JP2022533953A - Systems, devices and methods for treating vestibular conditions - Google Patents

Abstract

Devices and methods are described herein that provide vibratory devices that can apply vibratory signals to a user to treat physiological conditions such as those associated with the vestibular system. Vibrational signals can be conducted through the bone to the target area to produce a therapeutic effect. The vibrating device can be used in conjunction with a biometric sensor to predict the onset of symptoms related to a physiological condition, as well as to control the operation of the vibrating device (e.g., force level or can be used to change the frequency, power the device on and off, etc.). [Selection drawing] Fig. 4C

Description

(Cross reference to related applications)
This application claims priority to and benefit from U.S. Provisional Patent Application No. 62/847,757, entitled SYSTEMS, DEVICES, AND METHODS FOR TREATING VESTIBULAR CONDITES, filed May 14, 2019, and the disclosure thereof. The entirety is incorporated herein by reference.

The disclosed embodiments are systems, devices, and methods for treating conditions associated with a subject's vestibular system, such as motion sickness, vertigo, dizziness, migraines, tinnitus, and loss of consciousness. Regarding the method. More specifically, the present disclosure relates to devices capable of generating vibratory signals capable of affecting a subject's vestibular system.

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

An individual's inner ear has five receptors associated with equilibrium: three receptors associated with the three semicircular canals and two macules within the vestibule (ie, the utricle and the saccule). The utricle and saccule are involved in measuring the linear acceleration of the head, for example due to self-motion and constant gravitational acceleration. Each is covered by an otolithic membrane, as described below with reference to Figures 2A and 2B. Roughly speaking, the utricle measures acceleration in the horizontal plane and the saccule measures acceleration in the vertical plane. FIG. 1A shows a portion of the anatomy of subject 100, including the vestibular system associated with outer ear 110, portions of skull 114, bony portions of ear 116, ear canal 111, tympanic membrane 112, and middle ear. The bones of ear 113 are shown. The vestibular system includes the semicircular canals 122 , 124 , 126 and otolith organs 128 , 130 housed within the vestibule 121 of the bony labyrinth of the inner ear and is continuous with the cochlea 120 . FIG. 1B is a more detailed illustration of the vestibular system shown in FIG.

Each of the three semicircular canals 122, 124, 126 is oriented in a plane along one of three directions in which the head can be rotated or translated to detect movement in that direction, each direction being a nod up or down. The direction, the direction to shake the head left and right, and the direction to tilt the head left and right. The otolith apparatus in the vestibule of the inner ear 121 detects gravity and acceleration in the anterior and posterior directions. The otolith apparatus includes the utricle 128, which detects movement in the horizontal plane, and the saccule 130, which detects movement in the vertical plane. The semicircular canals 122, 124, 126 and otolith organs 128, 130 are filled with endolymph, a fluid that moves with head or body movement.

Endolymph movement within the vestibular system of the inner ear can be sensed by hair-tuft-bearing neurons to determine head movement and orientation. The semicircular canals of the otoliths and the portion called the ampulla in the macula contain hair cells, which function as sensory receptors in the vestibular system, and which detect the movement of the endolymph and signal body movements. Contains hair tufts or stereocilia that transmit to and report their signals to the brain. The otolith apparatus is also composed of calcium carbonate called equilibrium sands or otoliths that shift in response to changes in acceleration (e.g. changes in motion or orientation with respect to gravity) that lead to movement of the layers beneath the equilibrium sands and movement of the hair tufts. Contains a layer of crystals. In addition, otoliths sink in the direction of gravity and pull bundles of hair cells (eg, downward to upward), aiding in orientation discrimination.

2A and 2B show detailed views of the anatomy within the otolith apparatus (eg, utricle 128 and saccule 130 shown in FIG. 1B) and sensory receptors, respectively, in an upright and actuated state. FIG. 2A shows a plaque containing an otolithic membrane 132 and a cell layer containing hair cells 134 and supporting cells 136 . Hair cells 134 comprise hairs, such as projections or stereocilia 132, that extend over one or more layers of gelatin. The macula tissue also contains layers of equilibrium sands or otoliths 138 that move in response to endolymph movement and/or body acceleration. FIG. 2A shows hair cells 134 and otoliths 138 in an upright configuration, and FIG. 2B shows hair cells 134 and otoliths 138 in a displaced or tilted configuration when a directional force 140 (e.g., gravity) acts on otoliths 138 . An otolith 138 is shown. Similarly, the movement of endolymph within the semicircular canals 122, 124, 126 is associated with semicircular canals (not shown) that perceive and signal relative motion of the body and/or head (e.g., angular acceleration of the head). May result in migration of hair cells within the ampullary region.

Horizontal and vertical visual patterns received by the eye, in addition to signals from the vestibular system, can influence the perception of orientation, balance, and position. Also, the differential strain of the opposing neck muscles can affect the perception of head position and orientation. When signals from these sources do not match, individuals may develop motion sickness, experience vertigo, dizziness, vestibular migraines, unconsciousness, or other conditions. Uneven orientation, balance, position and motion signals can be the result of extreme or unaccustomed motion during travel in automobiles, trains, aircraft, and other modes of transportation, for example. Ragged signals can also result from simulations of perceived motion during, for example, three-dimensional (3D) movies, 3D video games, and virtual reality devices. Accordingly, it may be desirable to have a device for treating various vestibular conditions that may result from inconsistent signals received from the subject's vestibular system, eyes, or other anatomy.

The instruments and methods described herein allow the vibrational signal to be transmitted through the bone to the user's vestibular system and equivalent to a therapeutically effective vibrational signal applied to the region overlying the user's mastoid bone. A vibration device configured to apply a vibration signal to a portion of the user's head can be included such that the portion of the vestibular system can be moved in a manner. A therapeutically effective vibratory signal can (1) have a frequency of less than 200 Hz and a force level of 87-101 dB re 1 dyne, and (2) a therapeutic frequency for treating physiological conditions associated with the vestibular system. can be effectively effective.

Instruments and methods are described herein, and in some embodiments, a set of vibrational signals is delivered through a series of bones to the user's vestibular system to treat a physiological condition associated with the vestibular system. A vibrating device configured to apply a series of vibrating signals to a portion of the user's head can be included so that the vibrating signals can be conducted. A vibration device may be associated with a range of resonant frequencies, including the lowest resonant frequency that is less than 200 Hz. The series of vibration signals may collectively have an amount of power at the lowest resonant frequency that is greater than the amount of power at the remaining resonant frequencies from the series of resonant frequencies.

In some embodiments, the devices described herein transmit vibrational signals to the user's vestibular system through bones to treat physiological conditions associated with the vestibular system. As can be done, a vibrating element configured to apply a vibrating signal to a portion of the user's head can be included. The vibrational element includes a housing defining a chamber, a magnet movable within the chamber to generate a vibrational signal, a suspension element configured to suspend the magnet at a position within the chamber, and a magnet about the position. It may be configured to include a coil configured to generate a magnetic field to move.

The methods disclosed herein involve positioning a vibrating device over an area of the user's head and, after positioning, energizing the vibrating device so that a vibration signal can be transmitted through the bones to the user's vestibular system. and applying a vibration signal to the region. The vibratory signal is applied to the vestibular system in a manner comparable to that of the vibratory signal (1) applied to the area overlying the mastoid of the user and (2) having a frequency of less than 200 Hz and a force level of 87-101 dB re 1 dyne. It can be configured to move a portion. The method may further comprise treating a physiological condition associated with the vestibular system in response to energizing the vibrating device.

In some embodiments, the instrument is configured to generate a vibration signal and apply the vibration signal to a portion of the user's head such that the vibration signal can be transmitted through the bone to the user's vestibular system. and a biometric sensor configured to measure a biological characteristic of a user indicative of the onset of a physiological condition associated with said vestibular system of the user; and a control unit coupled to receive data associated with the biological characteristic from the biometric sensor and control the vibrating device such that the vibrating signal treats the physiological condition of the head. Control to generate vibration signals based on data relating to biological properties as applied to the part.

In some embodiments, the instrument is configured to generate a vibration signal and apply the vibration signal to a portion of the user's head such that the vibration signal can be transmitted through the bone to the user's vestibular system. a vibration device comprising a housing defining a chamber; a magnet disposed within the chamber and configured to oscillate about an equilibrium position to produce a vibration signal; and a magnetic field capable of causing the magnet to oscillate. and a series of metal components coupled to the ends of the magnet and configured to reduce stray magnetic flux and orient the magnetic field of the magnet in a direction that allows the magnet to oscillate. and at least one suspension component configured to suspend the magnet within the chamber such that the magnet can oscillate about the equilibrium position.

In some embodiments, the method includes receiving data related to the user's biological characteristics from a biometric sensor operably coupled to a vibrating device positioned on a portion of the user's head. , based on the data, detecting the onset of a physiological condition associated with the user's vestibular system and, in response to detecting the onset of the physiological condition, communicating a vibrational signal to the vestibular system through the bone; activating the vibration device to generate a vibration signal applied to the user's head so as to reduce symptoms associated with the physiological condition;

In some embodiments, the method includes receiving data related to the user's biological characteristics from a biometric sensor operably coupled to a vibrating device positioned on a portion of the user's head. , based on the data, generated by the vibrating device in response to detecting a change in severity of a physiological condition associated with the user's vestibular system and detecting an increase in the severity of the physiological condition; reducing symptoms associated with physiological conditions and reducing the severity of physiological conditions by increasing the force level of a vibratory signal applied to the head of and transmitted through the bones to the vestibular system. reducing the force level of the vibration signal in response to detecting

FIG. 1A shows a subject's anatomy, including the bony labyrinth of the inner ear, which houses the vestibular system. FIG. 1B provides a detailed view of the vestibular system and cochlea within the bony labyrinth of FIG. 1A. FIG. 2A is a view of the plaque portion of the otolith organ shown in FIG. 1B in an upright position and subjected to a respective directional force. FIG. 2B is a view of the plaque portion of the otolith organ shown in FIG. 1B in an upright position and each subject to a directional force. FIG. 3 is a schematic diagram of an arrangement of a vibratory device for applying a vibratory signal to the vestibular system, according to one embodiment. FIG. 4A is a schematic diagram of an exemplary system for treating symptoms associated with vestibular conditions, according to one embodiment. FIG. 4B is a schematic diagram of an exemplary system for treating symptoms associated with vestibular conditions, according to another embodiment. FIG. 4C is a schematic diagram of an exemplary system for treating symptoms associated with vestibular conditions, according to another embodiment. FIG. 5 is a schematic diagram of an exemplary vibrating device of a system for treating symptoms associated with vestibular conditions, according to embodiments. FIG. 6 is a cut-away schematic diagram of an exemplary vibrating device of a system for treating symptoms associated with vestibular conditions, according to another embodiment. FIG. 7A is a cross-sectional schematic diagram of a vibratory device in a system for treating symptoms associated with vestibular conditions, according to embodiments. Figure 7B is a cross-sectional schematic diagram of the vibration device of Figure 7A incorporated into a physical platform for placement on a subject, according to one embodiment. FIG. 8 is a cross-sectional schematic diagram of a vibrating device in a system for treating symptoms associated with vestibular conditions, according to another embodiment. FIG. 9A is a perspective view of a spring as a suspension element of a vibrating device within a system for treating symptoms associated with vestibular conditions, according to embodiments. Figure 9B is a top view of the spring of Figure 9A. Figure 9C is a bottom view of the spring of Figure 9A. FIG. 10 is a schematic diagram of an exemplary vibrating device that includes and/or incorporates different support elements, according to various embodiments. FIG. 11 is a schematic diagram of an exemplary vibratory device that includes and/or incorporates different support elements, according to various embodiments. FIG. 12 is a schematic diagram of an exemplary vibrating device that includes and/or incorporates different support elements, according to various embodiments. FIG. 13 is a schematic illustration of an exemplary vibrating device that includes and/or incorporates different support elements, according to various embodiments. FIG. 14 is a schematic diagram of an exemplary vibrating device that includes and/or incorporates different support elements, according to various embodiments. FIG. 15 is a schematic diagram of an exemplary vibrating device that includes and/or incorporates different support elements, according to various embodiments. FIG. 16 is a schematic diagram of a human skull showing exemplary locations for placing a vibrating device in a system for treating symptoms associated with vestibular conditions, according to various embodiments. FIG. 17A shows examples of two waveforms that may be used to energize a vibrating device within a system for treating symptoms associated with vestibular conditions, according to various embodiments. FIG. 17B shows examples of two waveforms that may be used to energize a vibrating device within a system for treating symptoms associated with vestibular conditions, according to various embodiments. FIG. 18 illustrates an example energization profile that can be used to energize a vibrating device in a system for treating symptoms associated with vestibular conditions, according to embodiments. FIG. 19 is a flowchart of an exemplary method for using a vibrating device to treat symptoms associated with vestibular conditions. FIG. 20A is a flow chart of the protocol of a study conducted to test a vibrating device for treating symptoms associated with vestibular conditions. FIG. 20B is a static schematic of exemplary visual stimuli used in the procedure depicted in FIG. 20A to test the vibration device. FIG. 21A depicts the results of the study procedure depicted in FIG. 20A for testing the vibration device at different force levels. FIG. 21B depicts the results of the study procedure depicted in FIG. 20A for testing the vibration device at different force levels. FIG. 22A depicts the results of the study procedure depicted in FIG. 20A for testing the vibration device at different frequencies. FIG. 22B depicts the results of the study procedure depicted in FIG. 20A for testing the vibration device at different frequencies. FIG. 23A, in yet another example, relates to a questionnaire completed by subjects in a study conducted to test a vibrating device for treating symptoms associated with vestibular conditions using the testing procedure. describe the data obtained. FIG. 23B, in yet another example, relates to a questionnaire completed by subjects in a study conducted to test a vibrating device for treating symptoms associated with vestibular conditions using the testing procedure. describe the data obtained. FIG. 24 shows, in yet another example, the results of a study conducted to test a vibratory device for treating symptoms associated with vestibular conditions using a test procedure. FIG. 25A is a schematic diagram of a perspective view of each vibration device, as described herein, according to one embodiment. FIG. 25B is a schematic diagram of a side view of each vibration device, as described herein, according to one embodiment. FIG. 25C is a schematic diagram of an exploded view of each vibration device, as described herein, according to one embodiment. Figure 26 is a cross-sectional view of the housing of the vibration device of Figures 25A-25C. 27A and 27B are schematic diagrams of perspective views of respective vibration devices, according to one embodiment. 27B are schematic diagrams of a side view of a vibration device, respectively, according to one embodiment. FIG. 27C is a schematic diagram of an exploded view of each vibration device, according to one embodiment. FIG. 28A is a schematic diagram of a perspective view of the vibration device of FIGS. 27A-27C. Figure 28B is a schematic illustration of a cross-sectional view of the vibration device of Figures 27A-27C. FIG. 29 is a diagram of magnetic field lines associated with a magnet of a vibrating device, such as the vibrating device of FIG. FIG. 30 is a plot of normalized magnetic flux densities associated with magnets of a vibrating device, according to some embodiments. 31A and 31B are schematic diagrams of perspective views of respective vibration devices, according to one embodiment. 31B are schematic diagrams of a side view of a vibration device, respectively, according to one embodiment. FIG. 31C is a schematic diagram of an exploded view of each vibration device, according to one embodiment. Figure 32A is a schematic illustration of two different cross-sectional views of the vibration device of Figures 31A-31C. Figure 32B is a schematic illustration of two different cross-sectional views of the vibration device of Figures 31A-31C. FIG. 33 is a schematic diagram of the magnets, coils, and metal plate of the vibration device of FIGS. 31A-31C. FIG. 34 is a diagram of magnetic field lines associated with the magnets of the vibration device of FIGS. 31A-31C. FIG. 35 is a plot of normalized magnetic flux densities associated with magnets of a vibrating device, according to some embodiments. FIG. 36A is a schematic illustration of a cross-sectional view of a vibratory device, according to three different embodiments; FIG. 36B is a schematic illustration of a cross-sectional view of a vibration device, according to three different embodiments; FIG. 36C is a schematic illustration of a cross-sectional view of a vibration device, according to three different embodiments. FIG. 37 is a cross-sectional schematic diagram of a vibration device, according to one embodiment. FIG. 38 is a perspective schematic view of a vibration device, according to one embodiment. FIG. 39 is a graph of skin conductance versus subject nausea level. FIG. 40 is a graph of the multivariate normal probability density function (MVNPDF) of the subject's electroencephalogram (EEG) data over time with the vibrating device off (shown in blue) and with the vibrating device on. (indicated in orange). FIG. 41A is a graph of heart rate versus nausea level for a subject. FIG. 41B is a graph of the cardiac cycle of the heart. FIG. 42 is an example of a vibration device including integrated sensors placed near a subject's ear, ear canal, and/or forehead, according to various embodiments. FIG. 43 is an example of a vibration device implemented with a headband and including integrated sensors, according to various embodiments. FIG. 44 is an example of a vibration device implemented as an over-ear device and including integrated sensors, according to various embodiments. FIG. 45 is a flowchart of an exemplary method for operating a vibration device using sensors, according to various embodiments. FIG. 46A shows different perspective views of an exemplary vibration device, according to various embodiments. FIG. 46B shows different perspective views of an exemplary vibration device, according to various embodiments. Figure 47 shows an exploded view of the vibratory device illustrated in Figures 46A and 46B. FIG. 48 shows a cross-sectional view of the vibration device illustrated in FIGS. 46A and 46B. FIG. 49 shows different perspective views of an exemplary vibration device, according to various embodiments. FIG. 50 shows an exploded view of the vibration device shown in FIG. FIG. 51 shows a cross-sectional view of the vibration device illustrated in FIG. 52 shows an enlarged view of the vibrating element of the vibrating device illustrated in FIG. 49. FIG. FIG. 53 is an example of a vibrating device attached to or incorporated into a hearing aid and/or tinnitus masker, according to various embodiments.

Herein, a vibrating device capable of generating a vibratory signal is used to transmit a vibratory signal to the subject's vestibular system via bone conduction, such that the vibratory signal can disrupt the anatomy of the subject's vestibular system. Devices and methods are described for treating vestibular conditions by applying

As described above, sensory signals from the subject's vestibular system aid in the perception of the subject's body orientation, balance, position, and movement. In addition to signals from the vestibular system, other sensory modalities such as visual signals from the eye can influence the perception of orientation, balance, and position. Also, different tensions on opposing neck muscles can affect the perception of head position and orientation. When signals from these various sensory sources, such as the vestibular, visual, and proprioceptive systems, are mismatched, the individual may experience motion sickness, vertigo, dizziness, vestibular migraines, unconsciousness, or other symptoms. state, such as For example, erratic orientation, equilibrium, position, and motion signals may result from extreme or unfamiliar motion (e.g., during travel in vehicles, trains, aircraft, and other modes of transport), or in virtual or augmented 3D environments ( 3D movies, 3D video games, virtual reality devices, etc.).

In a natural adaptive response, the brain can ignore perceptual information in chaotic, repetitive, or non-novel or incomprehensible signals. For example, it has been shown that vibrations from sound can affect the vestibular apparatus of the inner ear and reduce cerebellar responses (eg, amplitude of electrical signals). H. Sohmer et al. , "Effect of noise on the Vestibular imaginized potential studies in rats," 2 Noise Health 41 (1999). Nevertheless, the same studies show that very high intensities are required for sound to affect the vestibular system. Thus, conventional headphones, earbuds, and speakers, which are used to generate vibration signals in the air to produce sound, can cause symptoms such as motion sickness reactions, dizziness, vestibular migraines, and other physiological reactions. limited ability to treat Many of these technologies are not designed to transmit high intensity signals. Moreover, such high intensity signals can damage or interfere with human hearing.

As an alternative to using sound, mechanical vibrations can be used to affect the vestibular system to treat various conditions. One technique that can be used to generate mechanical vibrations is surface or bone conduction transducers. However, currently available bone conduction transducers have certain drawbacks associated with treating vestibular conditions or conditions. For example, existing devices often have significant limitations, such as the generation of substantial amounts of heat and/or audible noise, which prohibit use in direct contact with the user's skin or in close proximity to the user's ear. may hinder. Also, many of the existing devices are large and bulky, making them impractical for use in situations where therapeutic benefit is desired, such as, for example, while traveling, reading, or using a virtual reality device.

Existing devices such as surface conduction transducers or bone conduction transducers are inefficient in producing low frequency vibrations. Many produce vibration signals at high frequencies, which are audible and therefore distracting. Therefore, when such devices are used near a user's ear, the noise they produce can be disruptive and irritating. Many existing devices produce high frequency vibrations primarily because power is directed at the higher resonant frequencies instead of the lower fundamental frequencies of the vibration signals produced by such transducers. Even when designed to produce low frequency vibrations, existing bone conduction transducers have a wide frequency spectrum (e.g. frequencies at many harmonics) when lower frequencies are required. can be inefficient because it generates Accordingly, the disclosed systems and methods, among other features, do not produce high levels of heat or audible noise, and are highly efficient at transmitting lower frequency vibrational signals related to vestibular conditions. Intended for treatment of symptoms.

I. Overview FIG. 3 schematically illustrates the placement of a vibration device 200 near the outer ear 110 of a subject. Vibration device 300 can be configured to apply vibrational signals 202 conducted through bones to treat one or more symptoms or conditions associated with a subject's vestibular system. A portion 204 of the vibration signal 202 may be conducted through the bone 116 to the bony labyrinth and vestibular system of the inner ear. For example, a portion 204 of the vibrational signal travels through the bones to the semicircular canals 122, 124, 126 and the vestibule 121, which houses the otoliths, utricle and saccule.

Vibration device 200 applies a vibration signal to vestibule 121 to cause hair cells of otoliths and semicircular canals 122, 124, 126 within vestibule 121 to move in a repetitive, chaotic, or noisy manner, resulting in vestibular states. It can be positioned to alleviate, alleviate or treat the associated symptoms. Some examples of vestibular conditions include various types of motion sickness (e.g., seasickness, air sickness, motion sickness or train sickness, motion sickness from exposure to virtual reality or simulators, from experiences such as riding roller coasters). motion sickness, and effects of Sopaite's syndrome), dizziness such as benign paroxysmal positional vertigo, nausea from various causes (e.g., electrocaloric nystagmus (ENG)/video nystagmography (VNG) examination, head impulse examination, Vestibular evoked myopotential tests (VEMP), including cervical VEMP and ocular VEMP tests, vestibular system tests including functional gait assessment, or chemotherapy, radiotherapy to the base of the skull, nausea associated with pregnancy, nausea due to alcohol or toxic ingestion infections, vestibular neuritis, vestibular schwannoma, Meniere's disease, tinnitus, migraines, Mal de Barkment syndrome, spatial discordance, sopaite syndrome, vestibular hypofunction, global balance It can include anomalies and the like.

Vibration device 200 may also be used to prevent circulatory system disorders, such as orthostatic hypotension (low blood pressure), poor blood circulation due to cardiomyopathy, heart attack, arrhythmia, transient ischemia, for example, as described herein. seizures), neurological conditions (e.g. Parkinson's disease, multiple sclerosis), drugs (e.g. antiseizure drugs, antidepressants, sedatives, tranquilizers, antihypertensives), anxiety disorders, anemia due to low iron levels , provides vibrational signals conducted through bones to treat other conditions, including dizziness and loss of balance caused by hypoglycemia (low blood sugar), overheating, dehydration, and traumatic brain injury can be positioned as The vibrational signal can move a portion of the vestibular system in a manner equivalent to a therapeutically effective vibrational signal to treat the conditions described above. Additionally, the vibrating device 200 can be used, for example, to assist the pilot in training the pilot to ignore or reject the vestibular system under certain conditions. Vibration device 200 can also be used as a stroke diagnosis.

FIG. 4A schematically illustrates an exemplary system 350 for treating vestibular conditions. System 350 includes a vibration device 300 and a control unit 360 coupled to vibration device 300 for activating and/or controlling operation of vibration device 300 . Vibration device 300 may be an electromechanical transducer configured to produce a vibration signal when driven and energized by a suitable electrical signal from a signal source. Control unit 360 may include memory 362 , processor 364 , and input/output (I/O) devices 366 for sending and receiving electrical signals to and from other components of system 350 . Vibration device 300 may be configured to send and receive electrical signals to control unit 360 . Optionally, system 350 may include one or more sensors 390 for measuring voltage, current, impedance, movement, acceleration, or other data associated with vibratory device 300 . Alternatively or additionally, sensor 390 can be configured to measure information related to the subject's vestibular system VS and/or other body indices (eg, body temperature, skin conductivity, etc.). . The sensor 390 can send and receive signals to the control unit 360, the vibration device 300, and/or the vestibular system VS. By way of example, sensor 390 may include a microphone or other audio sensor that can be used to detect if vibrating device 300 has failed and the resulting vibrations produced an audible sound. The sensor 390 may be configured to detect audible sound and send a signal to the control unit 360, which controls the vibration device 300, the signal generator 370, and/or the system to reduce the audible sound. Other components can be stopped. Alternatively, system 350 may include circuitry that automatically shuts down the system, such as, for example, disconnecting power to vibrator 300, signal generator 370 and/or other components of the system upon detection of an audible sound. can include Once stopped, system 350 may remain stopped until system 350 undergoes maintenance and/or factory reset. In some embodiments, system 350 may include noise canceling components, such as those described with reference to FIG. can do.

System 350 may include signal generator 370 and/or amplifier 380 . Signal generator 370 may generate one or more signals that drive vibration device 300 to vibrate to generate a vibration signal. An amplifier 380 can be operatively coupled to the signal generator 370 and can amplify the signal from the signal generator 370 before the signal is used to drive the vibration device 300 . Control unit 360 may control the operation of signal generator 370 and/or amplifier 380 . A power supply, not shown, may be configured to power one or more of control unit 360, signal generator 370, amplifier 380, sensor 390, and/or other components of the system.

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

In some embodiments, control unit 360 is operable to store special instructions for controlling vibration device 300 . Such instructions may be stored in memory 362 or in a separate memory. Further, such instructions can be designed to incorporate special functions and features into the controller to complete specific functions, methods and processes related to treating vestibular conditions disclosed herein. In some embodiments, control unit 360 may be programmed with instructions using a software development kit.

The electrical signals that control the vibration device 300 may be generated by the control unit 360 based on stored instructions. These electrical signals may be communicated between the control unit 360 and the vibration device 300 via wired or wireless (eg, Bluetooth) methods. The electrical signal may include a stored pattern of motion, e.g., stored instructions accessed by the controller, based on usage data collected, accumulated and stored about the user, that pattern advantageous to that particular target audience. may be used by the controller to generate a series of electrical signals that are sent to the vibration device 300 to turn the vibration device 300 on and off at . One pattern may involve a series of vibration signals that may vary in the number of vibration signals generated and applied to the subject over a period of time (e.g., every minute), while a second pattern may involve: A series of vibration signals may be included in which the force level of the number of vibration signals may vary. Other types of control signals that may be used to control the force level and frequency of the vibration signal produced by vibration device 300 are based on data received from a sensor (eg, sensor 390 or other sensor), control unit 360 to the vibration device 300 . For example, acceleration sensors may be included in portable electronic devices (eg, cell phones) to sense changes in the user's physical acceleration. In an embodiment, control unit 360 may be operable to receive data from an acceleration sensor that indicates the type of acceleration that causes motion sickness. Accordingly, after receiving such data, control unit 360 may be operable to generate associated electrical signals and transmit such signals to vibration device 300 . Vibration device 300 is then operable to receive such electrical signals and generate vibration signals that can be conducted through the bones and applied to the vestibular system, for example, to preemptively respond to motion sickness. It may be possible. Vibrational signals can move portions of the vestibular system in a manner comparable to therapeutically effective vibrational signals. For example, a vibrational signal may be applied to a portion of the vestibular system (e.g., the semicircular canal and/or hair tufts that form the otolithic receptors) in a random fashion while simulating a noisy vestibular signal or a noisy vestibular sensation. or introduce some form of stochastic resonance within the vestibular system. In some instances, such noisy vestibular sensations may induce diminished effects caused by other vestibular signals or discrepancies in the signals perceived by the subject. Alternatively, a stored roadmap representing the path or tracks along which the user has previously experienced motion sickness due to motion sickness may be sent to the control unit 360 or portable device, e.g. It may be stored in conjunction with an appropriate positioning system such as a navigation system. In some embodiments, the control unit 360 generates an associated electrical signal as the positioning system indicates that the user is moving along a path or track and has reached a location that may induce motion sickness. and may be operable to transmit such signals to the vibration device 300 . Vibration device 300 then receives such electrical signals and conducts them through the bones and applies them to the vestibular system, for example, to preemptively respond to motion sickness before the user reaches the position. It may be operable to generate an audible vibration signal.

In some embodiments, wired and/or wireless communication between a vibration device or bone conduction device and one or more sensors (e.g., wearable sensors) including, for example, rings, watches, patches, and bracelets. There may be. In some embodiments, there may be wired or wireless communication between the vibration device and other connected devices, such as mobile devices (e.g., cell phones, tablets), computers, or smart home devices. .

The monitored biometric data may be recorded by either the device or a connected device, along with other data such as duration and frequency of use, preferred power settings, and the like. A historical record of this data may be used to change device settings for future use. Data can also be shared with healthcare professionals to inform treatment. Also, individual devices can be updated based on data collectively received from other devices, which can provide insight into the best settings for future use.

FIG. 4B schematically illustrates another exemplary system 350' for treating vestibular conditions according to embodiments. System 350 ′ may be similar to system 350 in that it includes control unit 360 and vibration device 300 coupled to control unit 360 and energized and/or controlled by control unit 360 . Furthermore, the system 350' may have a second vibration device 300' coupled to the control unit 360, whose actuation can be controlled by the control unit 360. The control unit 360 may be configured to control the vibration devices 300 and 300' such that the vibration signals generated by the vibration devices 300 and 300' can be transmitted simultaneously, alternately and/or independently. Although not shown in FIG. 4B, similar to system 300 shown in FIG. 4A, system 350′ includes a signal generator (eg, signal generator 370) coupled to control unit 360, signal generator A controlled amplifier (eg, amplifier 380), and/or a sensor (eg, sensor 390) can optionally be included. In some embodiments, the two vibration devices 300 and 300' are configured to split the signal generated by the signal generator and optionally amplified by an amplifier between the vibration devices 300 and 300'. , can be coupled to balance 382 . In some embodiments, vibration devices 300 and 300' can be coupled to each other and configured to send and receive signals from each other. Although two vibration devices 300 and 300' are illustrated in FIG. 4B, those skilled in the art will appreciate that any number of vibration devices can be used.

FIG. 4C schematically illustrates another exemplary system 350'' for treating vestibular conditions according to an embodiment. System 350'' may be similar to systems 350, 350' in that it includes control unit 360 and vibration device 300 (e.g., transducer). System 350 ″ also includes signal generator 370 , potentiometer 372 ′, and amplifier 380 . System 350' optionally provides signals associated with vibrating device 300, information relating to the ambient environment, and/or physiological information associated with the user of the vibrating device, for example, as further described below with respect to certain embodiments. One or more sensors 390 can be included for measuring data. Potentiometer 372'' may be configured to measure a potential associated with the signal generated by the signal generator. A potentiometer 372 ″ can be used to control the amplitude of the signal being sent to the vibration device 300 . Examples of suitable potentiometers include rotary potentiometers, linear potentiometers, rheostats, digital potentiometers, membrane potentiometers, and the like. Potentiometer 372'' can be used to ensure that any vibration generated by vibration device 300 does not exceed a predetermined acceptable level. A power supply (not shown) can be used to power one or more components of system 350'', such as signal generator 370, potentiometer 372', amplifier 380, and/or control unit 360. .

Although the systems 350, 350', 350'' are depicted as including components in addition to the vibration device, such components (e.g., amplifiers, sensors, potentiometers, signal generators, control units, balances, etc.) ) can be incorporated into the vibration device or form part of the vibration device. For example, a printed circuit board (eg, as described in further detail below with respect to embodiments such as vibrating device 700) may include one or more of signal generators, amplifiers, potentiometers, balances, etc. It may be attached to and/or incorporated within the vibration device.

II. Vibration Device FIG. 5 is a schematic illustration of an exemplary vibration device 400 according to an embodiment. Vibration device 400 includes a body (or housing) 410 that can define one or more chambers. Body 410 houses vibration element 423 , suspension element 420 , drive circuit 440 and transmission interface 430 . Vibration element 423 is suspended by suspension element 420 and is configured to be driven by drive circuit 440 to move (eg, oscillate back and forth or oscillate) to generate a vibration signal. The vibrating element 423 can be suspended within the body (eg, within the chamber) such that the vibrating element 423 can vibrate about the equilibrium position. Movement of vibrating element 423, as disclosed herein, vibrating device 400 to generate a vibrating signal that can be directed via transmission interface 430 to treat one or more vestibular conditions. for suspension element 420 and/or body 410. The vibration device 400 and/or the body 410 of the vibration device 400 connect the transmission interface 430 to the target area TA on the subject's head so that the vibration signal generated by the movement of the vibration element 423 can be applied to the target area TA. This vibration signal can then be conducted through the bony structure BS to the subject's vestibular system VS.

Optionally, in some embodiments, the vibratory device 400 includes an on-board power supply 414 for powering the components of the vibratory device 400 and a portion of the vibratory device 400, the vestibular system VS, or another portion of the body (e.g., , a portion of the body) from which the generated vibrational signal is applied, e.g. A sensor 416 may be included to sense the signal. In some embodiments, a remotely located power source (eg, a power source included in control unit 360) may be used to power vibration device 400. FIG. In some embodiments, a remote sensor (e.g., sensor 390) is used to control a portion of vibratory 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). part) can be detected.

Sensors 416 can be configured to measure and/or record information related to vibration device 400 and/or a subject (eg, vestibular system VS, target area TA, etc.). For example, sensor 416 may sense current, voltage (eg, a voltage change associated with an electrical signal across vibrating element 423), magnetic field (eg, a directional magnetic field generated by an electrical signal and applied near vibrating element 423), or movement. One or more suitable transducers may be included for measuring and/or recording information from vibrating device 400, including acceleration of vibrating element 423 therein.

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

As another example, sensor 416 may include a voltage sensor or voltmeter with a constant current amplifier. A voltage change in the electrical signal supplied to the portion of the vibrating device 400 that includes the vibrating element 423 can be measured using a voltmeter. The frequency of the electrical signal supplied to the vibrating device 400 (eg, from a suitable signal source) can be adjusted until a high voltage is measured by a voltmeter, since at the resonant frequency of the vibrating device: This is because the impedance of vibrating device 400 is higher than other frequencies and therefore the voltage is higher than other frequencies. Accordingly, the monitored voltage can be used to tune (eg, adjust) the frequency of the electrical signal such that high voltage is measured to achieve high efficiency.

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

The sensor 416 is also equipped to receive and/or measure information from the subject, such as movement associated with the transmitted vibration signals, the subject's bone structure, the subject's temperature, the subject's orientation or body position, and the like. can do.

The vibrating device 400 can also include a support element 418 that supports or positions the vibrating device 400 over the target area TA of the subject to transmit the vibration signal as disclosed herein. Support element 418 can be a device or clamping mechanism that can maintain contact and positioning of vibration device 400 with respect to a subject. For example, support element 418 may be a headband, eyeglasses, pillow, or the like, as disclosed in more detail below. In some embodiments, support element 418 may be an adhesive component such as, for example, an adhesive pad, tacky polymer, etc. that can maintain contact and positioning with vibratory device 400 .

Power source 414 , sensor 416 , and/or support element 418 may be housed and/or mounted within body 410 of 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 subject's head and the target area TA is an area that is proximate to and/or part of the bone structure BS. may be The vibration device can be configured to be engageable with the target area TA to effectively transmit therapeutic vibration signals. In an illustrative example, the target area TA may be the area behind the subject's outer ear overlying the mastoid process of the subject's skull (or the mastoid process of the mastoid or temporal bone). In such instances, the mastoid bone may form part of the bony structure BS used to transmit vibrational signals to the vestibular system VS through the bony structures of the inner ear that house the vestibular system VS. In some cases, the zygoma or zygomatic process of the temporal bone can be part of the bony structure BS used to transmit vibrational signals to the vestibular system VS. In another example, the target area TA may be a portion of the back of the head or forehead, with the underlying region of the skull serving as a bony structure BS that conducts vibration signals received from the vibration device 400 . Various force levels can be used to operate the vibration device 400 based on the selected target area TA and distance from the vestibular system VS. For example, when the device is placed in a target area TA, such as the subject's forehead area or behind the subject's head, in areas further from the vestibular system VS than the mastoid process, the device may Higher force levels may be used compared to when placed over the projection. By way of example, when placed on the subject's forehead or behind the head, the vibration device 400 produces a therapeutically effective vibration signal when transmitted elsewhere (e.g., the area overlying the mastoid bone). can be configured to apply a vibration signal having a force level up to 14 dB higher than the force level of . When the target area TA is the area overlying the mastoid bone and the vibrating device is placed over that area, a therapeutically effective force level for treating vestibular conditions is about 87-101 dB re 1 dyne, and desirably about 90-100 dB re 1 dyne, or about 93-98 dB re 1 dyne. Alternatively, when the vibration device 400 is placed behind the subject's forehead or head, the vibration signal applied by the vibration device 400 is between about 101 dB and about 115 dB (i.e., the vibration signal applied to the mastoid bone). 14 dB higher than the force level of ).

Body 410 of vibration device 400 may be configured to house various components of vibration device 400 . In some embodiments, body 410 provides a contact surface for coupling one or more components not housed within body 410, such as power source 414, sensor 416, and/or support element 418. can store some of the components. In some embodiments, the body 410 of the vibrating device 400 is a single piece for housing one or more components of the vibrating device, such as the vibrating element 423, the suspension element 420, the drive circuit 440, and/or the transmission interface 430. One or more chambers or receptacles can be defined. Body 410 may also be shaped and/or configured for desired positioning of transmission interface 430 relative to target area TA of the subject's body (eg, body 410 may be curved or malleable or flexible). flexible surfaces). In some embodiments, body 410 and/or one or more of its chambers may be filled with air, or possibly a liquid such as a lubricant to aid in the generation and transmission of vibrational signals. May be filled. In some embodiments, body 410 and/or one or more of its chambers may also include materials with properties such as audible noise attenuating agents, such as, for example, sponges or sound absorbing materials, heat dissipating materials, and the like.

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

で表されるフックの法則に基づいて決定することができ、ｆは共振周波数であり、ｋはばね定数であり、ｍは質量である。共振周波数での質量およびばねシステムは、より純粋なトーン（例えば、正弦波波形）と関連付けられうるため、質量の移動の振幅は、所与の電力について、他の周波数よりも共振周波数でより大きい。したがって、振動装置４００をその共振周波数で動作させることで、より強い振動信号が生成され、振動要素４２３および／またはサスペンション要素４２０の特性を選択して、特定の共振周波数を達成することができる。 For example, the vibrating element 423 may be a spring or elastic material having a stiffness (eg, spring constant) that enables efficient generation of low-frequency (eg, frequencies below 200 Hz) vibration signals. In one embodiment, vibratory element 423 may be a mass suspended by suspension element 420, which is a spring. The natural resonance of such a system is given by the formula

where f is the resonance frequency, k is the spring constant and m is the mass. Since mass and spring systems at resonant frequencies can be associated with purer tones (e.g., sinusoidal waveforms), the amplitude of mass movement is greater at resonant frequencies than at other frequencies for a given power. . Accordingly, operating the vibration device 400 at its resonant frequency produces a stronger vibration signal, and the properties of the vibration element 423 and/or the suspension element 420 can be selected to achieve a particular resonant frequency.

Other factors that can affect and/or determine the vibration signal generated include, for example, the mechanism of the driving force (e.g. mechanical, magnetic), the ease of movement of the vibrating element (e.g. the location of the target area TA (e.g., mastoid bone, cheekbone, skull near the subject's forehead), reduction of secondary or tertiary pathways of energy dissipation (e.g., off-axis migration, thermal, friction), direction of movement against external forces (e.g. pressure during use, gravity), requirements for ease of use by the subject under various conditions (e.g. subject's mobility, limits on distraction level). mentioned.

The vibrating element 423 can be configured so that it can be driven to produce vibratory movement along or about the axis of the vibrating device 400 (e.g., the longitudinal axis of the body 410), the movement affecting the vestibular state. Generating a vibration signal having appropriate characteristics (eg, frequency, amplitude, force level, etc.) for treatment. Vibrating device 400 includes, in some embodiments, an electromechanical transducer that includes a vibrating element 423 implemented as a magnet that can be driven to move along an axis using a suitable driving force, such as a magnetic field. may be Further details regarding such embodiments are described below with reference to FIGS. 6-9C.

Another method of producing a low frequency vibration signal is to modulate the ultrasound signal. In some embodiments, vibration device 400 may be a piezoelectric transducer driven by an electrical signal to produce vibrations in the ultrasonic frequency range. Vibration of the piezoelectric transducer at this higher frequency can produce acoustic radiation pressure. The drive electrical signal is clocked at a lower frequency of less than 200 Hz (e.g., 60 Hz) such that pressure from the piezoelectric transducer applied on and off at a lower frequency produces a corresponding vibration signal at a lower frequency. can be switched on/off. The use of piezoelectric transducers can reduce the size and weight of vibrating device 400 because piezoelectric transducers are typically smaller and lighter than other types of electromechanical transducers.

Depending on where the vibrating device 400 is placed, the dimensional limitations of the vibrating device 400, and/or the configuration or shape of the vibrating device 400, certain components of the vibrating device 400 may be used therapeutically to treat vestibular conditions. It can be selected to provide an effective level of vibration signal. Although one vibrating element 423 is illustrated in FIG. 5, those skilled in the art will appreciate that the vibrating devices 400 work together and/or independently to produce a vibrating signal for treating vestibular conditions. It will be appreciated that one or more additional vibrating elements may be included.

As with other vibrating devices or systems, vibrating device 400 can be associated with a range of resonant frequencies. In some embodiments, vibrating element 423 is such that the amount of power in the vibrating signal generated at the lowest resonant frequency associated with vibrating device 400 is reduced to the remaining resonant frequencies (eg, higher resonant frequencies) associated with vibrating device 400 . may be configured to move in response to a driving force greater than the amount of power of the vibration signal at the . For example, the vibration device has a lowest resonant frequency of about 10 Hz to about 200 Hz, about 10 Hz to about 150 Hz, about 10 Hz to about 100 Hz, about 10 Hz and about 80 Hz, about 30 Hz to about 80 Hz, or about 50 Hz to about 70 Hz; It may be configured to include other values and subranges therebetween. In some embodiments, vibration signals generated at the lowest resonant frequencies in these ranges may have a greater amount of power than vibration signals that may be generated at other resonant frequencies. In some embodiments, vibration element 423, suspension element 420, and/or other elements of vibration device 400 may be selected such that vibration device 400 vibrates at a lowest fundamental frequency of less than 200 Hz.

In some embodiments, vibrating element 423 vibrates at a first resonant frequency along a first axis (eg, an axis in the z direction) and a second axis (eg, an axis in the xy plane). ) at a second resonant frequency. To reduce vibration along the second axis, vibrate element 423, suspension element 420, and/or other elements of vibratory device 400 are arranged 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 from the second resonant frequency by several Hertz and/or is a harmonic of the second resonant frequency), It can be selected such that vibration along two axes can be reduced when vibrating device 400 is stimulated at the first resonant frequency. Vibration along the second axis may, for example, lead to internal collisions between components of vibrating device 400 and/or audible sounds.

The vibration device 400 can be placed in different areas on the subject's head. FIG. 16 depicts a human skull and several exemplary regions of the skull in which a vibration device 400 may be positioned to apply therapeutic vibration signals for treating vestibular conditions disclosed herein. indicates For example, as shown in FIG. 16, the vibration device 400 can be placed on the mastoid bone 1502 of the subject's skull in some cases. Although the left mastoid bone 1502 is identified in FIG. 16, those skilled in the art will appreciate that the vibrating device 400 can be placed over the subject's left or right mastoid bone. Will. In other examples, the vibrating device 400 can be applied to a portion of the back of the head (eg, the left, right, or middle portion of the occipital bone 1501) to treat vestibular and other conditions disclosed herein. It can be placed on top, or over a portion of the forehead (eg, the left, right, or middle portion of the frontal bone 1504) to transmit the vibration signal. Depending on the area in which the vibrating device 400 is placed (e.g., proximity to the vestibular system, regardless of whether vibrations from the device need to cross the suture line 1503), therapeutically to treat the condition. The force level of the vibration signal may be adjusted such that an effective level of vibration is transmitted to the vestibular system.

When the vibrating device 400 is positioned over the mastoid bone (e.g., the mastoid bone 1502 shown in FIG. 16), the vibrating device 400 vibrates below 200 Hz (e.g., about 10 Hz, about 30 Hz, about 50 Hz, about 70 Hz). , about 100 Hz, about 150 Hz, and all values and subranges therebetween), and a power level between 87 and 101 dB re 1 dyne (or about 90 and 100 dB re 1 dyne). A therapeutically effective oscillating signal (ie, a therapeutically effective oscillating signal) can be applied to treat the condition of the system. Vibration device 400 is positioned over different regions of the subject's head that are further from the subject's vestibular system than the mastoid bone (eg, cheekbone 1505 shown in FIG. 16, or frontal bone 1504 or posterior bone). If the skull 1501), the vibratory device 400 then vibrates the vestibular in a manner that is equivalent to the therapeutically effective vibratory signal applied to the region above the mastoid bone (e.g., 1502 shown in FIG. 16). A vibration signal can be generated with a greater force level so that it can affect a portion of the system. For example, if the vibration device 400 is placed over the subject's frontal bone (e.g., frontal bone 1504 in FIG. 16), the vibration device 400 is applied to the area overlying the mastoid bone. A vibration signal can be generated that has a higher force level (eg, up to 14 dB re 1 dyne or greater) than the force level of the vibration signal.

In the embodiments described herein, force level represents a unit of bone conduction “loudness” and increases with increasing amplitude of vibration, frequency of vibration, and mass of the system (e.g., vibrating device). can be done. Force levels combined with frequency produce impulses (changes in momentum) that can stimulate the vestibular system in a therapeutically effective manner. Momentum is directly proportional to force and inversely proportional to frequency. Therefore, at high frequencies, eg above 200 Hz, the force required to generate sufficient impulses to stimulate the vestibular system must also increase. Conventional bone conduction devices (e.g., bone conduction speakers) are designed to produce vibrations at a frequency of approximately 250 Hz, and therefore such devices can produce therapeutically effective vibrations. To do so, it is necessary to produce high force level vibrations that can produce undesirably loud sounds. Most conventional bone conduction systems overheat and fail before reaching such high force levels. In the systems and devices described herein, the frequencies applied by the vibratory device (eg, bone conduction device) are low (eg, less than 200 Hz), so therapeutically effective vibrations can be generated. The systems and devices described herein avoid producing perceptible levels of audible and/or tapping sensations, both of which are undesirable and distracting to the user. Possible.

Suspension element 420 of vibration device 400 may include one or more components housed in body 410 and interacting with vibration element 423 . In some embodiments, suspension element 420 and/or vibration element 423 may be configured with adaptations to accommodate each other. For example, suspension element 420 can include components that can extend through openings defined in vibrating element 423 .

In some embodiments, suspension element 420 may be housed within a chamber of body 410, and in some examples may be placed in a fluid, such as a lubricant. Suspension element 420 may be configured to exert a force on vibratory element 423 to suspend, hold, or support vibratory element 423 in an equilibrium position until driven to move by application of a drive signal. For example, suspension element 420 may be a spring coupled to vibratory element 423 (eg, magnet). Alternatively or additionally, suspension element 420 includes a pair of magnets arranged with oscillating element 423 (eg, another magnet), each of which exerts a force (eg, opposing force) between oscillating elements 423 . Forces can be applied to the vibrating elements 423 in opposite directions (e.g., opposing or repelling magnetic forces) to collectively hold the vibrating elements 423 in an equilibrium position. In such embodiments, a driving force (e.g., an applied magnetic field having a particular magnitude and acting along a particular direction) induces vibrating element 423 (e.g., a magnet in an equilibrium position) to can be moved between magnets. In other embodiments, suspension element 420 may be a resilient material or fluid. Although one suspension element 420 is illustrated in FIG. 5, those skilled in the art will appreciate that multiple suspension elements 420 can be used to support and/or suspend vibratory element 423 . Plurality of suspension elements 420 may include one or more different types of suspension elements (eg, magnets, springs, elastic materials, etc.).

The drive circuitry 440 of the vibration device 400 may include one or more suitable components capable of generating electrical signals. The electrical signal can generate a force to induce movement of the vibrational element 423 along the axis to generate a therapeutic vibrational signal. Drive circuit 440 may, in some embodiments, receive an electrical signal from a control unit (such as control unit 360 of FIGS. 4A and 4B). In some other embodiments, the drive circuit 440 itself may include an on-board unit capable of generating electrical signals.

The electrical signal generated or received by the drive circuit 440 and used to induce movement of the vibrating element 423 can have properties suitable for producing a vibrating signal having a particular frequency and force level. For example, the electrical signal can be selected to cause vibrating element 423 to generate a vibrating signal having a particular frequency range (eg, less than 200 Hz) for treating one or more particular vestibular conditions. In some embodiments, a control unit (eg, control unit 360) can change the frequency of the electrical signal until the electrical signal causes vibrating device 400 to vibrate with sensor 416 at a resonant frequency as described above.

In some embodiments, the drive circuit 440 converts the electrical signal to an on-board signal generator for generating the electrical signal, an amplifier for amplifying the signal, and suitable means for moving the vibrating element 423. Can contain one or more elements. For example, drive circuitry 440 can include one or more coils that can generate magnetic fields that move vibrating element 423 .

The transmission interface 430 of the vibration device 400 is adapted to transmit the vibration signal generated by the vibration element 423 to the subject's target area TA such that the vibration signal is transmitted through the bony structure BS underlying the vestibular system VS. can be configured to The transmission interface 430 conforms to the structure and/or shape of the user's target area TA such that the transmission interface can engage and/or maintain contact during use for the transmission of therapeutic vibration signals. , and/or can be adapted. In some embodiments, the transmission interface 430 can be configured for comfort and ease of use for the user, for example, during use of the vibration device 400 to alleviate vestibular conditions. The transfer interface 430 may also be configured to reduce undesirable secondary effects such as heat generation and accumulation, audible noise generation, lack of air circulation, and application of pressure to the target area TA. For example, the transmission interface 430 can include a layer of shape memory material that can help conform to the contours of the target area (eg, the area behind the ear overlying the mastoid). Shape memory materials may also aid in heat dissipation, dampening audible noise, promoting air circulation, minimizing discomfort due to pressure from support elements such as headbands, and the like.

FIG. 6 is a schematic illustration of an exemplary vibration device 500 according to one embodiment. Vibration device 500 includes a body (or housing) 510 that includes a tube 526 and end caps 525a, 525b. In some embodiments, the body 510 of the vibration device 500 can define a chamber. Body 510 houses a vibration element implemented as magnet 523 and suspension elements implemented as magnets 520a, 520b. The suspension elements include magnets 520a, 520b and the vibrating element 523 includes magnets 523, as shown in the cutaway view of FIG. Magnets 520, 520b act as suspension elements by exerting a repulsive force on magnet 523 to suspend magnet 523 in an equilibrium position, as shown in FIG. For example, magnet 520a may be configured to apply a force on first magnet 523 in a first direction, and magnet 520b may apply a force on first magnet 523 in a second direction (e.g., first can be configured to apply a force (eg, a force equivalent to the force applied to magnet 523 by second magnet 520a) in a second direction 180 degrees away from the direction of . In this manner, the first magnet 523 is arranged such that the second magnet 520a and the third magnet 520b collectively suspend the first magnet 523 at a position within the body 510 (eg, the equilibrium position). It can be positioned between a second magnet 520a and a third magnet 520b within the body 510 (eg, chamber).

Magnet 523 acts as a vibrating element configured to move (eg, oscillate back and forth or oscillate) to generate a vibration signal. Vibrational element 523 can be collectively suspended within body 510 (eg, chamber) by suspension elements 520a, 525b such that vibrational element 523 can vibrate about an equilibrium position.

In some embodiments, vibration device 500 can include an elongated member having a longitudinal axis. The elongated member can be configured to extend through the opening of the vibrating element 523 such that the vibrating element 523 can be configured to vibrate along the longitudinal axis of the elongated member. The elongated member can be further configured to reduce back-and-forth vibration or vibration of vibrating element 523 along any axis other than the longitudinal axis. As shown in FIG. 6, the vibration device 500 further includes an elongated member in the form of a pin 521 that can be secured to the end caps 525a, 525b. The pin 521 passes through openings 522a, 522b defined in the end caps 525a, 525b of the vibration device 500, openings defined in the magnets 520a, 520b, and openings defined in the magnet 523. Pin 521 provides an axis for movement of magnet 523 (eg, along the longitudinal axis of pin 521). Vibrating device 500 further includes a drive circuit including coils 524 configured to generate a magnetic field that can drive the vibrating device using an electrical signal. Vibration device 500 includes a bushing 522c configured to fit into an opening defined in magnet 523 and configured to provide a bond between pin 521 and magnet 523, allowing magnet 523 on pin 521 to engage. allows smooth movement of

During operation, vibration device 500 is driven at a low frequency (eg, less than 200 Hz) using an electrical signal comprising a sine wave or another type of signal waveform. Coil 524 is operable to generate a magnetic field with the induced current. The magnetic field then applies a magnetic force to magnet 523 . A magnetic force, when applied to magnet 523, causes magnet 523 to move along an axis indicated by arrow "A" in FIG. Magnet 523 is configured to move in one of the directions shown depending on the direction of the magnetic field vector.

Magnets 520a and 520b forming the suspension elements each produce a constant magnetic field, each of which is applied to magnet 523 (i.e., the north side of magnet 520a faces the north side of magnet 523 and the south side of magnet 520b). facing the south side of magnet 523). Magnets 520 a , 520 b thus exert a repulsive force on magnet 523 . The repulsive force generated by magnets 520a, 520b is operable to suspend magnet 523 in the balanced position such that magnet 523 oscillates back and forth about the balanced position and produces one or more vibration signals. . The electrical signal causes magnet 523 to oscillate or move back and forth along axis A, which may coincide with or substantially correspond to the longitudinal axis of pin 521 .

In some embodiments, magnets 520a, 520b and 523 are oriented other than along axis A, which can affect system efficiency and increase unwanted friction causing secondary vibration signals (e.g., buzzing). Vibration device 500 can be configured such that movement of magnet 523 is limited by pin 521 to prevent back-and-forth vibration or movement in the direction of . In some embodiments, each of the magnets 520a, 520b can be secured to the end caps 525a, 525b of the vibration device 500 using glue, epoxy, or another form of adhesive. A magnet 523 can be mated with the interface of bushing 522c around pin 526, thereby limiting any movement not along axis A while allowing magnet 523 to move smoothly over pin 521. to enable. 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, 522b.

In some embodiments, tube 526 includes a lubricant (e.g., ferrous fluid) or low friction material (e.g., a polytetrafluoroethylene) on its inner surface. Friction reduction can be configured to ensure quieter operation of the vibration device 500 (eg, less noise generated by potential friction from contact). Such lubricants may also be used to reduce friction between bushing 522c and pin 521. FIG.

In some embodiments, the outer surface of tube 526 and/or end caps 525a, 525b can be covered with a sound absorbing material. Additionally, in some embodiments, one or more of the end caps 525a, 525b may be covered with a friction reducing material (e.g., lubricious material), or a shock absorbing material or padding material, e.g., cork. Well, as a result, when the end caps come into contact with the user's skin or body, the contacts are less abrasive than if the end caps 525a, 525b were not covered with such material. Additionally, in some embodiments, one or more of the endcaps 525a, 525b may be attached to a structure that increases the surface area of the endcaps so that the endcaps are not exposed to the user's skin or body. When in contact with , the contact spreads over a larger area, reducing pressure on the skin or body by the end cap.

It should be understood that the magnets 520a, 520b are one example of elastic bodies that can be used to form suspension elements within the vibration device 500. FIG. In other embodiments, magnets 520a, 520b may be replaced by other elastic bodies (eg, springs, elastic polymers).

FIG. 7A shows an embodiment of a vibration device 600 that includes springs as suspension elements. Vibration device 600 may be similar to vibration device 500 shown in FIG. 6 described above. For example, vibrating device 600 can include housing 610 including tube 626 (eg, nylon tube) and end caps 625a, 625b. Vibration device 600 includes a magnet 623 forming a vibrating element and a coil 624 for driving movement of magnet 623 to generate a vibration signal used to treat the vestibular conditions disclosed herein. It can further include circuitry.

7A, the vibration device 600 can include suspension elements implemented as springs 620a, 620b in place of the magnets 520a, 520b of the vibration device 500 shown in FIG. Magnets 623 can be collectively suspended by springs 620a, 620b within housing 610 (eg, within a chamber) such that magnets 623 can oscillate about an equilibrium position when energized by an electrical signal.

As described above with reference to vibratory device 500, in some embodiments, vibratory device 600 can include an elongated member having a longitudinal axis. The elongated member can be configured to extend through an opening in the magnet 623 of the vibrating element such that the magnet 623 can be configured to vibrate along the longitudinal axis of the elongated member. The elongated member can be further configured to reduce back-and-forth oscillation or vibration of the magnet 623 along any axis other than the longitudinal axis.

Springs 620a, 620b may be elongated members, cavities in end caps 625a, 625b, and/or end caps such as rigid and/or flexible structures (eg, pins, foam, rubber, or any other material). It may be supported by other suitable structures (not shown in FIG. 7A) extending from the . Springs 620a, 620b may be configured to expand and compress along an axis (eg, a longitudinal axis), and magnets 623 attached to springs 620a, 620b may oscillate back and forth along the same axis. Or it can be configured to vibrate to produce a therapeutic vibration signal. The springs used as the elastic bodies forming the suspension elements can be attached to other parts of vibratory device 600 (e.g., magnet 623, tube 626, and/or or to the end caps 625a, 625b). Springs 620a, 620b may be configured to reduce back-and-forth vibration of the magnet along any axis other than the axis of the spring (eg, the longitudinal axis).

Springs 620a, 620b may be of any suitable material (eg, stainless steel) and may be selected to have a particular stiffness relative to the spring constant k so that they are driven by electrical signals. allows movement of the magnet 623 along the axis indicated by arrow "B". Springs 620 a , 620 b may be configured to be attached to magnet 623 and a portion of housing 610 . For example, each spring (620a and 620b) can have a first end that can be attached to a portion of housing 610 and a second end that can be attached to magnet 623. FIG. In this manner, the spring can be configured to exert a force on the magnet and suspend the magnet in position within the chamber. For example, springs 620a and 620b each move in opposite directions such that as one spring (e.g., 620a) expands, the other spring (e.g., 620b) contracts as magnet 623 moves, and vice versa. An equivalent force can be exerted, resulting in a back-and-forth oscillation or oscillation of the magnet 623 along an axis (eg, the longitudinal axis of the spring) and movement of the magnet 623 about the suspended position (eg, the equilibrium position). can be configured to occur at Vibration device 600 can include one or more adhesive pockets 632, 634 as respective coupling points between springs 620a, 620b and magnets 623. FIG.

In some embodiments, springs 620 a , 620 b are operable to prevent contact between magnet 623 and the inner surface of tube 626 . As described above with reference to vibration device 500, tube 626 of vibration device 600 reduces potential friction from any contact between magnet 623 and the inner surface of tube 626 during movement of magnet 623. To do so, the inner surface may contain and/or include a lubricant (eg ferrous fluid) or a low friction material (eg polytetrafluoroethylene). In some embodiments, rods or pins (not shown in FIG. 7A) and bushings (not shown in FIG. 7A) are used to further limit movement of magnet 623 in directions other than along axis B. may be included in

FIG. 7B shows a cutaway view of the vibration device 600 of FIG. 7A attached to a transmission interface 630 for transmitting therapeutic vibration signals. As mentioned above, magnet 623 acts as an oscillating element suspended by springs 620a, 620b. Transmission interface 630 may be a shape memory pad configured to transmit vibration signals from vibration device 600 to the subject's body. Although magnets and springs are provided as examples of suspension elements, those skilled in the art will appreciate that other types of elastic bodies may be used in place of and/or in addition to magnets and/or springs. will understand.

The vibrating devices disclosed herein (eg, vibrating devices 400, 500, 600, 700) can have a high Q factor (eg, can vibrate back and forth with greater amplitude in a narrow frequency range). In some embodiments, the vibration device is operable at a lowest fundamental frequency, such as a frequency of 50-70 Hz, with a low amount of power directed towards the higher and more audible resonant frequencies.

FIG. 8 illustrates a cross-sectional view of a vibration device 700 according to one embodiment. The vibration device 700 may be similar to the vibration devices 500,600. For example, vibration device 700 drives movement of housing 710, vibration elements implemented as magnets 723, suspension elements implemented as springs 720, and magnets 723 to treat vestibular conditions disclosed herein. A drive circuit may be included that includes a coil 724 that produces a vibration signal used for vibration. Magnet 723 can be suspended by a spring 720 within housing 710 (eg, within a chamber) such that magnet 723 can oscillate about an equilibrium position when energized by an electrical signal transmitted by a drive circuit.

In some embodiments, the length of spring 720 can be extended to reduce the spring constant of spring 720 and thereby affect the resonant frequency of vibrating device 700, which results in lower frequency generation. to enable. To change the length of the spring without changing the size of the vibration device 700, the spring 720 can be configured to pass through an opening 723a defined by the magnet 723. FIG. As shown in FIG. 8, the springs 720 are attached to a mounting plate 728 and can be glued beyond the magnets 723 rather than attached near the magnets 723 . In this way, the length of spring 720 can be increased to a length equal to or substantially equal to the thickness of magnet 723, while the length of vibration device 700 may remain the same. In some embodiments, instead of having a mounting plate 728, magnet 723 may have an opening extending through a portion of its length (eg, about 95% of its length), Spring 720 extends through the opening and may be attached to the distal end of magnet 723 in a manner similar to how spring 720 attaches to mounting plate 728 .

Similar to the vibration device 600 depicted in FIG. 7B, the vibration device 700 shown in FIG. 8 can also be attached to a transmission interface (eg, transmission interface 730) to transmit a vibration signal to the subject's vestibular system. . The transmission interface 730 conforms to the surface of the target area and acts as an interface between the vibration device 700 and the target area to effectively transmit the vibration signal using a pad material such as a shape memory pad. can contain.

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

Vibration device 700 may have a high Q factor. In operation, the frequency of the signal used to activate the vibration device 700 can be selected such that the vibration device 700 operates at its resonant frequency, increasing the amplitude of the back-and-forth vibration for a given power input. In one embodiment, sensor 790 can include a Hall effect sensor configured to monitor magnetic field fluctuations. If the frequency of the electrical signal supplied to vibrating device 700 from a signal source capable of varying force level and/or frequency (e.g., signal generator 370 and/or amplifier 380) matches the resonant frequency of vibrating device 700; , magnet 723 may move further (eg, oscillate back and forth or oscillate with greater amplitude) than at other frequencies. Therefore, the magnetic field fluctuation caused by the back-and-forth vibration of magnet 723 can increase when the frequency of the electrical signal matches the resonant frequency of vibration device 700 . This relative variation can be monitored using Hall effect sensors.

More specifically, a microcontroller or microprocessor (e.g., control unit 360) receives signals from Hall effect sensors and adjusts the frequency of electrical signals used to power vibration device 700 based on the sensor readings. may be operable to For example, the microcontroller may be operable to scan a set frequency range (eg, 50-65 Hz) and select the frequency of the electrical signal that produces the highest level of magnetic field fluctuations. This process is sometimes called "tuning." The sensor 790 and microcontroller combination may then continue to tune the frequency of the electrical signal supplied to the vibration device 700 in order to maintain its efficiency each time the device is powered on. Additionally, after the frequency of the electrical signal is selected, the frequency may vary over time due to temperature, wear, or other variables that may cause the properties of the components of the vibration device 700 (e.g., spring 720) to change over time. may be modified around the selected frequency to determine if the frequency of the electrical signal associated with peak efficiency changes.

In some embodiments, sensor 790 may include ammeters, voltage meter, accelerometer, or some other type of sensor.

Integrated circuit 706 can act as an end cap to further reduce the size of vibration device 700 . The transmission interface 730 is, for example, an operable foam pad that conforms to the user's skin surface and acts as a structure capable of transmitting vibration signals from the vibration device 700 to the body so that they can be transmitted to the vestibular system through the bones. There may be. The transmission interface 730 may be configured to efficiently transmit vibration signals to the head with good coupling.

In some embodiments, vibration device 700 may be configured to reduce friction and/or contact between internal structures to avoid audible sounds (ie, noise, buzzing). For example, the magnets 723, coils 724, housing 710, etc. may be positioned with sufficient tolerance to each other to reduce contact between the various components while allowing natural rocking and rocking of the components. .

Similar to magnet 623 of vibration device 600 , magnet 723 may also oscillate in directions not along axis C, which may cause magnet 723 to contact the inner surface of vibration device 700 . This contact may produce an audible sound and/or reduce the efficiency of vibrating device 700 . In some such embodiments, noise may be minimized by selecting springs 720 and magnets 723 whose characteristics make the shaft resonance frequency not the same as the rocking resonance frequency or any harmonics thereof. . Vibration device 700 is then operated at a frequency corresponding to the shaft resonance frequency rather than the vibration resonance frequency to reduce rocking and unintentional contact between magnet 723 and other components of vibration device 700. sell.

To adjust the output level of the mechanical vibration signal by vibration device 700, the voltage of the electrical signal input to vibration device 700 may be increased. Alternatively or additionally, the frequency of the electrical signal may be adjusted to the resonant frequency to adjust the power level of the vibration signal.

FIG. 9A shows a perspective view of a spring 820 that can act as a suspension element for a vibration device (eg, spring 720 of device 700 described above). Orienting the springs may reduce the amount of rocking, deflection, or unwanted movement of the magnet (eg, magnet 723) in the secondary direction. As shown in FIGS. 9B and 9C (which present views of two ends of spring 820), spring 820 begins at a 0° position where first end 820a of spring 820 begins at a second end 820b of spring 820. It may be oriented to terminate at the 180° position. In other embodiments, the springs 820 are at other angular intervals, e.g., 90°, 270°, etc., and end can do. In some embodiments, the orientation of spring 820 can be selected based on the placement of sensors such as accelerometers or Hall effect sensors, for example.

10-15 are illustrations of various embodiments of vibration devices that may be included in and/or incorporated into various support elements. Although one or two vibratory devices may be depicted in these figures, those skilled in the art will recognize that any number of vibratory devices can be included in various embodiments. With multiple vibrating devices, the force level of the vibrating signal from each device can be reduced because the combined effect of the vibrating signals can be a therapeutically effective level for treating vestibular conditions.

FIG. 10 shows a vibrating device 900 having a body 910 incorporated into a headband 918 worn on the subject's head HD. Vibration device 900 includes control unit 906, similar to control unit 360 described above. The headband 918 may be an elastic material, a hook-and-loop material, a metal material, or a plastic material, or the headband 918 may hold the vibration device 900 on the subject's head HD to be conducted through the bones to the vestibular system. It can be made from other materials that allow effective delivery of vibrational signals. The vibrating device 900 may include an on-board power source (e.g., battery) for powering the control unit 906 and/or other components of the vibrating device 900, or a power source separate from the headband 918 (e.g., a battery pack). ) via a wire. Control unit 906 may include the electrical drive circuitry necessary to generate vibration signals to treat vestibular or other conditions disclosed herein. Alternatively, such circuitry and power supply may be operably connected to vibratory device 900 . In some embodiments, the headband 918 may incorporate additional devices such as headlamps or other suitable headgear to meet various needs of the subject.

FIG. 11 illustrates the use of vibratory devices 1000a, 1000b incorporated into support elements in the form of headphones 1002, according to one embodiment. The headphones 1002 may include audio speakers 1003a, 1003b and an elongated portion 1018 (eg, band) connecting the audio speakers 1003a, 1003b. In some embodiments, headphones 1002 may be passive noise reduction devices such as earmuffs and do not include components such as audio speakers. Vibration devices 1000a, 1000b may be similar to any other vibration devices described herein (eg, vibration devices 300, 400, 500, 600, 700, 800). The headphones 1002 can be used to reduce the level of audible sound caused by the vibrations produced by the vibrating devices 1000a, 1000b, but not the vestibular system (e.g., the vibration signals produced by the vibrating devices 1000a, 1000b). It may include noise canceling circuitry that does not cancel other vibrations that are conducted (through the bone). For example, system 1002 may include noise canceling circuitry that produces a signal (or signals) that is out of phase with the audible signals produced by vibratory devices 1000a, 1000b (eg, 180 degrees out of phase). Such out-of-phase signals act to reduce the signal level of such audible signals detected by the subject's vestibular system so that the subject may not hear audible sounds.

When used with headphones 1002, the vibrating devices 1000a, 1000b are positioned over the mastoid bones when the audio speakers 1003a, 1003b are positioned over the ears. 1003a, 1003b. Alternatively or additionally, in some embodiments, one or more vibrating devices 1000a, 1000b are co-located with speakers 1003a, 1003b such that the decorative shape or contour of headphones 1002 is not affected. It may also be incorporated into the ear cups of the headphones 1002 that may be located.

Alternatively or additionally, in some embodiments, one or more of vibrating devices 1000a, 1000b (or additional vibrating devices not shown) may be positioned along headband 1018, Or it may extend from a portion of the headphones 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 used by the user without the vibrating devices 1000a, 1000b. It may be incorporated into an attachment that attaches to and detaches from headphones 1002 so that one can choose to have headphones or headphones with vibrating devices 1000a, 1000b.

FIG. 12 shows yet another embodiment of a vibration device 1100a, 1100b that may be incorporated into or connected to a pillow 1110 (eg, travel pillow, cushion, etc.). The position of the vibration devices 1100a, 1100b on the pillow 1110 may be configured such that when the subject places his or her head on the pillow 1110, the vibration devices 1100a, 1100b cover, for example, the subject's mastoid bone. . In other embodiments, the vibration devices 1100a, 1100b may be positioned over other areas of the subject's head.

FIG. 13 shows yet another embodiment of a vibration device 1200 that may be incorporated into or connected to a seat 1210 (eg, car seat, child's booster chair, office chair, etc.). The seat 1210 and vibration device 1200 are arranged such that, for example, when the subject's head hits the seat headrest 1212, the vibration device 1200 can cover a portion of the subject's head and transmit vibration signals to the head. can be configured. In some embodiments, the vibration device can be removably attached to seat 1210 using support elements 1218 so that it can be removed when not in use. In some embodiments, the vibrating device may be attached to the side of the seat belt or seat, in which case the subject may position their head laterally (e.g., in contact with the vibrating device). Vibration can be applied by

FIG. 14 shows another embodiment of vibration devices 1300a, 1300b that may be incorporated into or connected to a pair of glasses 1310. As shown in FIG. Although eyeglasses are depicted in FIG. 14, those skilled in the art will appreciate that other types of eyewear (e.g., goggles, sunglasses, safety glasses) may also be suitable with one or more vibrating devices. will recognize that The vibrating devices 1300a, 1300b may be positioned on the glasses 1310 on ear portions 1311a, 1311b that may come into proximal contact with the subject's head during use of the glasses 1310 . The vibrating devices 1300a, 1300b can be positioned such that when the subject wears the glasses 1310, the vibrating device covers a portion of the head, allowing vibration signals to be transmitted onto the head and vestibular system.

FIG. 15 illustrates another embodiment of a vibration device 1420 attached to or incorporated into a virtual reality device 1410 (eg, a device that can be used to experience a virtual reality or augmented reality environment). Vibration apparatus 1400 can be positioned on virtual reality device 1410 on band 1441 of virtual reality device 1410 and may be used to secure or support virtual reality device 1410 on a subject's head, and Proximal contact with the head may be made while using the virtual reality device 1410 . One or more vibration devices may be attached anywhere along band 1441 of virtual reality device 1410 . When the subject wears the virtual reality device 1410, the vibration device 1400 covers a portion of the subject's head such that the vibration device 1400 transmits vibration signals onto the head and vestibular system (e.g., It may be positioned on the virtual reality device 1410 so that it can be communicated (via a communication interface).

25A-25C show schematic diagrams of the housing 2410 of the vibration device 2400. FIG. Vibration device 2400 may be similar in structure and/or function to any of the vibration devices described herein. For example, vibration device 2400 may be similar to vibration devices 500, 600, and/or 700 described above. 25A-25C, vibration device 2400 can include transmission interface 2430 and inner housing 2426 within outer housing 2410. In FIGS. In some embodiments, outer housing 2410 can be formed by joining two portions 2410a and 2410b, as shown in the exploded view of FIG. 25C. FIG. 26 shows a cross-sectional view of housing 2410 showing the connection between the two portions 2410a and 2410b, which may be via mechanical attachment, adhesive, or the like. Inner housing 2426 may include vibrating elements (eg, magnets), coils, and/or other structures associated with vibrating devices described herein.

27A, 27B, and 27C show perspective, side, and exploded views, respectively, of vibration device 2500, according to one embodiment. 28A and 28B show perspective and cross-sectional side views, respectively, of vibration device 2500. FIG. Vibration device 2500 can be substantially similar in structure and/or function to other vibration devices described herein (eg, vibration devices 500, 600, and 700). For example, vibration device 2500 can include housing 2510 , transmission interface 2530 and end cap 2525 . Vibration device 2500 may include electromagnetic coils 2524 a and 2524 b configured to generate magnetic fields to move magnet 2523 . In some embodiments, coils 2524a and 2524b can, for example, be wound in opposite directions to produce magnetic fields of opposite polarities. Although illustrated as having two coils 2524a and 2524b, in some embodiments, vibrating device 2500 is a single coil configured to generate a magnetic field of varying polarity to induce movement of the magnets. It may contain one coil. A single coil may, for example, be driven by two separate drive circuits that generate drive signals of different polarities. In some other embodiments, a single driver circuit can be used to generate signals of different polarities, eg, using phase-switching circuits. Vibration device 2500 may include spring 2520 coupled to magnet 2523 and configured to act as a suspension element. Vibration device 2500 may include mounting plates 2528a and 2528b and magnet 2523 may be attached to the distal end of magnet 2523 so that spring 2520 may extend through the opening through mounting plate 2528b and be attached to the distal end of magnet 2523. It may have an opening extending through a portion of its length, similar to the way spring 720 is described as attached to mounting plate 728 in vibration device 700 .

Magnets 2523 of vibration device 2500 may include metal end plates 2529a and 2529b. In one embodiment, the end plate 2529b can serve as a mounting plate 2328b for the spring 2520. The endplates may be configured to reduce stray magnetic flux. For example, a vibrating device having a magnet acting as a vibrating element may have magnetic field lines straying far from the magnet, causing the vibrating device to be magnetically attracted to the metal object. This attraction can lead to unwanted side effects and be a hindrance during use. End plates 2529a and 2529b can reduce such stray magnetic flux so that vibratory device 2500 can be used near other metal objects without being attracted to those objects to the same extent. In addition, the end plates 2529a and 2529b are perpendicular to (e.g., toward) the magnetic field generating coils 2524a and 2524b such that more magnetic field lines are oriented to enable movement of the magnets relative to the vibration device 2500. ) direction, while reducing stray dissipation or leakage of the magnetic field lines in directions parallel to the coil (eg, away from the coil).

FIG. 38 shows a perspective view of a portion of a vibration device 2600, according to another embodiment. Vibration device 2600 may be substantially similar in some aspects of structure and/or function to other vibration devices described herein (eg, vibration devices 500, 600, 700, and 2500). good. For example, vibration device 2600 can include a housing and a transmission interface (not shown in FIG. 38). Vibration device 2600 may include an end cap 2625 that may be coupled to electromagnetic coils 2624 a and 2624 b configured to generate magnetic fields to move magnet 2623 . In some embodiments, endcap 2625 may include a suitable electrical interface 2627 for delivering electrical signals to electromagnetic coils 2624a and 2624b. In some embodiments, coils 2624a and 2624b can be wound in opposite directions to generate magnetic fields of opposite polarities. In some embodiments, coils 2624a and 2624b may be spaced a suitable distance from each other, as shown in FIG. 38, while in other embodiments (e.g., shown in FIGS. 28A and 28B). ) may place the coils close to each other in space.

Vibration device 2600 may include spring 2620 coupled to magnet 2623 and configured to act as a suspension element. Vibration device 2600 may include a mounting plate (not shown in FIG. 38) with magnet 2623 attached to the distal end of magnet 2623 via a mounting plate with spring 2620 extending through an opening. As can be seen, it may have an opening extending through a portion of its length, similar to the manner described as the spring 2520 is attached to the mounting plate 2528b in the vibration device 2500. The magnets 2623 of the vibration device 2600 may include metal end plates 2629a and 2629b (shown in FIG. 29) having substantially similar structure and/or function as the metal end plates 2529a and 2529b of the vibration device 2500. End plates 2629a and 2629b can be configured to reduce stray magnetic flux, as described with reference to vibration device 2500. FIG. End plates 2629a and 2629b can limit any stray magnetic flux so that vibratory device 2600 can be used near other metal objects without being attracted to those objects. The metal end plates 2629a and 2629b direct the magnetic field lines in a direction perpendicular to (e.g., toward) the magnetic field generating coils 2624a and 2624b such that more magnetic field lines enable movement of the magnets relative to the vibrating device 2600. while reducing stray dissipation or leakage of magnetic field lines in directions parallel to (eg, away from) the coils.

An exemplary illustration 2700a of magnetic field lines focused by metal end plates 2629a and 2629b is shown in FIG. Plot 2700b of FIG. 30 of the normalized flux density measured over the distribution of arc lengths shows the relative flux leakage of the vibrating device without end plates (line 2702) relative to end plates 2629a and 2629b (line 2704). , compared to the reduced magnetic flux leakage of vibrating device 2600 with As shown, the use of metal end plates (eg, 2629a and 2629b) can result in reduced leakage flux. In some embodiments, end plates 2629a and 2629b are coupled to coils 2624a and 2624b so that a lower driving force is used to induce the desired movement of magnetism 2623 and generate therapeutically effective vibrational signals. can allow for more efficient use of the magnetic field energy generated by In some embodiments, the metal end plates 2629a and 2629b focus the magnet's field lines in such a way that less power is required to drive movement of the magnet (e.g., in a directory towards the coil). can be used for In such embodiments, a smaller magnet 2623 may be used to generate a vibration signal of predetermined strength, thereby reducing the size of vibration device 2600 . Metal plates 269a and 2629b can be any suitable material capable of focusing magnetic field lines, as described above. In one embodiment, end plates 2529a and 2529b and/or end plates 2629a and 2629b can be made of low carbon steel.

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

Magnet 2823 may include metal end plates 2829a and 2829b. End plates 2829 a and 2829 b may be substantially similar to end plates 2529 a and 2529 b described with reference to vibration device 2500 . In one embodiment, metal end plates 2829a and 2829b can be made from low carbon steel. Metal end plates 2829a and 2829b focus the magnetic field lines of magnet 2823 in a direction perpendicular to coil 2824 (eg, cause the magnetic field lines of magnet 2823 to exit the end of the magnet in a direction perpendicular to coil 2824). , can be configured to reduce stray dissipation or leakage of the horizontal magnetic field. 33 shows the relative positioning of magnet 2823 with metal end plates 2829a, 2829b and coil 2824. FIG. FIG. 34 shows an exemplary view 3000 of magnetic field lines focused by metal end plates 2829a and 2829b, as shown in FIG. A plot 3100 of FIG. 35 of normalized flux density measured over a distribution of arc lengths compares the relative flux leakage of different vibratory devices. Line 2702 is the magnetic flux density for the vibratory device without endplates, line 2704 is the magnetic flux density with the endplate configuration shown in FIG. 38 described with reference to FIGS. , is the magnetic flux density of vibrating device 2800 with end plates 2829a and 2829b. As shown, the use of metal end plates 2829a and 2829b is caused by the drive circuitry of vibrating device 2800 compared to that of other vibrating devices described herein (eg, vibrating devices 2500 or 2600). This can lead to a reduction in leakage flux.

Vibration device 2800 includes suspension elements 2820a and 2820b (e.g., springs) configured to suspend and retain movement of magnet 2823, instead of springs, as described in the vibration device portion above. . Suspension elements 2820a and 2820b may be, for example, annular pieces of elastic and/or deformable material such as cloth, spider springs, or flexible membranes. An annular piece is coupled to magnet 2823 and suspends magnet 2823 at the equilibrium point such that the magnetic field produced by coil 2824 can move the magnet around the equilibrium point in the direction indicated by arrow E. configured as By having the suspension elements 2820a and 2820b extend laterally from the magnets rather than longitudinally from the magnets (e.g., such as the springs 2520 of the vibrating device 2500), the suspension elements 2820a and 2820b are able to move the device 2800. while reducing the off-axis motion or wobbling of magnet 2823 outside the axis defined by arrow E. Additionally, suspension elements 2820a and 2820b are angled in one or more directions relative to the axis of travel of magnet 2823 such that suspension elements 2820a and 2820b reduce oscillation of magnet 2823 in one or more directions. can be configured to expand and compress so as to provide resilience to

Figures 36A, 36B, and 36C show a comparison of the dimensions of vibration devices according to embodiments 700, 2500, and 2800, respectively, as described above. In some embodiments, the lateral dimension of the vibration device 2800 can be further reduced by decreasing the number of folds and/or the lateral extension of the folds of the suspension elements 2820a, 2820b. Another method of further reducing the dimensions of one or more of the vibrating devices described herein is to reduce components, e.g., remove plastic support structures, remove vibrating elements and/or other components, and It can be a direct attachment to the integrated circuit board.

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

Magnet 3223 may include metal end plates 3229a and 3229b. End plates 3229 a and 3229 b may be substantially similar to end plates 2829 a and 2829 b described with reference to vibration device 2800 . In one embodiment, metal end plates 3229a and 3229b can be made from low carbon steel. The metal end plates 3229a and 3229b can be configured to focus magnetic field lines in a direction perpendicular to the coil 3224 while reducing stray losses or leakage of the horizontal magnetic field.

Vibration device 3200 can include suspension elements 3220 (eg, springs) configured to suspend and support movement of magnets 3223 . Suspension element 3220 may be substantially similar in structure and/or function to suspension elements 2820 a and 2820 b described above with reference to vibration device 2800 . For example, suspension element 3220 may be an annular piece of one or more materials. The annular piece can be coupled to magnet 3223 via metal end plate 3229b as shown in FIG. Suspension element 3220 is bonded (eg, glued) to metal end plate 3229b in any suitable manner such that the magnetic field generated by coil 3224 moves the magnet about the equilibrium point in the direction indicated by arrow F. It can be configured to suspend the magnet 3223 at the equilibrium point so that the Similar to vibration device 2800, suspension elements 3220 can also be configured to reduce the overall height of device 3200 while reducing off-axis movement or rocking of magnet 3223 outside the axis defined by arrow F. . Furthermore, because the suspension element 3220 is positioned between the end plate 3229b and the coil 3224, the lateral dimensions of the vibration device 3200 can also be reduced relative to the vibration device 2800 shown in Figures 32A and 32B. For example, suspension element 3220 provides a restoring force in one or more directions at an angle to the axis of motion of magnet 3223 such that suspension element 3220 reduces back-and-forth vibration of magnet 3223 in one or more directions. It can be configured to extend and retract in the following manner.

In some embodiments, additional components (e.g., posts or pins such as pin 521) can be added to increase the stabilization of magnet 3223, which is similar to magnet 523 of vibration device 500. Similarly, it can be configured to have openings to receive components through magnets 3223 .

Figures 46A, 46B, 47, and 48 show different views of an exemplary vibration device 4100, according to embodiments disclosed herein. 46A and 46B show different perspective views of vibration device 4100. FIG. FIG. 47 shows an exploded view of vibration device 4100 . FIG. 48 shows a cross-sectional view of vibration device 4100 . Vibration device 4100 can include components that are structurally and/or functionally similar to components of other vibration devices described herein. For example, the vibration device can include a housing 4110 , a transmission interface 4130 , an electromagnetic coil 4124 , vibration elements implemented as magnets 4123 , and suspension elements implemented as springs 4120 .

The housing 4110 can be formed from one or more portions 4110a, 4110b that together define an interior space 4110c for receiving one or more other components of the vibration device 4100. As shown in FIG. For example, magnets 4123, electromagnetic coils 4124, springs 4120, etc. can be received within space 4110c. Magnet 4123, similar to other magnets described herein (eg, magnets 723, 2523), can include indentations or holes through which spring 4120 can extend. In some embodiments, the magnet 4123 can include a hole through its entire length such that the spring 4120 extends through the magnet 4123 and a plate or plate attached to the upper end of the magnet 4123 . Attached to cap 4128 . Alternatively, the magnet 4123 may have a recess extending through the length of a portion of the magnet 4123 and the spring 4120 extends into the recess and extends through a portion of the magnet 4123 (e.g., the top portion of the magnet 4123). ) can be installed. In some embodiments, magnet 4123 can be bounded at its two ends by two end plates, which are generated by coil 4124 as described in more detail above with respect to vibration device 2500. It can be configured to focus the magnetic field lines that are applied. Magnet 4123 , while suspended by spring 4120 , can oscillate along axis G, ie, along an axis parallel to the longitudinal axis of spring 4120 . The other end of spring 4120 extends into recess 4110d defined in portion 4110b of housing 4110 and can be attached to housing 4110 . Attachment between spring 4120 and magnet 4123 and/or housing 4110 can be via adhesives, welding, friction, screws, or any other suitable mechanism.

Coil 4124 may be configured to generate a magnetic field that causes magnet 4123 to move along axis G. FIG. A coil 4124 may be disposed in space 4110c around at least a portion of magnet 4123 . Coil 4124 can be operably coupled to circuitry (eg, on integrated circuit 4106 ) to generate a signal to drive movement of magnet 4123 . In some embodiments, the vibration device 4100 can include an on-board battery or power source for powering the device (eg, a signal generator coupled to the coil 4124).

In some embodiments, housing 4110 includes one or more loops, latches, hooks, or other fasteners to allow attachment of a headband or other support element (e.g., support element 418), not shown. Appropriate attachment mechanisms can be included. In some embodiments, housing 4110 can define ports or openings 4150 . In some embodiments, port 4150 can allow fluid communication of air into and out of the device. Such communication may prevent or reduce pressure and/or heat build-up within vibrating device 4100 as air moves in and out of the device and magnets 4123 vibrate within space 4110c. Alternatively, in some embodiments, housing 4110 can be configured to define a closed or sealed space 4110c that is fluidly isolated from the surrounding environment. Such embodiments may be suitable for applications in which vibratory device 4110 may be used underwater or in other environments that could potentially damage the internal circuitry and components of device 4100 . In some embodiments, port 4150 is coupled to, for example, a printed circuit board or other circuitry and/or electronics (eg, control unit, sensor(s), etc.) via a wired connection to the vibration device. It can be used to pass electrical connections into and out of the device, if required.

Other components and/or functions of vibrating device 4100, and variations of such components and/or functionality, are similar to those of other vibrating devices described herein; does not repeat again. Such components, functions, and/or variations thereof may be understood by reference to the relevant descriptions of other vibratory devices described herein.

49-52 provide different views of an exemplary vibration device 4200, according to embodiments disclosed herein. FIG. 49 shows a perspective view of vibration device 4200 . FIG. 50 shows an exploded view of vibration device 4200 . FIG. 51 shows a cross-sectional view of vibration device 4200 . FIG. 52 shows an enlarged view of the seismic masses (eg, magnets 4223, end plates 4229a, 4229b) and suspension elements or springs 4220a, 4220b of the vibratory device 4200. FIG. Vibration device 4200 can include components that are structurally and/or functionally similar to components of other vibration devices described herein. For example, the vibration device can include a housing 4210, a transmission interface 4230, an electromagnetic coil 4224, vibration elements implemented as magnets 4223, and suspension elements implemented as springs 4120a, 4120b.

As with other housings described herein, the housing 4210 can be formed from one or more portions 4210a, 4210b that together define an interior space for receiving other components of the vibration device 4210. As shown in FIG. In some embodiments, the housing 4210, similar to the vibrating device 4100, has an opening or port 4250 that can accept electrical wires within the device and/or allow fluid communication of air into and out of the device. can be defined. Alternatively, the housing 4210 can define a sealed space or compartment for housing the other components of the vibration device 4210.

Magnet 4223 may be structurally and functionally similar to magnet 2823, and magnet 4223 includes metal end plates 4229a, 4229b. Metal end plate 4229a may have a diameter substantially similar to magnet 4223, while metal end plate 4229b may include a portion surrounding magnet 4223 and/or metal end plate 4229a. The two end plates 4229a, 4229b can be configured to focus the magnetic field lines generated by the coil 4224. FIG.

Suspension elements or springs 4220 a , 4220 b may be configured to suspend and support movement of magnet 4223 . Springs 4220a, 4220b can be made of metal and have a generally flat structure. Springs 4220a, 4220b are made of metal to provide greater consistency, durability, and longevity to device 4200, such as maintaining more consistent movement of magnet 4223 over time compared to, for example, rubber springs. I will provide a. Springs 4220a, 4220b may be coiled or wrapped around the perimeter of magnet 4223 and/or metal end plates 4229a, 4229b. By having springs 4220a and 4220b extend laterally from magnet 4223, rather than longitudinally from magnet 4223, springs 4220a and 4220b can reduce the overall height of device 4200 while allowing the overall height of device 4200 to be reduced by arrow H. Off-axis movement or wobbling of the magnet 4223 outside of the defined axis can be reduced. In some embodiments, the springs 4220a or 4220b can be wound or coiled in opposite directions to further reduce lateral or off-axis movement of the magnet 4223. Magnets 4223 and/or metal end plates 4229a, 4229b may be configured to move through openings defined by springs 4220a, 4220b. Attachment between springs 4220a, 4220b and magnets 4223 and/or housing 4210 can be via adhesives, welding, friction, screws, or any other suitable mechanism.

In some embodiments, the magnets 4223 and/or metal end plates 4229a, 4229b coupled to the magnets have one or more openings or holes 4223a that allow air to pass between the sides of the magnets 4223. can include By allowing air to pass between the sides of the magnet 4223, the vibrating device 4200 will not accumulate on either side of the magnet 4223 when, for example, the magnet 4223 is within the sealed housing 4210. By reducing the pressure applied, it can operate more efficiently. Without these holes, movement of the magnet 4223 can create pressure that increases stiffness, which can increase the resonance of the device 4200 (eg, the vibrational frequency (eg, fundamental frequency) of the device). can. By adding holes to the magnets 4223 and/or the metal end plates 4229a, 4229b, the stiffness of the device 4200 can be reduced and the fundamental or lowest resonant frequency of the device 4200 can be lowered.

Other components and/or functions of vibrating device 4200, and variations of such components and/or functionality, are similar to those of other vibrating devices described herein; does not repeat again. Such components, functions, and/or variations thereof may be understood by reference to the relevant descriptions of other vibratory devices described herein.

III. Sensors and Feedback In embodiments described herein, a vibratory device that applies a vibratory signal that can be conducted via bone conduction to the vestibular system of a subject is used for such and/or associated with such a disease. It can be used to treat symptoms of For example, from the studies described herein, vibrating devices within specific frequency and force ranges have been shown to reduce vertigo, dizziness, toxic deafness, vestibular toxicity, motion sickness, virtual reality sickness, spatial disparity, It has been shown to be therapeutically effective in alleviating symptoms produced by vestibular disorders and neuropathies, including sopaite syndrome, and/or nausea. The onset of these symptoms was measured via, for example, skin conduction, electroencephalographic patterns measured by electroencephalogram (EEG), electromyography (EMG), body temperature, eye movement, heart rate, electrocardiogram (EKG). Subjects, including cardiac waveform (i.e., PQRST waveform), blood pressure, oxygen saturation (e.g., SpO2), respiratory signals, neural evoked potentials (e.g., vagus nerve monitoring), sweat toxicity, stress hormone levels (e.g., cortisol levels) can be predicted by monitoring the biometrics of Additionally or alternatively, the onset of these symptoms may also be predicted by monitoring environmental indicators including, for example, ambient sound, temperature, vibration/sway, position, movement, acceleration, position, and ambient air pressure. can be done.

In some embodiments, the therapeutic vibration device or bone conduction device can also be used in conjunction with one or more sensors (eg, biometric sensors, environmental sensors, etc.). The sensor may be incorporated into and/or operably coupled to the vibration device. Using a processor to monitor the onset of symptoms or a subset of symptoms (e.g., by monitoring data collected by one or more sensors) and operate the vibration device based on biometrics and/or environmental indicator feedback (eg, turning the vibrator on or off, varying the force level or frequency of the vibration). In some embodiments, the processor may also record historical trends in frequency, severity, and duration of vestibular disease and vestibular neuropathy, e.g., based on biometrics and/or monitoring of environmental indicators. good. The sensor and/or processor can be physically connected or coupled, for example, via wired and/or wireless connections, to a portion of the vibrating device or separate device(s) that can communicate with the vibrating device. .

Vibration device 350 can include one or more sensors 390, as described above with reference to FIG. 4A. Sensor 390 may be configured to measure information related to the subject's and/or other biometric vestibular systems. Optionally, sensor(s) 390 can be configured to measure information related to the environment surrounding the subject. As shown in FIG. 4A, the sensor(s) 390 can be operatively coupled to a control unit 360 that includes a processor 364 . Through this coupling, sensor 390 can communicate information related to one or more biometrics and/or environmental indicators to control unit 360 . Control unit 360 (e.g., via processor 364) then controls the vibration device (e.g., The operation of the vibration device 300) can be controlled. For example, upon detecting the onset of symptoms, the control unit 360 activates the signal generator 370 and/or the amplifier 380 to provide an electrical signal to power the vibration device 300 and/or a vibration applied to the subject. One or more parameters of the electrical signal can be adjusted to change the frequency and/or force level of the signal.

In some embodiments, skin conduction (eg, measured by sensor 390) is used to determine the user's physiological state, such as the onset, subset, and/or severity of a physiological condition, such as nausea. Changes can be detected. For example, nausea is often intermittent, resulting in a more hot sensation each time, leading to increased sweating. Skin conduction can be correlated with severity of nausea, for example, in reducing skin resistivity (ie, increasing skin conduction) due to sweat from nausea. These skin conduction increases are often spiked with intermittent nausea. Thus, skin conduction can be a biometric indicator that can be used to signal the control unit and/or processor of an episode of nausea. The processor can then turn on the vibrating device (eg, activate a signal generator that provides an electrical signal that causes the vibrating element to generate a vibrating signal) and/or increase power to the vibrating device. . In some embodiments, the processor responds to a sudden increase in skin conduction, for example, a sudden change in skin conduction, such as a change in skin conduction that is greater than a certain amount and/or a certain rate within a predetermined time period. to turn on and/or increase power to the vibration device. In some embodiments, the processor can turn on and/or increase the power of the vibration device in response to an increase in skin conduction above a certain threshold. For example, if an individual's baseline skin conduction is set at 2 μS, the force level of the transducer can be adjusted when the skin conduction rises above 6 μS.

FIG. 39 is a graph 3700 showing exemplary changes in skin conduction as a function of reported nausea. As shown, skin conduction increases with increasing nausea, with sharp increases in skin conduction at various points along increasing nausea levels.

In some embodiments, changes in electroencephalogram activity (eg, as measured by sensor 390) can be used to detect nausea episodes, subsets, and/or severity. Analysis of EEG-monitored brain waves can be a predictive tool as to whether a subject is getting closer or farther from the tendency to experience nausea. For example, if the subject's EEG data has a multivariate normal probability density function (MVNPDF) of 0, nausea is unlikely. Stated another way, if the EEG data has a MVNPDF of 1, nausea is likely. Therefore, the time average of the MVNPDF of EEG data can be used as a biometric indicator of nausea episodes. The processor can monitor this time average and adjust the power supplied to the vibration device based on the time average. For example, when the time average of MVNPDF increases, the processor can turn on and/or increase power to the vibration device. Alternatively, the processor can turn off and/or reduce power to the vibration device when the time average of the MVNPDF decreases. In some embodiments, another biometric indicator is whether the (average or instantaneous) MVNPDF is above or below a certain predetermined threshold, in which case the power to the vibrating device increases or decreases, respectively. can be done.

FIG. 40 is a graph 3800 showing the MVNPDF of EEG data as a function of time a subject sat in a flight simulator while wearing a therapeutic vibration device or bone conduction device. The darker line 3802 represents the subject's MVNPDF with the vibration device off, and the lighter line 3804 represents the subject's MVNPDF with the vibration device on. The MVNPDF trend lines are also shown as dotted lines 3806, 3808, rising to the right when the device is off (e.g., associated with increased probability of nausea) and falling to the left when the device is on (e.g., probability of nausea). associated with a decrease in ).

In some embodiments, EEG data can be used to measure a subject's cognitive load, which may indicate a headache or poor concentration, both of which are associated with vestibular migraine. and/or may be a symptom of dizziness.

In some embodiments, sensors such as EMG (eg, sensor 390) can be used to measure cervical vestibular evoked myopotentials (cVEMP) and ocular vestibular myopotentials (oVEMP). EMG data (eg, cVEMP and/or oVEMP) can be used, for example, to diagnose vestibular disease and/or vestibular neuropathy. For example, EMG data can be used to monitor muscle spasms, yawning, sneezing, and/or chewing, which may indicate episodes such as nausea or dizziness. The processor can then adjust (e.g., adjust) power to the vibrating device, e.g., based on sudden or rapid changes in EMG indications, or when EMG data exceeds or falls below one or more predetermined thresholds. can.

In some embodiments, a sensor (eg, sensor 390) can be used to measure body temperature. For example, an increase in body temperature can signal the onset of nausea. Body temperature fluctuates naturally, but a spike or spike can be an indication of an episode of nausea. Thus, a biometric indicator indicative of an episode of nausea may be, for example, a rapid increase in body temperature (e.g., a change in body temperature of greater than a certain amount and/or rate within a short period of time), a rise in body temperature above a predetermined threshold, etc. can contain Other factors to consider include, for example, ambient temperature, subject's degree of motion (e.g., subject's activity state or user's activity level), etc., using other sensor(s). can be detected by In some embodiments, additional sensors (e.g., thermometers or exercise sensors) may be used in conjunction with body temperature sensors (or other sensors described herein, such as skin conductance sensors, heart rate sensors, etc.). For example, a thermometer can be used to measure ambient temperature, and data from motion sensors, accelerometers, or other sensors can be used to determine user activity (e.g., resting, exercising, etc.) and/or Activity level (eg, light exercise, vigorous exercise) can be determined. In some embodiments, data collected by additional sensors can be used to adjust thresholds or other parameters used to evaluate body temperature data to determine nausea episodes. The processor monitors this data and, based on the data, adjusts its thresholds and adjusts the power supplied to the vibrating device and/or other parameters of the vibrating device to affect the frequency, force level, etc. of the vibration signal. can give

In some embodiments, a sensor (eg, sensor 390) can be used to measure changes related to the subject's eye, such as changes in the pupil of the eye, eye movement, and eyelid movement. . Such biometrics can be indicators of symptoms including, for example, vertigo, dizziness, and sopite. For example, nystagmus, pupil dilation and constriction, and/or changes in blink rate or frequency may indicate the onset of such symptoms. Thus, biometric indicators of the onset of such symptoms include, for example, nystagmus, sudden or rapid changes in pupillary diameter, pupillary diameter rising above or falling below one or more predetermined thresholds. an increase in the frequency of blinking, a decrease in the rate of opening and closing of the eyelids (e.g., below a predetermined threshold), and/or that the eyelids are closed for a longer period of time (e.g., longer than a predetermined threshold). may include performing or detecting. The processor monitors one or more of these indicators and, based on the indicators, adjusts the power supplied to the vibrating device and/or other parameters of the vibrating device to determine the frequency, force level, etc. of the vibration signal. etc., can be affected.

In some embodiments, a sensor (eg, sensor 390) can be used to measure the subject's heart rate. Heart rate can rise and fall with the onset of nausea and other symptoms, eg, associated with vestibular disease or disorders. For example, if nausea first occurs, the heart rate may increase to a certain level until the subject reports a 6 out of 10, eg, on a visual analogue scale for measuring nausea. However, at certain levels of nausea episodes, the subject may experience a rapid drop in heart rate, which may occur as a precaution against spreading toxins within the body. Biometric indicators of onset of nausea therefore include, for example, an increase or rise in heart rate (e.g., rate of change in heart rate greater than a predetermined value, or amount or percentage of change greater than a predetermined amount or percentage) , a rapid drop or decrease in heart rate, and the like. The processor monitors one or more of these indicators and, based on the indicators, adjusts the power supplied to the vibrating device and/or other parameters of the vibrating device to determine the frequency, force level, etc. of the vibration signal. etc. can be affected.

FIG. 41A is a graph 3900 of heart rate as a function of nausea showing an initial increase in heart rate with increasing nausea, followed by a decrease in heart rate as nausea levels continue to increase.

In some embodiments, a sensor such as an EKG device (eg, sensor 390) can be used to measure the subject's heartbeat or cardiac waveform. FIG. 41B shows an example heartbeat waveform 4000 with P, Q, R, S, and T points labeled. The heartbeat waveform, eg, the relative positions between the PQRS points of the heartbeat waveform, can change with the development of symptoms associated with various physiological conditions. Using an EKG, a subject's heartbeat waveform can be monitored by a processor. Thus, a biometric indicator of symptom onset may include, for example, a change in heartbeat waveform or a return to baseline. The processor monitors one or more of these indicators and, based on the indicators, adjusts the power supplied to the vibrating device and/or other parameters of the vibrating device to determine the frequency, force level, etc. of the vibration signal. etc. can be affected.

In some embodiments, a sensor (eg, sensor 390) can be used to measure blood pressure. Blood pressure can change with the development of symptoms associated with various physiological conditions. Thus, biometric indicators of symptom onset can include, for example, changes in blood pressure, blood pressure rising above or falling below a certain threshold, and the like. The processor monitors one or more of these indicators and, based on the indicators, adjusts the power supplied to the vibrating device and/or other parameters of the vibrating device to determine the frequency, force level, etc. of the vibration signal. etc., can be affected.

In some embodiments, a sensor (eg, sensor 390) can be used to measure oxygen saturation in blood. Oxygen saturation in the blood can change with the development of symptoms associated with various physiological conditions. Thus, biometric indicators of symptom onset can include, for example, rapid changes in oxygen saturation, oxygen saturation rising above or falling below certain thresholds, and the like. The processor monitors one or more of these indicators and, based on the indicators, adjusts the power supplied to the vibrating device and/or other parameters of the vibrating device to determine the frequency, force level, etc. of the vibration signal. etc., can be affected.

In some embodiments, a sensor (eg, sensor 390) can be used to measure nerve-evoked potentials (eg, vagus nerve monitoring). Nerve-evoked potentials (eg, vagus nerve monitoring) can change with the development of symptoms associated with various physiological conditions. Thus, biometric indicators of symptom onset can include, for example, rapid changes in evoked potentials, potential compound activity rising above or falling below a certain threshold, and the like. The processor monitors one or more of these indicators and, based on the indicators, adjusts the power supplied to the vibrating device and/or other parameters of the vibrating device to determine the frequency, force level, etc. of the vibration signal. etc. can be affected.

In some embodiments, a sensor (eg, sensor 390) can be used to measure sweat toxicology (eg, ethanol monitoring). Biometric indicators of symptom onset include, for example, rapid changes in measured chemicals (e.g., metabolites) oozing in perspiration, specific measured chemicals rising above or falling below certain thresholds. Perspiration toxicity metrics and the like may be included. The processor monitors one or more of these indicators and, based on the indicators, adjusts the power supplied to the vibrating device and/or other parameters of the vibrating device to determine the frequency, force level, etc. of the vibration signal. etc. can be affected.

In some embodiments, a sensor (eg, sensor 390) can be used to measure stress hormones (eg, cortisol). Stress hormones, such as cortisol, can change with the development of symptoms associated with various physiological conditions. Thus, biometric indicators of symptom onset include, for example, rapid changes in measured stress hormones oozing in sweat, certain measured hormonal metrics rising above or falling below certain thresholds, etc. can be included.

Some configurations of vibrating or bone conducting devices allow one or more biometric sensors to be integrated and/or coupled to an area where they can receive accurate or reliable data. For example, areas around the ears have been found to be effective in measuring heart rate, body temperature, and oxygen saturation. As another example, the forehead has been found to be an effective location for measuring skin conductance. Additional locations that may be beneficial for sensor placement include, but are not limited to, the auricle, ear canal, neck, mastoid process, wrist, and fingers.

FIG. 42 is an example of a vibrating or bone conducting device 3300 with sensors 3390, 3394 placed near the ear or auditory canal and on the forehead.

FIG. 43 is an example of a vibratory or bone conduction device 3400 including a headband 3418, where the sensor(s) can be placed around the subject's head along the headband 3418. FIG.

FIG. 44 is an example of a vibrating or bone conducting device 3500 in which the sensor(s) 3590 may be placed around the ear.

FIG. 53 is another example of a vibration device 4300 attached to or integrated with a hearing aid and/or tinnitus masker. Since hearing loss and tinnitus are often comorbid with vertigo or other vestibular dysfunction such as Meniere's disease, devices designed to provide vestibular stimulation (e.g., as described herein) vibration devices) may be combined with other therapies. In some embodiments, multiple functions (eg, hearing aid, tinnitus masker, vestibular stimulation) can be used simultaneously and turned on and off independently of each other. In some embodiments, one or more sensors 4390 may be attached to or integrated with the hearing aid.

Although different types of sensors are described herein for measuring different biometrics and/or environmental metrics, the vibrating device can be used with several different sensors and the It can be appreciated that the data obtained can be collectively used to predict the onset and/or subset of nausea and thus signal the processor to alter the operation of the vibrating device.

IV. Electrical Signals for Powering the Vibrating Device FIGS. 17A and 17B show examples of waveforms of electrical signals for powering the vibrating device. FIG. 17A shows a sinusoidal waveform 1600 having wavelength 1604 and amplitude 1602, which can be used, for example, to adjust magnetic field vectors to move vibrating elements of a vibrating device. FIG. 17B shows a square wave waveform 1610 that can be used, for example, as described above, to tune a piezoelectric vibrating element within a vibrating device to generate a vibrating signal. . A piezoelectric device can vibrate at a high frequency to produce pressure when activated by a square wave, which cycles on and off at a lower frequency of modulation (e.g., 60 Hz). It can be cycled at a lower frequency (eg, less than 200 Hz) to function similarly to low frequency vibration signals.

FIG. 18 is a graph 1700 showing the ramp-up and ramp-down of an electrical signal for powering a vibration device to generate a vibration signal. Graph 1700 shows how the amplitude of an electrical signal changes over time. As shown in Figure 18, the amplitude can be ramped up during the onset phase 1702, where the amplitude increases at a predetermined rate. Once a predetermined level is reached, the amplitude remains constant during a steady state phase 1706 for any suitable amount of time to treat the vestibular condition (represented by the dashed line ), you may continue. The amplitude can then be ramped down at a predetermined rate until the signal turns off. The onset phase 1702 and offset phase 1704 of the waveform can have different ramp profiles, as shown in FIG. For example, the increase in applied voltage amplitude in the onset phase 1702 can be a ramped increase at a particular rate of increase in amplitude per unit time. The offset phase 1704 can then be a downward ramp or ramped decrease in amplitude by a particular rate of decrease in amplitude per unit time that is different from that of the rate of increase. In some embodiments, the rate of amplitude increase in the onset phase 1702 can be higher than the rate of amplitude decrease in the offset phase 1704, as indicated by the different slopes. In some instances, the ramped increase in the onset phase 1702 and/or the ramped decrease in the offset phase 1704 can also be achieved at varying rates (eg, rates that increase and/or decrease over time). can be done.

In some instances, the rate of increase and/or 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 in amplitude may be adjusted by the user. In some embodiments, the rate or rate of increase and/or decrease in amplitude may be automatically adjusted (eg, by control unit 360) based on sensor readings. For example, sensors integrated into the vibrating device measure physical or physiological conditions and/or reactions (e.g., perspiration, temperature, changes in heart rate, etc.) as the vibrating device powers on and/or powers off. can be configured as follows. By monitoring physical condition and/or reaction, the ramp-up and/or ramp-down rate may respond differently (e.g., more sensitive to more habitual users of the device or by first-time users). can be adjusted to accommodate Furthermore, for subjects suffering from chronic conditions (e.g., vertigo, tinnitus), ramp-up and/or ramp-down may be associated with, for example, sudden recurrence of vestibular conditions and stronger onset of symptoms associated with vestibular conditions. It can be selected to reduce the objectionable effects of transitions between on and/or off of the device.

V. Methods FIG. 19 illustrates a method 1800 for using a vibrating device (eg, vibrating devices 300, 400, 500, 600, 700, etc.) to treat symptoms associated with vestibular conditions disclosed herein. . At 1802, a vibration device is placed on the head of a subject or user. The placement is on the appropriate area (eg, on the appropriate bony structure) so that the vibrational signal can be effectively transmitted to the subject's vestibular system.

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

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

If the electrical signal needs to be adjusted (1810: yes), the frequency or force level of the electrical signal is changed at 1812 and a new electrical signal is applied to the vibrating device at 1804 according to the flow chart as described above. Information gathered by monitoring the vibratory device and by monitoring the subject determines whether and how much and in what form the force level and/or frequency need to be changed. can be used to determine For example, if the measured voltage, current, and/or magnetic field variations indicate that the current frequency is not at the resonant frequency, the frequency may be adjusted to improve the efficiency of the vibrating device. As another example, if a signal is received from the user indicating that the vestibular condition is no longer present (eg, motion sickness is no longer present), the vibrating device turns off the device (eg, via ramp down). The frequency may be adjusted to As another example, the force level may be decreased in response to an indication of discomfort by the subject.

FIG. 45 illustrates a method 3600 that may be performed by one or more components associated with a vibration device (eg, any of the vibration devices described herein including one or more sensors). At 3602, a vibrating device can be placed on a user or subject, eg, on the user's head or ear. Placement can be over the appropriate area (eg, on the appropriate bony structure) so that the vibration signal can be effectively transmitted to the target area (eg, the vestibular system).

At 3604, an on-board or external processor or control unit (e.g., control unit 360) captures the user's biometrics, e.g., collected by one or more sensor(s) (e.g., sensor(s) 390). and/or monitor environmental metrics. One or more sensors may be integrated and/or operably coupled to the vibration device. At 3606, the processor may detect changes in biometrics and/or environmental factors, such as spikes in data, data above and/or below one or more thresholds, as described above. Based on the monitoring and detection, the processor adjusts the operation of the vibrating device (e.g., turns the vibrating device on or off; vibrating signals generated by the vibrating device and/or used for active vibrating devices). adjust the frequency, force level, or power of the signal; etc.).

VI. Experimental Studies Experimental studies were conducted to test experimental vibration devices similar to the example vibration devices disclosed herein for treating symptoms associated with vestibular conditions. The experimental vibrating device included a vibrating element implemented as a magnet suspended between two other magnets, similar to the vibrating device 500 shown in FIG. It contained a coil, which was energized by a custom-designed Arduino board that was a microcontroller. A microcontroller was able to energize the outer coil to generate a magnetic field, which was used to vibrate the suspended magnet. Three magnet/voice coil assemblies were placed inside the body or housing and connected to and powered by a rechargeable battery. A vibrating device could be attached to the human head and could produce vibrations that could be conducted through the bones to the vestibular system.

In the study, subjects were placed behind their ears against an area overlying the mastoid bone so that vibration signals generated by the device could be conducted through the bones to the subject's vestibular system. Wearing a vibrating device. Subjects were exposed to various conditions to induce motion sickness, nausea, and/or other vestibular conditions, and the effects of the vibrating device were evaluated based on information reported by the subjects. .

For experiments, the force level of the vibrations produced by the vibration device was measured with a calibrated Brüel & Kjær (B&K) artificial mastoid (No. 4930) coupled with a B&K sound level meter (No. 2234). . The vibrating device was inserted into a B&K promastoid holder designed to hold a bone conduction hearing aid. A force of 3.5-8 Newtons was exerted on the vibrator, which was placed against the B&K artificial mastoid. Bone conduction levels were quantified with a B&K sound level meter and are expressed in dB re 1 dyne (ie, force level).

Further information on each of the studies is provided below.

Experimental study I
FIG. 20A shows a flow chart 1900 of the procedure for the first experimental study. Study participants in this first experimental study had no history of vestibular disease, including dizziness. During the study, participants were seated in office chairs and asked to wear an Oculus Rift DK2 virtual reality system and vibration device according to the example design described above. The vibrator was held in place with a head strap.

The study was conducted according to the test procedure outlined in Figure 20A. Each participant went through the test procedure multiple times, first with the vibrator off and then on. During testing with the vibration device turned on, the frequency and/or force level of the vibration device was found to be more effective in treating vestibular conditions associated with the use of the virtual reality device. changed to test whether there is. The order of frequency and/or force level was randomized between participants during the test. Participants were also given the opportunity to discontinue the study at any time and recover from dizziness or other vestibular conditions caused by the use of the virtual reality device.

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

At 1904, the participant initiates the rotation of a sphere 1954 within a disk-shaped region 1956 about a central point (ie, central sphere 1952) by pressing the spacebar on the keyboard. At 1906, pressing the spacebar causes the sphere 1954 to gradually accelerate and begin spinning at a rate of 4 degrees/second/second. At 1908 and 1909, participants were instructed to press the space bar again when they felt discomfort or dizziness, at which point the angular velocity of the spinning ball 1954 was recorded and Stored as the "maximum angular velocity" for the participant. If a particular participant did not press the spacebar to indicate discomfort or dizziness, the angular velocity of sphere 1954 increased until it reached a predetermined angular velocity of 90 degrees/second.

At 1910, the angular velocity of the image is reduced to 90% of the user's pre-specified velocity (i.e., 90% of the velocity recorded as the maximum angular velocity), or 90% if the participant did not press the spacebar. It is reduced to 90% of degrees/second (ie, 81 degrees/second). The sphere 1954 slows down and rotates until the participant again presses the spacebar and indicates a return of discomfort or dizziness at 1911 or until a predetermined time (eg, 120 seconds) has elapsed at 1912 . Either specified by the participant at 1911 or after a predetermined period of time has elapsed at 1912, the participant slows down and views the disk-shaped area 1956, recording the length of viewing time as the 'Length of Viewing Time'. do.

For a given participant, the participant was first asked to perform the test procedure with the vibrating device turned off. Participants perform the test procedure twice, the first time sphere 1954 rotates clockwise and the second time sphere 1954 rotates counterclockwise. The same is then repeated with the vibration device turned on. Study participants were asked to place the vibrating device behind the ear and level it with the flat part of the mastoid bone and the ear canal. Participants were allowed time to rest between clockwise and counterclockwise trials (eg, 10-60 seconds) to recover from discomfort or dizziness, if necessary.

While using the vibration device, participants were asked to test either a different set of force levels or a different set of frequencies. For participants testing different force levels, the frequency of the vibration signal was kept constant (i.e., 50 Hz) and force levels were set at 87, 92, 94, 96, 98, 99, 100, and 101 dB re 1 dyne. . For participants testing different frequencies, the power level of the vibration signal was set at a constant level (ie, 96.5 dB re 1 dyne) and the frequency was varied between 30-75 Hz.

Eighteen participants participated in the study. Approximately one-third of those participants who volunteered in this study did not experience experimental motion sickness. These participants viewed the presented visual stimulus (FIG. 20B) until the spinning sphere 1954 was at 90 degrees/second, then slowed down and continued viewing the visual stimulus for 120 seconds. These motion sickness-prone participants were instructed to repeat the visual stimulus exposure with the vibratory device turned on to determine whether the vibration of the vibratory device caused motion sickness. None of these participants reported any adverse effects during or after using the vibratory device with the vibratory device set at 97 dB re 1 dyne or less.

Experimental data for the remaining 11 participants (ie, participants who reported experiencing motion sickness or dizziness at some point during the experimental study) are shown in Figures 21A, 21B, 22A, and 22B. For the data points in the graphs depicted in Figures 21A, 21B, 22A, and 22B, the clockwise and counterclockwise 'maximum angular velocity' and 'viewing time' were averaged for each participant in each test condition. , the 'with vibration device' data was normalized at baseline based on the 'without vibration device' data (i.e., data collected by participants while using the vibration device). After calculating these ratios for each participant, the ratios for the 11 participants were averaged and shown in Figures 21A, 21B, 22A, and 22B.

FIG. 21A shows a graph 2000 of the average "viewing time" ratios of 11 participants over a range of different power levels. A value greater than 1 indicates that the viewing time before discomfort is longer when using the vibrating device than when not using the vibrating device. FIG. 21B shows a graph 2002 of the average 'maximum angular velocity' ratios for the 11 participants over a range of different force levels. A value greater than 1 in FIG. 21B indicates an increase in angular velocity that does not cause discomfort when using the vibrating device compared to when not using the vibrating device. Experimental data showed that the vibratory device was most effective when the vibratory force level of the vibratory device was set at 96 dB re 1 dyne in 11 participants. After interpolating and fitting the data, the ratio of "viewing time" to "maximum angular velocity" peaked at 96.5 dB re 1 dyne. The ratio of 'viewing time' to 'maximum angular velocity' for force levels ranging from 93 dB to 98 dB was statistically significantly different and greater than 1, suggesting that vibratory devices set at these force levels It has been shown to be effective in treating vestibular diseases.

At 87 dB re 1 dyne, the ratio was not statistically different from 1, indicating that the device was ineffective in treating vestibular conditions. At levels of 100 dB re 1 dyne and above, many participants reported feeling unwell when the vibrator was turned on. Discomfort thresholds for these high force levels differed slightly between participants, with some reporting levels of discomfort as low as 99 dB, but once that threshold was reached for a particular participant, the participants felt more comfortable with the vibration. Reported discomfort almost immediately. Participants tested at 102 dB reported that the vibrations from the vibrating device alone caused discomfort, regardless of whether they were using a virtual reality system.

Figures 22A and 22B show the ratios of "viewing time" and "maximum angular velocity" for the 11 participants, normalized by frequency range and averaged. As shown, these results suggested that the effectiveness of the experimental vibration device in reducing or delaying the onset of virtual reality sickness did not appear to be dependent on the frequency of the vibration signal. Nevertheless, graphs 2100 and 2102 show larger ratio values between 45 and 65 Hz.

The results of this first experimental study may be limited by certain factors. For example, the angular velocity of sphere 1954 in disk-shaped region 1956 was limited by a visual display system. Specifically, the refresh rate of the Oculus DK2 screen is 90 Hz. The panel of the device is organic LED (OLED) with a persistence of 2 ms. These factors prevented the rotational speed of sphere 1954 in disk-shaped region 1956 from rotating beyond about 90 degrees per second. When the rotational speed exceeded 90 degrees/second, the virtual reality display started blinking. Many trial participants reached this upper limit while wearing the vibration device, resulting in a ceiling effect in the measurements.

Similarly, while viewing the slowing sphere 1954, some subjects complained of eye strain without complaining of discomfort or nausea. Participants were therefore also limited in how long they could view the spinning disc, another factor that contributed to the ceiling effect in the measure of the effectiveness of experimental vibrations in delaying the onset of virtual reality sickness. rice field.

Taking these factors into consideration, this first experimental study showed that the vibration device was effective in treating virtual reality sickness at a statistically significant level. The data presented in the graphs of Figures 20A and 20B showed that variations in force level had a statistically significant effect on the effectiveness of the vibratory device. Specifically, force levels below 93 dB re 1 dyne are not very effective in treating vestibular disorders, and force levels above 100 dB have been shown to cause discomfort and dizziness in certain patients and exacerbate vestibular disorders. The data therefore indicated that force levels between 93 dB and 98 dB re 1 dyne were effective in treating vestibular disorders. On the other hand, the data shown in the graphs of FIGS. 21A and 21B indicate that the vibrating device's effectiveness did not have a clear trend or peak between 45 Hz and 65 Hz, thus the variation in vibration frequency could have an impact on treating vestibular conditions. have a smaller effect on the effectiveness of the vibrating device.

Experimental research II
In a second experimental study, the results obtained in the first experimental study above were used to test the effectiveness of an experimental vibration device in mitigating or preventing motion sickness experienced by users of the virtual reality game EVE: Valkyrie. It was measured.

"EVE: Valkyrie" is a first-person spaceship shooter in which the player uses an Xbox 360 handheld controller to move through a field of spaceships and cosmic stones. This game is known to cause motion sickness in many players. In this game, you fly around gates placed in a field of asteroids and spaceships. In addition to movement in three-dimensional spatial dimensions, most "gates" require the player to rotate around a three-dimensional axis of rotation (eg, roll, pitch, or yaw).

In this study, subjects play the virtual reality game "EVE: Valkyrie" for up to 15 minutes using an Oculus Rift CV1 system. For testing, participants were instructed to play the game on two consecutive days in two sessions, with and without the experimental vibration device described above. On day 1 of the experiment, participants were asked to play the training mission portion of the virtual reality game for up to 15 minutes without using the experimental vibration device. Participants were instructed to stop if they began to feel nauseous before the 15 minute endpoint. Experienced gamers could go straight to the mission, bypassing the training mission and entering the virtual space battle directly. On the second day, participants who followed the same experimental procedure but wore the experimental vibration device set at a frequency of 60 Hz and a force level of 96.5 dB were effective according to the results of the first experimental study. I found out. The device was applied to the skull, behind the right ear, and horizontally to the ear canal and to the flattened portion of the mastoid, with an applied force of approximately 3.5-8 Newtons. Participants who experienced dizziness or discomfort during the study could discontinue at any time.

Participants were asked to complete a Motion Sickness Assessment Questionnaire (MSAQ) approximately 10 minutes after stopping the game. The MSAQ contains 16 descriptions or symptoms, which are grouped into four categories of motion sickness: (1) gastrointestinal, (2) central nervous system, (3) peripheral nervous system, and (4) sleepiness-related. This helps identify and classify independent descriptors of motion sickness. MSAQ scores range from 1 (not at all) to 9 (severe) for the 16 possible symptoms of motion sickness. Table 1 shows the 16 descriptions of the MSAQ that were used to assess the motion sickness experienced by the participants.

Motion Sickness Assessment Questionnaire administered 10 minutes after completing the experience of playing the Oculus Rift as described in Experimental Study II.

When participants were asked to play for 15 minutes without wearing the experimental vibration device on Day 1, 11 of 17 participants were able to complete the 15 minutes. The playing time of the remaining six players ranged from 4:05 to 14:50 minutes. The average playing time was 13 minutes and 25 seconds. In contrast, all 17 participants were able to play for 15 minutes when the participants wore the experimental vibration device while playing. Data were collected from MSAQ and are shown in Table 1. MSAQ scores range from 1 (not at all) to 9 (severe).

The MSAQ results are shown in graphical form in Figures 23A and 23B. Each graph shows the ratio of the MSAQ score obtained while not wearing the device to the MSAQ score obtained while wearing the device. FIG. 23A depicts a plot 2200 showing mean scores from the MSAQ across all four categories of motion sickness, and FIG. 23B depicts the four categories defined by the MSAQ: (1) gastrointestinal; Four subplots 2202, 2204, 2206, 2208 are shown showing scores related to nervous system, (3) peripheral nervous system, and (4) sleepiness. The line 2250 through each graph represents the same MSAQ score with and without the vibration device, thus the line representing no effect of the vibration device on motion sickness.

As shown in Figures 23A and 23B, all data points fall below line 2250, so the data indicates that the vibratory device is effective in treating motion sickness. Data points showed a significant decrease in MSAQ score from 9 (severe) to 1 (not at all). As shown in plots 2202, 2204, 2206, 2208 of FIG. 23B, even when divided into different categories of motion sickness, the vibration device was significantly effective in treating motion sickness in each category.

Experimental study III
In a third experimental study, participants were asked to be rear-seat passengers in a four-door sedan and drove a section of road based on a fixed 20-minute itinerary. On this set route, three road tests were conducted on the same day. During each drive, participants were asked to read articles using their smartphones or other small portable devices. Onset time was recorded and each participant reported the time when the first symptoms of motion sickness were first felt.

For each participant, a baseline measure of motion sickness was established by the participant driving and reading articles on a smart phone without wearing any type of assistive device. After the first drive, each participant was placed on the participant's head by (1) an experimental vibrator described herein placed over the right mammary bone, or (2) facing outward and using a rubber pad. Subject was isolated from the body and asked to wear a low-frequency sound generator that provided hearing levels comparable to a laboratory vibrator. The order of wearing each device was randomized for each participant.

The driving route was a fixed circular route with only one stop sign at the waypoint (ie approximately 10 minutes) and no signal lights. The fixed route took approximately 20 minutes with less than 10% drive-to-drive variability. Subjects were tested up to the stop sign only during the first half of the run. Subjects were allowed rest between sessions.

Feedback from participants indicated that participants did not experience motion sickness continuously, but generally experienced motion sickness when the vehicle accelerated, decelerated, or turned. rice field. Participants reported motion sickness as a cumulative effect, with the first turn causing mild discomfort, the second turn adding the first turn's effect, and repeating until a threshold was reached. While using the experimental vibrator, participants experienced discomfort during acceleration and turns, but the discomfort quickly returned to zero when the car returned to a constant speed, and the acceleration of the car continued. reported no cumulative nausea effects during the time-course change.

Figure 24 shows the seconds to first onset of motion sickness experienced by participants during the third experimental study. Bar 2302 represents seconds to first onset of motion sickness without device, bar 2304 represents seconds to first onset of motion sickness with sound generator, and bar 2306 represents experimental Represents seconds to early onset of motion sickness when using a shaking device. As shown, use of the experimental shaker apparatus described herein resulted in a significant increase in seconds to motion sickness onset at bar 2306 . Specifically, the experimental vibrator was associated with a two-fold time to onset of motion sickness compared to wearing no device (bar 2302) and wearing a sound generator (bar 2304). It was found that the effect was more than doubled. The data of this study show the effect of the experimental vibrator on preventing motion sickness when simulating the real-world situation of reading while sitting in the back seat of a car as an assistant. None of the subjects using the experimental vibration device reported discomfort after exiting the vehicle.

SUMMARY OF EXPERIMENTAL STUDIES AND OTHER INDICATORS Results from the experimental studies described above demonstrate that vibrating devices, such as the exemplary vibrating devices disclosed herein, can be effective in treating symptoms of various vestibular conditions. . Such devices have a low profile and can be coupled to the surface of the subject's head such that vibrations can be conducted through the bones (eg, skull) to the subject's vestibular system. The laboratory vibration device used in three experimental studies has been shown to be effective in mitigating and reducing motion sickness and/or virtual reality motion sickness. The experiments and results described demonstrate that the effectiveness of the disclosed vibratory device in reducing motion sickness is virtually instantaneous with no apparent adverse side effects.

Subsequent experiments demonstrated that the force and frequency levels found to be effective herein are also effective in reducing dizziness and nausea produced by calorie testing conducted in medical facilities. showed that For example, for dizziness, individuals with chronic or frequent episodes of dizziness were asked to wear an experimental vibrating apparatus and report the effects of wearing the device. In general, individuals reported fewer dizziness-related symptoms when using the device. As another example, for a calorie test, an Ear, Nose and Throat ("ENT") physician performed a calorie test on five subjects with and without an experimental vibration device. . All subjects experienced nausea when not wearing the device on the first day, and one subject was unable to complete the test due to severe nausea. When wearing the device the next day, all 5 subjects experienced a significant reduction in nausea, including no nausea; was able to complete Testing on both days showed similar vestibular function with and without the vibrating device.

The application of bone-conducted vibrational signals to mask disease-inducing signals coming from the vestibular system, also called vestibular masking, can be effective in alleviating a number of vestibular symptoms. For example, dizziness caused by a damaged vestibular system can be treated with applied osteoconducting vibrational signals. However, sometimes if the applied vibration signal is suddenly removed (eg, when the vibration device is off), the vibration signal can have adverse reactions. In some embodiments, such as those described above, these adverse reactions involve gradually decreasing the power of the applied vibration over a period of time (i.e., ramping down the power) instead of turning off the device abruptly. have).

As another example, vestibular masking can be effective in reducing motion sickness that occurs when an individual uses a virtual reality device such as those disclosed herein. Because virtual reality devices do not always cause motion sickness, in one embodiment, vibrating devices such as those disclosed herein are used to simulate motion sickness-inducing specific conditions and/or situations. It is operable to generate vibrations for masking the vestibular system when displayed and/or presented to a user of the real device. The vibrating device may be controlled, for example, by a microcontroller operable to store special instructions for controlling the vibrating element. Such instructions may be stored in onboard memory or in separate memory. Further, such instructions are designed to integrate special functions and features into the controller to perform specific functions, methods and processes related to treating conditions of the vestibular system. In one embodiment, the microcontroller can be programmed with instructions using a software development kit (SDK).

It should be appreciated that electrical signals for controlling and/or driving the generation of vibration signals may be generated by a microcontroller based on stored instructions. These electrical signals may be communicated between the microcontroller and the vibration device via wired or wireless (eg, Bluetooth) methods. Additionally, the electrical signal may include a stored motion pattern. For example, stored instructions accessed by the microcontroller may cause the vibrating element to turn "on" or "on" in a pattern advantageous to a particular user based on usage data accumulated and stored in the device containing the microcontroller and the vibrating element. It may be used by a microcontroller to generate a series of electrical signals that are sent to the vibrating element to cause it to be turned "off." One pattern may involve a series of vibrations that may vary in the number of vibrations generated over a period of time (e.g., every minute) and applied to the subject, while a second pattern may involve several vibrations. may include a series of vibrations in which the force level at may vary. Other types of electrical signals, such as those that can be used to control the force level and frequency of vibrations produced by the vibrating element, are sent from the microcontroller to the vibrating device based on data received from sensors. good too. For example, acceleration sensors may be included in portable electronic devices (eg, cell phones) to sense changes in the user's physical acceleration. In embodiments, the microcontroller may be operable to receive data from an acceleration sensor that indicates the type of acceleration that may lead to motion sickness. Accordingly, after receiving such data, the microcontroller may be operable to generate associated control signals and transmit such signals to the vibrating element. The vibrating element is then operable to receive such control signals and generate vibrations that can be applied in real time to the proprioceptive vestibular system, e.g., to preemptively minimize motion sickness. good. Alternatively, a stored roadmap representing routes or tracks that may result in the user becoming ill from motion sickness may be stored in a microcontroller or portable device in conjunction with a GPS circuit. In an embodiment, when the GPS circuitry indicates that the user is moving along a path or track and reaches a location that may induce motion sickness, the microcontroller generates associated control signals and vibrates such signals. It may be operable to send to an element. The vibrating element is then operable to receive such control signals and generate vibrations that can be applied to the vestibular system, for example, to account for possible motion sickness before the user reaches the position. may be

Several different types of medical tests, including caloric tests, VNG tests, and ENG tests, are used by audiologists and otolaryngologists to test a subject's vestibular function. ) is enforced by As part of the examination, a form of vertigo may be induced in the patient that may have the adverse side effect of causing nausea. Vestibular masking can be used to reduce nausea experienced by such patients while undergoing these examinations. Accordingly, the devices described herein may be included in medical examination systems used to complete such medical examinations, or alternatively, to alleviate or reduce such adverse side effects. , may be used (eg, worn) in conjunction with such medical testing systems.

In some embodiments, the devices and methods described can be used for applications unrelated to treating vestibular conditions. For example, some embodiments of vibrating devices can be used as devices for conducting haptic communication using a suitable communication channel. In some instances, silent and tactile sensation-based communication methods may be useful, such as in military or surveillance situations. Embodiments of the vibrating device to enable tactile communication between subjects such as operatives with suitable matching of reduced detectability, such as blind and deaf conditions of use. can be used for

While various inventive embodiments have been described and illustrated herein, it will be apparent to those skilled in the art to perform the functions described herein and/or enjoy one or more of the results and/or advantages. Various other means and/or structures for obtaining may be readily envisioned, and each such variation and/or modification is considered within the scope of the inventive embodiments described herein. More generally, all parameters, dimensions, materials, and configurations described herein are intended to be exemplary and that actual parameters, dimensions, materials, and/or configurations may vary according to the invention. Those skilled in the art will readily appreciate that the teachings of will depend on the particular application(s) for which they 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 that the foregoing embodiments are presented by way of example only and that, within the scope of the following claims and their equivalents, embodiments of the invention are particularly described and claimed. It will be appreciated that it may be implemented in other ways than 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 of such features, systems, articles, materials, kits, and/or methods is not mutually exclusive, unless such features, systems, articles, materials, kits, and/or methods are mutually exclusive. , are included within the scope of the present disclosure.

Also, various inventive concepts can be embodied in one or more methods, examples of which have been provided. The acts performed as part of the method may be ordered in any suitable manner. Accordingly, embodiments may be constructed such that acts are performed in a different order than illustrated, including some acts even though they are shown as sequential acts in the illustrated embodiment. simultaneously.

Claims (37)

a device,
A vibration device configured to generate a vibration signal and apply said vibration signal to a portion of a user's head such that said vibration signal can be conducted through bones to said user's vestibular system. When,
a biometric sensor configured to measure a biological characteristic of the user, the biological characteristic indicative of the onset of a physiological condition associated with the vestibular system of the user;
a control unit operatively coupled to the vibration device and the biometric sensor, the control unit comprising:
receiving data related to the biological characteristic from the biometric sensor;
Based on the data relating to the biological characteristic, controlling the vibration device to apply the vibration signal such that the vibration signal is applied to the portion of the head to treat the physiological condition. and a control unit configured to generate. said vibration device comprising a signal generator and a circuit configured to generate an electrical signal used to generate said vibration signal;
The control unit activates the signal generator to generate the electrical signal in response to detecting the onset of the physiological condition based on the data relating to the biological characteristic. 2. A device according to claim 1, configured to control the vibrating device by: said vibration device comprising a signal generator and circuitry configured to generate an electrical signal used to generate said vibration signal, said electrical signal having an amplitude and a frequency;
The control unit is configured to control the vibration device by controlling at least one of the signal generator or the circuit to adjust the amplitude or the frequency of the electrical signal. 2. The device of claim 1, wherein the device is 4. Apparatus according to any one of claims 2 or 3, wherein the circuit comprises at least one of an amplifier or a potentiometer. said biological characteristic is skin conductance;
The control unit is configured to control the vibration device by activating the vibration device in response to the data, the data indicating that the skin conductance exceeds a threshold. A device according to claim 1. said biological characteristic is skin conductance;
The control unit is configured to control the vibration device by activating the vibration device in response to the data, wherein the skin conductance is greater than a predetermined amount or percentage. 2. The device of claim 1, wherein the device is indicative of a change in . The control unit controls the vibration device by activating the vibration device to generate the vibration signal or by increasing the power supplied to the vibration device to increase the force level of the vibration signal. 7. Apparatus according to any one of claims 5 or 6, adapted to control. wherein said biological characteristic is electroencephalographic activity as measured by electroencephalogram (EEG) data;
2. The control unit of claim 1, wherein the control unit is configured to control the vibrating device by activating the vibrating device in response to changes in electroencephalographic activity indicative of the onset of the physiological condition. equipment. said change in brain wave activity is represented by the output of a multivariate normal probability density function (MVNPDF) of said EEG data of said user;
9. The apparatus of claim 8, wherein the control unit is configured to activate the vibration device in response to the output of the MVNPDF related to the physiological condition. said change in brain wave activity is represented by an MVNPDF output of said EEG data of said user;
power supplied to the vibration device such that the control unit increases the force level of the vibration signal based on at least one of the output of the MVNPDF or a time average of the output of the MVNPDF; 9. The apparatus of claim 8, configured to adjust the . the biological characteristic is body temperature;
the control unit is configured to control the vibrating device by activating the vibrating device in response to the data, the data indicating that the body temperature is above a threshold; A device according to claim 1 . said biological characteristic is associated with said user's eye,
wherein the control unit activates the vibrating device in response to detecting at least one of a pupillary change in the eye, eye movement, or eyelid movement indicative of the onset of the physiological condition; 2. The device of claim 1, configured to activate. the biological characteristic is at least one of the user's heart rate or the user's cardiac waveform;
The control unit is configured to activate the vibratory device in response to detecting a change in the at least one of the heart rate or the cardiac waveform indicative of the onset of the physiological condition. 2. The device of claim 1, wherein the device is further comprising one or more sensors configured to measure at least one of ambient temperature, motion of the user, or electrostatics of dynamic acceleration of the user;
the user's activity level determined based on the user's exercise; or the user's activity state based on the user's exercise. 12. Apparatus according to any one of claims 5 or 11, further configured to adjust the threshold. further comprising at least one additional biometric sensor, wherein the biometric sensor and the at least one additional biometric sensor are sensitive to skin conductance, body temperature, ambient temperature, movement of the user, brain wave activity, cardiac activity, eye blood pressure, oxygen saturation, nerve-evoked potentials, sweat toxicology, or stress hormone production.
The control unit controls the vibration device by at least one of activating the vibration device or adjusting power supplied to the vibration device based on the combination of biological characteristics. 11. The apparatus of claim 1, configured to. said physiological condition is one of vertigo, dizziness, motion sickness, virtual reality sickness, spatial disparity, sopaite syndrome, nausea, headache, migraine, tinnitus, vestibular hypofunction, or global imbalance 16. A device according to any one of the preceding claims, comprising at least one of . a device,
A vibration device configured to generate a vibration signal and apply said vibration signal to a portion of a user's head such that said vibration signal can be conducted through bones to said user's vestibular system. wherein the vibrating device comprises
a housing defining a chamber;
a magnet disposed within the chamber and configured to oscillate back and forth about an equilibrium position to produce the vibration signal;
a coil configured to generate a magnetic field that can cause the magnet to oscillate back and forth;
A metal component coupled to an end of the magnet and configured to reduce stray magnetic flux and orient the magnetic field of the magnet in a direction to permit back-and-forth oscillation of the magnet. and a set of
at least one suspension component configured to suspend the magnet within the chamber such that the magnet can oscillate back and forth about the equilibrium position. 18. The apparatus of claim 17, wherein the magnet includes at least one opening configured to allow air to pass through the magnet to equalize pressure between sides of the magnet within the chamber. wherein said at least one suspension component includes two springs, each spring defining an opening through which said magnet moves as said magnet oscillates back and forth about said equilibrium position. 19. Apparatus according to any one of clauses 17 or 18. said magnet is configured to oscillate back and forth about said equilibrium position along a major axis;
20. The apparatus of claim 19, wherein the two springs are configured to coil around the magnet in different directions to reduce movement of the magnet in directions different from the main axis. 21. The set of claims 17-20, wherein the set of metal components comprises two end plates, the two end plates comprising at least one end plate having an outer diameter substantially equal to the outer diameter of the magnet. A device according to any one of the preceding clauses. An endplate having a portion wherein the set of metal components includes two endplates, the two endplates being portions surrounding the magnet and extending toward the other of the endplates. 21. The apparatus of any one of claims 17-20, comprising a 23. The apparatus of any one of claims 21 or 22, wherein at least one suspension element is directly coupled to at least one of said two endplates. 23. The apparatus of any one of claims 17-22, wherein at least one suspension element is directly coupled to the magnet. 23. Apparatus according to any one of claims 21 or 22, wherein the coil extends through the space between the two endplates. 23. Apparatus according to any one of claims 21 or 22, wherein the coil is arranged around at least part of the magnet and the two end plates. 27. The apparatus of any one of claims 17-26, wherein the housing defines a port configured to allow air to flow into and out of the chamber. 27. The apparatus of any one of claims 17-26, wherein the housing fluidly seals the chamber from the external environment. 29. Any one of claims 17 to 28, wherein the housing includes at least one mounting mechanism configured to receive a support element for maintaining the vibration device against the surface of the user's head. 3. Apparatus according to paragraph. 30. Any of claims 17 to 29, wherein the set of metallic components is configured to direct the magnetic field of the magnet by orienting the field lines of the magnetic field of the magnet in a direction perpendicular to the coil. A device according to claim 1. receiving data related to the user's biological characteristics from a biometric sensor operably coupled to a vibrating device positioned on a portion of the user's head;
detecting the onset of a physiological condition associated with the user's vestibular system based on the data;
activating the vibratory device in response to detecting the onset of the physiological condition to cause a vibratory signal applied to the head of the user, the vibratory signal being conducted through the bone to the vestibular system; and C. to reduce symptoms associated with said physiological condition. detecting the onset of the physiological condition wherein the level of the biological characteristic is greater than a predetermined threshold or the change in the biological characteristic is greater than a predetermined amount or percentage; 32. The method of claim 31, comprising detecting based on said data. activating the vibration device activates a signal generator to generate an electrical signal used to generate the vibration signal; or increasing power supplied to the signal generator. 33. The method of any one of claims 31 or 32, comprising increasing the amplitude of the electrical signal used to generate the vibration signal. receiving data related to the user's biological characteristics from a biometric sensor operably coupled to a vibrating device positioned on a portion of the user's head;
detecting a change in severity of a physiological condition associated with the user's vestibular system based on the data;
In response to detecting the increased severity of the physiological condition, a vibration signal generated by the vibration device and applied to the head of the user to stimulate bone in the vestibular system. increasing the force level of the vibrational signal conducted through to reduce symptoms associated with said physiological condition;
reducing the force level of the vibration signal in response to detecting a reduction in the severity of the physiological condition. Detecting the change in the severity of the physiological condition may include a level of the biological characteristic greater than or less than a predetermined threshold or a change in the biological characteristic greater than or equal to a predetermined amount or a predetermined amount. 35. The method of claim 34, comprising detecting greater than or less than a percentage based on the data. wherein said biological characteristic is skin conductance, body temperature, ambient temperature, exercise of said user, electroencephalographic activity, cardiac activity, ocular characteristics, blood pressure, oxygen saturation, neural evoked potentials, sweat toxicology, or stress hormone production 36. The method of any one of claims 31-35, comprising at least one of said physiological condition is one of vertigo, dizziness, motion sickness, virtual reality sickness, spatial disparity, sopaite syndrome, nausea, headache, migraine, tinnitus, vestibular hypofunction, or global imbalance 37. A method according to any one of claims 31 to 36, comprising at least one of .

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