3229B and coils 3224, the lateral dimension of the vibration device 3200 may also be reduced relative to the vibration device 2800 as depicted in fig. 32A and 32B. For example, the suspension element 3220 may be configured to expand and compress to provide a restoring force in one or more directions that are angled relative to the axis of movement of the magnet 3223, such that the suspension element 3220 reduces oscillation of the magnet 3223 in the one or more directions.

In some embodiments, to increase the stability of the magnet 3223, additional components (e.g., posts or pins, such as pin 521) may be added, and the magnet 3223 may be configured with openings to receive the components through the magnet 3223, similar to the magnet 523 of the vibration device 500.

The application of a vibration signal to mask disease-inducing signals transmitted by the vestibular system (also referred to as vestibular masking) can effectively alleviate many vestibular conditions by applying a bone-conducted vibration signal. For example, vertigo caused by a damaged vestibular system may be treated by an applied bone conduction vibration signal. However, sometimes, if the applied vibration signal is suddenly removed (e.g., when the vibration device is turned off), the vibration signal may cause an adverse reaction. In some embodiments, such as those detailed above, these adverse effects may be minimized by gradually reducing the power of the applied vibrations over a period of time (i.e., power ramping down) rather than abruptly shutting down the device.

As another example, vestibular masking may be effective to mitigate motion sickness that occurs when individuals use virtual reality devices, such as disclosed herein. Because virtual reality devices do not always cause motion sickness, in embodiments, the vibration devices are such that when certain conditions and/or circumstances associated with the induced disease are displayed and/or presented to a user of the virtual reality device, those disclosed herein can be operable to generate vibrations for masking the vestibular system. The vibrating device may be controlled, for example, by a microcontroller operable to store dedicated instructions for controlling the vibrating element. Such instructions may be stored in on-board memory or in separate memory. Further, such instructions are designed to integrate specialized functions and features into the controller to perform certain functions, methods, and processes related to treating vestibular system conditions. In one embodiment, the microcontroller may be programmed with instructions using a software development kit ("SDK").

It should be understood that the microcontroller may generate an electrical signal for controlling and/or driving the generation of the vibration signal based on the stored instructions. These electrical signals may be communicated between the microcontroller and the vibrating device via wired or wireless (e.g., bluetooth) methods. Additionally, the electrical signal may include a stored mode of operation. For example, the microcontroller may use stored instructions accessed by the microcontroller to generate a series of electrical signals that are sent to the vibratory element to cause the vibratory element to "turn on" or "turn off in a mode that is advantageous to a particular user based on usage data that has been accumulated and stored in a device that includes the microcontroller and the vibratory element. One mode may involve a series of vibrations in which the number of vibrations generated and applied to the subject over a period of time (e.g., every minute) may vary, while a second mode may include a series of vibrations in which the force level in the plurality of vibrations may vary. Other types of electrical signals, such as electrical signals that may be used to control the force level and frequency of the vibrations generated by the vibratory element, may be sent from the microcontroller to the vibratory device 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 sense changes in body acceleration of a user. In an embodiment, the microcontroller may be operable to receive data from the acceleration sensor indicating a type of acceleration that may cause motion sickness. Thus, upon receiving such data, the microcontroller may be operable to generate an associated control signal and send such signal to the vibratory element. The vibratory element may in turn be operable to receive such control signals and generate vibrations that may be applied to the proprioceptive vestibular system in real time, for example to minimize motion sickness beforehand. Alternatively, a stored roadmap representing a path or route that may cause a user to become ill with motion sickness may be stored in the microcontroller or portable device and in the GPS circuitry. In an embodiment, when the GPS circuitry indicates that the user is moving along a path or route and arrives at a location that may cause motion sickness, the microcontroller may be operable to generate associated control signals and send such signals to the vibratory element. The vibration element may in turn be operable to receive such control signals and generate vibrations that may be applied to the vestibular system, for example to account for the possibility of motion sickness before, for example, the user reaches the location.

It should be noted that audiologists and otorhinolaryngologists perform several different types of medical tests, including caloric tests, VNG tests, and ENG tests, to test the vestibular function of a subject. As part of the test, some form of vertigo is induced in the patient, which can have side effects causing nausea. Vestibular masking may be used to reduce the nausea such patients experience when conducting these tests. Thus, the devices described herein may be included in, or alternatively used in conjunction with (e.g., worn by) a medical testing system for performing such medical testing to mitigate or reduce such adverse side effects.

In some embodiments, the described devices and methods may be used for applications unrelated to treatment of vestibular conditions. For example, some embodiments of the vibration device may be used as a device that performs haptic communication using a suitable communication channel. In some cases, silent and haptic sensation based communication methods may be used, such as in military or surveillance conditions. Embodiments of the vibration device may be used with suitable adaptations of reduced detectability, such as invisible and inaudible conditions of use, to allow tactile communication between subjects, such as operators.

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 function and/or obtaining the results and/or one or more of the advantages described herein, and each of such variations and/or modifications is deemed to be within the scope of the inventive embodiments described herein. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the teachings of the present invention is/are used. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific inventive embodiments described herein. It is, therefore, to be understood that the foregoing embodiments are presented by way of example only and that, within the scope of the appended claims and equivalents thereto; embodiments of the invention may be practiced other than as specifically described and claimed. Inventive embodiments of the present disclosure are directed to each individual feature, system, article, material, kit, and/or method described herein. In addition, 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 included within the inventive scope of the present disclosure.

Moreover, various inventive concepts may be embodied as one or more methods, examples of which have been provided. The actions performed as part of the method may be ordered in any suitable way. Thus, embodiments may be constructed in which acts are performed in an order different than illustrated, which may include performing some acts simultaneously, even though shown as sequential acts in illustrative embodiments.

Claims

1. An apparatus, comprising:

a vibration device configured to apply a vibration signal to a portion of the user's head such that the vibration signal is conducted to the user's vestibular system via bone and such that the portion of the vestibular system moves in an equivalent manner to a therapeutically effective vibration signal applied to a region overlying the user's mastoid bone,

the therapeutically effective vibration signal (1) has a frequency of less than 200Hz and a force level greater than 87dB re1 dynes and less than or equal to 100dB re1 dynes, and (2) is therapeutically effective to treat a physiological condition associated with the vestibular system.

2. The apparatus of claim 1, wherein the vibration device is engageable with at least one of: covering an area of the mastoid bone of the user, an area behind the head of the user, or an area on the forehead of the user.

3. The apparatus of claim 2, wherein when the vibration device is engaged with the region of the head other than the region covering the mastoid bone, the vibration device is configured to apply the vibration signal at a force level greater than the force level of the therapeutically effective vibration signal and equal to or less than 14 dB.

4. The apparatus of claim 1, wherein the physiological condition comprises at least one of: dizziness, motion sickness, virtual reality disorders, spatial incoordination, sleep-onset syndrome, nausea, headache, migraine or tinnitus.

5. The apparatus of claim 1, wherein the vibrating device is an electromechanical transducer comprising:

a housing defining a chamber;

a magnet disposed within the chamber and configured to oscillate to generate a vibration signal;

at least one suspension element configured to suspend the magnet within the chamber such that the magnet is capable of vibrating about the equilibrium position.

6. The apparatus of claim 1, wherein the vibrating device is associated with a resonant frequency, the apparatus further comprising:

a signal source configured to supply an electrical signal to a vibration device to vibrate the vibration device; and

a sensor configured to measure information comprising at least one of: the current of the electrical signal, the voltage change of the electrical signal across the vibrating device, the magnetic field generated in the vicinity of the vibrating device, and the acceleration of the vibrating device.

7. The apparatus of claim 6, further comprising a processor configured to adjust a frequency of the electrical signal based on the information such that the electrical signal causes the vibrating device to vibrate at the resonant frequency.

8. The apparatus of claim 1, wherein the force level of the therapeutically effective vibration signal is between 93 and 98dB re1 dynes.

9. An apparatus, comprising:

a vibration device configured to apply a set of vibration signals to a portion of a user's head such that the set of vibration signals is conductable to a vestibular system of the user via bone to treat a physiological condition associated with the vestibular system,

the vibratory device is associated with a set of resonant frequencies including a lowest resonant frequency of less than 200Hz,

the set of vibratory signals collectively has an amount of power at a lowest resonant frequency that is greater than an amount of power at remaining resonant frequencies in the set of resonant frequencies.

10. The apparatus of claim 9, further comprising:

a signal generator configured to generate an electrical signal; and

an amplifier configured to amplify the electrical signal to produce an amplified electrical signal,

a vibration device configured to receive the amplified electrical signals and to generate a set of vibration signals in response to receiving the amplified electrical signals.

11. The apparatus of claim 9, wherein the lowest resonant frequency is between 50 and 70 Hz.

12. The device of claim 9, wherein the physiological condition comprises at least one of: dizziness, motion sickness, virtual reality sickness, spatial incoordination, sleep onset syndrome or nausea.

13. The apparatus of claim 9, wherein the vibrating device is an electromechanical transducer comprising:

an elongated member having a longitudinal axis; and

a magnet configured to oscillate along a longitudinal axis of the elongated member to produce a set of vibration signals,

the elongated member extends through the opening of the magnet and is configured to reduce oscillation of the magnet along an axis other than the longitudinal axis of the elongated member.

14. The apparatus of claim 9, wherein the vibrating device is an electromechanical transducer comprising:

a spring configured to expand and compress along a shaft; and

a magnet mounted on the spring and configured to oscillate along the axis to produce a set of vibration signals,

the spring is configured to reduce oscillation of the magnet along an axis other than an axis of the spring.

15. The apparatus of claim 9, wherein the vibrating device is an electromechanical transducer comprising:

a magnet configured to oscillate along an axis to produce a set of vibration signals;

at least one spring mounted to and extending radially from the magnet, the at least one spring configured to expand and compress to provide a restoring force in one or more directions that are at an angle relative to the axis such that the spring reduces oscillation of the magnet in the one or more directions.

16. An apparatus, comprising:

a vibration device configured to apply a vibration signal to a portion of a user's head such that the vibration signal is conductable to a vestibular system of the user via bone to treat a physiological condition associated with the vestibular system, the vibration device comprising:

a housing defining a chamber;

a magnet movable within the chamber to generate a 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.

17. The apparatus of claim 16, wherein the magnet is a first magnet and the suspension element comprises:

a second magnet configured to apply a force to the first magnet in a first direction; and

a third magnet configured to apply a force to the first magnet in a second direction opposite to the first direction,

the first magnet is disposed in the chamber between the second magnet and the third magnet such that the second magnet and the third magnet together suspend the first magnet at the location within the chamber.

18. The apparatus of claim 16, wherein the suspension element comprises a spring (i) having a first end attached to a portion of the housing and a second end attached to the magnet, and (ii) configured to apply a force to the magnet to suspend the magnet at the location within the chamber.

19. The apparatus of claim 16, further comprising a mounting plate,

the magnet defines an opening extending from a first end to a second end of the magnet, the second end of the magnet is attached to the mounting plate,

the suspension element includes a spring having a first end attached to a portion of the housing and a second end extending through the opening of the magnet and attached to a portion of the mounting plate.

20. The apparatus of claim 16, wherein the suspension element comprises a spring coupled to the magnet and configured to apply a force to the magnet to suspend the magnet at the location,

the spring has a spring constant associated with a natural frequency of the magnet of less than 200 Hz.

21. The apparatus of claim 16, wherein the suspension element comprises a solid elastic material coupled to the magnet and configured to exert a force on the magnet to suspend the magnet at the location within the chamber.

22. The apparatus of claim 16, wherein the suspension element is configured to reduce movement of the magnet along an axis other than a longitudinal axis of the chamber.

23. The apparatus of claim 16, further comprising an elongated member extending along a longitudinal axis of the chamber,

the elongated member extends through an opening in the magnet and is configured to reduce movement of the magnet along an axis other than a longitudinal axis of the chamber.

24. The apparatus of claim 16, wherein the suspension element is configured to suspend the magnet to reduce contact between the magnet and the housing.

25. The apparatus of claim 16, wherein the physiological condition comprises at least one of: dizziness, motion sickness, virtual reality disorders, spatial incoordination, sleep-onset syndrome, nausea, headache, migraine or tinnitus.

26. A method, comprising:

positioning a vibration device over an area of a user's head;

exciting the vibration device after positioning to apply a vibration signal to the region such that the vibration signal is conducted to the vestibular system of the user via the skeleton, the vibration signal configured to cause a portion of the vestibular system to move in the same manner as the vibration signal, the vibration signal (1) applied to a region overlying the mastoid bone of the user and having (2) a frequency less than 200Hz and a force level greater than 87dB re1 dynes and less than or equal to 100dB re1 dynes; and

a physiological condition associated with the vestibular system is treated in response to exciting the vibrating device.

27. The method of claim 26, wherein the physiological condition comprises at least one of: dizziness, motion sickness, virtual reality sickness, spatial incoordination, sleep onset syndrome or nausea.

28. The method of claim 26, further comprising securing the vibration device over the region of the head using a rigid or elastic headband.

29. The method of claim 26, wherein the vibration device comprises a magnet and the exciting comprises vibrating the magnet to generate the vibration signal.

30. The method of claim 26, wherein stimulating comprises:

generating an electrical signal;

amplifying the electrical signal to generate an amplified electrical signal; and

the amplified electrical signal is supplied to a vibration device to cause the vibration device to generate a vibration signal.

31. The method of claim 26, the exciting comprising supplying an electrical signal to the vibratory element to vibrate the vibratory element, the method further comprising:

measuring information including at least one of: a current of the electrical signal, a voltage change of the electrical signal across the vibrating device, a magnetic field generated near the vibrating device, and an acceleration of the vibrating device; and

adjusting a frequency of the electrical signal based on the information such that the electrical signal causes the vibratory device to vibrate at a resonant frequency associated with the vibratory device.